System to mechanically and conformally load a flexible reservoir to allow complete emptying and prevent premature collapse and entrapment of fluid

Abstract

A flexible reservoir in a fluid delivery device is arranged with a conformal member to prevent premature collapse of the flexible reservoir as fluid is removed therefrom by a pumping mechanism. The conformal member is arranged to abut the reservoir and comprises a material that allows the conformal member to conform to at least part of the reservoir, to compress as fluid is supplied to the reservoir, and decompress and fluid is removed from the reservoir. The conformal member material can be an elastomeric foam, and can be pre-loaded with respect to compression relative to the reservoir. The flexible reservoir and the conformal member can be arranged in a shell of one or more rigid or semi-rigid parts that at least partially surrounds the flexible reservoir and the conformal member or fully surrounds them.

Description

SYSTEM TO MECHANICALLY AND CONFORMALLY LOAD A FLEXIBLE RESERVOIR TO ALLOW COMPLETE EMPTYING AND PREVENT PREMATURE COLLAPSE AND ENTRAPMENT OF FLUID BACKGROUND Field:

[0001] The present disclosure relates to fluid delivery devices, and more particularly, to medical devices with a flexible reservoir that is in fluid communication with a pump to deliver medicament to a patient. Description of Related Art:

[0002] Bolus and / or infusion pump therapy generally requires an infusion cannula, typically in the form of an infusion needle or a flexible catheter, that pierces the patient's skin and through which, infusion of a medicament takes place. Infusion pump therapy offers the advantages of continuous infusion, precision dosing, and programmable delivery schedules.

[0003] To facilitate drug delivery therapy, there are generally two types of wearable fluid delivery pumps, namely, conventional pumps and patch pumps. Conventional pumps require the use of a disposable component, typically referred to as an infusion set, tubing set or pump set, which conveys the medicament from a reservoir within the pump into the skin of the user. The infusion set consists of a pump connector, a length of tubing, and a hub or base from which a cannula, in the form of a hollow metal infusion needle or flexible plastic catheter extends. The base typically has an adhesive that retains the base on the skin surface during use. The cannula can be inserted onto the skin manually or with the aid of a manual or automatic insertion device. The insertion device may be a separate unit required by the user.

[0004] Another type of wearable fluid delivery pump is a patch pump. Unlike a conventional infusion pump and infusion set combination, a patch pump is an integrated device that combines most or all of the fluidic components, including the fluid reservoir, pumping mechanism and mechanism for automatically inserting the cannula, in a single housing which is adhesively attached to an infusion site on the patient's skin, and does not require the use of a separate infusion or tubing set. A patch pump containing a medicamentadheres to the patient’s skin and delivers the medicament over a period of time or at a selected time via an integrated subcutaneous cannula. Some patch pumps may wirelessly communicate with a separate controller device, while others are completely self-contained. Such devices can be replaced on a frequent basis, such as every three days, when the medicament reservoir is exhausted or when complications may otherwise occur, such as restriction in the cannula or the infusion site.

[0005] Some patch pumps can be designed with reservoirs that are integrated as opposed to a patch pump in which a pre-filled cartridge is inserted into the patch pump housing. Patch pumps with integrated reservoirs may require filling after patch pump assembly at the manufacturing stage, or at the end user stage wherein a healthcare provider or patch pump wearer provides a medicament to the patch pump reservoir using a filling method.

[0006] As patch pumps are designed to be a self-contained unit that is worn by the patient, preferably, the patch pump is small, so that it does not interfere with the activities of the user. Thus, to minimize discomfort to the user, it is preferable to minimize size of the patch pump such as the overall thickness and perimeter of the patch pump. However, to minimize the size of the patch pump, the size of its constituent parts and the number of parts should be reduced as much as possible and their arrangement within the pump should be optimized within the volume defined by the patch pump housing and / or constituent enclosure parts.

[0007] Further, it is an important aspect of fluid delivery devices to deliver accurate and predictable amounts of medicament. SUMMARY

[0008] A need exists for a reservoir that is flexible and therefore versatile in terms of how it can be disposed or otherwise arranged within a patch pump housing.

[0009] A need exists for a flexible reservoir that reliably drains throughout discharging of fluid therefrom.

[0010] The above and other problems are overcome, and additional advantages are realized, by illustrative embodiments described in the present disclosure.

[0011] A system is provided for mechanically and conformally loading a flexible reservoir to allow its complete emptying and prevent premature collapse of the reservoir and entrapment of fluid.

[0012] It is an aspect of illustrative embodiments to provide a wearable fluid delivery device, comprising: a pumping mechanism; a reservoir configured to store a liquid medicament and provide the medicament to the pumping mechanism, the reservoir being composed of at least one material configured to enclose the medicament therein and comprising at least one port through which the liquid medicament can be evacuated from the reservoir and provided to the pumping mechanism; and a conformal member arranged to abut the reservoir and configured to be at least partially compressed by the reservoir when the reservoir has the medicament stored therein and to decompress as the medicament is removed from the reservoir.

[0013] In accordance with aspects of illustrative embodiments, the conformal member is a foam member. For example, the conformal member can comprise elastomeric foam. As another example, the conformal member can comprise preloaded elastomeric foam.

[0014] In accordance with aspects of illustrative embodiments, the conformal member is a spring-loaded conformal member.

[0015] In accordance with aspects of illustrative embodiments, the conformal member is a conformal plate member having a surface that abuts a surface of the reservoir. For example, the conformal member is a conformal spring-loaded plate.

[0016] In accordance with aspects of illustrative embodiments, the conformal member comprises a material with a conformability characteristic that allows the material to conform to the shape of at least part of the reservoir.

[0017] In accordance with aspects of illustrative embodiments, the conformal member comprises a conformal material selected from the group consisting of elastomeric closed cell foam, elastomeric open-cell foam, flexible elastomeric foam (FEF), polyethylene foam (PEF), cellular polyethylene, rubber, latex, polyisoprene, neoprene (CR), nitrile butadienerubber (NBR), ethylene-propylene-dienne monomer (EPDM), chloroprene rubber (CR), polyvinylchloride (PVC), fluoropolymer.

[0018] In accordance with aspects of illustrative embodiments, the wearable fluid delivery device further comprises a shell surrounding at least part of the reservoir and the conformal member. For example, the shell comprises a shell material chosen from a rigid material, and a semi-rigid material.

[0019] In accordance with aspects of illustrative embodiments, the wearable fluid delivery device further comprises a housing enclosing at least the reservoir, the conformal member, and the pumping mechanism, wherein the shell is separate from the housing.

[0020] In accordance with aspects of illustrative embodiments, the wearable fluid delivery device further comprises a housing enclosing at least the reservoir, the conformal member, and the pumping mechanism, wherein at least part of the shell is formed by a surface of the housing.

[0021] In accordance with aspects of illustrative embodiments, the shell is constituted of an assembly of parts chosen from rigid parts, and flexible parts.

[0022] In accordance with aspects of illustrative embodiments, the shell is formed as a continuous member that fully encapsulates the reservoir.

[0023] In accordance with aspects of illustrative embodiments, the shell comprises one or more holes, slits or gaps therein.

[0024] In accordance with aspects of illustrative embodiments, the reservoir is configured as a flexible bag.

[0025] In accordance with aspects of illustrative embodiments, the wearable fluid delivery device further comprises a housing enclosing at least the reservoir, the conformal member, and the pumping mechanism, wherein the at least one material of the reservoir enclosing the medicament is separate from the housing. For example, the reservoir is disposed freely within the housing except for a fluid path connection to the pumping mechanism.

[0026] In accordance with aspects of illustrative embodiments, the reservoir comprises a fluid chamber defined by two layers of flexible material sealed along a perimeter of the fluid chamber to enclose the liquid medicament therein and comprising at least onefluid path port connected to a fluid path to the pumping mechanism. For example, the at least one fluid path port can comprise a tubular fluid path member extending at least partially in between the two layers of flexible material and open at one end thereof to receive the liquid medicament stored within the reservoir and to carry the liquid medicament toward the pumping mechanism. As a further example, the two layers of flexible material are heat staked along the perimeter defining the fluid chamber and around the at least one port.

[0027] Additional and / or other aspects and advantages of illustrative embodiments will be set forth in the description that follows, or will be apparent from the description, or may be learned by practice of the illustrative embodiments. The illustrative embodiments may comprise apparatuses having one or more of the above aspects, and / or one or more of the features and combinations thereof. The illustrative embodiments may comprise one or more of the features and / or combinations of the above aspects as recited, for example, in the attached claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The above and / or other aspects and advantages of the illustrative embodiments will be more readily appreciated from the following detailed description, taken in conjunction with the accompanying drawings, of which:

[0029] Fig.1 is a perspective view of a patch pump in accordance with an illustrative embodiment of the present invention;

[0030] Fig.2 is a cross-sectional view of Fig.1 taken along line 2-2 of Fig.1, omitting an adhesive layer and a liner;

[0031] Fig.3 is a perspective view of the patch pump of Fig.2, omitting a cover and a reservoir;

[0032] Fig.4 is a perspective view of the patch pump of Fig.2, omitting the cover;

[0033] Fig.5 is a perspective view of a tubular fluid path member connected to an example reservoir;

[0034] Fig.6 is a block diagram of components in an example fluid delivery device; and

[0035] Figs.7A and 7B are cross-section side views of a reservoir and related component configured in accordance with an example embodiment and in an empty reservoir state and a full reservoir state, respectively.

[0036] Throughout the drawing figures, like reference numbers will be understood to refer to like elements, features and structures. DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0037] Reference will now be made in detail to illustrative embodiments, which are depicted in the accompanying drawings. The embodiments described herein exemplify, but do not limit, the illustrative embodiments by referring to the drawings.

[0038] An improved and advantageous reservoir for fluid in a fluid delivery device (e.g., a wearable delivery device such as a patch pump) is described herein in accordance with example embodiments of the present disclosure. Example embodiments of reservoir are described below in the context of medicament delivery devices that comprise a flexible reservoir bag from which a fluid medicament is pulled via a pump and injected into a target injection site on a patient.

[0039] Fig.1 is a perspective view of an example patch pump 1. The patch pump 1 has a housing 10, which includes a main cover 2 liquid sealed (e.g., hermetically sealed) to a base 9. The base 9 carries various components described below.

[0040] Fig.2 is a cross-sectional view of the patch pump 1 illustrating various internal components. The main cover 2 and the base 9 house the components of the patch pump 1. The patch pump 1 includes a reservoir 4 for storing medicament and a pump 3 for pumping the medicament to exit the reservoir 4. The patch pump 1 also includes electronics 8 for programming and operating the patch pump 1, and an insertion mechanism 7 for inserting a cannula 47 into a skin of the patient to deliver medicament. Examples of the electronics 8 include semiconductor chips, controllers, diodes, antennas, coils, batteries, discrete components (resistors and capacitors, for example) and circuit boards used to operate and control the patch pump 1 and operate the pump 1.

[0041] Fig.3 illustrates some of the main components of the patch pump 1 in a perspective view with the main cover 2 and the reservoir 4 removed for clarity. The reservoir can be placed over components and not attached to the housing.

[0042] Fig.4 is an illustrative system diagram that illustrates example components in an example fluid delivery device 40 having an infusion pump such as the pump described in WO 2015 / 157174, the content of which is hereby incorporated herein by reference in its entirety. The fluid delivery device 40 can include an electronics sub-system 52 for controlling operations of components in a fluidics sub-system 54 such as a metering sub- system 62 and optional deploy electronics 60 for an insertion mechanism 74 to insert a cannula 72 into an infusion site on a patient’s skin. It is to be understood that the insertion mechanism 74 can also be operated manually to insert the cannula. A power storage sub- system 50 can include batteries 56, for example, for providing power to components in the electronics and fluidics sub-systems 52 and 54. The fluidics sub-system 54 can comprise, for example, an optional fill port 68 for filling a reservoir 70 (e.g., with medicament), although the fluid delivery device 40 can be optionally shipped from a manufacture having its reservoir 70 already filled. The fluidics sub-system 54 also has a metering sub-system 62 comprising the pump 64 and a pump actuator 66. The pump 64 can have two ports and related valve sub-assembly that controls when fluid enters and leaves a pump chamber via the respective ports. One of the ports is an inlet port through which fluid such as liquid medicament flows from the reservoir 70 into the pump 64 as the result of a pump intake or pull stroke on a pump plunger or piston, for example. The other port is an outlet port through which the fluid leaves the pump’s chamber and flows toward a cannula 72 for administration to a patient as the result of a pump discharge or push stroke on the pump plunger or piston. The pump actuator 66 can be a DC motor and gearbox assembly or other pump driving mechanism for controlling the plunger or piston and other related pump parts such as a sleeve that may rotate relative to the translational movement of the pump piston. The microcontroller 58 can be provided with an integrated or separate memory device having computer software instructions to actuate, for example, rotation of the sleeve in a selected direction, translational or axial movement of a piston in the sleeve for an aspirate ordispense stroke, and optionally the rotation of the sleeve and piston together during a valve state change as described in the above-referenced WO 2015 / 157174.

[0043] The example fluid delivery device 40 in Fig.4 can be implemented, for example, in a patch pump such as the patch pump 1 shown in Figs.1 through 3. For example, the pump 3 can be the metering sub-system 62. The reservoir 4 can be the reservoir 70. The insertion mechanism 7 can be the insertion mechanism 74. The control electronics 8 can be implemented as the electronics sub-system 52.

[0044] Fig.5 depicts an example reservoir 4 as described in WO 2017 / 053284, the content of which is incorporated herein by reference in its entirety. A port connector or joint 14B connects a tubular fluid path member 14A to the reservoir 4. The reservoir 4 can be a compact, smaller size compared to what is generally used in the industry. The reservoir 4 is a flexible, collapsible reservoir made from plastic or film materials ranging in thickness between 0.002 - 0.015 inches, for example. The thickness can be varied depending on the need for structural integrity, flexibility, barrier properties, filling / emptying operational behavior and drug type. For example, material-type and thickness can be selected to accommodate a selected pressure (e.g., which is affected by how much fluid is being delivered and by fluid properties), to preserve the integrity of reservoir 4 during shipping and handling, to achieve desired flexibility to conform to the tubular fluid path member 44A and to prevent leakage of reservoir fluid, and / or to achieve a desired fill rate and / or volume.

[0045] The film perimeter is sealed according to a variety of methods such as heat- sealing, radio frequency welding, laser welding, or other joining techniques that cause melting of the two film faces together.

[0046] The reservoir 4 can be formed in a variety of ways. According to one embodiment, the reservoir 4 is formed by using two film sheets at each of the top and bottom surfaces that flexibly goes around the reservoir tube 14A. Such a configuration can provide optimal sealing between the reservoir 4 and the reservoir tube 14A. According to another embodiment, the reservoir 4 is formed by folding a single flexible sheet or thin layer of film or plastic material on one edge and sealing the remaining edges. In another embodiment, the reservoir 4 may be formed by taking a tubular film and sealing at two opposite ends. The reservoir 4 is formed in another embodiment by using a rigid backing onthe top surface and a flexible film on the bottom surface. During the perimeter sealing process, the reservoir 4 can be formed in any desired shape. The example reservoir 4 is disposed within the housing 10 of the example patch pump 1 such that it is freestanding or, in other words, not attached to anything else in the housing 10 or with respect to the housing, except for the fluidic coupling of the reservoir tube 14A or other reservoir fluid interface to a fluid pathway toward the pump 3. The reservoir 4 can also be formed to include features to enable attachment to specific anchor points in the patch pump 1 for mounting purposes. The reservoir 4 satisfies industry sterilization and aging requirements and all operational loads / conditions.

[0047] A reservoir tube 14A is attached to the reservoir 4 on one end (e.g., forming a reservoir port connector or joint 14B), and can be connected to a filling member or port at another end as described in WO 2017 / 053284. According to one embodiment, the reservoir tube 14A is a rigid port connection. Specifically, the reservoir tube 44A is laser welded to the reservoir 4 and the filling member 43 at each end. According to another embodiment, the reservoir tube 14A is a flexible port connection that is heat sealed to the reservoir 4. According to another embodiment, the reservoir tube 14A is molded or formed with the reservoir 4. For example, the processes of heat sealing, molding or forming the reservoir tube 14A and the reservoir 4 simultaneously advantageously improves manufacturability and sealing effectiveness. In another embodiment, the reservoir tube 14A is mechanically pressed to the reservoir 4. Finally, another embodiment adhesively bonds the reservoir tube 14A to the reservoir 4. In accordance with another embodiment, a flexible port connector or joint 14B can be heat sealed by applying heat and pressure to join two parts at a joining surface (joint). Specifically, the joint 14B is where the reservoir tube 14A is sealed directly into the perimeter seal of the reservoir 4.

[0048] The reservoir 4 can be prefilled in a device or filled in the patch pump 1 prior to use by an appropriate filling port 68. Fig.4 is a perspective view of the patch pump 10, omitting the cover. The patch pump 10 includes a filling member 16 directly connected to a reservoir 4 via a flexible reservoir tube 14A engaging the reservoir 4. The filling member 16 is also in fluid communication with the base 9.

[0049] In operation, when the flexible reservoir 4 is filled, it will expand to a final, filled shaped that is dependent on material properties, size and shape. When the reservoir 4 is connected to the pump 3 during operation, the fluid is driven and withdrawn from the reservoir 4. The reservoir 4 generally immediately collapses (self-collapsing) by an amount equal to the volume of fluid removed. The flexibility of the film of the reservoir 4 allows for the emptying (reservoir collapsing) behavior. The flexibility of the reservoir 4 advantageously provides optimal use of the internal volume of the patch pump 1. The fluid subsequently travels to the filling member 16 upon exiting the reservoir 4 and can be directed toward the pump 3 as described in WO 2017 / 053284. It is to be understood that a different fluid pathway configuration can be used in lieu of the filling member 16 to send fluid from the reservoir 4 to the pump 3.

[0050] As stated above, example embodiments of the present disclosure are described herein in the context of fluid delivery devices (e.g., for delivery of a fluid medicament to patient) that comprise a flexible reservoir bag from which a medicament is pulled via a pump and injected into a target injection site on a patient. In this configuration, the pump generates a negative pressure relative to atmosphere to pull the medicament from the reservoir 4. With a flexible reservoir 4 such as a reservoir bag, the atmospheric pressure exerts a force on the bag inducing a (progressive) collapse and allowing for the fluid to exit the reservoir bag. In certain conditions related to the geometry and mechanical properties of the flexible bag implementation of the reservoir 4, the surfaces of the bag may acquire some slack and can collapse in some areas before the reservoir 4 is fully empty. Such prematurely collapsed areas may create a seal and entrap pockets of liquid medicament (or air) before the reservoir 4 is fully empty, subsequently hindering or completely preventing proper emptying of the reservoir bag.

[0051] In accordance with example embodiments of the present disclosure, a compressible elastomer 82 is provided that is confined by an outer shell 80 and arranged to press against the outer shell 80 and a flexible bag implementation of the reservoir 4 indicated at 84 in Figs.7A and 7B. The reservoir bag 84 shown in Figs.7A and 7B can have a reservoir fluid path interface 86 configured similarly to the reservoir tubular fluid path member interface 14B described above. The compressible elastomer 82 is disposed withinthat shell 80 to induce a homogeneous pressure in the flexible bag 84 and thereby prevent entrapment of fluid caused by any premature collapse of the flexible reservoir bag 84. In one initial position, the reservoir bag 84 is empty and fully collapsed, with the elastomeric foam 82 mechanically pre-loaded and exerting a force on the reservoir bag 84. In a transitory position, the reservoir bag 84 is full of medicament and the elastomeric foam 82 is compressed. In a terminal position, the reservoir bag 84 is empty and fully collapsed, with the elastomeric foam 82 mechanically pre-loaded and exerting a force on the reservoir bag 84. It is to be understood that the elastomeric foam 82 is configured to exhibit increasing and decreasing amounts of pressure on the flexible reservoir bag 84 as the bag 84 is, respectively, filled and emptied and therefore in various stages of expansion and collapse that are not shown relative to their initial and transitory positions illustrated in Figs.7A and 7B.

[0052] Example embodiments for the elastomeric foam or conformable member 82 can comprise highly deformable elastomeric foam with shape memory to create positive pressure on the entire surface of the reservoir bag 84. Conformability of the material 82 to the shape of the reservoir bag 84 is particularly useful for pushing harder on the surface of the reservoir bag 84 that is the most arisen from a flat position (e.g., the initial position of the reservoir bag 84 shown in Fig.7A, thus preventing wrinkling and collapse of that area during evacuation of fluid from the reservoir bag 84.

[0053] Different example materials can be used for the foam or conformable member 82 to act as a conformal spring-loaded plate, for example, with respect to the reservoir bag 84. A material that can be compressed and that will spontaneously tend to return to its initial shape can be, for example, any of: elastomeric closed cell foam, elastomeric open-cell foam, flexible elastomeric foam (FEF), polyethylene foam (PEF), cellular polyethylene, rubber, latex, polyisoprene, neoprene (CR), nitrile butadiene rubber (NBR), ethylene-propylene- dienne monomer (EPDM), chloroprene rubber (CR), polyvinylchloride (PVC), and / or fluoropolymer.

[0054] In accordance with an example embodiment, the outer shell 80 is formed as a rigid shell from a rigid material (e.g., a plastic material such as polycarbonate, or Nylon 66). In accordance with another example embodiment, the outer shell 80 is a flexible shell orsemi-rigid shell (e.g., a plastic material such as ethylene vinyl acetate (EVA), polyethylene (PE), polyethylene based polyolefin elastomers (POE)). In accordance with another embodiment, the outer shell is constituted of an assembly of several rigid and / or flexible parts.

[0055] In accordance with another embodiment that is particularly advantageous, the shell 80 is continuous and fully encapsulates the reservoir bag 84. In accordance with another embodiment, the shell 80 can comprise one or more holes, slits or gaps.

[0056] The reservoir assembly shown in Figs.7A and 7B comprising a flexible reservoir (e.g., a bag 84), a conformable member 82, and a shell 80 achieves advantages and improvements over existing reservoirs operable with a pump to draw fluid therefrom such as low cost of manufacture, and its ability to obviate a potential failure mode (e.g., premature collapse of the bag 84, trapping fluid in the bag 84, and so on). The reservoir assembly shown in Figs.7A and 7B is also able to aide evacuation of the bag since orientation of the bag and air in the system can impact pump performance, and maximize dose efficiency while maintaining essentially constant dose accuracy. The reservoir assembly shown in Figs.7A and 7B achieves improvements over existing reservoirs that (a) do not employ a flexible reservoir and therefore lack the advantages of compactness and versatility in terms of reservoir placement within a wearable medicament delivery device; and (b) cannot effectively prevent premature collapse of a flexible reservoir bag.

[0057] It will be understood by one skilled in the art that this disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the above description or illustrated in the drawings. The embodiments herein are capable of other embodiments, and capable of being practiced or carried out in various ways. Also, it will be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless limited otherwise, the terms "connected," "coupled," and "mounted," and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms "connected" and "coupled" and variations thereof are not restricted to physical or mechanicalconnections or couplings. Further, terms such as up, down, bottom, and top are relative, and are employed to aid illustration, but are not limiting.

[0058] The above-presented description and figures are intended by way of example only and are not intended to limit the illustrative embodiments in any way except as set forth in the following claims. It is particularly noted that persons skilled in the art can readily combine the various technical aspects of the various elements of the various illustrative embodiments that have been described above in numerous other ways, all of which are considered to be within the scope of the claims.

Claims

CLAIMS:

1. A wearable fluid delivery device, comprising: a pumping mechanism; a reservoir configured to store a liquid medicament and provide the medicament to the pumping mechanism, the reservoir being composed of at least one material configured to enclose the medicament therein and comprising at least one port through which the liquid medicament can be evacuated from the reservoir and provided to the pumping mechanism; and a conformal member arranged to abut the reservoir and configured to be at least partially compressed by the reservoir when the reservoir has the medicament stored therein and to decompress as the medicament is removed from the reservoir.

2. The wearable fluid delivery device of claim 1, wherein the conformal member is a foam member.

3. The wearable fluid delivery device of claim 1, wherein the conformal member comprises elastomeric foam.

4. The wearable fluid delivery device of claim 3, wherein the conformal member comprises preloaded elastomeric foam.

5. The wearable fluid delivery device of claim 1, wherein the conformal member is a spring-loaded conformal member.

6. The wearable fluid delivery device of claim 1, wherein the conformal member is a conformal plate member having a surface that abuts a surface of the reservoir.

7. The wearable fluid delivery device of claim 1, wherein the conformal member is a conformal spring-loaded plate.

8. The wearable fluid delivery device of claim 1, wherein the conformal member comprises a material with a conformability characteristic that allows the material to conform to the shape of at least part of the reservoir.

9. The wearable fluid delivery device of claim 1, wherein the conformal member comprises a conformal material selected from the group consisting of elastomeric closed cell foam, elastomeric open-cell foam, flexible elastomeric foam (FEF), polyethylene foam (PEF), cellular polyethylene, rubber, latex, polyisoprene, neoprene (CR), nitrile butadiene rubber (NBR), ethylene-propylene-dienne monomer (EPDM), chloroprene rubber (CR), polyvinylchloride (PVC), fluoropolymer.

10. The wearable fluid delivery device of claim 1, further comprising a shell surrounding at least part of the reservoir and the conformal member.

11. The wearable fluid delivery device of claim 10, further comprising a housing enclosing at least the reservoir, the conformal member, and the pumping mechanism, wherein the shell is separate from the housing.

12. The wearable fluid delivery device of claim 10, further comprising a housing enclosing at least the reservoir, the conformal member, and the pumping mechanism, wherein at least part of the shell is formed by a surface of the housing.

13. The wearable fluid delivery device of claim 10, wherein the shell comprises a shell material chosen from a rigid material, and a semi-rigid material.

14. The wearable fluid delivery device of claim 10, wherein the shell is constituted of an assembly of parts chosen from rigid parts, and flexible parts.

15. The wearable fluid delivery device of claim 10, wherein the shell is formed as a continuous member that fully encapsulates the reservoir.

16. The wearable fluid delivery device of claim 10, wherein the shell comprises one or more holes, slits or gaps therein.

17. The wearable fluid delivery device of claim 1, wherein the reservoir is configured as a flexible bag.

18. The wearable fluid delivery device of claim 1, further comprising a housing enclosing at least the reservoir, the conformal member, and the pumping mechanism, wherein the at least one material of the reservoir enclosing the medicament is separate from the housing.

19. The wearable fluid delivery device of claim 18, wherein the reservoir is disposed freely within the housing except for a fluid path connection to the pumping mechanism.

20. The wearable fluid delivery device of claim 1, wherein the reservoir comprises a fluid chamber defined by two layers of flexible material sealed along a perimeter of the fluid chamber to enclose the liquid medicament therein and comprising at least one fluid path port connected to a fluid path to the pumping mechanism.

21. The wearable fluid delivery device of claim 20, wherein the at least one fluid path port comprises a tubular fluid path member extending at least partially in between the two layers of flexible material and open at one end thereof to receive the liquid medicament stored within the reservoir and to carry the liquid medicament toward the pumping mechanism.

22. The wearable fluid delivery device of claim 21, wherein the two layers of flexible material are heat staked along the perimeter defining the fluid chamber and around the at least one port.

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