System and method for differentiating containers in medication delivery

TECHNICAL FIELD [0001] The invention relates to a system and method for distinguishing between syringes and other drug dispensing containers, which prevents the administration of an incorrect drug and ensures that the dispensed drug is compatible with the delivery apparatus.

BACKGROUND ART [0002] Health care professionals are often forced to treat patients for one type of physiological condition while monitoring at least one or more physiological parameters. It is often necessary to give the patient various medications to control these physiological parameters. Monitoring and controlling many physiological parameters in many patients requires a lot of time and resources on the part of healthcare professionals. With the constantly growing shortage of healthcare professionals, it has been found that workload is directly proportional to the increase in medication errors. Medication errors occur more frequently than is commonly known and many of the errors are life-threatening. In addition, these errors often remain undetected and / or reported.

[0003] In physiological conditions, numerous physiological conditions are monitored, including glycemic status, blood coagulation and overall physiological stability of the patient. Usually, however, healthcare professionals measure only one physiological parameter, such as glucose level, prothrombin time, blood flow, hemoglobin level, heart rate, blood pressure, arterial oxygen concentration, or other cardiac output, to treat the particular physiological condition tested. Based on this measurement or a series of these measurements, the employee administers the drug to the patient to stabilize the physiological parameter and thus treat the physiological condition.

[0004] Control of glucose levels in seriously ill patients has proved to be a significant problem. Hyperglycaemia is a common consequence of severe disease, occurring in both diabetic and non-diabetic patients, due to changes in the metabolism and hormonal system, gastrointestinal motility disorders, changes in heart function, increased catecholamine production, changes in hepatic gluconeogenesis, relative insulin resistance and increased levels of corticosteroids. Symptoms associated with elevated blood glucose levels include dehydration, weakness, a greater risk of poor healing, and infections, frequent urination and thirst. Insulin infusion has proved to be an effective treatment for hyperglycaemia. However, insulin infusion without proper glucose monitoring can lead to hypoglycemia problems.

[0005] Visually distinguishing one drug from another can be difficult in many circumstances. Syringes and other containers have standardized sizes and different liquid drugs may look identical. Printed labels often become the only mechanism for determining that a drug installed in a pump or other administration device is the intended one. If the label is misread, the patient's health consequences can be severe.

[0006] The possibility of error increases when the use of treatment allows or requires the administration of multiple substances. The healthcare professional must then use multiple potentially conflicting drugs simultaneously, identifying and installing them without error. When this process is repeated often and for many patients, the burden of being faultless becomes overwhelming.

[0007] One particularly important application includes compensatory treatment. In such applications

In parallel, opposing biological drugs are used to strengthen the body's innate push-pull mechanisms, by raising or lowering specific biological levels as needed. Examples of this include the regulation of serum glucose using insulin and glucose as mentioned above, vasodilation using a vasoconstrictor and a vasodilator, and coagulation using a coagulant and anticoagulant. If you switched the opposite biological drugs, such treatment could cause worsening of imbalances in proportion to their size, rather than improving them. This effect can be difficult to detect at low levels of imbalance and intensify to an uncontrolled effect, exposing the patient to significant danger.

[0008] In addition to significant health risks, erroneous drugs may also be incompatible with delivery devices. For example, the pump must exert a certain force on the fluid to displace the intended volume. Fluid with a viscosity beyond the expectation and tolerances of the pump may be dosed in the wrong amounts and possibly damage the pump mechanism.

[0009] There is therefore a need for a physical system and method that ensures that the installed drug container is the one that is expected for a given treatment application.

[0010] In US 2009/0112333 an apparatus for administering fluid to a patient is disclosed. The apparatus includes an infusion pump for fluid delivery and a control unit electrically connected to the infusion pump. The control unit is adapted to read the RFID tag associated with the container containing the fluid and read the RFID tag associated with the patient. The control unit can be programmed to check the patient's name associated with the patient's RFID tag and the patient's name associated with the container.

[0011] US 6,743,202 discloses an apparatus for injecting fluid into a patient in which information about the syringe relevant to the procedure is encoded and transmitted to the pen.

[0012] WO 03/026558 discloses methods for marking elements of drug delivery devices and other medical systems with quality assurance information. Drug containers can be labeled with quality assurance tags such as barcodes, holograms, RFID, smart cards, and EEPROMs. [0013] WO 03/047665 discloses a drug cassette that can be designed for a particular drug delivery apparatus. The medicine cassette may contain a convex ring used as an indicator of the medicine contained within the medicine cassette. The medicine cassette works with an administration apparatus containing a processor and switch. The medication delivery device will only work when the switch is turned on by a convex ring.

SUMMARY OF THE INVENTION [0014] A fluid delivery system for drug delivery and a method of connecting a fluid container to the delivery device are defined in the appended claims. independent, to which reference should now be made. Preferred features of the invention are defined in the various claims. dependent.

[0015] The invention is defined in claim independent and solves the above problems by providing a fluid supply system comprising a fluid container having a chamber constructed to hold fluid therein and a delivery device adapted to control fluid delivery from the fluid container chamber. The fluid container comprises a matching geometric member protruding from its outer surface. The delivery device includes a matched geometric seat constructed to fit at least a portion of the matched fluid member geometric member to verify fluid container compliance with the delivery device.

[0016] According to another embodiment of the invention, there is provided a fluid delivery system that includes

A fluid container having a chamber constructed to hold a fluid therein and a delivery device adapted to control fluid delivery from the fluid container chamber. The fluid container contains the associated element of the first data device. The delivery device includes the associated second data device component that interacts with the first fluid device data device component to verify fluid container compatibility with the delivery device.

DESCRIPTION OF THE FIGURES [0017]

FIG. 1 is a block diagram illustrating one exemplary system for providing balanced, automated regulation of a patient's physiological condition, which uses the system and method of distinguishing between syringes according to the invention.

FIG. 2A and 2B are perspective views showing one example syringe that may contain geometric differentiation means according to the invention.

FIG. 3 is a perspective view of the syringe of FIG. 2 operationally connected to one sample infusion pump.

FIG. 4A-4C are diagrams illustrating the fit relationship between a matched geometric member and the corresponding matched geometric seat of the invention. FIG. 5 is a perspective view showing the fit relationship between the matched geometric member of FIG. 4A-4C and an example of an alternative matching socket. FIG. 6 is a perspective view showing the fit relationship between the matched geometric member of FIG. 4A-4C and another example alternative matched socket.

FIG. 7A-7I are diagrams showing exemplary differential geometries that can be used according to the invention.

FIG. 8 is a diagram showing different differential geometries embedded in a two-channel delivery environment.

FIG. 9 is a diagram showing different differential geometries embedded in a three-channel delivery environment.

FIG. 10 is a partial perspective view of a syringe that includes both a matched geometric member and additional matched devices for additional verification of syringe compliance.

FIG. 11 is a diagram illustrating the use of an active data device for additional syringe compliance verification.

FIG. 12 is a flow chart showing the steps in the procedure for distinguishing one exemplary drug container according to the invention.

FIG. 13 is a perspective view of an exemplary administration apparatus that is adapted to distinguish / identify a syringe solely on the basis of information provided by the geometry sensors and / or data device.

FIG. 14 is a condensed version of the flowchart of FIG. 12 showing some sample steps in a procedure for distinguishing a drug container.

FIG. 15 is a block diagram illustrating example components of a controller that can be used to process information collected during a drug discriminating procedure.

DETAILED DESCRIPTION OF THE INVENTION

[0018] In general, the invention is a system and method for distinguishing between syringes and other drug dispensing containers, which protects against the administration of the incorrect drug and verifies the compatibility of the dispensed drug with the administration apparatus. As will be discussed in more detail in particular, the invention relates to distinguishing between infusion syringes and other drug containers by using independent syringe geometries and corresponding seats on syringe caps or drug delivery devices. Alternatively or additionally, the invention relates to distinguishing drug containers by using data devices associated with the drug container and the delivery device. One specific embodiment of the invention relates to distinguishing drug containers in a multi-channel delivery environment.

[0019] FIG. 1 is a block diagram illustrating one example system 10 for providing balanced, automated regulation of a patient's physiological condition, which uses the system and method of distinguishing between syringes according to the invention. As shown in FIG. 1, the system 10 generally includes a physiological monitor 12, an electronic control unit 14 and an administration apparatus 16 comprising a single administration channel or multiple administration channels. In particular, the delivery apparatus may comprise one or more delivery lines, pumps or other suitable dispensing devices. In a multi-channel environment, the delivery apparatus can be configured with multiple single-channel devices, one or more multi-channel devices, or a combination of single and multi-channel devices. The controller 14 may be separate from or built into the feeding apparatus 16.

[0020] In one exemplary embodiment, the delivery apparatus 16 comprises two pumps, a first pump 18A and a second pump 18B for administering drugs to patient 20. In an alternative embodiment, the delivery apparatus 16 may include one or more additional pumps, such as a third pump 18C for administering one or more additional drugs to patient 20. Those skilled in the art will know that the delivery apparatus 16 may contain any number of pumps for administering any number of drugs. In the above embodiments, the use of multiple pumps may allow simultaneous monitoring and control of several parameters and physiological conditions.

[0021] Those skilled in the art will know that 18A, 18B and 18C pumps can be selected from a wide variety of infusion pumps commonly used in the medical industry, including pumps for continuous and / or intermittent operation, the choice of which will vary depending on such criteria, as desired flow rates and / or delivery of large or small volumes. Infusion pumps can deliver fluids in ways that would be unrealistically expensive or unreliable if healthcare professionals performed them manually. For example, pumps may give injections as small as 0.1 ml per hour (too low per drip), injections every minute, multiple bolus injections, up to a maximum per hour, or fluids whose volumes vary depending on the time of day.

[0022] In one exemplary embodiment, pumps 18A, 18B and 18C are all designed to receive a syringe containing drug for administration to patient 20. In this embodiment, the pumps are provided with a signal regarding the desired volume of each drug to be administered from the syringe to the patient. The 18A, 18B and 18C pumps can be driven by fixed or variable speed drives to control the volume of drug being delivered to the patient and the speed at which the drug is being delivered. Data regarding volume and feeding speed can be stored by the controller 14. In this way, the delivery apparatus 16 is adapted to provide controlled delivery of a first drug by means of a first pump 18A, a second drug by means of a second pump 18B and a third drug by means of a third

Pump 18C, as determined by controller 14. Controller 14 may receive input from one device or multiple different devices, providing data point information about a basic physiological condition and, optionally, data point information about additional physiological conditions. The controller 14 may additionally be equipped with adaptive logic for the gradual, optimized stabilization of one or more physiological conditions of the patient.

[0023] Those skilled in the art will know that the system 10 can be constructed as a stationary system used in intensive care and emergency departments in hospitals; a portable device for use by paramedics, such as in ambulances, at places of accidents or in cases of responding to other emergencies; or a portable device for use in the day-to-day care of outpatient and non-hospital patients. In this way, the "user" of the system can be a healthcare professional or the patient himself. Those skilled in the art will also know that the system 10 may alternatively include a miniature chip as controller 14, wherein the chip can be operatively connected to means for encapsulating administered drugs, so that the encapsulated drugs can be implanted in the patient's body and released on demand based on output signal from the controller.

[0024] Although the administration apparatus 16 of the system 10 has been described as administering medicine from syringes, the administration apparatus 16 may be adapted to administer the drug from any type of drug storage container. Syringes are therefore described for the purpose of example only and not limitation.

[0025] The system 10 has also been described as comprising a physiological monitor 12 operably connected to the controller 14, for purposes of example only and not limitation. In various other embodiments, drug administration can be performed under the guidance of a healthcare professional and independent of the embedded physiological monitor.

[0026] As previously discussed, errors in drug delivery threaten the patient with serious injury or death, and the possibility of error increases when the use of treatment allows or requires the administration of multiple drugs. This is especially true when the healthcare professional needs to identify, use and install many potentially conflicting drugs at the same time, as during "compensatory" treatment. In addition to significant health risks, erroneous medications may also be incompatible with the given administration device. Thus, to counteract the above hazards, the storage container and administration apparatus may contain discriminating agents that protect against the administration of the incorrect drug and maintain compatibility of the dispensed drug with the administration apparatus. It will be apparent to those skilled in the art that the discrimination means can be adapted for use with any type of drug storage container without departing from the intended scope of the invention.

[0027] FIG. 2A is a perspective view showing one exemplary syringe 30 that may include the discrimination means of the invention. As shown in FIG. 2A, the syringe 30 generally includes a cylindrical cylinder 32 having a larger first end 34 with an outwardly extending flange 36 and a smaller second end 38 with a corresponding connector 40, such as a luer connector, for engagement with the delivery apparatus. The flange 36 typically, but not necessarily, projects substantially perpendicular to the outer surface of the cylindrical cylinder. Cylinder 32 defines an internal chamber for storing liquid drug.

[0028] It will be appreciated by those skilled in the art that the syringe 30 can be used either manually, by a healthcare professional or in an automated administration apparatus. In the manual application of the syringe 30, the healthcare professional may hold a cylinder 32 between the first two fingers of the hand, with an outwardly extending collar 36 to prevent the syringe from falling between the two fingers.

EP 2 482 870 B1

In automated use, the syringe 30 may be operatively connected to a suitable administration device, as will be shown in more detail in FIG. 3.

[0029] The piston rod 42 is attached at its front end to a respective piston member whose size and structure prevent any drug leakage through the first end 36 of the cylinder 32. The round rim 45 protrudes from the opposite end of the piston rod 42 and provides a surface to exert an actuation force on the piston 44 for dispensing the drug contained within the cylinder 32. A suitable sealing member 46, such as a rubber plug, can be placed inside the cylinder 32 adjacent to the other end 38 to prevent unintentional leakage through the connection 40. In one exemplary embodiment, the sealing member 46 is pierced with a needle when the syringe 30 is introduced into the delivery device.

[0030] The syringe 30 is shown in FIG. 2A only for the purposes of example as having a conventional design using a cylindrical cylinder and a piston. Those skilled in the art will know that numerous other drug container designs that deliver medication when under positive pressure are also possible. One example of such an alternative container design is a flexible container, such as a flexible bag or flask, in which, during use, the pressure is increased by a cooperating pump to withdraw medication from the container.

[0031] Referring additionally to FIG. 2A, the discrimination means in the form of the matched geometrical member 48 protrude outward from at least part of the cylinder 32. The matched geometrical member 48 allows the syringe 30 to be identified to protect against incorrect drug delivery and to ensure that the dosed drug is compatible with the delivery device. Additional details of these differentiation means will be given below.

[0032] Those skilled in the art will know that the matched geometric member 48 may be a separate element that is permanently connected to the barrel 32 of the syringe 30 or other drug container. The connection of the fitted member 48 to the cylinder 32 can be achieved by any suitable means including, but not limited to, welding, glue or the like. Alternatively, the matched geometric member 48 can be made integral with the cylinder 32 rather than modifying the "standard" syringe with the geometric member. When it is formed integral with the cylinder 32, the internal geometry of the chamber may remain the same (e.g. cylindrical), so only the outer part of the cylinder is manufactured differently, or it can take on the geometry of the matched member.

[0033] In yet another embodiment, the adjustment of the syringe or other drug container may be temporary, such that the matching geometric member 48 can be removed from the syringe barrel 32 as shown in FIG. 2B. In this embodiment, the matched geometric member 48 may be connected to the syringe 30 in a removable manner, in any suitable manner including but not limited to a compression fitting, unstable adhesive, or the like. One of the advantages of providing a differentiating geometric member that can be removed from the container is that it is possible to reuse the differentiating geometric member in another drug container in the future.

[0034] While FIG. 2A and 2B show the differential geometrical member as applied to a syringe barrel, the differential geometrical member can be applied to any suitable part of the container, with a corresponding seat applied in the same way to the corresponding element on the administration apparatus, as will be discussed in more detail below. Examples may include the positioning of the differential geometrical members on the plunger or syringe needle cup. In addition, multiple differentiating geometrical members can be applied to a single syringe or container, including

EP 2 482 870 B1 thus providing redundancy for additional security and compliance.

[0035] FIG. 3 this is a perspective view of the syringe 30 of FIG. 2A and 2B operatively linked to one of the exemplary delivery apparatuses 16 including a pump 18 for dispensing drug from a syringe 30 based on measurement input from a physiological monitor 12. As shown in FIG. 3, pump 18 includes the controller 14 described above with reference to the incorporated FIG. 1. However, it should be understood that the controller 14 may alternatively be provided as a separate element that is operatively connected to the delivery apparatus 16.

[0036] The delivery apparatus 16 will be illustrated with reference to a single-channel pump that is adapted to administer a drug from a single syringe, for simplicity purposes. However, it will be apparent to those skilled in the art that the disclosure of the invention can be extended to systems having more than one feed channel or pump.

[0037] As shown in FIG. 3, the controller 14 includes control means 50 including a microprocessor within the syringe pump body 18 and associated keyboard 52 and display 54. Various other switches, indicators, input devices and the like may be provided on the syringe pump body 18, as will be apparent to those skilled in the art, and which isn't detailed here.

[0038] The pump 18 includes a delivery channel 56 protruding along its side surface, which is constructed to receive a syringe 30. In detail, feed channel 56 includes pump motor 58, pump slider 60, stop member 62, and matching geometry seat 64. As generally shown in FIG. 3, the matched geometrical seat 64 is constructed to match a matched matched geometric member, such as the matched geometric member 48, to protect against the administration of the wrong drug and to ensure that the dosed drug is compatible with the syringe pump 18. When the fitted geometric member 48 is correctly fitted to the fitted seat 64, the outwardly projecting flange 36 adjoins the retaining member 62 to prevent the syringe 30 from moving axially in the forward direction. Furthermore, the round rim 45 protruding from the rear end of the piston rod 42 is received by the pump slider 60. The pump motor 58 is adapted to drive the pump slider 60 in the axial direction, which in turn actuates the piston 44 for controlled delivery of the drug contained within the cylinder 32.

[0039] The pump motor 58, including the pump slider 60 for actuating the piston rod 42 and piston 44, can be operated by the controller 14 after verifying that the syringe 30 is the correct syringe containing the correct drug. The controller 14 may control a number of parameters including, but not limited to, feed volume, feed rate, duration of feeding, or the like.

[0040] It will be appreciated by those skilled in the art that the administration apparatus shown in FIG. 3 represents only one exemplary type of administration apparatus that can operate with the means of distinguishing between syringes according to the invention and is provided for purposes of example only and not by way of limitation. In this way, the matching geometrical sockets can be included in any suitable delivery apparatus without departing from the intended scope of the invention.

[0041] FIG. 4A and 4B are perspective views showing the fit relationship between the fitted geometrical member 48 of the syringe 30 and the fitted seat 64. In particular, FIG. 4A is a perspective view that shows the geometric member 48 and the corresponding seat 64 before fitting, while FIG. 4B is a perspective view that shows the geometric member 48 and the corresponding socket 64 after matching the elements. For ease of presentation

In the aspect of geometrical discrimination according to the invention, only a portion of the matched seat 64 which includes the matched surface 65 is shown.

[0042] As shown in FIG. 4A and 4B, the matched surface 65 of the matched seat 64 is constructed to match the matched geometric member 48 on one "side". In particular, the matched surface 65 includes a first matched groove 66A constructed to match the first portion 68A of the matched geometric member 48, a second matched groove 66B constructed to fit the second portion 68B of the matched geometric member 48 and a third matched groove 66C constructed to that matches the third part 68C of the matched geometrical member 48. FIG. 4C is a diagram showing a front view of the matched geometrical member 48 after matching the matched surface 65 of the seat 64. Although FIG. 4C shows the spacing between matching items, those skilled in the art will know that such matching can be combined items evenly, without any spacing between them, so that a geometric "matching" will be more obvious to the user.

[0043] FIG. 5 is a perspective view showing the fit relationship between the syringe 30 and an exemplary alternative fitted seat 64 '. The matched socket 64 'is generally similar to the matched socket 64 previously described and illustrated in connection with FIG. 4A-4C, but additionally has a matched surface 65 'that is constructed to match the matched geometric member 48 on many "sides". Providing a matching seat that requires matching the matching geometry member 48 on multiple sides can give additional assurance that the appropriate syringe is provided with the delivery device.

[0044] FIG. 6 is a diagram showing the front view of the syringe 30 in a matched engagement with another exemplary alternative 64 '' fit seat. The matched 64 '' socket is generally similar to the matched socket previously described and illustrated in connection with FIG. 4A-4C and 5, but additionally has a matched 65 '' surface that is constructed to surround the matched geometric member 48 on all 'sides'. As will be apparent to those skilled in the art, providing a matching seat that requires matching the matching geometric member 48 on all sides can even give additional assurance that the appropriate syringe is provided with the delivery apparatus.

[0045] Those skilled in the art will know that the matched geometric member on the drug container and the corresponding matched seat on the administration container can be designed to connect in one or more of many ways. For example, in one exemplary embodiment, the matched geometric member can be designed to slide into its matched seat from above or below. In another exemplary embodiment, the matched geometric member can be designed for insertion from the side. The matching geometric member and corresponding matching seat can be designed to engage in any suitable manner without departing from the intended scope of the invention.

[0046] Now, when one of the exemplary constructions of the matched geometric member and the corresponding matched seat has been described in detail, numerous exemplary and non-limiting alternative constructions will be described and shown. In particular, FIG. 7A-7I are diagrams showing exemplary differential geometries that can be used according to the invention. The circle in the center of each diagram represents the outer circumference of the syringe barrel 32, with a matching geometric member attached to the barrel, as previously described. Matched sockets

The geometric shapes that can be attached to the delivery device are given to show the relationship between the syringe and the delivery device.

[0047] FIG. 7A is a diagram illustrating a 30A syringe having a first alternative matched geometric member 48A according to the invention. As shown in FIG. 7A, the matched geometric member 48A generally includes a triangular geometrical discrimination member that is constructed to match the matched surface 65A. The matched geometric member 48A is defined in part by three substantially identical flat surfaces. As a result, those skilled in the art will know that the matched geometric member 48A can be placed in the corresponding matched geometric socket 64A in three different orientations.

[0048] FIG. 7B is a diagram showing a 30B syringe having a second alternative matched 48B geometric member according to the invention. As shown in FIG. 7B, the matched geometric member 48B generally has a pentagonal geometric discrimination member that is constructed to fit into the matched surface 65B. The matched geometric member 48B is defined in part by five substantially identical flat surfaces. As a result, those skilled in the art will know that the matched 48B geometric member can be adopted by the corresponding matched 64B geometric nest in five different orientations.

[0049] FIG. 7C is a diagram illustrating a 30C syringe having a third alternative matched 48C geometric member according to the invention. As shown in FIG. 7C, the matched geometric member 48C includes a generally star-shaped geometrical discrimination member that is constructed to match the matched surface of 65C. The matched 48C geometric member is defined in part by ten substantially identical flat surfaces and can be adopted by the corresponding matched 64C geometric nest in five different orientations, as will be known to those skilled in the art.

[0050] FIG. 7D is a diagram illustrating a 30D syringe having a fourth alternative matched 48D geometric member according to the invention. As shown in FIG. 7D, the matched geometric member 48D includes a generally cross-shaped geometrical discrimination member that is constructed to match the matched surface 65D. The four segments of the matched 48D geometric member are defined in part by both straight and curved surfaces, and the matched 48D geometric member can be adopted by the corresponding matched 64D geometric member in four different orientations, as will be known to those skilled in the art.

[0051] FIG. 7E is a diagram illustrating a 30E syringe having a fifth alternative matched 48E geometric member according to the invention. As shown in FIG. 7E, the matched geometric member 48E includes a generally oval geometrical discrimination member that is constructed to match the matched surface 65E. The matched 48E geometric member is defined in part by a single, continuous, curved perimeter surface. The matched 48E geometric member is symmetrical and can thus be adopted by the corresponding 64E matched geometric seat in two different orientations, as will be known to those skilled in the art.

[0052] FIG. 7F is a diagram illustrating a 30F syringe having a sixth alternative matched 48F geometric member according to the invention. As shown in FIG. 7F, the matched 48F geometric member comprises an irregularly shaped geometrical discrimination member that is constructed to match the matched 65F surface. The matched 48F geometric member is defined by both flat and curved surfaces, and can be adopted by the matched seat

Geometric 64F in only one orientation.

[0053] FIG. 7G is a diagram illustrating a 30G syringe having a seventh alternative matched 48G geometric member according to the invention. As shown in FIG. 7G, the 48G matched geometric member differs from those previously shown in that the matched member only projects from part of the syringe barrel 32. In particular, the 48G matched geometric member is defined in part by a single protruding tab member that can be received by the corresponding 64G geometrically matched seat in only one orientation.

[0054] FIG. 7H is a diagram depicting a 30H syringe having an eighth alternative matched 48H geometric member according to the invention. As shown in FIG. 7H, the 48H matched geometric member differs from those previously shown in that the matched member includes a recess or cutout that is constructed to receive a protrusion projecting from the 64H matched geometric seat. In this way, the matched 64H geometric socket adopts the 48H matched geometric member, which in turn adopts a portion of the 64H matched geometric socket. Those skilled in the art will know that a 48H matched geometric member can be adopted by a 64H matched geometric seat in only one orientation.

[0055] FIG. 7I is a diagram showing another alternative 30I syringe and a corresponding matching 64I geometrical socket according to the invention. As shown in FIG. 7I, the matching geometry of the syringe 30I is defined by the shape of the syringe barrel 32 itself, and not by the protruding fitted geometric member as in the previous embodiments. As a result, those skilled in the art will know that the syringe barrel geometry itself can serve as a differential geometry. Furthermore, the round cylinder 32 is shown for purposes of example only and not limitation, and any geometrically shaped cylinder may be used without departing from the intended scope of the invention.

[0056] In connection with the above non-limiting exemplary embodiments, those skilled in the art will know that any suitable geometry that makes it possible to distinguish between different containers can be used without departing from the intended scope of the invention. In this way, the shape of the "discrimination geometry" can be polygonal or small-angle, regular or irregular, flat / straight or curved, concave or convex, etc., or any combination thereof.

[0057] Those skilled in the art will also know that container distinguishing geometries can be intentionally made compatible with multiple nest geometries, providing the possibility of indicating one-to-many treatment applications. And, mutually, matching sockets can be designed to accept multiple container geometries to indicate that any of the drug groups is acceptable for a given treatment application.

[0058] When used in a multi-channel delivery environment, the geometries used can be selected so that they are apparently incompatible as to form with each other. For example, in a two-channel environment, a first matching geometric socket 70A with a convex shape and a second matching geometric socket 70B with a concave shape can be used, as shown in FIG. 8. In a three-channel environment, a first 70C matched square socket, a second 70D triangular shaped geometric socket and a third 70E matched 70E geometric socket can be used, as shown in FIG. 9. Such designs facilitate discrimination by visual and tactile means as well as by matching part-equivalent on the delivery apparatus. Of course, the above geometries are only shown

EP 2 482 870 B1 for the purpose of example and not limitation. In this way, any suitable differential geometry can be used without departing from the intended scope of the invention.

[0059] In addition to or instead of using matched geometrical members and corresponding matched geometrical sockets as described above, various active or passive devices can be used to identify and distinguish drug containers. Such devices can be placed anywhere on the medicine container and administration apparatus to provide an additional level of verification, and can be designed to only fit if the surfaces of the geometric equivalents are matched appropriately. As will be described in more detail below, passive embodiments of such devices may include smaller geometric equivalents, such as protrusions and patterned seats. These devices can also serve as tactile means for "feeling" when the elements have been properly matched. Active embodiments of such devices may include electrical contacts that close the circuit, or a reflecting surface that allows optical detection when the elements are matched together. In other active embodiments, mechanical stresses, magnetic fields, or some other measurable physical property may be used.

[0060] FIG. 10 is a perspective view of the syringe 30 (with the matched geometrical member 48) and the matched geometrical seat 64 previously described with reference to FIG. 4A-4C, which further includes additional matched devices in the form of geometrical protrusions 72A, 72B and 72C designed to be received within the corresponding matched socket 74A, 74B and 74C. Experts in the field will know that, additional matched devices provide a second level of container verification. In particular, geometrical protuberances 72A, 72B and 72C may be adopted inside the corresponding seats 74A, 74B and 74C when the matched geometric member 48 is suitably aligned with the matched seat 64. Those skilled in the art will know that any number, shape and location of secondary matched devices can be used without departing from the intended scope of the invention.

[0061] As an alternative to using reliefs and geometrical sockets as secondary matched devices, the syringe may use different types of active data devices, as shown in FIG. 11. In particular, as shown in FIG. 11, the matched geometric member 48 includes a non-volatile memory chip 80 (such as an EEPROM chip) and one or more electrical contacts (not shown) that are designed to match one or more corresponding electrical contacts 82 on the matched socket geometric 64, for transmitting, communicating or providing a signal, or for closing a circuit. In addition, means for sensing the geometry or other physical properties of the syringe 30, such as one or more syringe geometry sensors 84, may be associated with the delivery apparatus. In one exemplary embodiment, the sensors 84 may be attached directly or indirectly to the pump motor 58, as shown in FIG. 11. Further details on the function and operation of data devices and sensors will be given below.

[0062] FIG. 12 is a flowchart showing the steps in one exemplary procedure to distinguish 100 drug container according to the invention. The discrimination procedure 100 starts at block 102, from a user attempting to insert a drug container into the container slot associated with the administration apparatus. As indicated in block 104, the container is physically constrained by the nest geometry and therefore it must be possible to fit it within the physical boundaries imposed by

EP 2 482 870 B1 socket. For example, in one exemplary embodiment, the container must be introduced so that all geometrically distinctive parts on the container are equally aligned with their counterparts on the socket.

[0063] The discrimination procedure 100 continues at block 106, where the user determines whether the container is physically compatible with the socket. If the container does not meet the above physical insertion criteria, the container cannot be placed in the medication delivery device and the user has a clear visual and tactile hint that the container is not intended for the current slot as indicated in block 108. However, if the container meets the required criteria as indicated in block 110, optional detection means for detecting the presence of the container, geometry and / or other physical properties of the container may be activated to determine the exact physical nature of the introduced container as indicated in block 112. Any suitable detection means may be used including, but not limited to, sensors that verify the presence and position of specific physical properties including more detailed differences in container geometry and composition (such as "passive" devices previously described) and / or sensors that identify the exact shape , dimensions, proportions, conductivity, hardness, weight, density, chemical composition or other material or physical properties of the container. The detection means can transmit information to the controller for further processing.

[0064] Upon receiving information characterizing one or more container properties, the controller determines whether the container geometry is exactly correct at block 114. If the controller determines that the container is not of a type compatible with the current treatment application and / or delivery device, the container insertion will be "rejected" as indicated in block 116. Whenever the controller rejects the container, the user can optionally be notified of the rejection as indicated in block 118, also receiving a summary or details of the reason for the rejection. Notification may come through one or more appropriate notification mechanisms, such as, e.g, visual tips including displaying simple characters, colorful or flashing lights and / or graphical user interface; audio tips such as a buzzer, generated audio sequences and / or pre-recorded sound clips; touch tips such as haptic feedback and / or violent disposal of the container; or any other appropriate means of notification, as will be known to specialists in the field. Alternatively, if the controller determines that the container is compliant, based on information characterizing one or more properties of the container, optional data device elements on the container can be analyzed by one or more reader devices associated with the socket (such as direct or indirect attached to it) as indicated in block 120. In one example of implementation, the controller sends queries to the EEPROM chip on the container. However, any suitable component of the data device may be used without departing from the intended scope of the invention.

[0065] In particular, data devices contain elements that contain, generate or otherwise indicate information that can be detected and received by a reader element and then forwarded to a controller. Information can be transmitted as digital or analog signals. For example, information can be as simple as a binary signal (e.g. the container is compliant if the specified signal is present and non-compliant if the signal is not present), or they can implement a complete protocol for the exchange of detailed information with the reader, including identification of the container and its contents. Data devices may be of the type requiring physical contact between the data device element on the container and the corresponding reader, such as electrical or optical contacts adapted for transmission

Simple signal or complex information. Alternatively, the data devices may be of a type that allows detection or transmission of information over a certain distance, such as by radio frequency or other electromagnetic means, optical bar code scanning, machine vision, or the like. In this way, data devices can be passive, such as a reflecting surface, which reflects the light source when in the expected location, or active, such as a microprocessor located on the container, without departing from the intended scope of the invention.

[0066] Those skilled in the art will know that suitable technologies for data devices ( data fixtures) may include simple electrical means including circuit closure; more complex electrical means including electronic computer devices and memories; simple optical means including reflecting surfaces; advanced optical means including bar code scanning and optical / laser information storage and transmission; visual measures including machine vision and recognition; physical / mechanical means including means for interpreting hills, depressions and / or holes in the physical support; chemicals including means for determining the chemical reactivity and / or material composition; material analysis means including means for determining the load of a substance or series thereof, or means for determining the vibration and / or resonance of a material; electromagnetic agents, such as RFID identification and radio communication, Bluetooth or similar technology; and any other suitable technology, which makes it possible to detect or identify a container. Data device techniques can be applied to the entire container, container portion (either temporarily or permanently), the packaging in which the container is delivered, the container contents including the drug contained, or the like.

[0067] It should be understood that the above list of relevant technologies is provided for purposes of example only and not limitation. In this way, the scope of the invention is not limited by the specific technologies cited.

[0068] By proceeding to block 122, the controller determines if the container data source is properly aligned. If the controller determines that the reader cannot detect a compatible signal from or close the circuit with its expected corresponding data device as indicated in block 124, then no data will be received by the controller as indicated in block 126. Consequently, the controller determines that the container is not of a type compatible with the current treatment application and / or delivery apparatus on block 116 and the insertion of the container is rejected. Optionally, the user may be notified of a rejection at block 118, as discussed above. However, if the controller determines that the reader is able to detect a compatible signal with or close the circuit with its expected suitable data device as indicated in block 128, then the reader will receive the information provided by the data device element as indicated in block 130 and provide the information to the controller. The controller then analyzes this information at block 132 to determine if the container is of a type compatible with the current treatment application and / or delivery apparatus. This process is performed for all data devices expected by the controller and supported by a set of socket sensors.

[0069] If, for any data device, the controller determines that the container data does not confirm compliance with the current treatment application and / or delivery apparatus, the insertion of the container is rejected as indicated in block 116. Optionally, the user may be notified of a rejection at block 118, as discussed above. However, if for all data devices the controller finds that the container data confirms its compliance with the current treatment application and / or delivery device, the container insertion is accepted,

As indicated in block 134. At this point, treatment can be started using the contents of the drug container.

[0070] Although several exemplary steps have been described with reference to the discrimination procedure 100, those skilled in the art will know that the order and number of steps can be modified without departing from the intended scope of the invention. Thus, the example steps are given for the purpose of example only and not limitation.

[0071] Additionally, although the discrimination procedure 100 has been described as including three "levels" of discrimination / identification based on physical compatibility (e.g. block 106), information provided by geometry sensors (e.g. block 114) and information provided by data devices (e.g. block 122), it is not necessary to provide all three levels of discrimination / identification. Thus, any procedure that includes one or more of the above compliance checks (in any combination) is within the intended scope of the invention. For example, FIG. 13 is a perspective view of an alternative delivery apparatus 90 that is adapted to distinguish / identify a syringe 92 based solely on information provided by the geometry sensors and / or data devices. Thus, unlike the various previously described embodiments of the syringe 30, the syringe 92 does not contain a matched geometric member for a matched engagement with a matched geometric socket. Accordingly, it should be understood that the invention includes distinguishing between drug containers with or without the use of physical geometric differences in the container geometry.

[0072] FIG. 14 is a condensed version of the flowchart of FIG. 12 illustrating several sample steps in the procedure for distinguishing 100 drug containers and identifying the three levels of discrimination / identification discussed above.

[0073] FIG. 15 is a block diagram showing example elements of controller 14. As shown in FIG. 15, controller 14 may include memory 200, additional memory device 202, processor 204, HID device 206, display device 208 and output device 210. Memory 200 may include random access memory (RAM) or similar types of memory, and may store one or more applications 212, including system software 214 and network server 216, for execution by processor 204. Additional storage device 202 may include a hard disk drive, floppy disk drive, CD-ROM drive, or other suitable type of non-volatile data storage.

[0074] Information about the drug containers may be stored in memory 200 or secondary memory device 202. Processor 204 may execute system software 214 and other applications 212 stored in memory 200 or secondary memory device 202, or alternatively downloaded from the Internet or other network, as will be known to those skilled in the art. Processor 204 may execute system software 214 to provide the functions described in this description, including determining if the container geometry is accurately based on information from the geometry sensors, determining if the container data device components are properly aligned with the corresponding readers, and verifying that the content of the container is correct based on information from data devices. HID device 206 may include any device for entering information into controller 14 including, but not limited to, a keyboard (such as keyboard 52 in FIG. 3), mouse, cursor control device, touch screen, infrared, microphone, digital camera, video recorder or any other suitable instrument or device. Device

The display 208 (such as display 54 in FIG. 3) may include any type of visual information display device, such as, for example, a computer monitor or flat screen display. Output device 210 may include any type of device for presenting information to a user, such as speakers or a printer.

[0075] Network server 216 can be used to provide access to information that is stored in memory 200 and / or on secondary storage device 202, as well as to display such information remotely. The web server 216 allows users to secure remote access to a system through which they can perform functions such as registering and programming rules for distinguishing between drug containers, monitoring the delivery of the appropriate drug to a patient, and the like. Those skilled in the art will know that the web server 216 may allow access to a user starting a web browser. Examples of web browsers include Netscape Navigator and Microsoft Internet Explorer. However, you can use any web browser, co-browser or other application capable of recovering content from the web and displaying pages or screens.

[0076] Examples of drivers 14 for interacting within a syringe discrimination system may include personal computers, laptops, notebooks, palmtops, network computers, internet devices or any processor controlled device capable of executing web browser 216, system software 214 and any other type of application 212 stored in memory 200 and / or available through an additional storage device 202. The controller 14 may either be built into the drug delivery device or provided separately as will be known to those skilled in the art.