Small patch pump system

Abstract

The patch pump system (100) includes an electronic assembly (106), a reservoir (102) for containing a fluid, and an inserter (104) for selectively transitioning a needle (206) from a retracted position to an extended position. The inserter provides a fluid channel that selectively fluidly couples a distal tip of the needle to the reservoir. The needle at least partially deforms as it transitions from the retracted position to the extended position, and the electronic assembly selectively dispenses fluid from the reservoir to the distal tip of the needle.

Description

Technical Field

[0001] The present disclosure relates to a patch system for delivering fluid subcutaneously to a user, and more particularly to a small patch system having a needle insertion mechanism.

Background Art

[0002] Pump systems have been developed to provide a user with a long-term subcutaneous infusion of fluid. In many cases, the pump system pumps fluid from a reservoir to a tube that leads to an infusion set having a needle or cannula positioned subcutaneously in the user. The pump system can have corresponding electronic or mechanical components to provide the user with a metered fluid delivery. In many cases, the pump and reservoir are separate from the infusion set, and fluid from the reservoir is pumped through the tube to the infusion set.

Summary of the Invention

Means for Solving the Problems

[0003] One embodiment includes an electronic assembly, a reservoir for containing fluid, and an inserter for selectively moving a needle from a retracted position to an extended position, the inserter providing a fluid channel for selectively fluidly coupling a distal tip of the needle to the reservoir. In this embodiment, the needle at least partially deforms as it moves from the retracted position to the extended position, and the electronic assembly selectively dispenses fluid from the reservoir to the distal tip of the needle.

[0004] In an example of this embodiment, the reservoir has a base surface configured to be coupled to the user, the base surface defining a base plane. The inserter has an inner component that rotates about a rotational axis substantially parallel to the base plane to move the needle from the retracted position to the extended position. A part of this example has a filter positioned between the reservoir and the distal tip of the needle. However, another part of this example has no filter at all.

[0005] In examples with a filter, the filter filters at least partially one or more of the phenol and metacresol residues from the fluid passing through it.

[0006] In this embodiment, the patch system is less than 49 millimeters wide, less than 39 millimeters deep, and less than 12 millimeters thick.

[0007] In other examples of this embodiment, the patch system is less than approximately 41 millimeters wide, less than approximately 36 millimeters deep, and less than approximately 10 millimeters thick.

[0008] Another example of this embodiment includes a valve positioned along a fluid channel between the distal tip of the needle and a reservoir. In some of these examples, the valve is a one-way valve that allows fluid to flow from the reservoir through the fluid channel to the distal tip of the needle.

[0009] Further examples of this embodiment include a filter positioned in-line with a fluid channel between the reservoir and the distal tip of the needle, and a first one-way valve positioned along the fluid channel between the filter and the reservoir. In additional examples, a second one-way valve can be added, positioned along the fluid channel between the distal end of the needle and the filter.

[0010] In other examples of this embodiment, the reservoir is removable from the electronic assembly and inserter.

[0011] In other examples of this embodiment, the electronic assembly selectively moves the needle between a retracted position and an extended position.

[0012] In other examples of this embodiment, the electronic assembly selectively controls a motor to rotate the inserter and move the needle between a retracted position and an extended position. As part of this example, the electronic assembly selectively controls the extended length of the needle. In other parts of this example, the electronic assembly selectively controls the insertion angle of the needle.

[0013] Further examples of this embodiment include an inner component configured to selectively move the needle from a retracted position to an extended position, and an insertion angle component. In this example, as the inner component moves from the retracted position to the extended position, the needle is deformed at least partially by the insertion angle component. In some parts of this example, the needle elastically deforms to fit within the inserter in the retracted position, and deflects through contact with the insertion angle component as the needle moves from the retracted position to the extended position. In other parts of this example, the needle maintains a substantially linear shape as it extends outward from the base.

[0014] Another embodiment of the present disclosure is a patch pump system comprising an electronic assembly, a reservoir for containing fluid, and an inserter for selectively moving a needle from a retracted position to an extended position, the inserter providing a fluid channel for selectively fluidically connecting the distal tip of the needle to the reservoir. In this embodiment, the patch pump system is less than 49 millimeters wide, less than 39 millimeters deep, and less than 12 millimeters thick.

[0015] In one example of this embodiment, the reservoir has a base surface configured to be coupled to the user, and the base surface defines a base plane. The inserter extends the needle at the extended position, at least about 4 millimeters beyond the base plane. In part of this example, the patch system is about 41 millimeters or less in width, about 36 millimeters or less in depth, and about 10 millimeters or less in thickness.

[0016] In other examples of this embodiment, the reservoir is removable from the electronic assembly and inserter.

[0017] Another example of this embodiment includes an internal component of an inserter configured to selectively move a needle from a retracted position to an extended position, and an insertion angle component. In this example, as the internal component moves from the retracted position to the extended position, the needle is deformed at least partially by the insertion angle component. In part of this example, the needle elastically deforms to fit within the inserter in the retracted position and deflects through contact with the insertion angle component as the needle moves from the retracted position to the extended position. In other parts of this example, the needle maintains a substantially linear shape as it extends outward from the base. [Brief explanation of the drawing]

[0018] The above-described aspects of this disclosure and the methods for obtaining them will become clearer by referring to the following description of embodiments of this disclosure in conjunction with the accompanying drawings, and the disclosure itself will be better understood.

[0019] [Figure 1] This is a top perspective view of the patch pump system. [Figure 2] Figure 1 is a cross-sectional view of the patch pump system. [Figure 3] Figure 1 shows another cross-sectional view of the patch pump system. [Figure 4a] This is a schematic diagram of the inserter of the patch pump system in the retracted configuration shown in Figure 1. [Figure 4b] This is a schematic diagram of the inserter of the patch pump system in the extended configuration shown in Figure 1. [Figure 4c] Figure 1 is a schematic diagram of the inserter of the patch pump system, which has an adjustable insertion angle. [Figure 5] Figure 1 is a schematic cross-sectional view of the patch pump system. [Figure 6a] One embodiment of this disclosure is shown, which utilizes a spring to extend the needle to an extended position. [Figure 6b] One embodiment of this disclosure is shown, which utilizes a spring to extend the needle to an extended position. [Figure 7a]An embodiment is shown in which the reservoir is removable from the patch pump system. [Figure 7b] An embodiment is shown in which the reservoir is removable from the patch pump system. [Figure 7c] An embodiment is shown in which the reservoir is removable from the patch pump system. [Figure 8a] An embodiment of a geared motor assembly for an inserter is shown. [Figure 8b] An embodiment of a geared motor assembly for an inserter is shown.

[0020] Throughout several of the figures, corresponding reference numerals are used to indicate corresponding parts. **DETAILED DESCRIPTION**

[0021] The embodiments of the present disclosure described below are not intended to be exhaustive or to limit the present disclosure to the exact forms set forth in the following detailed description. Rather, the embodiments are selected and described so that others skilled in the art can appreciate and understand the principles and practices of the present disclosure.

[0022] Referring to FIG. 1, an embodiment of a patch pump system 100 is shown. The patch pump system 100 can have a reservoir 102 that provides fluid to an injection assembly having an inserter 104. Further, an electronic assembly 106 may be part of the patch pump system 100 that controls the distribution of fluid from the reservoir 102 to components of the patch pump system 100, as will be described in more detail herein.

[0023] Referring more specifically to the cross-sectional views of the patch pump system in Figures 2 and 3, the reservoir 102 may have a piston 202, etc., within it to selectively apply pressure to the fluid in the reservoir 102. The piston 202 can be connected to a motor and gear assembly 204, which selectively drives the piston 202 to move axially through the reservoir 102. This motor and gear assembly 204 can be energized and controlled by components from an electronic assembly 106. For example, the electronic assembly 106 may have a power source such as a battery and a controller having a processor and memory unit. The controller can selectively energize the motor and gear assembly 204 to move the piston 202 through the reservoir 102. In this configuration, the electronic assembly can dispense any fluid in the reservoir 102 at a predetermined rate or cycle.

[0024] While the motor and gear assembly are described here, another possible embodiment may not have a motor and gear assembly, and may use a spring or the like to move the piston 202. Alternatively, in one possible embodiment, the motor may directly drive the piston 202, and there may be no gear assembly at all.

[0025] A portion of the reservoir 102 is fluidically coupled to the inserter 104, allowing fluid to be distributed from the reservoir 102 to the needle 206. The inserter 104 can selectively move the needle 206 from a retracted position 400 (see Figure 4a), and the needle is substantially housed within the inserter 104 to an extended position 401 (see Figure 4b), with the needle 206 extending from the base plane along the base surface 302 of the patch pump system 100. More specifically, the inserter 104 may have an internal component 208 that rotates around a pivot axis 304 relative to the housing 210 of the inserter 104. The pivot axis 304 may be substantially parallel to the base plane of the base surface 302. Furthermore, the internal component 208 may have a fluid channel 212 that is fluidically coupled to the reservoir 102. The fluid channel 212 guides the fluid from the reservoir 102 through the injector 102 into the needle 206 when the piston 102 applies sufficient pressure to the fluid in the reservoir 102, and discharges it from the distal portion of the needle 206.

[0026] In one aspect of this disclosure, a valve 214 is positioned at least partially between a fluid channel 212 and a reservoir 102. The valve 214 may be a one-way valve, allowing fluid to flow from the reservoir 102 to the fluid channel 212 but not from the fluid channel 212 back to the reservoir 102. In particular, this prevents contaminated fluid from entering the reservoir 102. Furthermore, the reservoir 102 may be detachable from the rest of the patch pump system 100. In this configuration, when the fluid in the reservoir 102 of the patch pump system 100 is depleted, the depleted reservoir can be removed and a full reservoir can be fluidically coupled to the inserter 102 as a replacement.

[0027] One embodiment of the removable reservoir 702 is shown in Figures 7a to 7c. More specifically, the reservoir 702 can be detachably coupled to the patch housing 704, and the reservoir 702 can slide to switch the fluid connection with the inserter 104 on and off. The patch housing 704 can define a receiving portion corresponding to the reservoir 702, and the reservoir 702 can slide to switch the fluid connection with the inserter 104 on and off. In the fluid connection position, the reservoir 702 may have a latch or the like to lock the reservoir 702 in the fluid connection position with the inserter 104. However, when the reservoir 702 is depleted, the user can release the latch and remove the reservoir 702 from the patch housing 704. A reservoir full of fluid can then be coupled to it for subsequent use. In one aspect of this embodiment, a substantially circular seal can be positioned around the fluid channel 212 between the removable reservoir 702 and the inserter 104, ensuring that when the removable reservoir 702 is latched to the patch housing 704, the fluid channel 212 is substantially sealed in the exchange portion between the removable reservoir 702 and the inserter 104.

[0028] In other embodiments of this disclosure, the filter 216 can be positioned along the fluid channel 212. The filter 216 can filter out phenol and metacresol residues from the fluid flowing from the reservoir 102 to the needle 206, among other things. However, other types of filters are also conceivable here as the filter 216.

[0029] The injector 102 may also have a valve 218 positioned between the inner component 208 and the needle 206. Similar to valve 214, valve 218 may also be a one-way valve that substantially prevents backflow of fluid from the needle 206 to the reservoir 102. The embodiments considered herein may have only one of valves 214, 218, and not the other. Alternatively, one embodiment considered herein has both valves 214, 218 positioned as described and illustrated herein.

[0030] The inner component 208 can be coupled to the needle 206, and rotation of the inner component 208 allows the needle 206 to move between a retracted position 400 and an extended position 401. The inner component 208 can be coupled to the needle 206, and rotation of the inner component 208 relative to the housing 210 around the pivot axis 304 allows the needle to move along the insertion guide channel 402 within the insertion angle component 406 before extending beyond the base surface 302. More specifically, the needle 206 can be formed from a material having material properties such that the needle 206 can be elastically deformed inside the inserter 102. The needle 206 typically has a nearly straight shape, but the elastic properties of the needle 206 allow it to bend along the inner surface of the housing 210 when the needle 206 is in the retracted position.

[0031] This arc-shaped elastic deformation of the needle 206 allows the inserter 102 and the corresponding patch pump system 100 to have a low profile (i.e., a thickness of 112), so that at the extended position 401 the needle 206 can extend beyond the base surface 302 to achieve the desired extension depth 404, and so that the needle does not require additional axial clearance to reach the retracted position 400. In one example, the extension depth 404 may be about 4 millimeters. However, in other embodiments considered herein, the extension depth 404 may be greater than or less than 4 millimeters. Furthermore, the extension depth 404 of the needle 206 can be modified by the degree to which the inner component 208 rotates. In one aspect of this disclosure, the degree of rotation of the inner component 208 is controlled by an electronic assembly 106 to modify the extension depth 404.

[0032] In other words, a nearly straight needle typically moves axially along its longitudinal axis, transitioning between a retracted position and an extended position. This requires sufficient axial space along the longitudinal axis of the needle for the needle to maintain its retracted position. By implementing the configuration of the bent needle 206 described herein, the needle 206 can be partially bent along the housing 210 in the retracted position 400, thereby reducing the required thickness 112 of the patch pump system 100 while achieving the same extended depth 404 as the prior art design.

[0033] The insertion guide channel 402 can be formed within an insertion angle component 406, which may be part of the housing 210. The insertion guide channel 402 can have any desired angular orientation with respect to the base surface 302, which is intended to be positioned on the user's skin. The embodiments shown in Figures 4a and 4b primarily show a needle 206 extending substantially perpendicularly from the base surface 302, but other embodiments may have the needle 206 extending at about 30 degrees from the base surface 302. Alternatively, other embodiments considered here may utilize an insertion guide channel 402 that guides the needle 206 to extend at an angle greater than 30 degrees but less than 90 degrees with respect to the base surface 302. Furthermore, other embodiments may utilize an insertion guide channel 402 that guides the needle 206 to extend at an angle less than 30 degrees.

[0034] In one aspect of the present disclosure shown in Figure 4c, the inserter 104 can pivot within the patch pump system 100, thereby changing the insertion angle 408 of the needle 206 relative to the base surface 304 of the patch pump system 100. This allows a user or medical professional to select an insertion angle 408 that is ideal for the user. The needle 206 may have an extendable sleeve 410 along the needle 206, ensuring that the needle 206 extends beyond the base surface 304 in a substantially linear configuration. The sleeve 410 may have a spring 412 axially positioned around the needle 206 between the sleeve 410 and the inserter 104. In this configuration, when the insertion angle 408 is about 90 degrees, the sleeve 410 can compress the spring 412 and be positioned substantially inside the cavity of the inserter 104. However, if the insertion angle 408 is less than 90 degrees, the spring 412 biases toward the base surface 304 so that the sleeve 410 can extend at least partially out of the cavity, thereby ensuring that the sleeve 410 provides a channel for the needle 206 to be further inserted into the user.

[0035] In yet another aspect of this embodiment, the electronic assembly 106 can control the insertion angle 408. More specifically, the inserter 104 and housing 210 may be rotatable relative to the electronic assembly 106 to change the insertion angle 408, as described herein. Furthermore, a motor or the like can selectively rotate the inserter 104 through the housing 210 to change the insertion angle 408. In this configuration, the electronic assembly 106 can selectively change the insertion angle 408 by selectively rotating the inserter 104 via the motor.

[0036] Referring here to Figure 5, a schematic cross-sectional view 500 of the patch pump system 100 is shown. More specifically, the motor 502 is shown as part of the electronic assembly 106. The motor 502 has a shaft coupled to the inner component 208 of the inserter 102. Furthermore, the motor 502 can be selectively energized by the controller of the electronic assembly 106. Alternatively, the motor 502 may be selectively energized by user input. The motor 502 can still be energized to rotate the inner component 208 and the needle 206 between a retracted position 400 and an extended position 401. Furthermore, in one embodiment assumed here, the motor 502 can be coupled to gear assemblies 802, 804 (see Figures 8a and 8b) to selectively rotate the inner component 208. Furthermore, the gear assemblies 802, 804 may be planetary gear assemblies or other types of gear assemblies known in the art.

[0037] In other embodiments of the present disclosure shown in Figures 6a and 6b, the inner component 208 may have a mechanical assembly configured to move the needle 206 from a retracted position 400 to an extended position 401. More specifically, a spring 602 can be positioned to bias the inner component 308 relative to the housing 210 toward the extended position 401. The inner component 308 can be locked in the retracted position using an activator 604 and a locking pin 606. The activator 604 can be engaged by the user and, due to the bias applied by the spring 602, can release the inner component 208 and rotate it toward the extended position 401.

[0038] The fluid channel 212 can be moved along the rotation axis 304 to the inner component 208. In this configuration, the fluid channel 212 of the inner component 208 can be fluidly coupled to the reservoir 102 via the fluid channel, regardless of the angular orientation of the inner component 208 (i.e., regardless of whether the needle 206 is in the retracted position 400 or the extended position 401). In one aspect of the present disclosure, a seal can be positioned between the inner component 208 and the reservoir 102. The seal can be positioned circularly around the fluid channel 212 in the exchange portion between the inner component 208 and the reservoir 102. Positioning the seal in this location ensures that the fluid in the fluid channel 212 is guided from the reservoir 102 to the needle 206.

[0039] In one aspect of this disclosure, an inserter 102 utilizing a bent needle 206 provides an entire patch pump system 100 that is significantly smaller than a prior art patch pump system. More specifically, the patch pump system 100 may have a length 108, a width 110, and a thickness 112, resulting in a smaller patch pump system compared to a prior art device. In one example, the width 110 is less than 56 millimeters, the length 108 is less than 41 millimeters, and the thickness is less than 14.5 millimeters. In another example, the width 110 is less than 49 millimeters, the length 108 is less than 39 millimeters, and the thickness is less than 12 millimeters. In yet another example, the width 110 is about 41 millimeters, the length 108 is about 36 millimeters, and the thickness is about 10 millimeters.

[0040] When in use, the patch pump system 100 may have an adhesive or the like on the base surface 302. Alternatively, the patch pump system 100 may have an adhesive element extending over at least a portion of the patch pump system 100. In any case, the patch pump system 100 can be bonded to the user's skin so that the base surface 302 is adjacent to the user's skin. The patch pump system 100 can be bonded to the user with the needle 206 in the retracted position 400. Furthermore, the reservoir 102 may contain at least some fluids ready to be administered to the user. Once the patch pump system 100 is bonded to the user, the electronic assembly 106 can move the needle 206 from the retracted position 400 to the extended position 401 using the inserter 102. This extends the distal tip of the needle 206 subcutaneously to the user. The inserter 102 can initiate the insertion process by direct user input to the electronic assembly 106 or to the motor 502. Alternatively, the inserter may be manually engaged to move the needle 206 to the extended position 401. Once the needle 206 is in the extended position, the electronic assembly 106 can selectively engage with the motor and gear assembly 204 to selectively drive the piston 202, thereby providing the user with a set amount of fluid in the reservoir 102 via the needle 206.

[0041] Once the user is ready to remove the patch pump system 100, the inserter 102 can move the needle 206 to the retracted position 400 via the electronic assembly 106 or by manually engaging the inserter 102. Once the needle 206 is in the retracted configuration 400, the adhesive holding the patch pump 100 to the user can be removed, or the patch pump can be peeled off the user's skin.

[0042] While embodiments incorporating the principles of this disclosure have been described above, this disclosure is not limited to such embodiments. Rather, this application intends to cover any variations, uses, or adaptations of this disclosure using its general principles. Furthermore, this application intends to cover any deviations from this disclosure that are within the scope of known or customary practices in the art relating to this disclosure and fall within the scope of the appended claims.

Claims

1. A patch pump system, Electronic assembly and, A reservoir for containing the fluid, Needle and, An inserter for moving the needle, It comprises a housing surrounding the inserter, The inserter is selectively transitionable between a retracted position in which the needle is housed within the housing and an extended position in which the distal tip of the needle is positioned outside the housing, and provides a fluid channel that selectively fluidically connects the distal tip of the needle to the reservoir. The needle deforms at least partially as it moves from the retracted position to the extended position, and the electronic assembly controls the distribution of fluid from the reservoir to the distal tip of the needle. The patch pump system further comprises a filter positioned in series with a fluid channel between a reservoir and the distal tip of a needle, and a first one-way valve positioned along the fluid channel between the filter and the reservoir.

2. The reservoir has a base surface configured to be connected to the user, The base surface defines the base plane, The patch pump system according to claim 1, wherein the inserter has an internal component that rotates about a rotation axis substantially parallel to the base plane in order to move the needle from a retracted position to an extended position.

3. The patch system according to claim 1, wherein the filter filters at least partially one or more of the phenol and metacresol residues from the fluid passing therethrough.

4. The patch system according to claim 1, wherein the patch system is 49 millimeters wide, 39 millimeters deep, and less than 12 millimeters thick.

5. The patch system according to claim 4, wherein the patch system is less than approximately 41 millimeters in width, less than approximately 36 millimeters in depth, and less than approximately 10 millimeters in thickness.

6. The patch system according to claim 1, further comprising a second one-way valve positioned along a fluid channel between the distal tip of a needle and a filter.

7. The patch system according to claim 1, wherein the reservoir is removable from the electronic assembly and inserter.

8. The patch system according to claim 1, wherein the electronic assembly selectively moves the needle between a retracted position and an extended position.

9. The patch system according to claim 1, wherein the electronic assembly selectively controls a motor to rotate the inserter and move the needle between a retracted position and an extended position.

10. The patch system according to claim 9, wherein the electronic assembly selectively controls the extension length of the needle.

11. The patch system according to claim 9, wherein the electronic assembly selectively controls the insertion angle of the needle.

12. An internal component configured to selectively move the needle from a retracted position to an extended position, It also includes an insertion angle component, The patch system according to claim 1, wherein the needle is at least partially deformed by the insertion angle component when the inner component moves from a retracted position to an extended position.

13. The patch system according to claim 12, wherein the needle elastically deforms to fit within the inserter in the retracted position, and deflects through contact with the insertion angle component as the needle moves from the retracted position to the extended position.

14. The patch system according to claim 13, wherein the needle maintains a substantially straight shape as it extends outward from the base.

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