Conformable patch pump

• US 10,398,832 B2
• Filed: 02/27/2017
• Issued: 09/03/2019
• Est. Priority Date: 08/05/2013
• Status: Active Grant

• Current Assignee: Cam Med Ltd.
• Original Assignee: Cam Med Ltd.
• Inventors: Qin, Yanzhe, Ge, Zhifei
• Primary Examiner(s): Tucker, Philip C
• Assistant Examiner(s): Slawski, Brian R
• Application Number:
  US15/443,484
• Publication Number:
  US 20170232189A1
• Time in Patent Office: 918 Days
• Field of Search: 156 60, 156 64, 156 70, 156 731, 156 734, 156145, 156146, 156155, 156156, 156242, 156245, 156246, 1562722, 1562739, 1562744, 156289, 156290, 156291, 156292, 156293, 156297, 156298, 1563031, 1563082, 1563096, 1563099, 264239, 264248, 264249, 264250, 264254, 264259, 2642711, 264299, 604 67, 604131, 604132, 604151, 604153, 604246, 604247, 604500, 6048901, 6048911
• 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 method of manufacturing a flexible patch pump for delivering a medicament to a patient, the method comprising the steps of:

providing a reservoir layer comprising a plurality of rigid reservoirs disposed in a flexible material, wherein the rigid reservoirs are adapted to contain medicament;

adhering to the reservoir layer a flexible microfluidic layer comprising;

an element for sealing the rigid reservoirs;

a network of microfluidic channels connecting the rigid reservoirs; and

at least one outlet valve connected to the network; and

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

2. The method of claim 1, further comprising the step of adhering below the flexible-rigid electronic circuit layer at least one of a pressure sensitive adhesive layer and a hydrogel layer.

3. The method of claim 1, further comprising the step of filling the rigid reservoirs with medicament.

4. The method of claim 1, further comprising the step of disposing in the actuators at least one of an electrolytic material, a volume change material, and a shape change material.

5. The method of claim 1, further comprising the step of sterilizing at least a portion of the flexible patch pump.

6. The method of claim 1, further comprising the step of connecting a controller to the flexible-rigid electronic circuit layer.

7. The method of claim 1, wherein the network of microfluidic channels comprises a plurality of materials.

8. The method of claim 7, wherein the network of microfluidic channels comprises polyethylene formed by supersonic welding encapsulated in another material.

9. The method of claim 1, further comprising the step of connecting a power source to the flexible patch pump.

10. The method of claim 1, further comprising the step of connecting an infusion set to an outlet of the flexible patch pump.

11. The method of claim 1, further comprising the step of verifying operation of the flexible patch pump.