Reservoir connection interface with detectable label

Abstract

A connector interface system includes a cap connected to a reservoir to form a reservoir / cap unit for installation into an infusion pump device. The cap has at least one receiver for receiving one or more detectable features, the one or more detectable features including at least one disc-shaped member to be detected by at least one sensor element on the infusion pump device when the reservoir of the reservoir / cap unit is received in the reservoir receiver of the infusion pump device. The at least one detectable feature has at least one detectable parameter, the at least one detectable parameter being associated with one or more characteristics of the cap, the reservoir, the infusion pump device, a cannula associated with the cap, or a tubing connected between the cap and the cannula.

Description

Technical Field

[0001] The present disclosure relates to connection interfaces for syringes and reservoirs, and in certain embodiments, to connection interfaces for interfacing a syringe or reservoir to an infusion pump, an infusion set conduit, or both, and for providing any one of a plurality of different detectable features or detectable signals in an effective manner. Additional embodiments relate to infusion pump systems and infusion set systems that include such connection interfaces, and to methods employing the infusion pump systems and infusion set systems. Background Art

[0002] Infusion pump devices and systems are used in medical settings to deliver or dispense an infusion medium to a patient, where such an infusion medium may be, for example, a prescription medication such as insulin, a cancer therapy drug, an HIV therapy drug, or other media used to treat a medical or biological condition. In one form, such an infusion pump device has a relatively compact pump housing adapted to receive a syringe or reservoir containing the prescription medication for administration to the patient.

[0003] Infusion pump devices typically include a small drive motor connected to a piston in a syringe or reservoir by a drive rod. The drive motor operates to selectively move the piston in the syringe or reservoir to drive the fluid medium from the reservoir to the user. Programmable control is typically provided for operating the drive motor continuously or at periodic intervals to obtain controlled drug delivery over a period of time. Such infusion pumps are used to administer insulin and other drugs, wherein exemplary pump configurations are shown and described in the following: U.S. Patent Nos. 4,562,751; 4,678,408; 4,685,903; 5,080,653 and 5,097,122, each of which is incorporated herein by reference in its entirety.

[0004] An infusion set is a tubing and connection device that provides a fluid flow path for the infusion medium to flow from a reservoir or syringe in a pump to a user. The connector used to connect the infusion set tubing to the reservoir can take a variety of forms. Some examples of such connectors are described in U.S. Patent No. 6,585,695, which is incorporated herein by reference in its entirety. Summary of the invention

[0005] The connection interface for the syringe and the reservoir is configured to interface the syringe or the reservoir to an infusion pump, an infusion set conduit, or both. The infusion pump system includes an infusion pump device, an infusion set, and a connection interface connecting the infusion pump device to the infusion set. In a specific embodiment, the connection interface includes a cap, which is configured to be fixed to the reservoir to form a reservoir / cap unit (or base / reservoir / cap unit) configured to be installed in a reservoir receiver of the infusion pump device. Other embodiments relate to an infusion pump system including the connection interface, an infusion pump device, and a reservoir.

[0006] In certain embodiments, at least one detectable feature is disposed on the cap to be detected by at least one sensor element when the reservoir of the reservoir / cap unit is received in the reservoir receiver of the infusion pump device. The sensor element may be any one or more of a magnetic detection sensor or an inductive sensor. Similarly, the detectable feature may be any one or more of a magnetically detectable feature or one or more inductively detectable features.

[0007] According to an example embodiment, a connector interface system includes a cap that is connected to a reservoir to form a reservoir / cap unit for installation in an infusion pump device. The cap has at least one receiver for receiving one or more detectable features. At least one detectable feature including at least one disc-shaped member is received in the at least one receiver to be detected by at least one sensor element on the infusion pump device when the reservoir of the reservoir / cap unit is received in the reservoir receiver of the infusion pump device. The at least one detectable feature has at least one detectable parameter that is associated with one or more characteristics of the cap, the reservoir, the infusion pump device, a cannula associated with the cap, or a tubing connected between the cap and the cannula.

[0008] In further examples of the connector interface system as described above, the at least one detectable feature includes a plurality of disc-shaped members arranged in a stack within the at least one receiver.

[0009] In further examples of the connector interface system as described above, the at least one receiver includes a plurality of receivers, each receiver being configured to receive one or more detectable features.

[0010] In another example of a connector interface system as described above, the at least one detectable feature includes a plurality of disc-shaped members arranged in a stack within one of the at least one receiver, while another of the at least one receiver lacks a disc-shaped member.

[0011] In further examples of the connector interface system as described above, the at least one detectable feature includes a plurality of disc-shaped members arranged in a stack within each of the plurality of receivers.

[0012] In another example of a connector interface system as described above, the cap and the reservoir have a common longitudinal axis A, and wherein the at least one receiver includes a first receiver having a partial cylindrical or semi-cylindrical configuration, the first receiver having a cylindrical axis extending in a direction transverse to the direction of the axis A.

[0013] In further examples of the connector interface system as described above, the at least one receiver includes a second receiver having a cylindrical configuration, the second receiver having a cylindrical axis extending in a direction parallel to the direction of the axis A.

[0014] In further examples of the connector interface system as described above, the at least one receiver includes a second receiver having a cylindrical configuration, the second receiver having a cylindrical axis extending in a direction at an oblique angle relative to the direction of the axis A.

[0015] In another example of a connector interface system as described above, the cap and the reservoir have a common longitudinal axis A, and wherein the at least one receptacle includes a receptacle having a cylindrical configuration having a cylindrical axis extending in a direction parallel to the direction of the axis A.

[0016] In another example of a connector interface system as described above, the cap and the reservoir have a common longitudinal axis A, and wherein the at least one receiver includes a plurality of receivers, the plurality of receivers including a first receiver having a cylindrical configuration, the first receiver having a cylindrical axis extending in a direction oblique to the direction of the axis A.

[0017] In further examples of the connector interface system as described above, the at least one disc-shaped member comprises at least one disc-shaped magnet, and wherein the at least one detectable feature provides a detectable magnetic field.

[0018] In another example of a connector interface system as described above, the cap and the reservoir have a common longitudinal axis A, and wherein the at least one detectable parameter includes at least one of: the amplitude of the magnetic field, the polarity direction of the magnetic field, and the angle of the magnetic field relative to axis A.

[0019] In another example of a connector interface system as described above, the at least one disk-shaped member includes a plurality of disk-shaped magnets, and wherein the detectable magnetic field depends on the number of disk-shaped magnets in the detectable feature, and wherein the number of disk-shaped magnets in the detectable feature is adjustable.

[0020] In further examples of the connector interface system as described above, the at least one disc-shaped member comprises at least one disc-shaped conductive member, and wherein the at least one detectable feature provides an inductively detectable marking.

[0021] In another example of a connector interface system as described above, the at least one disc-shaped member includes a number of disc-shaped conductive members, the number being greater than one, and wherein the inductively detectable mark depends on the number of disc-shaped members in the detectable feature, and wherein the number of disc-shaped members in the detectable feature is adjustable.

[0022] A connector interface system according to another embodiment includes a cap connected to a reservoir to form a reservoir / cap unit for installation in an infusion pump device. The cap has at least one receptacle for receiving one or more detectable features. At least one detectable feature is received in at least one receptacle. The at least one detectable feature includes a number of detectable members, the number being greater than one, wherein each detectable member has the same shape and size and is configured to be selectively received in the at least one receptacle to be detected by at least one sensor element on the infusion pump device when the reservoir of the reservoir / cap unit is received in the reservoir receptacle of the infusion pump device. The at least one detectable feature has at least one detectable parameter, the at least one detectable parameter at least partially depending on the number of detectable members received in the at least one receptacle. The at least one detectable parameter is associated with one or more characteristics of the cap, the reservoir, the infusion pump device, a cannula associated with the cap, or a pipe connected between the cap and the cannula.

[0023] In further examples of the connector interface system as described above, the at least one detectable feature includes at least one disc-shaped magnet providing a detectable magnetic field.

[0024] In further examples of the connector interface system as described above, the at least one detectable feature comprises at least one disc-shaped conductive member, and wherein the at least one detectable feature provides an inductively detectable mark.

[0025] In another example of a connector interface system as described above, the one or more characteristics include one or more of the following: the type or identity of the manufacturer of the reservoir or the cap; the size of the reservoir or the cap; the type or concentration of the infusion medium in the reservoir; the volume of the infusion medium in the reservoir; a date corresponding to a manufacturing date, an expiration date, or a fill date associated with the infusion medium in the reservoir; a date corresponding to a manufacturing date or an expiration date of the reservoir or the cap; a location corresponding to a location where the reservoir or the infusion medium in the reservoir is made, filled, or otherwise processed; a location corresponding to a location where the cap is made, assembled, or otherwise processed; a location corresponding to a location where the reservoir, the infusion medium in the reservoir, or the cap is authorized for use; a batch number or code associated with a batch of the reservoir, the cap, or the infusion medium; a serial number; a unique ID; user identification information for an authorized user; the type, length, or size of a cannula associated with the cap; or the type, length, or size of a tubing connected between the cap and the cannula.

[0026] A method for using a connector interface system according to an embodiment includes connecting a cap to a reservoir to form a reservoir / cap unit for installation in an infusion pump device, wherein the cap has at least one receiver for receiving one or more detectable features. The method further includes inserting at least one detectable feature comprising a plurality of disc-shaped members into the at least one receiver to be detected by at least one sensor element on the infusion pump device when the reservoir of the reservoir / cap unit is received in the reservoir receiver of the infusion pump device, the number of the disc-shaped members being greater than one. The at least one detectable feature has at least one detectable parameter, which depends in part on the number of disc-shaped members. The at least one detectable parameter is associated with one or more characteristics of the cap, the reservoir, the infusion pump device, a cannula associated with the cap, or a pipe connected between the cap and the cannula. The at least one detectable parameter includes a magnetic field marker or an inductive detectable marker. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 is a partially exploded perspective view of an infusion pump system including an infusion pump device, a reservoir, an infusion set, and a connection interface device.

[0028] Figure 2 is an enlarged cross-sectional side view of a cap of a reservoir connection interface device.

[0029] Figure 2A yes Figure 2 An enlarged cross-sectional view of a portion of the cap.

[0030] Figure 3 yes Figure 2 A partial cross-sectional side view of an embodiment of a cap connected to a reservoir.

[0031] Figure 4 yes Figure 2 A partial bottom perspective view of a cap of an embodiment of the invention including a detectable feature in a first configuration.

[0032] Figure 5 yes Figure 2 A partial bottom perspective view of a cap of an embodiment of the invention including a detectable feature in a second configuration.

[0033] Figure 6 yes Figure 2 A partial bottom perspective view of a cap of an embodiment of the invention including a detectable feature in a third configuration.

[0034] Figure 7 yes Figure 2 A partial bottom perspective view of a cap of an embodiment of the invention including a detectable feature in a fourth configuration.

[0035] Figure 8 is a perspective view of a detectable feature in a first orientation.

[0036] Fig. 9 is a perspective view of the detectable feature in a second orientation.

[0037] Fig.10 is a perspective view of a detectable feature in a third orientation.

[0038] Fig.11 is with Figure 1 Schematic diagram of the electronics associated with the infusion pump system.

[0039] Fig.12 Is Fig.11 Flowchart of an example process performed by processing electronics in an electronic device. DETAILED DESCRIPTION

[0040] In the following description, reference is made to the accompanying drawings, which form a part of this application and illustrate several embodiments of the present invention. It should be understood that other embodiments may be utilized and structural and operational changes may be made without departing from the scope of the present invention.

[0041] In the various drawings, the same reference numerals are used to represent the same elements or similar elements that may perform or operate in a similar manner. As used herein, the term "and / or" is intended to mean an "inclusive or." Additionally, the use of the term "or" herein is intended to mean an "inclusive or" unless such meaning does not make sense.

[0042] Embodiments of the present invention relate to connection interfaces for syringes and reservoirs. Specific embodiments relate to connection interfaces for connecting syringes or reservoirs to infusion pump devices, infusion tubes, or both. Other embodiments relate to infusion pump systems and infusion tube systems comprising such connection interfaces, and to methods for manufacturing and using such connection interfaces and systems. One or more aspects of the present invention may be adopted or included in connection interfaces, infusion pump systems, and infusion tube systems of the type described in U.S. Patents Nos. 6,585,695 and 9,452,255 (each of which is incorporated herein by reference in its entirety), or included in other suitable connection interfaces, infusion pump systems, and infusion tube systems.

[0043] An infusion pump system 10 according to an exemplary embodiment of the present invention is shown in a partially exploded perspective view. Figure 1 Shown in. Figure 1 The infusion pump system 10 in the embodiment includes a reservoir 20, an infusion pump device 30, a connection interface 40 and an infusion set 50. Other system embodiments may include one or more, but not all, of the above components, and / or Figure 1 Additional components not shown.

[0044] The reservoir 20 is a closed container, and the internal volume of the closed container contains an infusion medium. The infusion medium can be, for example, a prescription drug, such as insulin, a cancer therapy drug, an HIV therapy drug, or other media for treating medical or biological conditions. As described below, the reservoir 20 is configured to be received in the receiver 32 of the infusion pump device 30 and interfaced with a drive device (not shown) positioned in the infusion pump device for selectively driving the infusion medium from the reservoir in a controlled manner. The reservoir 20 is also configured to be connected to the infusion set 50 fluid flow communication to provide a flow path for the infusion medium from the reservoir to the user. In the specific embodiment described herein, the connection interface 40 is configured to connect and interface the reservoir 20 with the infusion set 50 and with the infusion pump device 30 using a releasable coupling structure.

[0045] The infusion set 50 includes a conduit 52 and a needle or cannula housing 54. In certain embodiments, the conduit 52 may be generally flexible and bendable. The needle or cannula housing 54 is configured to be secured to a user, such as, but not limited to, adhering the housing 54 to the user's skin at the user's desired infusion location. The housing 54 may include an adhesive material on its base, or other suitable material or structure, for securing the housing 54 to the user's skin. The housing 54 contains and supports a hollow needle or cannula 56, which is in fluid flow communication with the conduit 52 and is configured to extend (or extend) out from the base and into the user's skin when the housing 54 is secured to the user's skin. When extended into the user's skin, the hollow needle or cannula 56 can deliver the infusion medium from the conduit 52 to the user. Examples of infusion sets that can be used as infusion sets 50 include, but are not limited to Infusion Set, Infusion Set, Infusion Set, Infusers, etc. However, other embodiments of the invention may include or operate with other suitable infusor configurations.

[0046] Examples of infusion pump devices that may be used as the infusion pump device 30 include, but are not limited to Infusion pump, Revel TM Infusion pumps, 530G infusion pump, MiniMed 640G, _________________, etc. Other examples include those described in the following: U.S. Patent Nos. 4,562,751; 4,678,408; 4,685,903; 5,080,653 and 5,097,122, each of which is incorporated herein by reference in its entirety. However, other embodiments of the present invention may include or operate with other suitable infusion pump devices. The infusion pump device 30 includes a drive motor or other drive device having a drive connecting rod (not shown), which is arranged to engage a corresponding drive connecting rod 22 on a piston in the reservoir 20 when the reservoir 20 is properly received in the reservoir receiver 32. In certain embodiments, the drive link 22 corresponds to the "engagement side 128" described in U.S. Pat. No. 8,167,846, entitled "Reservoir Filling System and Method," which is incorporated herein by reference in its entirety. In other embodiments, when the reservoir 20 is received in the reservoir receiver 32 of the infusion pump device 30, other suitable drive link structures are used as the drive link 22 to operably connect the piston in the reservoir 20 to the drive device in the infusion pump device 30.

[0047] The drive device operates to selectively move the piston within the syringe or reservoir to drive the fluid medium from the reservoir to the user. The infusion pump device 30 includes control electronics connected to the drive device for controlling the drive device to selectively drive the piston and dispense the fluid from the reservoir and into the conduit 52 of the infusion set 50. In certain embodiments, the control electronics can be programmed to deliver fluid from the reservoir continuously or at one or more predetermined intervals over time according to one or more programmed delivery routines. The control electronics can be further configured to operate one or more display devices and user input devices on or associated with the infusion pump device. The control electronics can be included in the following reference to Fig.11 The electronic device 80 described herein is in or connected to the electronic device.

[0048] exist Figure 1 In the embodiment of the present invention, the connection interface 40 includes a base 42 and a connection cap 44. In other embodiments, the base 42 is omitted or formed as part of (integrated with or fixed to) the reservoir 20 or the cap 44. Figure 1 In an embodiment of the present invention, the base 42 is a separate element that is fixedly attached to the reservoir 20 by securing it around the mold 24 of the reservoir 20 during (or after) the manufacture of the reservoir 20. For example, the base 42 may include one or more grooves 42a and may be made of a rigid but sufficiently ductile material that can be crimped over the mold 24 to secure the base 42 to the reservoir 20. In a particular embodiment, the base 42 is fixedly connected to the reservoir 20 in a manner that inhibits rotation or movement of the base 42 relative to the reservoir 20. Other embodiments may include other suitable structures or materials for securing the base 42 to the mold 24. In other embodiments of the present invention, the base 42 is configured to be attachable to (and removable from) the reservoir so that the connector interface can be used with a reservoir, cartridge, or syringe that was not originally manufactured on the base.

[0049] Base 42, mold 23 and cap 44 can be made of any one or more suitable materials having sufficient rigidity and strength to operate as described herein, including but not limited to plastic, metal, ceramic, composite material or other suitable material. In a specific embodiment, cap 44 is made of molded plastic material.

[0050] The cap 44 of the connector interface 40 is connected to the tubing 52 of the infusion set 50 in fluid flow communication. An exemplary embodiment of the cap 44 is Figure 2 and Figure 3 A cross-sectional view of the cap 44 is shown in Figure 2 44 is shown in FIG. 44, wherein the cap is separated from the reservoir. Figure 3 , where the cap is attached to the neck portion of the reservoir 20. Figure 2 and Figure 3 In the embodiment of the present invention, the cap 44 includes a body 45 forming a housing, the body having an open end open to the internal volume of the cap housing. The body 45 also has a closed end defined by a transverse wall, and the closed end is longitudinally spaced apart from the open end by a cylindrical longitudinal wall around the internal volume. Rising from the transverse wall at the closed end of the cap body (45) is an outlet port 46, which is connected to the pipeline 52 of the infusion set 50 in any suitable manner, including but not limited to friction fit, clips, adhesives, combinations thereof, etc. In a specific embodiment, before the cap 44 is made available to the user, the cap 44 is connected to the pipeline 52 during the manufacture or assembly of the cap 44. In other embodiments, the cap 44 has a port, which is configured to be connected to the pipeline 52 by a user, a medical technician or other authorized personnel after the cap is manufactured. The cap 44 also includes a hollow needle 47 positioned inside the cap housing and extending into the internal volume through the transverse wall at the closed end of the cap body 45 to provide fluid flow communication with the outlet port 46. At the open end of the cap, the cylindrical wall terminates in a transverse annular end surface 44b which may include a flat portion and an inwardly facing chamfer, such as Figure 2 Alternatively, the transverse annular end surface 44b may consist of a flat portion alone, such as Figure 3 As shown, the cap 44 may be subjected only to the radius dictated by the molding process, or may have steps, radii, and chamfers in any combination. In certain embodiments, the cap 44 may correspond to the cap 4 described in U.S. Pat. Nos. 6,585,695 and 9,452,255 cited above. In other embodiments, the cap 44 may have another suitable configuration.

[0051] The cap 44 is removably attached or attachable to the base 42 (and therefore to the reservoir 20) via a first releasable connector. In embodiments where the base 42 is omitted, the first releasable connector removably attaches the cap 44 directly to the reservoir 20. Additionally, the cap 44 is removably attached or attachable to an infusion pump device 30 having a second releasable connector. In particular embodiments, the first releasable connector includes any suitable structure that allows the cap to be selectively coupled and decoupled from the base 42, while the second releasable connector includes similar or different structure that allows the cap 44 to be selectively coupled and decoupled from the infusion pump device 30. Example embodiments of a first releasable connector for connecting a cap to a base of a connection interface and a second releasable connector for coupling the cap to an infusion pump device are described in U.S. Patent No. 6,585,695 cited above.

[0052] In one embodiment, the first releasable coupling includes one or more protrusions (extended features) or receivers (openings, slots, or detents) disposed on one of the base 42 or the cap 44, and corresponding receivers or protrusions in the other of the base 42 or the cap 44 for receiving the protrusions. Figure 2 and Figure 3 The cap 44, base 42, and reservoir 20 shown in Figure 4 depict an example embodiment of a first releasable coupler in which a protrusion 42b on the base 42 is received within a slot or opening 44a in a cylindrical longitudinal wall of the cap 44. In other embodiments, other suitable coupler structures are employed for releasably coupling or permanently coupling the cap 44, base 42, and reservoir 20 (or for releasably coupling or permanently coupling the cap 44 directly to the reservoir 20).

[0053] Thus, in certain examples, the base 42 is connected to the reservoir 20 to form an integrated unit with the reservoir 20. The integrated unit of the reservoir 20 and the base 42 is in turn connected to the cap 44. Figure 1 In the embodiment of the present invention, the integrated base / reservoir unit is connected to the cap 44 by inserting the base 42 into the open lower end of the cap 44 and engaging the protrusions and receptacles on the base 42 and the cap 44. Thus, the base / reservoir unit can be connected to the cap 44 to form an integrated base / reservoir / cap unit. (In embodiments where the base 42 is omitted or incorporated into the reservoir or cap, references to the base / reservoir / cap unit herein should be understood to mean the reservoir / cap unit). When the cap 44 is coupled to the reservoir 20 (e.g. Figure 3 As shown), the surface 44b of the cap 44 (i.e., the cap 44 is Figure 2 and 3 The downwardly facing surface in the orientation shown faces the reservoir 20.

[0054] In certain embodiments, the internal needle 47 of the cap 44 is positioned so that when the base / reservoir unit is fully inserted into the cap 44, the needle pierces the septum (not shown) of the reservoir 20. In such embodiments, the insertion movement and force of the base / reservoir unit into the open end of the cap 44 to connect the base / reservoir unit to the cap 44 causes the needle 47 to pierce the reservoir septum, allowing fluid in the reservoir to flow into the needle 47 and the tubing 52 of the infusion set 50. In certain embodiments, the base 42 (after being connected to the cap 44) can be selectively disconnected from the cap 44 by manually moving the cap 44 relative to the base 42 in an opposite directional motion relative to the direction of motion of the connection to remove the protrusion 42b from the receiver 44a.

[0055] like Figure 1As shown, the cap 44 is connected to the base 42 and the reservoir 20 along a common axis A to form a unit (base / reservoir / cap unit). When connected together, the base / reservoir / cap unit can be received along axis A in the reservoir receiver 32 of the infusion pump device 30. Figure 1 Axis A in corresponds to the longitudinal axis of the reservoir 20 and the reservoir receiver 32, and the insertion direction when the base / reservoir / cap unit is inserted (or aligned for insertion) into the reservoir receiver 32. Axis A also corresponds to Figure 1 The cap 44 and the central axis of the base 20. When the base / reservoir / cap unit is received in the reservoir receiver 32, the surface 45a of the cap body 45 can abut or seal against the surface of the infusion pump device around the reservoir receiver 32.

[0056] When properly installed within the reservoir receiver 32, the cap 44 (or base / reservoir / cap unit) is releasably secured within the housing of the infusion pump device 30, such as by a second releasable coupling. Figure 1 and Figure 2 In an embodiment of the present invention, the second releasable connector includes external threads 44c on the housing 45 of the cap 44. The threads 44c are arranged to engage with corresponding threads (not shown) in the reservoir receiver 32 of the infusion pump device 30 to secure the base / reservoir / cap unit to the infusion pump device 30. In other embodiments, the second releasable connector includes other suitable coupling structures for selectively releasably coupling the cap 44 to the infusion pump device 30, including but not limited to structures described in U.S. Patent No. 6,585,695 cited above.

[0057] Thus, the cap 44 can be configured as described above for selectively coupling the reservoir 20 to the infusion set 50 and for securing the base / reservoir / cap unit to the infusion pump. In some instances, the cap 44 can be manufactured and configured (by molding, machining, or forming by other suitable manufacturing techniques) to couple to and operate with one particular type, model, or version of the infusion pump 30. In other instances, the cap 44 can be manufactured to couple to and operate with any of a plurality of different types, models, or versions of infusion pumps.

[0058] Some types, models or versions of infusion pumps (such as, but not limited to, those described in U.S. Pat. No. 9,452,255 cited above) may include sensing features for sensing or detecting information about the cap 44. Thus, in some instances, the cap 44 is configured with one or more detectable features so that the cap 44 can be coupled to and operated with one or more types, models or versions of infusion pumps that include sensing features to sense or detect information about the cap 44. However, other types, models or versions of infusion pumps may not include such sensing features or operate using such sensing features. Thus, in some instances, the cap 44 is configured so that the cap can be easily manufactured without one or more detectable features (for operation with an infusion pump that does not have or operates using sensing features), or a cap with one or more detectable features (for operation with an infusion pump that has sensing features) can be easily manufactured with relatively small or minimal adjustments to the manufacturing process. In a specific instance, one or more detectable features may have any one of a variety of different configurations, each of which provides a different detectable signal or mark. In a particular example, cap 44 is made using a manufacturing process that effectively allows for the production of multiple individual caps, wherein each cap (or group of caps) has a different detectable feature configuration relative to each other cap (or relative to the caps in each other cap group).

[0059] In some instances, the cap 44 is formed with and includes one or more (or more) receptacles for receiving and accommodating one or more (or more) detectable features. One or more (or more) detectable features can be inserted into and accommodated in the one or more (or more) receptacles. In some instances, by selectively making relatively minor adjustments to the molding process (or other manufacturing process) during or after the manufacture of the cap 44, a cap 44 with or without one or more (or more) receptacles for accommodating detectable features can be formed.

[0060] For example, in some embodiments, a molding process is used to form a cap 44 (or a portion of a cap 44), wherein the mold is configured to define a cap body 45 (or a portion of a cap body 45) that includes a surface 44b. The mold includes a segment having a relief shape for forming the surface 44b, wherein the mold segment includes one or more mounting structures (such as but not limited to openings, brackets, or other receptacles), and the one or more mounting structures are configured to selectively receive a pin or a plug. When manufacturing a cap 44 having one or more receptacles for accommodating detectable features, the mold segment is prepared (by a technician, an automated system, etc.) by adding a pin to the mounting structure. On the other hand, when manufacturing a cap 44 without a receptacle for accommodating a detectable feature, the same mold segment is prepared (by a technician, an automated system, etc.) by adding a plug (rather than a pin) to cover the mounting structure.

[0061] In such instances, the pin includes a head that extends partially into the relief shape and has a head shape corresponding to the shape of one or more receptacles (such as, but not limited to, receptacles 60 and 62 described below). Thus, when the pin is mounted to the mold segment and the cap 44 is molded, the pin forms (during the molding process) one or more recesses in the surface 44b, corresponding to the shape of one or more receptacles. On the other hand, the plug includes a substantially flat or flat surface that results in a surface 44b without a receptacle. Thus, when the plug is mounted to the mold segment (rather than the pin) and the cap is molded, the cap can be made without a receptacle for accommodating detectable features. Therefore, in some instances, a relatively simple adjustment can be made in the manufacturing process (to install the pin or to install the plug to the mold segment) to determine whether the cap 44 has one or more receptacles for accommodating detectable features or does not have such a receptacle.

[0062] exist Figure 2 and 2A In the example of FIG. 4 , the cap 44 has two receptacles 60 and 62, each receptacle having an internal volume shaped and sized to receive and hold one or more detectable features. Other examples may include more than two receptacles or a single receptacle. Figure 4-7 , receptacles 60 and 62 are shown as containing or housing detectable features in a variety of different arrangements.

[0063] like Figure 2-7 In the example of FIG. 4 , when the cap 44 is coupled to the reservoir 20, the receivers 60 and 62 are positioned on the surface 44b of the cap 44 facing the reservoir 20 (i.e., the annular end surface of the cylindrical wall of the cap 44, with Figure 2 and 3oriented facing downward). In a particular example, when the base / reservoir / cap unit is fully received by the reservoir receiver 32 and coupled to the infusion pump device 30, the surface 44b is positioned within the reservoir receiver 32 of the infusion pump device 30. Thus, when (or only when) the base / reservoir / cap unit is fully received by the reservoir receiver 32 and coupled to the infusion pump device 30, the surface 44b can be positioned proximate to one or more sensor elements 34 in the infusion pump device 30. The surface 44b extends circumferentially about the axis A of the cap, and thus can provide a plurality of suitable locations at which one or more receivers (such as receivers 60 and 62) can be positioned to adequately align with any one or more of a plurality of locations on the infusion pump device 30 at which one or more sensor elements 34 can be provided. In certain examples where cap 44 is formed by a molding process, surface 44b may be readily configured to include one or more (or more) receivers (such as receivers 60 and 62) at one or more suitable locations along surface 44b by making relatively simple adjustments to the mold (or mold segments) forming cap 44, as described herein. Figure 2 , the receiver is shown in the inwardly facing slope of the annular end surface 44b. Alternatively, the receiver can be disposed in the flat portion of the surface 44b. In other examples, the receivers 60 and 62 can be positioned on other suitable surfaces or locations of the cap 44 (such as, but not limited to, other suitable locations below the adjacent or sealing surface 45a of the cap body 45, in Figure 2 and 3 Moreover, in other examples, receivers 60 and 62 can be formed by any suitable manufacturing process or post-manufacturing process.

[0064] exist Figure 2-7 In the example of the embodiment, the receptacles 60 and 62 are each configured to receive and hold one or more disc-shaped members, wherein the one or more disc-shaped members define a detectable feature. In a specific example, each disc-shaped member is a disc-shaped magnet. Such disc-shaped magnets may include any suitable permanent magnet material. In other embodiments, the disc-shaped magnets include but are not limited to magnetically conductive materials connected to permanent magnets or electromagnet magnets, electromagnets or other suitable magnetized materials or devices.

[0065] For example, each disc-shaped member can have a relatively small size, such as a diameter of about 1 mm and a thickness of about 1 mm. In other examples, such disc-shaped magnets can have other suitable sizes (including but not limited to a diameter in the range of about 0.5 mm to about 4 mm and a thickness of up to about 10 mm). In a specific example, such disc-shaped magnets can be easily available and relatively inexpensive disc-shaped members (such as but not limited to multi-purpose disc-shaped magnets or metal discs that are easily available or can be effectively manufactured on the market). Therefore, the use of relatively small disc-shaped magnets can reduce the cost of detectable features and caps 44.

[0066] A single disc-shaped magnet can provide a limited amount of variable detectable information alone. However, depending on the positioning and arrangement of the magnet, a plurality of disc-shaped magnets can be arranged to provide a greater number of detectable signal changes. Therefore, the embodiments described herein include one or more receivers (such as but not limited to receivers 60 and 62), which are configured to receive and hold a plurality of disc-shaped magnets in various orientations, positions, or combinations thereof, for providing various detectable signals according to the orientation and positioning of the magnet. In addition, the embodiments described herein can be configured to provide such various magnet orientations and magnet positions, while also reducing or minimizing manufacturing complexity and cost to adapt to such different changes.

[0067] like Figure 8 , 9 As shown in Figures 1 and 10, multiple disk-shaped magnets can be arranged in various stacked arrangements (where each stack has one or more disk-shaped magnets) to provide a variety of different detectable signals. Figure 8 , 9 and 10, each individual or single disc-shaped magnet having a cylindrical axis A defined c , thickness dimension T c and diameter. Each disc-shaped magnet has opposing magnetic poles on opposing disc surfaces. For example, each disc-shaped magnet may have Fig. 9 and 10 The upward facing surface or Figure 8 The North Magnetic Pole on the left-facing surface and Fig. 9 and 10 The downward facing surface or Figure 8 Alternatively, each disc magnet may have a south magnetic pole on the right-facing surface. Fig. 9 and 10 The downward facing surface or Figure 8 The north magnetic pole on the right-facing surface and the Fig. 9 and 10 The upward facing surface or Figure 8In other examples, the magnetic field direction of one (or each) disc magnet may be set (during or after manufacturing) relative to the cylindrical axis A. c Therefore, depending on the direction chosen for the magnetic poles, Figure 8-10 Each stack of the disc-shaped magnets in the embodiment can selectively provide two (or more) different magnetic signals.

[0068] like Figure 8 As shown, any suitable number of disc-shaped magnets 701, 702, ... 70 N (where N represents any suitable integer) can be coaxially stacked, with their axes arranged in a direction perpendicular to the direction of the axis A of the cap 44. Fig. 9 As shown, any suitable number of disc-shaped magnets 701, 702, ... 70 N (where N represents any suitable integer) can be coaxially stacked, with their axes arranged in a direction parallel to the direction of the axis A of the cap 44. Fig.10 As shown, any suitable number of disc-shaped magnets 701, 702, ... 70 N (where N represents any suitable integer) can be coaxially stacked, with their axes arranged in a direction of an inclination angle β that is neither parallel nor perpendicular to the axis A of the cap 44. Thus, Figure 8-10 Each of the stack of disc-shaped magnets in the embodiment of the present invention can selectively provide any of a variety of different magnetic signal amplitudes depending on the number and strength of the disc-shaped magnets in the stack.

[0069] More specifically, if Figure 8 , 9 The disc-shaped magnets in the stacked arrangement shown in 10 provide a detectable magnetic field or signal having detectable parameters that depend at least in part on the number of disc-shaped magnets in the stack and the orientation of the magnetic poles of the disc-shaped magnets in the stack. The amplitude or strength of the magnetic field provided by each disc-shaped magnet affects the overall amplitude of the magnetic field provided by one or more disc-shaped magnet stacks. In addition, the number of disc-shaped magnets in the stack can affect and determine the amplitude of the detectable magnetic field provided by the disc-shaped magnet stack. Generally, a stack having a greater number of disc-shaped magnets will provide a greater magnetic field amplitude than a stack having a lesser number of disc-shaped magnets. Disk Axis A c The angle (relative to the cap axis A) can correspond to (be the same as or determine) the angle of the magnetic field provided by the stack, and is determined in part by the orientation of the poles of the disc magnets in the stack (whether parallel, perpendicular, or obliquely angled relative to the cap axis A).

[0070] Therefore, in a specific example, the number or axis A of the disk-shaped magnets is selected cto provide a desired or definable magnetic field (definable magnetic mark or signal). Alternatively or additionally, the magnetic field is selected relative to the cylindrical axis A of the disc. c to at least partially determine a desired or definable magnetic field (definable magnetic marker or signal). Thus, each cap 44 can include one or more detectable features that provide a detectable magnetic field signal or marker that depends at least in part on one or more of the following: (a) the number of disk-shaped magnets in the stack; (b) the number of magnet stacks in the detectable feature; (c) the amplitude of the magnetic signal provided by each disk-shaped magnet; (d) the orientation of each stack (e.g., vertical, parallel, or obliquely angled relative to the cap axis A); and (e) the magnetization angle of each disk-shaped magnet in each stack.

[0071] In some instances, based on such detectable parameters, a plurality of different corresponding caps 44 having different corresponding values ​​of one or more parameters in the above parameters (a)-(e) can be easily distinguished from each other. In some instances, a plurality of predefined combinations of values ​​of one or more parameters in parameters (a)-(e) can be associated with a plurality of corresponding predefined characteristics (characteristics of one or more of the cap, reservoir, infusion device or infusion pump device or its components). In the aspect, the detection of a specific value combination of one or more parameters (a)-(e) corresponds to the detection of a cap (or reservoir, infusion device or infusion pump device) having a predefined characteristic associated with the parameter combination. In some instances, each corresponding cap 44 can have a unique magnetic field mark relative to each other's caps 44. In other instances, each corresponding cap 44 can be part of a group of caps 44, wherein each cap in the group has corresponding, similar or identical characteristics, wherein each cap in the group 44 can have a public magnetic field mark unique to the group (relative to other cap groups with other characteristics).

[0072] exist Figure 4-7 In the example shown, the first receiver 60 of the two receivers 60, 62 is composed of a groove-shaped recess, which is set into the annular end surface 44b of the cylindrical wall of the cap molding 45 and has a partial cylindrical or semi-cylindrical shape defined by a pair of end walls separated by a curved cylindrical wall. The axis of the recess is oriented in a direction generally transverse or perpendicular to the direction of the axis A of the cap 44. The receiver 60 is configured to receive and hold one or more (or more) disc-shaped magnets stacked or arranged side by side, with their cylindrical axis A c Arranged in a direction perpendicular to (or generally perpendicular to) the axis A of the cap 44 (corresponding to Figure 8 Medium disc magnet 701-70 N In the direction of the stacking orientation). Figure 2-7In the example shown, the cylindrical axis of the groove-shaped recess generally extends in a circumferential direction relative to the axis A of the cap 44 (or a direction generally tangential to the circumferential direction). In other examples, the cylindrical axis of the groove-shaped recess extends in a radial direction relative to the axis A, or extends in a direction oblique to the radial direction. As described above, the receiver can be provided in a chamfered portion of the annular end surface 44b.

[0073] Figure 4-7 The second receiver 62 of the two receivers 60, 62 shown consists of a hole set in the annular end surface 44b of the cylindrical wall of the cap body 45. This hole is defined by the inner end wall and the cylindrical tubular wall leading to the surface 44b. Therefore, the receiver 62 has a cylindrical shape with its axis in a direction parallel to (or generally parallel to) the direction of the axis A of the cap 44. The receiver 62 is configured to receive and hold one or more (or more) disc-shaped magnets in a stacked arrangement, wherein the cylindrical axis A thereof is oriented in a direction parallel to (or generally parallel to) the direction of the axis A of the cap 44. c Arranged in a direction parallel to (or generally parallel to) the axis A of the cap 44 (corresponding to Fig. 9 Medium disc magnet 701-70 N In another example, a receiver similar to receiver 62 (having a cylindrical hole shape) can be arranged with its cylindrical axis in a direction at an oblique angle relative to the axis A of cap 44 (e.g., corresponding to Fig.10 Disc magnet 701-70 N orientation of the stack).

[0074] although Figure 4-7 The examples in the embodiment include a single slot-shaped receiver 60 and a single cylindrical / hole-shaped receiver 62, but other examples may include multiple slot-shaped receivers 60 or multiple cylindrical receivers 62 (or a combination of multiples of each) positioned at any suitable location (or locations) on the annular end surface 44b or other suitable locations on the cap 44. In some examples, the cap 44 may include one or more slot-shaped receivers 60, or one or more cylindrical receivers 62, or any suitable combination of one or more of each of the receivers 60 or 62. In a particular example, the number and orientation of the receivers are selected for each cap 44 (or each group of caps 44 having similar characteristics) to receive a specific number of disc-shaped magnets and hold the disc-shaped magnets in one or more specific orientations and provide a specific, detectable magnetic field (magnetic marker or signal).

[0075] exist Figure 4-7In the example of the embodiment, each of the receivers 60 and 62 is configured to receive and hold at most two disc-shaped magnets 701 and 702. In other examples, one or each receiver 60 and 62 is configured to receive and hold no more than a single disc-shaped magnet, or to hold more than two disc-shaped magnets. In some examples, one or both of the receivers 60 and 62 are configured to hold at most three disc-shaped members, or at most four disc-shaped members, or at most five disc-shaped members or more.

[0076] like Figure 4-7 As shown in the example of FIG. 1 , a single slot-shaped receiver 60 and a single cylindrical receiver 62 can accommodate one, two (or more) disc-shaped magnets 701 and 702 in a variety of different orientations, wherein each orientation provides a different detectable magnetic field marker or signal relative to each other orientation. For example, in Figure 4 In the embodiment, two disk-shaped magnets 701 and 702 are stacked in a cylindrical receiver 62 (wherein the cylindrical axis A c Arranged in a direction parallel to the axis A of the cap 44) with their respective north poles facing downwards. Figure 5 In the embodiment, two disk-shaped magnets 701 and 702 are stacked in a cylindrical receiver 62 (wherein the cylindrical axis A c Arranged in a direction parallel to the axis A of the cap 44) with their respective north poles facing downwards. Figure 6 In the embodiment, two disk-shaped magnets 701 and 702 are stacked in a slotted cylindrical receiver 62 (wherein the cylindrical axis A c arranged in a direction perpendicular to the axis A of the cap 44) and with their respective north poles facing outwardly relative to the plane of the page. Figure 7 In the embodiment, two disk-shaped magnets 701 and 702 are stacked in a slotted cylindrical receiver 62 (wherein the cylindrical axis A c arranged in a direction perpendicular to the axis A of the cap 44) and with their respective north poles facing inwardly relative to the plane of the page.

[0077] because Figure 4-7 The different orientations of the disk-shaped magnets 701 and 702 in the different corresponding figures are determined by Figure 4-7 The detectable magnetic labels or signals provided by the detectable features in the will be different relative to each other. In this way, each different orientation of the disk-shaped magnets 701 and 702 can be associated with a different characteristic value (such as, but not limited to, a value corresponding to the type of insulin in the reservoir 20, the length or diameter of the conduit 52, or other characteristics as discussed herein). Thus, as a non-limiting example, Figure 4 The orientation shown in may correspond to one or more of those characteristic values ​​(such as, but not limited to, the first specific pipe length), while Figure 5 , 6The orientations shown in FIGS. 1 and 7 may correspond to one or more other characteristic values ​​(such as, but not limited to, the second, third, and fourth specific pipe lengths).

[0078] exist Figure 4-7 In the example shown, two receptacles 60 and 62 and two disc-shaped magnets can provide a variety of different possible orientations, and therefore provide a variety of different possible detectable magnetic labels. Therefore, multiple caps 44 can be configured with the same arrangement of two receptacles 60 and 62, but are loaded with disc-shaped magnets of different arrangements to provide different detectable signals. In other examples, multiple caps 44 can be configured to have other suitable receptacle shapes and arrangements (but with a common or identical receptacle arrangement between multiple caps) for accommodating disc-shaped magnets in one of multiple possible orientations. Therefore, in a specific example, by adopting a common receptacle arrangement between multiple caps, but loading the receptacles of different corresponding caps with disc-shaped magnets of different corresponding arrangements, the manufacturing cost of multiple caps with multiple different detectable labels can be reduced or minimized.

[0079] For example, the same two receivers 60 and 62 and the two disc-shaped magnets can be respectively Figure 4-7 In another example, additional different detectable labels (distinguished from the above description of the invention) can be provided by selectively reducing the number of disk-shaped magnets received in the receiver to no more than one disk-shaped magnet. Figure 4-7 Thus, by selectively selecting one or two disk-shaped magnets and by selecting Figure 4-7 One of the arrangements shown in can provide any of up to eight different distinctly detectable labels or signals.

[0080] In other examples, additional different detectable labels (distinguished from those described above with respect to the magnetic disc) may also be provided by providing receivers 60 and 62 of sufficient size to receive and hold up to three (or other defined number) of magnetic discs. Figure 4-7 Thus, by selectively selecting one, two or three (or more) disk-shaped magnets and by selecting Figure 4-7 One of the directional arrangements shown in , may also provide an additional visibly detectable marker or signal.

[0081] In the examples described above, although the cap 44 is provided with two (or more) receivers 60 and 62, only one receiver receives and holds the selected number and polarity orientation of the disc-shaped magnets. However, in other embodiments, further different detectable markers (distinguished from those described above with respect to the magnetic field) may be provided by selectively loading one, two or more disc-shaped magnets into both receivers 60 and 62 in any arrangement described herein. Figure 4-7 Detectable markers discussed herein). Thus, the same arrangement of two receptacles 60 and 62 (but where each receptacle is large enough to receive and hold more than two disc-shaped magnets) can provide a number of distinctly different detectable markers or signals, depending on the number and arrangement of the disc-shaped magnets within the receptacles. In additional examples comprising more than two receptacles, additional distinctly different detectable markers or signals can be selectively provided, depending on the number and arrangement of the disc-shaped magnets within the plurality of receptacles.

[0082] Thus, by providing the same (or common) arrangement of one, two or more receptacles in a plurality of caps 44, the receptacles of each cap 44 (or each group of multiple caps 44) can be loaded with differently arranged disc-shaped magnets relative to each other's caps (or groups of caps relative to each other) to provide a detectable magnetic marker signal that is detectably different from the signal provided by each other's caps (or by the caps in each other's groups of caps). Each different detectable signal can be associated with a corresponding different characteristic or characteristic value, as described herein, such that detection of the detectable signal corresponds to detection of the associated characteristic or characteristic value.

[0083] In a specific example, each of the receivers 60 and 62 is configured to receive and hold one or more (or more) disc-shaped magnets of the same type, shape, size, so that the same disc-shaped magnet can be arranged in any one of the receivers 60 and 62. In a specific example, the receivers 60 and 62 are configured to receive and hold disc-shaped magnets, which are easily available and relatively cheap types, which can reduce or minimize manufacturing costs. By avoiding the need to keep a plurality of detectable features with mutually different detectable parameters, the use of disc-shaped magnets that can be selectively arranged in a plurality of different stacks and directional arrangements to provide different detectable signals can simplify manufacturing inventory requirements. In other examples, the disc-shaped magnet can have any suitable shape or configuration, including customized shapes or configurations. In other examples, in addition to the disc-shaped magnet or as a substitute for the disc-shaped magnet, a magnet member with other shapes (except the disc shape) can be adopted. Such other shapes may include, but are not limited to, cubic or cuboid shapes, polygonal cuboid shapes, spherical or hemispherical shapes, etc. In such other examples, the shapes of receivers 60 and 62 may be configured to correspond to the shapes of the magnetic members to allow the receivers to receive one or more of such magnetic members in one or more orientations as described herein.

[0084] In certain instances, each of the receptacles 60 and 62 is configured to receive and hold one or more (or more) disc-shaped magnets in a press-fit or friction-fit manner. In such instances, the diameter of the cylindrical shape of the receptacles 60 and 62 is approximately the same as (or slightly smaller than) the diameter of each disc-shaped magnet, so that during manufacturing (or post-manufacturing processes), the disc-shaped magnets can be slid or pressed into the receptacles and securely held in place within the receptacles by friction fit with the inner surface of the receptacles. In some instances, the friction fit is sufficient to hold the disc-shaped magnets in place on the cap 44 without the need for adhesives or additional fixing mechanisms. However, in other instances, the diameter of the cylindrical shape of the receptacles 60 and 62 is greater than the diameter of each disc-shaped magnet, so that the disc-shaped magnets can be easily slid into the receptacles. In any of those examples, the disc-shaped magnet may be secured within receiver 60 or 62 and to cap 44 by swaging, glue or other bonding material, solder, welding, heat staking, molding, or the like.

[0085] As described above, the infusion pump device 30 includes one or more sensor elements 34 configured to detect the presence of a detectable feature or other parameter of a detectable feature when in sufficient proximity or position relative to the detectable feature. In instances where the detectable feature is comprised of one or more disc-shaped magnets as described herein, such sensors may include, but are not limited to, magnetoresistive (MR), anisotropic magnetoresistive (AMR), Hall effect, magnetic reed, or other sensor devices that provide a detectable response to the presence or alignment (or both) of a magnet.

[0086] In yet other embodiments, one or more detectable features 60 are one or more conductive metals or other conductive materials that can be inductively detected by one or more inductive sensors, wherein one or more sensor elements 34 include one or more inductive sensors. In such other embodiments, the conductive member that can be inductively detected (by an inductive detector) does not need to be a magnet or magnetized. In such examples, one or more (or each) of the disc-shaped magnets (e.g., disc-shaped magnets 701 and 702) in the above examples can be replaced with a disc-shaped conductive member, such as but not limited to a metal disc or a conductive ceramic disc. In such examples, one or more (or more) disc-shaped conductive members can be arranged in various possible orientations within one or more (or more) receptacles (such as receptacles 60 and 62 discussed herein) to provide corresponding various possible inductive detectable marks in a manner similar to the disc-shaped magnets discussed herein. In such instances, one or more (or more) disc-shaped members can be made of one or more different metals or other materials selected to provide a definable detectable inductive marker, such that any one or more of the different disc-shaped members can be selected and used in a stack to provide a selected different inductive detectable marker.

[0087] Thus, in a particular example, the one or more detectable features include one or more (or more) magnetically detectable magnetic features or one or more (or more) inductively detectable conductive features, or a combination of both magnetically detectable features and inductively detectable features, carried by the cap 44 at one or more predetermined locations on or in the cap housing 45. The sensor element 34 may include one or more (or more) sensors at predetermined locations in or near the reservoir receiver 32 of the infusion pump device 30. In a particular embodiment, the sensor element 34 and the detectable features are arranged so that they are aligned or in proximity (or both) when the base / reservoir / cap unit is fully or properly received in the reservoir receiver 32 of the infusion pump device 30. Various types and arrangements of detectable features and sensor elements that may be employed in the examples described herein are described in U.S. Pat. No. 9,452,255 cited above.

[0088] According to the embodiments described herein, when the cap 44 (or the corresponding reservoir / base / cap unit) is received in the infusion pump device 30, one or more sensors 34 on the infusion pump device 30 interact with the detectable features to detect proper (or improper) coupling of the cap 44 (or reservoir / base / cap unit) to the infusion pump device 30. In yet other embodiments, the one or more sensors and the detectable features interact in some manner to convey certain information related to characteristics of one or more of the reservoir 20, the reservoir contents, the cap 44, the infusion set 50, or the infusion pump device 30.

[0089] For example, the sensor and detectable features may be such that the sensor 34 and the electronic device 80 ( Fig.11 ) detects the presence or position (or both) of a detectable feature or other parameter of a detectable feature when the cap 44 is properly received or operably coupled with the infusion pump device 30 (or both). As referenced herein, proper reception or operative coupling corresponds to a position of the cap 44 (or base / reservoir / cap unit) at which the drive link 22 of the reservoir 20 is operably engaged with a drive mechanism in the infusion pump device 30. In other embodiments, proper reception or operative coupling corresponds to another suitable predetermined position of the cap 44 (or base / reservoir / cap unit).

[0090] When the connection interface 40 is coupled to the reservoir 20 and the base / reservoir / cap unit is fully and properly received in the reservoir receiver 32 of the infusion pump device 30 (eg, Figure 3 ), the detectable features in one or both of the receivers 60 or 62 on the cap 44 are sufficiently aligned with or in proximity (or both) to the sensor element 34 to allow the sensor to detect the detectable features. However, when the connection interface 40 is not coupled to the reservoir 20, or when the base / reservoir / cap unit is not fully or properly received in the reservoir receiver 32 of the infusion pump device 30, the detectable features in one or both of the receivers 60 and 62 are not sufficiently aligned with or in proximity (or both) to the sensor element 34, so that the sensor element cannot properly detect at least one detectable feature.

[0091] Alternatively or additionally, one or more magnets and sensor elements as described above are used to detect one or more other features associated with the cap 44 or base / reservoir / cap unit, the infusion set 50 (or a combination or assembly thereof) in addition to or as an alternative to detecting the presence in or proper connection with the infusion pump device 30. In various embodiments, such other characteristics include, but are not limited to, characteristics of the cap 44, the reservoir 20 (or its contents), the infusion set 50, the connection interface 40, or any combination thereof.

[0092] Fig.11The electronics 80 includes processing electronics 82 connected to receive electronic signals from the sensor via a communication link 84. In one embodiment, the communication link 84 includes one or more conductive wires or traces or other conductive materials, a wireless connection (such as but not limited to radio frequency RF, Bluetooth, WiFi, inductive coupling or other wireless communication links), or a combination thereof.

[0093] In certain embodiments, the processing electronics 82 includes one or more electronic processors configured to process information received from the sensor element 34. Such electronic processors may include, but are not limited to, programmable general-purpose processors, microprocessors, programmed or hardware-configured special-purpose processors, etc., which are programmed or otherwise configured with software, hardware, firmware, combinations thereof to perform the operations described herein. The electronic device 80 includes one or more electronic memory devices 86, which store data, programs, or other software used by the processing electronics 82 to perform the operations described herein. In certain embodiments, the electronic device 80 also includes a receiver, transmitter, or transceiver 88, which is configured to receive information from another electronic device (not shown), transmit information to the other electronic device, or both receive information from another electronic device and transmit information to the other electronic device, such as, but not limited to, a user's computer, a computer of a healthcare entity, etc. The electronic device 80 also includes one or more power supplies (not shown) or is connected to the one or more power supplies for providing power to the processing electronics 82 and, as needed, to the memory 86 and the transceiver 88. In certain embodiments where sensor element 34 requires power, the power source described above or a separate power source associated with the sensor element provides power to the sensor element, such as via link 84 or via a separate electrical connection (not shown).

[0094] The processing electronics 82 are programmed or otherwise configured to process information received from the sensor element 34 and determine the presence or position of the cap 44 relative to the reservoir receiver 32 of the infusion pump device 30 or other characteristics of the cap 44 (or base / reservoir-cap unit) based on specific parameters detected by the sensor element. In one example embodiment, the processing electronics 82 are configured to detect the presence or absence of a signal from the sensor element 34 to determine the presence or absence of the cap 44 in a predetermined position relative to the reservoir receiver 32. In other embodiments, the processing electronics 82 are configured to process the signal from the sensor element 34 to determine one or more parameters associated with the position of the cap 44, such as, but not limited to, the amount of rotation or linear displacement of the cap 44 relative to the reservoir receiver 32, the rotational position of the cap 44 about the axis A, the linear position of the cap 44 along a dimension of the axis A, the angular position of the axis A of the cap 44 relative to the axis A of the reservoir receiver 32, or any combination thereof.

[0095] In certain embodiments, the processing electronics 82 are configured to process the signals from the sensor element 34 to determine one or more other parameters associated with characteristics of the cap 44, the reservoir 20 (or other components of the base / reservoir / cap unit), the infusion set, the infusion pump device 30, or the user. In certain embodiments, such characteristics may include, but are not limited to, the type or characteristics of the infusion set connected to the cap 44. For example, the cap (or base / reservoir / cap unit) may be configured to be compatible with a variety of different infusion set products, such as, but not limited to, the following infusion set products: Infusion Set, Infusion Set, Infusion Set, In addition, different infusers can be configured with a variety of different feature options to meet the needs or preferences of the user, such as but not limited to tubing length, cannula length, and cannula type. In certain embodiments, different infusers, features, and options can be associated with different perceived detectable parameters of the detectable feature and thus differentiated based on the detectable parameter of the detectable feature. In some instances, the electronic device (such as Fig.11 The electronic device 80 in can be configured to control the operation of the infusion pump device based on (or partially based on) the detected parameters.

[0096] For example, once a parameter associated with tubing length is detected, the infusion pump device 30 can automatically set a start sequence that corresponds to or is appropriate for the detected tubing length (and / or perform one or more other predefined tasks that depend at least in part on the detected tubing length). Such embodiments can further automate infusion media delivery (such as, but not limited to, insulin delivery), thereby making therapy easier for the user.

[0097] In those embodiments, the particular characteristic can be associated with one or more detectable parameters of the detectable feature, where the detectable parameters include, but are not limited to, one or more of the following: the presence of one or more magnets on the cap 44, the pattern or positioning of the one or more magnets on the cap 44 (circumferential or linear positioning relative to the dimension of axis A), the amplitude or strength of the magnetic field of the detectable feature, the polarity direction of the detectable feature, the magnetic field angle β, etc.

[0098] Thus, in certain embodiments, each different characteristic of the reservoir 20, infusion set 50, or connection interface 40 is associated with a corresponding different detectable parameter of the magnet. By reading the indicia of the cap 44, the parameters defining the indicia are detected. Thus, the processing electronics 82 may be configured to detect one or more detectable parameters of the magnet or sensor element; then determine one or more characteristics of the cap, base / reservoir / cap unit, reservoir, or infusion set based on the detectable parameters; and perform one or more additional predefined actions based on or using the determined characteristics.

[0099] In certain embodiments, the electronic device 80 (including the processing electronic device 82) is configured to perform the process 90 as described in reference to Fig.12 For example, in process 90, a plurality of predefined parameters (parameters that may be potentially detected) are associated (or other predefined associations) in a one-to-one manner with a corresponding plurality of characteristics of the cap 44, the base / reservoir / cap unit, the reservoir 20 or its contents, the infusion set 50, the connection interface 40, or any component or combination thereof. At 92, the association of the detectable parameters and the plurality of characteristics is stored in a memory, such as the memory 86.

[0100] At 94 in process 90, one or more detectable features (eg, disk-shaped magnets 701, 702, ... 70 N ) is detected by one or more sensor elements 34, for example, during installation or installation (or attempted installation) of the cap 44 or base / reservoir / cap unit in the infusion pump device 30. At 96, the processing electronics 82 compares the information received from the sensor element 34 with one or more predefined stored thresholds, or with information stored in a table (or in another data arrangement that associates a plurality of different detectable magnet positions or other magnet parameters with a corresponding plurality of characteristics, such as, but not limited to, a one-to-one correspondence of each different magnet position with a different characteristic). Alternatively or in addition, the processing electronics 82 may be configured to compare the information received from the sensor element 34 with one or more thresholds, or with information stored in a table or in another data arrangement that associates a plurality of different types of magnets (such as, but not limited to, magnets with different polarities, magnetic field angles β, field strengths, or combinations of the foregoing) with corresponding plurality of characteristics (such as, but not limited to, a one-to-one correspondence of each different magnet type with different characteristics). In those embodiments, processing electronics 82 is configured to determine magnet location, magnet type, or both based on one or more comparisons of information received from sensor element 34 with stored information. In certain embodiments, the stored tables or other data arrangements are stored in electronic memory 86.

[0101] Example characteristics of the reservoir 20 (or its contents) include, but are not limited to, one or more of the following: the type or identity of the manufacturer of the reservoir 20 or its components or contents, the size of the reservoir 20, the type of infusion medium in the reservoir 20 (such as, but not limited to, the type of insulin, other medication, or other medium), the concentration of the infusion medium in the reservoir 20, the volume of the infusion medium in the reservoir 20, a date (such as, but not limited to, a date corresponding to an expiration date, a fill date, or other date associated with the infusion medium in the reservoir 20 or the reservoir 20 itself), a location (such as, but not limited to, a location corresponding to the location where the reservoir 20, the cap 44, or the infusion medium (or all) in the reservoir 20 was made, filled, or otherwise processed, or a location for authorized use of the reservoir 20), a batch number (or other code associated with a batch of the reservoir 20 or the infusion medium that was made, cleaned, filled, or otherwise processed), a serial number, a unique ID, a manufacturing date, user identification information (for authorized users of the reservoir 20), or other predefined characteristics.

[0102] Example characteristics associated with the infusion set 50 connected to the cap 44 include, but are not limited to, one or more of the following: type or manufacturer of the infusion set 50 or its components, length of the tubing 52, diameter of the tubing 52, length of the needle or cannula 56, diameter of the needle or cannula 56, date (such as, but not limited to, a date corresponding to an expiration date, a manufacturing date, or an assembly date of the needle or cannula 56), location (such as, but not limited to, a location corresponding to a location where the needle or cannula 56 was made or assembled with the housing 54, or a location for authorized use of the infusion set or its components), batch number (or other code associated with a batch of the infusion set 50 or its components that were made, cleaned, or otherwise processed), cannula type, needle type, batch number, serial number, unique ID, user identification information (for authorized users of the infusion set 50), or other predefined characteristics.

[0103] Example characteristics associated with the connection interface 40 include, but are not limited to, one or more of the following: the type or manufacturer of the connection interface 40, cap 44, base 42, or components thereof, the length, diameter, or other size of the cap 44, a date (such as, but not limited to, a date corresponding to an expiration date, a manufacturing date, or an assembly date of the cap 44 or base 42), a positioning (such as, but not limited to, a positioning corresponding to a location at which the cap 44 or base 42 was made or assembled, or a positioning for authorized use of the cap 44 or base 42), a batch number (or other code associated with a batch of the cap 44 or base 42 that was made, cleaned, or otherwise processed), a serial number, a unique ID, user identification information (for authorized users of the infusion set 50), or other predefined characteristics.

[0104] In certain embodiments, the processing electronics 82 is further configured to perform one or more predefined actions at 99 in process 90 based on or using the characteristics determined at 98 in process 90. The one or more predefined actions may include, but are not limited to, determining one or more operational settings of the infusion pump device 30 based on one or more of the characteristics determined from the detected parameters of the signal from the sensor element 34. In further examples of such embodiments, the processing electronics 82 also provides signals to the drive device or other components of the infusion pump device 30 to control the operation of the drive device (or other components) based on the one or more characteristics determined from the detected parameters. In one instance, based at least in part on the detected parameters, the processing electronics 82 determines and sets operational settings for one or more of: pumping rate (amount of fluid pumped per unit time), pumping time period (amount of time pumping), pumping power (amount of fluid pressure), priming (filling) the infusion set tubing 52, priming (filling) the infusion set needle or cannula 56, detecting a blockage in the fluid path from the reservoir 20 to the infusion set needle or cannula 56, and handling a blockage (pumping time, pressure, or procedure used to remove, compensate for, or otherwise handle a blockage).

[0105] Thus, in one example, the detectable indicia or signal from the detectable feature corresponds to one or more characteristics associated with a particular type or size of infusion set 50 connected to the cap 44, wherein the detected characteristics are employed by the processing electronics 82 to determine a pumping rate or a pumping time period (or both) sufficient to prime (fill) the infusion set tubing 52 or the needle or cannula 56 (or both). In another example, the detectable indicia or signal from the detectable feature corresponds to one or more characteristics associated with a pumping time, a pumping pressure, or a pumping program that is sufficient to remove or compensate for an obstruction in the particular type or size of infusion set 50.

[0106] In further embodiments, the processing electronics 82 is configured to perform (at 99 in the process 90) one or more other predefined actions based on or using the characteristic determined at 98. Such other predetermined actions may include, but are not limited to, providing a control signal to deactivate or inhibit activation of a pump drive in the infusion pump device 30 when the signal received from the sensor member 34 indicates that the cap 44 or the base / reservoir / cap unit is not fully or properly received within the reservoir receiver 32 of the infusion pump device 30. Alternatively or in addition, the processing electronics 82 is configured to provide a control signal to activate or allow activation of a pump drive in the infusion pump device 30 when the signal received from the sensor member 34 indicates that the cap 44 or the base / reservoir / cap unit is fully or properly received within the reservoir receiver 32 of the infusion pump device 30.

[0107] Alternatively or in addition, the processing electronics 82 is configured to perform (at 99 in process 90) yet one or more other predefined actions, such as, but not limited to, providing an alarm signal to activate an alarm indicator when the signal received from the sensor member 34 indicates that the cap 44 or base / reservoir / cap unit is not fully or properly received within the reservoir receiver 32 of the infusion pump device 30. In certain embodiments, the processing electronics 82 is configured to provide such an alarm or control signal (or both) only when the processing electronics 82 detects that the cap 44 or base / reservoir / cap unit is not fully and properly received within the reservoir receiver 32, after previously detecting that the cap 44 or base / reservoir / cap unit is fully and properly received within the reservoir receiver 32 (e.g., indicating that a previously properly received cap 44 has been moved or otherwise displaced out of said position within the reservoir receiver 32). In such embodiments, processing electronics 82 may include (or be connected to communicate with) a display device for displaying the alarm condition.

[0108] The alarm display device may include any suitable indicator, such as, but not limited to, one or more of the following: a light emitting device, an LED, an LCD or other visual display device; a sound emitting device, a speaker, a buzzer or other audio display device; a vibrator, a heater or other tactile display device, etc. In a particular embodiment, the alarm display device is attached to the infusion pump device 30 or included in the infusion pump device. In other embodiments, the alarm display device is attached to the cap 44 or included in the cap. In yet other embodiments, the alarm display device is in an external device (such as, but not limited to, a computer, a smart phone, a pager or other electronic communication device) connected for communicating with the electronic device 80, for example, via a wired or wireless communication link.

[0109] In further embodiments, the processing electronics 82 is configured to perform (at 99 in process 90) other actions, such as, but not limited to, recording data representing the state or condition (or characteristics) of one or more of the detected cap 44, base / reservoir / cap unit, and infusion pump device 30. In a particular embodiment, the processing electronics 82 records such data in an electronic memory 86 in a form that can be retrieved by the processing electronics 82 or other processing electronics (not shown) at a time or date after recording. In such embodiments, the processing electronics 82 or other processing electronics may employ such data to generate a report, table, or other data structure to aid in evaluating the recorded data. In yet further embodiments, the processing electronics 82 is configured to send such recorded data, report, table, or other data structure to a predefined entity, such as, but not limited to, transmitting information via a transceiver 88. For example, in a particular embodiment, the electronics 80 is configured to transmit the recorded information to a remote facility at predefined or periodic intervals or upon receiving such information from a sensor element.

[0110] In the particular embodiments described above, the processing electronics 82 is configured to determine an operational setting for the infusion pump device 30, provide an alarm or control signal, record data, or perform other predefined tasks based at least in part on the detection of one or more detectable features (or information provided by detectable parameters of the detectable features). In certain embodiments, the processing electronics 82 is configured to verify the base / reservoir / cap unit, cap 44, or reservoir 20 based on one or more of the parameters detected in the signal received from the sensor element 34. For example, the processing electronics 82 determines whether the detected parameters correspond to predefined characteristics associated with an authentic base / reservoir / cap unit, cap 44, or reservoir 20. In such embodiments, the authentic base / reservoir / cap unit, cap 44, or reservoir 20 can be, for example, a base / reservoir / cap unit, cap, or reservoir authorized for use with the infusion pump device 30 by a manufacturer of at least one of the infusion pump device, base / reservoir / cap unit, cap 44, or reservoir 20. Alternatively or additionally, the actual base / reservoir / cap unit, cap 44 or reservoir 20 can be a base / reservoir / cap unit, cap or reservoir authorized by another predefined entity (such as but not limited to a government or industry standards or regulatory entity, or other predefined entity).

[0111] In some embodiments, the processing electronics 82 coupled to the transceiver 88 can access a database (e.g., on the Internet), for example, directly or through another device, via a wired or wireless connection, to verify the authenticity of one or more of the base, reservoir, and / or cap, respectively, using serial numbers (unique IDs, etc.) obtained from the base, reservoir, and / or cap to confirm that such units are authentic and genuine. Medical devices are rigorously tested and strictly regulated, and the use of unauthorized components may jeopardize the appropriate treatment of a patient. Many components, such as bases / reservoirs / caps, infusers, etc., are single-use components, and the processing electronics 82 on the infusion pump device 30 can, for example, keep track of serial numbers so that a patient is prohibited from intentionally or unintentionally reusing a component whose safe useful life has been exhausted. Furthermore, in addition to verifying authenticity, for example, the batch number of the corresponding base, reservoir and / or cap can be checked against a database to ensure that there are no outstanding recalls and that the user is warned (or even prohibited) by the infusion pump device 30 (or any other suitable device) not to use the particular base, reservoir and / or cap and, if a recall is ongoing, return it to the manufacturer, thereby further enhancing patient safety by using the latest available information.

[0112] In certain embodiments, the detected geolocation, time, or date (or any combination thereof) is included in the determination of authenticity. For example, when the parameters detected from the signal received from the sensor element 34 correspond to the characteristics of the authentic base / reservoir / cap unit, cap, or reservoir that have been predefined (e.g., prestored in the memory 86) as being used at a particular time, date, or geolocation (or a combination thereof), the processing electronics 82 can be configured to determine that the base / reservoir / cap unit, cap 44, or reservoir 20 installed in the infusion pump device 30 is authentic. In such embodiments, the memory 86 can store a table or other suitable data configuration that associates a combination of detectable magnet parameters and one or more dates, times, and geolocations (or any combination thereof) with an authentication determination. Examples of suitable tables are described in U.S. Patent No. 9,452,255 cited above.

[0113] In certain embodiments, the electronics 80 are configured to allow operation of the infusion pump device 30 when the processing electronics 82 determines that the base / reservoir / cap unit, the cap 44, or the reservoir 20 is authentic, and to disallow infusion operation of the infusion pump device 30 when the processing electronics 82 does not determine that the base / reservoir / cap unit, the cap 44, or the reservoir 20 is authentic. For example, the processing electronics 82 may be configured to provide a control signal to the drive device to stop operation of the drive device, or to inhibit sending a drive or power signal to the drive device, or to perform another predefined action to disallow dispensing of infusion medium from the infusion pump device 30. In other embodiments, the electronics 80 are configured to allow infusion operation (or limited or other predefined infusion operation) of the infusion pump device 30, but also perform one or more additional predefined actions when the processing electronics 82 does not determine that the base / reservoir / cap unit, the cap 44, or the reservoir 20 is authentic. Such other predefined actions include, but are not limited to, one or more of: providing a readable message on a display device of the infusion pump device 30, providing an alarm signal for operating an alarm indicator on the infusion pump device 30, and recording data associated with one or more of the infusion operation, detected characteristics, time, date, and geographic location, or any combination thereof.

[0114] In further embodiments, the processing electronics 82 is configured to employ detection of parameters of detectable features to determine the presence or proper alignment, installation, and connection of a base / reservoir / cap unit, cap 44, or reservoir 20 in an infusion pump device 30. Additionally, the detected parameters are associated with one or more characteristics discussed herein (e.g., in a table or otherwise, as discussed above). Then, once proper alignment, installation, or connection of a base / reservoir / cap unit, cap 44, or reservoir 20 in an infusion pump device 30 is detected, the processing electronics controls the operation of the infusion pump device 30 based on the one or more characteristics. In further embodiments, the processing electronics 82 may be configured to determine a geographic location, time, date (or any combination thereof) at a predetermined time, periodically, randomly, etc., once the infusion pump device 30 has begun operation.

[0115] In any of the above or additional embodiments, the processing electronics 82 may be configured to record information about the infusion pump device 30, the base / reservoir / cap unit, the cap 44, or the reservoir 20, or the use and operation thereof. In a particular embodiment, the processing electronics 82 is configured to record in the memory 86, for example, data corresponding to one or more of the following: identification information associated with the base / reservoir / cap unit, the cap 44, or the reservoir 20, a connection date or time, operation or disconnection of the base / reservoir / cap unit, the cap 44, or the reservoir 20 with the infusion pump device 30, a date or time of an alarm condition, a date or time of operation of the infusion pump device 30, a detected parameter, or a condition associated with a detected parameter. In additional embodiments, as an alternative to or in addition to the recording of date or time information, the geographic location of the infusion pump device at the time of any of the above recorded events is recorded. In such embodiments, a record may be made of the use of the infusion pump device 30, base / reservoir / cap unit, cap 44, or reservoir 20 outside of a predetermined geographic region, date, or time (e.g., beyond a predetermined expiration date). In further embodiments, as an alternative to or in addition to recording an event, the processing electronics 82 is configured to provide one or more of an alarm indication and a warning message display on a display device in the infusion pump device upon detecting use of the infusion pump device 30, base / reservoir / cap unit, cap 44, or reservoir 20 outside of a predetermined geographic region, date, or time.

[0116] In other embodiments, one or more wireless or wired communication devices are provided on the infusion pump device 30 (or other delivery device) and are configured and controlled to transmit volume information related to the volume of infusion fluid retained in the reservoir 20 or dispensed from the reservoir (or other information corresponding to the detected parameters or related characteristics) for display on another electronic device that is separate from or located away from the infusion pump device 30. In a specific embodiment, the wireless communication device is configured to connect to one or more predefined network connection devices to communicate on a communication network (such as but not limited to the Internet). Such one or more predefined network connection devices can be located at a remote geographical location relative to the infusion pump device 30 (or other delivery device). In a specific embodiment, such a network connection device includes a server that is configured to receive information from the infusion pump device 30 (or other delivery device) or from another network connection device (such as a stand, a user computer, etc.) that communicates with the infusion pump device 30 (or other delivery device). Such information may include, but is not limited to, information corresponding to one or more detected parameters or one or more relevant characteristics, or other information related to the reservoir 20, cap 44, base / reservoir / cap unit, or infusion set as described above.

[0117] In such embodiments, the network-connected server may be associated with an entity that records information, supplies related products such as refills or replacement parts, provides medical or health insurance to users, etc. In one example, the network-connected server is associated with Carelink from Medtronic Inc. TM The network-connected server is associated with the system. In other embodiments, the network-connected server is one or more other servers and related entities. Therefore, the server (or related entity) can use such information to determine whether (or when) to send a refill, a new or replacement reservoir, a cap, an infusion set needle housing, an infusion set tubing or cap, a base / reservoir / cap unit, or other components 44 of the infusion set. In other embodiments, such information can be provided to the user's doctor or other medical entity associated with the user (for tracking, diagnosis, adjusting treatment plans, or other suitable purposes). Therefore, in such embodiments, refills or replacement parts can be automatically sent to the user (without the need for the user to place an order), and usage information can be automatically provided to the user's healthcare provider, insurance provider, or other suitable entity.

[0118] In further embodiments, the network-connected server is configured to provide (and the infusion pump device 30 or other delivery device is configured to receive) information via the above-mentioned network communication connection or other network connection. Such information may include, but is not limited to, instructions or suggestions for replacing or refilling the reservoir 20, cap 44, base / reservoir / cap unit or infusion set, messages or notifications from healthcare providers, insurance companies or manufacturers, recall notices, etc. In certain embodiments, the electronics (such as the electronics 80) in the infusion pump device 30 (or other delivery device) are configured to perform one or more predefined actions (as discussed above) in response to receiving a predefined instruction, notification or message.

[0119] Although the above description refers to a specific embodiment of the present invention, it should be understood that many modifications can be made without departing from the spirit of the present invention. The attached claims are intended to cover such modifications that fall within the true scope and spirit of the present invention. Therefore, the presently disclosed embodiments should be considered in all respects to be illustrative rather than restrictive, the scope of the present invention is indicated by the attached claims rather than the foregoing description, and all changes falling within the equivalent meaning and scope of the claims are intended to be included therein.

[0120] The following numbered paragraphs set forth further embodiments that form part of the present disclosure.

[0121] Paragraph 1. A connector interface system comprising:

[0122] a cap connected to a reservoir to form a reservoir / cap unit for installation into an infusion pump device, the cap having at least one receptacle for receiving one or more detectable features; and at least one detectable feature comprising at least one disc-shaped member received within the at least one receptacle for detection by at least one sensor element on the infusion pump device when the reservoir of the reservoir / cap unit is received in the reservoir receptacle of the infusion pump device;

[0123] Wherein the at least one detectable feature has at least one detectable parameter, and the at least one detectable parameter is associated with one or more characteristics of the cap, the reservoir, the infusion pump device, a sleeve associated with the cap, or a tube connected between the cap and the sleeve.

[0124] Paragraph 2. The connector interface system of Paragraph 1, wherein the at least one detectable feature comprises a plurality of disc-shaped members arranged in a stack within the at least one receiver.

[0125] Paragraph 3. The connector interface system of Paragraph 1, wherein the at least one receiver comprises a plurality of receivers, each receiver being configured to receive one or more detectable features.

[0126] Paragraph 4. A connector interface system according to Paragraph 3, wherein the at least one detectable feature includes a plurality of disc-shaped members arranged in a stacked form within one of the at least one receivers, while another of the at least one receivers lacks a disc-shaped member.

[0127] Paragraph 5. The connector interface system of Paragraph 3, wherein the at least one detectable feature comprises a plurality of disc-shaped members arranged in a stack within each of the plurality of receivers.

[0128] Paragraph 6. A connector interface system according to Paragraph 1, wherein the cap and the reservoir have a common longitudinal axis A, and wherein the at least one receiver includes a first receiver having a partial cylindrical or semi-cylindrical configuration, the first receiver having a cylindrical axis extending in a direction transverse to the direction of the axis A.

[0129] Paragraph 7. A connector interface system as described in Paragraph 6, wherein the at least one receiver includes a second receiver having a cylindrical configuration, the second receiver having a cylindrical axis extending in a direction parallel to the direction of the axis A.

[0130] Paragraph 8. A connector interface system according to Paragraph 6, wherein the at least one receiver includes a second receiver having a cylindrical configuration, the second receiver having a cylindrical axis extending in a direction at an oblique angle relative to the direction of the axis A.

[0131] Paragraph 9. A connector interface system according to Paragraph 1, wherein the cap and the reservoir have a common longitudinal axis A, and wherein the at least one receiver includes a receiver having a cylindrical configuration, the receiver having a cylindrical axis extending in a direction parallel to the direction of the axis A.

[0132] Paragraph 10. A connector interface system according to Paragraph 1, wherein the cap and the reservoir have a common longitudinal axis A, and wherein the at least one receiver includes a plurality of receivers, the plurality of receivers including a first receiver having a cylindrical configuration, the first receiver having a cylindrical axis extending in a direction at an oblique angle relative to the direction of the axis A.

[0133] Paragraph 11. A connector interface system as described in Paragraph 1, wherein the at least one disk-shaped member comprises at least one disk-shaped magnet, and wherein the at least one detectable feature provides a detectable magnetic field.

[0134] Paragraph 12. A connector interface system according to Paragraph 11, wherein the cap and the reservoir have a common longitudinal axis A, and wherein the at least one detectable parameter includes at least one of: the amplitude of the magnetic field, the polarity direction of the magnetic field, and the angle of the magnetic field relative to axis A.

[0135] Paragraph 13. A connector interface system according to paragraph 1, wherein the at least one disk-shaped member includes a plurality of disk-shaped magnets, and wherein the detectable magnetic field depends on the number of disk-shaped magnets in the detectable feature, and wherein the number of disk-shaped magnets in the detectable feature is adjustable.

[0136] Paragraph 14. The connector interface system of Paragraph 1, wherein the at least one disk-shaped member comprises at least one disk-shaped conductive member, and wherein the at least one detectable feature provides an inductively detectable indicia.

[0137] Paragraph 15. A connector interface system according to paragraph 14, wherein the at least one disc-shaped member includes a certain number of disc-shaped conductive members, the number being greater than one, and wherein the inductively detectable mark depends on the number of disc-shaped members in the detectable feature, and wherein the number of disc-shaped members in the detectable feature is adjustable.

[0138] Paragraph 16. A connector interface system comprising:

[0139] a cap connected to the reservoir to form a reservoir / cap unit for installation into an infusion pump device, the cap having at least one receptacle for receiving one or more detectable features; and at least one detectable feature received in the at least one receptacle, the at least one detectable feature comprising a number of detectable members, the number being greater than one, wherein each detectable member has a same shape and size and is configured to be selectively received in the at least one receptacle for detection by at least one sensor element on the infusion pump device when the reservoir of the reservoir / cap unit is received in the reservoir receptacle of the infusion pump device;

[0140] wherein the at least one detectable feature has at least one detectable parameter that is dependent, at least in part, on the number of detectable members received within the at least one receptacle; and

[0141] Wherein the at least one detectable parameter is associated with one or more characteristics of the cap, the reservoir, the infusion pump device, a cannula associated with the cap, or a tubing connected between the cap and the cannula.

[0142] Paragraph 17. The connector interface system of Paragraph 16, wherein the at least one detectable feature comprises at least one disc-shaped magnet that provides a detectable magnetic field.

[0143] Paragraph 18. The connector interface system of Paragraph 16, wherein the at least one detectable feature comprises at least one disc-shaped conductive member, and wherein the at least one detectable feature provides an inductively detectable indicia.

[0144] Paragraph 19. A connector interface system according to paragraph 16, wherein the one or more characteristics include one or more of the following: the type or identity of the manufacturer of the reservoir or the cap; the size of the reservoir or the cap; the type or concentration of the infusion medium in the reservoir; the volume of the infusion medium in the reservoir; a date corresponding to a manufacturing date, an expiration date, or a fill date associated with the infusion medium in the reservoir; a date corresponding to a manufacturing date or an expiration date of the reservoir or the cap; a location corresponding to a location where the reservoir or the infusion medium in the reservoir is made, filled, or otherwise processed; a location corresponding to a location where the cap is made, assembled, or otherwise processed; a location corresponding to a location where the reservoir, the infusion medium in the reservoir, or the cap is authorized for use; a batch number or code associated with a batch of the reservoir, the cap, or the infusion medium; a serial number; a unique ID; user identification information for an authorized user; the type, length, or size of the cannula associated with the cap; or the type, length, or size of the tubing connected between the cap and the cannula.

[0145] Paragraph 20. A method of using a connector interface system, the method comprising:

[0146] connecting a cap to the reservoir to form a reservoir / cap unit for installation into an infusion pump device, the cap having at least one receptacle for receiving one or more detectable features; and

[0147] inserting at least one detectable feature comprising a plurality of disc-shaped members into the at least one receiver for detection by at least one sensor element on the infusion pump device when the reservoir of the reservoir / cap unit is received in the reservoir receiver of the infusion pump device, the number of the disc-shaped members being greater than one;

[0148] wherein the at least one detectable feature has at least one detectable parameter that depends in part on the number of disc-shaped members, wherein the at least one detectable parameter is associated with one or more characteristics of the cap, the reservoir, the infusion pump device, a cannula associated with the cap, or a tube connected between the cap and the cannula, and wherein the at least one detectable parameter comprises a magnetic field characteristic or an inductively detectable marker.

Claims

1. A connector interface system for transmitting indicia representing characteristics of a reservoir / cap unit and connected structure to an infusion pump device (30), the connector interface system comprising: The reservoir / cap unit has a cap (44) and a reservoir (20) of a medical fluid, wherein the cap (44) includes a molded body (45) adapted to removably secure the reservoir (20) in a reservoir receiver (32) of the infusion pump device (30) and has an outlet port (46) for directing the medical fluid from the reservoir (20) to the connected structure during operation of the infusion pump device (30); The cap (44) has at least one receptacle (60, 62) provided in a surface (44b) of the body (45) of the cap (44) and containing one or more detectable features (701-702) indicative of a tag to be transferred. N ); wherein the at least one detectable feature (701-70 N ) includes at least one disc-shaped member (701) received in the at least one receiver (60, 62) to detect, via at least one sensor element (34) on the infusion pump device (30), when the reservoir of the reservoir / cap unit is received in the reservoir receiver (32) of the infusion pump device (30); wherein the at least one receiver comprises: a first receiver (60) comprising a slot provided into the surface (44b) of the body (45) of the cap (44) and defined by a pair of end walls separated by a curved cylindrical wall, and A second receiver (62) includes a hole provided into the surface (44b) of the body (45) of the cap (44) and defined by an inner end wall and a cylindrical tubular wall opening to the surface (44b).

2. The connector interface system of claim 1 , wherein the at least one detectable feature (701-70 N ) includes a plurality of disc-shaped members of the same shape and size arranged in a stacked form within the at least one receiver (60, 62).

3. The connector interface system of claim 1 , wherein the at least one detectable feature comprises a plurality of disc-shaped members arranged in a stack within one of the at least one receptacle, while another of the at least one receptacle lacks a disc-shaped member. 4 . The connector interface system of claim 1 , wherein the at least one detectable feature comprises a plurality of disc-shaped members arranged in a stack within each of the plurality of receivers.

5. A connector interface system for transmitting indicia representing characteristics of a reservoir / cap unit and connected structure to an infusion pump device (30), the connector interface system comprising: The reservoir / cap unit has a cap (44) and a reservoir (20) of a medical fluid, wherein the cap (44) includes a molded body (45) adapted to removably secure the reservoir (20) in a reservoir receiver (32) of the infusion pump device (30) and has an outlet port (46) for directing the medical fluid from the reservoir (20) to the connected structure during operation of the infusion pump device (30); The cap (44) has at least one receptacle (60, 62) provided in a surface (44b) of the body (45) of the cap (44) and containing one or more detectable features (701-702) indicative of a tag to be transferred. N ); wherein the at least one detectable feature (701-70 N ) includes at least one disc-shaped member (701) received in the at least one receiver (60, 62) to detect, via at least one sensor element (34) on the infusion pump device (30), when the reservoir of the reservoir / cap unit is received in the reservoir receiver (32) of the infusion pump device (30); wherein the cap and the reservoir have a common longitudinal axis A, and wherein the at least one receptacle comprises a first receptacle having a part-cylindrical or semi-cylindrical configuration, the first receptacle having a cylindrical axis extending in a direction transverse to the axis A. 6 . The connector interface system of claim 5 , wherein the at least one receiver comprises a second receiver having a cylindrical configuration, the second receiver having a cylindrical axis extending in a direction parallel to the axis A. 7 .

7. The connector interface system of claim 5, wherein the at least one receiver comprises a second receiver having a cylindrical configuration, the second receiver having a cylindrical axis extending in a direction at an oblique angle relative to the direction of the axis A.

8. A connector interface system for transmitting indicia representing characteristics of a reservoir / cap unit and connected structure to an infusion pump device (30), the connector interface system comprising: The reservoir / cap unit has a cap (44) and a reservoir (20) of a medical fluid, wherein the cap (44) includes a molded body (45) adapted to removably secure the reservoir (20) in a reservoir receiver (32) of the infusion pump device (30) and has an outlet port (46) for directing the medical fluid from the reservoir (20) to the connected structure during operation of the infusion pump device (30); The cap (44) has at least one receptacle (60, 62) provided in a surface (44b) of the body (45) of the cap (44) and containing one or more detectable features (701-702) indicative of a tag to be transferred. N ); wherein the at least one detectable feature (701-70 N ) includes at least one disc-shaped member (701) received in the at least one receiver (60, 62) to detect, via at least one sensor element (34) on the infusion pump device (30), when the reservoir of the reservoir / cap unit is received in the reservoir receiver (32) of the infusion pump device (30); wherein the cap and the reservoir have a common longitudinal axis A, and wherein the at least one receptacle comprises a receptacle having a cylindrical configuration, the receptacle having a cylindrical axis extending in a direction parallel to the axis A.

9. A connector interface system for transmitting indicia representing characteristics of a reservoir / cap unit and connected structure to an infusion pump device (30), the connector interface system comprising: The reservoir / cap unit has a cap (44) and a reservoir (20) of a medical fluid, wherein the cap (44) includes a molded body (45) adapted to removably secure the reservoir (20) in a reservoir receiver (32) of the infusion pump device (30) and has an outlet port (46) for directing the medical fluid from the reservoir (20) to the connected structure during operation of the infusion pump device (30); The cap (44) has at least one receptacle (60, 62) provided in a surface (44b) of the body (45) of the cap (44) and containing one or more detectable features (701-702) indicative of a tag to be transferred. N ); wherein the at least one detectable feature (701-70 N ) includes at least one disc-shaped member (701) received in the at least one receiver (60, 62) to detect, via at least one sensor element (34) on the infusion pump device (30), when the reservoir of the reservoir / cap unit is received in the reservoir receiver (32) of the infusion pump device (30); wherein the cap and the reservoir have a common longitudinal axis A, and wherein the at least one receptacle comprises a plurality of receptacles including a first receptacle having a cylindrical configuration having a cylindrical axis extending in a direction at an oblique angle relative to the direction of the axis A.

10. The connector interface system of any one of claims 1 to 9, wherein the at least one disc-shaped member comprises at least one disc-shaped magnet, and wherein the at least one detectable feature provides a detectable magnetic field.

11. The connector interface system of claim 10, wherein the disc-shaped magnet is stacked with at least one non-magnetizable metal or ceramic disc.

12. The connector interface system of claim 10 , wherein the cap and the reservoir have a common longitudinal axis A, and wherein the indicia is conveyed as at least one of: the amplitude of the magnetic field, the polarity direction of the magnetic field, the angle of the magnetic field relative to the axis A, and the number of magnets detected.

13. The connector interface system of any one of claims 1 to 9, wherein the at least one disc-shaped member comprises at least one disc-shaped conductive member, and wherein the at least one detectable feature provides an inductively detectable indicia.

14. The connector interface system of claim 13, wherein the detectable feature comprises a disk of a different metal or other material.

15. The connector interface system of any one of claims 1 to 9, wherein the at least one disc-shaped member is sized to be press-fit or friction-fit into its corresponding receiver.

16. The connector interface system of any one of claims 1 to 9, wherein the indicia to be communicated includes one or more of: the type or identity of the manufacturer of the reservoir or the cap; the size of the reservoir or the cap; the type or concentration of the infusion medium in the reservoir; the volume of the infusion medium in the reservoir; a date corresponding to a manufacturing date, an expiration date, or a fill date associated with the infusion medium in the reservoir; a date corresponding to a manufacturing date or an expiration date of the reservoir or the cap; a location corresponding to a location where the reservoir or the infusion medium in the reservoir was made, filled, or otherwise processed; a location corresponding to a location where the cap is made, assembled, or otherwise processed; a location corresponding to a position at which the reservoir, the infusion medium in the reservoir, or the cap is authorized for use; A batch number or code associated with the batch that made, cleaned, filled, or otherwise processed the reservoir, the cap, or the infusion medium; a serial number; a unique ID; user identification information for an authorized user; the type, length, or size of the cannula associated with the cap; or the type, length, or size of tubing connected between the cap and the cannula.

17. The connector interface system according to any one of claims 1 to 9, further comprising: at least one sensor element (34) on the infusion pump device (30), the at least one sensor element being positioned to detect the at least one detectable feature (701-702) when the reservoir of the reservoir / cap unit is received in the reservoir receiver (32) of the infusion pump device (30). N ); and sensor electronics connected to said one sensor element (34) to recover said marker.

18. An infusion pump system comprising: The connector interface system according to claim 17; and an infusion pump device (30) having a reservoir receiver (32) for receiving the reservoir / cap unit, a drive structure for advancing the medical fluid from the reservoir to the connected structure, and a control unit; wherein when the cap (44) secures the reservoir (20) in the infusion pump device (30), the control unit of the infusion pump device is coupled to the sensor electronics to receive the marker and control the drive structure in accordance with the characteristics of the reservoir / cap unit and the connected structure as conveyed by the marker.

19. An infusion pump system according to claim 18, wherein the control unit is further configured to determine whether the reservoir / cap unit is compatible with the infusion pump device (30) based on the marking, and if not compatible, or if the reservoir / cap unit is not fully or properly received in the reservoir receiver (32), prevent the delivery of fluid and / or activate an alarm.

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