Flexible and conformal patch pump

• US 10,092,691 B2
• Filed: 09/02/2009
• Issued: 10/09/2018
• Est. Priority Date: 09/02/2009
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Searle, Gary, Knapp, Keith N, Skutnik, Peter, Petrie, Aidan, Nelsen, Dan, Brown, Paul
• Primary Examiner(s): GRAY, PHILLIP A
• Application Number:
  US12/585,062
• Publication Number:
  US 20110054285A1
• Time in Patent Office: 3,324 Days
• Field of Search: 604133, 604 27, 604 19, 604 28, 604 30, 604 48, 604 65, 604 67, 604 9301, 604 9501, 604117, 604156, 604131, 604256, 604264, 604500-506, 6048901, 604132
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1583 Needle extractors
• CPC Class Codes: A61M 2205/36 related to heating or cooling
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/16804 Flow controllers
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

Provided is a flexible and conformal wearable, self-contained medical device. The medical device comprises an integral housing formed by a flexible upper portion and a flexible lower portion joined along their perimeters. The medical device is also provided in a plurality of shapes and configurations for increasing the flexibility and conformability of the housing. The components contained within the housing, such as a drug reservoir, printed circuit board, and power supply are preferably constructed from flexible materials and are formed, connected and positioned according to the configuration of the housing in a manner for enhancing flexibility of the housing. A thermal bubble micropump is provided for controlling flow of a drug from the flexible reservoir, that utilizes a thermal resistor provided locally to a thermal expansion fluid that causes a surrounding membrane to expand and displace a volume of drug to be provided to the user.

Claims

1. A wearable medical device for administering drug therapy to a user, said medical device comprising:

an integral housing comprising a flexible upper housing having an upper surface and a lower surface, and a flexible lower housing having an upper surface and a lower surface, the flexible upper housing lower surface sealed to the flexible lower housing upper surface to form a sealed compartment between the upper housing lower surface and the lower housing upper surface, wherein a flexible reservoir for housing a supply of a drug, in fluid communication with an infusion cannula for delivering the drug to the user, and a fluid metering device for metering delivery of the drug from the reservoir to the user through the infusion cannula are sealed entirely within the compartment.

2. The medical device of claim 1, wherein the flexible upper housing portion and the flexible lower housing are sonically welded together along their respective perimeters.

3. The medical device of claim 1, wherein the thickness of said integral housing is from 0.25 to 1.25 inches.

4. The medical device of claim 1, wherein the thickness of said integral housing is no more than about 0.75 inches.

5. The medical device of claim 1, wherein said flexible upper housing and said flexible lower housing are constructed from a flexible polymer.

6. The medical device of claim 1, wherein said flexible lower housing of said housing is affixed to a user'"'"'s skin with an adhesive layer.

7. The medical device of claim 6, further comprising an elastomer or foam layer provided between the adhesive layer and the lower portion of said housing.

8. The medical device of claim 1, wherein said fluid metering device comprises at least one thermal resistor.

9. The medical device of claim 8, wherein each said thermal resistor is provided locally to a thermal expansion fluid encapsulated by a flexible membrane, wherein heating of each said thermal expansion fluid causes expansion of said flexible membrane resulting in displacement of the drug and actuation of said drug into said user through the infusion needle.

10. The medical device of claim 9, wherein a plurality of thermal resistors, each provided locally to a thermal expansion fluid encapsulated by a flexible membrane, are provided in sequence and are sequentially charged to effect a flow of drug to said user.

11. The medical device of claim 9, wherein said fluid metering device further comprises at least one one-way check valve for promoting a flow of the drug to said user.

12. The medical device of claim 9, wherein said fluid metering device further comprises at least one electronically controlled gate or valve for promoting a flow of the drug to said user.

13. The medical device of claim 1, wherein said fluid metering device comprises one of a Belleville spring washer, stamped leaf spring, snap disk or flexure, for exerting pressure on said reservoir, and a metering valve.

14. The medical device of claim 1, wherein said housing further contains a flexible circuit board for electronically connecting at least the fluid metering mechanism with a controller.

15. The medical device of claim 14, wherein said flexible circuit board further comprises at least one recess extending inwardly from an outer edge of said circuit board.

16. The medical device of claim 1, wherein said housing further comprises a chassis, the chassis comprising at least a first frame flexibly connected to a second frame for positioning a first system component in said first frame and a second system component in said second frame relative to each other in said housing.

17. The medical device of claim 1, wherein said housing further comprises an infusion needle deployment mechanism actuated by a push button deployable within said housing.

18. The medical device of claim 17, wherein said needle deployment mechanism comprises a spring disk for driving said infusion needle into the user.

19. The medical device of claim 17, wherein said needle deployment mechanism comprises a torsion spring for driving said infusion needle into the user.

20. The medical device of claim 19, wherein the torsion spring is actuated by a finger lever for driving said infusion needle into the user.

21. The medical device of claim 17, wherein said needle deployment mechanism comprises a needle carriage and a cannula carriage initially engaged with each other for driving a flexible cannula into the user using an insertion needle.

22. The medical device of claim 17, wherein said needle deployment mechanism comprises a single carriage for driving a flexible needle or cannula assembly into the user.

23. The medical device of claim 17, wherein said needle deployment mechanism comprises a needle carriage and a biosensor carriage initially engaged with each other for driving a biosensor into the user using an insertion needle.

24. The medical device of claim 21, wherein said needle deployment mechanism further comprises a spring member for withdrawing said insertion needle from the user upon insertion of said flexible cannula into the user.

25. The medical device of claim 1, wherein said housing further comprises a mechanism for manually actuating a bolus dose by applying a force to a specific area on said upper portion of said housing.

26. The medical device of claim 1, wherein said housing further comprises a mechanism for deploying an analyte sensor for determining a blood glucose level of the user.

27. The medical device of claim 1, wherein said housing further comprises a second flexible reservoir for housing a volume of drug for bolus dose delivery to the user.

28. The medical device of claim 27, wherein said second flexible reservoir is in fluid communication with a second infusion cannula.

29. The medical device of claim 27, wherein said medical device is used for administering drug therapy to a user with Type II diabetes.

30. The medical device of claim 1, wherein said fluid metering mechanism provides a preprogrammed drug delivery profile to the user.

31. The medical device of claim 1, wherein said flexible reservoir houses a supply of drug for basal rate infusion into the user.

32. The medical device of claim 31, wherein said medical device is used in conjunction with a programmable injection device for providing a bolus dose of drug therapy to the user.

33. The medical device of claim 32, wherein said programmable injection device is programmed by a host device which calculates the bolus dose for injection to said user and programs said injection device to administer the calculated dose.

34. The medical device of claim 33, wherein said programmable injection device is a programmable insulin pen.

35. A wearable medical device for administering drug therapy to a user, said medical device comprising:

an integral housing comprising a flexible upper housing having an upper surface and a lower surface and a flexible lower housing having an upper surface and a lower surface, the flexible upper housing lower surface contacting the flexible lower housing upper surface to form a compartment between the upper housing lower surface and the lower housing upper surface, the lower housing lower surface adapted for contact with a skin surface, wherein said housing is formed into an elongate shape comprising a length dimension that is longer than a width dimension, and further comprising a waist portion that is narrower than the width dimension, said housing being contoured such that the housing is narrowest at the waist portion to flex according to contours of said skin surface; and

further comprising a flexible reservoir for housing a supply of a drug entirely sealed within the housing.

36. The medical device of claim 35, wherein said flexible upper and lower housings are sonically welded together along their respective perimeters.