System, device, and method for safeguarding wellbeing of patients for fluid injection

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63/017,942, filed April 30, 2020, U.S. Provisional Patent Application No. 62/706,597, filed August 27, 2020, U.S. Provisional Patent Application No. 62/704,954, filed June 4, 2020, and U.S. Provisional Patent Application No. 62/705,613, filed July 7, 2020, the disclosures of which are incorporated by reference in their entireties.

With the increase in medical imaging over the past few decades, the use of radiological contrast agents has increased substantially across all modalities. Typically, 76 million computed tomography (CT) and 34 million magnetic resonance (MR) imaging examinations are performed annually, with approximately half of these examinations using intravenous contrast agents. The use of intravenous contrast agents is accepted by the radiological community, and the contrast agent material itself is recognized as safe. In addition to the drug safety of contrast agents, the actual use of contrast agents may involve various risks depending on the application itself.

For example, issues that exist related to patient safety and contrast injection include, at least, (i) prevention, detection, and minimization of extravasation of material; (ii) minimization of acute adverse events or documented acute adverse events due to contrast injection in contrast-naive patients and patients with known atopy; (iii) prevention of contrast-induced nephrotoxicity and/or post-contrast renal injury; and (iv) patient management to prevent thyroid disorders, such as thyrotoxicosis (TX).

Extravasation is a rare but significant problem in contrast medical imaging procedures. Extravasation occurs when contrast media that should be delivered to the central circulation through peripheral vascular access instead enters peripheral tissues (e.g., when contrast media leaks out of the vascular lumen and infiltrates interstitial tissues during injection). The incidence of intravenous contrast media extravasation is typically reported as less than 1% and has no direct correlation with the flow rate of the injection. However, some patients with extravasation may remain asymptomatic, while others may report swelling, tightness, stinging, or burning pain and may exhibit edema, erythema, or tenderness at the injection site. Serious complications of extravasation include compartment syndrome, skin ulceration, and/or tissue necrosis.

Acute adverse events depend on the substance applied. The rate of acute adverse events for low-permeability iodized contrast agents is approximately 0.2%-0.7%, with 0.04% for severe acute reactions. The incidence of acute adverse events to gadolinium-based contrast agents (GBCAs) is low, occurring approximately 1 in 10,000-40,000 injections. Most reactions are mild and transient, with cutaneous reactions being the most frequent. Severe and life-threatening anaphylactoid reactions to GBCAs are rare. Risk factors for acute adverse events to contrast agents include previous reactions to iodized contrast agents, severe allergies and reactions to drugs and/or foods, a history of asthma, bronchospasm, and/or atopy, and a history of cardiac or renal disease.

Contrast-induced nephrotoxicity can be defined as "a sudden deterioration in renal function (e.g., acute kidney injury) following a recent intravascular administration of a contrast agent in the absence of another nephrotoxic event." Risk factors for contrast-induced nephrotoxicity may include hypertension, proteinuria, gout, and/or previous renal surgery. The risk of contrast-induced nephrotoxicity is considered low in patients with normal, stable renal function. Similarly, post-contrast acute kidney injury is a general term used to indicate a sudden deterioration in renal function within 48 hours of intravascular administration of an iodine-based contrast agent.

For the application of iodized contrast agents, which reflect the majority of contrast agent uses, patients not being treated for Graves' disease and/or with multinodular goiter and thyroid autonomy, elderly patients, and patients living in areas where dietary iodine deficiency is common may be at increased risk for thyrotoxicosis due to excess iodine absorption. Furthermore, the use of iodized contrast agents prior to any planned radioiodine imaging or treatment may decrease radioiodine uptake.

Additionally, the relative rarity of adverse events makes it difficult to justify the cost and time of monitoring infusions for adverse events using existing devices, and it is difficult for attentive medical professionals to manually identify the very small number of patients who may experience adverse events. Additionally, in recent years, patient satisfaction has become an increasingly important factor in financial reimbursement for medical providers.

<p>Thus, improved systems, devices, products, apparatus, and/or methods are provided for assessing, promoting, and protecting patient health for fluid injection (e.g., before, during, and/or after contrast injection), thereby providing sensing and/or interpretation capabilities that utilize multiple data sources to assess at least one of the patient's health, risk of an adverse event, maintain patient health, and/or reduce or prevent the occurrence of an adverse event, minimize the occurrence or severity of an adverse event, detect an adverse event, and/or make recommendations or actions to manage an adverse event, e.g., extravasation, acute adverse events, contrast induced nephrotoxicity and/or post-contrast renal injury, and/or thyroid disease, thereby improving patient satisfaction, reimbursement, and reducing the occurrence of complications associated with contrast injection. A further advantage of the provided systems, devices, products, apparatus, and/or methods may be that by assessing and assisting in the promotion of the patient's overall health, they are applicable and useful in the medical care of all patients, not just in preventing or reducing harm to the minority who may experience significant adverse events. Thus, the systems, devices, products, apparatus, and/or methods provided are more likely to become part of the normal workflow and be used for all patients, thereby providing these benefits to all patients.</p><p>Non-limiting embodiments or aspects are described in the following numbered callouts.</p><p>Appendix 1. A system comprising at least one processor programmed and/or configured to: acquire patient data associated with a patient; determine an initial risk prediction for the patient associated with a fluid injection administered to the patient based on the patient data, the initial risk prediction including a probability that the patient will experience at least one adverse event in response to the fluid injection; provide the initial risk prediction to a user device before the fluid injection is administered to the patient; acquire sensor data associated with the patient, the sensor data determined after the fluid injection has been initiated; determine a current risk prediction for the patient associated with the fluid injection based on the sensor data determined after the fluid injection has been initiated, the current risk prediction including a probability that the patient will experience the at least one adverse event in response to the fluid injection; and provide the current risk prediction to the user device.</p><p>Appendix 2. The system of Appendix 1, wherein the at least one processor is further programmed and/or configured to automatically control at least one of: (i) a fluid injection system to stop the fluid injection; and (ii) an imaging system to adjust timing of imaging operations based on the current risk prediction.</p><p>Appendix 3. The system of appendix 1 or 2, wherein the patient data includes at least one of the following parameters associated with the patient: age, sex, weight, previous chemotherapy status, estimated glomerular filtration rate (eGFR), thyroid stimulating hormone (TSH) level, triiodothyronine (FT3) thyroxine (FT4) ratio (FT3/FT4), level of environmental influence, prior response to previous fluid infusion status, atopic disease status, medical status associated with at least one of diabetes and hypertension, congestive heart failure status, hematocrit level, renal failure status, malignancy status, implanted device for central venous access status, type of medication, type of fluid medium administered in the fluid infusion, infusion protocol associated with the fluid infusion, type of imaging test, flow rate associated with the fluid infusion, catheter gauge associated with the fluid infusion, total volume of fluid associated with the fluid infusion, pressure curve associated with the fluid infusion, pressure limit curve associated with the fluid infusion, infusion site location associated with the fluid infusion, or any combination thereof.</p><p>Clause 4. The system of any one of clauses 1 to 3, wherein the at least one adverse event comprises at least one of the following adverse events: extravasation, post-contrast acute kidney injury, an acute adverse event, contrast-induced nephrotoxicity, thyrotoxicosis, or any combination thereof.</p><p>Appendix 5. The system of any one of Appendixes 1 to 4, wherein the initial risk prediction further includes at least one of a prompt to administer medication to the patient prior to the fluid injection, a prompt to adjust an injection protocol for the fluid injection, a prompt to adjust an imaging protocol for an imaging scan, a prompt to prepare the patient before the fluid injection, a prompt to observe and/or follow up with the patient after the fluid injection, or any combination thereof.</p><p>Appendix 6. The system of any one of appendices 1 to 5, wherein the sensor data includes at least one of the following parameters related to the patient: heart rate, sound or vibration, temperature, oxygen saturation, ECG, body fat/water ratio, tissue impedance, vascularity level, vascular diameter, hydration level, hematocrit level, skin resistivity, blood pressure, muscle tension level, light absorptance level, exercise level, arm position, arm circumference, respiratory rate, radiation absorption, EMG, skin color, surface vasodilation, bioimpedance, light absorptance, hemoglobin level, inflammation level, ambient temperature of the patient's environment, air pressure of the patient's environment, ambient light level, ambient sound level, or any combination thereof.</p><p>Addendum 7. The system of any one of Addendums 1 to 6, further comprising at least one sensor configured to determine the sensor data associated with the patient after the fluid injection has been initiated.</p><p>Appendix 8. The system of any one of Appendixes 1 to 7, wherein the at least one sensor is further configured to determine the sensor data during a test injection administered to the patient prior to the fluid injection, and the at least one processor is further programmed and/or configured to: determine a test prediction based on the sensor data determined during the test injection, the test prediction comprising a probability that the patient will experience extravasation in response to the fluid injection; and provide the test prediction to the user device.</p><p>Appendix 9. The system of any one of appendices 1 to 8, wherein the at least one sensor includes three sound or vibration sensors positioned at three different locations on the patient's limb proximate an injection site for the test injection, and the at least one processor is further programmed and/or configured to: combine through triangulation data streams of the sensor data from each sound or vibration sensor of the three sound or vibration sensors to create a combined data stream; and determine the test prediction based on the combined data stream.</p><p>Addendum 10. The system of any one of Addendums 1 to 9, wherein the at least one sensor is further configured to determine the sensor data prior to the test injection, and determining the initial risk prediction is further based on the sensor data determined prior to the test injection.</p><p>Addendum 11. The system of any one of Addendums 1 to 10, wherein the at least one sensor is further configured to determine the sensor data during the fluid injection, and the at least one processor is further programmed and/or configured to: determine the current risk prediction based on the sensor data determined during the fluid injection; and provide the current risk prediction to the user device during the fluid injection.</p><p>Addendum 12. The system of any one of Addendums 1 to 11, wherein the at least one sensor is further configured to determine the sensor data after the fluid injection, and the at least one processor is further programmed and/or configured to: determine the current risk prediction based on the sensor data determined after the fluid injection; and provide the current risk prediction to the user device after the fluid injection.</p><p>Clause 13. The system of any one of Clauses 1 to 12, wherein the at least one adverse event includes an extravasation, and wherein the at least one processor is further programmed and/or configured to, in response to determining that the patient is experiencing the extravasation, provide the current risk prediction by automatically controlling a fluid injection system to stop the fluid injection.</p><p>Addendum 14. The system of any one of Addendums 1 to 13, wherein the at least one sensor includes at least one of the following sensors: an image capture device; an accelerometer; a strain gauge; a global positioning system (GPS); a skin resistivity or conductance sensor; a heart rate monitor; a microphone; a thermal or temperature sensor; a pulse oximeter; a hydration sensor; a dosimeter; an ultrasonic sensor; an acoustic sensor; one or more electrodes configured to measure at least one of tissue impedance, an electromyogram (EMG), and an electrocardiogram (ECG); a microwave sensor; a mechanical impedance sensor; a chemical sensor; a force or pressure sensor; or any combination thereof.</p><p>Addendum 15. The system of any one of Addendums 1 to 14, further comprising a sensor device, the at least one sensor being included in the sensor device, the sensor device including an elongated housing extending between a first end and a second end, the elongated housing configured to surround a patient's limb, the elongated housing including a flexible exterior, an interior of the elongated housing including the at least one sensor and a wireless communication device, the wireless communication device configured to wirelessly transmit the sensor data to an external device.</p><p>Addendum 16. The system of any one of Addendums 1 to 15, wherein the interior of the elongated housing containing the at least one sensor and the wireless communication device is fluidly sealed from the external environment by the flexible exterior of the elongated housing.</p><p>Addendum 17. The system of any one of Addendums 1 to 16, wherein the at least one sensor includes a plurality of sensors spaced apart from one another along a length of the elongated housing extending from the first end of the elongated housing to the second end of the elongated housing, whereby the plurality of sensors are oriented in a circumferential pattern around the patient's limb as the elongated housing encircles the patient's limb, and the plurality of sensors are configured to determine the sensor data in a cross-section of the patient's limb.</p><p>Appendix 18. The system of any one of Appendixes 1 to 17, wherein the at least one adverse event comprises an extravasation, the at least one sensor comprises an image capture device, the image capture device configured to determine the sensor data, the sensor data determined by the image capture device is associated with a plurality of images of the patient over a period of time, and the at least one processor is further programmed and/or configured to determine the current risk prediction comprising the probability that the patient will experience the extravasation based on the plurality of images of the patient over the period of time.</p><p>Appendix 19. The system of any one of Appendixes 1 to 18, wherein the at least one processor is further programmed and/or configured to at least one of: process the plurality of images of the patient over the period of time to highlight at least one of changes in color and movement between the plurality of images; display the plurality of images including the highlighted changes to a user using a display; and determine the current risk prediction including the probability that the patient will experience the extravasation based on the highlighted changes; and in response to determining that the current risk prediction including the probability that the patient will experience the extravasation meets a threshold probability, using the at least one processor, automatically control a fluid injection system to stop the fluid injection.</p><p>Appendix 20. The system of any one of appendices 1 to 19, wherein the image capture device includes an infrared (IR) camera, and wherein the at least one processor is further programmed and/or configured to at least one of: process the plurality of images to determine a difference in absorption spectra between a first location on the patient and a second location on the patient in the plurality of images; display the difference in absorption spectra between the first location on the patient and the second location on the patient to a user on a display; and determine the current risk prediction including the probability that the patient will experience the extravasation based on the difference in absorption spectra between the first location on the patient and the second location on the patient, and automatically control a fluid injection system to stop the fluid injection in response to determining that the current risk prediction including the probability that the patient will experience the extravasation meets a threshold probability.</p><p>Addendum 21. The system of any one of Addendums 1 to 20, wherein the first location on the patient includes a blood vessel of the patient and the second location on the patient includes tissue of the patient surrounding the blood vessel of the patient.</p><p>Addendum 22. The system of any one of Addendums 1 to 21, further comprising a sound generating device configured to induce a sound signal during fluid injection in fluid delivered to the patient during the fluid injection, and wherein the at least one sensor includes a sound or vibration sensor.</p><p>Addendum 23. The system of any one of Addendums 1 to 22, wherein the sound generating device includes an oscillator connected to at least one of a syringe and a fluid path element that delivers the fluid to the patient during the fluid injection.</p><p>Addendum 24. The system of any one of Addendums 1 to 23, wherein at least one of the frequency and amplitude of the sound signal is adjusted to improve detection by the at least one sensor.</p><p>Addendum 25. The system of any one of Addendums 1 to 24, wherein the at least one sensor includes a sound or vibration sensor configured to measure at least one of a frequency and an amplitude of sound or vibration of the patient, and the at least one processor is further programmed and/or configured to: determine, based on the at least one of the frequency and the amplitude of the measured sound or vibration of the patient, the current risk prediction including the probability that the patient will experience the extravasation; and, in response to determining that the current risk prediction including the probability that the patient will experience an extravasation meets a threshold probability, using the at least one processor, automatically control a fluid injection system to stop the fluid injection.</p><p>Addendum 26. The system of any one of Addendums 1 to 25, wherein the at least one processor is further programmed and/or configured to determine a patient's distress level based on the sensor data determined after the fluid injection has been initiated, and provide the patient's distress level to the user device.</p><p>Addendum 27. The system of any one of Addendums 1 to 26, wherein the at least one processor is further programmed and/or configured to compare the patient's pain level with at least one threshold level, and in response to determining that the patient's pain level meets the at least one threshold level, provide an alert to a user device, and at least one of automatically controlling at least one of (i) a fluid injection system to stop the fluid injection, and (ii) an imaging system to adjust timing of imaging operations.</p><p>Addendum 28. The system of any one of Addendums 1 to 27, wherein the at least one processor is further programmed and/or configured to determine the distress level of the patient by determining a change in one or more parameters of the sensor data over a period of time and comparing the change in the one or more parameters to at least one threshold change.</p><p>Addendum 29. The system of any one of Addendums 1 to 28, wherein the sensor data includes at least one of the following parameters associated with the patient: heart rate, oxygen saturation, skin resistivity, skin color, exercise level, temperature proximate to the injection site, or any combination thereof.</p><p>Addendum 30. The system of any one of Addendums 1 to 29, wherein the at least one sensor includes at least one of a pulse oximeter, a skin resistance sensor, a skin color sensor, an accelerometer, a temperature sensor, or any combination thereof.</p><p>Addendum 31. The system of any one of Addendums 1 to 30, further comprising a sensor device, the at least one sensor being included in the sensor device, the sensor device including a glove-shaped housing configured to be worn on the patient's hand, the housing including the at least one sensor and a wireless communication device, the wireless communication device configured to wirelessly transmit the sensor data to an external device.</p><p>Addendum 32. The system of any one of Addendums 1 to 31, further comprising a sensor device, the at least one sensor being included in the sensor device, the sensor device including an elongated housing extending between a first end and a second end, and a pulse oximeter connected to the elongated housing via a wire, the elongated housing configured to encircle at least one of a patient's hand and wrist, the elongated housing including a wireless communication device and at least one of a skin resistance sensor, an accelerometer, a temperature sensor, or any combination thereof, the pulse oximeter and the at least one of the skin resistance sensor, the accelerometer, the temperature sensor, or any combination thereof, configured to determine the sensor data, and the wireless communication device configured to wirelessly transmit the sensor data to an external device.</p><p>Addendum 33. The system of any one of Addendums 1 to 32, wherein the at least one processor is further programmed and/or configured to control at least one of lights, displays, speakers, and haptic devices to provide at least one of visual, audio, and tactile instructions to guide breathing and/or positioning of the patient.</p><p>Addendum 34. The system of any one of Addendums 1 to 33, wherein the at least one processor is further programmed and/or configured to adjust the at least one of the visual instructions, the audio instructions, and the tactile instructions for guiding the breathing and/or the positioning of the patient based on timing of an imaging operation of an imaging system.</p><p>Addendum 35. The system of any one of Addendums 1 to 34, wherein the at least one processor is further programmed and/or configured to: determine a level of distress of the patient based on the sensor data determined after the fluid injection has been initiated; and, in response to determining that the patient is in distress, adjust the at least one of the visual, audio, and tactile instructions for guiding the breathing and/or the positioning of the patient.</p><p>Addendum 36. A system comprising: at least one sensor configured to determine sensor data associated with a patient before a fluid infusion associated with the patient is initiated; and at least one processor programmed and/or configured to: acquire patient data associated with the patient; determine an initial risk prediction for the patient associated with a fluid infusion to be administered to the patient based on the patient data and the sensor data, the initial risk prediction including a probability that the patient will experience at least one adverse event in response to the fluid infusion; and provide the initial risk prediction to a user device before the fluid infusion is administered to the patient.</p><p>Addendum 37. A system comprising: at least one sensor configured to determine sensor data associated with a patient after a fluid infusion associated with the patient has been initiated; and at least one processor programmed and/or configured to: determine a current risk prediction for the patient associated with the fluid infusion based on the sensor data determined after the fluid infusion has been initiated, the current risk prediction including a probability that the patient will experience at least one adverse event in response to the fluid infusion; and provide the current risk prediction to the user device.</p><p>Addendum 38. A system comprising at least one processor, the processor programmed and/or configured to: acquire sensor data associated with a patient, the sensor data associated with the patient, the sensor data being determined after a fluid injection has been initiated; determine a current risk prediction for the patient associated with the fluid injection based on the sensor data determined after the fluid injection has been initiated, the current risk prediction including a probability that the patient will experience at least one adverse event in response to the fluid injection; provide the current risk prediction to the user device; and automatically control at least one of: (i) a fluid injection system to stop the fluid injection; and (ii) an imaging system to adjust timing of imaging operations based on the current risk prediction.</p><p>Addendum 39. A system comprising: at least one sensor configured to determine sensor data associated with a patient at least one of before, during, and after a fluid injection associated with the patient; and at least one processor programmed and/or configured to: determine a fitness level of the patient at least one of before, during, and after the fluid injection based on the sensor data; and provide the fitness level of the patient to a user device.</p><p>Addendum 40. A system comprising at least one processor programmed and/or configured to: acquire sensor data associated with the patient, the sensor data associated with the patient, the sensor data being determined after a fluid injection has been initiated; determine a fitness level of the patient during the fluid injection based on the sensor data determined after the fluid injection has been initiated; provide the fitness level of the patient to a user device; and automatically control at least one of: (i) a fluid injection system that adjusts at least one of a maximum flow rate, a maximum pressure, an injection duration, a total amount of fluid, or any combination thereof, of the fluid injection; and (ii) an imaging system that adjusts a timing of an imaging operation based on the fitness level of the patient.</p><p>Addendum 41. A system comprising at least one processor programmed and/or configured to: provide, via an application program interface (API), to at least one user device, information related to a fluid injection to be administered to a patient; receive, via the API, patient data related to the patient from the at least one user device prior to the fluid injection, the patient data including at least one patient preference related to the fluid injection, the at least one patient preference related to the fluid injection including at least one of the following patient preferences: lighting preferences during the fluid injection, sound preferences during the fluid injection, temperature preferences during the fluid injection, or any combination thereof; and automatically control, during the fluid injection, at least one of: (i) light sources; (ii) sound sources; (iii) haptic devices; (iv) a heating, ventilation, and air conditioning (HVAC) system, or any combination thereof, based on the at least one patient preference.</p><p>Addendum 42. The system of Addendum 41, further comprising at least one of a fluid injector and a medical imaging device, the at least one of the fluid injector and the medical imaging device including at least one of (i) the light source, (ii) the sound source, (iii) the tactile device, or any combination thereof.</p><p>Addendum 43. The system of Addendums 41 and 42, wherein the light source includes a display of at least one of the fluid injector and the medical imaging device.</p><p>Addendum 44. The system of any one of Addendums 41 to 43, wherein the tactile device includes a bed or table of the medical imaging apparatus.</p><p>Addendum 45. The system of any one of Addendums 41 to 44, further comprising at least one sensor configured to determine sensor data associated with the patient during the fluid injection, wherein the at least one processor is further programmed and/or configured to automatically control at least one of (i) the light source, (ii) the sound source, (iii) the tactile device, or any combination thereof, to guide breathing and/or positioning of the patient during the fluid injection based on the sensor data.</p><p>Addendum 46. The system of any one of Addendums 41 to 45, wherein the at least one processor further automatically controls at least one of (i) the light source, (ii) the sound source, (iii) the tactile device, or any combination thereof, based on timing of an imaging operation of the medical imaging device during the fluid injection.</p><p>Addendum 47. The system of any one of Addendums 41 to 46, wherein the at least one processor is further programmed and/or configured to automatically control at least one of (i) a fluid injector to stop the fluid injection, and (ii) a medical imaging device to adjust timing of imaging operations based on the sensor data.</p><p>Addendum 48. A system comprising at least one processor, the processor programmed and/or configured to: provide, via an application program interface (API), to at least one user device, information related to a fluid injection to be administered to a patient; and receive, via the API, patient data related to the patient from the at least one user device prior to the fluid injection, the patient data including at least one patient preference related to the fluid injection, the at least one patient data being used for risk prediction to assess a probability that the patient will experience an adverse event during the fluid injection.</p><p>Addendum 49. The system of Addendum 48, further comprising at least one of a fluid injector and a medical imaging device, wherein at least one parameter of an injection protocol of the fluid injection and an imaging protocol of the medical imaging device are adjusted based on the at least one patient data.</p><p>Addendum 50. A sensor device comprising: at least one sensor configured to determine sensor data associated with a patient at least one of before, during, and after a fluid injection associated with the patient; and an elongated housing extending between a first end and a second end, the elongated housing configured to encircle a limb of the patient, the elongated housing including a flexible exterior, an interior of the elongated housing including the at least one sensor and a wireless communication device, the wireless communication device configured to wirelessly transmit the sensor data to an external device.</p><p>Addendum 51: The system of Addendum 50, wherein the interior of the elongated housing containing the at least one sensor and the wireless communication device is fluidly sealed from the external environment by the flexible exterior of the elongated housing.</p><p>Addendum 52. The system of Addendums 50 and 51, wherein the at least one sensor includes a plurality of sensors spaced apart from one another along a length of the elongated housing extending from the first end of the elongated housing to the second end of the elongated housing, whereby the plurality of sensors are oriented in a circumferential pattern around the patient's limb as the elongated housing encircles the patient's limb, and the plurality of sensors are configured to determine the sensor data in a cross-section of the patient's limb.</p><p>Addendum 53. The system of any one of Addendums 50 to 52, wherein the at least one sensor includes at least one of the following sensors: an image capture device; an accelerometer; a strain gauge; a global positioning system (GPS); a skin resistivity or conductance sensor; a heart rate monitor; a microphone; a thermal or temperature sensor; a pulse oximeter; a hydration sensor; a dosimeter; an ultrasonic sensor; an acoustic sensor; one or more electrodes configured to measure at least one of tissue impedance, an electromyogram (EMG), and an electrocardiogram (ECG); a microwave sensor; a mechanical impedance sensor; a chemical sensor; a force or pressure sensor; or any combination thereof.</p><p>Addendum 54. A sensor device comprising: at least two sensors configured to measure at least two different parameters associated with a patient, at least one of before, during, and after a fluid injection associated with the patient; and at least one processor, programmed and/or configured to: determine, based on the at least two different parameters, (i) a patient distress level, and (ii) at least one of a risk prediction for the patient associated with the fluid injection, the risk prediction including a probability that the patient will experience at least one adverse event in response to the fluid injection; and provide the at least one of the patient distress level and the risk prediction to a user device.</p><p>Addendum 55. A sensor device comprising: at least one sensor configured to determine sensor data associated with a patient at least one of before, during, and after a fluid injection associated with the patient; and a glove-shaped housing configured to be worn on a hand of the patient, the housing containing the at least one sensor and a wireless communication device, the wireless communication device configured to wirelessly transmit the sensor data to an external device.</p><p>Addendum 56. A sensor device comprising: an elongated housing extending between a first end and a second end; and a pulse oximeter connected to the elongated housing via a wire, the elongated housing configured to encircle at least one of a hand and a wrist of the patient, the elongated housing comprising a wireless communication device and at least one sensor, the at least one sensor comprising at least one of a skin resistance sensor, an accelerometer, a temperature sensor, or any combination thereof, the pulse oximeter and the at least one of the skin resistance sensor, the accelerometer, the temperature sensor, or any combination thereof, configured to determine sensor data associated with the patient at least one of before, during, and after a fluid injection associated with the patient, and the wireless communication device configured to wirelessly transmit the sensor data to an external device.</p><p>Addendum 57. A method comprising: acquiring, using at least one processor, patient data associated with a patient; determining, using the at least one processor, an initial risk prediction for the patient associated with a fluid injection administered to the patient based on the patient data, the initial risk prediction comprising a probability that the patient will experience at least one adverse event in response to the fluid injection; providing, using the at least one processor, the initial risk prediction to a user device before the fluid injection is administered to the patient; determining, using at least one sensor, sensor data associated with the patient after the fluid injection has been initiated; determining, using the at least one processor, a current risk prediction for the patient associated with the fluid injection based on the sensor data determined after the fluid injection has been initiated, the current risk prediction comprising a probability that the patient will experience the at least one adverse event in response to the fluid injection; and providing, using the at least one processor, the current risk prediction to the user device.</p><p>Appendix 58. The method of appended claim 57, wherein the patient data includes at least one of the following parameters associated with the patient: age, sex, weight, previous chemotherapy status, estimated glomerular filtration rate (eGFR), thyroid stimulating hormone (TSH) level, triiodothyronine (FT3) thyroxine (FT4) ratio (FT3/FT4), level of environmental influence, prior response to previous fluid infusion status, atopic disease status, medical status associated with at least one of diabetes and hypertension, congestive heart failure status, hematocrit level, renal failure status, malignancy status, implanted device for central venous access status, type of medication, type of fluid medium administered in the fluid infusion, type of the fluid infusion, type of imaging test, flow rate associated with the fluid infusion, catheter gauge associated with the fluid infusion, total volume of fluid associated with the fluid infusion, pressure curve associated with the fluid infusion, infusion site location associated with the fluid infusion, or any combination thereof.</p><p>59. The method of claim 57 or 58, wherein the at least one adverse event comprises at least one of the following adverse events: extravasation, post-contrast acute kidney injury, acute adverse event, contrast-induced nephrotoxicity, thyrotoxicosis, or any combination thereof.</p><p>Addendum 60. The method of any one of Addendums 57 to 59, wherein the initial risk prediction further includes at least one of a prompt to administer medication to the patient prior to the fluid injection, a prompt to adjust an injection protocol for the fluid injection, a prompt to adjust an imaging protocol for an imaging scan, a prompt to prepare the patient before the fluid injection, a prompt to observe and/or follow up with the patient after the fluid injection, or any combination thereof.</p><p>Addendum 61. The method of any one of Addendums 57 to 60, wherein the sensor data includes at least one of the following parameters related to the patient: heart rate, sound or vibration, temperature, oxygen saturation, ECG, body fat/water ratio, tissue impedance, vascularity level, vascular diameter, hydration level, hematocrit level, skin resistivity, blood pressure, muscle tension level, light absorptance level, exercise level, arm position, arm circumference, respiratory rate, radiation absorption, EMG, skin color, surface vasodilation, bioimpedance, light absorptance, hemoglobin level, inflammation level, ambient temperature of the patient's surrounding environment, air pressure of the patient's surrounding environment, ambient light level, ambient sound level, or any combination thereof.</p><p>Addendum 62. The method of any one of Addendums 57 to 61, further comprising the steps of: determining, using the at least one sensor, sensor data during a test injection administered to the patient prior to the fluid injection; determining, using the at least one processor, a test prediction based on the sensor data determined during the test injection, the test prediction comprising a probability that the patient will experience extravasation in response to the fluid injection; and providing, using the at least one processor, the test prediction to the user device.</p><p>Addendum 63. The method of any one of Addendums 57 to 62, wherein the at least one sensor includes three sound or vibration sensors positioned at three different locations on the patient's limb proximate an injection site for the test injection, the method further comprising: using the at least one processor to combine, through triangulation, the data streams of sensor data from each of the three sound or vibration sensors to create a combined data stream; and using the at least one processor to determine the test prediction based on the combined data stream.</p><p>Addendum 64. The method of any one of Addendums 57 to 63, further comprising a step of determining the sensor data prior to the test injection using the at least one sensor, wherein the step of determining the initial risk prediction is further based on the sensor data determined prior to the test injection.</p><p>Addendum 65. The method of any one of Addendums 57 to 64, further comprising: determining, using the at least one sensor, sensor data during the fluid injection; determining, using the at least one processor, the current risk prediction for the patient associated with the fluid injection based on the sensor data determined during the fluid injection; and providing the current risk prediction to the user device during the fluid injection.</p><p>Addendum 66. The method of any one of Addendums 57 to 65, further comprising: determining, using the at least one sensor, sensor data after the fluid injection; determining, using the at least one processor, the current risk prediction of the patient associated with the fluid injection based on the sensor data determined after the fluid injection; and providing the current risk prediction to the user device after the fluid injection.</p><p>Addendum 67. The method of any one of Addendums 57 to 66, wherein the at least one adverse event includes extravasation, and the step of providing a current risk prediction further includes, in response to determining that the patient is experiencing the extravasation, automatically controlling, using the at least one processor, a fluid injection system to stop the fluid injection.</p><p>Addendum 68. The method of any one of Addendums 57 to 67, wherein the at least one sensor includes at least one of the following sensors: an image capture device; an accelerometer; a strain gauge; a global positioning system (GPS); a skin resistivity or conductance sensor; a heart rate monitor; a microphone; a thermal or temperature sensor; a pulse oximeter; a hydration sensor; a dosimeter; an ultrasonic sensor; an acoustic sensor; one or more electrodes configured to measure at least one of tissue impedance, an electromyogram (EMG), and an electrocardiogram (ECG); a microwave sensor; a mechanical impedance sensor; a chemical sensor; a force or pressure sensor; or any combination thereof.</p><p>Addendum 69. The method of any one of Addendums 57 to 68, wherein the at least one sensor is included in a sensor device, the sensor device including an elongated housing extending between a first end and a second end, the elongated housing configured to surround a patient's limb, the elongated housing including a flexible exterior, an interior of the elongated housing including the at least one sensor and a wireless communication device, the method further including the step of wirelessly transmitting the sensor data to an external device using the wireless communication device.</p><p>Addendum 70. The method of any one of Addendums 57 to 69, wherein the interior of the elongated housing containing the at least one sensor and the wireless communication device is fluidly sealed from the external environment by the flexible exterior of the elongated housing.</p><p>Addendum 71. The method of any one of Addendums 57-70, wherein the at least one sensor comprises a plurality of sensors spaced apart from one another along a length of the elongated housing extending from the first end of the elongated housing to the second end of the elongated housing, whereby the plurality of sensors are oriented in a circumferential pattern around the patient's limb as the elongated housing encircles the patient's limb, the method further comprising using the plurality of sensors to determine the sensor data in a cross-section of the patient's limb.</p><p>Addendum 72. The method of any one of Addendums 57-71, wherein the at least one adverse event includes an extravasation, and the at least one sensor includes an image capture device, and the method further includes the steps of determining, using the image capture device, the sensor data, wherein the sensor data determined by the image capture device is associated with a plurality of images of the patient over a period of time, and determining, using the at least one processor, the current risk prediction including the probability that the patient will experience the extravasation based on the plurality of images of the patient over the period of time.</p><p>Addendum 73. The method of any one of Addendums 57-72, further comprising at least one of the following steps: processing, with the at least one processor, the plurality of images of the patient over the period of time to highlight at least one of changes in color and movement between the plurality of images; displaying, with the at least one processor, the plurality of images including the highlighted changes to a user on a display; and determining, with the at least one processor, the current risk prediction including the probability that the patient will experience the extravasation based on the highlighted changes; and, in response to determining that the current risk prediction including the probability that the patient will experience the extravasation meets a threshold probability, with the at least one processor, automatically controlling a fluid injection system to stop the fluid injection.</p><p>Addendum 74. The method of any one of Addendums 57-73, wherein the image capture device includes an infrared (IR) camera, the method further including at least one of the following steps: processing the plurality of images with the at least one processor to determine a difference in absorption spectrum between a first location on the patient and a second location on the patient in the plurality of images; displaying the difference in absorption spectrum between the first location on the patient and the second location on the patient to a user on a display with the at least one processor; and determining the current risk prediction including the probability that the patient will experience the extravasation based on the difference in absorption spectrum between the first location on the patient and the second location on the patient, and automatically controlling a fluid injection system to stop the fluid injection in response to determining that the current risk prediction including the probability that the patient will experience the extravasation meets at least one threshold probability.</p><p>Addendum 75. The method of any one of Addendums 57 to 74, wherein the first location on the patient includes a blood vessel of the patient and the second location on the patient includes tissue of the patient surrounding the blood vessel of the patient.</p><p>Addendum 76. The method of any one of Addendums 57 to 75, further comprising, during the fluid injection, inducing a sound signal in fluid delivered to the patient during the fluid injection using a sound generating device.</p><p>Addendum 77. The method of any one of Addendums 57 to 76, wherein the sound generating device includes an oscillator connected to at least one of a syringe and a tube that delivers the fluid to the patient during the fluid injection.</p><p>Addendum 78. The method of any one of Addendums 57 to 77, wherein at least one of the frequency and amplitude of the sound signal is adjusted to improve detection by the at least one sensor.</p><p>Addendum 79. The method of any one of Addendums 57-78, wherein the at least one sensor includes a sound or vibration sensor, the method further including the steps of: measuring at least one of a frequency and an amplitude of sound or vibration of the patient using the sound or vibration sensor; determining, using the at least one processor, the current risk prediction including the probability that the patient will experience an extravasation based on the at least one of the frequency and the amplitude of the measured sound or vibration of the patient; and, in response to determining that the current risk prediction including the probability that the patient will experience the extravasation meets at least one threshold probability, using the at least one processor, automatically controlling a fluid injection system to stop the fluid injection.</p><p>Addendum 80. The method of any one of Addendums 57-79, further comprising at least one of the following steps: using the at least one processor to determine a patient's distress level based on the sensor data determined after the fluid injection has been initiated; using the at least one processor to compare the patient's distress level to at least one threshold level; and in response to determining that the patient's distress level meets the at least one threshold level, using the at least one processor to provide an alert to a user device; and using the at least one processor to automatically control at least one of: (i) a fluid injection system to stop the fluid injection; and (ii) an imaging system to adjust timing of imaging operations.</p><p>Addendum 81. The method of any one of Addendums 57 to 80, wherein the step of determining the patient's pain level includes determining a change in one or more parameters of the sensor data over a period of time and comparing the change in the one or more parameters to at least one threshold change.</p><p>Addendum 82. The method of any one of Addendums 57 to 81, wherein the sensor data includes at least one of the following parameters associated with the patient: heart rate, oxygen saturation, skin resistivity, skin color, exercise level, temperature proximate to the injection site, or any combination thereof.</p><p>Addendum 83. The method of any one of Addendums 57 to 82, wherein the at least one sensor includes at least one of a pulse oximeter, a skin resistance sensor, an accelerometer, a temperature sensor, or any combination thereof.</p><p>Addendum 84. The method of any one of Addendums 57 to 83, wherein the at least one sensor is included in a sensor device, the sensor device including a glove-shaped housing configured to be worn on the patient's hand, the housing including the at least one sensor and a wireless communication device, and the method further includes a step of wirelessly transmitting the sensor data to an external device using the wireless communication device.</p><p>Addendum 85. The method of any one of Addendums 57-84, wherein the at least one sensor is included in a sensor device, the sensor device including an elongated housing extending between a first end and a second end, and a pulse oximeter connected to the elongated housing via a wire, the elongated housing configured to encircle at least one of a patient's hand and wrist, the elongated housing including a wireless communication device and at least one of a skin resistance sensor, an accelerometer, a temperature sensor, or any combination thereof, the method further including the steps of determining the sensor data using the pulse oximeter and the at least one of the skin resistance sensor, the accelerometer, the temperature sensor, or any combination thereof, and wirelessly transmitting the sensor data to an external device using the wireless communication device.</p><p>Addendum 86. The method of any one of Addendums 57 to 85, further comprising using the at least one processor to control at least one of lights, displays, speakers, and haptic devices to provide at least one of visual, audio, and haptic instructions for guiding breathing and/or positioning of the patient.</p><p>Addendum 87. The method of any one of Addendums 57 to 86, further comprising using the at least one processor to adjust the at least one of the visual instructions, the audio instructions, and the tactile instructions for guiding the breathing and/or positioning of the patient based on timing of an imaging operation of an imaging system.</p><p>Addendum 88. The method of any one of Addendums 57 to 87, further comprising: using the at least one processor to determine a patient's level of distress based on the sensor data determined after the fluid injection has begun; and using the at least one processor to adjust the at least one of the visual, audio, and tactile instructions for guiding the breathing and/or positioning of the patient in response to determining that the patient is in distress.</p><p>Addendum 89. The method of any one of Addendums 57 to 88, further comprising using the at least one processor to automatically control, based on the current risk prediction, at least one of: (i) a fluid injection system to stop the fluid injection; and (ii) an imaging system to adjust timing of imaging operations.</p><p>Further advantages and details are explained in more detail below with reference to exemplary embodiments shown in the accompanying schematic drawings.</p>

<figref num="1A">FIG. 1 illustrates a non-limiting embodiment or aspect of an environment in which the systems, devices, products, apparatus, and/or methods described herein may be implemented.</figref><figref num="1B">FIG. 1B is a diagram of a non-limiting embodiment or aspect of an implementation of the environment of FIG. 1A.</figref><figref num="2">FIG. 1C is a diagram of a non-limiting embodiment or aspect of components of one or more devices and/or one or more systems of FIGS. 1A and 1B.</figref><figref num="3">1 is a flow chart of a non-limiting embodiment or aspect of a process for protecting patient health for fluid infusion.</figref><figref num="4A">FIG. 2 is a perspective view of a non-limiting embodiment or aspect of a contact sensor device.</figref><figref num="4B">FIG. 2 is a perspective view of a non-limiting embodiment or aspect of a contact sensor device.</figref><figref num="4C">1A-1C are diagrams of non-limiting embodiments or aspects of components of a contact sensor device.</figref><figref num="4D">FIG. 1 is a perspective view of a non-limiting embodiment or aspect of a contact sensor device attached to a patient's extremity.</figref><figref num="4E">FIG. 13 is a cross-sectional view of a non-limiting embodiment or aspect of a contact sensor device attached to a patient's extremity.</figref><figref num="5A">1 is a flow chart of a non-limiting embodiment or aspect of a process for protecting patient health for fluid infusion.</figref><figref num="5B">1 is a flow chart of a non-limiting embodiment or aspect of a process for protecting patient health for fluid infusion.</figref><figref num="6">1 is a flow chart of a non-limiting embodiment or aspect of a process for protecting patient health for fluid infusion.</figref><figref num="7">1 is a perspective view of a non-limiting embodiment or aspect of an implementation of a fluid injector including a sound generating device.</figref><figref num="8A">FIG. 2 is a perspective view of a non-limiting embodiment or aspect of a contact sensor device.</figref><figref num="8B">FIG. 2 is a perspective view of a non-limiting embodiment or aspect of a contact sensor device.</figref><figref num="8C">FIG. 2 is a perspective view of a non-limiting embodiment or aspect of a contact sensor device.</figref><figref num="8D">FIG. 2 is a perspective view of a non-limiting embodiment or aspect of a contact sensor device.</figref><figref num="8E">FIG. 2 is a perspective view of a non-limiting embodiment or aspect of a contact sensor device.</figref><figref num="9">1 is a flow chart of a non-limiting embodiment or aspect of a process for protecting patient health for fluid infusion.</figref><figref num="10">1 is a flow chart of a non-limiting embodiment or aspect of a process for protecting patient health for fluid infusion.</figref><figref num="11">1 illustrates a non-limiting embodiment or aspect of a visual instruction for guiding a patient's breathing.</figref><figref num="12">FIG. 1 is a diagram of a non-limiting embodiment or aspect of data processing to protect patient health for fluid injection.</figref><figref num="13A">1 illustrates a non-limiting embodiment or aspect of a patient portal application accessible via a user device.</figref><figref num="13B">1 illustrates a non-limiting embodiment or aspect of a patient portal application accessible via a user device.</figref><figref num="14A">1 illustrates a non-limiting embodiment or aspect of a patient portal application accessible via a user device.</figref><figref num="14B">1 illustrates a non-limiting embodiment or aspect of a patient portal application accessible via a user device.</figref><figref num="14C">1 illustrates a non-limiting embodiment or aspect of a patient portal application accessible via a user device.</figref><figref num="15A">1 illustrates a non-limiting embodiment or aspect of a patient portal application accessible via a user device.</figref><figref num="15B">1 illustrates a non-limiting embodiment or aspect of a patient portal application accessible via a user device.</figref>

It is to be understood that the present disclosure may contemplate various alternative variations and step sequences unless expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following specification are merely exemplary and non-limiting embodiments or aspects. Hence, specific dimensions and other physical characteristics relating to the embodiments or aspects disclosed herein are not to be considered as limiting.

Similarly, it should also be understood that contrast injections are merely exemplary of drugs or pharmaceuticals that may be injected into blood vessels, injections of which may benefit from the use of non-limiting embodiments or aspects of the present disclosure. In addition to or in place of contrast agents, exemplary intravascular injectates may include any imaging agent, saline, any flushing fluid, stress agents, chemotherapy agents, radiotherapy agents, antispasmodic or antispasmodic agents, thrombolytic agents, antithrombotic agents, antibiotics, intravenous immunoglobulin (IVIG), parenteral nutrition, analgesics, and/or radiopharmaceuticals. Similarly, the use of the devices, systems, and processes of the present disclosure is not limited to imaging suites, but may be useful anywhere intravascular injections are performed, including, for example, other medical facilities, the patient's home, and the like.

For purposes of the following description, the terms "end", "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof, shall refer to the embodiment or aspect as they are oriented in the drawings. However, it should be understood that the embodiment or aspect may assume various alternative variations and step sequences unless expressly specified to the contrary. It should also be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following specification are merely non-limiting exemplary embodiments or aspects. Thus, specific dimensions and other physical characteristics associated with the embodiments or aspects disclosed herein should not be considered limiting unless otherwise indicated.

No aspect, component, element, structure, operation, step, function, instruction, etc. used herein should be construed as critical or essential unless expressly described as such. Also, as used herein, the articles "a" and "an" are intended to include one or more items and may be used interchangeably with "one or more" and "at least one." Additionally, as used herein, the term "set" is intended to include one or more items (e.g., related items, unrelated items, combinations of related and unrelated items, etc.) and may be used interchangeably with "one or more" or "at least one." When only one item is intended, the term "a" or similar language is used. Also, as used herein, terms such as "has," "have," "having," etc. are intended to be open-ended terms. Additionally, the phrase "based on" is intended to mean "based at least in part on," unless otherwise specified.

As used herein, the terms "communication" and "communicating" may refer to receiving, receiving, transmitting, forwarding, providing, etc., information (e.g., data, signals, messages, instructions, commands, etc.). One unit (e.g., a device, a system, a component of a device or system, combinations thereof, etc.) communicating with another unit means that one unit is capable of receiving information directly or indirectly from the other unit and/or transmitting information to the other unit. This may refer to a direct or indirect connection that is wired and/or wireless in nature. In addition, two units may communicate with each other even if the transmitted information may be modified, processed, relayed, and/or routed between the first and second units. For example, a first unit may communicate with a second unit even if the first unit passively receives information and does not actively transmit information to the second unit. As another example, a first unit may communicate with a second unit if at least one intermediate unit (e.g., a third unit informationally located between the first unit and the second unit) processes information received from the first unit and communicates the processed information to the second unit. In some non-limiting embodiments or aspects, a message may refer to a network packet (e.g., a data packet, etc.) that includes data. It will be understood that numerous other configurations are possible. Communication between the first unit and the second unit may occur via any medium or intermediary, including, for example, a human communicating information manually or verbally.

As used herein, the term "computing device" may refer to one or more electronic devices configured to communicate with or directly or indirectly through one or more networks. A computing device may be a mobile or portable computing device, a desktop computer, a server, etc. Furthermore, the term "computer" may refer to any computing device that includes the necessary components to receive, process, and output data, typically including a display, a processor, memory, input devices, and a network interface. A "computing system" may include one or more computing devices or computers. An "application" or "application program interface" (API) refers to computer code or other data grouped on a computer-readable medium that may be executed by a processor to facilitate interaction between software components, such as a client-side front-end for receiving data from a client and/or a server-side back-end. An "interface" refers to a generated display, such as one or more graphical user interfaces (GUIs), with which a user may directly or indirectly interact (e.g., through a keyboard, mouse, touch screen, etc.). Furthermore, multiple computers, e.g., servers, or other computerized devices, communicating directly or indirectly in a network environment may constitute a "system" or a "computing system."

As used herein, terms such as user, physician, medical professional, and/or caregiver may include any person associated with the devices, systems, and processes of the present disclosure and/or any person assisting in the care of a patient, including the patient himself or herself or the patient's guardian or representative. For example, these terms are intended to include such persons as doctors, attending physicians, radiologists, nurses, technicians, radiologists, oncologists, radiology technicians, social service workers, assistants, volunteers, family members, etc. Users may also include employees in a healthcare delivery or payment system, such as hospital or radiology administrators, office staff, regulators, insurance or payment company employees, and others who may own, manage, and/or provide information used by non-limiting embodiments or aspects, or who may benefit from information provided by the system.

It will be apparent that the systems and/or methods described herein may be implemented in different forms of hardware, software, or a combination of hardware and software. The actual dedicated control hardware or software code used to implement these systems and/or methods is not intended to limit the implementation form. Thus, the operation and behavior of the systems and/or methods are described herein without reference to specific software code, and it will be understood that software and hardware can be designed to implement the systems and/or methods based on the description herein.

Some non-limiting embodiments or aspects are described herein in relation to threshold values. As used herein, meeting a threshold can refer to a value being greater than the threshold, more than the threshold, higher than the threshold, equal to or greater than the threshold, less than the threshold, less than the threshold, lower than the threshold, equal to or less than the threshold, etc. Unless otherwise stated, threshold values are exemplary and may depend or vary based, for example, on the patient population involved.

[0023] Referring now to Figure 1A, Figure 1A is a diagram of an example environment 100 in which the systems, devices, products, apparatuses, and/or methods described herein may be implemented. As shown in Figure 1A, the environment 100 includes a fluid injector system 102, an imaging system 104, a sensor system 106, a user device 108, a management system 110, an auxiliary system 112, and/or a communication network 114. Referring also to Figure 1B, Figure 1B is a diagram of a non-limiting embodiment or aspect of an implementation 150 of the environment 100 of Figure 1A. 1B , implementation 150 may include injector 152, injector control computing system 154, injector user interface 156, imager 158, imager control computing system 160, imager user interface 162, one or more contact sensors 164a, one or more non-contact sensors 164b, control computing system 166, one or more hospital information systems 168, cloud computing and off-site resources 170, and/or administrative user interface 172. The systems and/or devices of environment 100 and/or implementation 150 may be interconnected (e.g., communicate information and/or data, etc.) via wired connections, wireless connections, or a combination of wired and wireless connections (e.g., via communications network 114, etc.).

The fluid injection system 102 may include one or more devices, software, and/or hardware configured to set one or more injection protocols and deliver one or more fluids (e.g., contrast media, etc.) to a patient according to the one or more injection protocols. An injection protocol generally includes one or more phases, each phase defining the fluid to be injected and optionally the fluid concentration, and two of the flow rate, volume, and duration of that phase of the injection (e.g., volume injected=flow rate×duration, so there are only two independent variables from those three parameters). Other injection parameters may be different for different phases or may be constant for all phases and may include at least one of a pressure limit, a flow limit, an occlusion indication, or any combination thereof. Some injectors may be configured to have time-varying values of one, some, or all of the injection parameters. For example, the fluid injection system 102 may include an injector 152, an injector control computing system 154, and/or an injector user interface 156. By way of example, the fluid injection system 102 may include a contrast injection system such as described in U.S. Patent Nos. 6,643,537 and/or 7,937,134, and/or as described in published International Application No. WO2019046299A1, the entire contents of each of which are incorporated herein by reference. By way of example, the fluid injection system 102 may include a MEDRAD® Stellant FLEX CT Injection System, a MEDRAD® MRXperion MR Injection System, a MEDRAD® Mark 7 Arterion Injection System, a MEDRAD® Intego PET Infusion System, a MEDRAD® Spectris Solaris EP MR Injection System, a MEDRAD® Stellant CT Injection System With Certegra® Workstation, and the like.

The imaging system 104 may include one or more devices, software, and/or hardware configured to set up imaging protocols and acquire non-contrast and contrast-enhanced scans of a patient. For example, the imaging system 104 may include an imager 158, an imager control computing system 160, and/or an imager user interface 162. By way of example, the imaging system 104 may include a magnetic resonance imaging (MRI) system, a computed tomography (CT) system, an ultrasound system, a single photon emission computed tomography (SPECT) system, a positron emission tomography-magnetic resonance (PET/MRI) system, a positron emission tomography-computed tomography (PET/CT) system, an angiography system, an interventional radiology (IR) system, and/or other imaging modalities used on humans or animals. By way of example, the imaging system 104 may include an imaging system as described in U.S. Patent Application Publication No. 2020/0146647 A1, filed December 11, 2019, the entire contents of which are incorporated herein by reference. In some non-limiting embodiments or aspects, the imaging system 104 may include Somatom Go CT Systems from Siemens Healthineers, Signa MR Systems from General Electric, and the like.

The sensor system 106 may include one or more sensors 164 configured to determine (e.g., determine, collect, obtain, capture, measure, sense, etc.) sensor data related to a patient and/or a fluid injection (e.g., contrast injection, etc.) for the patient. For example, the sensor system 106 may include one or more contact sensors 164a (e.g., sensors that contact a patient to determine the sensor data, sensors included in contact sensor devices 400 and/or 800 wearable by the patient, etc.) and/or non-contact sensors 164b (e.g., sensor devices that do not contact a patient to determine the sensor data, etc.).

The contact sensor 164a may include at least one of the following sensors: an accelerometer; a strain gauge; a global positioning system (GPS); a skin resistivity or conductance sensor; a heart rate monitor; a microphone (e.g., a microphone configured to measure sounds within the patient's tissue, such as the influx of contrast agent, saline, or other drugs in the blood vessels); a thermal or temperature sensor (e.g., a temperature sensor configured to measure changes in tissue temperature due to injected saline and/or contrast fluid, etc.); a pulse oximeter (e.g., a pulse oximeter configured to measure pulse rate, changes in oxygenation levels, patient hydration, and/or local tissue perfusion, etc.); a hydration sensor; a dosimeter; an epiwatch; an ultrasonic sensor; an acoustic sensor (e.g., a sonic acoustic sensor, an infrasound acoustic sensor, etc.); one or more electrodes configured to measure tissue impedance and perform an electromyogram (EMG) and/or an electrocardiogram (ECG or EKG); a respirometry sensor; a microwave sensor; a mechanical impedance sensor; a chemical sensor; a force or pressure sensor; or any combination thereof. In some non-limiting embodiments or aspects, the contact sensor 164a may be included in the contact sensor device 400 and/or the contact sensor device 800 as described herein. In some non-limiting embodiments or aspects, the contact sensor 164a may be included in at least one of the following locations: the catheter (e.g., at the tip of the catheter), the patient's arm over the tip of the catheter, the patient's arm proximate the infusion site or tip of the catheter, a connector tube upstream of the catheter, another part of the patient's body, an area surrounding the infusion site, or any combination thereof. In some non-limiting embodiments or aspects, the contact sensor 164a may include a single device including a single sensor, a single device including multiple sensors, and/or multiple devices including either a single sensor or multiple sensors. Existing devices including existing sensors may be incorporated into non-limiting embodiments or aspects of the sensor system 106 and/or may provide measurements to the sensor system 106. Exemplary existing devices may include an Apple Watch that the patient may wear, a Fitbit exercise monitor, or the like, an ECG or respiratory monitor that may be part of the imaging system 104, a pulse oximeter, or other monitoring equipment that may already be available and/or in use in the imaging room and/or medical facility, etc.

The non-contact sensor 164b may include one or more image capture devices configured to capture multiple images of the patient over a period of time (e.g., images of the injection site and/or the area surrounding the injection site, etc.), such as a camera (e.g., a visible light camera, an infrared (IR) camera, etc.), a LiDAR sensor, or any combination thereof. The IR camera may include at least one of the following IR cameras: a near-IR camera (e.g., Silicon Sensing, etc.) configured to capture light having a near-IR wavelength, a short-wavelength IR camera configured as a spectral imager to capture light having a short-IR wavelength, a mid-wavelength IR camera configured to capture light having a mid-IR wavelength, a long-wavelength IR camera configured to capture light having a long-IR wavelength, or any combination thereof.

In some non-limiting embodiments or aspects, the non-contact sensor 164b may include an image capture device configured to capture images using ambient illumination. In some non-limiting embodiments or aspects, the non-contact sensor 164b may include one or more illumination devices configured to provide at least one of the following types of illumination for the image capture device for use by the image capture device in capturing images: additional ambient illumination, localized additional illumination (e.g., at the injection site), illumination through tissue, projection pattern or grid, cross projection, or any combination thereof. For example, the non-contact sensor 164b may include a camera as described in International Patent Application No. PCT/US2020/061733, filed November 23, 2020, the contents of which are incorporated herein by reference in their entirety. The non-contact sensor 164b may continue with two or more cameras to provide binocular or 3D vision, which may enable 3D determination of phenomena such as swelling, gross motion in 3D, or vibration or small motion in 3D.

In some non-limiting embodiments or aspects, the non-contact sensor 164b can be mounted on the imaging device 158, on the injector 152, on the patient's bed, on a pedestal pole, on an adjustable overhead counterpoise, on a ceiling, etc. In some non-limiting embodiments or aspects, the non-contact sensor 164b can be held by the patient during fluid injection (e.g., contrast injection, etc.) and/or imaging examination. In some non-limiting embodiments or aspects, the non-contact sensor 164b can be remotely controlled by a user (e.g., via the user device 108, etc.) to pan and zoom to a desired field of view. In some non-limiting embodiments or aspects, the sensor system 106 can control the non-contact sensor 164b using one or more object tracking techniques to automatically track the patient's extremities (e.g., arms, legs, hands, feet, etc.) including the injection site.

In some non-limiting embodiments or aspects, the fluid injection system 102, the imaging system 104, the user device 108, and/or the auxiliary system 112 may include one or more additional sensors (e.g., contact sensor 164a, non-contact sensor 164b, etc.) configured to determine sensor data associated with the patient and/or fluid injection (e.g., contrast injection, etc.) for the patient, and/or to store and/or provide sensor data determined by the patient and/or one or more additional sensors configured to determine sensor data associated with the patient and/or fluid injection for the patient. Exemplary sensors may include a respiratory band and/or ECG electrodes to enable injection and/or image acquisition in relation to the patient's respiration and/or heartbeat, respectively.

4A and 4B, which are perspective views of a non-limiting embodiment or aspect of a contact sensor device 400. The sensor system 106 can include the contact sensor device 400 and/or the contact sensor device 400 may include at least one contact sensor 402 of the contact sensors 164a of the sensor system 106 configured to determine sensor data related to a patient and/or a fluid infusion for the patient. Referring also to FIG. 4C, the contact sensor device 400 may include a housing 404 that houses the contact sensor 402, a communication device 406, a processor 408, a user input/feedback device 410, and/or a battery 412. The housing 404 can provide a watertight seal between an interior of the housing 404, including the contact sensor 402, communication device 406, processor 408, user input/feedback device 410, and/or battery 412, and an exterior of the housing 404, such that the contact sensor 402, communication device 406, processor 408, user input/feedback device 410, and/or battery 412, and/or their electronic components are sealed from the external environment surrounding the contact sensor device 400 and/or such that the contact sensor device 400 can be easily sanitized and qualified for multi-patient use. The housing 404 can have an elongated shape extending between a first end 405a and a second end 405b. For example, as shown in FIG. 4D, the housing 404 may include a patient-wearable bracelet shape configured to be attached proximate an injection site on a patient's extremity (e.g., arm, leg, etc.) to measure sensor data related to patient data before, during, and/or after fluid injection and/or examination (e.g., MRI examination, CT examination, etc.). As an example, the housing 404 may include a flexible exterior or frame (e.g., an antimicrobial silicone exterior or frame, etc.) configured to bend or curve to encircle the patient's extremity and house the contact sensor 402, communication device 406, processor 408, user input/feedback device 410, and/or battery 412 and/or its electronic components therein and fluidically seal the internal components of the contact sensor device 400 from the external environment. As an example, the housing 404 may include one or more elastic members (e.g., metal, plastic, or foam) that bias the one or more sensors against the skin with an appropriate force or pressure. The elastic members may also bias the housing into a shape that aids in gripping the patient's extremity.

4D, the contact sensor device 400 may include a removable strip or sheath 450 configured to surround, cover, or separate the housing 404 from skin contact to protect the contact sensor device 400 from cross-contamination (e.g., from patient to patient, or via the hands of a technician, etc.). In some non-limiting embodiments or aspects, the contact sensor device 400 may be a disposable or single-use device including a printed sensor 402 and a printed sensor pad or housing 404 that can be adhered (e.g., via an adhesive layer, etc.) to the patient's skin adjacent the injection site.

In some non-limiting embodiments or aspects, the housing 404 can be configured to immobilize the patient's limb (e.g., arm, etc.) by preventing or restricting the patient from bending the limb, thereby clamping the vein and/or catheter or removing the catheter from the vein. For example, the housing 404 may be configured as an elbow brace or exoskeleton. As an example, the housing 404 may also immobilize the infusion site to facilitate observation of the infusion site by one or more non-contact sensors 164b.

In some non-limiting embodiments or aspects, the housing 404 may include removable and/or disposable attachment means such as a flexible patch, a fabric strip, an adhesive connector, a mechanical latch, a blood pressure cuff, a hook-and-loop fastener such as a Velcro® type attachment, and/or a suction cup. For example, the contact sensor device 400 may be attached to a BD Tegaderm Transparent Film via physical alignment markings. The housing 404 may be configured to be attached to a dressing, such as a dressing, to another device (e.g., the injector 152, the imaging device 158, a disposable dressing, etc.), and/or to a patient. As an example, the housing 404 may have a cylindrical or hockey puck shape with an adhesive connected to attach the housing 404 to a patient. In some non-limiting embodiments or aspects, the housing 404 may include a clear disposable band that allows a user to visually inspect the patient's skin adjacent the injection site. Depending on the shape or shapes of the various segments of the housing 404, attachment mechanisms configured to place the housing 404 and/or the one or more contact sensors 164a in proper contact with the patient may include double-sided adhesive tape that conforms to the skin, a disposable strap or band, a strap with a disposable isolation patch or element (which may be particularly useful for patients with a significant amount of hair on their arms), a wrap that is inflated to a desired non-occlusive pressure similar to a blood pressure cuff, an elastic force such as a "slap" bracelet, an elastomeric band or bracelet that may be disposable and/or transparent, if desired, to allow visual inspection of the skin near the injection site, and/or attachment to a Tegaderm or similar existing device on the patient's arm via physical markings on the existing device. Additionally or alternatively, the housing 404 and/or the one or more contact sensors 164a may not be mechanically attached to the patient, but may be held in contact with the patient by having the patient lie on the housing 404 and/or the one or more contact sensors 164a or by placing the patient's arm on the housing 404 and/or the one or more contact sensors 164a. The housing 404 and/or the one or more contact sensors 164a may also be placed loosely on the patient. In these cases, gravity and/or the patient's efforts may hold the housing 404 and/or the one or more contact sensors 164a in contact with the patient.

Because the non-contact sensor 164b does not need to contact a patient, sterility and/or cross-contamination concerns for the non-contact sensor 164b are relatively low. Disposable mounting barriers; cleaning of the contact aspects of the contact sensor device 400 and/or the contact sensor 164a (e.g., electrodes, housing 404, etc.) with disinfectant wipes or sprays; a "home base" or mount for holding and optionally storing and/or charging the contact sensor device 400 and/or the contact sensor 164a between patients, which may also include sterilizing devices, e.g., UV lamps, ozone treatments, or disinfectant wipe stations; inclusion of a self-sterilizing surface, e.g., a silver nanoparticle surface or film; a sheath into which the contact sensor device 400 and/or the contact sensor 164a may be slipped prior to use; a surface that is in contact with the patient's skin, One or more of the following approaches can provide sufficient sterility and/or cross-contamination prevention aspects for the contact sensor device 400 and/or contact sensor 164a: an intervening disposable barrier layer disposed between the sensor device 400 and/or contact sensor 164a; and/or some or all of the contact sensor device 400 and/or contact sensor 164a can be sufficiently low cost that at least one section or portion thereof can be used once for the patient and given to the patient or discarded as a free bee for subsequent medical or home/personal use.

Providing at least one segment or portion of the contact sensor device 400 and/or contact sensor 164a can be an activity or action for good "marketing" and patient satisfaction. Applications described herein related to patient information, education, e-consent, and similar functions can be configured to interface with a Freebie segment or portion to enable the segment or portion to be, for example, a personal pulse oximeter and/or a skin contact thermometer.

The communication device 406 may include wired and/or wireless communication devices configured to communicate sensor data related to the patient to external devices and/or systems (e.g., the fluid injection system 102, the imaging system 104, the sensor system 106, the user device 108, the management system 110, the auxiliary system 112, etc.).

The processor 408 may be programmed and/or configured to control one or more operations of the contact sensor 402 and/or to determine sensor data related to the patient. In some non-limiting embodiments or aspects, the processor 408 may include a low power microcontroller unit (MCU).

The user input/feedback device 410 may be configured to receive user input from a user and/or provide feedback to a user. For example, the user input/feedback device 410 may include at least one of a display, a light emitting diode (LED), an audio output device (e.g., a buzzer, a speaker, a headset, etc.), a tactile output device (e.g., a vibrator, etc.), or any combination thereof. As an example, a user may establish communication (e.g., pair, etc.) between the contact sensor device 400 and an external device and/or system via the user input/feedback device 410 and/or provide prompts and/or instructions to a patient via the user input/feedback device 410 that may be received from an external device and/or system. In some non-limiting embodiments or aspects, the user input/feedback device 410 may function as a patient call button configured to automatically call a user outside the scan room in response to being actuated.

The user input/feedback device 410 may be divided among various hardware. For example, some input and/or output features or functions may be implemented on the contact sensor device 400. Some of the same and/or other functions may be accessible through a separate dedicated special-purpose user input/feedback device 410. Some of the same and/or other functions may be accessible through a general-purpose or multi-purpose user input/feedback device 410, e.g., an iPhone. Some of the same and/or other functions may be accessible through a user interface of other equipment associated with the test or procedure being performed, e.g., the injector interface 156 and/or the imager user interface 162. The battery 412 may include a rechargeable battery (e.g., a battery rechargeable via inductive charging technology, etc.), a single-use battery, a replaceable battery, a wired connection to an external battery and/or power source, or any combination thereof. The battery 412 may provide power to operate the components of the contact sensor device 400.

4A-4D, and also with reference to FIG. 4E, the contact sensors 402 may be oriented in a pattern, for example circumferentially around the patient's limb, such that when the contact sensor device 400 is attached to the patient's limb, the contact sensors 402 may measure sensor data including tissue parameters and the like in a cross-section of the patient's limb. For example, the contact sensors 402 may be spaced apart from one another along a length of the housing 404 extending from the first end 405a to the second end 405b. The sensing modes of the contact sensors 402 may include a transmission mode, a reflection mode, an absorption mode, a listen mode, or a passive measurement mode. Different modes may be used for different sensors. Multiple and/or hybrid modes may be used depending on the ambient and/or patient conditions. Phase-gated sensing (e.g., a phase-locked loop (PLL), etc.), synchronous sensing, and/or other existing sensing means may be used for noise/interference reduction and/or ambient signal cancellation. The sensed signal may be a narrow segment of the possible spectrum and/or a wide segment of the possible spectrum to which subsequent processing may be applied.

8A-8E, which are perspective views of non-limiting embodiments or aspects of a contact sensor device 800. The sensor system 106 may include the contact sensor device 800 and/or the contact sensor device 800 may include at least one contact sensor (e.g., 804, 808, 810, etc.) of the one or more contact sensors 164a of the sensor system 106 configured to determine sensor data related to a patient and/or a fluid injection (e.g., a contrast injection, etc.) for the patient. In some non-limiting embodiments or aspects, the sensor system 106 may include one of the contact sensor device 400 and the contact sensor device 800, the contact sensor device 400 and the contact sensor device 800, or neither the contact sensor device 400 nor the contact sensor device 800. Further, the contact sensor device 400 may be implemented within the contact sensor device 800 (or vice versa) and/or the contact sensor device 400 may perform one or more functions as described as being performed by the contact sensor device 800 (or vice versa).

The contact sensor device 800 may include a housing 802 and a finger sensor 804 (e.g., a pulse oximeter, etc.). The finger sensor 804 may be connected to the housing 802 via wires 806. The housing 802 may include electronic components 808, a conductive probe or electrode 810, and/or a disposable adhesive protector 812. The electronic components 808 may include the contact sensor 164a, a processor, memory, wired and/or wireless communication devices, user input/feedback devices, and/or a battery. For example, the electronic components 808 of the contact sensor device 800 may be the same as or similar to the components of the contact sensor device 400 described herein with respect to FIG. 4C.

The housing 802 may include a soft molded strap (e.g., a plastic strap, etc.) overmolded onto a stiffener (e.g., a bendable wire, a semi-flexible metal frame, etc.). In some non-limiting embodiments or aspects, the housing 802 may extend between a first end 805a and a second end 805b and be configured to wrap around a patient's palm and/or wrist. For example, as shown in FIG. 8A, the housing 802 may be configured to wrap around the center of the patient's palm with a finger sensor 804 connected to the housing 802 via a wire 806. For example, as shown in FIG. 8B, the housing 802 may be configured to wrap around the patient's wrist with a finger sensor 804 connected to the housing 802 via a wire 806. For example, as shown in FIG. 8C, the housing 802 may be configured to wrap around the patient's palm and wrist with a finger sensor 804 connected to the housing 802 via a wire 806. In some non-limiting embodiments or aspects, the first end 805a of the housing 802 can be configured to connect to the second end 805b of the housing 802 via a connection mechanism (e.g., a strap, a hook-and-loop fastener, a button, etc.). In some non-limiting embodiments or aspects, the housing 802 can include a glove configured to be worn on a patient's hand such that the housing 802 completely covers the patient's hand and wrist, as shown in FIG. 8D, which allows the finger sensor 804 to be connected to the housing 802 without exposed wires.

The conductive probe or electrode 810 may provide direct conductive contact with the patient's skin, for example for a skin resistance sensor configured to detect the patient's skin resistivity. The electrical properties of tissue can be measured using direct and/or alternating current, including various RF and microwave frequencies up to visible light.

The disposable adhesive protector 812 may include a disposable film configured to reduce or eliminate direct contact between the housing 802 and the patient. For example, the disposable adhesive protector 812 may include a sheet (e.g., a plastic sheet, a vinyl sheet, a latex sheet, a paper sheet, etc.) including a first aspect configured to directly contact the patient and a second aspect including an adhesive configured to adhere the disposable adhesive protector 812 to the aspect of the housing 802 that faces the patient when the contact sensor device 800 is worn by the patient. In such a configuration, the disposable adhesive protector 812 may include openings sized and shaped to allow the conductive probes or electrodes 810 to directly contact the patient's skin through the disposable adhesive protector 812, or the adhesive protector 812 may include segments of conductive material to make or enhance contact between the skin and the contact sensor device 800.

Selected embodiments of the contact sensor 400, 800 may be disposable or single use, while other embodiments may be reusable or multiple use, depending on the approach taken for cross-contamination reduction and prevention and/or the cost of the various embodiments. This may include a range of different options. At one end of this range, the contact sensor 400, 800 may be completely multi-use and may be decontaminated, for example, by spraying, wiping, or dipping in a cleaning solution, or may have a surface that kills any biologically active entities and/or catalyzes the destruction of contaminating chemicals, and at the other end of the range of options, the sensor 400, 800 may be completely single use and may be discarded or given to a patient, taken home and used elsewhere as the patient's health and medical management needs may find useful. Intermediate aspects or embodiments of this range of usability can be provided where a single layer of material between the contact surface and the skin can be demonstrated to be single use, the sensor can be encapsulated in a single use sheath (such as sheath 450), some sensors or aspects of the sensor can be single use, for example including thermistors or photodiodes and phototransistors of a pulse oximeter, the electronics that read the sensor can be reusable, all sensors and materials in contact with the skin can be single use, and the data processor, battery, and communications portions of the contact sensor 400, 800 can be reusable.

1A and 1B, the user device 108 may include one or more devices capable of receiving information and/or data from the fluid injection system 102, the imaging system 104, the sensor system 106, the management system 110, and/or the auxiliary system 112 (e.g., via the communication network 114, etc.) and/or communicating information and/or data to the fluid injection system 102, the imaging system 104, the sensor system 106, the management system 110, and/or the auxiliary system 112 (e.g., via the communication network 114, etc.). For example, the user device 108 may include one or more computing systems including one or more processors (e.g., one or more computing devices, one or more server computers, one or more mobile computing devices, one or more tablet computers, one or more mobile phones, etc.). In some non-limiting embodiments or aspects, the user device 108 may include at least one of an injector user interface 156, an imager user interface 162, an administrative user interface 172, or any combination thereof.

The user device 108 may take various forms, be referred to by various names, and/or be implemented by various specific devices or systems, depending on the user or users involved and the medical environment/system in which it is being used. For example, the user device 108 may be a patient device, a patient portal, or a patient care portal where the patient enters information, signs in for a medical appointment or procedure, provides electronic consent, and/or receives information/training/support/comfort regarding any procedure to occur, or answers any questions regarding future or past procedures. The user device 108 may include the user's personal phone, tablet, and/or computer, which may be running applications or accessing web-based services to provide functionality of the non-limiting embodiments or aspects described herein. The user device 108 may be part of a patient care portal provided by the patient's medical provider or insurer. The user device 108 may be a physician device 108 or a physician portal 108 that provides patient data and/or adverse event risk assessments. The user device 108 may be specifically associated with one or more of the other devices in the system, for example, the fluid injector system 102, the imaging system 104, or the sensor system 106. Additionally or alternatively, the user device 108 may be physically located where it is most advantageous for the user to perform a particular function or use a particular output or system aspect. For example, a patient may use a patient portal (e.g., the user device 108) to input data or receive information, which may occur at a referring or prescribing physician's office or location, at home, in a waiting room, or in a public location such as a restaurant or parking lot. For example, a patient or caregiver may access the user device 108 whenever it is convenient to do so and functionally enabled by the particular implementation of the system. For example, a radiologist may access the user device 108, for example, in his/her office, preparation room, imaging room, or reading room. For example, a technician may access the user device 108 through aspects of the fluid injection system 102, the sensor system 106, and/or the imaging system 104.

The management system 110 may include one or more devices capable of receiving information and/or data from (e.g., via a communications network 114, etc.) and/or communicating information and/or data to (e.g., via a communications network 114, etc.) the fluid injection system 102, the imaging system 104, the sensor system 106, the user device 108, and/or the auxiliary system 112. For example, the management system 110 may include one or more computing systems including one or more processors (e.g., one or more computing devices, one or more server computers, one or more mobile computing devices, etc.). As an example, the management system 110 may include an administrative control computing system 166 and/or an administrative user interface 172. In some non-limiting embodiments or aspects, the management system 110 may be implemented within the fluid injection system 102, the imaging system 104, the sensor system 106, the user device 108, and/or the auxiliary system 112 (which may or may not be associated with the fluid injection system 102 and/or the imaging system 104).

The auxiliary system 112 may include one or more devices capable of receiving information and/or data from (e.g., via communications network 114, etc.) and/or communicating information and/or data to (e.g., via communications network 114, etc.) the fluid injection system 102, the imaging system 104, the sensor system 106, the user devices 108, and/or the management system 110. For example, the auxiliary system 112 may include one or more computing systems including one or more processors (e.g., one or more computing devices, one or more server computers, one or more mobile computing devices, etc.). By way of example, the auxiliary systems 112 may include one or more hospital information systems (HIS) 168, cloud computing and off-site resources 170, electronic medical records (EMR), one or more radiology information systems (RIS), modality worklists (MWLs), patient portals to the healthcare system, telemedicine portals, one or more picture archiving and communication systems (PACS), one or more laboratory information systems (LIS), one or more injection systems (e.g., fluid injection system 102, etc.), one or more imaging systems (e.g., imaging system 104, etc.), a smartphone, a tablet computer, or any combination thereof.

The communications network 114 may include one or more wired and/or wireless networks. For example, the communications network 114 may include a cellular network (e.g., a Long Term Evolution (LTE) network, a third generation (3G) network, a fourth generation (4G) network, a fifth generation (5G) network, a code division multiple access (CDMA) network, etc.), a short-range wireless communications network (e.g., a Bluetooth network, etc.), a public land mobile network (PLMN), a local area network (LAN), a wide area network (WAN), a metropolitan area network (MAN), a telephone network (e.g., a public switched telephone network (PSTN)), a private network, an ad-hoc network, an intranet, the Internet, an optical fiber-based network, a cloud computing network, etc., and/or a combination of these or other types of networks.

The number and configuration of systems and devices shown in Figures 1A and 1B are provided as examples. There may be additional, fewer, different, or differently arranged systems and/or devices than those shown in Figures 1A and 1B. Furthermore, two or more systems or devices shown in Figures 1A and 1B may be implemented within a single system or device, or a single system or device shown in Figures 1A and 1B may be implemented as multiple distributed systems or devices. Additionally or alternatively, a set of systems or devices (e.g., one or more systems, one or more devices, etc.) of environment 100 and/or implementation 150 may perform one or more functions described as being performed by another set of systems or devices of environment 100 and/or implementation 150.

2, which is a diagram of example components of device 200. Device 200 may correspond to one or more devices of fluid injection system 102, one or more devices of imaging system 104, one or more devices of sensor system 106, user device 108 (e.g., one or more devices of a system of user device 108, etc.), one or more devices of management system 110, and/or one or more devices of auxiliary system 112. In some non-limiting embodiments or aspects, one or more devices of fluid injection system 102, one or more devices of imaging system 104, one or more devices of sensor system 106, user device 108 (e.g., one or more devices of a system of user device 108, etc.), one or more devices of management system 110, and/or one or more devices of auxiliary system 112 may include at least one device 200 and/or at least one component of device 200.

As shown in FIG. 2, device 200 may include a bus 202, a processor 204, a memory 206, a storage component 208, an input component 210, an output component 212, and/or a communication interface 214.

The bus 202 may include components that enable communication between components of the device 200. In some non-limiting embodiments or aspects, the processor 204 may be implemented in hardware, software, or a combination of hardware and software. For example, the processor 204 may include a processor (e.g., a central processing unit (CPU), a graphics processing unit (GPU), an accelerated processing unit (APU), etc.), a microprocessor, a digital signal processor (DSP), and/or any processing component that can be programmed to perform a function (e.g., a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), etc.). The memory 206 may include random access memory (RAM), read only memory (ROM), and/or another type of dynamic or static storage device (e.g., flash memory, magnetic memory, optical memory, etc.) that stores information and/or instructions for use by the processor 204.

The storage component 208 may store information and/or software related to the operation and use of the device 200. For example, the storage component 208 may include a hard disk (e.g., a magnetic disk, optical disk, magneto-optical disk, solid-state disk, etc.), a compact disk (CD), a digital versatile disk (DVD), a floppy disk, cartridges, magnetic tape, and/or another type of computer-readable medium along with a corresponding drive.

The input components 210 may include components (e.g., a touch screen display, a keyboard, a keypad, a mouse, buttons, switches, a microphone, etc.) that enable the device 200 to receive information via user input or the like. Additionally or alternatively, the input components 210 may include sensors for sensing information (e.g., a global positioning system (GPS) component, an accelerometer, a gyroscope, an actuator, a contact sensor 164a, a non-contact sensor 164b, and/or any of the sensors described herein, etc.). The output components 212 may include components that provide output information from the device 200 (e.g., a display, a speaker, a tactile or haptic output, one or more light emitting diodes (LEDs), etc.).

The communications interface 214 may include transceiver-like components (e.g., a transceiver, a separate receiver and transmitter, etc.) that enable the device 200 to communicate with other devices via a wired connection, a wireless connection, or a combination of wired and wireless connections, etc. The communications interface 214 may enable the device 200 to receive information from another device and/or provide information to another device. For example, the communications interface 214 may include an Ethernet interface, an optical interface, a coaxial interface, an infrared interface, a radio frequency (RF) interface, a universal serial bus (USB) interface, a Wi-Fi interface, a cellular network interface, etc.

The device 200 can perform one or more processes described herein. The device 200 can perform these processes based on the processor 204 executing software instructions stored by a computer-readable medium, such as the memory 206 and/or the storage component 208. A computer-readable medium (e.g., a non-transitory computer-readable medium) is defined herein as a non-transitory memory device. A memory device includes a memory space located within a single physical storage device or a memory space distributed across multiple physical storage devices.

Software instructions may be loaded into memory 206 and/or storage component 208 from another computer-readable medium or from another device via communication interface 214. When executed, the software instructions stored in memory 206 and/or storage component 208 can cause processor 204 to perform one or more processes described herein. Additionally, or as an alternative, hardwired circuitry may be used in place of, or in combination with, software instructions to perform one or more processes described herein. Thus, the embodiments or aspects described herein are not limited to any specific combination of hardware circuitry and software.

The memory 206 and/or the storage component 208 may include a data storage or one or more data structures (e.g., a database, etc.). The device 200 may be capable of receiving information from, storing information in, communicating information to, or retrieving information stored in the data storage or one or more data structures in the memory 206 and/or the storage component 208.

The number and configuration of components shown in Figure 2 are provided as an example. In some non-limiting embodiments or aspects, device 200 may include additional components, fewer components, different components, or components arranged differently than those shown in Figure 2. Additionally or alternatively, a set of components of device 200 (e.g., one or more components) may perform one or more functions described as being performed by another set of components of device 200.

Reference is now made to Figure 3, which is a flow chart of non-limiting embodiments or aspects of a process 300 for protecting patient health for fluid infusion. In some non-limiting embodiments or aspects, one or more of the steps of process 300 may be performed (e.g., completely, partially, etc.) by management system 110 (e.g., one or more devices of management system 110, etc.). In some non-limiting embodiments or aspects, one or more of the steps of process 300 may be performed (e.g., completely, partially, etc.) by a user or another device or group of devices separate from or including management system 110, such as fluid injection system 102 (e.g., one or more devices of fluid injection system 102), imaging system 104 (e.g., one or more devices of imaging system 104), sensor system 106 (e.g., one or more devices of sensor system 106), user device 108 (e.g., one or more devices of the user device 108 system), and/or auxiliary system 112 (e.g., one or more devices of auxiliary system 112).

3, in step 302, the process 300 includes acquiring patient data. For example, the management system 110 may acquire patient data associated with the patient. As an example, the management system 110 may receive and/or retrieve patient data associated with the patient from at least one of the fluid injection system 102, the imaging system 104, the sensor system 106, the user device 108, the auxiliary system 112, or any combination thereof. The patient data may also be acquired directly from the patient by a human or by interaction with a user interface of the management system 110, which may prompt and record such data to the user and/or patient.

Patient data included the following parameters relevant to the patient: age; sex; weight; previous chemotherapy status, such as adverse peripheral venous conditions due to long-term tumor treatment (e.g., yes, no, number of chemotherapy cycles received, etc.); estimated glomerular filtration rate (eGFR) (e.g., 45 ml/min/1.73 m²eGFR less than 0.05; thyroid stimulating hormone (TSH) level; triiodothyronine (FT3) thyroxine (FT4) ratio (FT3/FT4); amount or level of environmental influence (e.g., regional iodine saturation or nutritional amount or level in an area or location relevant to the patient); prior response to previous fluid infusion conditions (e.g., yes, no, level, etc.); atopic disease conditions (e.g., yes, no, level, etc.); medical conditions related to the presence of diabetes and/or hypertension such as diabetic nephropathy conditions (e.g., yes, no, level, etc.); congestive heart failure conditions (e.g., yes, no, level, etc. the patient's blood pressure, blood volume, blood pressure, blood pressure level ...

In some non-limiting embodiments or aspects, the management system 110 may provide and/or implement a patient care system or patient care portal accessible via applications (e.g., via the user device 108, etc.), for example, as software on a personal device, a smart phone, a tablet computer and/or other computer, a website, and/or a custom device that may be loaned or given to the patient. The patient care portal may promote patient health, primarily prior to fluid delivery and imaging studies, by providing information to and collecting information from the patient, as described herein. The applications may provide patient support for imaging procedure referral, screening, preparation, access, education (e.g., video and/or written/graphical materials, etc.), health information management, and/or patient feedback to the provider regarding the user experience. For example, the applications may be used to integrate and manage patient data, sensor data, and/or other information during a series of patient care steps for a diagnostic imaging procedure, from initial prescription for an imaging scan to tracking diagnostic results for future reference. The applications may promote mental health by providing relevant information to the patient to help them have a more normal and more positive diagnostic imaging experience. The application can make patient experience information more visible to the patient community, attending clinicians, provider networks, and/or others to improve diagnostic imaging procedures, as well as other aspects of the management system 110, such as the risk assessment aspects of the management system 110. The application can eliminate or substantially reduce the possibility of inadvertent patient missed appointments, cancelled appointments due to fear of the procedure, workflow delays while the patient fills out forms, the possibility of poor imaging results due to lack of proper patient preparation or the patient's inability to accomplish certain tasks related to the procedure, such as breathing at the correct time, and/or patient discomfort due to patient uncertainty or unfamiliarity with the usual aspects of the procedure. Thus, the patient care portal or system can provide medical community-based diagnostic imaging patient support, connect the user experience to diagnostic imaging, link information together to help patients provide a better patient experience, improve patient referrals and care for improved diagnostic imaging experiences and outcomes, increase patient compliance and comfort, utilize diagnostic imaging center resources more efficiently, and/or improve diagnostic imaging quality.

The management system 110 can obtain patient data and/or sensor data related to the patient via a patient care portal or application for the system. The application can be accessible by the attending physician prescribing the imaging scan to assist in scheduling the imaging scan for the patient. For example, FIGS. 13A and 13B show that the application can apply one or more user-selected filters and/or weighted sum algorithms (e.g., patient location, patient insurance type, type of scan prescribed, quality ratings, etc.) to a list of available imaging center locations to determine imaging center locations to recommend to the patient. The application can provide information to the patient to assist the patient in preparing for and learning about the imaging procedure experience. FIG. 14A shows a patient portal displayed on a user device 108, which allows the patient to pre-configure imaging scan room options, such as ambience or lighting, music, temperature, etc., prior to the imaging scan, and/or provide additional patient data. This data can be automatically communicated to the imaging room at the time of the patient's scan. FIG. 14B shows a patient portal displayed on a user device 108, which provides information (e.g., videos, etc.) of what the patient can expect on the day of the scan. FIG. 14C illustrates a patient portal displayed on a user device 108, providing calendar notifications and directions to an imaging scan location, which may improve patient comfort, health, and/or satisfaction.

Upon checking in for an imaging scan, patient data associated with the patient may be automatically synced or retrieved from the auxiliary system 112 and/or cloud and/or patient portal via the user device 108, thereby reducing the amount of time required for the patient to check in. As shown in FIG. 15A, the management system 110 can automatically retrieve medical records and patient preferences prior to or during check-in and present the medical records and patient preferences to the patient via an application on the user device 108 to more quickly verify the accuracy and completeness of the records and patient preferences. As shown in FIG. 15B, the management system 110 can use an application to provide an automated and integrated consent process where the patient electronically consents to one or more procedures via the application (e.g., on the user device 108, etc.), thereby improving and/or increasing the technician's quality time with the patient.

After check-in, the patient's veins may be scanned by the imaging system 104 (e.g., by one or more cameras of the imaging system 104, etc.), and the management system 110 may analyze and/or store the scanned images of the patient's veins. Systems such as those in U.S. Patent Application Publication Nos. 2004/0171923A1 and/or 2008/0147147A1, filed December 6, 2003 and December 18, 2006, respectively, the entire contents of each of which are incorporated herein by reference, may be used to evaluate the patient's veins and, if desired, facilitate access to the veins. For example, patient data and vein analysis may be used to adjust or recommend adjustments or restrictions to the fluid injection protocol and/or imaging protocol for the patient, which may be presented to a user (e.g., a radiologist, etc.) via an application on the user device 108 for approval, or directly to the injector system 102 or imaging system 104. The sensor system 106 (e.g., smart bed sensors, cameras, contact sensor devices 400 and/or 800, etc.) may continuously determine patient, sensor and/or scan data associated with the patient, and the management system 110 may adjust the fluid injection and/or imaging protocols for the patient based on the measured patient, sensor and/or scan data, which may be presented to a user (e.g., a radiologist, etc.) via an application on the user device 108 for approval by the user. Alternatively, such adjustments may be made automatically within preselected limits. For example, patient-based dose and cardiac output of the patient may allow fluid injection protocols and scan durations to be adjusted for the patient.

The management system 110 may perform one or more scan image evaluations of medical images acquired by the imaging system 104, which may be presented to a user (e.g., a radiologist, etc.) via an application on the user device 108 for review of the scan image evaluation. For example, the management system 110 may apply one or more artificial intelligence based image evaluation tools to the patient's scanned images to evaluate the quality of the scan and/or provide diagnostic recommendations. The medical scan images and/or their analysis may be stored (e.g., in the auxiliary system 112, in the cloud, etc.) for retrieval via an application by the radiology team and/or the patient.

The management system 110 may use applications to continuously monitor equipment and/or supplies and automatically order new equipment and/or supplies if inventory levels do not meet threshold levels and/or if equipment breaks down or malfunctions.

As shown in FIG. 3, at step 304, the process 300 includes determining an initial risk prediction for the patient to a fluid injection. For example, the management system 110 may determine an initial risk prediction for the patient to a fluid injection (e.g., a contrast injection, etc.) to be administered to the patient based on the patient data. As an example, the initial risk prediction may include a probability that the patient will experience at least one adverse event in response to the fluid injection. Such risk prediction may be a numerical value between 0 and 100%, or may be bucketed, for example, into low, medium, and high buckets.

The adverse events may include at least one of the following adverse events: extravasation, catheter clotting, post-contrast acute kidney injury, acute adverse events (e.g., atopic or allergic reactions, hives, etc.), contrast-induced nephrotoxicity, thyroid disorders or thyrotoxicosis, headache, taste changes, visual disturbances, chest pain, enlargement of blood vessels (vasodilation) and continuous hypotension, nausea, vomiting, back pain, urinary urgency, and injection site reactions such as bleeding, swelling, itching, and pain, or any combination thereof.

The management system 110 may apply an algorithm or aspects of one or more algorithms, which may be an adaptation or implementation of an individual physician's practice, professional society guidelines, and/or hospital procedures into computer code, to the patient data and/or sensor data associated with the patient to determine an initial risk prediction for the patient (and/or to determine a test prediction, and/or to determine a patient's level of motion that may cause artifacts in an imaging scan, and/or to determine a patient's health level, and/or to determine a current risk prediction, and/or to determine a patient's distress level). In such an example, different hospitals may have different algorithms or aspects of one or more algorithms based on local preferences, practices, countries, and/or other factors associated with different hospitals. In another aspect or embodiment, the management system 110 may present the patient data to a physician or healthcare provider who may make their own mental assessment of risk, health, or distress, which may be manually entered into the management system 110 for use in subsequent steps.

In some non-limiting embodiments or aspects, the management system 110 may include algorithms that use baseline comparisons (e.g., to determine parameter change from baseline parameters, etc.); time sequence algorithms (e.g., using mean, gradient, second moment, SPC of parameters vs. normal, etc.); monotonic continuous function transformations; algorithms that convert continuous functions to discrete functions; threshold-based algorithms (e.g., algorithms with at least one threshold that varies based on patient parameters, time, volume of fluid infused, etc.); goodness-of-fit functions; dictionary modes of curve fitting (e.g., MRF, etc.); artificial intelligence applied to time sequences of a single data stream; artificial intelligence applied to multiple data streams simultaneously; sound triangulation algorithms; algorithms that classify individual parameters and combine categories of parameters; algorithms that normalize individual data streams using continuous (linear or non-linear) functions; algorithms that arrange parameters in multidimensional space. at least one of the following algorithms may be applied to the patient data and/or sensor data associated with the patient to determine an initial risk prediction for the patient (and/or to determine an exam prediction, and/or to determine a patient's level of motion that may cause artifacts in an imaging scan, and/or to determine the patient's health level, and/or to determine a current risk prediction, and/or to determine the patient's distress level).

In some non-limiting embodiments or aspects, the management system 110 may apply one or more algorithms and/or methods disclosed by U.S. Patent Application Publication No. 2016/0224750A1, filed January 29, 2016, the contents of which are incorporated herein by reference in their entirety, to patient data and/or sensor data associated with the patient to determine an initial risk prediction for the patient (and/or determine a test prediction, and/or determine a patient's level of motion that may cause artifacts in an imaging scan, and/or determine the patient's health level, and/or determine a current risk prediction, and/or determine the patient's distress level).

Exemplary Algorithms Tables 1-4 below provide exemplary algorithms that may be utilized to determine an initial risk prediction for a user. The exemplary algorithms may be executed by the management system 110 and/or a healthcare provider based on information provided by the management system 110 (e.g., via the user device 108, etc.) and/or by utilizing the user device 108 or a human, which may then provide the initial risk prediction results to the management system 110.

<tables><img file="JP7635259B2_D0001.tif" /></tables>

Table 1 lists in the left-most column exemplary patient-related parameters that may be considered to determine an initial risk prediction, including the probability that the patient will experience extravasation in response to a fluid injection (e.g., contrast injection, etc.). As shown, these parameters include the patient's age (in years), the patient's sex, the patient's body mass index (BMI), the patient's prior chemotherapy status (e.g., yes, no, number of cycles, etc.), the Eastern Cooperative Oncology Group (ECOG) status, and the probability that the patient will experience extravasation in response to a fluid injection (e.g., contrast injection, etc.). The parameters may include the performance status of the patient (Group), the medication status of the patient (e.g., yes, no, current medication, etc.), etc. Each parameter may be given a score of 1, 2, or 3, as listed at the top of columns 2 through 4 depending on the value of each parameter. When each of the parameters for the algorithm is assessable and/or available, the sum of the scores may provide a score used to represent the patient's initial risk prediction for extravasation, as shown in the rightmost column of Table 1. For example, a patient who is 55 years old would get 2 points for age, 1 point for being male, 2 points for a BMI of 27, 3 points for two previous cycles of chemotherapy, 2 points for ECOG1 status, and being on medication but not on corticosteroids would count 2 points. The sum for that patient would therefore be 2+1+2+3+2+2=12, which would make this exemplary patient at moderate risk for extravasation.

<tables><img file="JP7635259B2_D0002.tif" /></tables>

Table 2 lists in the left-most column exemplary patient-related parameters that may be considered to determine an initial risk prediction, including the probability that the patient will experience an acute adverse event in response to a fluid infusion (e.g., contrast injection, etc.). As shown, these parameters may include the patient's atopic disease state (e.g., yes, no, level, etc.) and/or the patient's prior response to a previous fluid infusion state (e.g., yes, no, level, etc.). Atopic disease refers to a form of allergy in which hypersensitivity reactions such as dermatitis and/or asthma may occur in parts of the body that have not come into contact with the allergen. The prior response to a previous fluid infusion may include indications related to the patient having had some previous allergic reaction to a previous fluid infusion. Low prior responses may include feelings, flushing, nausea, etc. High prior responses may include urticaria and/or anaphylactic reactions requiring treatment. If each of the parameters for the algorithm is assessable and/or available, the sum of the scores may provide a score used to represent the patient's initial risk prediction for an acute adverse reaction, as shown in the right-most column of Table 2.

<tables><img file="JP7635259B2_D0003.tif" /></tables>

Table 3 lists in the left-most column exemplary patient-related parameters that may be considered to determine an initial risk prediction, including the probability that the patient will experience post-contrast acute kidney injury in response to a fluid injection (e.g., contrast injection, etc.). As shown, these parameters may include the patient's age, the patient's BMI, the level of chronic kidney disease (CKD) as assessed using a 5-stage glomerular filtration rate scale, medical conditions such as those related to the presence of the patient's diabetes and/or hypertension, and/or the patient's history and condition of malignancy. When each of the parameters for the algorithm is assessable and/or available, the sum of the scores may provide a score used to represent the patient's initial risk prediction for post-contrast acute kidney injury, as shown in the right-most column of Table 3.

<tables><img file="JP7635259B2_D0004.tif" /></tables>

Table 4 lists in the left-most column exemplary patient-related parameters that may be considered to determine an initial risk prediction, including the probability that the patient will experience thyrotoxicosis in response to a fluid injection (e.g., contrast injection, etc.). As shown, these parameters may include the patient's age, the patient's sex, the patient's BMI, and the iodine deficiency status of the patient's geographic region. When each of the parameters for the algorithm is assessable and/or available, the sum of the points may provide a score that is used to represent the patient's initial risk prediction for thyrotoxicosis, as shown in the right-most column of Table 4.

The exemplary initial risk prediction algorithms presented above with respect to Tables 1 through 4 are intended to be simple and understandable to convey the variety and flexibility of algorithms that may be used to determine an initial risk prediction according to non-limiting embodiments or aspects of the present disclosure. The exemplary algorithms may be executed by the management system 110 and/or a healthcare provider based on information provided by the management system 110 (e.g., via the user device 108, etc.) and/or may be executed by utilizing the user device 108 or a human who may subsequently provide the initial risk prediction results to the management system 110. It is anticipated that as additional data is collected from the patient using data collection processes, systems, and/or devices according to non-limiting embodiments or aspects of the present disclosure, the algorithms used may be improved and/or modified. This improvement and/or modification may be created and implemented by the management system 110 in collaboration with humans and/or supervised machine learning and/or may be performed by the management system 110 itself, which may also be referred to as unsupervised machine learning.

As another example, if each of the parameters for the algorithm cannot be evaluated and/or are not available for the patient, one or more alternative algorithms or functions can be used to provide an initial risk prediction based on the parameters of the patient data and/or sensor data that are available for the patient. For example, one approach is to reduce the threshold for the initial risk prediction by an amount proportional to the parameters available for the patient. For example, Table 1 includes six data or parameters and thresholds of &lt;9, 9-14, and &gt;14. If one data element or parameter is missing for a patient, the threshold becomes 5/6 of the full set of thresholds, i.e., &lt;7.5, 7.5-11.7, and &gt;11.7. Another exemplary approach is to automatically assume a medium risk score for any missing parameters, e.g., a score of 2. A more conservative approach can automatically assume a high risk value of 3 for any missing parameters for the patient.

As another example, as more data is collected from more patients, the weighting given to the individual parameters in the scoring table may be adjusted, for example, from the uniform distribution shown in the examples of Tables 1 to 4. In Tables 1 to 4, a simple sum of the scores gives each parameter an equal weighting. For example, for an early risk prediction of extravasation assessed using Table 1, if analysis of data collected through the use of a non-limiting embodiment or aspect of the present disclosure shows that BMI has a two times stronger relationship to risk of extravasation than other parameters, then BMI can be given a weighting of 2/7 and each of the other factors can be given a weighting of 1/7, as opposed to the uniform distribution of 1/6, respectively, implicitly used in Table 1.

As another example, the relationship between a parameter, such as age, BMI, etc., and the number of points assigned based on the parameter's value may be expanded to be a continuous functional relationship, rather than a discrete binning relationship as shown in the examples of Tables 1 to 4. For example, such a functional relationship may be refined to the extent that the data allows without overfitting the situation, assuming reasonable expectations of human variability. As an example, such a functional relationship may be determined using any applicable multivariate analysis technique. As mentioned above, in some non-limiting embodiments or aspects, the initial risk prediction may be determined by a human health care provider based at least in part on data collected by non-limiting embodiments or aspects of the present disclosure, which may have the advantage of allowing the health care provider to gradually gain trust in the system. There may also be advantages to using multivariate analysis for similar reasons, making the operation of these algorithms understandable to humans who use and need to trust the algorithms.

In some non-limiting embodiments or aspects, the management system 110 can process patient data and/or sensor data associated with the patient using a machine learning model to determine an initial risk prediction for the patient. For example, the management system 110 may generate an initial risk prediction model (e.g., an estimator, classifier, predictive model, detector model, etc.) using machine learning techniques including, for example, supervised and/or unsupervised techniques such as decision trees (e.g., gradient boosted decision trees, random forests, etc.), logistic regression, artificial neural networks (e.g., convolutional neural networks, etc.), Bayesian statistics, learning automata, hidden Markov models, linear classifiers, quadratic classifiers, association rule learning, etc. The initial risk prediction machine learning model can be trained to provide an output including a probability that the patient will experience at least one adverse event in response to an input including patient data and/or sensor data associated with the patient in response to a fluid injection (e.g., a contrast injection, etc.). In such an example, the initial risk prediction can include a probability score associated with a prediction that the patient will experience at least one adverse event in response to the fluid injection.

The management system 110 can generate an initial risk prediction model based on patient data and/or sensor data (e.g., training data, etc.). For example, non-limiting embodiments or aspects of the present disclosure may collect patient data and/or sensor data associated with the patient over a period of time to determine an initial risk prediction for the patient using one of the simpler algorithms described above, and when data has been collected from a sufficient number of patients (e.g., when the precision, prediction, and/or recall of the machine learning model generated based on the collected data meets a threshold, etc.), the machine learning model may be used to determine an initial risk prediction for the patient. In some implementations, the initial risk prediction model is designed to receive as input patient data and/or sensor data (e.g., one or more parameters of the patient data and/or sensor data, etc.) and provide as output a prediction (e.g., a probability, a binary output, a yes-no output, a score, a prediction score, a classification, etc.) regarding whether the patient will experience at least one adverse event (e.g., extravasation, post-contrast acute kidney injury, an acute adverse event (e.g., atopic or allergic reaction, etc.), contrast-induced nephrotoxicity, thyroid disorder, etc.) in response to a fluid injection (e.g., a contrast injection, etc.). In some non-limiting embodiments or aspects, the management system 110 stores the initial prediction model (e.g., stores the model for later use). In some non-limiting embodiments or aspects, the management system 110 stores the initial prediction model in a data structure (e.g., a database, a linked list, a tree, etc.). In some non-limiting embodiments, the data structure is located within the management system 110 or external (e.g., remote) to the management system 110 (e.g., within the auxiliary system 112, etc.).

3, in step 306, the process 300 includes providing an initial patient risk prediction and/or a patient health level for a fluid injection. For example, the management system 110 may provide the patient's initial risk prediction and/or the patient's health level to the user device 108 before a fluid injection (e.g., a contrast injection, etc.) is administered to the patient. As an example, the user device 108 may display the patient's initial risk prediction and/or the patient's health level to a user (e.g., a physician, etc.) before a fluid injection is administered to the patient.

In some non-limiting embodiments or aspects, the initial risk prediction and/or health level may further include at least one of a prompt to administer medication to the patient prior to fluid infusion, a prompt to adjust an infusion protocol for fluid infusion and/or an imaging protocol for an imaging scan, a prompt to prepare the patient prior to fluid infusion, a prompt to consult a specialist about at least one adverse event, a prompt to observe and/or follow up with the patient after the fluid infusion and/or imaging scan, or any combination thereof. For example, the management system 110 may, in response to determining the initial risk prediction (e.g., in response to determining an initial risk prediction that includes a probability that the patient will experience an adverse event that meets a threshold probability), determine and recommend actions that a user (e.g., a medical professional, etc.) may take to reduce the probability that the patient will experience an adverse event. As an example, the management system 110 may consult a lookup table and/or apply an algorithm (e.g., a machine learning model, etc.) to the initial risk prediction and/or the patient data and/or sensor data used to generate the initial risk prediction to determine and provide to the user one or more prompts or recommendations that may reduce the probability that the patient will experience an adverse event. The management system 110 can adjust one or more thresholds used by the sensors to monitor for successful infusion and/or adverse events.

In some non-limiting embodiments or aspects, in response to determining an initial risk prediction (e.g., in response to determining an initial risk prediction that includes a probability that a patient will experience an adverse event that meets a threshold probability), the management system 110 may recommend to a healthcare provider that they control and/or adjust one or more operations of the fluid injection system 102 and/or the imaging system 104, and/or may automatically control and/or adjust one or more operations of the fluid injection system 102 and/or the imaging system 104, if legally permitted. For example, the management system 110 may recommend manual or automatic adjustments to an injection protocol for a fluid injection (e.g., adjust maximum flow rate, adjust maximum pressure, adjust injection duration, adjust total volume of fluid or contrast delivered or to be delivered (e.g., to reduce total iodine burden), etc.) and/or an imaging protocol for an imaging scan (e.g., adjust scan time and/or duration (e.g., to accommodate a patient who is unable to hold their breath for the originally planned scan duration), adjust kVp (e.g., reduce kVp to allow adequate image contrast with reduced total iodine burden), adjust breathing instructions, etc.). As an example, the management system 110 may consult a lookup table and/or apply algorithms (e.g., response surfaces, machine learning models, etc.) to the initial risk prediction and/or the patient data and/or sensor data used to generate the initial risk prediction to determine one or more adjustments to the injection protocol and/or imaging protocol that can reduce the probability that the patient will experience an adverse event.

For example, based on patient data related to the patient's known adverse events (e.g., allergic reactions, etc.) following a previous fluid injection (e.g., a previous contrast injection) and/or the patient's atopic tendencies, the management system 110 may determine an initial risk prediction of an acute adverse event, including a prompt to administer medication to the patient prior to contrast injection in accordance with applicable guidelines (e.g., American College of Radiology (ACR) guidelines, etc.) and/or a prompt to observe the patient for a predetermined interval after contrast injection (e.g., for a longer period than usual for high-risk patients) while monitoring one or more patient parameters related to the predicted adverse event.

Based on patient data related to the patient's individual renal function, such as, for example, its laboratory surrogate parameters (e.g., eGFR, etc.) and/or the patient's current medications, the management system 110 may determine an initial risk prediction of contrast-induced nephrotoxicity, including prompts to prepare the patient prior to contrast injection in accordance with applicable guidelines (e.g., European Society of Genitourinary Radiology guidelines, etc.), prompts (and/or automatic control) to adjust the injection protocol for the contrast injection and/or the imaging protocol for the imaging scan, and/or prompts to follow up with the patient regarding renal function after the examination, for example, by administering intravenous hydration, etc., to reduce the total iodine given to the patient.

For example, based on patient data related to the patient's known thyroid disorder, the patient's environmental influences (e.g., regional iodine saturation or nutrition in the area in which the patient lives), and/or the patient's current medications, the management system 110 may determine an initial risk prediction for a thyroid disorder (e.g., thyrotoxicosis, etc.), including a prompt to forgo contrast injection and associated imaging until consultation with an endocrinologist has been obtained, and/or a prompt to administer medication to the patient prior to contrast injection.

3, at step 308, the process 300 includes determining sensor data. For example, the sensor system 106 may determine (e.g., determine, collect, obtain, capture, measure, sense, etc.) sensor data associated with the patient before, during, and/or after a fluid injection (and/or before, during, and/or after a test injection administered to the patient before the fluid injection). As an example, the sensor system 106 may determine (e.g., determine, collect, obtain, capture, measure, sense, etc.) sensor data associated with the patient before, during, and/or after a fluid injection (and/or before, during, and/or after a test injection administered to the patient before the fluid injection).

The sensor data may include the following parameters related to the patient, i.e., firstly, parameters that may be affected by changes in the infusion and/or the patient's health, such as heart rate; sound or vibration (e.g., sound or vibration associated with fluid inflow, sound or vibration proximate to the infusion site, etc.); temperature (e.g., temperature of the fluid inflow, temperature proximate to the infusion site, local temperature, tissue temperature, etc.); oxygen saturation (e.g., oxygen saturation of the fluid inflow, oxygen saturation proximate to the infusion site, etc.); pulse rate; ECG; body fat/water ratio; tissue impedance; vascularity level; blood vessel diameter; hydration level; hematocrit level; skin resistivity; blood pressure; muscle tension level; light absorptance level; shaking or trembling or movement/motion (e.g., yes, no, level, etc.); arm position; arm circumference; breathing rate; breathing depth; amount of absorbed radiation; tightness, positional stability, and/or contact integrity of the contact sensor devices 400 and/or 800; amount of swelling and/or displacement; EMG; skin color; amount of surface vasodilation (flushing); bioimpedance; light absorption rate; inflammation level; secondly, parameters that are unlikely to be immediately affected by changes in the injection and/or patient's health, such as fat/muscle ratio; hemoglobin level; thirdly, environmental parameters, such as ambient temperature of the patient's surrounding environment, air pressure of the patient's surrounding environment, ambient light level, ambient sound level; or any combination thereof.

As described in more detail herein below, the management system 110 can determine predictions related to the patient (e.g., initial risk predictions, test predictions, current risk predictions, etc.) and/or patient health based on patient data and/or sensor data related to the patient. Overall patient health or patient comfort can be considered to include multiple aspects or dimensions. One aspect can be that of medical health, which is generally considered to be free of adverse events. A patient can be said to be comfortable when they do not have adverse events. A patient can be mildly uncomfortable, for example, having a feeling of heat or hot flushes, a feeling of the need to urinate, a dry stomach, or itchy skin, or the patient can have a serious or severe reaction (e.g., nausea, hives, or anaphylactic shock requiring timely medical intervention, for example with epinephrine). Another aspect of patient health is physical health. The patient may be comfortable lying on the infusion bed or table of the imaging system, may have mild discomfort with some tingling or pain that may induce the patient to move to relieve the discomfort, or may have severe discomfort that may cause the patient to move involuntarily or uncontrollably, leading to deterioration of the images. The third aspect of the patient's health is the patient's mental state. The patient may be at ease and comfortable, accepting the procedure and cooperating as required, or anxious and alert, overreacting to unexpected noises or movements, etc., or may be in an excited mental state and have difficulty controlling their reactions. It is clear that these three aspects of health may overlap and are somewhat arbitrary, but are beneficial for the purposes of this specification. It is known to those skilled in the art that physiological parameters such as heart rate, respiratory rate, skin conductance, etc. can be used to assess the comfort of the patient, and increases in these parameters can be used by the management system 110 to alert medical personnel to check on the patient, for example, when the patient's condition transitions from comfortable to moderate with respect to one or more of these aspects. It is difficult for medical personnel to manually or mentally attend to these subtle changes, and it is an object of non-limiting embodiments or aspects of the present disclosure to synthesize these measurements into a simple alert system for use by medical personnel or the entire system, including the fluid delivery system and/or imaging system. It is also an object of non-limiting embodiments or aspects of the present disclosure to provide an aspect that prophylactically and proactively promotes patient health, such as proactive education or a more comfortable environment.

12, multiple data processors, data paths, and/or data analysis algorithms may be used to condition the various forms and/or streams of patient and/or sensor data and/or combine the various forms and/or streams of patient and/or sensor data into new forms and/or new streams of data and/or distinguish additional streams of data. The patient and/or sensor data and/or their data streams may be used by the management system 110 to make recommendations to a user and/or control the operation of the fluid injection system 102 and/or imaging system 104 (e.g., determine an initial risk prediction, determine a test prediction, determine whether the injection is progressing normally as expected, determine a patient's health level, generate a current risk prediction, control the fluid injection system 102 and/or imaging system 104 in response to such determinations, etc.). For example, the recommendations and/or system controls may assess risk, guide preventative measures, and minimize the occurrence of, detect and/or manage extravasation, post-contrast acute kidney injury, acute adverse events, contrast-induced nephrotoxicity, and/or thyroid disorders or thyrotoxicosis, thereby reducing one or more serious complications that may be associated with contrast injection.

As an example, to detect extravasation, the management system 110 may receive three data streams representing sound or vibration measured by three different sensors located at three different locations on a patient's extremity (e.g., arm, leg, hand, foot, etc.) proximate and/or surrounding an injection site for test injection and/or fluid injection (e.g., contrast injection, etc.). For example, with further reference to FIG. 12 and again to FIG. 4E, the rightmost image in the series of images in FIG. 4E shows three sensor array coverages of a cross section of a patient's extremity that may be used to capture three data streams of sensor data, e.g., data related to sound or vibration. The management system 110 may combine the three audio data streams 1201, 1202, 1203 by a data combination technique 1204 (e.g., triangulation, etc.) to generate a combined data stream 1205 indicative of the center of one or more sound sources in space. Additionally or alternatively, the management system 110 may apply a data extraction process 1206 to one or more of the three acoustic data streams to generate one or more additional data streams 1207. For example, the management system 110 may apply a real-time Fourier transform to the data streams to generate a multi-dimensional data stream of amplitude as a function of frequency over time. Such signals may be combined by the management system 110 with information about the infusion fluid, e.g., fluid type, viscosity, temperature, flow rate, and catheter or other fluid pathway element characteristics, to assess the sound spectrum and determine, for example, whether the sound spectrum is indicative of a normal or adequate infusion, a marginal infusion, or an abnormal or improper infusion that may lead to an adverse event.

In such examples, the management system 110 may receive a data stream 1208 including data that changes over time and use the data "as is" or without processing the data in any additional manner before using the data to make recommendations to a user and/or control the operation of the fluid injection system 102 and/or the imaging system 104. For example, a data stream of sensor data including a parameter related to a patient's skin temperature may include data that changes over time and is used "as is" without additional processing of the data.

In such an example, the management system 110 can receive data 1209 that does not change over time. For example, the received data may include information related to the patient, such as the patient's age, the patient's chemotherapy status (which may indicate, for example, a higher likelihood of weaker veins), etc. As an example, the data may include fixed information, e.g., catheter gauge, contrast injection, such as contrast concentration, and/or information regarding fluid pathways.

In such examples, the management system 110 can receive data streams 1210 of sensor data and/or patient data from at least one of the fluid injection system 102, the imaging system 104, the sensor system 106, the user device 108, the auxiliary system 112, or any combination thereof. For example, the management system 110 may receive data related to programmed flow rates, actual or measured flow rates, pressures, concentrations, and/or other injection-related data from the fluid injection system 102.

In such an example, the management system 110 may apply one or more algorithms 1211 as described herein to the data stream of patient data and/or sensor data to determine recommendations and/or system controls 1212 (such as determining a risk prediction, determining a test prediction, determining a patient's health level, generating a current risk prediction, controlling the fluid injection system 102 and/or the imaging system 104 in response to such determinations, etc.). For example, the sound data stream may be affected by unknown variables or factors such as contrast concentration, temperature, flow rate, and catheter type and/or size, as well as the patient's venous anatomy and/or the position of the catheter within the patient's vein. At the start of a test or contrast injection, the management system 110 may expect the sound frequency and amplitude to be within certain normal or expected ranges, which may be learned and/or determined from previous studies and fixed in the algorithm. Additionally or alternatively, the algorithm may employ ongoing learning and adaptation. If the sound at the start of the test or contrast injection is outside of the normal or expected range, the algorithm may cause the management system 110 to indicate to the user that the sound is outside of the normal or expected range, which may indicate that the wrong catheter is being used and/or that the wrong fluid is being used for the contrast injection. For example, the frequency of the sound (e.g., a "whoosh," "whistle," or "trill," etc.) may depend on the catheter gauge, length and stiffness, as well as the fluid and fluid properties, flow rate, vessel properties, and the position of the catheter or needle within the patient's vein or tissue (e.g., pressed against a vessel wall). This information, on which the frequency of the sound depends, may be entered as data into the management system 110 manually by the user and/or automatically from the fluid injection system 102.

In such an example, during an injection, the algorithm may expect the acoustic data to be relatively consistent until there is a change in fluid concentration, fluid temperature, and/or fluid flow rate. For example, the management system 110 may alert the user if there is a change in fluid concentration, fluid temperature, and/or fluid flow rate that meets a threshold change or magnitude when no change is expected by the algorithm. The management system 110 may alert the user if conditions change (e.g., contrast concentration changes, etc.) when there is no expected change in the acoustic data. Similarly, during a proper contrast injection, the sound spectrum and/or the location in space of the source of the sound may be relatively constant (e.g., the tip of the catheter does not move except at the very beginning of the injection, etc.). For example, the management system 110 may allow for modest spectrum changes or movement at the beginning of the injection or when there is a change in the total volumetric or mass flow rate, but if the initial movement meets a threshold movement level at the associated time, the management system 110 may provide the user with an indication to move (e.g., as part of the patient's health level, etc.). In such examples, the management system 110 may use parameters such as the patient's venous status to set one or more thresholds used to determine one or more alerts, e.g., setting lower thresholds for patients at more risk. In such examples, the management system 110 may use multiple data streams and sub-algorithms as a "double check" against each other, e.g., only alerting a user if two or more sub-algorithms indicate an alert, thereby reducing the likelihood of false alarms. Other methods of combining sub-algorithm results, such as response surfaces and non-linear functions, may also be utilized.

As shown in FIG. 3, in step 310, the process 300 includes determining a test prediction. The test prediction determination in step 310 may be optional, for example, performing a test injection and determining sensor data during the test injection may be optional. For example, the management system 110 may determine the test prediction based on sensor data determined during a test injection administered to the patient prior to fluid injection (e.g., prior to contrast injection, etc.). As an example, the test prediction may include a probability that the patient will experience extravasation in response to a fluid injection (e.g., contrast injection, etc.). For example, the patient's intravenous access may be checked in a standardized manner, a standardized stepwise saline test injection for the patient (manually and/or mechanically) is performed, and uncomplicated high flow and high pressure contrast application is predicted by using the sensor system 106 to determine sensor data related to the patient during the test injection. In such an example, changes in the patient's sound or measured parameters (e.g., changes in blood vessels and/or tissues proximate to the injection site, etc.) may be determined under controlled dynamic low flow and low pressure conditions of the test injection. For example, the management system 110 may determine test predictions (e.g., probability of extravasation under high flow rates and high pressures of contrast injection) and/or assess the sufficiency of the test injection based on turbulence sounds (which are caused by fluid entering the blood vessels) measured by at least one sound or vibration sensor positioned proximate the injection site, changes in temperature, changes in oxygenation levels, comparison with the load pressure of the injector 152, etc.

The management system 110 can apply algorithms or aspects of algorithms, which may be adaptations and/or implementations of professional society guidelines and/or hospital procedures into computer code, to the patient data and/or sensor data associated with the patient to determine a test prediction for the patient. In such an example, different hospitals may have different algorithms or aspects of one or more algorithms based on local preferences, practices, countries, and/or other factors associated with the different hospitals. In some non-limiting embodiments or aspects, the management system 110 can use a scoring table, such as those described above in this specification with respect to the examples of Tables 1 through 4, to determine a test prediction for the patient based on one or more parameters (e.g., change in temperature, change in oxygenation level, etc.) of the patient data and/or sensor data associated with the patient.

In some non-limiting embodiments, the management system 110 can generate the test predictive machine learning model in the same or similar manner as the initial risk predictive machine learning model (e.g., as described herein). In some non-limiting embodiments or aspects, the test predictive machine learning model can be different from the initial risk predictive machine learning model. For example, the inputs provided to or outputs provided by the test predictive machine learning model may be different from the inputs provided to or outputs provided by the initial risk predictive machine learning model. As an example, the test predictive model may be designed to receive as input patient data and/or sensor data (e.g., one or more parameters of the patient data and/or sensor data measured during a test injection, etc.) and provide as output a prediction (e.g., a probability, a binary output, a yes-no output, a score, a predictive score, a classification, etc.) regarding whether the patient has or will experience extravasation in response to a contrast injection.

As shown in FIG. 3, in step 312, the process 300 includes providing a test prediction. Providing the test prediction in step 312 may be optional, e.g., performing a test injection and determining sensor data during the test injection may be optional. For example, the management system 110 may provide the user device 108 with a test prediction that includes a probability that the patient will experience an adverse event, e.g., extravasation, in response to a fluid injection (e.g., contrast injection, etc.). As an example, the user device 108 may display the test prediction to a user (e.g., physician, etc.) before a fluid injection (e.g., contrast injection, etc.) is administered to the patient and an imaging study is performed.

In some non-limiting embodiments or aspects, the exam prediction may further include at least one of a prompt to administer medication to the patient prior to contrast injection, a prompt to adjust an injection protocol for the contrast injection and/or an imaging protocol for the imaging scan, a prompt to prepare the patient prior to contrast injection, a prompt to consult a specialist regarding the predicted extravasation, a prompt to observe and/or follow up with the patient after the contrast injection and/or the imaging scan, or any combination thereof. For example, the management system 110 may determine and recommend actions that a user (e.g., a medical professional, etc.) may take to reduce the probability that the patient will experience an extravasation in response to determining the exam prediction (e.g., in response to determining an exam prediction that includes a probability that the patient will experience an extravasation that meets a threshold probability, etc.). As an example, the management system 110 may consult a lookup table and/or apply an algorithm (e.g., a machine learning model, etc.) to the test prediction and/or the patient data and/or sensor data used to generate the test prediction to determine and provide to the user one or more prompts or recommendations that may reduce the probability that the patient will experience an extravasation.

In some non-limiting embodiments or aspects, in response to determining the test prediction (e.g., in response to determining the test prediction including the probability that the patient will experience an extravasation that meets a threshold probability, etc.), the management system 110 can automatically control and/or adjust one or more operations of the fluid injection system 102 and/or the imaging system 104. For example, the management system 110 may automatically adjust an injection protocol for a contrast injection (e.g., adjust a maximum flow rate, adjust a maximum pressure, etc.) and/or an imaging protocol for an imaging scan (e.g., adjust a scan time, etc.). As an example, the management system 110 may consult a lookup table and/or apply an algorithm (e.g., a machine learning model, etc.) to the test prediction and/or the patient data and/or sensor data used to generate the test prediction to determine one or more automatic adjustments to the injection protocol and/or imaging protocol that may reduce the probability that the patient will experience an extravasation.

As shown in FIG. 3, in step 314, the process 300 includes determining at least one of a current risk prediction and a health level of the patient. For example, the management system 110 may determine at least one of the current risk prediction and the health level of the patient based on sensor data determined after a fluid injection (e.g., contrast injection, etc.) has been initiated (e.g., during and after the fluid injection period, simultaneously with initiating the fluid injection, etc.). As an example, the current risk prediction may include a probability that the patient will experience at least one adverse event in response to the fluid injection (e.g., a probability that the patient is currently experiencing at least one adverse event, a probability that the patient will experience at least one event in the future, etc.). In such an example, a probability that the patient will experience at least one adverse event that meets at least one threshold probability (e.g., a 90 percent probability, a 100 percent probability, etc.) may indicate that the patient is currently experiencing at least one adverse event, and/or a probability that the patient will experience at least one adverse event that does not meet at least one threshold probability may indicate a probability that the patient will experience at least one adverse event in the future. In some non-limiting embodiments or aspects, the management system 110 can further determine at least one of a current risk prediction and health level of the patient during and/or after the fluid injection based on patient data associated with the patient.

In some non-limiting embodiments or aspects, the management system 110 can determine (e.g., during fluid injection) at least one of a patient's current risk prediction and health level based on sensor data determined during fluid injection. For example, even in the case of a test prediction indicating a low probability of patient extravasation for contrast injection, extravasation may still occur during contrast injection due to, for example, an intravenous access that is incorrectly placed outside of the vein, misalignment and/or kinking after placement or during contrast injection, and/or patient movement and/or rupture of the patient's blood vessels due to high pressure and high flow conditions.

In some non-limiting embodiments or aspects, the management system 110 can determine at least one of the patient's current risk prediction and health level based on sensor data determined after fluid injection is completed (e.g., determined after fluid injection is completed, during and/or after the imaging scan, etc.).

The management system 110 can apply algorithms or aspects of algorithms, which may be in the form of adaptations and/or implementations of professional society guidelines and/or hospital procedures into computer code, to the sensor data associated with the patient to determine at least one of the patient's current risk prediction and health level. In such an example, different hospitals may have different algorithms or aspects of one or more algorithms based on local preferences, practices, countries, and/or other factors associated with the different hospitals. In some non-limiting embodiments or aspects, the management system 110 can use a scoring table, such as those described above in this specification with respect to the examples of Tables 1 to 4, to determine at least one of the patient's current risk prediction and health level based on one or more parameters of the sensor data associated with the patient (e.g., change in temperature, change in oxygenation level, movement level, heart rate, etc.).

In some non-limiting embodiments or aspects, the management system 110 can generate the current risk predictive machine learning model in the same or similar manner as the initial risk predictive machine learning model and/or the test predictive machine learning model (e.g., as described herein). In some non-limiting embodiments, the current risk predictive machine learning model can be different from the initial predictive machine learning model and/or the test predictive machine learning model. For example, the inputs provided to and/or the outputs provided by the current risk predictive machine learning model may be different from the inputs provided to and/or the outputs provided by the initial predictive machine learning model and/or the test predictive model. As an example, the current risk predictive machine learning model may be designed to receive as input sensor data (e.g., one or more parameters of the sensor data measured during and/or after contrast injection, etc.) and provide as output a prediction (e.g., a probability, a binary output, a yes-no output, a score, a prediction score, a classification, etc.) regarding whether a patient will experience at least one adverse event in response to a fluid injection. As an example, a current risk prediction machine learning model may be designed to receive as input sensor data (e.g., one or more parameters of the sensor data measured during and/or after contrast injection) and provide as output a classification (e.g., a probability, a binary output, a yes-no output, a score, a prediction score, a classification, etc.) regarding the patient's health level.

As shown in FIG. 3, in step 316, the process 300 includes providing a current risk prediction and/or health level of the patient. For example, the management system 110 may provide the patient's current risk prediction and/or health level to the user device 108 during and/or after the fluid injection (e.g., after the fluid injection is started, etc.). As an example, the management system 110 may provide the patient's current risk prediction and/or health level to the user device 108 during the fluid injection, and/or the user device 108 may display the current risk prediction and/or health level during the fluid injection to a user (e.g., a physician, etc.) during the fluid injection. As an example, the management system 110 may provide the patient's current risk prediction and/or health level to the user device 108 after the fluid injection, and/or the user device 108 may display the patient's current risk prediction and/or health level after the fluid injection to a user (e.g., a physician, etc.) after the fluid injection.

In some non-limiting embodiments or aspects, the current risk prediction may include an alert generated in response to and/or associated with at least one of catheter tip movement meeting a threshold movement, a change in fluid concentration meeting a threshold change, a fluid temperature meeting a threshold temperature, a fluid flow rate meeting a threshold magnitude, or any combination thereof. For example, the management system 110 may provide an alert with the current risk prediction in response to the current risk prediction meeting at least one threshold probability that the patient will experience at least one adverse event, e.g., to alert a user of a condition that may lead to the patient experiencing at least one event.

In some non-limiting embodiments or aspects, the current risk prediction may include visualization of changes to the patient's tissues associated with, caused by, and/or reflecting fluid inflow from the fluid injection.

In some non-limiting embodiments or aspects, in response to determining a current risk prediction that meets at least one threshold level (e.g., indicating that the patient is experiencing an adverse event (e.g., extravasation, etc.) during the fluid injection (and/or test injection) and/or will experience an adverse event), the management system 110 can automatically control the fluid injection system 102 to stop the fluid injection (and/or test injection) (e.g., controlling the injector 152 to stop the injection or delivery of contrast agent or fluid to the patient) and/or control or cause the imaging system 104 to abort the imaging procedure, thereby protecting the patient from unproductive radiation exposure due to a possible lack of or shortage of contrast agent required for the procedure and/or patient movement or other imaging impairments associated with an adverse event.

In some non-limiting embodiments or aspects, in step 316, process 300, management system 110 can receive feedback from a user or operator that the management system 110 can use to update and/or adjust one or more of the algorithms described herein with respect to steps 308-314. For example, a user may inform management system 110 whether an assessment or determination of a successful infusion or occurrence of an adverse event made by management system 110 is correct or if reality is inconsistent with the assessment or determination, such that one or more algorithms can be improved as more experience is gained in actual practice with the wide variety of patients encountered.

5A, which is a flowchart of non-limiting embodiments or aspects of a process 500 for evaluating the normality or abnormality of a patient and/or an infusion, thereby protecting the health of the patient before, during, and/or after a fluid infusion. In some non-limiting embodiments or aspects, one or more of the steps of process 500 may be performed (e.g., completely, partially, etc.) by management system 110 (e.g., one or more devices of management system 110, etc.). In some non-limiting embodiments or aspects, one or more of the steps of process 500 may be performed (e.g., completely, partially, etc.) by a user or another device or group of devices separate from or including management system 110, such as fluid injection system 102 (e.g., one or more devices of fluid injection system 102), imaging system 104 (e.g., one or more devices of imaging system 104), sensor system 106 (e.g., one or more devices of sensor system 106), user device 108 (e.g., one or more devices of a system of user device 108), and/or auxiliary system 112 (e.g., one or more devices of auxiliary system 112).

As shown in FIG. 5A, in step 502, the process 500 includes capturing an image of the patient. For example, the sensor system 106 may capture an image of the patient. As an example, the sensor system 106 may include a non-contact sensor 164b including an image capture device (e.g., a camera, etc.), and the sensor data captured by the image capture device may include multiple images (e.g., video streams, etc.) of the patient captured over a period of time (e.g., images including the patient's infusion site and/or areas proximate and/or surrounding the patient's infusion site, etc.). In some non-limiting embodiments or aspects, the step 502 of the process 500 may be performed as part of the step 308 of the process 300 and/or in the same or similar manner. In such an example, the at least one adverse event may include extravasation.

As shown in FIG. 5A, in step 504, the process 500 includes processing the images to highlight, magnify, or amplify color and/or motion changes between the images. For example, the management system 110 may process multiple images of the patient captured over a period of time to highlight, magnify, or amplify at least one of color and motion (e.g., low frequency motion, high frequency sound-based motion or vibration, etc.) changes between the multiple images (e.g., between one or more objects and/or regions in the multiple images, etc.). As an example, the management system 100 may process the multiple images using Eulerian Video Magnification techniques as described in a paper entitled "Eulerian Video Magnification for Revealing Subtle Changes in the World" by Wu et al., published in July 2012, the disclosure of which is incorporated herein by reference in its entirety.

As shown in FIG. 5A, in step 506, the process 500 includes displaying an image including the enhanced changes. For example, the management system 110 may display a plurality of images including the enhanced changes to a user (e.g., via the user device 108, etc.). Thus, a user (e.g., a physician, etc.) viewing the enhanced images can more easily detect whether the patient is experiencing extravasation due to the enhanced changes in color and/or motion in the images. In some non-limiting embodiments or aspects, step 506 of the process 500 may be performed as part of step 312 and/or step 316 of the process 300 and/or in the same or similar manner. In some non-limiting embodiments or aspects, the enhanced images are not displayed to the user and/or the management system 110 processes and evaluates the enhanced images internally.

As shown in FIG. 5A, in step 508, the process 500 includes determining a current risk prediction and/or health level of the patient. For example, the management system 110 may determine whether the infusion is progressing as expected, whether the patient is experiencing discomfort, and/or whether the patient is experiencing or is likely to experience extravasation or another adverse event. As an example, the management system 110 may determine a current risk prediction (e.g., extravasation probability, etc.) and/or a health level of the patient based on the enhanced changes. As an example, the management system 110 may apply an algorithm or an aspect of one or more algorithms (e.g., a machine learning model, etc.) to the multiple images including the enhanced changes to determine a current risk prediction (e.g., extravasation probability, etc.) and/or a health level of the patient. In some non-limiting embodiments or aspects, step 508 of the process 500 can be performed as part of step 310 and/or step 314 of the process 300 and/or in the same or similar manner.

As shown in FIG. 5A, in step 510, the process 500 includes automatically responding to the patient's current risk prediction and/or health level. For example, the management system 110 may perform one or more operations in response to a determination that the injection is proceeding as expected, that the patient is experiencing discomfort, or that the patient is experiencing extravasation or another adverse event. For example, the management system 110 may perform one or more desired steps or actions in response to a determination that an adverse event is occurring, is about to occur, or is likely to occur (e.g., in response to a current risk prediction that includes a probability of meeting at least one threshold probability, etc.). By way of example, the one or more desired steps or actions may be set by a user, a hospital, or any suitable body through the management system 110. Such actions may include alerting an operator for evaluation or decision, automatically controlling the injector 152 to slow the injection rate of the injection, automatically controlling the injector 152 to pause the injection, and/or automatically stopping the fluid injection (e.g., contrast injection, etc.). As an example, the management system 110 may automatically stop fluid injection (e.g., control the fluid injection system 102 to stop the flow and/or delivery of fluid or contrast agent) in response to determining that the patient is experiencing an extravasation or another adverse event and/or in response to determining that the patient's health level meets at least one threshold level.

5B, which is a flowchart of a non-limiting embodiment or aspect of a process 550 for assessing the normality or abnormality of a patient and/or an infusion, thereby evaluating and/or protecting the health of a patient before, during, and/or after a fluid infusion. In some non-limiting embodiments or aspects, one or more of the steps of process 550 may be performed (e.g., completely, partially, etc.) by management system 110 (e.g., one or more devices of management system 110, etc.). In some non-limiting embodiments or aspects, one or more of the steps of process 550 may be performed (e.g., completely, partially, etc.) by a user or another device or group of devices separate from or including management system 110, such as fluid injection system 102 (e.g., one or more devices of fluid injection system 102), imaging system 104 (e.g., one or more devices of imaging system 104), sensor system 106 (e.g., one or more devices of sensor system 106), user device 108 (e.g., one or more devices of the user device 108 system), and/or auxiliary system 112 (e.g., one or more devices of auxiliary system 112).

As shown in FIG. 5B, in step 552, process 500 includes capturing an image of the patient. For example, sensor system 106 may capture an image of the patient. As an example, sensor system 106 may include non-contact sensor 164b including an image capture device (e.g., a camera, an IR camera, etc.), and the sensor data determined by the image capture device may include multiple images (e.g., multiple IR images, etc.) of the patient (e.g., of the patient's infusion site and/or an area proximate and/or surrounding the patient's infusion site, etc.) captured over a period of time. In some non-limiting embodiments or aspects, step 552 of process 500 may be performed as part of step 308 of process 300 and/or in the same or similar manner. In such an example, the at least one adverse event may include extravasation.

As shown in FIG. 5B, in step 554, the process 500 includes processing the images to determine a difference in absorption spectrum between a first location and a second location on the patient and/or between two time points at the same location. For example, the sensor system 106 may include an image capture device including an infrared (IR) camera, and the plurality of images may include a plurality of IR images. As an example, the management system 110 may process the plurality of IR images to determine a difference in absorption spectrum between a first location on the patient (e.g., a location associated with the patient's blood vessels, etc.) and a second location on the patient (e.g., a location associated with the patient's tissue outside the patient's blood vessels, etc.) in the plurality of images. For example, the fluid injected via contrast injection is typically cooler than the patient's body temperature, so a longer wavelength IR spectrum may be used to assess temperature. As an example, the management system 110 may process the plurality of images using the methods described in U.S. Patent Application Publication No. 2006/0173360A1, filed Jan. 7, 2005, the contents of which are incorporated herein by reference in their entirety.

As shown in FIG. 5B, in step 556, process 550 includes displaying an image including the difference in absorption spectra and/or the absorption spectra over time. For example, management system 110 may display a plurality of images including the difference in absorption spectra to a user in a manner visible to the user (e.g., via user device 108, etc.). Thus, a user (e.g., a physician, etc.) viewing the images can more easily detect whether the patient is experiencing a normal infusion or an extravasation due to the difference in absorption spectra depicted in the displayed images. As an example, the first location of the patient may include a blood vessel or vein of the patient, and the second location of the patient may include a tissue of the patient surrounding the blood vessel or vein of the patient. In some non-limiting embodiments or aspects, step 556 of process 550 may be performed as part of step 312 and/or step 316 of process 300 and/or in the same or similar manner.

As shown in FIG. 5B, in step 558, process 550 includes process 500 determining a current risk prediction and/or health level of the patient. For example, management system 110 may determine whether the infusion is progressing as expected, whether the patient is experiencing discomfort, and/or whether the patient is experiencing extravasation and/or another adverse event. For example, management system 110 may determine whether the patient is experiencing extravasation and/or another adverse event based on a difference in absorption spectra between a first location on the patient and a second location on the patient. As an example, management system 110 may compare the difference in absorption spectra to one or more thresholds to determine whether the patient is experiencing extravasation and/or another adverse event and/or determine the health level of the patient. In some non-limiting embodiments or aspects, step 558 of process 550 may be performed as part of step 310 and/or step 314 of process 300 and/or in the same or similar manner.

As shown in FIG. 5B, in step 560, the process 560 includes automatically responding to the patient's current risk prediction and/or health level. For example, the management system 110 may automatically perform an operation in response to a determination that the infusion is progressing as expected, a determination that the patient is experiencing discomfort, or a determination that the patient is experiencing an extravasation or another adverse event. For example, the management system 110 may perform one or more desired steps or actions in response to a determination that an extravasation or another adverse event is occurring, is likely to occur, or is likely to occur (e.g., in response to a current risk prediction that includes a probability of meeting at least one threshold probability, etc.). The desired steps or actions can be set by the user, the hospital, and/or some appropriate body through the management system 110. Such actions can include alerting an operator for evaluation or decision, automatically controlling the injector 152 to slow the infusion rate of the infusion, automatically controlling the injector 152 to pause the infusion, and/or automatically stopping the fluid infusion. For example, the management system 110 may automatically stop fluid injection (e.g., control the fluid injection system 102 to stop the flow and/or delivery of fluid or contrast agent) in response to determining that the patient is experiencing an extravasation or another adverse event and/or in response to determining that the patient's health level meets at least one threshold level.

Reference is now made to Figure 6, which is a flow diagram of a non-limiting embodiment or aspect of a process 600 for assessing the normality or abnormality of a patient and/or an infusion, thereby assessing and/or protecting the patient's health for a fluid infusion. In some non-limiting embodiments or aspects, one or more of the steps of process 600 may be performed (e.g., completely, partially, etc.) by management system 110 (e.g., one or more devices of management system 110, etc.). In some non-limiting embodiments or aspects, one or more of the steps of process 600 may be performed (e.g., completely, partially, etc.) by a user or another device or group of devices separate from or including management system 110, such as fluid injection system 102 (e.g., one or more devices of fluid injection system 102), imaging system 104 (e.g., one or more devices of imaging system 104), sensor system 106 (e.g., one or more devices of sensor system 106), user device 108 (e.g., one or more devices of the user device 108 system), and/or auxiliary system 112 (e.g., one or more devices of auxiliary system 112).

As shown in FIG. 6, in step 602, the process 600 includes inducing a sound or vibration signal in a fluid delivered to the patient during a fluid injection (and/or test injection). For example, referring also to FIG. 7, an implementation 700 of the fluid injector 152 may include a sound generating device 702 (e.g., an oscillator, speaker, vibrator, whistle, etc.) connected to at least one of the injector, syringe, and fluid path that delivers the fluid to the patient during a fluid injection (and/or test injection). As an example, the sound generating device 702 may induce a sound signal during a fluid injection (and/or test injection) into the patient in the fluid (e.g., contrast agent, saline, etc.) delivered to the patient during the fluid injection (and/or test injection), thereby inducing or transmitting sound waves or pulses in the patient's vasculature, surrounding tissue, and/or blood to improve assessment of injection health, injection progress, and/or detection of extravasation. Although shown in FIG. 7 as being connected to a contrast injector used for CT imaging procedures, non-limiting embodiments or aspects are not so limited, and the sound generating device 702 may be incorporated into any type of fluid delivery device. In another non-limiting embodiment or aspect of the present disclosure, the sound generating device 702 may generate sound as the fluid being delivered to the patient flows through the fluid path and/or the patient. Special devices or elements of the fluid path may be used to generate this sound, similar to how a whistle generates sound in the air as air flows over it. One phenomenon that may be used is vortex shedding. In vortex shedding, the frequency of the sound may depend on the fluid flow rate, velocity, and other characteristics. This has the advantage of providing the management system 110 with a qualitative and potentially quantitative indication of one or more local characteristics of the infusion, which may be used to assess the normality, progression, and/or risk of occurrence of an adverse event. Sound or vibration may include any mechanical oscillation or vibration phenomenon of any duration, whether within or outside the range of normal human hearing, externally generated, imposed and/or inserted, or inherently created and/or generated.

As shown in step 604 of FIG. 6, the process 600 includes measuring sounds or vibrations of an area or portion of the patient. For example, the sensor system 106 may measure sounds or vibrations of the patient (e.g., simultaneously with the induction of sound signals into the fluid during fluid infusion). As an example, the sensor system 106 may include a sound or vibration sensor (e.g., implemented with the contact sensor device 400 positioned proximate to an infusion site of the patient), and the sensor system 106 may use the sound or vibration sensor to measure, for example, at least one of the frequency and amplitude of the sounds or vibrations of the patient (e.g., proximate to the infusion site of the patient) as sensor data related to the patient. In such an example, the sound waves or pulses induced in the patient may improve the quality or signal-to-noise ratio of the sound or vibration signal captured by the sound or vibration sensor, which may enable the management system 110 to more easily determine extravasation during fluid infusion based on the sounds or vibrations captured by the sound or vibration sensor. For example, the frequency and/or amplitude of the sound signal may be adjusted to improve detection by the sound or vibration sensor. In some non-limiting embodiments or aspects, step 604 of process 600 may be performed as part of step 308 of process 300 and/or in the same or similar manner.

As shown in FIG. 6, in step 606, the process 600 includes determining a current risk prediction and/or health level of the patient. For example, the management system 110 may determine whether the infusion is progressing as expected, whether the patient is experiencing discomfort, and/or whether the patient is experiencing extravasation or another adverse event. For example, the management system 110 may determine the status of the infusion (e.g., the current risk prediction and/or health level of the patient, etc.) based on at least one of the frequency, amplitude, apparent center or location of the sound, and/or changes over time in any of the measured sound or vibration related characteristics of the patient. As an example, infused fluid that pools under the patient's skin during extravasation may generate a different sound signature compared to fluid flowing through the patient's vasculature, which may manifest as an increase in the local loudness where the fluid pools and/or a shift in the frequency of the sound due to the Doppler effect. In such examples, the management system 110 may determine whether the patient is experiencing extravasation by comparing the measured frequency and/or amplitude to one or more thresholds, a library of known frequencies and/or amplitudes, and/or reference frequencies and/or amplitudes determined during a test injection. Thus, non-limiting embodiments or aspects of the present disclosure may address the signal-to-noise limitations of passively monitoring fluid injections and associated fluid extravasation using an external sensor array by generating and measuring an enhanced signal that is more detectable in the patient's vasculature. In some non-limiting embodiments or aspects, step 606 of process 600 may be performed as part of step 310 and/or step 314 of process 300 and/or in the same or similar manner.

As shown in FIG. 6, in step 608, the process 600 includes automatically responding to the patient's current risk prediction and/or health level. For example, the management system 110 may automatically perform one or more operations in response to a determination that the infusion is progressing as expected, that the patient is experiencing discomfort, or that the patient is experiencing an extravasation or another adverse event. For example, the management system 110 may perform one or more desired steps or actions in response to a determination that an extravasation has occurred, is about to occur, or is likely to occur (e.g., in response to a current risk prediction that includes a probability of meeting at least one threshold probability, etc.). The desired steps or actions can be set by a user, a hospital, or some suitable body through the management system 110. Such actions can include alerting an operator for evaluation or decision, automatically controlling the injector 152 to slow the infusion rate of the infusion, automatically controlling the injector 152 to pause the infusion, and/or automatically stopping the fluid infusion. For example, the management system 110 may automatically stop fluid injection (e.g., control the fluid injection system 102 to stop the flow and/or delivery of fluid or contrast agent) in response to determining that the patient is experiencing an extravasation or another adverse event and/or in response to determining that the patient's health level meets at least one threshold level.

Medical imaging can be a stressful experience for patients. Stress can begin when a patient learns that they have a condition that requires further "tests." The term "test" can mean that the patient may be very ill, and may induce fear as the patient may not know what the test is. Stress can increase when a particular test is prescribed and the patient gets secondhand and incorrect information about the medical imaging to be performed. Medical imaging can also be a potentially painful experience for patients, for example, if the patient experiences extravasation. However, in the focus on detecting and/or reducing a particular adverse event, e.g., extravasation, more general patient distress and causes of patient distress may be overlooked. Thus, there is a need for systems and methods that provide a solution for assessing or determining general patient distress and improving the level of patient care in response thereto.

Reference is now made to Figure 9, which is a flow chart of non-limiting embodiments or aspects of a process 900 for protecting patient health for fluid infusion. In some non-limiting embodiments or aspects, one or more of the steps of process 900 may be performed (e.g., completely, partially, etc.) by management system 110 (e.g., one or more devices of management system 110, etc.). In some non-limiting embodiments or aspects, one or more of the steps of process 900 may be performed (e.g., completely, partially, etc.) by a user or another device or group of devices separate from or including management system 110, such as fluid injection system 102 (e.g., one or more devices of fluid injection system 102), imaging system 104 (e.g., one or more devices of imaging system 104), sensor system 106 (e.g., one or more devices of sensor system 106), user device 108 (e.g., one or more devices of the user device 108 system), and/or auxiliary system 112 (e.g., one or more devices of auxiliary system 112).

As shown in FIG. 9, in step 902, the process 900 includes determining a change in one or more parameters of sensor data associated with the patient over a period of time. For example, the management system 110 may determine a change in one or more parameters of sensor data associated with the patient over a period of time. As an example, the contact sensor device 800 (and/or the contact sensor device 400) may determine sensor data (e.g., heart rate, oxygen saturation, skin resistivity, movement or activity level, temperature proximate to the injection site, etc.) (e.g., using a pulse oximeter, skin resistance sensor, accelerometer, temperature sensor, etc.) and transmit the sensor data to the management system 110. Alternatively or in addition, the non-contact sensor 164b may measure the patient's movement, flushing, swelling, and/or any other measurement described herein as measured by the non-contact sensor 164b and transmit the sensor data to the management system 110.

As shown in FIG. 9, in step 904, the process 900 includes determining a patient distress level associated with the patient. For example, the management system 110 may determine whether the patient is comfortable or in distress or may be in distress. For example, the management system 110 may determine whether the patient is in distress based on sensor data determined after fluid infusion has begun. As an example, the management system 110 may determine a change in one or more parameters of the sensor data over a period of time, compare the change in the one or more parameters to at least one threshold change, and determine the patient distress level and/or that the patient is in distress in response to a change in the one or more parameters that meets the at least one threshold change. In some non-limiting embodiments or aspects, step 904 of the process 900 may be performed as part of step 310 and/or step 314 of the process 300 and/or in the same or similar manner.

As shown in FIG. 9, in step 906, the process 900 includes providing an alert. For example, the management system 110 may provide an alert to the user device 108 indicating that the patient is in pain (e.g., in response to the patient's pain level meeting at least one threshold level, etc.) in response to determining that the patient is in pain. As an example, the user device 108 may display an alert to a user (e.g., a physician, etc.) that may include information and/or data related to the type of discomfort and/or pain experienced by the patient. For example, the user may take one or more actions to help improve the patient's comfort to reduce the patient's pain level. In some non-limiting embodiments or aspects, step 906 of the process 900 may be performed as part of step 312 and/or step 316 of the process 300 and/or in the same or similar manner.

9, in step 908, process 900 includes controlling a fluid injection system and/or an imaging system. For example, in response to determining that the patient is in distress (e.g., in response to the patient's distress level meeting at least one threshold level), management system 110 may automatically control at least one of: (i) the fluid injection system to modify, pause, or stop the fluid medium injection (and/or test injection), and (ii) the imaging system to adjust the timing of imaging operations (e.g., to delay or pause imaging until management system 110 determines that the patient is no longer in distress). In some non-limiting embodiments or aspects, step 908 of process 900 may be performed as part of step 312 and/or step 316 of process 300 and/or in the same or similar manner.

In some non-limiting embodiments or aspects, the management system 110 can automatically or semi-automatically take action to control one or more devices of the fluid injection system 102, the imaging system 104, and/or the sensor system 106 to distract a patient experiencing distress. For example, in response to determining that a patient is in distress (e.g., in response to a patient's distress level meeting at least one threshold level, etc.), the management system 110 can automatically control haptic devices (e.g., the patient's bed or table, the contact sensor devices 400 and/or 800, vibrators, acupressure devices, etc.), speakers, and/or displays to distract the patient (e.g., distract a patient experiencing nausea, distract a patient from an IV placement, etc.).

10, which is a flowchart of non-limiting embodiments or aspects of a process 1000 for promoting and/or protecting patient health for fluid infusion. In some non-limiting embodiments or aspects, one or more of the steps of process 1000 may be performed (e.g., completely, partially, etc.) by management system 110 (e.g., one or more devices of management system 110, etc.). In some non-limiting embodiments or aspects, one or more of the steps of process 1000 may be performed (e.g., completely, partially, etc.) by a user or another device or group of devices separate from or including management system 110, such as fluid injection system 102 (e.g., one or more devices of fluid injection system 102), imaging system 104 (e.g., one or more devices of imaging system 104), sensor system 106 (e.g., one or more devices of sensor system 106), user device 108 (e.g., one or more devices of the user device 108 system), and/or auxiliary system 112 (e.g., one or more devices of auxiliary system 112).

10, in step 1002, process 1000 includes providing breathing, posture (e.g., still, holding posture, etc.), and/or other behavior guidance. For example, management system 110, using at least one processor, may control at least one of lights (e.g., lights of injector 152, etc.), displays (e.g., injector user interface 156, etc.), speakers, and haptic devices (e.g., patient bed or table, contact sensor devices 400 and/or 800, etc.) to provide at least one of visual, audio, and haptic instructions to guide the patient's breathing (e.g., before, during, or after contrast injection).

It is useful for radiological imaging procedures for a patient to be able to control their breathing and remain still. The design of a powered injector is usually highly focused on the needs and interactions of the user (e.g., medical professional, etc.). However, typically less attention is paid to the patient and their interactions and perceptions, which may be overlooked during the development of a medical device. In a typical procedure, breathing induction is typically instructed by a medical professional (e.g., via an intercom). Also, many medical environments are perceived as cold (e.g., lacking emotionality and warmth). There are various patients who are overwhelmed with stress and anxiety, leading to and undergoing medical procedures.

Using illustrations, lighting, and sounds to improve meditation practice within a medical environment, such as a radiology suite scanning room, can change the patient's experience throughout the procedure. Patients typically lie supine during imaging procedures and look primarily at the ceiling and walls of the scanner's inner bore. In the absence of direct line of sight, the use of colored lighting (e.g., blue=calm, etc.) and ambient sounds (e.g., calming voice prompts, and white noise) can reach the patient to help them relax. Also referring to FIG. 11, FIG. 11 illustrates a non-limiting embodiment or aspect of instructions 1100 for guiding the patient's breathing, which can be delivered in the form of an animated video to the patient in the scanning room via a display (e.g., an injector display, an imager display, a user device, etc.). As shown in FIG. 11, an animated halo (e.g., on a graphical user interface, as lighting from the injector 152 and/or imager 158) showing shallow and deep breathing with expansion and closure can be displayed to the patient.

As the halo expands from the starting state, audio instructions may prompt the patient to take a deep breath, and illumination from the injector intensifies and colored lights shine into the scanner bore. At the fully expanded state, the display may remain fully illuminated as the audio prompts the patient to hold their breath. Once the patient is able to exhale (e.g., due to the end or pausing of an imaging operation, etc.), the halo may shrink back to the starting state and illumination may be of lower intensity. Optionally, the halo may include a number that counts down to inform the patient when they can breathe again. This gives the patient information about what is expected of them. Thus, visual output with audio prompts may be used to demonstrate proper breathing for patients undergoing and/or about to undergo a radiological procedure, such as contrast injection, imaging scan, etc., to calm the patient prior to the procedure, and/or to provide respiratory guidance during the procedure. In this manner, visual output and audio prompts can be used to calm the patient from the radiology scanning room by using mood lighting, soothing audio prompts, ambient noise, and/or haptic feedback (e.g., a vibrator in contact sensor device 400 and/or 800 that vibrates in time with animations, etc.), which are commonly used in meditation to relax patients who feel tense and anxious. Variations in the guidance and/or its presentation can be used to accommodate different patients (e.g., everyday, pediatric, cognitively impaired, phobic, etc.).

In some non-limiting embodiments or aspects, instructions for guiding the patient's breathing can be provided before and/or outside the patient entering the procedure or scanning room. For example, the instructions can be used as an educational tool to inform and/or prepare the patient and can be provided to the patient via a patient care portal or application for the system as described herein. In some non-limiting embodiments or aspects, the guidance can be used to practice before the procedure, optionally in the imaging room. The management system 110 in combination with the sensors 164a and 164b can assess the patient's ability to follow the planned instructions. If the management system 110 determines that the patient is unable to follow the planned instructions, the contrast injection and imaging procedure can be modified to accommodate the patient.

In some non-limiting embodiments or aspects, the management system 110 may adjust at least one of visual, audio, and haptic instructions for guiding the patient's breathing based on the timing of the imaging operations of the imaging system 104. For example, the management system 110 may automatically adjust instructions for instructing the patient to hold their breath when the imaging system 104 (e.g., imager 158, etc.) is actively imaging the patient.

As shown in FIG. 10, in step 1004, the process 1000 includes determining a distress level associated with the patient. For example, the management system 10 may determine whether the patient is comfortable, in distress, or in distress (e.g., whether the patient's distress level meets at least one threshold level, etc.). For example, the management system 110 may determine the patient's distress level and/or whether the patient is in distress based on sensor data determined after fluid infusion is initiated (e.g., based on sensor data determined via the contact sensor device 400, based on sensor data determined via the contact sensor device 800, etc.). As an example, the management system 110 may determine a change in one or more parameters of the sensor data over a period of time, compare the change in the one or more parameters to at least one threshold change, and determine the patient's distress level and/or whether the patient is in distress in response to a change in the one or more parameters that meets at least one threshold change. In some non-limiting embodiments or aspects, step 1004 of the process 1000 may be performed as part of step 904 of the process 900 and/or in the same or similar manner.

In some non-limiting embodiments or aspects, the management system 110 may determine whether the patient fluid injection and/or imaging scan meets one or more compliance thresholds (e.g., thresholds related to patient movement during the imaging scan, thresholds related to the quality of images acquired during the imaging scan, etc.) based on sensor data determined after fluid injection has been initiated. For example, the management system 110 may process sensor data related to patient movement/motion during the scan and artifact generation in the images of the scan to determine the effect of table motion.

As shown in FIG. 10, in step 1006, process 1000 includes adjusting behavioral guidance. For example, management system 110 may adjust at least one of visual, audio, and haptic instructions to guide the patient's breathing and/or positioning in response to determining that the patient is in pain (e.g., in response to the patient's pain level meeting at least one threshold level). As an example, management system 110 may provide audio and/or visual feedback to the patient related to the patient's measured breathing and/or adjust the timing of instructions and/or imaging scan time corresponding to the instructions. In some non-limiting embodiments or aspects, step 1006 of process 1000 may be performed as part of step 312 and/or step 316 of process 300 and/or in the same or similar manner.

In some non-limiting embodiments or aspects, the contact sensor device 400, 800 may remain in contact with the patient for a period of time after fluid infusion to provide information to the management system 110 to enable the management system 110 to assess the patient's ongoing post-infusion health and monitor for possible delayed adverse events, e.g., delayed allergic reactions. The management system 110 may notify the user (e.g., via the user device 108, etc.) of the patient's condition and can recommend additional monitoring time and/or other actions if the patient's condition or health is not optimal or sufficient for release.

The present disclosure anticipates continuous improvement of the devices, systems, and processes described herein. As measurements are made, data is collected, and predictions are compared to actual outcomes for more patients, the algorithms may be improved or replaced with more advanced algorithms, for example, a trained neural network may replace the total scores used in Tables 1 through 4. Initially, the management system 110 may only provide predictions to the healthcare professional and alert the healthcare professional to potential adverse events or discomfort. The management system 110 may do more, become more intelligent, and become less reliant on the healthcare professional as data is collected by the management system 110.

As an example, consider sound or vibration measurements via contact sensor 164a and/or non-contact sensor 164b. While it is common for medical personnel to place two fingers on the skin over the catheter exit or tip to "feel" the vibration of the fluid exiting the catheter at the beginning of a test or fluid injection (e.g., contrast injection), medical personnel generally cannot continue doing so because they need to be out of the imaging room when the imaging itself occurs. Thus, there is little data on how these vibrations evolve over the time course of the injection. Some data has been obtained in phantom and phantom/human hybrid settings. However, because adverse events such as extravasation or allergic reactions are very rare and phantom or animal models only go so far, it is anticipated that the management system 110 may initially provide a feature that may be referred to as a "remote electronic stethoscope" that allows medical personnel to remotely hear or feel the injection throughout the entire injection, rather than just feeling the injection site for a few seconds at the beginning of the injection. Initially, the management system 110 may not make any decisions or take any action to modify the injection or imaging study itself. However, as normal and abnormal injections are monitored and measured and correlated to outcomes, the management system 110 may provide the ability to alert a medical professional to the possible presence of an adverse event and/or alert a medical professional to a prediction of the onset of an adverse event, similar to the devices and systems of U.S. Patent Application Publication No. 2016/0224750A1, filed January 29, 2016, the entire contents of which are incorporated herein by reference. The management system 110 may recommend an action to the medical professional or may take an action that the medical professional can reverse. As normal and abnormal injections continue to be monitored, measured and correlated to outcomes, the management system 110 may become sufficiently sophisticated and/or trained in one or more areas that the management system 110 can sense and act in response to situations in ways that a human cannot. Additionally, over time and with improvement, medical personnel can gain confidence in the management system 110, which can then make more automated recommendations and actions. Additionally, the electrical or physical configurations of the various sensors can be improved based on learning from accumulated data.

The description and disclosure herein makes clear that devices, systems, and methods can gather and evaluate information about any infusion and ultimately evaluate any infusion along a continuum of benign or normal versus the presence of an adverse event, going beyond the typical two-bucket, single-threshold distinction between normal and abnormal that has been used in past devices looking for anomalies.

In many of the aspects and embodiments described herein, the sensor 164a and/or 164b and the management system 110 are considered to be in association with and in communication with other systems. In some non-limiting embodiments or aspects, the sensor 164a and/or 164b management system 110 may be a stand-alone system. An example of this may include the remote electronic stethoscope functionality described herein. This may be a simple system that senses sound and amplifies and transmits the sensed and amplified sound so that medical personnel can hear the sound emanating from the injection. A second example of a simple stand-alone system is the non-contact sensor 164b that monitors the injection site, enhances selected aspects of the image, and transmits them for medical personnel to view.

Although the embodiments or aspects have been described in detail for purposes of illustration and description, it should be understood that such details are for that purpose only and that the embodiments or aspects are not limited to the disclosed embodiments or aspects, but rather are intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment or aspect may be combined with one or more features of any other embodiment or aspect. Indeed, many of these features may be combined in ways not specifically recited in the claims and/or disclosed herein. Although each dependent claim listed below may depend directly on only one claim, the disclosure of possible implementations includes each dependent claim in combination with all other claims in the claim set.

100 environment

102 Fluid Injector System

104 Imaging System

106 Sensor Systems

108 User Device

110 Management System

112 Auxiliary Systems

114 Communication Network

150 Implementation

152 Injector

154 Injector control calculation system

156 Injector User Interface

158 Imaging device

160 Imaging device control calculation system

162 Imaging Device User Interface

164 One or more sensors

164a One or more contact sensors

164b One or more non-contact sensors

166 Control Calculation System

168 One or more hospital information systems

170 Cloud Computing and Off-Site Resources

172 Admin User Interface

200 device

202 bus

204 Processor

206 Memory

208 Storage Components

210 Input Components

212 Output Components

214 Communication Interface

300 process

400 Contact Sensor Device

402 Contact Sensor

404 housing

405a First end

405b Second end

406 Communication Devices

408 Processor

410 User Input/Feedback Devices

412 Battery

450 sheath

500 process

550 process

600 process

700 Implementation

702 Sound Generating Device

800 Contact Sensor Device

802 housing

804 Finger Sensor

805a First end

805b Second end

806 Wire

808 Electronic Components

810 Conductive Probes or Electrodes

812 Disposable adhesive protector

900 process

1000 process

1100 instruction

1201 Audio Data Stream

1202 Audio Data Stream

1203 Audio Data Stream

1204 Data Combining Technology

1205 Combined Data Streams

1206 Data Extraction Process

1207 Additional Data Streams

1208 Data Stream

1209 data

1210 Data Stream

1211 algorithm

1212 System Control