WO2024118976A1

WO2024118976A1 - Insulin pump system incorporating sensor feedback

Info

Publication number: WO2024118976A1
Application number: PCT/US2023/081925
Authority: WO
Inventors: Byron COHEA; Amrith Karunaratne; Kennie HSU; Justin COKER; Virginia S. Lu
Original assignee: Tandem Diabetes Care, Inc.
Priority date: 2022-12-01
Filing date: 2023-11-30
Publication date: 2024-06-06

Abstract

Embodiments disclosed herein are directed to ambulatory infusion pump systems that integrate a CGM sensor and/or a pressure sensor with an ambulatory infusion pump via a pump holder or tray that releasably holds the pump and is configured to be worn by a user, wherein the ambulatory infusion pump includes an inductive charging coil and the tray includes an inductive coil configured to be aligned with the inductive charging coil to receive power from the inductive charging coil, and wherein a processor is configured to receive and process glucose signals from the CGM sensor and pressure signals from the pressure sensor through the inductive charging coil.

Description

INSULIN PUMP SYSTEM INCORPORATING SENSOR FEEDBACK

This application is being filed on November 30, 2023, as a PCT International Patent application and claims the benefit of and priority to U.S. Provisional patent application Serial No. 63/429,442, filed December 1, 2022, the entire disclosure of which is incorporated by reference herein in its entirety.

TECHNICAL FIELD

The present disclosure relates generally to ambulatory infusion pumps and, more particularly, to operation of ambulatory infusion pumps in conjunction with a continuous glucose monitor.

BACKGROUND

There are a wide variety of medical treatments that include the administration of a therapeutic fluid in precise, known amounts at predetermined intervals. Devices and methods exist that are directed to the delivery of such fluids, which may be liquids or gases, are known in the art.

One category of such fluid delivery devices includes insulin injecting pumps developed for administering insulin to patients afflicted with type 1, or in some cases, type 2 diabetes. Some insulin injecting pumps are configured as portable or ambulatory infusion devices that can provide continuous subcutaneous insulin injection and/or infusion therapy as an alternative to multiple daily insulin injections via syringe or injector pen. Such ambulatory infusion pumps may be worn by the user, may use replaceable medicament cartridges, and may deliver other medicaments alone, or in combination with insulin. Such medicaments include glucagon, pramlintide, and the like. Examples of such pumps and various features associated therewith include those disclosed in U.S. Patent Publication Nos. 2013/0324928 and 2013/0053816 and U.S. Patent Nos. 8,287,495; 8,573,027; 8,986,253; and 9,381,297, each of which is incorporated herein by reference in its entirety.

Ambulatory infusion pumps for delivering insulin or other medicaments can be used in conjunction with blood glucose monitoring systems, such as continuous glucose monitoring devices (CGMs). A CGM device consists of a sensor placed under the patient’s skin and affixed to the patient via an adhesive patch, a transmitter, and a monitor. A CGM device samples the patient’s interstitial fluid periodically (e.g., once every 1-5 minutes) to estimate blood glucose levels over time. CGMs are advantageous because they provide more frequent insights into a user’s blood glucose levels yet do not require a finger stick each time a reading is taken.

Ambulatory infusion pumps may communicate with a dedicated CGM directly via a wired connection or indirectly via a wireless connection using wireless data communication protocols to communicate with a separate device (e.g., a dedicated remote device or a smartphone). One example of integration of ambulatory infusion pumps with CGM devices is described in U.S. Patent Publication No. 2014/0276419, which is hereby incorporated by reference herein. Ambulatory infusion pumps typically allow the user or caregiver to adjust the amount of insulin or other medicament delivered by a basal rate or a bolus, based on blood glucose data obtained by a CGM device, and in some cases include the capability to automatically adjust such medicament delivery. For example, based on CGM readings, some ambulatory infusion pumps may automatically adjust or prompt the user to adjust the level of medicament being administered or planned for administration or, in cases of abnormally low blood glucose readings, reducing or temporarily ceasing insulin administration.

As noted above, ambulatory infusion pumps often communicate wirelessly with a CGM. These communications therefore require a pairing procedure to establish communications between the devices. Both the pump and the CGM therefore also need to each have a battery, processor, communications element, etc.

SUMMARY

Embodiments disclosed herein are directed to ambulatory infusion pump systems that integrate a CGM sensor and/or a pressure sensor with an ambulatory infusion pump via a pump holder or tray that releasably holds the pump and is configured to be worn by a user.

In an embodiment, an ambulatory infusion pump includes a housing, a reservoir configured to contain a medicament, a pumping mechanism configured to deliver the medicament from the reservoir to a user, an inductive charging coil and a processor configured to control the pumping mechanism to deliver the medicament from the reservoir to the user. The processor can be configured to receive and process glucose signals received through the inductive charging coil from a glucose sensor and pressure signals received through the inductive charging coil from a pressure sensor. In an embodiment, an ambulatory infusion pump system includes a glucose sensor configured to be inserted into a user, a pressure sensor and an ambulatory infusion pump. The ambulatory infusion pump can include a housing, a reservoir configured to contain a medicament, a pumping mechanism configured to deliver the medicament from the reservoir to a user and an inductive coil. The pump can further include a processor configured to receive and process glucose signals received through the inductive charging coil from a glucose sensor and pressure signals received through the inductive charging coil from pressure sensor. In some embodiments, the glucose sensor and the pressure sensor can be integrated into a tray configured to be worn by a user and to releasably hold the pump.

In an embodiment, an ambulatory infusion pump system can include an ambulatory infusion pump including a housing, a reservoir configured to contain a medicament, a pumping mechanism configured to deliver the medicament from the reservoir to a user and an inductive charging coil. The ambulatory infusion pump can further include a processor configured to control the pumping mechanism to deliver the medicament from the reservoir to the user. The processor can be configured to receive and process glucose signals received through the inductive charging coil from a glucose sensor and pressure signals received through the inductive charging coil from a pressure sensor.

In embodiments, an ambulatory infusion pump system can include an ambulatory infusion pump including a housing, a reservoir configured to contain a medicament, a pumping mechanism configured to deliver the medicament from the reservoir to a user and an inductive charging coil and a processor configured to control the pumping mechanism to deliver the medicament from the reservoir to the user. The system can further include a tray configured to be worn by a user to releasably hold the ambulatory infusion pump. The tray can include a cannula port configured to receive a cannula therethrough for delivering medicament from the ambulatory infusion pump through the tray and a glucose sensor port configured to receive a glucose sensor therethrough. The ambulatory infusion pump can be configured to interface with the cannula and the glucose sensor when inserted onto the tray.

The above summary is not intended to describe each illustrated embodiment or every implementation of the subject matter hereof. The figures and the detailed description that follow more particularly exemplify various embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

Subject matter hereof may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying figures, in which:

Figure 1 is an embodiment of an ambulatory infusion pump for use with embodiments of the disclosure.

Figure 2 is a block diagram of the ambulatory infusion pump of Figure 1.

Figures 3A-3B are an alternate embodiment of an ambulatory infusion pump for use with embodiments of the disclosure.

Figure 4 is an embodiment of a CGM for use with embodiments of the disclosure.

Figures 5A-5C depict a holder for an ambulatory infusion pump system according to the disclosure.

Figures 6A-6D depict an ambulatory infusion pump system according to the disclosure incorporating the holder of Figures 5A-5C.

Figures 7 schematically depicts the electrical connections in an ambulatory infusion pump system according to the disclosure.

Figures 8A-8E depict an ambulatory infusion pump system incorporating a CGM sensor and an extended wear infusion site according to an embodiment of the disclosure.

Figures 9A-9E depict an ambulatory infusion pump system incorporating a CGM sensor and an extended wear infusion site according to an embodiment of the disclosure.

Figures 10A-10D depict an ambulatory infusion pump system incorporating a CGM sensor and an extended wear infusion site according to an embodiment of the disclosure.

While various embodiments are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the claimed inventions to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims. DETAILED DESCRIPTION OF THE DRAWINGS

The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

Figure 1 depicts an example infusion pump that can be used in conjunction with one or more embodiments of the ambulatory infusion pump system of the present disclosure. Pump 12 includes a pumping or delivery mechanism and reservoir for delivering insulin or other medicament to a patient and an output/di splay 44. The output/di splay 44 may include an interactive and/or touch sensitive screen 46 having an input device such as, for example, a touch screen comprising a capacitive screen or a resistive screen. The pump 12 may additionally or instead include one or more of a keyboard, a microphone or other input devices known in the art for data entry, some or all of which may be separate from the display. The pump 12 may also include a capability to operatively couple to one or more other display devices such as a remote display (e.g., a dedicated remote display or a CGM display), a remote control device, or a consumer electronic device (e.g., laptop computer, personal computer, tablet computer, smartphone, electronic watch, electronic health or fitness monitor, or personal digital assistant). Further details regarding such pump devices can be found in U.S. Patent No. 8,287,495, previously incorporated by reference above. It is to be appreciated that pump 12 may be optionally configured to deliver one or more additional or other medicaments to a patient.

Figure 2 illustrates a block diagram of some of the features that may be included within the housing 26 of pump 12. The pump 12 can include a processor 42 that controls the overall functions of the pump. The pump 12 may also include, e.g., a memory device 30, a transmitter/receiver 32, an alarm 34, a speaker 36, a clock/timer 38, an input device 40, a user interface suitable for accepting input and commands from a user such as a caregiver or patient, a drive mechanism 48, an estimator device 52 and a microphone (not pictured). One embodiment of a user interface is a graphical user interface (GUI) 60 having a touch sensitive screen 46 with input capability. In some embodiments, the processor 42 may communicate with one or more other processors within the pump 12 and/or one or more processors of other devices through the transmitter/receiver 32 such as a remote device (e.g., CGM device), a remote control device, or a consumer electronic device (e.g., laptop computer, personal computer, tablet computer, smartphone, electronic watch, electronic health or fitness monitor, or personal digital assistant). In some embodiments, the communication is effectuated wirelessly, by way of example only, via a near field communication (NFC) radio frequency (RF) transmitter or a transmitter operating according to a “Wi-Fi” or Bluetooth® protocol, Bluetooth® low energy protocol or the like. The processor 42 may also include programming to receive signals and/or other data from an input device, such as, by way of example, a pressure sensor, a temperature sensor, or the like.

Figures 3A-3B depicts a second infusion pump that can be used in conjunction with one or more embodiments of the ambulatory infusion pump system of the present disclosure. Pump 102 includes a pump drive unit 118 and a medicament cartridge 116. Pump 102 includes a processor that may communicate with one or more processors within the pump 102 and/or one or more processors of other devices such as a remote device (e.g., a CGM device), a remote control device, or a consumer electronic device (e.g., laptop computer, personal computer, tablet computer, smartphone, electronic watch, electronic health or fitness monitor, or personal digital assistant). The processor 42 may also include programming to receive signals and/or other data from an input device, such as, by way of example, a pressure sensor, a temperature sensor, or the like. Pump 102 also includes a processor that controls some or all of the operations of the pump. In some embodiments, pump 102 receive commands from a separate device for control of some or all of the operations of the pump. Such separate device can include, for example, a dedicated remote control device or a consumer electronic device such as a smartphone executing an application configured to enable the device to transmit operating commands to the processor of pump 102. In some embodiments, processor can also transmit information to one or more separate devices, such as information pertaining to device parameters, alarms, reminders, pump status, etc. Such separate device can include any remote display, remote control device, or a consumer electronic device as described above. Pump 102 can also incorporate any or all of the features described with respect to pump 12 in Figure 2. In some embodiments, the communication is effectuated wirelessly, by way of example only, via a near field communication (NFC) radio frequency (RF) transmitter or a transmitter operating according to a “Wi-Fi” or Bluetooth® protocol, Bluetooth® low energy protocol or the like. Further details regarding such pumps can be found in U.S. Patent No. 10,279,106 and U.S. Patent Publication Nos. 2016/0339172 and 2017/0049957, each of which is hereby incorporated herein by reference in its entirety. Figure 4 depicts an example CGM system that can be used in conjunction with one or more embodiments of an ambulatory infusion pump system. The CGM system includes a sensor 101, a sensor probe 106, a sensor body 108, a receiver, and a monitor (receiver and monitor are depicted as device 100 in Fig. 4). The sensor 101 is removably affixed to a user 104 and includes a sensor probe 106 configured for transcutaneous insertion into the user 104. When placed, the sensor probe 106 reacts with the user’s interstitial fluid which produces a signal that can be associated with the user’s blood glucose level. The sensor 101 further includes a sensor body 108 that transmits data associated with the signal to the receiver 100 via wired or wireless connection (as represented by arrow line 112). In preferred embodiments, the receiver 100 receives the transmitted data wirelessly by any suitable means of wireless communication. By way of example only, this wireless communication may include a near field communication (NFC) radio frequency (RF) transmitter or a transmitter operating according to a “Wi-Fi” or Bluetooth® protocol, Bluetooth® low energy protocol or the like. Further detail regarding such systems and definitions of related terms can be found in, e.g., U.S. Patent Nos. 8,311,749, 7,711,402 and 7,497,827, each of which is hereby incorporated by reference in its entirety.

Although as described above infusion pumps and continuous glucose monitors are separate devices, there are disadvantages to this configuration. For example, the requirement for Bluetooth or other wireless communications between the pump and the CGM require the devices to be paired. This requires the user to undertake a complex pairing procedure to pair the two devices and errors can arise if the devices become unpaired or communications issues arise between the devices. The CGM sensor and the pump also require two different attachment sites and separate insertions into the user’s body. In addition, the separate devices each require their own batteries, processors, communications devices and associated circuitry. Embodiments described herein therefore incorporate the CGM into the ambulatory infusion pump to address each of these disadvantages.

Figures 5A-5C depict a pump holder or tray 200 for an ambulatory infusion pump system that aids in transmitting CGM data and optionally other data according to the disclosure. Tray 200 can include a tray body 202 having a base 204 on which the pump rests as well as sidewalls 206 that interface with a perimeter of pump. Tray 200 can further include a pump retention feature 208 to retain the pump on the tray 200 and a tab 210 that aids in releasing the pump from the tray 200. A cannula interface 212 can engage with the pump for delivering medicament from the pump reservoir through a cannula 214 extending beneath the tray 200.

Tray 200 can further include a recess 216 in base 204 in which an inductive coil 218 is disposed. Although depicted as open in the figures for sake of clarity, in some embodiments a cover can be overmolded or installed over the recess 216 to cover the inductive coil 218 to prevent damage. The coil 218 can be connected in a circuit with a resistive CGM sensor 220 that extends beneath the tray 200 and into the user’s skin. As will be discussed in more detail below, the inductive coil 218 in the tray can be aligned with an inductive coil in the pump, such that the inductive coil in the pump provides power to the tray coil 218 and uses signals from the tray coil 218 to obtain blood glucose information from the CGM sensor 220. The pump will generally already include an inductive coil for wireless charging of the pump battery, so no new components would be needed to add this functionality, such that the only change would be to the programming of the processor to enable the function.

Tray 200 can further incorporate a pressure sensor 222 that interfaces with the cannula 214 and can be disposed in the cannula interface 212. Pressure sensor 222 can be a capacitive pressure sensor positioned adjacent the cannula 214 in order to sense the pressure within cannula. A pair of wires 224 can be positioned within a channel on tray 200 or printed onto tray 200 in order to connect the pressure sensor 222 with the inductive coil 218.

Figures 6A-6D depict an ambulatory infusion pump system according to the disclosure incorporating the holder of Figures 5A-5C. As noted above, pump 102 includes an inductive charging coil 120 for wirelessly charging of the pump battery. When the pump 100 is inserted onto the tray 200, the inductive charging coil 120 of the pump is brought into alignment coplanar with the inductive charging coil 218 in the tray.

Figure 7 schematically depicts the electrical connections in the system. The charging coils of the tray and pump are aligned such that the pump coil can wirelessly provide power used to operate the CGM sensor and/or pressure sensor in the tray. In operation, the pump would pass a transient current at some voltage through the pump coil, which would induce a current in the tray coil. This can be done periodically to enable the sensors to take measurements, such as, for example, every minute. Because the tray has resistive, inductive and capacitive elements in a circuit, the tray acts as an RLC circuit including circuit oscillations. The oscillating current in the tray coil would in turn induce current coil to create a signal that could be detected by the currentsensing resistor in the pump. By looking at the current through the current sensing resistor of the pump over time, information can be gathered about the status of the resistor and the capacitor that enables measurement of glucose levels with the resistive CGM sensor and pressure values with the capacitive pressure sensor. The pressure measurements can then be used to detect occlusions in the cannula as indicated by pressure spikes.

In these embodiments, pump 102 includes internal circuitry to transmit the signals measured by the CGM sensor and pressure sensor to the pump processor. The processor of pump can include programming sufficient to receive the CGM and pressure signals and to process those signals for use of the glucose and pressure levels indicated by the signals in providing therapy with the pump.

Integrating the CGM sensor and pressure sensor with the pump 102 in the manner described herein addresses a number of issues with current systems. No Bluetooth or other wireless communications between the devices is required because the CGM and pressure sensor signals are sent to the pump via utilizing the inductive charging coil already present in the pump. As such, the CGM does not require a complex pairing procedure and wireless connectivity issues preventing transmission of CGM data will not occur. In addition, there are cost savings in the system because the CGM does not need a separate battery, processor, wireless communications elements and associated circuitry. Further, the disclosed integrated solutions require only one attachment site on the body rather than two separate placements with independent adhesive attachment points. The battery life of the pump will also be enhanced due to reduced power consumption from not having continual wireless communications with the CGM. Patient safety is improved by incorporating a pressure sensor into the tray.

One issue with attempting to incorporate a CGM sensor with an infusion site on a pump is that there is a discrepancy in the amount of time that most CGM sensors and infusion sites can be in use. For example, most infusion sets can only remain in place for 2-3 days whereas a CGM sensor may be active for 7-14 days. However, some technology is extending the wearable life of infusion sets, including those disclosed in U.S. Patent Publication Nos. 2018/0280608, 2021/0402084, 2022/0226568 and 2023/0277765, each of which is hereby incorporated by reference in its entirety. A system that combines a CGM sensor with an infusion site for a pump provides further advantages with respect to reducing user burden when the useful life of the two technologies is aligned.

Ambulatory infusion pump systems that incorporate such extended wear infusion sets and CGM sensors into a wearable patch pump are disclosed herein. Such systems can include a tray that can be placed on the user’s body that houses all three devices and interfaces with each device’s respective insertion device. For example, the tray can include guide features that interface with the infusion set insertion device on one end of the tray and have opposing guide features that integrate with a CGM on the other end of the tray with a central part of the tray including features that interface with an infusion pump. In some embodiments, a tray can interface with a single integrated insertion device that simultaneously inserts both an insulin infusion cannula and a CGM. Other embodiments can include a linked rotatable tray that allows for greater insertion location flexibility for long term wear applications. Such designs can be utilized to ensure sufficient distance between the CGM sensor and the infusion cannula, which reduces the risk of insulin infusion causing inaccuracy of glucose readings. Systems disclosed herein can further simplify CGM device design by integrating the transmitter hardware directly into the patch pump, such as described above, which removes the need for an external transmitter device for the CGM.

Figures 8A-8E depict an ambulatory infusion pump system 300 incorporating a CGM sensor and an extended wear infusion site according to an embodiment of the disclosure. System 300 can include a holder 302 including a tray 304 disposed on a patch 306 having an adhesive on the underside for attachment to the user. A cannula insertion device 350 may temporarily attach to the tray 304 for placement of the patch 306 on the user. Cannula insertion device 350 may include a button or trigger 352 used to insert a cannula 308 through the tray 304 and into the user’s body. Following insertion of the cannula 308 into the user’s body, the cannula insertion device 350 can be disconnected from the tray. (In some embodiments, insertion of the cannula 208 by activation of the trigger 352 may automatically cause the cannula insertion device 350 to become disconnected from the tray.) Further details regarding such cannula insertion devices can be found in U.S. Patent Publication No. 2018/0280608 and 2021/0402084, previously incorporated herein by reference.

After removal of the cannula insertion device 350, a sensor insertion device 360 can be interfaced with tray. Cannula insertion device 360 can also include a button or trigger 362 that causes a CGM sensor 310 to be inserted through the tray 306 and into the user’s body. The cannula insertion device 360 can then be removed. Following these two insertion procedures, a cannula 308 is inserted through a cannula port 312 in the tray 306 and into the user’s body and a CGM sensor 310 is inserted through a sensor port 314 through the tray 306 and into the user’s body, as can be seen in Figures 8C and 8E. An infusion pump 370 can then be attached to tray 306. Tray 306 may include features for guiding the pump 370 onto tray 306 to properly position pump to interface with cannula 308 and CGM sensor 310 and pump and/or tray may include features for releasably locking the pump onto the tray. Further detail regarding such pumps and trays can be found in U.S. Application Publication No. 2023-0173170, U.S. Patent Application No. 18/448,584 and U.S. Provisional Patent Application Nos. 63/445,962 and 63/437,872, each of which is hereby incorporated herein by reference in its entirety. Referring to Figure 8E, upon insertion cannula 308 and CGM sensor 310 can be sufficiently spaced apart to prevent infusion of insulin too near to the sensor that sensor accuracy is affected.

Figures 9A-9E depict an ambulatory infusion pump system 400 incorporating a CGM sensor and an extended wear infusion site according to another embodiment of the disclosure. Infusion pump system 400 can similarly include a holder 402 with a tray 404 for releasably holding an infusion pump 470 an adhesive patch 406 for adhering the holder to a user’s body. In this embodiment, a single insertion device 450 can be used to insert both a cannula 408 for delivering medicament to the user and a CGM sensor 410 through corresponding ports through the tray 404 into the user’s skin. In some embodiments, a common mechanism within the inserter can be used to insert both devices through the tray 404 and into the user’s skin either simultaneously or serially. As shown in Figure 9E, this may result in the cannula 408 and CGM sensor 410 being positioned in closer proximity than the embodiment of Figures 8A-8E, but provides significant added convenience to the user by enabling a simpler and faster setup by inserting the device with only a single activation of a trigger 452 or other device on the inserter. Cannula 408 and CGM sensor 410 can still be positioned to reduce a likelihood of interference. In embodiments, the distance between the cannula and CGM sensor can be 13 mm or greater. In one embodiment, the distance is 17 mm. In some embodiments, a single spring can cause both the cannula and CGM sensor to be inserted. In other embodiments, separate springs can cause each device to be inserted with both springs being actuated by a common trigger 452 on the insertion device 450. Figures 10A-10D depict an ambulatory infusion pump system 500 incorporating a CGM sensor and an extended wear infusion site according to an embodiment of the disclosure. Infusion pump system 500 also includes a holder 502 having a tray 504 for releasably holding a pump 570 and a patch 506 for adhering the holder to the user’s body. In this embodiment, the holder 502 includes a plurality of openings 512 through the tray 504. Each opening can be capable of receiving an infusion cannula and/or CGM sensor therethrough. In one embodiment, the infusion cannula 508 and CGM sensor 510 can be integrated into a common insertion module 514 having a base 516 from which both the infusion cannula 508 and CGM sensor 510 extend sized to be receiving within one of the openings 512 through tray 504. An insertion device 550 can be configured to insert the insertion module 514 through the tray 504. Insertion device 550 can be configured to be positioned in various orientations and/or locations with respect to holder 502 to insert the module 514 into the various openings 512. In an embodiment, insertion device 550 can seat on the holder 502 in an initial orientation and then be rotatable about a gear or other mechanism to align insertion device 550 with any of the openings to insert the module 514 through a selected opening. In another embodiment, the tray 504 can include a plurality of alignment features that enables the insertion device 550 to be aligned with a given opening 512. Following insertion of the module 514, the pump 570 can be attached to the tray 504 and interfaced with module 514. This embodiment therefore enables the user to change the infusion cannula and CGM sensor as needed without having to employ a new holder 502 such that the holder can be used for a longer period of time reducing cost and waste and increasing convenience for the user.

Although the embodiments above describe an infusion cannula and CGM sensor that are inserted in separate locations on the body, in other embodiment the infusion cannula and CGM sensor can be integrated such that there is only a single insertion point on the user. For example, the infusion cannula and CGM sensor can configured such that either the CGM sensor extends through a lumen in the infusion cannula or the infusion cannula extends through the CGM sensor. In another embodiment, the sensor can be coated around the infusion set cannula.

As noted above, by integrating the CGM sensor with the pump as described herein the sensor can be powered with the existing battery of the pump and not require a separate power source. In some embodiments, the CGM sensor may be able to continue sensing based on stored power received from the pump even when the pump is removed from the holder. Similarly, if the CGM sensor requires a transmitter, the transmitter can be incorporated into the pump. Although the embodiments described above that integrate the sensor through a tray holding a pump enable a direct connection between the sensor and the pump, embodiments that utilize a tubed infusion set that extends from the pump to a location remote from the pump can also integrate a CGM sensor. In such embodiments, the CGM can be integrated with the pump via a connection cord extending back through the infusion tubing to the pump.

In embodiments, an ambulatory infusion pump system can include an ambulatory infusion pump including a housing, a reservoir configured to contain a medicament, a pumping mechanism configured to deliver the medicament from the reservoir to a user and an inductive charging coil. The ambulatory infusion pump can further include a processor configured to control the pumping mechanism to deliver the medicament from the reservoir to the user. The processor can be configured to receive and process glucose signals received through the inductive charging coil from a glucose sensor and pressure signals received through the inductive charging coil from a pressure sensor.

In some embodiments, the system can further include a tray configured to be worn by a user to releasably hold the ambulatory infusion pump.

In some embodiments, the system can further include an inductive coil disposed in the tray configured to be aligned with the inductive charging coil in the ambulatory infusion pump to receive power from the inductive charging coil in the ambulatory infusion pump.

In some embodiments, the system can further include a glucose sensor integrated into the tray connected in circuit with the inductive coil in the tray such that the inductive coil in the tray transmits a signal from the glucose sensor to the inductive charging coil in the pump.

In some embodiments, the pumping mechanism is configured to deliver the medicament from the reservoir through a cannula extending beneath the tray and the system further includes a pressure sensor configured to interface with the cannula to sense a pressure within the cannula.

In some embodiments, the system further includes an inductive coil disposed in the tray communicatively linked to the pressure sensor and configured to be aligned with the inductive charging coil in the ambulatory infusion pump to receive power from and transmit data sensed by the pressure sensor to the inductive charging coil in the ambulatory infusion pump.

In some embodiments, the inductive coil is communicatively linked to the pressure sensor via a direct electrical connection.

In some embodiments, the processor is configured to periodically pass a transient current through the inductive charging coil to induce a current in the inductive coil in the tray to enable the glucose sensor and pressure sensor to take measurements.

In some embodiments, the inductive charging coil in the ambulatory infusion pump and the inductive coil in the tray are aligned coplanar when the ambulatory infusion pump is disposed on the tray.

In some embodiments, the system further includes an insertion device configured to insert the glucose sensor through the tray into the user’s body.

In embodiments, an ambulatory infusion pump system can include an ambulatory infusion pump including a housing, a reservoir configured to contain a medicament, a pumping mechanism configured to deliver the medicament from the reservoir to a user and a processor configured to control the pumping mechanism to deliver the medicament from the reservoir to the user. The system can further include a tray configured to be worn by a user to releasably hold the ambulatory infusion pump. The tray can include a cannula port configured to receive a cannula therethrough for delivering medicament from the ambulatory infusion pump through the tray and a glucose sensor port configured to receive a glucose sensor therethrough. The ambulatory infusion pump can be configured to interface with the cannula and the glucose sensor when inserted onto the tray.

In some embodiments, the system can include a cannula insertion device configured to insert the cannula through the cannula port and a glucose sensor insertion device configured to insert the glucose sensor through the glucose sensor port.

In some embodiments, the tray includes cannula alignment features to engage with the cannula insertion device to align the cannula insertion device to insert the cannula through the cannula port and glucose sensor alignment features to engage with the glucose sensor insertion device to align the glucose sensor insertion device to insert the glucose sensor through the glucose sensor port.

In some embodiments, the cannula port and the glucose sensor port are spaced apart a sufficient distance to prevent delivery of medicament through a cannula inserted into the cannula port from interfering with accuracy of a glucose sensor inserted through the glucose sensor port.

In some embodiments, the system further includes a combination insertion device configured to insert both a cannula through the cannula port and a glucose sensor through the glucose sensor port.

In some embodiments, the combination insertion device includes a trigger mechanism and wherein actuation of the trigger mechanism causes both the cannula and the glucose sensor to be inserted.

In some embodiments, the combination insertion device inserts both the cannula and the glucose sensor with a common mechanism disposed within the combination insertion device.

In some embodiments, the cannula port and the glucose sensor port comprise a common opening through the tray configured to receive an insertion module containing both a cannula and a glucose sensor.

In some embodiments, the tray includes a plurality of common openings capable of receiving the insertion module.

In some embodiments, the system further includes an insertion device configured to insert the insertion module through one of the common openings, and the insertion device is configured to interface with engagement features on the tray and be rotatable about the tray to insert the insertion module into a selected one of the common openings.

Although embodiments described herein may be discussed in the context of the controlled delivery of insulin, delivery of other medicaments, singly or in combination with one another or with insulin, including, for example, glucagon, pramlintide, etc., as well as other applications are also contemplated. Device and method embodiments discussed herein may be used for pain medication, chemotherapy, iron chelation, immunoglobulin treatment, dextrose or saline IV delivery, treatment of various conditions including, e.g., pulmonary hypertension, or any other suitable indication or application. Non-medical applications are also contemplated.

Various embodiments of systems, devices, and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the claimed inventions. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the claimed inventions.

Persons of ordinary skill in the relevant arts will recognize that the subject matter hereof may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter hereof may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the various embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted.

The entirety of each patent, patent application, publication, and document referenced herein is hereby incorporated by reference. Citation of the above patents, patent applications, publications and documents is not an admission that any of the foregoing is pertinent prior art, nor does it constitute any admission as to the contents or date of these documents.

Also incorporated herein by reference in their entirety are commonly owned U.S. Patent Nos. 6,999,854; 8,133,197; 8,287,495; 8,408,421 8,448,824; 8,573,027; 8,650,937; 8,986,523; 9,173,998; 9,180,242; 9,180,243; 9,238,100; 9,242,043;

9,335,910; 9,381,271; 9,421,329; 9,486,171; 9,486,571; 9,492,608; 9,503,526;

9,555,186; 9,565,718; 9,603,995; 9,669,160; 9,715,327; 9,737,656; 9,750,871;

9,867,937; 9,867,953; 9,940,441; 9,993,595; 10,016,561; 10,201,656; 10,279,105; 10,279,106; 10,279,107; 10,357,603; 10,357,606; 10,492,141; 10/541,987; 10,569,016; 10,736,037; 10,888,655; 10,994,077; 11,116,901; 11,224,693; 11,291,763; 11,305,057; 11,458,246; 11,464,908; and 11,654,236 and commonly owned U.S. Patent Publication Nos. 2009/0287180; 2012/0123230; 2013/0053816; 2014/0276423; 2014/0276569; 2014/0276570; 2018/0071454; 2019/0307952; 2020/0206420; 2020/0329433;

2020/0368430; 2020/0372995; 2021/0001044; 2021/0113766; 2021/0353857;

2022/0062553; 2022/0139522; 2022/0223250; 2022/0233772; 2022/0233773;

2022/0238201; 2022/0265927; 2023/0034408; 2022/0344017; 2022/0370708; ; 2022/0037465; 2023/0040677; 2023/0047034; 2023/0113545 and 2023/0113755 and commonly owned U.S. Patent Applications Nos. 17/368,968; 17/896,492; 18/011,060; 18/071,814; 18/071,835; 18/075,029; 18/090,788 18/115,316; 18/139,391; 18/201,645;

18/207,094; 18/448,584; 18/474,839; 18/475,916 and 18/478,552.

Claims

1. An ambulatory infusion pump system, comprising: an ambulatory infusion pump including a housing, a reservoir configured to contain a medicament, a pumping mechanism configured to deliver the medicament from the reservoir to a user and an inductive charging coil, wherein the ambulatory infusion pump further includes - a processor configured to control the pumping mechanism to deliver the medicament from the reservoir to the user, the processor configured to receive and process glucose signals received through the inductive charging coil from a glucose sensor and pressure signals received through the inductive charging coil from a pressure sensor.

2. The ambulatory infusion pump system of claim 1, further comprising a tray configured to be worn by a user and to releasably hold the ambulatory infusion pump.

3. The ambulatory infusion pump system of claim 2, further comprising an inductive coil disposed in the tray configured to be aligned with the inductive charging coil in the ambulatory infusion pump to receive power from the inductive charging coil in the ambulatory infusion pump.

4. The ambulatory infusion pump system of claim 3, further comprising a glucose sensor integrated into the tray connected in circuit with the inductive coil in the tray and wherein the inductive coil in the tray transmits a signal from the glucose sensor to the inductive charging coil in the pump.

5. The ambulatory infusion pump system of claim 2, wherein the pumping mechanism configured to deliver the medicament from the reservoir through a cannula extending beneath the tray and further comprising a pressure sensor configured to interface with the cannula to sense a pressure within the cannula.

6. The ambulatory infusion pump system of claim 5, further comprising an inductive coil disposed in the tray communicatively linked to the pressure sensor and configured to be aligned with the inductive charging coil in the ambulatory infusion pump to receive power from and transmit data sensed by the pressure sensor to the inductive charging coil in the ambulatory infusion pump.

7. The ambulatory infusion pump system of 6, wherein the inductive coil is communicatively linked to the pressure sensor via a direct electrical connection.

8. The ambulatory infusion pump system of claim 3, wherein the processor is configured to periodically pass a transient current through the inductive charging coil to induce a current in the inductive coil in the tray to enable the glucose sensor and pressure sensor to take measurements.

9. The ambulatory infusion pump system of claim 3, wherein the inductive charging coil in the ambulatory infusion pump and the inductive coil in the tray are aligned coplanar when the ambulatory infusion pump is disposed on the tray.

10. The ambulatory infusion pump system of claim 2, further comprising an insertion device configured to insert the glucose sensor through the tray into the user’s body.

11. An ambulatory infusion pump system, comprising: an ambulatory infusion pump including a housing, a reservoir configured to contain a medicament, a pumping mechanism configured to deliver the medicament from the reservoir to a user and a processor configured to control the pumping mechanism to deliver the medicament from the reservoir to the user; and a tray configured to be worn by a user and to releasably hold the ambulatory infusion pump, wherein the tray includes a cannula port configured to receive a cannula therethrough for delivering medicament from the ambulatory infusion pump through the tray and a glucose sensor port configured to receive a glucose sensor therethrough, wherein the ambulatory infusion pump is configured to interface with the cannula and the glucose sensor when inserted onto the tray.

12. The ambulatory infusion pump system of claim 11, further comprising a cannula insertion device configured to insert the cannula through the cannula port and a glucose sensor insertion device configured to insert the glucose sensor through the glucose sensor port.

13. The ambulatory infusion pump system of claim 12, wherein the tray includes cannula alignment features to engage with the cannula insertion device to align the cannula insertion device to insert the cannula through the cannula port and glucose sensor alignment features to engage with the glucose sensor insertion device to align the glucose sensor insertion device to insert the glucose sensor through the glucose sensor port.

14. The ambulatory infusion pump system of claim 11, wherein the cannula port and the glucose sensor port are spaced apart a sufficient distance to prevent delivery of medicament through a cannula inserted into the cannula port from interfering with accuracy of a glucose sensor inserted through the glucose sensor port.

15. The ambulatory infusion pump system of claim 11, further comprising a combination insertion device configured to insert both a cannula through the cannula port and a glucose sensor through the glucose sensor port.

16. The ambulatory infusion pump system of claim 15, wherein the combination insertion device includes a trigger mechanism and wherein actuation of the trigger mechanism causes both the cannula and the glucose sensor to be inserted.

17. The ambulatory infusion pump system of claim 15, wherein the combination insertion device inserts both the cannula and the glucose sensor with a common mechanism disposed within the combination insertion device.

18. The ambulatory infusion pump system 11, wherein the cannula port and the glucose sensor port comprise a common opening through the tray configured to receive an insertion module containing both a cannula and a glucose sensor.

19. The ambulatory infusion pump of claim 18, wherein the tray includes a plurality of common openings capable of receiving the insertion module.

20. The ambulatory infusion pump of claim 19, further comprising an insertion device configured to insert the insertion module through one of the common openings, and wherein the insertion device is configured to interface with engagement features on the tray and be rotatable about the tray to insert the insertion module into a selected one of the common openings.