Patent Application
20240189504
The present invention relates generally to ambulatory infusion pumps and, more particularly, to operation of ambulatory infusion pumps in conjunction with a continuous glucose monitor.
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. Pat. 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.
Embodiments disclosed herein are directed to ambulatory infusion pump systems that integrate a CGM sensor with an ambulatory infusion pump. An electrical connection can be established between the CGM sensor and the pump such that no wireless connectivity between the devices is required.
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 and an electrical contact on the housing. The electrical contact can be configured to receive data from a glucose sensor. At least one processor can be configured to control the pumping mechanism to deliver the medicament from the reservoir to the user and to receive and process the data from the glucose sensor for use in calculating medicament delivery parameters.
In an embodiment, an ambulatory infusion pump system includes a glucose sensor configured to be inserted into a user 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 electrical contact on the housing configured to receive data from the glucose sensor via an electrical connection. The pump can further include at least one processor configured to receive and process the data from the glucose sensor for use in calculating medicament delivery parameters.
In an embodiment, an ambulatory infusion pump system includes 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 electrical contact on the housing configured to receive data from a glucose sensor via an electrical connection. The pump can further includes at least one processor configured to receive and process the data from the glucose sensor for use in calculating medicament delivery parameters. A tray can be configured to releasably hold the ambulatory infusion pump such that the tray facilitates the electrical connection between the ambulatory infusion pump and the glucose sensor.
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.
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:
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.
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.
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.
Referring to
In these embodiments, pump 102 includes internal circuitry to transmit the signals measured by the CGM sensor to the pump processor. The processor of pump can include programming sufficient to receive the CGM signals and to process those signals for use of the glucose levels indicated by the signals in providing therapy with the pump.
Integrating the CGM 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 sensor signals are sent to the pump via the direct electrical connection. 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. In addition, the CGM does not require a separate battery as the pump battery can be used to provide the power required for the CGM sensor through for example, an inductive coupling, direct voltage, near field communications, etc.
The embodiments of
It should be noted that while the embodiments described above primarily relate to an electrical contact that is exposed on the exterior of the housing of the pump to establish direct electrical connection with the glucose sensor, embodiments are contemplated in which the electrical contact is not exposed on the exterior of the housing and/or the connection is not a direct electrical connection. For example, the connection can be an indirect connection such as through a capacitive coupling or an inductive coupling.
In addition, although primary described with respect to a glucose sensor, it should be understood that integration of other types of analyte sensor in a same or similar manner is contemplated herein, alternatively or in addition to a glucose sensor.
In embodiments, 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 and an electrical contact on the housing. The electrical contact can be configured to receive data from a glucose sensor. At least one processor can be configured to control the pumping mechanism to deliver the medicament from the reservoir to the user and to receive and process the data from the glucose sensor for use in calculating medicament delivery parameters.
In some embodiments, the electrical contact is exposed on an exterior of the housing and is configured to receive data from the glucose sensor via a direct electrical connection.
In some embodiments, the electrical contact is configured to receive data from the glucose sensor via an indirect electrical connection.
In some embodiments, the electrical contact is configured to receive data from the glucose sensor via a capacitive coupling.
In some embodiments, the at least one processor is configured to receive the data from the glucose sensor without undergoing a pairing procedure that pairs the ambulatory infusion pump with the glucose sensor over wireless communications.
In some embodiments, the pump further comprises a battery, and the processor is configured to provide power to the glucose sensor with the battery.
In embodiments, an ambulatory infusion pump system includes a glucose sensor configured to be inserted into a user 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 electrical contact on the housing configured to receive data from the glucose sensor via an electrical connection. The pump can further include at least one processor configured to receive and process the data from the glucose sensor for use in calculating medicament delivery parameters.
In some embodiments, the system further comprises a tray configured to releasably hold the ambulatory infusion pump, and the tray facilitates the electrical connection between the ambulatory infusion pump and the glucose sensor.
In some embodiments, the electrical contact is exposed on an exterior of the housing and is configured to receive data from the glucose sensor via a direct electrical connection.
In some embodiments, the electrical contact is configured to receive data from the glucose sensor via an indirect electrical connection.
In some embodiments, the electrical contact is configured to receive data from the glucose sensor via a capacitive coupling.
In some embodiments, the at least one processor is configured to receive the data from the glucose sensor without undergoing a pairing procedure that pairs the ambulatory infusion pump with the glucose sensor over wireless communications.
In some embodiments, the ambulatory infusion pump further comprises a battery, and the processor is configured to provide power to the glucose sensor with the battery.
In embodiments, an ambulatory infusion pump system includes 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 electrical contact on the housing configured to receive data from a glucose sensor via an electrical connection. The pump can further includes at least one processor configured to receive and process the data from the glucose sensor for use in calculating medicament delivery parameters. A tray can be configured to releasably hold the ambulatory infusion pump such that the tray facilitates the electrical connection between the ambulatory infusion pump and the glucose sensor.
In some embodiments, the electrical contact is exposed on an exterior of the housing and is configured to receive data from the glucose sensor via a direct electrical connection through the tray.
In some embodiments, the electrical contact is configured to receive data from the glucose sensor via an indirect electrical connection.
In some embodiments, wherein the electrical contact is configured to receive data from the glucose sensor via a capacitive coupling.
In some embodiments, the at least one processor is configured to receive the data from the glucose sensor without undergoing a pairing procedure that pairs the ambulatory infusion pump with the glucose sensor over wireless communications.
In some embodiments, the ambulatory infusion pump further comprises a battery, and wherein the processor is configured to provide power to the glucose sensor with the battery.
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. Pat. 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 application Ser. 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; and Ser. No. 18/139,391.
This application claims the benefit of U.S. Provisional Application No. 63/359,759 filed Jul. 8, 2022, which is hereby fully incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63359759 | Jul 2022 | US |
