Displacement pump mechanism with flexible reservoir, drug delivery system, patch pump and drug delivery device

Abstract

To provide a system including a container for a medium, a plunger disposed in the container, and a mechanism for distally advancing the plunger to dispense the medium from the container, which minimizes discomfort to a user.SOLUTION: In the above system, the mechanism is disposed outside the container, the container includes a sliceable portion extending essentially linearly from a proximal portion to a distal portion of the container, the plunger includes a distal surface disposed within the container, the distal surface facing the medium within the container, and the mechanism includes a pusher acting on the plunger and a cutter with the pusher behind the plunger, the cutter slicing the sliceable portion of the container as the plunger advances distally to dispense the medium from the container. The present disclosure is also directed to a patch pump or drug delivery device comprising the above system.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] Generally, exemplary embodiments of the present disclosure relate to the field of drug delivery devices. More specifically, exemplary embodiments of the present disclosure relate to drug delivery devices in which a stopper or plunger is advanced through a reservoir to dispense a drug from the reservoir.

[0002] This application claims priority under 35 U.S.C. §119(e) from U.S. Provisional Patent Application No. 63 / 062,158, filed August 6, 2020, the contents of which (including all attachments filed therewith) are incorporated herein by reference in their entirety. [Background technology]

[0003] In an example medical application, a patch pump is an integrated device that facilitates infusion therapy for diabetic patients. A patch pump is an integrated device that combines most or all of the fluid components, including a fluid reservoir, pumping mechanism, and a mechanism for automatically inserting a cannula, into a single housing that adhesively attaches to an infusion site on the patient's skin, eliminating the need for a separate infusion or tubing set. Insulin-containing patch pumps adhere to the skin and deliver insulin over a period of time via a built-in subcutaneous cannula. While some patch pumps can be configured to include wireless communication with a separate controller device, others are completely self-contained. Such devices are replaced frequently, such as every three days, especially when the insulin reservoir is depleted.

[0004] Because patch pumps are designed to be self-contained units worn by diabetic patients, it is preferable to make them as small as possible so as not to interfere with the user's activities. Therefore, it is preferable to minimize the overall size of the patch pump to minimize discomfort to the user. Conventional patch pumps or syringe-type devices typically include a drive mechanism with a single advancement lead screw that forces, advances, or otherwise applies force to a plunger into a media or fluid reservoir or chamber to dispense the media or fluid from the chamber. To minimize the size of a patch pump, components such as the drive mechanism must be made as small as possible without compromising the accuracy and reliability of the device or its feature set. Summary of the Invention

[0005] An exemplary embodiment provides a system comprising a container for a medium, a plunger disposed within the container, and a mechanism for distally advancing the plunger to dispense the medium from the container, the mechanism being disposed outside the container.

[0006] An exemplary implementation of the exemplary embodiment is one in which the container includes a sliceable portion extending essentially linearly from a proximal portion to a distal portion of the container, a plunger disposed inside the container with a distal surface facing the medium inside the container, and a mechanism including a pusher acting on the plunger and a cutter with the pusher behind the plunger, the cutter configured to slice the sliceable portion of the container as the plunger advances distally to dispense the medium from the container.

[0007] Another exemplary implementation of any exemplary embodiment provides a mechanism further comprising a lead screw disposed outside the container and axially fixed relative to the container, the lead screw laterally engaging the pusher.

[0008] Yet another exemplary implementation of any exemplary embodiment provides a mechanism that further comprises a driver that rotates the lead screw to advance the plunger.

[0009] Yet another exemplary implementation of any exemplary embodiment provides a mechanism including at least one gear that transmits rotation of the driver to the lead screw, the gear being disposed at a proximal end of the container and the media being disposed at a distal end of the container. Additionally, a further exemplary implementation of any exemplary embodiment provides a system further comprising a nut threaded by the lead screw and connected to at least one of the pusher and the cutter, wherein the nut moves axially relative to the housing with rotational movement of the lead screw, thereby advancing the pusher and the cutter.

[0010] Another exemplary implementation of any exemplary embodiment provides a cutter including a blade, the blade laterally connecting the pusher and the nut, the blade including a slicing edge that slices the slicable portion of the container.

[0011] A further exemplary implementation of any exemplary embodiment provides that the container includes an end cap disposed at a distal end portion of the container, the end cap comprising at least one of an outlet for dispensing the medium and an inlet for filling the container.

[0012] Yet another exemplary implementation of any exemplary embodiment provides a system in which the container comprises a soft inner layer that contains a medium, a hard outer layer, and a sliceable portion that exposes a portion of the soft inner layer and includes a cutting channel that extends linearly between the proximal and distal ends of the container.

[0013] According to an exemplary implementation of any exemplary embodiment, a cutting channel configured to accommodate a cutter is provided when the plunger advances to dispense the media, and the cutter advances through the channel and slices through the exposed portion of the soft inner layer.

[0014] According to an exemplary implementation of any exemplary embodiment, the soft inner layer comprises an overmolded within the hard outer layer.

[0015] According to an exemplary implementation of any exemplary embodiment, the soft inner layer is adhered to the inside of the hard outer layer.

[0016] Another exemplary implementation of any exemplary embodiment provides a cylindrical container having one of a circular or oval cross section.

[0017] Another exemplary implementation of any exemplary embodiment provides a system in which the container is cylindrical having one of a circular or elliptical cross section, and the outer wall of the inner layer extends parallel to the inner wall of the outer layer.

[0018] Another exemplary embodiment of the present disclosure provides a patch pump including a system including any combination of the disclosed features, the patch pump including a container for medium, a plunger disposed within the container, and a mechanism disposed outside the container for distally advancing the plunger to dispense the medium from the container.

[0019] Yet another exemplary embodiment of the present disclosure provides a medication delivery device including a system including any combination of the disclosed configurations, the medication delivery device including a container for a medium, a plunger disposed within the container, and a mechanism disposed outside the container for distally advancing the plunger to dispense the medium from the container.

[0020] Objects, advantages, and salient features of the present disclosure will become apparent from the following detailed description, which, taken in conjunction with the accompanying drawings, discloses illustrative embodiments and non-limiting combinations of features of the present disclosure. [Brief explanation of the drawings]

[0021] Referring now to the drawings, in which like reference numerals indicate identical or corresponding parts throughout the several views, embodiments of the present disclosure are described as follows. [Figure 1] FIG. 1 diagrammatically illustrates a combination of system components according to an exemplary embodiment of the present disclosure. [Figure 2A]FIG. 2A is an example of a perspective view of the exterior of a device according to an exemplary embodiment of the present disclosure. [Figure 2B] FIG. 2B is an example of a perspective view of the exterior of a device according to an exemplary embodiment of the present disclosure. [Figure 3A] FIG. 3A is an example of a perspective view of components of a device according to an exemplary embodiment of the present disclosure. [Figure 3B] FIG. 3B is an example of a perspective view of components of a device according to an exemplary embodiment of the present disclosure. [Figure 4] FIG. 4 shows a top view of components of a device according to an exemplary embodiment of the present disclosure. [Figure 5A] FIG. 5A shows a top view of components of a device according to an exemplary embodiment of the present disclosure. [Figure 5B] FIG. 5B shows a side view of the components of a device according to an exemplary embodiment of the present disclosure. [Figure 5C] FIG. 5C shows details of certain components of a device according to an exemplary embodiment of the present disclosure. [Figure 6A] FIG. 6A shows an example of a top view of components of a device at different stages of operation, according to an exemplary embodiment of the present disclosure. [Figure 6B] FIG. 6B shows an example of a top view of the components of a device at different stages of operation, according to an exemplary embodiment of the present disclosure. [Figure 7A] FIG. 7A diagrammatically shows a perspective view of components according to an exemplary embodiment of an embodiment of the present disclosure. [Figure 7B] FIG. 7B diagrammatically shows a cross-sectional view of a component according to an exemplary embodiment of an embodiment of the present disclosure. [Figure 7C] FIG. 7C diagrammatically illustrates a three-dimensional view of components according to an exemplary embodiment of an embodiment of the present disclosure. [Figure 7D] FIG. 7D diagrammatically shows a cross-sectional view of a component according to an exemplary embodiment of an embodiment of the present disclosure. [Figure 7E] FIG. 7E diagrammatically shows a perspective view of components according to an exemplary embodiment of an embodiment of the present disclosure. [Figure 8A]FIG. 8A diagrammatically shows a perspective view of components according to an exemplary embodiment of an embodiment of the present disclosure. [Figure 8B] FIG. 8B diagrammatically shows a cross-sectional view of a component according to an exemplary embodiment of an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0022] The matters exemplified in this description are provided to facilitate a comprehensive understanding of the exemplary embodiments of the present disclosure. Therefore, those skilled in the art will recognize that various changes and modifications can be made to the embodiments described herein without departing from the scope and intent of the present disclosure. In addition, descriptions of well-known functions and structures are omitted for the sake of clarity and conciseness.

[0023] As will be readily understood by one of ordinary skill in the art, descriptive terms such as "vehicle," "agent," "stopper," "plunger," "screw," "syringe," "motor," "bridge," "nut," "blade," "cutter," "slice," "slicable," "gear," "sharp," "wall," "top," "side," "bottom," "upper," "lower," "proximal," "distal," "container," "reservoir," "chamber," and the like are used throughout this specification for ease of understanding, but are not intended to limit any components that may be used in combination or individually to implement various aspects of the embodiments of the present disclosure.

[0024] Exemplary embodiments of the present disclosure provide system components that can facilitate reducing the overall size or footprint of a drug delivery device, such as a patch pump, through the configuration of a container, reservoir, or chamber for a medium or fluid, and a mechanism or drive component for advancing a plunger to dispense the medium or fluid, which mechanism or drive component can be located outside of the fluid or medium chamber.

[0025] Exemplary embodiments of the present disclosure provide a combination of various features of a flexible reservoir design and a ratchet mechanism for operational sequencing.

[0026] According to an exemplary embodiment of the present disclosure, a system includes a syringe-style drug container, reservoir, or chamber containing a medium or fluid that can be dispensed by advancing a plunger disposed within the container, the container including a sliceable portion, the plunger including a distal surface disposed within the container facing, contacting, or proximate to the medium within the container, and a cutter or slicer configured on a plunger holder or pusher behind the plunger, such that as the plunger advances, it slices or cuts the sliceable portion of the container to dispense the medium or fluid from the container.

[0027] According to exemplary embodiments of the present disclosure, significant space savings can be achieved by utilizing exemplary implementations of the mechanical drive mechanism that reside entirely outside the syringe barrel, e.g., behind the moving plunger as provided in the present disclosure, thus simplifying, for example, drug compatibility of the device.

[0028] In an exemplary embodiment of an embodiment of the present disclosure, the mechanism includes a screw pump with a frangible (flexible) reservoir. Such a configuration can ensure high performance by advantageously utilizing a screw pump type design that can facilitate high precision while reducing the footprint, for example, compared to conventional designs of a single advance lead screw in the reservoir.

[0029] Additionally, in exemplary embodiments of the present disclosure, the frangible reservoir can be configured with cuttable sections and features that minimize cutting forces while simultaneously not allowing pressure loss and crack propagation.

[0030] In yet another exemplary embodiment of the present disclosure, the blade approach angle and thickness may be optimized to minimize cutting and drag forces.

[0031] In yet another exemplary embodiment of the present disclosure, the features of the configuration, including the frangible reservoir, cutting blade, and pusher, can be optimized to, for example, limit moments and transmit forces to displace the stopper.

[0032] FIG. 1 diagrammatically illustrates the general concept of a system 10 according to an exemplary embodiment of the present disclosure, which includes a syringe-style drug container 11 containing a medium 14 that can be dispensed by advancing a plunger 12 disposed in a direction 15 at the distal end of the container 11 toward an outlet 13 of the container 11 via any suitable attached or integrally designed feature, such as a needle or tube 16. The container 11 includes a sliceable portion 19. The plunger 12 includes a distal surface 21 configured to be disposed inside the container 11, facing, contacting, or proximal to the medium 14 within the container 11. A cutter or slicer, such as a blade 20, is configured on a plunger holder or pusher 18, behind the distal surface 21 of the plunger 12, at a distance D from the distal surface 21, and can be a separate structure or an integral part of the plunger 12. Distance D can be selected arbitrarily or optimally based on desired design factors. Blade 20 is configured to slice or cut through slicable portion 19 as plunger 12 advances in direction 15 .

[0033] Plunger system 10 includes a mechanism 17 outside of container 11 for advancing plunger 12 at least in distal direction 15, for example, by driving a rotatable rod 22 in threaded communication 23 with a threaded cutter or bridge 24 that mechanically connects plunger holder or pusher 18 to driver 17. In an exemplary implementation, bridge 24 may be configured to include or be at least a portion of cutter or blade 20. All components except for a portion of pusher 18 are located outside of container 11.

[0034] 2A-6B, exemplary embodiments of the present disclosure can be applied to pump concepts such as, for example, a wearable disposable patch pump 100 configured to include a base 102, an outer housing 104, and an insertion mechanism 106, as shown in the perspective views of FIGS. 2A and 2B. FIG. 3A is a perspective view of pump 100 without the outer housing or cover 104 and illustrates at least some of the various components that may be configured on the base 102 of pump 100 according to exemplary embodiments of the present disclosure. Such components include a pumping mechanism 300 behind a pusher 302 and stopper or plunger of a syringe-style drug container 306 (having a distal end or portion 307 and a proximal end or portion 309) configured with a slicable reservoir 308 for dispensing a medium. Examples of configurations of pumping mechanisms and syringe-style drug containers with slicable reservoirs according to exemplary embodiments of the present disclosure are described in more detail below.

[0035] As shown diagrammatically in the example of FIG. 3A , mechanism 300 can be implemented to function as a screw pump, or positive displacement pump, that displaces a fluid or medium with positive pressure from point A to point B. Driven by a gear train 320 that rotates a lead screw 310 parallel to a reservoir 308, the positive displacement pump displaces the lead screw 310 and a bridge, nut, or threaded cutter 312 that is threaded 311 with a pusher 302. In the exemplary configuration, lead screw 310 is essentially axially parallel to reservoir 308 and extends between proximal and distal portions of reservoir 308. Lead screw 310 is laterally engaged with pusher 302 and / or plunger 304. In a further exemplary configuration, the blade 314 may be secured to the nut 312 and / or the pusher 302 as an interconnection between the nut 312 and the pusher 302, such that when the mechanism 300 drives the lead screw 310 to advance the nut 312, the blade 314 slices through the reservoir 308 and the pusher 302 displaces or advances the plunger 304 to generate pressure (see also FIG. 8 ).

[0036] 4, 5A-5C, and 6A-6B, in an exemplary implementation of an embodiment of the present disclosure, mechanism 300 includes a spur gear 430 driven by a motor 432 connected to a power source, such as a battery 400, and controlled by electronics (which may include a programmable microprocessor, a memory module, and wires and / or wireless communication modules) disposed on PCB 402. As shown in the examples of FIG. 5A (a top view of pump 100) and FIG. 5B (a proximal side view of pump 100), mechanism 300 may be configured relative to the proximal end 309 of reservoir 308, including one or more spur gears 430 in communication with motor 432. FIGS. 5B and 5C also show an example of the attachment of blade 314 to pusher 302 (see also FIG. 8A). Additionally, FIGS. 5A-5B include example exterior dimensions of a patch pump 100 embodying components according to an exemplary embodiment of the present disclosure. In a further exemplary implementation, lead screw 310 may be threaded 0-80.

[0037] The distal end 307 of the reservoir 308 may include an end cap 408 to facilitate connection of the reservoir 308 to the insertion mechanism 106 for dispensing a medium or fluid from the reservoir 308, for example, via tubing 116. The end cap 408 may also be configured to facilitate connection of the reservoir 308 to the filling port 404, for example, via tubing 406, for filling the reservoir 308 with a medium or fluid, as illustrated in FIGS. 6A-6B, where the reservoir 308 is empty in FIG. 6A and filled in FIG. 6B, with the pusher 304 remaining in its initial position and the reservoir 308 intact (unsliced) by displacement of the plunger 302.

[0038] 7A-7E, in an exemplary implementation, reservoir 308 has cuttable sections and / or features 318 that minimize cutting forces while simultaneously not allowing pressure loss and crack propagation. In an exemplary embodiment, reservoir 308 can include a soft inner layer 702 and a hard outer layer 704, where hard outer layer 704 exposes a portion of soft inner layer 202 therethrough and includes a cutting channel 706 that extends linearly and / or longitudinally between proximal end 309 and distal end 307 of reservoir 308. As shown in FIG. 7E, width 708 of channel 706 can be configured to accommodate blade 314, and length 710 of channel 706 can be configured based on the desired movement of plunger 304 between proximal end 309 and distal end 307 of reservoir 308. The channel 706 can optionally be configured with features such as lip(s) 712 to facilitate precise displacement and / or slicing by the blade 314 (see, e.g., FIG. 8A ). FIG. 7B shows an example of an overmolded inner reservoir layer 702, and FIG. 7C shows an example of an extruded inner reservoir layer 702. In the exemplary embodiment shown in FIG. 7B , the end caps 408 can be integrally formed with the hard outer layer 704. In the exemplary embodiment of FIG. 7C , the end caps 408 can be welded and / or bonded to the extrusion, for example, as shown in FIG. 7D .

[0039] 8A and 8B, in an exemplary embodiment, the cutting section 802 of the blade 314 can be optimized to have minimal cutting and pulling forces at a cutting location 804 behind the plunger seal 806 of the plunger 302. In a further exemplary implementation, the pusher 304 can include anti-rotation features 808 at predetermined locations to inhibit rotation transferred from the lead screw 310 with minimal energy loss.

[0040] While the present disclosure has been shown and described with reference to specific exemplary embodiments thereof, those skilled in the art will understand that various changes in form and detail can be made therein without departing from the spirit and scope of the embodiments of the present disclosure. For example, operational variations and alternative different lead designs can be used to change the dosing resolution, encoders can be used to provide feedback for the drive mechanism, and indexing drives can be used to advance the plunger repeatably and fail-safely. In general, for example, non-circular syringe barrel cross sections can be used to optimize space utilization and tailor device size to optimal user comfort. Furthermore, without departing from the spirit and scope of the embodiments of the present disclosure, any of the features or elements of any exemplary implementations of the embodiments of the present disclosure described above and illustrated in the drawings can be implemented individually or in any combination as would be readily apparent to one skilled in the art.

[0041] Additionally, the accompanying drawings further describe non-limiting examples of certain exemplary embodiments of the present disclosure and aid in explaining the related technology. Specific or relative dimensions or measurements set forth in the drawings, other than those described above, are exemplary and are not intended to limit the scope or content of the inventive designs or methods as understood by those skilled in the relevant disclosure field. The following non-limiting examples of underlying technical principles may be applicable and further facilitate understanding of exemplary implementations of embodiments of the present disclosure, such as anti-rotation features in drive nuts, friction, gear power transmission, syringe barrel drug containers, use of flat cell batteries for space saving, use of ratchet mechanisms for actuation sequencing, single action valves / plugs for connection to insertion mechanisms after filling via cables or linkages, valves / plugs that are rotated or pulled / pushed to expose patient-side fluid paths, simultaneous mechanism action, etc.

[0042] Other objects, advantages and salient features of the present disclosure will become apparent to those skilled in the art from the detailed disclosure of illustrative embodiments thereof taken in conjunction with the accompanying drawings.

Claims

1. a medium container; a plunger disposed in the container; a mechanism for distally advancing the plunger to dispense media from the container; A system comprising: the mechanism is located outside the container; the container includes a slicable portion extending essentially linearly from a proximal portion to a distal portion of the container; the plunger includes a distal surface disposed within the container, the distal surface facing the medium within the container; The mechanism comprises: a pusher acting on the plunger; a cutter with the pusher behind the plunger, the cutter slicing the sliceable portion of the container as the plunger advances distally to dispense the medium from the container; Including, the system.

2. 10. The system of claim 1, wherein the mechanism further comprises a lead screw disposed outside the container and axially fixed relative to the container, the lead screw laterally engaging the pusher.

3. The system of claim 2 , wherein the mechanism further comprises a driver that rotates the lead screw to advance the plunger.

4. 4. The system of claim 3, wherein the mechanism includes at least one gear that transmits rotation of the driver to the lead screw, the gear being located at a proximal end of the container, and the medium being dispensed at a distal end of the container.

5. 5. The system of claim 2, further comprising a nut threadedly engaged with the lead screw and connected to at least one of the pusher and the cutter, wherein rotational movement of the lead screw causes the nut to move axially relative to the housing, thereby advancing the pusher and the cutter.

6. 6. The system of claim 5, wherein the cutter includes a blade laterally connecting the pusher and the nut, the blade including a slicing edge that slices the slicable portion of the container.

7. 7. The system of claim 1, wherein the container includes an end cap disposed at a distal end portion of the container, the end cap including at least one of an outlet for dispensing the medium and an inlet for filling the container.

8. The container comprises: a soft inner layer containing the medium; a hard outer layer; the sliceable portion exposes a portion of the soft inner layer and has a cut channel extending linearly between the proximal and distal ends of the container; The system according to any one of claims 1 to 7, comprising:

9. 9. The system of claim 8, wherein the cutting channel is configured to accommodate the cutter when the plunger advances to dispense the media, and the cutter advances through the channel and slices through the exposed portion of the soft inner layer.

10. The system of claim 8 , wherein the soft inner layer comprises an overmold within the hard outer layer.

11. The system of claim 8 , wherein the soft inner layer is bonded within the hard outer layer.

12. 12. The system of claim 1, wherein the container is cylindrical with either a circular or elliptical cross section.

13. 12. The system of claim 8, wherein the container is cylindrical with either a circular or elliptical cross section, and the outer wall of the inner layer extends parallel to the inner wall of the outer layer.

14. A patch pump comprising the system according to any one of claims 1 to 13.

15. A drug delivery device comprising a system according to any one of claims 1 to 13.

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