Patent Application
20240277924
The present disclosure relates to medical pumps for delivering medicament to a patient, and more specifically, to a user-wearable infusion pump that can be worn on the body of a user.
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.
One type of pump that has been developed is a patch pump, also known as a micropump. Patch pumps are small pumps that may be carried directly on the skin under the user's clothing. In some cases, the pumps are situated directly on, or very near to, the injection site such that little or no tubing is required to deliver the insulin or other medicament to the patient. These pumps can therefore be worn directly on the body of the user or carried in close proximity to the body. Typically, patch pumps that are worn on the body are affixed to the body with an adhesive patch. Such pumps may need to be periodically removed from the body to e.g., charge a battery, refill a medicament reservoir, be replaced with a new pump, etc.
Embodiments of the present disclosure relate to a holder or carrier for a user-wearable infusion pump (patch pump) that can be worn on the patient's body and a corresponding system. Embodiments depicted and described herein provide a more versatile and secure way to hold and carry a user-wearable infusion pump that enables easy removal and insertion of the pump into the holder and further provides access to pump functions while the pump is in the holder.
In embodiments, a user-wearable infusion pump system includes a user-wearable infusion pump configured to contain a medicament and a retention frame including a frame base having a first side and an opposing second side and a first end and opposing second end defining a frame perimeter having a shape generally matching an outer perimeter of the user-wearable pump. An elastic sleeve can be attached to the retention frame and extend across the retention frame from the first side of the retention frame to the second side of the retention frame. The elastic sleeve can be configured to be stretched away from the retention frame to enable insertion of the user-wearable infusion pump onto the retention frame and to flex back against the user-wearable infusion pump to provide a force biasing the infusion pump on the retention frame.
In embodiments, a pump holder for selectively retaining a user-wearable infusion pump, comprising can include a retention frame including a frame base having a first side and an opposing second side and a first end and opposing second end defining a frame perimeter having a shape generally matching an outer perimeter of a user-wearable pump and an elastic sleeve attached to the retention frame and extending across the retention frame from the first side of the retention frame to the second side of the retention frame. The elastic sleeve can be configured to be stretched away from the retention frame to enable insertion of the user-wearable infusion pump onto the retention frame and to flex back against the user-wearable infusion pump to provide a force biasing the infusion pump on the retention frame.
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.
Referring to
As depicted in the embodiment of
In one embodiment, pump 102 includes a processor that controls operations of the pump and, in some embodiments, may communicate in either one-way or two-way modes to, e.g., receive operational commands and/or other signals, including data, from a separate device and/or, e.g., to send signals, including data, to a separate device. Pump 102 can include one or more buttons configured to cause the processor to initiate one or more functions. In the depicted embodiment, pump 102 includes only a single button 172, although more than one button may be present on pump 102. Button 172 can be configured to, for example, initiate delivery of medicament. Any single button such as button 172 can be utilized to execute a plurality of functions or operations. For example, a single press of button may initiate one function, holding the button down for a predetermined period of time may initiate another function, etc. Because the depicted pump 102 optionally does not itself include a display or user interface, information and feedback regarding medicament delivery or dosing initiated with button 172 can be communicated to and displayed on a remote control device or other device having a display and/or other type of user interface. Further details regarding use of button 172 can be found in U.S. Patent Publication No. 2018/0193555, which is hereby incorporated by reference in its entirety
In one embodiment, pump 102 includes a light source, such as a light emitting diode (LED) 174. Light source 174 can be configured to provide user feedback regarding user input and/or the performance of a desired function. For example, in one embodiment, light source 174 can illuminate or blink one or more times to indicate that the one or more buttons 172 have been activated and/or that a desired function has been initiated. In one embodiment, pump 102 can additionally and/or alternatively vibrate and/or provide audible notifications to indicate that the one or more buttons 172 have been activated and/or that a desired function has been initiated or, e.g., to provide user feedback regarding user input and/or the performance of the desired function. Illumination of light source 174 and/or vibrations and/or audible notifications may be executed in any number of patterns, frequencies, durations, sequences, combinations, colors, brightness levels, etc. to indicate particular information, such as particular input received and/or particular functions or operations enabled and/or initiated, to the pump user or caregiver. In other embodiments, pump 102 includes two indicator lights 174.
Referring to
Embodiments of the present invention include components capable of and methods using wired and wireless transmission and receipt of signals for exchange of information and commands between and among any of the components as described herein, including, e.g., between a pump and a smartphone; among a pump, a CGM and a smartphone; between a dedicated remote controller and a pump; among a dedicated remote controller, a CGM and a pump; among a dedicated remote controller, a BGM and a pump, and other combinations as would be contemplated by those of skill in the art.
As noted above, patch pumps such as pump 102 are typically worn directly on the user's body via an adhesive patch or can alternatively be carried near the body in, e.g., a pocket. Embodiments depicted and described herein provide a more versatile and secure way to hold and carry a user-wearable infusion pump. The figures discussed below depict and describe such a cradle/holder or carrying case for an infusion pump. Various features and advantages of such carriers include, for example, 1) an open ended cradle design that allows for lateral insertion and removal of the pump from either end; 2) an open ended cradle design that allows for multiple set connector orientations; 3) an open ended cradle design that prevents infusion line snags during removal; 4) an open ended cradle design that allows for insertion after an infusion set has been attached to set connector; and 5) a flexible retaining sleeve that securely retains the pump in the holder while allowing for easy insertion and removal.
In particular,
Sleeve 204 can be comprised of a flexible, woven fabric material having elastic properties such as, for example, spandex. As can be seen in
Patch 206 can include an adhesive on the bottom of patch for adhering to a user's body. In this embodiment, patch 206 includes a central aperture 212 beneath the tray 202. This reduces the amount of adhesive that will be applied to the user's skin to make it easier for the user to remove the carrier 200 from the body (while still providing sufficient adhesive to securely retain the carrier on the body). Patch 206 can have a shape that generally matches the shape of tray 202 along the sides and ends except for one or more protruding corners 214. Corners 214 can provide greater stability for pump 100 and carrier 200 by adhering to the user beyond a perimeter shape of the pump and carrier and can further aid in removal of the carrier 200 by providing a convenient point from which to begin peeling the patch 206 from the skin. As depicted in
Referring now primarily to
The combination of sleeve 204 and tray 202 in the embodiments described herein therefore operates to securely retain a pump on the carrier while enabling easy insertion and removal of pump. Namely, sleeve 204 provides a force holding the pump on the tray to prevent the pump from falling vertically off of the tray whereas the one or more retention walls 218A, 218B of the tray prevent the pump from sliding horizontally out of the open ends of the sleeve 204. The elastic nature of sleeve 204 and the tabs 208 that aid lifting the sleeves enable easier insertion and removal of the pump by pulling the sleeve away from the pump without sacrificing secure retention of the pump when the sleeve flexes back towards its original shape to hold the pump on the tray.
Another embodiment of a holder or carrier 200 for a user-wearable infusion pump is depicted in
In some embodiments, a patch pump carried by one or more of the tray embodiments disclosed herein includes a set connector 152 that extends from pump 102 and carrier 200 for connection to an infusion set 145 that includes a site connector 146 that attaches to the user at a separate location from the carrier 200 for delivery of insulin or other medicament through a cannula inserted into the user's skin. In particular, such pump holders can be advantageous for use with shorter length (e.g., 5 inch) infusion sets that do not provide sufficient length to store a pump in a user's pocket or otherwise off of the body. In other embodiments, a cannula can be integrated with the carrier such that the pump delivers medicament to the user at a location directly beneath the carrier. For example,
In embodiments, a user-wearable infusion pump system includes a user-wearable infusion pump configured to contain a medicament and a retention frame including a frame base having a first side and an opposing second side and a first end and opposing second end defining a frame perimeter having a shape generally matching an outer perimeter of the user-wearable pump. An elastic sleeve can be attached to the retention frame and extend across the retention frame from the first side of the retention frame to the second side of the retention frame. The elastic sleeve can be configured to be stretched away from the retention frame to enable insertion of the user-wearable infusion pump onto the retention frame and to flex back against the user-wearable infusion pump to provide a force biasing the infusion pump on the retention frame.
In some embodiments, the elastic sleeve provides an opening with the retention frame at both the first and the second end of the retention frame such that the user-wearable infusion pump can be inserted into the retention frame from either the first end or the second end of the retention frame.
In some embodiments, the elastic sleeve extends around the first side and the second side of the retention frame such that the elastic sleeve is attached to the retention frame on a bottom surface of the retention frame adjacent both the first side and the second side of the retention frame.
In some embodiments, the system includes a tab extending outwardly from the elastic sleeve adjacent at least one of the first end and the second end of the retention frame.
In some embodiments, there is a tab extending outwardly from the elastic sleeve adjacent both the first end and the second end of the retention frame.
In some embodiments, the tab comprises a more rigid material than the elastic sleeve.
In some embodiments, the tab comprises a flexible material configured to be releasably wrapped around an end of the user-wearable infusion pump.
In some embodiments, the user-wearable infusion pump includes at least one of a button and one or more indicator lights, and the tab is offset from the at least one of the button and the one or more indicator lights such that the button is accessible and/or the one or more indicator lights are visible when the user-wearable infusion pump is disposed on the retention frame.
In some embodiments, the retention frame further includes a retention wall extending upwardly from and around the frame perimeter.
In some embodiments, the retention frame includes a first retention wall extending along the first side of the retention frame and around corners at the first end and the second end of the retention frame adjacent the first side and a second retention wall extending along the second side of the retention frame and around corners at the first end and the second end of the retention frame adjacent the second side. The first retention wall and the second retention wall can define openings therebetween at both the first end and the second end of the retention frame.
In embodiments, a pump holder for selectively retaining a user-wearable infusion pump, comprising can include a retention frame including a frame base having a first side and an opposing second side and a first end and opposing second end defining a frame perimeter having a shape generally matching an outer perimeter of a user-wearable pump and an elastic sleeve attached to the retention frame and extending across the retention frame from the first side of the retention frame to the second side of the retention frame. The elastic sleeve can be configured to be stretched away from the retention frame to enable insertion of the user-wearable infusion pump onto the retention frame and to flex back against the user-wearable infusion pump to provide a force biasing the infusion pump on the retention frame.
In some embodiments, the elastic sleeve provides an opening with the retention frame at both the first and the second end of the retention frame such that the user-wearable infusion pump can be inserted into the retention frame from either the first end or the second end of the retention frame.
In some embodiments, the elastic sleeve extends around the first side and the second side of the retention frame such that the elastic sleeve is attached to the retention frame on a bottom surface of the retention frame adjacent both the first side and the second side of the retention frame.
In some embodiments, a tab can extend outwardly from the elastic sleeve adjacent at least one of the first end and the second end of the retention frame.
In some embodiments, there is a tab extending outwardly from the elastic sleeve adjacent both the first end and the second end of the retention frame.
In some embodiments, the tab comprises a more rigid material than the elastic sleeve.
In some embodiments, the tab comprises a flexible material configured to be releasably wrapped around an end of the user-wearable infusion pump.
In some embodiments, the tab is configured to be offset from at least one of a button of the user-wearable pump and one or more indicator lights of the user-wearable pump such that the button is accessible and/or the one or more indicator lights are visible when the user-wearable infusion pump is disposed on the retention frame.
In some embodiments, the retention frame further includes a retention wall extending upwardly from and around the frame perimeter.
In some embodiments, the retention frame includes a first retention wall extending along the first side of the retention frame and around corners at the first end and the second end of the retention frame adjacent the first side and a second retention wall extending along the second side of the retention frame and around corners at the first end and the second end of the retention frame adjacent the second side. The first retention wall and the second retention wall can define openings therebetween at both the first end and the second end of the retention frame.
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.
With regard to the above detailed description, like reference numerals used therein may refer to like elements that may have the same or similar dimensions, materials, and configurations. While particular forms of embodiments have been illustrated and described, it will be apparent that various modifications can be made without departing from the spirit and scope of the embodiments herein. Accordingly, it is not intended that the invention be limited by the forgoing detailed description.
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.
Modifications may be made to the foregoing embodiments without departing from the basic aspects of the technology. Although the technology may have been described in substantial detail with reference to one or more specific embodiments, changes may be made to the embodiments specifically disclosed in this application, yet these modifications and improvements are within the scope and spirit of the technology. The technology illustratively described herein may suitably be practiced in the absence of any element(s) not specifically disclosed herein. The terms and expressions which have been employed are used as terms of description and not of limitation and use of such terms and expressions do not exclude any equivalents of the features shown and described or portions thereof and various modifications are possible within the scope of the technology claimed. Although the present technology has been specifically disclosed by representative embodiments and optional features, modification and variation of the concepts herein disclosed may be made, and such modifications and variations may be considered within the scope of this technology.
This application claims the benefit of U.S. Provisional Application No. 63/209,210 filed Jun. 10, 2021, which is hereby fully incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2022/033000 | 6/10/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63209210 | Jun 2021 | US |
