Many conventional drug delivery systems are well known, including, for example, wearable drug delivery devices of the type shown in
The drug delivery device 100 can be a single-use device (e.g., filled once and used once and then discarded) or can be a multiple-use device (e.g., filled one or more times and used after one or more fillings). In specific embodiments, the drug delivery device 100 can be, for example, an OmniPod® drug delivery device manufactured by Insulet Corporation of Acton, Mass. The drug delivery device 100 can be a drug delivery device such as those described in U.S. Pat. Nos. 7,303,549, 7,137,964, or U.S. Pat. No. 6,740,059, each of which is incorporated herein by reference in its entirety.
An exemplary pump system 300 is shown in perspective view in
One limitation of this design is that the total footprint of the reservoir 202 and drive mechanism 302 is greater than the length of reservoir 202 by as much as 2 times. This is due to the fact that the leadscrew 304 needs to reach all the way into reservoir 202 when reservoir 202 is in the empty state (i.e. it must be approximately equal to the length of reservoir 202 minus space taken by plunger 204). When reservoir 202 is full, leadscrew 304 will necessarily extend behind reservoir 202 to occupy space 308 at a length up to the length of the reservoir.
In wearable, on-body devices, it is desirable to keep pump mechanism 300, as well as the overall drug delivery device 100, as small as possible to minimize the impact to the wearer. Therefore, it would be desirable to replace the prior art pump system 300 with a positive displacement pump system having a different method of driving the plunger 204 within the reservoir that does not require the large footprint of the prior art pump mechanism 300. This would reduce the size footprint of pump mechanism 300, thereby improving the size impact of the overall drug delivery system 100 while maintaining the benefits of the pumping methodology.
This disclosure presents various systems, components and methods for moving a liquid, typically a liquid drug, such as insulin or GLP-1, from a liquid reservoir in a wearable drug delivery device to a patient interface, typically a needle or cannula. Each of the systems, components and methods disclosed herein provides one or more advantages over conventional, prior art systems, components and methods.
In various embodiments of the invention, the reservoir and pump are integrated into a single component (referred to herein as the “pump mechanism”) and the drive mechanism of the prior art pump mechanism is replaced by a new drive mechanism which reduces the overall size footprint of the pump mechanism.
All embodiments of the pump mechanisms described herein comprise various components including a reservoir, a plunger configured to translate longitudinally through the interior of the reservoir, a drive mechanism and a linkage between the drive mechanism and the plunger. In all described embodiments, the reservoir may comprise a tube-like structure having a proximal, open and a distal, closed-end, wherein the closed-end may be configured with a fluid path such as to allow the liquid drug disposed between the plunger and the closed end of the reservoir to be forced through the fluid path to a patient interface. The reservoir may, in preferred embodiments of the invention, be composed of a polyethylene or an injection-molded plastic, but, in other embodiments, may be composed of any material impermeable to the liquid drug disposed therein. The plunger may be composed of any material and may be configured with one or more O-rings along a circumferential surface such as to create a seal between the plunger and the reservoir when the plunger is disposed within the reservoir. The cross-sectional area of the reservoir and plunger may be of any convenient shape; however, in preferred embodiments, the cross-sectional shape of both the reservoir and the plunger is oval or circular.
A first, preferred embodiment of the invention is shown in various views in
Reservoir 202 stores the liquid drug prior to delivery to the user. In some embodiments, the drug delivery device may come with a prefilled reservoir containing the liquid drug. In other embodiments, the reservoir 202 may be filled or refillable by the user. Reservoir 202 may be fitted with a plunger 204 which is longitudinally translatable through the interior length of reservoir 202. The liquid drug is stored in the area 208 of reservoir 202 between plunger 204 and the distal end of reservoir 202. Longitudinal translation of plunger 204 toward the distal end of reservoir 208 will force the liquid drug from area 208 via fluid path 206 to a patient interface, typically a needle or cannula (not shown). Fluid path 206 may be provided with a one-way valve that prevents fluids from entering area 208 of reservoir 202 (not shown). Fluid path 206 may be located at any point such as to be in fluid communication with space 208 within reservoir 202; however, in preferred embodiments, fluid path 206 is located as close to the distal end of reservoir 202 as possible to avoid wasting any liquid drug that would otherwise get trapped at the far distal end of the reservoir. Preferably, reservoir 202 is rigidly attached to the body of the drug delivery device.
The longitudinal translation of the plunger 204 within reservoir 202, in the preferred embodiments, is accomplished via a scissor mechanism 402. Scissor mechanism 402 is attached, at one end, to plunger 204 and at the other end, to support structure 410. Support structure 410 may be rigidly attached to the body of the drug delivery device 100 or may be part of and integral with the body of the drug delivery device 100. As such, references to “the body of the drug delivery device” herein are also meant to refer to embodiments in which support structure 410 is separate from and attached to the body of the drug delivery device. As such, reference number 410 may hereinafter refer to a support structure attached to the body of the device or to the body of the device directly.
Reservoir 202 should be rigidly coupled to the body 410 of the device such as to prevent movement between reservoir 202 and the body 410 of the device. Additionally, one end of scissor mechanism 402 should be rigidly attached to the body 410 of the device such as to prevent relative movement between the end of the scissor mechanism 402 attached to the body 410 of the device and the reservoir 202. As such, the expansion of scissor mechanism 402 will drive plunger 204 toward the distal end of reservoir 202, thereby expelling a quantity of the liquid drug contained within space 208 through fluid path 206.
The mechanical motion needed to expand or contract scissor mechanism 402 is provided by a drive mechanism. In the preferred embodiment, the drive mechanism may comprise leadscrew 406 and a drive nut 408. In other embodiments, the drive mechanism may be any mechanism capable of imparting a force to scissor mechanism 402 necessary to expand scissor mechanism 402 and to overcome any resistance from the liquid drug located in area 208 of reservoir 202. In the case wherein the drive mechanism is as shown in
Drive nut 408 may be coupled to scissor mechanism 402 via a linkage 404 which is coupled to drive nut 408 and to scissor mechanism 402 at connection point 412. In addition, linkage 404 may have one or more attachments to the body 410 of the device.
As shown in
As such, the linear motion of drive nut 408 imparts a mechanical force through linkage 404 such as to cause the expansion or contraction of scissor mechanism 402. Linear motion of the drive nut 408 in one direction may cause the expansion of scissor mechanism 402, while linear motion of the drive nut 408 in the opposite direction may cause the contraction of scissor mechanism 402. In the arrangement shown in
As can be seen in
Leadscrew 406, drive nut 408, scissor mechanism 402 and linkage 404 may, in some preferred embodiments, be composed of an injection-molded plastic or a metal, for example, stainless steel. However, these components may also be composed of any materials capable of withstanding the required forces to make the pump mechanism operable.
In this embodiment, the second magnet 802 may be configured as a collar surrounding the outside surface of reservoir 202. Second magnet 802 may be guided as it moves longitudinally along the outside surface of reservoir 202 by one or more guides (not shown) which may be, for example, ridges or channels defined on the outside surface of reservoir 202.
In this embodiment, the drive mechanism may comprise any mechanism configured to cause second magnet 804 to move longitudinally along the outer surface of reservoir 202. In preferred embodiments, the drive mechanism comprises a leadscrew 406 and wherein second magnet 802 has outside threads which are in threaded engagement with leadscrew 406. Second magnet 802 conforms to and encircles the outside surface of reservoir 202 such that second magnet 802 is able to slide in the longitudinal direction along the outside surface of reservoir 202 when driven by the rotation of leadscrew 406.
As with other embodiments herein, leadscrew 406 may be rotationally driven via any known means, including, for example, a motor (not shown) coupled directly or via gearing to leadscrew 406. The advantage of the embodiment shown in
In this embodiment, plunger 204 is pulled by exerting a force on the back side of plunger 204, for example, on opposite ends of plunger 204, at stationary pulleys 1008(a,b), as shown in
Tether 1002 may be provided with a means to alternately pass and block light therethrough. In one embodiment, tether 1002 mat be provided with holes 1018 at regularly spaced intervals, as shown in
The embodiment of
Further, when reservoir 202 is being filled with a liquid drug by a user, light source 1022 and sensor 1024 may be operative to determine how much liquid drug has been inserted into reservoir 204. As the user injects the liquid drug through an inlet (not shown), tether 1002 may unwind from take-up reel 1006. As the holes 1018 in the tether 1002 pass (to the left in
The following examples pertain to various embodiments of the pump mechanism suitable for use in a wearable drug delivery device:
Example 1 is a first embodiment of a pump mechanism comprising a reservoir, a plunger disposed in the reservoir and a scissor mechanism coupled to the plunger for moving the plunger longitudinally through the interior of the reservoir.
Example 2 is an extension of Example 1, or any other example disclosed herein, wherein the pump mechanism further comprises a drive mechanism coupled to the scissor mechanism for expanding and contracting the scissor mechanism.
Example 3 is an extension of Example 2, or any other example disclosed herein, wherein the drive mechanism comprises a leadscrew and a drive nut in threaded engagement with the leadscrew, the drive nut being coupled to the scissor mechanism.
Example 4 is an extension of Example 3, or any other example disclosed herein, wherein the drive nut is coupled to the scissor mechanism via a linkage.
Example 5 is an extension of Example 4, or any other example disclosed herein, when the scissor mechanism is connected at one end to the plunger and at the other end to the body of the device.
Example 6 is an extension of Example 5, or any other example disclosed herein, wherein the reservoir and one end of the scissor mechanism are coupled to the body such as to prevent relative movement therebetween.
Example 7 is a second embodiment of a pump mechanism comprising a reservoir, a plunger disposed in the reservoir, a first scissor mechanism coupled to the plunger for moving the plunger longitudinally through the interior of the reservoir and a second scissor mechanism coupled to the first scissor mechanism via a linkage.
Example 8 is an extension of Example 7, or any other example disclosed herein, wherein the pump mechanism further comprises a drive mechanism coupled to the second scissor mechanism.
Example 9 is an extension of Example 8, or any other example disclosed herein, wherein the drive mechanism comprises a leadscrew in threaded engagement with a drive nut and wherein the drive nut is coupled to the second scissor mechanism.
Example 10 is an extension of Example 9, or any other example disclosed herein, wherein the reservoir and the linkage are coupled to the body of the device such as to prevent relative movement therebetween.
Example 11 is a third embodiment of a pump mechanism comprising a reservoir, a plunger disposed in the reservoir and coupled to a first magnet, a second magnet disposed along the outside surface of the reservoir, and a drive mechanism coupled to the second magnet for driving the second magnet along the outside surface of the reservoir.
Example 12 is an extension of Example 11, or any other example disclosed herein, wherein the first and second magnets are in magnetic engagement with each other such that movement of the second magnet along the outside surface of the reservoir causes longitudinal movement of first magnet and, thereby, the plunger, in the interior of the reservoir.
Example 13 is an extension of Example 12, or any other example disclosed herein, wherein the second magnet is in the shape of a collar disposed around the outside circumference of the reservoir.
Example 14 is an extension of Example 13, or any other example disclosed herein, wherein outside surface of the reservoir is configured with ridges to guide movement of the second magnet along the outside surface of the reservoir.
Example 15 is extension of Example 11, or any other example disclosed herein, wherein the outside surface of the second magnet is configured with threads and further wherein the second magnet is in threaded engagement with the leadscrew such that rotational motion of the leadscrew is translated to linear motion of the second magnet.
Example 16 is an extension of Example 11, or any other example disclosed herein, wherein the reservoir and drive mechanism are rigidly attached to the body of a device such as to prevent relative movement therebetween.
Example 17 is a fourth embodiment of a pump mechanism comprising a reservoir, a plunger disposed in the reservoir, a tether coupled to the plunger and extending through a sealed opening in the closed end of the reservoir, and a drive mechanism for pulling the tether through the sealed opening.
Example 18 is an extension of Example 17, or any other example disclosed herein, wherein the drive mechanism comprises a take-up reel coupled to the tether such that rotation of the take-up reel will cause a tether to be pulled through the sealed opening of the reservoir.
Example 19 is an extension of Example 18, or any other example disclosed herein, wherein the pump mechanism further comprises one or more pulleys to guide the tether from the take-up reel to the sealed opening in the reservoir.
Example 20 is an extension of Example 17, or any other example disclosed herein, wherein the reservoir and the drive mechanism are rigidly connected to the body of the device such as to prevent relative movement therebetween.
Example 20 is an extension of Example 17, or any other example disclosed herein, wherein the tether is coupled to an interior surface of the plunger.
Example 21 is an extension of Example 17, or any other example disclosed herein, wherein the tether is anchored at one end and coupled to an exterior surface of the plunger via one or more pulleys.
To those skilled in the art to which the invention relates, many modifications and adaptations of the invention may be realized. Implementations provided herein, including sizes, shapes, ratings and specifications of various components or arrangements of components, and descriptions of specific manufacturing processes, should be considered exemplary only and are not meant to limit the invention in any way. As one of skill in the art would realize, many variations on implementations discussed herein which fall within the scope of the invention are possible. Moreover, it is to be understood that the features of the various embodiments described herein were not mutually exclusive and can exist in various combinations and permutations, even if such combinations or permutations were not made express herein, without departing from the spirit and scope of the invention. Accordingly, the method and apparatus disclosed herein are not to be taken as limitations on the invention but as an illustration thereof. The scope of the invention is defined by the claims which follow.
This application claims the benefit of U.S. Provisional Patent Application No. 63/160,240, filed Mar. 12, 2021, entitled “IMPROVED DRIVE MECHANISMS FOR POSITIVE DISPLACEMENT PUMPS”, and U.S. Provisional Patent Application No. 63/306,765, filed Feb. 4, 2022, entitled “PUMPING MECHANISM WITH WIRE-PULLED PLUNGER”. The contents of these application are incorporated herein in their entireties.
Number | Date | Country | |
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63160240 | Mar 2021 | US | |
63306765 | Feb 2022 | US |