Patent Application
20230047034
The present invention relates generally to ambulatory infusion pumps and, more particularly, to a user-wearable pump, such as a patch pump, for delivering medicament such as insulin to a patient.
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 I, or in some cases, type II diabetes. Some insulin injecting pumps are configured as portable or ambulatory infusion devices can provide continuous subcutaneous insulin injection and/or infusion therapy as an alternative to multiple daily injections of insulin via a syringe or an injector pen. Such ambulatory infusion pumps are worn by the user and may use replaceable cartridges. In some embodiments, these pumps may also deliver medicaments other than, or in addition to, insulin, such as 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, or micro pump. Patch pumps generally are small pumps, typically ambulatory, that are carried directly on the skin under the user's clothing. Many such pumps are situated directly on the infusion site such that no tubing is required to deliver the insulin and/or other medicament to the patient. Other patch pumps can be positioned on the patient's body with a short length of tubing extending to a nearby infusion site. Patch pumps can be at least in part disposable, meant to be worn for a period of time such as, e.g., a day or two, and then discarded and replaced by a new patch pump. Other patch pump designs contemplate a disposable component, such as a cartridge that contains medicament, and a reusable or durable component. In such configurations, the disposable and durable components may be joined together by the patient or caregiver in preparation for delivery of the medicament.
Ambulatory infusion pumps can employ various actuation mechanisms for driving the system to deliver medicament to the user, including electromagnetic drive motors, piezoelectric motors, and electrically driven shape-memory alloy (SMA) wire actuators. With regard to SMA wire, using SMA wire has been used in a variety of miniaturized mechanism designs, including patch pumps, and has cost and size advantages over other actuation mechanism.
Such SMA actuators operate by heating the SMA wire to transition the wire from a first configuration to a second configuration to drive a plunger to deliver medicament. One of the characteristics of electrically driven SMA wire actuators is that high current is required to heat the wire to generate the strain used to actuate the mechanism. Some low cost batteries which are suitable for disposable medicament devices, such as patch pumps, are not optimized for high current short duration duty cycles and exposing them to this duty cycle reduces usable capacity compared to duty cycles that have high duration low current duty cycles. For this reason, it is desirable to minimize the number of high current short duration cycles required for a given application such as a patch pump that uses SMA wire and these types of batteries. For an application like diabetes that generally delivers a dose every five minutes often of a size that requires more than one pulse, a series of pulses is regularly needed that can quickly drain the batteries.
Disclosed herein are apparatuses and methods for a user-wearable infusion pump actuated with a shape memory alloy (SMA) wire. Embodiments enable an SMA wire driven infusion pump using a single length of SMA wire to provide multiple pulse sizes and corresponding medicament dispensing sizes. The multiple pulse sizes can include a larger pulse size for larger volumes to limit battery drain but smaller pulse sizes for precision of delivery.
In an embodiment, a user-wearable infusion pump can include a housing, a reservoir configured to contain a medicament disposed in the housing and a delivery mechanism configured to deliver medicament from the reservoir to a user. An actuation wire can be configured to be energized to actuate the delivery mechanism to deliver medicament from the reservoir to a user.
In an embodiment, user-wearable infusion pump can include a housing, a reservoir configured to contain a medicament disposed in the housing and a delivery mechanism configured to deliver medicament from the reservoir to a user. The delivery mechanism can be configured to provide two different predetermined medicament dispense sizes.
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.
The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:
While the invention is 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 invention 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 invention.
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.
A shape memory alloy (SMA) wire 108, such as Nitinol, can be crimped to and extend from a plurality of crimp connectors 110 and be routed around a plurality of pulleys 112 within housing 102. In embodiments, SMA wire 108 can be configured as a single continuous wire. Referring to
A delivery mechanism frame 124 can be disposed around delivery mechanism 115 to hold the delivery mechanism in place and axially constrain the delivery mechanism. The delivery mechanism 115 of pump 100 includes a drive gear 116 that is rotated when SMA wire 108 is actuated and a syringe body 126. Delivery mechanism frame 124 can include a flexible member 128 extending around syringe body 126 and along both sides of drive gear 116 to define a living hinge that provides the actuation force. Referring in particular to
Referring now to
Flexible member 128 can also provide the spring force required to reset the drive mechanism after actuation. When the SMA wire 108 is de-energized, the wire 108 returns to its initial, longer length and the force pulling down on pulley 112a and flexible member 128 is released, which causes the flexible member to flex back up to its original position. An anti-back-drive tooth 120 of delivery mechanism frame 124 can interface with teeth to prevent the drive gear 116 from rotating in the opposite direction and back-driving during this reset phase. Delivery mechanism frame 124 can also function to retain the pulleys around which the SMA wire is routed in a plurality of pulley supports 132. Delivery mechanism frame 124 can further include a one-way crimp stop 111a that prevents the wire crimp 110a from moving in one direction when a smaller pulse is desired, but allows the crimp to move in the other direction when the larger pulse is desired, as will be discussed in more detail below.
Patch pump can be actuated to give a consistent volume of fluid per electrical pulse at regular intervals such as every five minutes such that one or more pulses is required to deliver the desired volume of medicament each interval. Often the desired volume at a given time is more than a single pulse so embodiments herein are provided with an optionally larger pulse size so that the number of actuations can be reduced to limit the drain on the batteries, but a small pulse size is still enabled so that precision of delivery can be maintained.
Referring to
The different electrical paths can be selectively actuated by energizing respective electrical contacts at the corresponding crimp connectors. Actuation of the shorter electrical path of
Pump 100 therefore allows for multiple pulse and delivery sizes in an SMA wire driven infusion pump using a single length of SMA wire. The ability to provide a second, larger dispense size results in fewer total actuations over the life of the pump which improves battery life and increases bolus rate of delivery. In one embodiment, use of two delivery sizes provides an approximately 40% increase in efficiency over use of a single delivery size. Use of a single length of SMA wire is also advantageous for reducing cost and complexity. In embodiments, patch pump can be assembled modularly to enable the pump to be assembled and tested prior to mating the PCBA which is desirable for manufacturability. Although described herein as having two different dispense sizes, it should be understood that embodiments contemplated herein could include more than two electrical paths that would define more than two dispense sizes.
Referring to
Embodiments of the present disclosure 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.
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.
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; and 11,305,057 and commonly owned U.S. Patent Publication Nos. 2009/0287180; 2012/0123230; 2013/0053816; 2014/0276423; 2014/0276569; 2014/0276570; 2018/0071454; 2019/0240398; 2019/0307952; 2020/0206420; 2020/0261649; 2020/0329433; 2020/0368430; 2020/0372995; 2021/0001044; 2021/0113766; 2021/0154405; 2021/0353857; 2022/0062553; 2022/0139522 and 2022/0223250 and commonly owned U.S. patent applications Ser. Nos. 17/368,968; 17/587,412; 17/587,434; 17/587,468; 17/677,621; 17/729,464; 17/732,208; 17/878,681; and 17/879,959.
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.
The present application claims the benefit of U.S. Provisional Application No. 63/232,300, filed Aug. 12, 2021, which is hereby incorporated herein in its entirety by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63232300 | Aug 2021 | US |
