Conformable patch pump

• US 9,616,171 B2
• Filed: 02/04/2016
• Issued: 04/11/2017
• Est. Priority Date: 08/05/2013
• Status: Active Grant

• Current Assignee: Cam Med LLC
• Original Assignee: Cam Med LLC
• Inventors: Qin, Yanzhe, Ge, Zhifei
• Primary Examiner(s): Bosques, Edelmira
• Application Number:
  US15/015,627
• Publication Number:
  US 20160193407A1
• Time in Patent Office: 432 Days
• Field of Search: 604506
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/35 Communication
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14586 pressurised by means of a flexible diaphragm
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28
• CPC Class Codes: B29C 65/08 using ultrasonic vibrations non-plastics element to plastics elements B29C65/645
• CPC Class Codes: B29C 65/4825 Pressure sensitive adhesives
• CPC Class Codes: B29C 66/301 Three-dimensional joints, i.e. the joined area being substantially non-flat B29C66/5223, B29C66/5224, B29C66/5225 take precedence
• CPC Class Codes: B29C 66/474 said single elements being substantially non-flat
• CPC Class Codes: B32B 2535/00 Medical equipment, e.g. bandage, prostheses or catheter
• CPC Class Codes: B32B 37/12 characterised by using adhesives
• CPC Class Codes: B81B 2201/036 Micropumps
• CPC Class Codes: B81C 1/00158 Diaphragms, membranes manufacture process for semi-permeable inorganic membranes B01D67/0039
• CPC Class Codes: B81C 2201/034 Moulding
• CPC Class Codes: F04B 43/043 Micropumps
• CPC Class Codes: F04B 53/10 : Valves; Arrangement of valves
• CPC Class Codes: F16K 2099/008 : Multi-layer fabrications
• CPC Class Codes: F16K 2099/0094 : Micropumps

Abstract

A flexible patch pump for controllable accurate subcutaneous delivery of one or more medicaments to a patient includes a laminated layered structure. The pump may have a rigid reservoir layer including a number of rigid reservoirs disposed in a flexible material; a flexible microfluidic layer including a compliant membrane for sealing the rigid reservoirs, a network of microfluidic channels connecting the rigid reservoirs, and a number of inlet and/or outlet valves corresponding to the rigid reservoirs; and a flexible-rigid electronic circuit layer including a number of individually-addressable actuators. In operation, the rigid reservoirs may contain medicament that is dispensed in precise volumes at appropriate times due, for example, to a pressure change in an addressed reservoir caused by displacement of the compliant membrane or other actuation element.

Claims

1. A patch pump for delivering a medicament to a patient, the patch pump comprising a flexible layered structure comprising:

a reservoir layer comprising a plurality of rigid reservoirs disposed in a flexible material and an element for sealing the rigid reservoirs, wherein the rigid reservoirs are adapted to contain medicament;

a flexible microfluidic layer comprising;

a network of microfluidic channels connecting the rigid reservoirs; and

a plurality of outlet valves corresponding to the plurality of rigid reservoirs connected to the network; and

a flexible-rigid electronic circuit layer below the microfluidic layer comprising a plurality of individually-addressable actuators.

2. The patch pump of claim 1, wherein the plurality of rigid reservoirs are arranged in an array.

3. The patch pump of claim 1, wherein at least a portion of an interior surface of each rigid reservoir forms at least one flow channel.

4. The patch pump of claim 1, wherein the plurality of rigid reservoirs comprises at least three reservoirs.

5. The patch pump of claim 1, wherein the rigid reservoirs comprise at least one of glass, polymer, and polypropylene and the flexible material comprises at least one of elastomer, protein hydrogel, polyurethane, and polyethylene.

6. The patch pump of claim 1, wherein each rigid reservoir is adapted to contain a volume of medicament in a range from about 10 nanoliters to about 10,000 microliters.

7. The patch pump of claim 6, wherein each rigid reservoir is adapted to contain a volume of medicament in a range from about 6 microliters to about 135 microliters.

8. The patch pump of claim 1, wherein the sealing element comprises a compliant membrane comprising at least one of a resilient material and a folded material.

9. The patch pump of claim 8, wherein the compliant membrane comprises polyethylene.

10. The patch pump of claim 1, wherein the flexible microfluidic layer comprises a laminated structure comprising an upper layer adhered to a middle layer adhered to a lower layer.

11. The patch pump of claim 10, wherein the upper, middle, and lower layers form the plurality outlet valves corresponding to the plurality of rigid reservoirs.

12. The patch pump of claim 11, wherein each outlet valve comprises a one-way valve.

13. The patch pump of claim 11, wherein the outlet valves are formed from corresponding apertures and resilient blocking portions.

14. The patch pump of claim 11, wherein the middle layer is not adhered at each outlet valve allowing pressurized fluid to flow through each outlet valve.

15. The patch pump of claim 1, wherein each actuator is adapted to contain at least one of an electrolytic material, a volume change material, and a shape change material.

16. The patch pump of claim 1, wherein each actuator operates based on a technique selected from the group consisting of electrolysis of liquid, electrolysis of hydrogel, a piezoelectric technique, a thermopneumatic technique, an electrostatic technique, a pneumatic technique, a linear piston drive mechanism, a rotary drive mechanism, a shape change mechanism, a phase change technique, an electrowetting/thermocapillary technique, an electrohydrodynamic technique, an electroosmotic technique, a magnetohydrodynamic technique, an electrochemical technique, and a selectively permeable membrane technique.

17. The patch pump of claim 1, wherein the flexible-rigid electronic circuit layer is selected from the group consisting of stretchable electronics and rigid-flexible circuitry.

18. The patch pump of claim 1, wherein the flexible-rigid electronic circuit layer is adapted to permit filling of each actuator.

19. The patch pump of claim 1 wherein the individually-addressable actuators comprise individually-addressable electrode pairs selected from the group consisting of stainless steel, iron, nickel, cobalt, Fe—

Ni alloy, indium tin oxide, gold, platinum, a coating film comprising a low surface energy material, fluorine, and alloys and combinations thereof.

20. The patch pump of claim 19, where each individually-addressable electrode pair comprises a working perimeter electrode surrounding a counter electrode.

21. The patch pump of claim 20, wherein each individually-addressable electrode pair is adapted to contact an electrolyte comprising an aqueous ion solution.

22. The patch pump of claim 1, wherein the patch pump comprises a thickness of up to about 5 millimeters.

23. The patch pump of claim 1, further comprising at least one inlet in fluidic communication with the reservoir layer.

24. The patch pump of claim 1, further comprising at least one outlet in fluidic communication with the reservoir layer.

25. The patch pump of claim 1, further comprising a controller connected to the flexible electronic circuit layer, wherein the controller is adapted to selectively energize the actuators.

26. The patch pump of claim 25, further comprising a power source for powering the controller and the actuators.

27. A method of using a disposable flexible patch pump for delivering a medicament to a patient, the method comprising the steps of:

providing a flexible patch pump comprising a plurality of rigid reservoirs disposed in a flexible material connected by a network of microfluidic channels, a plurality of outlet valves corresponding to the plurality of rigid reservoirs, and a plurality of corresponding actuators;

adhering the flexible patch pump to a skin surface of a patient; and

controlling the flexible patch pump to selectively energize at least one of the plurality of actuators to deliver medicament disposed in a corresponding rigid reservoir through a corresponding outlet valve to the patient.

28. The method of claim 27, further comprising the step of filling the rigid reservoirs with medicament.

29. The method of claim 27, further comprising the step of subcutaneously inserting a cannula fluidicly connected to the flexible patch pump into the patient.