ONE TIME USE FLUID METERING DEVICE

Abstract

A wearable fluid metering device for delivering medication subcutaneously, intramuscularly or intravenously to a patient, includes a polymer actuator pump. The polymer actuator pump is flexible so it will conform to shape and yet can be used to rapidly displace a volume within a confined area. The actuator is much faster than prior art polymer actuator designs and can be actuated in multiple ways including introduction and hydration of the polymer matrix by a solution or the actuator can be actuated via pH change while it is in solution. The pH change can be made via electrical current such as that used in electro chemistry or the pH change can be made via a chemical change introduced to the actuator hydrating solution.

Claims

1-15. (canceled)

16. A wearable device for metering fluids comprising; a rigid or semi rigid outer shell; at least one metered fluid chamber having at least one inlet, at least one outlet, and at least one sidewall, wherein an interior of the sidewall is in contact with and retains or separates fluid in the fluid chamber from other components of the device, said device comprising at least one actuator assembly comprising a flexible outer shell containing at least one polymer actuator material and a wicking material in contact with the polymer actuator material, said actuator assembly having an inlet configured to provide a fluid path for a polymer actuator hydrating solution, and including a one way valve configured to allow flow of hydrating fluid into but not out of the actuator assembly; a connector configured to allow introduction of a hydrating solution into the actuator assembly; at least one platen located between an exterior wall of the actuator assembly outer shell and an exterior wall the metered fluid chamber; an actuator hydrating solution reservoir having one or more inlets or outlets, in fluid communication via a fluid path for delivering the actuator hydrating solution to the polymer actuator assembly; and a fluid gate configured to open or close the fluid path between the hydrating solution reservoir and the actuator assembly, effectively keeping the actuator material dry until the gate is opened; wherein the rigid or semi rigid external shell is configured to encase the actuator assembly, the platen and the metered fluid chamber and hold all components other than the hydration solution reservoir, whereby the polymer actuator assembly in contact with the at least one platen, once hydrated is configured to expand and apply pressure to the at least one platen which in turn in contact with the fluid chamber, applies pressure to the fluid chamber whereby to force fluid from fluid chamber.

17. The device of claim 16 where the fluid chamber and/or the polymer actuator assembly and/or the hydration solution reservoir is/are removable.

18. The device of claim 16, characterized by one or more of the following features: (a) wherein the fluid chamber inlet is capped or sealed by a pierceable septum; (b) wherein the polymer actuator material comprises a hydrophilic material, or a combination of a hydrophilic and a hydrophobic material; (c) wherein the fluid gate is configured to open or close by piercing, dissolving, tearing, pushing, bursting, pinching the connector, or by pulling the fluid gate out of the way of the hydrating solution path to allow path of hydration fluid to the polymer actuator; (d) wherein the fluid gate comprises a mechanical valve; and (e) further comprising tubing removably attached to the device for introducing the hydrating solution into the device.

19. The device of claim 16, characterized by one or both of the following features: (a) wherein the metered fluid chamber is configured for filling in the device; (b) wherein the metered fluid chamber is configured for filling via an injection of fluid into the septum and fluid in the metered fluid chamber is released through to a desired wearer contact point; and (c) said device optionally further comprising a subcutaneous needle, an intramuscular needle, an intravenous needle, a catheter or a luer connection configured to allow metering of released fluid directly to a desired contact point of a wearer.

20. The device of claim 16 characterized by one or more of the following features: (a) wherein the actuator material has varying layers of density and porosity; (b) wherein the actuator material has both reacted and unreacted molecular sites, preferably varying degrees of reacted and unreacted molecular sites; (c) wherein the actuator hydrating solution comprises a combination of actuator materials having a ratio of reacted to unreacted molecular sites selected to determine a speed and pressure generation of the actuator material, and preferably wherein protonation of reactive molecular sites within the actuator material, by interaction with the actuator hydrating solution or chemical byproduct of that interaction, determines the speed and pressure generation of the actuator material; (d) wherein the actuator materials are selected by density or porosity to determine a speed and pressure generation of the actuator material; (e) wherein the actuator material surface in fluid contact with the actuator hydrating solution material is configured to determine a speed and pressure generation of the actuator; and (f) wherein the actuator hydrating solution pH or chemical makeup is selected to determine a speed and pressure generation of the actuator material.

21. The device of claim 16, characterized by one or more of the following features: (a) the device rigid or semi rigid exterior case has one or more windows configured to allow visualization of a metered fluid volume indicator; (b) wherein the device rigid or semi-rigid exterior case has a door or hatch configured to cover the two fill ports and latch closed when the fluid chamber is filled and the actuator activated, so that the device cannot be reopened during the use; and (c) wherein the device rigid or semi-rigid exterior case has an interior pocket configured to shield and protect outlet tubing running from the exterior case, and wherein the outlet tubing has a flow restrictor or anti siphon valve in the fluid path to stop un-authorized removal or theft of medications from the device; (d) wherein the rigid or semi rigid outer shell comprises a syringe.

22. The device of claim 16, wherein the actuator hydrating solution container is contained within the outer shell of the device, and the outer shell is hinged like a clam shell and is configured to release the actuator hydrating solution into the actuator assembly when the outer shell is shut, and wherein the device optionally is configured so that shutting the clam shell activates the metering device, and wherein activation triggers a spring loaded subcutaneous needle and canula to project through a side of the exterior case into a wearer’s skin, wherein the needle is configured to retract back into the exterior case in the same action, leaving the canula in a subcutaneous layer below the skin of the wearer and in fluid connectivity to the fluid chamber.

23. The device in claim 22, wherein the device is configured so the action of closing the device additionally pierces a septum or housing of a prefilled fluid container thereby making fluid connectivity between prefilled fluid container and subcutaneous fluid exit point.

24. The device of claim 16, wherein the actuator is electrically activatable and the actuator assembly includes electrodes configured to eliminate electrolysis gas production at the electrodes via double layer capacitor, and wherein said device also contains a power source and electrical controller connected to the actuator.

25. The device of claim 16, wherein the actuator is electrically activatable and the actuator assembly includes electrodes configured to eliminate electrolysis gas production at the electrodes via carbon double layer capacitor, and wherein said device also contains a power source and electrical controller connected to the actuator and said controller is in wireless communication with a sensor and or hand held device wireless device.

26. The device of claim 16, wherein the actuator assembly comprises a flexible container containing a stack of flexible polymer gel loaded substrates, wherein the stack of flexible polymer gel loaded substrates are donut shaped having central holes which are aligned at least in part in said stack, or the stack of flexible polymer gel loaded substrates is formed by wrapping the flexible polymer gel loaded substrates around the metered fluid container, or the stack of flexible polymer gel loaded substrates is formed by folding the flexible polymer gel substrate, or the stack of flexible polymer gel loaded substrates is heat staked or heat sealed or sewn or glued together in one or more locations.

27. The device of claim 16, wherein the fluid in the fluid chamber comprises a medication, a therapeutic material, a gene therapy or a protein, and optionally wherein said device is configured to deliver said medication, therapeutic material, gene therapy or protein to a predetermined site on or in a patient.

28. An actuator assembly comprising a water tight outer shell that is configured to be reversibly extended in at least one direction, a stack or roll of flexible polymer gel loaded substrate, an electrolyte, at least one anode and at least one cathode each extending through the outer shell, and wherein at least one of said anode or cathode is coated with activated carbon and is ionically separated from an opposing cathode or anode as the case may be via an ion separator material.

29. An actuator assembly comprising an outer shell with an inlet port or opening that is in fluid connectivity with a one way valve configured to allow liquid in but not out, wherein the outer shell is configured to expand or contract in at least on direction, said actuator assembly further including a stack of two or more flexible polymer gel loaded substrates within the outer shell.

30. The actuator assembly of claim 29, wherein the flexible polymer gel loaded substrates have holes which are aligned at least in part within the outer shell, and wherein the flexible polymer gel loaded substrates preferably are donut shaped.

Description

[0047] Further features and advantages of the present disclosure will be seen from the following detailed description, taken in conjunction with the accompanying drawings, wherein

[0048] FIG. 1 is a perspective view of a metering device in accordance with one embodiment the present disclosure;

[0049] FIG. 2 is an exploded view of the fluid metering device of FIG. 1;

[0050] FIGS. 3 and 4 are exploded views showing details of the upper case and lower case, respectively of the fluid metering device of FIG. 1;

[0051] FIGS. 5 and 6 are perspective views showing details of the upper case and lower case, respectively, partially assembled;

[0052] FIG. 7 is an enlarged view showing details of an end view of the metering device of FIG. 1;

[0053] FIG. 8 is a perspective view showing the fluid metering device of the present invention taped to the back of a patient;

[0054] FIG. 9 is a flow diagram showing use of the fluid metering device of the present disclosure;

[0055] FIG. 10 is a perspective view of a dry stacked actuator assembly made in accordance with a a second embodiment of the present disclosure; and

[0056] FIG. 11 is a view, in cross section, of a syringe incorporating actuator assembly made in accordance with the present disclosure.

[0057] Referring to FIGS. 1-7, fluid metering device 10 of a first embodiment of the present disclosure comprises a shell including an upper case 12 and a lower case 14 each formed of a rigid or semi-rigid material such as vinyl, plastic, metal, glass, ceramic, carbon or a combination thereof, affixed to one another by screws 16. A window 17 may be provided in the wall of upper case 12 to permit a caretaker to view the drug chamber to allow visualization of a metered fluid volume indicator. Referring in particular to FIGS. 3 and 4, the fluid metering device includes a drug chamber 18 formed of a flexible bladder sandwiched between an upper and lower platens 20, 22. An actuator assembly 24 is disposed over platen 22. Actuator assembly 24 comprises a flexible chamber containing a polymer actuator material formed of a hydrophilic material or a combination of a hydrophilic material and a hydrophobic material such as hydrogel polymer as described in U.S. Application 2014/0221913 or PCT Application WO 2008/07944082, the contents of which are incorporated herein by reference. Drug holding chamber 18 includes an inlet or fill port 26 and an outlet 28 preferably in the form of a luer connector as will be described below.

[0058] As will be described below, when water is introduced into the actuator assembly 24 via a fluid gate such as a one way valve or pierceable septum 32, the polymer actuator material swells to a controlled linear rate and creates a high pressure. The fluid gate also may be removable by piercing, dissolving, tearing, pushing, pinching the tubing connector or by pulling the gate away from hydrating solution path to allow hydration of the polymer actuator, or a membrane material that can be burst, pierced or dissolved, or a mechanical valve. High pressure created by the swelling polymer is transferred via platen 22 to the drug holding chamber which then pushes medication out of the metering device at a very linear and controlled rate.

[0059] Fill port 26, which typically comprises a tubing connector or the like is protected behind a hinged door 30, which door protects fill port 26 and septum 32, and covers the two fill ports and latch closed when the fluid chamber is filled and the actuator activated, so that the device cannot be reopened during the use of the metering device.

[0060] Referring also to FIGS. 8 and 9, use of the above described metering device of the present invention will now be described.

[0061] In step 50, the patient’s weight and medication therapy level is determined. Then in step 52, using a simple look-up table a, e.g., 10 mL supply of desired medication at a desired concentration or dilution is prepared. The diluted 10 mL drug is then injected into the drug fill port 26 at step 54 using a hypodermic needle or the like and tubing. The metering device 10 is then fixed to the patient’s skin by suture or stapling, adhesive tape, or wrapping around a limb or torso of the patient in a step 56, and the luer connector 28 is affixed to a subcutaneous needle, an intramuscular needle, an intravenous needle, a catheter or a luer connection that allows metering of released fluid to a desired wearer contact point, that was previously inserted into the patient in a step 58. A measured quantity of water is then supplied via septum to the actuator assembly 24, for example, using a syringe, in step 60, and the door 30 is closed at step 62. The actuator hydrating solution comprises a combination of actuator materials having a ratio of reacted to unreacted molecular sites selected to determine the speed and pressure generation of the actuator material. The actuator hydrating solution pH or chemical makeup is selected to determine a speed and pressure generation of the actuator material. Alternatively, the pump starts automatically and as the polymer actuator swells it puts pressure in the drug holding chamber 18 and delivers drug at a very linear rate.

[0062] As will be appreciated, the above described device has several features and advantages. The metering device can be worn by a patient without any external leads, lines or tethers. The metering device provides extremely constant subcutaneous flow. Also, being affixed immediately adjacent to subcutaneous catheter, there is little likelihood of IV line pullout.

[0063] Also, not being tied to external lines or tethers, the patients can ambulate without disruption of medication delivery. And, by eliminating the need for towers, expensive pumps, and electrical power, the fluid metering device of the present invention eliminates substantial capital equipment expenditures and associated carrying costs. Also, drug delivery calculations are simplified since capacity of the drug reservoir is standardized. Thus it is a simple dilution calculation to determine dosage. As a result, medication errors may be reduced.

[0064] The specific embodiments disclosed and illustrated herein should not be considered as limiting the scope of the disclosure, and numerous variations are possible. By way of example, actuating assembly 24 may include one or more internal wicks, shown in phantom at 70, to even the delivery of the hydrating water into the actuating assembly. Also, the device rigid or semi-rigid exterior case has an interior pocket configured to shield and protect the outlet tubing where it exits the exterior case, and located in the vicinity of the interior pocket the outlet tubing has a flow restrictor or anti siphon valve in the fluid path to stop un-authorized removal or theft of medications from the device while it is operating. Also, the actuator hydrating solution may container comprise a syringe or other containment device which is configured to be removably clipped to the external shell of the device, and removed once the metering device is activated by hydrating the actuator assembly. Still other product features are possible. For example, the actuator hydrating solution container may be contained within the external shell of the device, and the external shell is hinged like a clam shell which is configured to release the actuator hydrating solution into the actuator assembly when the external shell is shut, or wherein shutting the clam shell to release the hydrating solution, also activates the metering device, and wherein activation of the clam shell triggers a spring loaded subcutaneous needle and canula to project through a side of the exterior case into a wearer’s skin, wherein the needle is configured to retract back into the exterior case in the same action, leaving the canula in a subcutaneous layer below the skin of the wearer and in fluid connectivity to the fluid chamber.

[0065] Still other variations are possible. For example, referring to FIG. 10, in yet another embodiment an actuator assembly 100 comprises a flexible container 101 formed of a poly bag film with a stack of flexible polymer gel loaded substrates 102 and a fill port where polymer gel hydrating liquid can be injected is provided. A rigid container shown in phantom at 103 surrounds flexible container 101.

[0066] Referring to FIG. 11, in yet another embodiment the actuator assembly is held within a syringe tube 201 having a moveable rubber plunger 202. The actuator assembly is formed of donut shaped actuator substrates 203 stacked with holes in the centers 204. A tube end cap 205 constricts the actuator stack and includes a fill port 206 for introducing hydrating polymer to the actuator stack. The syringe tube is made of glass or a rigid plastic that is compatible with the liquid that will be dispensed such as a medication or drug or chemical. Alternatively, actuator substrates 203 may include a plurality of aligned through holes to carry the activating liquid.

[0067] The foregoing description of the disclosure is not meant to limit it in any way as there can be many other variants of the described disclosure such as multiple cylinders and actuators that can be activated together or separately at predetermined times using a power source such as a battery, electrical controller, electrical circuitry and program or by simple mechanical means of timed release by a clock and one or more mechanical valves. Additionally, envisioned are actuators for devices that are shaped to fit a contour such as on a human body, or other geometric shapes. Also, if desired, the actuator assembly, and/or the metered fluid chamber, and/or the actuator hydrating solution reservoir, and/or the needle, etc. connection may be removable and replaceable so that the outer shell and electronics may be reused, while the removable parts are in a single assembly or cartridge.

[0068] The subject matter of the disclosure includes all novel and nonobvious combinations and subcombinations of the various elements, features, functions, and/or properties disclosed herein.