Infusion pump system

• US 8,475,408 B2
• Filed: 11/08/2006
• Issued: 07/02/2013
• Est. Priority Date: 11/08/2005
• Status: Active Grant

• Current Assignee: Insulet Corporation, M2 Medical Group Holdings, Inc.
• Original Assignee: Asante Solutions, Inc
• Inventors: Mernoe, Morten, Causey, James, Wenger, Mitchell, Estes, Mark C.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): MEDWAY, SCOTT J
• Application Number:
  US11/557,910
• Publication Number:
  US 20070123819A1
• Time in Patent Office: 2,428 Days
• Field of Search: 417/477.2, 604/131, 604/151, 604/156, 604/174, 604/175, 604/177, 604/110, 604/123, 604/132, 604/135, 604/136, 604/142, 604/157, 604/158, 604/161, 604/162, 604/164.01, 604/164.08, 604/198, 604/263, 604/264, 604/273, 604/506, 604/890.1, 604/93.01
• US Class Current: 604/131
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/16854 by monitoring line pressure

Abstract

An infusion pump system is described that increases patient comfort and convenience. The infusion pump system includes an infusion site interface that is releasably connected to an infusion pump body, and has no tubing associated between the infusion site interface and the pump body. The infusion pump body may include a carrier frame that may be adhered to the skin of a user.

Claims

1. An infusion pump system, comprising:

an infusion site interface structure that is adhesively attachable to a skin surface, the infusion site interface structure including;

a frame with a generally flat lower surface, a soft cannula coupled to the frame for penetration of the skin surface when the soft cannula extends below the lower surface of the frame, and an upward extension member that extends above the lower surface such that a septum coupled to the upward extension member extends substantially parallel to the generally flat lower surface of the frame and is positioned above the soft cannula when the soft cannula extends below the lower surface of the frame, wherein the infusion site interface structure lacks tubing above the septum coupled to the upward extension member;

an infusion pump body comprising an infusion site docking area to receive the upward extension member; and

a needle extending from the infusion pump body downwardly toward the lower surface of the frame to penetrate the septum of the infusion site interface structure, wherein the infusion pump body comprises;

a housing having a substantially flat lowermost surface and a substantially flat upper surface, a medicine reservoir in fluid communication with the needle, a drive mechanism, and a control system that governs actuation of the drive mechanism,

wherein the infusion site docking area and the upward extension member comprise corresponding guiding members that, during engagement, restrict relative rotational and vertical motion between the pump body and the infusion site interface, and

wherein a fluid path between the pump body and the soft cannula intermittently breaks and re-establishes as the pump body repeatedly disconnects from and reconnects with the infusion site interface structure while the infusion site interface structure remains adhesively attached to the skin surface.

2. The system of claim 1, wherein the infusion site interface structure is adhesively attachable to an infusion site on the skin surface a body.

3. The system of claim 1, further comprising an adhesive on the pump body that enables temporary adhesion of the pump body to another surface.

4. The system of claim 1, wherein the infusion site interface structure further comprises an adhesive on an upper surface of the frame, enabling temporary adhesion of the pump body to the upper surface of the frame.

5. The system of claim 1, wherein the needle extending from the infusion pump body connects directly to an entry port on the infusion site interface structure.

6. The system of claim 1, wherein the pump body releasably connects to the infusion site interface structure using a locking mechanism on the infusion site interface structure.

7. The system of claim 1, wherein the pump body releasably connects to the infusion site interface structure when guided by the upward extension member of the infusion site interface structure.

8. The system of claim 1, wherein the pump body detachably couples to the infusion site interface structure using the penetration of the needle extending from the infusion pump body through the septum.

10. The system of claim 1, wherein the frame is adhesively attachable to the skin surface near an infusion site location, and the frame is connected to the upward extension member that includes a hub.

11. The system of claim 10, wherein the frame is connected to the hub via structural supports between the hub and an outer frame portion.

12. The system of claim 10, wherein the frame comprises a webbing.

13. The system of claim 1, wherein the infusion site interface structure has no tubing above the septum and external to the skin of a user after installation of the infusion site interface structure.

14. The system of claim 1, wherein a fluid path between the infusion pump body and the infusion site interface structure intermittently breaks and re-establishes when the infusion pump body which houses the medicine reservoir is temporarily disconnected from and reconnected with the infusion site interface structure while the infusion site interface structure is adhesively attached the skin surface.

15. The system of claim 1, wherein the septum of the infusion site interface structure is arranged in a position above a generally upward facing surface of the frame which is opposite from the generally flat lower surface of the frame.

16. The system of claim 15, wherein the infusion pump body covers over the generally upward facing surface of the frame of the infusion site interface structure when the infusion pump body is detachably coupled to the infusion site interface structure.

17. The system of claim 1, wherein the needle of the infusion pump body extends downwardly through an upper face of the septum such that the needle extends generally perpendicular to the skin surface when the needle penetrates the septum of the infusion site interface structure.

18. The system of claim 1, wherein the upward extension member of the infusion site interface structure comprises an inner ring hub that carries the septum, and the frame includes an outer wall that is spaced apart from the inner ring hub and surrounds the inner ring hub.

19. The system of claim 18, wherein the soft cannula is rigidly attached to the inner ring hub of the frame of the infusion site interface structure.

20. The system of claim 18, wherein when the infusion pump body is detachably coupled to the infusion site interface structure, the needle of the infusion pump body is aligned with the inner ring hub of the frame of the infusion site interface structure.

21. The system of claim 1, wherein when the infusion pump body is detachably coupled to the infusion site interface structure, and a mechanical coupling secures the infusion pump body with the frame of the infusion site interface structure.

22. The system of claim 21, wherein the mechanical coupling between the infusion pump body and the frame of the infusion site interface structure is secured by a detent fit.

23. The system of claim 21, wherein the mechanical coupling between the infusion pump body and the frame of the infusion site interface structure is secured by an insert-and-rotate fit.

24. The system of claim 1, further comprising a leak detection mechanism that provides a positive indication when the fluid path is compromised by a leak.

25. The system of claim 1, wherein the housing of the infusion pump body defines a docking space surrounding at least a portion of the needle and further defines the substantially flat lowermost surface extends from a lowermost edge of the docking space.

26. The system of claim 1, wherein the docking space is sized to receive the upward extension member of the infusion site interface structure when the needle penetrates the septum.

27. The system of claim 1, wherein the docking space is a generally cylindrical docking space.

9. An infusion pump system, comprising:

an infusion site interface structure that is adhesively attachable to a skin surface, the infusion site interface structure including;

a frame with a lower surface, a soft cannula coupled to the frame for penetration of the skin surface when the soft cannula extends below the lower surface of the frame, and a septum that is positioned within a septum support member and above the soft cannula and extends substantially parallel to the lower surface of the frame when the soft cannula extends below the lower surface of the frame;

an infusion pump apparatus; and

a needle extending from the infusion pump apparatus downwardly toward the soft cannula to penetrate the septum of the infusion site interface structure, wherein the infusion pump apparatus comprises;

a medicine reservoir in fluid communication with the needle, a drive mechanism, and a control system that governs actuation of the drive mechanism, and a housing defining a docking area surrounding at least a portion of the needle and further defining a flat lower surface region adjacent to a lowermost edge of the docking area and proximate to the needle, wherein the docking area and the septum support member comprise corresponding guiding members that, during engagement, restrict relative rotational and vertical motion between the pump body and the infusion site interface, and

wherein a fluid path between the infusion pump apparatus and the soft cannula intermittently breaks and re-establishes as the infusion pump apparatus repeatedly disconnects from and reconnects with from the infusion site interface structure while the infusion site interface structure remains adhesively attached to the skin surface.

28. The system of claim 9, wherein the housing includes a substantially flat lowermost surface and a substantially flat upper surface.

29. The system of claim 9, wherein the infusion site interface structure includes upward extension member that extends above the lower surface frame and is coupled with the septum when the soft cannula extends below the lower surface of the frame.

30. The system of claim 29, wherein the docking space is sized to receive the upward extension member of the infusion site interface structure when the needle penetrates the septum.

31. The system of claim 9, wherein the docking area is a generally cylindrical docking area.

32. The system of claim 9, wherein a fluid path between the infusion pump apparatus and the infusion site interface structure intermittently breaks and re-establishes when the infusion pump apparatus which houses the medicine reservoir is temporarily disconnected from and reconnected with the infusion site interface structure while the infusion site interface structure is adhesively attached to the skin surface.

33. The system of claim 9, wherein the septum of the infusion site interface structure is arranged in a position above a generally upward facing surface of the frame which is opposite from the lower surface of the frame.

34. The system of claim 33, wherein the infusion pump apparatus covers over the generally upward facing surface of the frame of the infusion site interface structure when the infusion pump apparatus is detachably coupled to the infusion site interface structure.

35. The system of claim 9, wherein the needle of the infusion pump apparatus extends downwardly through an upper face of the septum such that the needle extends generally perpendicular to the skin surface when the needle penetrates the septum of the infusion site interface structure.

36. The system of claim 9, wherein the frame of the infusion site interface structure comprises an inner ring hub that carries the septum and an outer wall that is spaced apart from the inner ring hub and surrounds the inner ring hub.

37. The system of claim 36, wherein the soft cannula is rigidly attached to the inner ring hub of the frame of the infusion site interface structure.

38. The system of claim 37, wherein when the infusion pump apparatus is detachably coupled to the infusion site interface structure, and the needle of the infusion pump apparatus is aligned with the inner ring hub of the frame of the infusion site interface structure.

39. The system of claim 9, wherein when the infusion pump apparatus is detachably coupled to the infusion site interface structure, a mechanical coupling secures the infusion pump apparatus with the frame of the infusion site interface structure.

40. The system of claim 39, wherein the mechanical coupling between the infusion pump apparatus and the frame of the infusion site interface structure is secured by a detent fit.

41. The system of claim 39, wherein the mechanical coupling between the infusion pump apparatus and the frame of the infusion site interface structure is secured by an insert-and-rotate fit.

42. The system of claim 9, further comprising a leak detection mechanism that provides a positive indication when the fluid path is compromised by a leak.