Implantable, refillable infusion device and septum replacement kit

• US 7,108,686 B2
• Filed: 01/11/2001
• Issued: 09/19/2006
• Est. Priority Date: 01/11/2000
• Status: Expired due to Term

• Current Assignee: Flowonix Medical, Inc.
• Original Assignee: BARD Access Systems Incorporated (Becton, Dickinson & Co)
• Inventors: Fine, Kenneth A., Burke, Paul
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US10/169,821
• Publication Number:
  US 20030208184A1
• Time in Patent Office: 2,077 Days
• Field of Search: 604/890.1, 604/891.1, 604/19, 604/21, 604/93.01, 604131-134, 604140-141, 604/143, 604145-146, 604/151, 604/153, 604246-250, 604/256, 60428801-28804
• US Class Current: 604/891.1
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/14586 pressurised by means of a flexible diaphragm
• CPC Class Codes: A61M 5/14593 the diaphragm being actuated by fluid pressure

Abstract

An implantable infusion device (10) includes a lightweight, inert housing (12) which contains an infusate (18) for administration to a patient, and an enclosed, gas-impermeable variable volume chamber (30) which contains a pressure source, such as propellant, mechanical spring, or the like. The variable volume chamber may be in the form of a rigid-walled expandable bellows structure or a nonstretchable flexible bag and is attached to the housing so as not to obstruct the entry port for introduction of infusate. A recharging fluid flow path (31) is provided adjacent to where the variable volume chamber is attached to the housing. The infusate is delivered from the device via a catheter in response to expansion of the variable volume chamber against the volume of infusate in the housing. A separate bolus injection port (38) is provided which allows infusate to be safely introduced directly into the catheter and overrides the controlled pressure-driven delivery. The lightweight housing may include integrally formed needle stops (32 and 34) and suture fastening loops (36).

Claims

1. An implantable infusion device, comprising:

a housing including an inner wall and having an interior region defined at least in pat by the inner wall, at least a portion of the interior region defining an infusate reservoir adapted to store an infusate therein for delivery to a patient;

a closed free-floating variable volume chamber having an outer wall, the variable volume chamber disposed within the interior region of the housing with the outer wall of the variable volume chamber being spaced from the inner wall of the housing, the variable volume chamber being supported within the interior region from an internal portion of the inner wall of the housing;

a pressure source contained within the variable volume chamber;

an infusate recharging fluid flow path adapted to recharge the infusate reservoir by carrying infusate to the infusate reservoir through the internal portion of the housing from which the variable volume chamber is supported within the interior region; and

an exit fluid flow path adapted to deliver infusate from the infusate reservoir out of the housing.

2. The implantable infusion device according to claim 1, wherein the infusate reservoir substantially surrounds the chamber.

3. The implantable infusion device according to claim 1, wherein the housing includes a top portion and a bottom portion connected by an annular portion, the variable volume chamber being supported within he interior region from one of the top and bottom portions of the housing.

4. The implantable infusion device according to claim 3, wherein the exit fluid flow path is provided adjacent to the annular portion of the housing and adapted to deliver infusate from the infusate reservoir out of the housing.

5. The implantable infusion device according to claim 1, further comprising a pierceable, self-sealing septum disposed in the infusate recharging fluid flow path.

6. The implantable infusion device according to claim 5, further comprising an infusate recharging fluid reservoir disposed along the infusate recharging fluid flow path.

7. The implantable infusion device according to claim 1, wherein the housing is made of gas-impermeable material.

8. The implantable infusion device according to claim 1, wherein the pressure source includes one or more of the group consisting of a multiple-phase fluid, a spring, a shape memory device, a Belville washer, and a compressible material.

9. The implantable infusion device according to claim 1, wherein the exit fluid flow path is adapted to deliver the infusate from the infusate reservoir out of the housing.

10. The implantable infusion device according to claim 9, further comprising a flow restrictor disposed along the exit fluid flow path.

11. The implantable infusion device according to claim 9, further comprising a filter disposed along the exit fluid flow path.

12. The implantable infusion device according to claim 9, wherein the pressure source includes a multiple-phase fluid propellant that exists in at least one of a liquid phase and a gas phase within the variable volume chamber as a function of ambient temperature, wherein conversion of the propellant from a liquid phase to a gas phase increases the volume displaced by the variable volume chamber in the interior region of the housing, thereby exerting a force on the infusate in the infusate reservoir so as to provide a substantially constant flow rate of the infusate out of the housing through the exit fluid flow path.

13. The implantable infusion device according to claim 12, wherein the propellant is disposed in the variable volume chamber at a pressure which is not less than atmospheric pressure at ambient temperature.

14. The implantable infusion device according to claim 9, further comprising a bolus port in fluid communication with the exit fluid flow path.

15. The implantable infusion device according to claim 14, further comprising a pair of septa disposed in the bolus port wherein the septa are spaced apart to define a bolus reservoir therebetween that is adapted to receive a bolus dose deliverable thereto using a delivery needle having an opening displaced from a tip of the needle.

16. The implantable infusion device according to claim 1, wherein the variable volume chamber is made of a substantially rigid, gas-impermeable material.

17. The implantable infusion device according to claim 1, wherein the variable volume chamber is hermetically sealed.

18. The implantable infusion device according to claim 1, further comprising a support region between the internal portion of the housing and the variable volume chamber, the support region including a fluid dispersal flow path to direct infusate along the infusate recharging fluid flow path to the infusate reservoir.

19. The implantable infusion device according to claim 1, wherein the variable volume chamber includes an annular peripheral region disposed about a central region thereof, the central region being offset from a plane defined by the annular peripheral region of the variable volume chamber.

20. The implantable infusion device according to claim 19, further comprising a support region between the internal portion of the housing and the variable volume chamber, the support region including a fluid dispersal flow path adjacent the central region of the variable volume chamber to direct fluid along the infusate recharging flow path to the infusate reservoir.

21. The implantable infusion device according to claim 20, wherein the fluid dispersal flow path includes regions of increased surface contact area in the support region between the housing and the variable volume chamber.

22. The implantable infusion device according to claim 19, wherein the recharging fluid flow path includes at least one channel between the variable volume chamber and the housing extending adjacent from the central region to the annular peripheral region of the variable volume chamber.

23. The implantable infusion device according to claim 19, wherein the internal portion of the housing includes a central portion and an annular peripheral portion disposed about the central portion, the central portion being offset from a plane defined by the annular peripheral portion of the housing, wherein the central portion of the housing substantially nests within the central region of the variable volume chamber.

24. The implantable infusion device according to claim 23, wherein the housing includes a fluid dispersal flow path between the central portion of the housing and the central region of the variable volume chamber.

25. The implantable infusion device according to claim 1, wherein the variable volume chamber includes an accordion-type bellows.

26. The implantable infusion device according to claim 25, wherein the bellows includes a plurality of serially coupled annular members extending between top and bottom portions thereof.

27. The implantable infusion device according to claim 26, wherein junctions of the coupled annular members are coupled with flexures.

28. The implantable infusion device according to claim 1, wherein the interior region and the variable volume chamber are substantially cylindrical.

29. The implantable infusion device according to claim 1, wherein the housing includes at least one integral suture loop.

30. An implantable infusion device, comprising:

a housing including an inner wall and having an interior region defined at least in part by the inner wall, at least a portion of the interior region defining an infusate reservoir adapted to store an infusate therein for delivery to a patient;

a closed free-floating variable volume chamber having an outer wall, the variable volume chamber disposed within the interior region of the housing with the outer wall of the variable volume chamber being spaced from the inner wall of the housing, the variable volume chamber being supported within the interior region from an internal portion of the inner wall of the housing;

a pressure source contained within tie variable volume chamber;

an infusate recharging fluid flow path adapted to recharge the infusate reservoir by directing infusate into the infusate reservoir;

an exit fluid flow path adapted to carry infusate from the infusate reservoir out of the housing; and

a bolus port in fluid communication with the exit fluid flow path.

31. The implantable infusion device according to claim 30, wherein the bolus port includes a pair of septa spaced apart to define a bolus reservoir therebetween that is adapted to receive a dose of bolus deliverable thereto using a delivery needle having an opening displaced from a tip of the needle.

32. The implantable infusion device according to claim 30, further comprising a pierceable, self-sealing septum disposed in the infusate recharging fluid flow path.

34. The implantable infusion device according to claim 30, wherein the housing is made of gas-impermeable material.

35. The implantable infusion device according to claim 30, wherein the pressure source comprises one or more of the group consisting of a multiplephase fluid, a spring, a shape memory device, a Belville washer, and a compressible material.

36. The Implantable infusion device according to claim 30, further comprising a flow restrictor disposed along the exit fluid flow path.

37. The implantable infusion device according to claim 30, further comprising a filter disposed along the exit fluid flow path.

38. The implantable infusion device according to claim 30, wherein the pressure source includes a multiple-phase fluid propellant that exists in at least one of a liquid phase and a gas phase within the variable volume chamber as a function of ambient temperature, wherein conversion of the propellant from a liquid phase to a gas phase increases the volume displaced by the variable volume chamber in the interior region of the housing, thereby exerting a force on the infusate in the infusate reservoir so as to provide a substantially constant flow-rate of the infusate out of the housing through the exit fluid flow path.

39. The implantable infusion device according to claim 38, wherein the propellant is disposed in the variable volume chamber at a pressure which is not less than atmospheric pressure at ambient temperature.

40. The implantable infusion device according to claim 30, wherein the variable volume chamber is made of a substantially rigid, gas-impermeable material.

41. The implantable infusion device according to claim 30, wherein the variable volume chamber is hermetically sealed.

42. The implantable infusion device according to claim 30, wherein the variable volume chamber includes an accordion-type bellows.

43. The implantable infusion device according to claim 30, wherein the interior region and the variable volume chamber are substantially cylindrical.

44. The implantable infusion device according to claim 30, wherein the housing includes at least one integral suture loop.

33. The implantable infusion device according to clam 32, further comprising a recharging fluid reservoir disposed along the infusate recharging fluid flow path.

45. An implantable infusion device, comprising:

a housing including an inner wall and having an interior region defined at least in part by the inner wall, at least a portion of the interior region defining an infusate reservoir adapted to store an infusate therein for delivery to a patient;

a closed variable volume chamber free-floating within the interior region of the housing;

a pressure source contained within the variable volume chamber;

a fluid flow path adapted to carry infusate between a point external to the housing and the interior region of the housing; and

a spacer supported by at least one of the housing and the variable volume chamber to maintain the fluid flow path unobstructed by the variable volume chamber.

46. The implantable infusion device according to claim 45, wherein the spacer includes a groove provided on the at least one of the housing and the variable volume chamber.

47. The implantable infusion device according to claim 45, wherein the spacer includes at least one standoff.

48. The implantable infusion device according to claim 45, wherein the spacer is at least in part molded on the at least one of the housing and the variable volume chamber.

49. The implantable infusion device according to claim 45, wherein the fluid flow path is an infusate recharging fluid flow path.