Fillable drug delivery device

Abstract

A fillable drug delivery device includes a body, a reservoir disposed on the body and having an end wall, and a plunger movably disposed within the reservoir. The device further includes an input port and an output port disposed on one of the end wall and the plunger, and a patient cannula in fluid connection with the output port. The one of the end wall and the plunger has a face oriented toward an interior of the reservoir and the other of the end wall and the plunger, and the face has a channel recessed therefrom. The channel fluidly connects the input port and the output port.

Description

Technical Field

[0001] This invention relates to medical devices, and more specifically, to refillable medical devices having a reservoir and a movable plunger. Background Technology

[0002] The process of filling the reservoir of a drug delivery device may trap air within the reservoir. For conventional manual syringes, this problem can be solved by user training and the use of gravity to help orient the syringe, causing air to rise towards the cannula end of the syringe, thus allowing the user to push the plunger and expel the air through the cannula.

[0003] However, the same method is unavailable for complex micro-dosing syringe pump systems that lack a clear line of sight to allow for the detection of potential air trapping. In related art devices, small variations in the mating surfaces between the bottom-floating plunger and the reservoir wall can be driving factors determining fluid flow, potentially manifesting as splashing around the inlet port. This uncontrolled behavior is not ideal for ensuring air evacuation and preventing air trapping. Improvements are desired. Summary of the Invention

[0004] Therefore, one aspect of the present invention is to provide a fillable drug delivery device having an improved ability to expel air trapped in the reservoir.

[0005] The foregoing and / or other aspects of the present invention are achieved by providing a refillable drug delivery device comprising a body, a reservoir disposed on the body and having end walls, and a plunger movably disposed within the reservoir. The device further includes an input port and an output port disposed on one of the end walls and the plunger, and a patient cannula fluidly connected to the output port. The end wall and the plunger have a surface oriented toward the interior of the reservoir and the other end wall and plunger, and the surface has a recessed channel therein. The channel fluidly connects the input port and the output port.

[0006] The foregoing and / or other aspects of the present invention are also achieved by providing a refillable drug delivery device comprising a reservoir, a plunger movably disposed within the reservoir, an input port and an output port disposed on the plunger, and a patient cannula fluidly connected to the output port.

[0007] The foregoing and / or other aspects of the present invention are further achieved by providing a refillable drug delivery device comprising a body; a reservoir disposed on the body and having an end wall having an input port and an output port disposed therethrough; a plunger movably disposed within the reservoir; and a patient cannula fluidly connected to the output port. The end wall has a channel recessed from its inner surface, the channel fluidly connecting the input port and the output port.

[0008] Additional and / or other aspects and advantages of the invention will be set forth in the description which follows, or will be apparent from the description, or may be learned by practicing the invention. Attached Figure Description

[0009] The above and / or other aspects and advantages of embodiments of the present invention will be more readily understood from the following detailed description taken in conjunction with the accompanying drawings, in which:

[0010] Figure 1 This is a perspective view of a wearable fluid delivery device constructed according to an embodiment of the present invention;

[0011] Figure 2 This is a block diagram of exemplary components of a fluid delivery device according to an embodiment of the present invention;

[0012] Figure 3 This is a perspective top view of a wearable fluid delivery device according to another embodiment of the present invention;

[0013] Figure 4 yes Figure 3 A perspective view of the device from below;

[0014] Figure 5 yes Figure 3 A perspective sectional view of the device;

[0015] Figure 6 yes Figure 3 A cross-sectional view of the device's storage unit;

[0016] Figure 7 yes Figure 6 A cross-sectional view of the storage device, showing the channels within it;

[0017] Figure 8 yes Figure 3 A partial cross-sectional view of the storage device;

[0018] Figure 9 yes Figure 6 A cross-sectional view of the reservoir shows the channel in the plunger. Detailed Implementation

[0019] Reference will now be made in detail to embodiments of the invention illustrated in the accompanying drawings, wherein like reference numerals denote like elements throughout. The embodiments described herein are illustrated by way of example with reference to the drawings, but do not limit the scope of the invention.

[0020] The embodiments are not intended to be mutually exclusive, such that features of one embodiment can be combined with other embodiments, as long as they do not contradict each other.

[0021] Those skilled in the art will understand that this disclosure, in its application, is not limited to the construction details and component arrangements set forth in the following description or shown in the accompanying drawings. The embodiments herein are capable of having other embodiments and can be practiced or performed in various ways. The wording and terminology used herein are for descriptive purposes and should not be considered limiting. The use of "comprising," "including," or "having," and variations thereof, is intended to cover the items listed thereafter and their equivalents, as well as additional items.

[0022] Unless otherwise limited, the terms "connection," "link," and "installation," and their variations, are used broadly herein and cover both direct and indirect connections, links, and installations. Furthermore, the terms "connection" and "link," and their variations, are not limited to physical or mechanical connections or links. Additionally, terms such as "upper," "lower," "bottom," "top," "front," "rear," "upper part," "lower part," "upward," "downward," and other orientation descriptors are intended to facilitate the description of exemplary embodiments of the invention and are not intended to limit the structure of exemplary embodiments of the invention to any particular location or orientation. Those skilled in the art will understand that degree terms such as "substantially" or "generally" refer to a reasonable range around a given value and include both the given value and ranges beyond the given value, for example, general tolerances associated with the manufacture, assembly, and use of the embodiments. The term "substantially" when referring to a structure or characteristic includes a characteristic that is primarily or entirely present in the characteristic or structure.

[0023] Figure 1 This is a perspective view of an example of a wearable fluid delivery device 10 constructed according to an exemplary embodiment. Figure 1 As shown, the drug delivery device 10 includes a body or base plate 12, a cap 14, and an insertion mechanism 16 in an undeployed position. The reservoir of the fluid delivery device 10 can be filled with fluid (e.g., a drug or pharmaceutical product) by a user inserting the needle of a filled syringe 36 into a filling port (not shown) disposed in the base plate 12, the filling port having an inlet fluid path from the filling port to the reservoir. It should be understood that the fluid delivery device 10 can be filled with fluid (e.g., a drug) using different mechanisms and methods.

[0024] Figure 2This is an illustrative systems diagram showing exemplary components in an exemplary drug delivery device 10, which includes, for example, an infusion pump. The drug delivery device 10 may include an electronic device subsystem 52 for controlling the operation of components such as pump 64 in a fluid subsystem 54. A power storage subsystem 50 may include one or more batteries 56, for example, for providing power to the components in the electronic device subsystem 52 and the fluid subsystem 54. The fluid subsystem 54 may include, for example, an optional filling port 68 for filling a reservoir 70 (e.g., with medication), although the drug delivery device 10 may optionally be transported from a manufactured part whose reservoir is already filled, or may be configured to receive a filled reservoir from a healthcare professional or user. The drug delivery device 10 also includes an insertion mechanism 74 for deploying a cannula 72 for insertion into an infusion site on a patient's skin. The fluid subsystem 54 also has a metering subsystem 62, which includes pump 64 and pump actuator 66.

[0025] The pump actuator 66 may be a DC motor and gearbox assembly or other pump drive mechanism for controlling the plunger or piston 30. The microcontroller 58 may be provided with an integrated or separate memory device 76 having computer software instructions for controlling, for example, the operation of the pump actuator 66.

[0026] Figure 3 This is a perspective view of a wearable fluid delivery device 100 according to another embodiment of the present invention, wherein the cover 114 is removed to aid clarity. Similar to... Figure 1 and Figure 2 In one embodiment, device 100 includes a substrate or body 112, on which one or more batteries 156, a drive actuator 166 (such as a DC motor and gearbox assembly or other drive mechanism), an insertion mechanism 174, and a reservoir 170 are mounted. According to one embodiment, the reservoir 170 is fixedly mounted to the body 112. Device 100 also includes a patient cannula 130 (in... Figure 5 (best shown in the image), as part of the insertion mechanism 174.

[0027] Preferably, the reservoir 170 is rigid. The reservoir 170 may be integrally formed from non-metallic and metallic materials, such as polymeric materials (including but not limited to thermoplastics), stainless steel, or other metal alloys.

[0028] The reservoir 170 has a stopper or plunger 180 movably disposed therein. According to one embodiment, the stopper is freely movable within the reservoir 170. The stopper 180 is not connected to a drive mechanism that would inhibit the movement of the stopper 180, and the stopper 180 moves within the reservoir due to the pressure of a fluid (e.g., a drug) in the reservoir. According to one embodiment, the stopper is freely movable within the reservoir 170 before filling. After filling with the drug, a drive mechanism, such as a drive actuator 166, engages the stopper to drive it to dispense the drug.

[0029] For example, according to one embodiment, the reservoir 170 is initially filled by a patient or medical professional using a syringe 36 to create a volumetric displacement for fluid delivery. This is achieved by starting the stopper 180 at the distal or distal end of the reservoir 170 with the reservoir 170 completely empty. The stopper 180 is pushed back by the incoming fluid introduced by the patient via the filling port 168. That is, when the reservoir 170 is filled by the syringe 36 via the filling port 168, the stopper 180 is driven towards the proximal or rearward side of the reservoir 170 by the incoming fluid.

[0030] The plunger 180 is a sealing member that can be constructed from one or more components to form a floating piston face. The plunger 180 may have more than one contact point for sealing along the longitudinal axis of the reservoir 170 to balance forces and prevent tilting of the plunger 180 relative to the reservoir 170. The plunger 180 may be integrally formed from non-metallic and metallic materials, such as polymeric materials (including but not limited to thermoplastics), stainless steel, or other metal alloys. The plunger 180 may also have an O-ring seal 182, which is present to achieve a robust sealing connection with the reservoir 170.

[0031] According to one embodiment, the reservoir 170 has an end wall 172 having an input port 176 and an output port 178 disposed therethrough. The end wall has a surface 173 oriented toward the interior of the reservoir 170 and the plunger 180, and the surface 173 has a recessed channel 190 therein. The channel 190 fluidly connects the input port 176 and the output port 178.

[0032] More specifically, such as Figure 7As shown, channel 190 includes a first lateral portion 192 extending from input port 176 toward a first intersection 193 on the inner wall of reservoir 170. From the first intersection 193, channel 190 divides in opposite directions into a first peripheral portion 194 and a second peripheral portion 195, which extend around the periphery of surface 173 to a second intersection 196. The first peripheral portion 194 and the second peripheral portion 195 reconnect at the second intersection 196. From the second intersection 196, channel 190 includes a second lateral portion 197 leading to output port 178. Output port 178 is in fluid connection to patient cannula 130.

[0033] According to one embodiment, there is a downstream flow path from the output port 178 through the patient cannula 130, and a selective permeable membrane is provided in the downstream flow path.

[0034] In operation, before filling reservoir 170, plunger 180 is positioned adjacent to face 173. According to one embodiment, plunger 180 is positioned to contact face 173 of end wall 172. During filling reservoir 170, the shape and position of channel 190 guide fluid (drug) entering reservoir 170 through inlet port 176 to outlet port 178 to expel air from reservoir 170 before moving plunger 180 and at least partially filling the remainder of reservoir 170.

[0035] According to one embodiment, the pressure required to propel the drug through the selective permeation membrane is greater than the pressure required to move the plunger 180. Therefore, when the drug is introduced through the inlet port 176, once the air is driven out of the reservoir 170 by the drug flow through the channel 190 and propelled through the selective permeation membrane, once the fluid (drug) reaches the selective permeation membrane, the fluid pressure is established only in the downstream flow path and the reservoir 170. At this point, because the pressure required to move the plunger 180 is less than the pressure required to pass the fluid through the selective permeation membrane, the plunger 180 moves within the reservoir by the fluid entering the reservoir 170 via the inlet port 176. Once the plunger 180 bottoms out at the rear of the reservoir 170, the continued fluid inflow via the inlet port 176 causes the pressure in the reservoir and downstream flow path to increase to a point where the fluid can pass through the selective permeation membrane, thus confirming that the device 100 has been filled. Subsequently, the operation of the actuator 166 drives the plunger forward to dispense fluid.

[0036] Preferably, the cross-sectional shape of channel 190 is semi-circular, such as... Figure 8 As best shown. However, those skilled in the art will understand that channel 190 can have different cross-sectional shapes without departing from the scope of the invention.

[0037] According to another embodiment, such as Figure 9As shown, instead of the end wall 170 having an input port 176 and an output port 178, the plunger 180 has an input port 176 and an output port 178 disposed thereon (through it).

[0038] According to another embodiment, the plunger 180 further has a plunger surface 183 oriented toward the interior of the reservoir 170 and a face 173 toward the end wall 172. The plunger surface 183 has a plunger channel 200 recessed therefrom. Similar to a previous embodiment, the plunger channel 200 includes a first lateral portion 202 extending from the input port 176 toward a first intersection 203 at the inner wall of the reservoir 170. From the first intersection 203, the plunger channel 200 divides in opposite directions into a first peripheral portion 204 and a second peripheral portion 205, the first and second peripheral portions extending around the periphery of the face 183 to a second intersection 206. The first peripheral portion 204 and the second peripheral portion 205 are reconnected at the second intersection 206. From the second intersection 206, the plunger channel 200 includes a second lateral portion 207 leading to an output port 178. The output port 178 is in fluid connection to a patient cannula 130.

[0039] According to one embodiment, there is a downstream flow path from the output port 178 through the patient cannula 130, and a selective permeable membrane is provided in the downstream flow path.

[0040] During operation, prior to filling reservoir 170, the plunger face 183 of plunger 180 is positioned adjacent to face 173. According to one embodiment, plunger face 183 is positioned to contact face 173 of end wall 172. During filling reservoir 170, the shape and position of plunger channel 200 guide fluid (drug) entering reservoir 170 through inlet port 176 to outlet port 178 to expel air from reservoir 170 before moving plunger 180 and at least partially filling the remainder of reservoir 170.

[0041] According to one embodiment, the pressure required to propel the drug through the selective permeation membrane is greater than the pressure required to move the plunger 180. Therefore, when the drug is introduced through the inlet port 176, once the air is driven out of the reservoir 170 by the drug flow through the plunger channel 200 and propelled through the selective permeation membrane, once the fluid (drug) reaches the selective permeation membrane, the fluid pressure is established only in the downstream flow path and the reservoir 170. At this point, because the pressure required to move the plunger 180 is less than the pressure required to pass the fluid through the selective permeation membrane, the plunger 180 moves within the reservoir by the fluid entering the reservoir 170 via the inlet port 176. Once the plunger 180 bottoms out at the rear of the reservoir 170, the continued fluid inflow via the inlet port 176 causes the pressure in the reservoir and downstream flow path to increase to a point where the fluid can pass through the selective permeation membrane, thus confirming that the device 100 has been filled. Subsequently, the operation of the actuator 166 drives the plunger forward to dispense fluid.

[0042] Preferably, the cross-sectional shape of the plunger channel 200 is semi-circular, such as... Figure 8 As best shown. However, those skilled in the art will understand that the plunger channel 200 can have different cross-sectional shapes without departing from the scope of the invention.

[0043] According to another embodiment, the input port 176 and the output port 178 can be disposed in one of the end wall 172 and the plunger 180, but the end wall 172 and the plunger 180 respectively include a channel 190 and a plunger channel 200, such as Figure 8 As shown. In this embodiment, before filling the reservoir, the inner surface (face 173) of the end wall 172 and the plunger face are disposed adjacent to each other, and the channel 190 and the plunger channel together form the combined channel 210.

[0044] Embodiments of the invention employ flow channel features of appropriate size and shape to specifically coordinate the connection of inlet port 176 and outlet port 178 to control the flow direction, such that fluid is uniformly wicked throughout the design combination of reservoir 170 and plunger 180, thereby pushing most of the air in the system toward outlet port 178 during filling operations. To achieve the high precision of the micro-dosing syringe pump, these design features are designed to prevent air from remaining trapped within reservoir 170 itself. All air can be permanently discharged from the entire system via one or more selectively permeable membranes integrated into the downstream flow path through outlet port 178, provided that the air is properly vented to the outlet port before the fluid reaches the same location.

[0045] Embodiments of the invention may include channel features as part of the end wall of the free-floating plunger 180, the reservoir 170, or both. Any interface (or combination thereof) will create a flow channel that reduces the probability of random splashing of fluid due to very small component clearances by providing a fluid path with minimal resistance. Embodiments of the invention aim to reduce the rate of air introduction due to system architecture and geometry.

[0046] Embodiments of the invention can be adapted to optimize the size, number, and shape of flow channels to allow timely and stable flow between the input and output ports under a given input pressure range. The positions of the input and output ports can vary the orientation of the features. The channels in these embodiments are ideally located in areas where stagnant air trapping may occur, such as where plungers and sealing gaps may be present. Ideally, the channels have a continuous path with a clear start at the input port and an end at the output port. Embodiments of the invention also benefit from symmetry in the channel design to ensure that if a split exists in the path, both paths reach the output port simultaneously.

[0047] Although only a few embodiments of the invention have been shown and described, the invention is not limited to the described embodiments. Those skilled in the art will understand that other changes can be made to the disclosed embodiments without departing from the scope of the invention. Furthermore, any embodiments, features, and / or elements disclosed herein can be combined with each other to form various additional combinations not specifically disclosed, provided that the combined embodiments, features, and / or elements do not contradict each other. All such variations and combinations are considered to be within the scope of the invention as defined by the appended claims and their equivalents.

[0048] Various aspects of the multiple embodiments can be used independently or in combination.

Claims

1. A refillable drug delivery device, comprising: main body; A reservoir, which is disposed on the main body and has end walls; A plunger, which is movably disposed within the reservoir; An input port is disposed on one of the end wall and the plunger; An output port, wherein the output port is disposed on one of the end wall and the plunger; as well as The patient is intubated, and the patient cannula is fluidly connected to the output port. The end wall and the plunger, one of which has a face oriented toward the interior of the reservoir and the other of the end wall and the plunger, and the face has a recessed channel therein that fluidly connects the input port and the output port.

2. The apparatus of claim 1, wherein the channel comprises: A first lateral portion extends from the input port toward a first intersection at the inner wall of the storage unit; A first peripheral portion and a second peripheral portion, the first peripheral portion and the second peripheral portion extending in opposite directions from the first intersection to the second intersection around the perimeter of the surface; as well as The second lateral portion extends from the second intersection to the output port.

3. The apparatus of claim 1, wherein the shape and position of the channel guide fluid entering the reservoir through the input port to the output port to expel air from the reservoir before at least partially filling the remainder of the reservoir.

4. The apparatus of claim 1, wherein the plunger is freely movable within the reservoir.

5. The apparatus of claim 4, wherein the shape and position of the channel direct fluid entering the reservoir to the output port to expel air from the reservoir before the plunger is moved and at least partially fills the remainder of the reservoir.

6. The apparatus according to claim 1, wherein the cross-sectional shape of the channel is semi-circular.

7. The apparatus of claim 1, wherein the other of the end wall and the plunger has a second surface oriented toward the interior of the reservoir and the other of the end wall and the plunger, and the second surface has a second channel recessed therefrom.

8. The apparatus of claim 7, wherein the second channel has a shape corresponding to the channel.

9. The apparatus according to claim 7, wherein the cross-sectional shape of both the channel and the second channel is semi-circular.

10. The apparatus of claim 7, wherein before filling the reservoir, the face and the second face are disposed adjacent to each other, and the channel and the second channel together form a combined channel.

11. The apparatus of claim 10, wherein the cross-sectional shape of the combined channel is circular.

12. The apparatus of claim 1, wherein the body has a filling port disposed thereon; and the input port is fluidly connected to the filling port.

13. A refillable drug delivery device, comprising: Storage container; A plunger, which is movably disposed within the reservoir; An input port is disposed on the plunger; An output port is disposed on the plunger; as well as The patient is intubated, and the patient cannula is fluidly connected to the output port.

14. The apparatus of claim 13, wherein the plunger has a face oriented toward the interior of the reservoir, the face having a channel recessed therein and fluidly connecting the input port and the output port.

15. The apparatus of claim 13, wherein the plunger is freely movable within the reservoir.

16. The apparatus of claim 14, wherein the channel comprises: A first lateral portion extends from the input port to a first intersection point on the inner wall of the storage unit; A first peripheral portion and a second peripheral portion, the first peripheral portion and the second peripheral portion extending in opposite directions from the first intersection to the second intersection around the perimeter of the surface; as well as The second lateral portion extends from the second intersection to the output port.

17. A refillable drug delivery device, comprising: main body; A storage device is disposed on the main body and has an end wall having an input port and an output port disposed therethrough; A plunger, which is movably disposed within the reservoir; as well as The patient is intubated, and the patient cannula is fluidly connected to the output port. The end wall has a channel recessed from its inner surface, the channel fluidly connecting the input port and the output port.

18. The apparatus of claim 17, wherein the channel comprises: A first lateral portion extends from the input port toward a first intersection at the inner wall of the storage unit; A first peripheral portion and a second peripheral portion, the first peripheral portion and the second peripheral portion extending in opposite directions from the first intersection to the second intersection around the perimeter of the surface; as well as The second lateral portion extends from the second intersection to the output port.

19. The apparatus of claim 17, wherein the plunger has a plunger face oriented toward the inner surface of the end wall, the plunger face having a plunger channel recessed therefrom, the plunger channel having a shape corresponding to the channel.

20. The apparatus of claim 19, wherein before filling the reservoir, the inner surface of the end wall and the plunger surface are disposed adjacent to each other, and the channel and the plunger channel together form a combined channel.

Images