Medical device configuration based on recognition of identification information
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9 claims: 6 independent, 3 dependent
- 1Patent claims Zastrzeżenia patentowe 1. A medical supply system (10, 30) for delivering a medicament (17) to a patient, the system comprising:1. Medyczny system zasilający (10, 30), do dostarczania środka leczniczego (17) do pacjenta, przy czym system zawiera: a set of conduits (14, 34) adapted to be attached to a container (16) containing a medicament;zestaw przewodów (14, 34) dostosowanych do dołączenia do pojemnika (16) zawierającego środek leczniczy;identifier (18) integrated with the slide clamp (42) assigned to the cable set and containing the identification information related thereto and a supply device (12, 32) configured to couple the cable set and deliver the therapeutic agent to the patient, the supply device comprising a recognition system (20) capable of receiving identification information associated with the identifier and a slide clamp socket (44), integral with the recognition system 20 and configured to accommodate the slide clamp (42) associated with the cable set (14, 34), the power supply device being able to configure based on identification information, the identification information including the type of application associated with kit. identyfikator (18) zintegrowany z zaciskiem suwakowym (42) przyporządkowanym do zestawu przewodów i zawierający informację identyfikacyjną z nim związaną oraz urządzenie zasilające (12, 32) skonfigurowane odpowiednio do sprzężenia zestawu przewodów i dostarczania środka leczniczego do pacjenta, przy czym urządzenie zasilające zawiera system rozpoznający (20) nadający się do otrzymywania informacji identyfikacyjnej związanej z identyfikatorem i gniazdo (44) zacisku suwakowego, integralne z systemem rozpoznającym 20 i skonfigurowane odpowiednio do umieszczenia w nim zacisku suwakowego (42) związanego z zestawem (14, 34) przewodów, przy czym urządzenie zasilające jest w stanie dokonywać konfiguracji na podstawie informacji identyfikacyjnej, przy czym informacja identyfikacyjna obejmuje typ aplikacji związany z zestawem.
- 4System according to any of claims 1 to 3, wherein the identification information comprises information regarding the identification of at least one of the therapeutic agents (17), and the type of wired assembly (14, 34). 4. System według dowolnego z zastrz. 1 do 3, przy czym informacja identyfikacyjna zawiera informację dotyczącą identyfikacji co najmniej jednego ze środków leczniczych (17), i typu zespołu przewodowego (14, 34).
- 5System according to any of claims previous ones, wherein the supply device (12, 32) is an infusion pump (32). 5. System według dowolnego z zastrz. poprzednich, przy czym urządzenie zasilające (12, 32) jest pompą infuzyjną (32).
- 6System according to any of claims previous, wherein the therapeutic agent (17) is an enteric fluid, drug, electrolyte, blood or blood preparation. 6. System według dowolnego z zastrz. poprzednich, przy czym środek leczniczy (17) jest płynem dojelitowym, lekiem, elektrolitem, krwią lub preparatem krwi.
- 8System according to any of claims previous ones, where the identifier (18) is a bar code, passive RF element, magnetic element or non-volatile memory element. 8. System według dowolnego z zastrz. poprzednich, przy czym identyfikator (18) jest kodem kreskowym, biernym elementem RF, elementem magnetycznym lub elementem pamięci nieulotnej.
- 9System according to any of claims previous, but after configuration, the power supply device (12, 32)) is suitable for the implementation of functions related in particular to the type of application. 9. System według dowolnego z zastrz. poprzednich, przy czym po konfiguracji, urządzenie zasilające (12, 32)) nadaje się do realizacji funkcji związanych w szczególności z typem aplikacji. V2321PLOO / L V2321PLOO/L EP 1 755 729 B1 EP 1 755 729 B1 EP 1 755 729 Β1 EP 1 755 729 Β1 Y2321PL00 / L Y2321PL00/L V2321PL00 / L V2321PL00/L EP 1 755 729 B1 EP 1 755 729 B1 V2321PL00 / L V2321PL00/L EP 1 755 729 B1 EP 1 755 729 B1 FIG. 6 • 2I6 FIG. 6 •2I6 200 .220 oooo oooo 200 .220 oooo oooo 2I2 2i2 JL • 230 ^ 214 JL •230 ^214 2ΙΘ 2ΙΘ
Independent claims6
68 paragraphs, as filed
Technical Field [0001] The present invention relates generally to medical power systems, and more specifically to an application wire set, for use with medical power devices and a system for identifying information related to this wire set.
Background of the Invention [0002] The application of therapeutic fluids to a patient is known. There are many types of medical supply devices for the delivery of various therapeutic fluids, such as, for example, parenteral fluids, drugs or other medical supplies, electrolytes, blood and blood preparations, and the like. One particular type of medical delivery device is an infusion pump that can deliver one or more of these therapeutic fluids to a patient through various types of administration, such as intravenous (IV), intraarterial (IA), subcutaneous, epidural, irrigation, and fluid similar. Many medical delivery devices that operate under these types of administration typically use an application line set and associated container containing one or more therapeutic fluids. In the case of an infusion pump, the tubing set is usually included in the pump supply mechanism that facilitates the delivery of fluid to the patient.
[0003] US 2001/0040127 describes a dialysis machine having a detection device that detects identifiers disposed on the joints of containers with components of the dialysis solution. The detection device identifies the type and volume of the components of the dialysis solution.
[0004] US 5,980,501 describes a medicine container having an electric and / or magnetically actuated device embedded therein that carries data such as the identity and / or concentration of the drug. A separate clip-on reading device attached to the power supply reads data on the medium. [0005] US 2003/0139701 describes a medical infusion pump with an attached reader for barcode scanning on drug containers and on stamps of authorized healthcare professionals and patients.
[0006] US 2001/0020148 describes a medical device that reads identification information in the form of a bar code on accessories prior to their use in the device. If identification information is recognized, the device is activated ready for use.
[0007] US 5,647,854 describes a pump provided with a control module and an attachable cassette with a fluid tank provided with identification indicators. The control module contains the identification structure of the cassette indicators.
[0008] US 6,285,285 describes an assembly comprising a container and a device for computer monitoring the content of the container, provided with a printed circuit, an antenna and an electronic chip or memory card. The device is attached to a detachable compartment that contains a sample of the contents of the container.
[0009] US 5,926,014 describes a computerized mixing control device for preparing and administering therapeutic solutions. Barcode readers monitor the drug type and expiration date of the drug vials inserted into the device.
[0010] US 6,626,862 describes an angiographic injector system that uses ribs and flanges as key elements to ensure that the correct syringe body and accessories are used.
[0011] US 2002/0038392 describes a method and device for controlling IV drug delivery using identification labels on IV bags that identify specific input parameters.
[0012] US 2003/0135388 describes a drug delivery system comprising a hand-held device that reads a label on a drug container and a patient tag. After checking that the drug and patient match, the device transmits orders to the delivery device.
[0013] Each type of administration and type of therapeutic fluid typically requires numerous operational parameters, variables, restrictions, and other related information, such as relevant medical and pharmaceutical information that must be monitored and adhered to to ensure proper, effective and reliable delivery of therapeutic fluids. to the patient, and effective patient treatment. The nature and amount of this information makes its introduction into a medical device an overwhelming task that can be prone to human error. Although the majority of known delivery devices are microprocessor-based units, program-controlled, with assigned memory, and therefore can be adapted to the needs and control by the user - typically by loading specific data or software from another source, there is a risk of incorrect matching data and software for the application of appropriate treatment, medicine or fluid, or application team, especially from a logistical point of view. In addition, currently known delivery devices, such as infusion pumps, operate in a fixed operating configuration with a fixed set of functions, regardless of treatment, drug and fluid, or application assembly. This can be an additional source of error. The potential for errors in the delivery of fluids to a patient is numerous and minimizing such potential errors is an important goal.
[0014] The present invention solves these and other issues and generally provides new and improved systems, devices and methods associated with application line sets and associated therapeutic fluids for use with medical delivery devices for delivering fluids to a patient.
Brief description of the invention [0015] The present invention provides a medical delivery system for delivering a drug or fluid to a patient according to claim 1. In accordance with a specific aspect of the present invention, a disposable item having a certain identifier is used. The medical device associated with the system is able to recognize the identifier. In a specific embodiment, the system comprises a line set associated with a fluid containing container, an identifier associated with the line set and having associated identification information, and a supply device configured to engage the line set and deliver fluid to the patient. The power supply device includes a recognition system that is able to obtain identification information related to the identifier.
[0016] According to another aspect, the identification information is obtained by the device after coupling between the device and the line set. The identification information includes the type of application associated with the line set and may also include information regarding fluid identification, the type of line set or the type of administration associated with the line set.
[0017] According to another aspect, the identifier may be a bar code, a passive HF element, a magnetic element, a non-volatile memory element or the like.
[0018] The identifier is integrated with a slide clamp associated with the line set. [0019] The power supply device comprises a slide clamp socket configured to seat the slide clamp associated with the line set.
[0020] The recognition system is integrated with the slide clamp socket.
[0021] According to yet another aspect, the device may be configurable based on identification information.
[0022] According to yet another aspect, the device is automatically configured after receiving identification information from the identifier.
[0023] According to yet another aspect, the device, after configuration, may be specific functions related to identification information.
[0024] According to another aspect, a disposable element, such as a MEMS pump, may be used in the system of the present invention.
[0025] These and other aspects of the present invention are apparent from the drawings and the description provided herein, together with the appended claims.
Brief description of the drawings [0026]
Fig. 1 is a general simplified sketch of a medical delivery system according to the principles of the present invention.
Fig. 2 is a simplified sketch of the medical delivery system generally shown in simplified Fig. 1, including a medical infusion pump.
Fig. 3 is a perspective view of a slide clamp for use with a set of application wires according to the principles of the present invention.
Fig. 4 is a general view of the display screen of the medical pump of Fig. 2, showing various display fields that can be configured according to the identification information received by the pump.
Fig. 5 is a simplified sketch of a medical supply system according to another embodiment of the present invention.
Fig. 6 is a simplified sketch of a comparative medical power supply system.
Detailed Description of Preferred Embodiments [0027] Although the invention may be practiced in a variety of different forms, the drawings and the description describe the preferred embodiments in detail, understanding that the present descriptions should be considered as an exemplification of the principles of the invention and are not intended to be limiting. broad aspects of the invention to the illustrated embodiments.
[0028] As shown in Fig. 1, the medical delivery system or therapeutic fluid delivery system 10 is shown generally. The system 10 includes a medical power supply device 12 comprising a controller (C) having an allocated memory (M), a processor (P) and an input device (I). While it is preferred that the controller (C) is integrated into the device 12, it should be noted that the controller (C) may also be separate and / or different from the device 12. For example, the controller (C) may be associated with a personal digital assistant (PDA) or other external counting device that is different from device 12.
[0029] As also shown in Fig. 1, the system 10 further includes at least one set of wires 14, which can be considered as a disposable member or element. The conduit set 14 may be in communication with a container 16 containing medicament 17, or some fluid 17 for delivery to the patient. The combination of a conduit set 14 and a fluid containing container 16 is sometimes referred to as a delivery set. The container 16 can take many different forms, in one preferred embodiment, the container is a flexible bag. The wire set 14 typically includes wires having one end connected, or otherwise, in communication with the container 16 and the other end with a catheter or other device for communicating with the patient. The device 12 operates on part of a set of conduits 14 for delivering fluid 17 to the patient. The device 12 may be of any type suitable for delivering various fluids to a patient, such as parenteral fluids, drugs or other therapeutic agents, electrolytes, blood and blood preparations and the like. Fluid 17 may contain any fluid that can be delivered to the patient. The device 12 can deliver one or more types of fluids to a patient via a variety of types of administration, such as intravenous (IV), intraarterial (IA), subcutaneous, epidural, fluid space irrigation, and the like, one of the preferred forms of device 12 is infusion pump, as described, for example, in US Patent Nos. 5,782,805 and 5,842,841.
[0030] As shown in Figure 1, an identifier 18 is assigned to the application set 14 of wires. The identifier 18 may be referred to as an indicator 18. The identifier 18 may be physically attached to the wiring set 14 and loosely connected to it, or be in its vicinity. The identifier 18 may also be integral with the set of 14 wires, or attached separately. The identifier 18 has associated identification information. The identification information, which may include an identification code or data set composed of multiple data components, or a single data component, can be any type of information that the device 12 can use in the operation and treatment of a patient. The identification information includes the type of feed associated with this set of wires. In a preferred embodiment, the identification information also includes information regarding the patient's identity, medicament or fluid 17, type of conduit set 14, material forming the conduit set 14 (e.g. PVC, non-PVC) and / or other operational parameters. The identification information may also include information regarding a measure of the hardness of the line set, dimensions of the line set, e.g., data about the outside and inside diameter, information about the lines with small diameters, and / or other parameters necessary for accurate delivery of the drug through the line set. With respect to the drug, the identifier 18 may contain identification information, such as a drug identification number, as is known in the art. The identifier 18 may also contain information regarding: the patient, e.g., patient's name, age, sex, weight, allergies, disease, condition, etc .; a medicament attached as part of a set of 14 ducts (i.e. in container 16), e.g. drug / non-drug type, name, concentration, etc .; and medical therapy to be carried out with a set of 14 lines, including any or any of the process parameters necessary for drug therapy. Such process parameters may include at least the type of drug, concentration of drug, amount of drug, individual swallowing volumes, total swallowed volume, swallowing speed of the drug, dose, time intervals between administration of the swallowed dose, maximum number of swallowed doses, maximum number of swallowed doses per unit of time, initial dose volume, dose rate, duration of dose, maintenance rate maintenance volume, maintenance time, maintenance dose, dilution volume and patient weight. Finally, identifier 18 may include information about profile data, including, but not limited to, patient profile data such as patient pain status, chronological age, age group, pregnancy advancement and status profile data such as medical or medical condition including, but not limited to limitations with kidney disease, congenital heart disease, and liver damage. In addition to including specific information about treatment with a particular therapeutic agent, identifier 18 may also include general therapy with the primary therapeutic agent. For example, identifier 18 may include process parameters and data applicable to a variety of drugs, drug categories or patient profile categories and / or condition.
[0031] The information or code for the identifier 18 may be provided by a programming device and installed on the identifier 18. As explained in more detail below, the identifier 18 may be associated with a medical device, the medical device being authorized by recognizing the identifier 18. The identifier 18 may also be programmed with an additional component or information bit that allows the programming device in the previous system to reuse the identification information or data code. This is also described below with reference to other embodiments.
[0032] The identifier 18 may be attached to the set of 14 wires by the manufacturer of the set of 14 wires, by a hospital pharmacy or by another unit. When the identifier 18 is attached to the cable set 14 by the manufacturer, the cable set typically does not yet contain a container 16. The cable set 14 as such may be prefabricated and provided as having information applicable to a certain category or group of therapeutic agents. This set of wires with identifier 18 can then be attached to a container 16 containing a therapeutic agent from this category. Alternatively, a set of 14 wires can be largely adapted to the specific needs and contain many of the specific patient parameters and / or treatment parameters specified above. Such customization is typically performed by a pharmacy, with specific prescription and treatment directions typically being added to Identity Identifier 18.
[0033] The identifier 18 may have any form, for example a bar code or other, associated with an IR technique, an RFID technique, like an RFID tag, any other passive RF element that can be checked by calling, a magnetic memory device, or any other device or method that can provide information or enable it to be loaded into another device or system. The device 12 includes a recognition system 20 that is able to recognize the identifier 18 and / or receive or download identification information for use by the device 12. In a preferred embodiment, the recognition system 20 is part of the controller (C). The form of the recognition system 20 will depend on the particular form of the identifier 18 and associated technology. For example, if the identifier 18 is a bar code, then the recognition system will be an IR element or other light-emitting element capable of reading the bar code. The appropriate form of the recognition system 20 will be apparent to those skilled in the art after determining the form of the identifier 18, and will include all known devices and methods that are suitable for receiving or retrieving identification information from a particular form of identifier 18. It is understood that the identifier 18 and the recognition system 20 can be used such that when the identifier 18 is in a particular proximity to the recognition system 20, the recognition system 20 can recognize and identify information associated with the identifier 18, without being physically connected or directly oriented.
[0034] Fig. 2 shows a preferred embodiment in the form of a medical supply system 30. The system 30 comprises an infusion pump 32 and at least one application set 34 connected to a container 35 containing fluid 36 intended for delivery to a patient. It should be noted that the infusion pump 32 may be of any type, including volumetric infusion pumps, cassette pumps, syringe pumps, or HEMS (microelectromechanical) pumps. The infusion pump 32 is preferably a microprocessor pump that can be programmed using software and / or firmware to ensure operation and function of the pump 32. The software is preferably stored on a computer-readable storage medium residing in the pump controller (C) 32, such as memory (M). The line set 34 includes a fluid tube 38 that is used by the pump 32 and allows fluid 36 to flow to the pump 32. The system 30 is shown in Figure 2 as comprising three application line sets 34, although a single line set and a single pump could be used channel. Pump 32 can deliver one or more types of fluids to a patient via various types of administration methods, such as intravenous (IV), intraarterial (IA), subcutaneous, epidural, irrigated fluid and similar applications. Fluid types may include, for example, parenteral fluids, drugs or other medical supplies, electrolytes, blood and blood preparations, and the like. In this particular embodiment, the pump 32 includes three channels 40, each configured to insert a tube 38 of one of the sets 34. As is known in the art, the pump channels 40, operating fluid, deliver fluid 36 from the container 35, through the tube 38 of the tube set 34 to the patient. Each of the feeding wire sets 34 includes a slide clamp 42, as for example shown in Fig. 3. The slide clamp 42 is shaped to interact with the tube 38 of the conduit set to prevent unwanted flow through the tube until it is inserted into the seat 43 of the tube associated with the pump channel 40. The pump has a slide clamp socket 44 for each of the channels 40.
[0035] The slide clamp 42 includes an identifier 18 as previously described. The slide clamp 42 and identifier 18 can be considered as disposable. The slide clamp identifier 42 may have any form, e.g., a bar code (including, but not limited to, one or two-dimensional bar codes) or other IR-related RFID technique such as RFID tag, any other passive RF element or transponder which can be checked by calling, magnetic storage device, non-volatile memory or any other device or method, capable of providing information or enabling it to be read into the pump 32. The pump 32 includes a recognition system 20, as described previously, which is able to recognize the identifier 18 and / or receive or receive identification information for use by the pump 32. The identification information includes the type of administration assigned to the cable set. In a preferred embodiment, the identifier 38 is a bar code 50 on the slide clamp 42, as shown in Fig. 3 and the recognition system 20 is a bar code reader (in a preferred embodiment it is integrated with the terminal socket 44) which can read the bar code 50 'and receive identification information for use by the pump 32. In a preferred embodiment, the identification information also includes information about the identity of the medicament 36 or fluid 36, type of tubing set 34 and / or other desired information, such as patient age or other patient data, type of treatment, type of disease, and type of patient condition . It is further evident that the identifier 18 can be placed in a number of different locations of the slide clamp 42. The recognition system 20 is arranged based on the position of the identifier 18 or the clamp slide 42, respectively.
[0036] When the pump 32 receives identification information from the identifier 18, the pump 32 can use the information in a number of ways, including changing the operation of the pump. For example, after the pump 32 receives identification information, the pump 32 can be configured according to this identification information. In a preferred embodiment, the pump 32 is configured automatically after receiving identification information from identifier 18, i.e. configured in connection with receiving this information. The configuration may include setting and / or implementing any number of operating parameters and / or pump user interfaces 32. For example, after configuration, the pump operating system may modify the availability of some functions, for example by adding or unlocking some functions, especially related to identification information. For example, the configuration may include unlocking a function that should only be available for a particular type of administration, fluid or line set. Conversely, the pump operating system may modify the availability of some functions by blocking the function of specific types of delivery, fluid or line set. For example, identifier 18 may include information that identifies the type of wire set used, e.g., epidural. based on the identification of the 34 wire set being the epidural 34 wire set, the next pump operation 32 and patient treatment will be dictated by this initial identification. The pump 32 could also be configured to operate on the basis of recognizing the type of material from which the pipe set 34 is formed. [0037] The configuration aspect of the present invention may have numerous applications in the context of a medical power supply system. Although some examples of specific configurations are described herein, it is obvious that there are numerous other potential configurations that are available, alone or in combination, in accordance with the basic principles of the present invention, and although they have not been described in detail, they are considered to be falling within the scope of the present invention by the application of these principles.
[0038] According to the principles of the present invention, the pump controller (C) 32 may be configured to facilitate pump configuration based on a set of configuration information related to the designated configuration information which is pre-loaded into memory (M). In such cases, the recognition system receives identification information from the identifier assigned to the application wire set and the processor retrieves a set of configuration information assigned to the received identification information based on a comparison of the pre-determined identification information with the received identification information. With a match between the received identification information and the pre-determined identification information, the processor configures the controller based on a set of configuration information. Compliance criteria can be defined in a number of ways, such as compatibility between the type of cable set or the type of application associated with the cable set. Compliance criteria can also be defined by identifying certain parameters or values falling within a designated range. It is considered that the healthcare facility can customize the pump controller by defining predefined identification information, compliance criteria and / or preloaded configuration information set or profiles.
[0039] In some cases, it may be desirable to modify the availability of components and functions of the pump 32 based on identification information, for example, adding a function or unblocking the function of the pump 32 for some information and unblocking the function of the pump 32 for some identification information or other criteria. For example, added functions may include notification specifically related to identification information, e.g., notifying the user about the unique characteristics of a particular fluid type or application line set. The added functional capabilities may also include the user's availability of a set of directions for applying a particular fluid, e.g. directions for the recommended application of a particular drug. The added functions may also relate to the administration of a particular fluid, for example, provide directions for the recommended administration of a particular drug. Functionalities added may also include the user's availability of a set of tips on pre-established rules for the application of a particular fluid, such as those set by the hospital for changing a set of lines. Features may include some notifications, such as notifying the user about the type of delivery assigned to a particular fluid. In some cases, it may be desirable to provide functional capabilities that include connecting the user to certain types of information, such as a drug protocol associated with a drug identified by identification information. In this embodiment, the protocol may contain drug-specific information regarding dosing and administration. In other cases, it may be desirable to add functional capabilities that include a warning system, which may include alerting, in the event of incompatibility of a drug, based on the identification of a particular drug. In some cases, it may also be desirable to provide functional capabilities that include the escalation of an alarm, which leads to an escalation of the alarm associated with a particular treatment related event when the alarm is not dealt with by the caregiver. In some cases, it may be desirable to remove or block a portion of the pump function 32 based on identification information. For example, a particular function may be blocked based on identification information, e.g., blocking a certain function based on the application type identification. In a more specific example, the automatic tandem transport function can be blocked in the pump 32 based on identification of the epidural type of administration.
[0040] The configuration may include adjustments or changes to the system. For example, based on the identification information, advantageously, adjustment to the pump sensor system of the pump can take place.
[0041] It is also contemplated that the feature may be enabled when configuring the system based on the identification of the treatment system, e.g., identification of a particular combination of container, fluid, line set and / or type of administration, e.g., complete line set application. In these cases, functions that are specific to the treatment system may be added, such as entering notifications or tips for a particular combination. For example, a particular fluid container with a line set combination, e.g., a combination included in a particular line set combination, may have certain rules that apply only to a particular combination. [0042] The configuration may also include changes to the user interface 46 (shown in Figure 2) of the pump 32 based on the configuration. For example, as shown in Fig. 4, the introduced functions may require the addition of one or more soft keys 60 on the display 48 of the pump 32. On
- display 48, based on the added functionalities, in display field 62 of display 48, some labels, messages or other information may also be given. Conversely, some soft keys 60 may be "grayed out" or deleted if a function is blocked, and some labels or information in the display field 62 may be deleted. The display field 62 can be further divided into smaller sub-fields, which can also be customized. It should be noted that the software keys 60 may alternatively serve as labels for hardware keys (not shown) on the user interface 46 popy 32. It is obvious that when the user interface of the pump 32 is customized based on identification information, it is possible to eliminate multiple sources potential errors.
[0043] The identification information associated with the identifier 18 can be used in diagnostic applications. For example, information may indicate to pump 32 that some tests or diagnostic procedures should be performed. It is also contemplated that the identifier 18 may be associated with a diagnostic cable set. In this case, specific parameters, mechanisms and operational alarms in pump 32 can be evaluated to ensure correct operation when the diagnostic cable set is inserted into the pump 32 and the pump 32 recognizes identification information as indicating that a diagnostic cable set has been loaded. For example, the identifier 18 assigned to the diagnostic cable set may instruct the pump 32 to check and confirm that the associated alarms are in the correct operating state. The diagnostic delivery kit may contain a container containing a particular fluid to be used for testing. In this case, when the pump 32 recognizes the identifier 18 assigned to the diagnostic set, this pump 32 can perform a series of checks, where the expected operating parameters of the pump 32 based on a particular fluid can be used as diagnostic standards.
[0044] Fig. 5 shows another embodiment of the system of the present invention, generally designated with reference numeral 100. Similar to the embodiments described above, the system 100 uses a disposable element and identifier. In a preferred embodiment, a disposable element, such as a disposable pump, is used. The single-use pump can be a micro-pump, MEMS pump (microelectromechanical system), or other type of single-use pump. As shown in Figure 5, the system 100 generally includes a medical device 112, preferably a MEMS pump, an application set 114, and a container 116. System 100 may also take the form of any of the systems, such as, for example, described in patent application US 2003/0130625 belonging to the same owner (application number 10 / 040,887), under the title "Infusion System".
[0045] The container 116 is a container similar to the container 16 described above. In a preferred embodiment, the container 116 is a flexible bag adapted to contain a medical or therapeutic agent, for example a medical fluid. The application set of 114 wires is similar to the set of 14 wires described above. The conduit set 114 includes a tube having one end connected, or otherwise, in communication with the container 116 and the other end having catheters or other device for communicating with the patient.
[0046] As it is further shown in Fig. 5, the MEMS 112 pump is operatively connected to a line set 114. The MEMS 112 pump can be connected to a set of 114 lines in various configurations. For example, the MEMS 112 pump may have an inlet window 120 and an outlet window 122, at
- whereby the MEMS 112 pump is connected in the intermediate part of the 114 wires set. Accordingly, part of the conduit set 114 is attached to the inlet window 120 and part of the conduit set 114 is attached to the outlet window 122, wherein the MEMS 112 pump is operably connected to the conduit set 114. When properly connected, the MEMS 112 pump can pump fluid from container 116 through a set of 114 patient lines. The disposable pump 112 could be additionally incorporated into the interior of the 114 conduit set or otherwise take some form integral with the 114 conduit set.
[0047] As described, the pump 112 may be a MEMS 112 pump. MEMS components are typically etched in silicon. It is further evident that other types of electromechanical system components, such as devices that are micro-cast in plastic, can also be referred to as MEMS. Thus, MEMS components may contain silicon etched, molded or otherwise small-scale components.
[0048] System 100 may also use an identifier 118. In one preferred embodiment, the identifier 118 is associated with, or otherwise connected to, the MEMP pump 112. It is understood, however, that the identifier 118 can also be associated with other elements, and attached elsewhere, such that the disposable cord set 114 as shown in Figure 5. The identifier 118 is similar to that described above and may contain any of the identifying information or indicators or data as described above.
[0049] The system 100 may further use the controller 130. The controller 130 is operably associated with the MEMS 112 pump. The controller 130 may communicate with the MEMS 112 pump via a wireless connection. Alternatively, a hardware connection may be used, with the MEMS 112 pump being inserted into the controller 130. It is further understood that the controller 130 may be an integral part of the MEMS 112 pump. It is further understood that the controller 130 may be a separate portable computer or a separate network computer that controls the pump 112 via a communication network link. As in the above discussion, the controller 130 has a recognition system 132. The recognition system 132 is able to recognize the contained data and identifier 118.
[0050] The recognition system 132 may interact with the identifier 118 in operation of the system 100. For example, the identifier 118 may include information that identifies the type of wiring set 114 attached to the MEMS 112 pump. The identifier 118 may further include any of the other types of information described above . The information contained on identifier 118 may also include data relating to functions that instruct the controller 130 in controlling the MEMS 112 pump. It is further understood that a disposable element such as the MEMS 112 pump can be activated by a separate patient care system.
[0051] It is understood that the disposable element can take many different forms. The MEMS 112 pump or a set of 114 wires could be considered a disposable element, or a combination of both. In addition, other MEMS parts could also be used in the system 100.
[0052] Fig. 6 shows a comparison system, generally indicated by reference number 200.
Like the embodiments described above, the system 200 uses a disposable item and identifier. Like the system 100 of Fig. 5, a MEMS component, such as a pump, is used
MEMS. As shown in Figure 6, the system 200 generally includes a medical device 212, preferably a MEMS 212 pump, an application cable set 214 and a container 216. The system further includes a programming device 220 and a controller 230.
[0053] As in the systems described above, the identifier 218 in the preferred embodiment of Fig. 6 is associated with the disposable element, the identifier 218 is associated with the MEMS 212 pump and may contain any type of data as previously described. As further shown in Fig. 6, the programming device 220 is used to program the identifier 218 with the data, identification code or other identification information needed. Partly as part of the programming function, the programming device 220 may program the identifier 218 with an additional identification component intended for use in a separate stage of the system 200. It is understood that the identifier 218 will be a device that is known in a known manner in memory as well as capable of being reconfigured, reset or changed . After programming by programming device 220, the MEMS 212 pump can be activated by the controller 230. The controller 230 may be part of a general patient care system operated, for example, in a hospital environment, in one arrangement, the controller 230 could be in the form of a portable computer, e.g. a personal digital assistant. The controller 230 recognizes the identifier 218 and activates the pump 212. When activated, the controller 230 controls the MEMS 212 pump, wherein the pump 212 operates to deliver medicament to the patient. Pump 212 has the ability to recognize a predetermined event, e.g., a complete emptying of a container when the fluid is generally, generally, pumped from that container 216. For example, the MEMS 212's detection of reaching a certain pressure should cause the MEMS 212 to shut down. When the MEMS 212 pump was turned off, this state could trigger an additional identification component, stored in memory with the identifier 218, or in another location, in a separate memory element, to change the status of the additional identification component, to indicate that the MEMS 212 memory has been disabled.
[0054] Thus, when the pump 212 recognizes that the container 216 is empty, the additional identification component changes state of memory and can be considered activated. Once activated, the additional identification component may be recognizable. This recognition can take many forms. For example, in one embodiment, a signal is fed back to the controller 230 and / or programming device 220, indicating that the original identification data can be reused in the next operation of the system 200. In an alternative solution, the controller 230 and / or the programming device 220 may download, i.e. read in an additional information component from its location, e.g. from identifier 218 on pump 212. Thus, the additional identification component allows the identifier 218 to have a reusable identification component. In addition, the identifier 218 can be set and then reset or configured and then reconfigured (e.g. to be changed). In one setting, the identifier 218 is an RFID identifier. This component may additionally contain any form of electrically convertible non-volatile memory. It is understood that communication can take place directly with the programming device 220 or in communication via the controller 230. When using an additional identification component or an additional identification bit, the identification code can be reused to enhance the overall operation of the system. It is also understood that the above-described event could also be, for example, an event in which the controller indicates the end of infusion therapy (e.g., regardless of the amount of drug remaining in the container).
[0055] It is further understood that although the additional identification component may be reused for a new infusion therapy with a new set of system components, the system is configured to prevent the use of an additional identification component with the same components as in the original therapy. Thus, the additional identification component and, for example, the disposable MEMS pump in the first infusion therapy cannot be reused with the second infusion therapy. If there were such an attempt, the system would not work for the second infusion therapy. The additional identification component may be used for new therapy only with new components.
[0056] Additional features may be used together with any of the above described embodiments. As stated, a complete kit may be formed, which may include a container 16, a set of wires 14 and an identifier 18. The identifier 18 may be associated with or connected to both the container 16 and the set of wires 14. In some embodiments, the container 16 may include a pre-attached regenerative device having a pre-attached drug container, e.g. a vial. The regenerating device could be activated to regenerate the drug along with the fluid 17 in the container 16. It is understood that the identifier 18 may also contain information about the vial that can be pre-attached to the regenerating device. In another embodiment, a disposable pump, for example a micropump or MEMS pump, may be connected to the set of 14 ducts and be considered part of the set. The identifier 18 associated with such sets may have any of the information described above for the overall proper operation of the system. In yet another embodiment, the container 16, or container 16 associated with the set, may include pre-mixed medicament 17. The identifier 18 associated with the premixed medicament 17 may have an expiration date assigned to it. The supply device, i.e. the pump, used in such a set has a recognition system that recognizes identifier 18 and the date the pump was started. The pump is configured so that it will not operate if the recognition system determines that the start date is after the recognized expiration date. Thus, if the pump recognition system reads the invalid date, the pump will not start and indicates the medicine with the expiration date exceeded. In one preferred embodiment, the system will also include an alarm system functionally connected to the system that is able to generate an alarm if an expired therapeutic agent is detected. An alarm may take different forms and may contain acoustic components, visual components or a combination of both.
[0057] It is further understood that the pump used in the present invention will contain security software. The security software is able to generate basic fault alerts, with the pump assuming a failure condition, for example without the free flow of medications through the pump. It is possible to use different software / pump configurations. For example, all software may be located in the pump head, or all software may be located outside or away from the pump head. In addition, all software can be located outside the pump head, except for special security software that is located in the pump head.
Specific examples [0058] Two specific examples of applying the principles of the present invention are described below.
[0059] In the first example, an application cable set provided with an identifier is introduced into the pump. After inserting the slide clamp into the slide clamp socket on the pump, the pump recognition system receives identification information from the identifier. In this example, the identification information indicates to the pump that the type of application associated with the tubing that has been introduced into the pump is intestinal. Based on the identification of the enteric type of application, the pump software performs pump configuration for enteral introduction based on one of the sets of application set of cables associated with enteric application. In this particular example, the pump unlocks saving the history of the volume.
[0060] In a second embodiment, an application line set having an identifier is introduced into the pump. After inserting the slide clamp into the slide clamp socket on the pump, the pump recognition system obtains identification information from the identifier. In this example, the identification information indicates to the pump that the type of application associated with the line set that has been introduced into the pump is intestinal. Based on the intestinal type identification in the application, the pump software makes the pump configuration for enteral application. In this case, the pump unlocks features that include continuous fluid dripping, unlocking the tandem transport related pump properties, blocking the airway sensor, and blocking the properties of the occlusion detection pump.
[0061] It should be understood that the invention may be implemented in other specific forms, without departing from its main characteristics. These embodiments should be followed
0 therefore considered to be illustrative in all respects, and the invention is not limited to the details set forth herein.
24 members in 15 offices
Priority claims8
| Document | Office | Kind | Date |
|---|---|---|---|
| 85585504 | United States of America | A | |
| 85585504 | United States of America | A | |
| 05737651 | European Patent Office (EPO) | A | |
| 2005013350 | United States of America | W | |
| 2005013350 | United States of America | W | |
| EP20050737651 | – | – | – |
| US20040855855 | – | – | – |
| WO2005US13350 | – | – | – |
Members24
| Document | Office | Kind | |
|---|---|---|---|
| AU2005249904A1 | Australia | A1 | |
| CA2560996A1 | Canada | A1 | |
| US2005277890A1 | United States of America | A1 | |
| WO2005118054A1 | World Intellectual Property Organization (WIPO) | A1 | |
| IL177514A0 | Israel | A0 | |
| IL177514D0 | Israel | D0 | |
| EP1755729A1 | European Patent Office (EPO) | A1 | |
| MXPA06013556A | Mexico | A | |
| CN1950125A | China | A | |
| BRPI0511611A | Brazil | A | |
| HK1104165A1 | Hong Kong, China | A1 | |
| EP1755729B1 | European Patent Office (EPO) | B1 | |
| AT422935T | Austria | T | |
| ATE422935T1 | Austria | T1 | |
| DE602005012820D1 | Germany | D1 | |
| DK1755729T3 | Denmark | T3 | |
| ES2322658T3 | Spain | T3 | |
| PL1755729T3This record | Poland | T3 | |
| CN1950125B | China | B | |
| AU2005249904B2 | Australia | B2 | |
| IL177514A | Israel | A | |
| US7927313B2 | United States of America | B2 | |
| IL205828A | Israel | A | |
| CA2560996C | Canada | C |
Numbers
- Publication, DOCDB
- 1755729
- Publication, EPODOC
- PL1755729T
- Application
- 737651
- Application, DOCDB
- 05737651
- Application, EPODOC
- PL20050737651T
Titles2
- English
- Medical device configuration based on recognition of identification information
- Polish
- Konfigurowanie elementu medycznego na podstawie rozpoznawania informacji identyfikacyjnej
Classification
- CPC, 8
- A61M5/172
- A61M5/1413
- A61M39/287
- A61M2005/14208
- A61M2205/0244
- A61M2205/14
- A61M2205/6018
- G16H20/17
- IPC, 5
- A61M5 14
- A61M39 00
- A61M5 172
- A61M39 28
- G16H20 17