Implantable, refillable infusion device and septum replacement kit

• US 20040249363A1
• Filed: 06/17/2004
• Published: 12/09/2004
• Est. Priority Date: 01/11/2000
• Status: Abandoned Application

• Current Assignee: Flowonix Medical, Inc.
• Original Assignee: BARD Access Systems Incorporated (Becton, Dickinson & Co)
• Inventors: Burke, Paul F., Fine, Kenneth A.
• Application Number:
  US10/869,978
• Publication Number:
  US 20040249363A1
• Time in Patent Office: Days
• US Class Current: 604/890.1
• 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 includes a lightweight, inert housing which contains an infusate for administration to a patient, and an enclosed, gas-impermeable variable volume chamber 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. 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 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 and suture fastening loops.

Claims

1. An implantable infusion device, comprising:

A. a housing having (a) an annular portion with an inner wall defining an interior region having a width dimension D and extending along a central axis, (b) a bottom portion extending from said annular portion and spanning a first end of said interior region, and (c) a top portion extending from said annular portion and spanning a second end of said interior region, said top portion being opposite said bottom portion, wherein said interior region is substantially closed; and

B. a closed fluid-impermeable hollow bellows extending from one of the top and bottom portions of the housing and defining a variable volume region therein and having a plurality of serially coupled annular members extending between top and bottom portions of the bellows, wherein junctions of said coupled annular members are coupled with flexures, said bellows having a maximum outer width dimension D′

where D′

is less than D, wherein the portion of the housing from which the bellows extends includes a substantially planar annular peripheral portion disposed about a central portion, wherein a pressure source is contained within said variable volume region of said bellows, and wherein said bellows is disposed within said interior region of said housing and rigidly coupled to said portion of the housing from which the bellows extends, whereby said annular members of said bellows are spaced apart from said annular portion of said housing,

wherein said housing includes a recharging fluid flow path from points external to said housing to a region adjacent to said central portion of said portion of said housing from which the bellows extends, and

wherein said housing further defines a fluid exit flow path extending from the region between said bellows and said annular portion of said housing to points external to said housing.

2. An implantable infusion device according to claim 1, further comprising a pierceable, self-sealing septum disposed in said recharging fluid flow path.

3. An implantable infusion device according to claim 2, wherein the septum is removable from the housing.

4. An implantable infusion device according to claim 1, further comprising a recharging fluid reservoir disposed along said recharging fluid flow path.

5. An implantable infusion device according to claim 1, further comprising at least one of a flow restrictor and a filter disposed along said fluid exit flow path.

6. An implantable infusion device according to claim 1, wherein said housing is made of a gas-impermeable material.

7. An implantable infusion device according to claim 1, wherein the pressure source comprises one or more of the group consisting of multiple-phase fluids, springs, shape memory metal alloys, Belville washers, and compressible materials.

8. An implantable infusion device according to claim 1, wherein a multiple-phase fluid propellant is present in at least one of a liquid phase and a gas phase within said variable volume region of said bellows 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 bellows in the interior region of the housing, thereby exerting a force on a fluid external to said bellows in said housing so as to provide a substantially constant flow rate of said fluid through said fluid exit flow path.

9. An implantable infusion device according to claim 8, wherein said propellant is disposed in said variable volume region of said bellows at a pressure which is not less than atmospheric pressure at ambient temperature.

10. An implantable infusion device according to claim 1, wherein said bellows is made of a substantially rigid, gas-impermeable material.

11. An implantable infusion device according to claim 1, wherein said bellows is hermetically sealed.

12. An implantable infusion device according to claim 1, wherein said central portion of said bellows is offset from the plane of said annular peripheral portion of said bellows.

13. An implantable infusion device according to claim 12, wherein a central region of said portion of said housing from which the bellows extends is correspondingly offset from the plane of the annular portion of the housing, wherein the offset central region of the housing substantially nests within said offset central portion of said bellows.

14. An implantable infusion device according to claim 1, wherein the housing and bellows are cylindrical.

15. An implantable infusion device according to claim 1, further comprising a separate bolus port in fluid communication with said fluid exit flow path.

16. An implantable infusion device according to claim 15, further comprising a pair of septa disposed in said bolus port, wherein the septa are spaced apart to define a bolus reservoir therebetween, wherein a delivery needle having an opening near the center of its length is required to deliver infusate to the bolus reservoir.

17. An implantable infusion device according to claim 1, wherein the bellows extends from the top portion of the housing.

18. An implantable infusion device according to claim 1, wherein the bellows extends from the bottom portion of the housing.

19. An implantable infusion device, comprising:

A. a housing having (a) an annular portion with an inner wall defining an interior region having a width dimension D and extending along a central axis, (b) a bottom portion extending from said annular portion and spanning a first end of said interior region, and (c) a top portion extending from said annular portion and spanning a second end of said interior region, said top portion being opposite said bottom portion, wherein said interior region is substantially closed; and

B. a closed fluid-impermeable hollow bellows disposed about a variable volume region and having a top member, a bottom member, and a plurality of serially coupled annular members extending therebetween, wherein junctions of said coupled annular members are coupled with flexures, said bellows having a maximum outer width dimension D′

where D′

is less than D, wherein at least one of said top and bottom members includes a substantially planar annular peripheral portion disposed about a central portion, wherein a pressure source is contained within said variable volume region of said bellows, and wherein said bellows is disposed within said interior region of said housing with one of said top and bottom members facing and rigidly coupled to a corresponding portion of said housing, whereby said annular members of said bellows are spaced apart from said annular portion of said housing,

wherein said housing includes a recharging fluid flow path from points external to said housing to a region adjacent to said central portion of one of said top and bottom members of said bellows, and wherein the region of coupling between said housing and said bellows defines a fluid dispersal flow path from said region adjacent to said central portion of said coupled member of said bellows to a region between said annular members of said bellows and said annular portion of said housing, and

wherein said housing further defines a fluid exit flow path extending from the region between said bellows and said annular portion of said housing to points external to said housing.

20. An implantable infusion device according to claim 19, further comprising a pierceable, self-sealing septum disposed in said recharging fluid flow path.

21. An implantable infusion device according to claim 20, wherein the septum is removable from the housing.

22. An implantable infusion device according to claim 19, further comprising a recharging fluid reservoir disposed along said recharging fluid flow path.

23. An implantable infusion device according to claim 19, further including at least one of a flow restrictor and a filter disposed along said fluid exit flow path.

24. An implantable infusion device according to claim 19, wherein said housing is made of a gas-impermeable material.

25. An implantable infusion device according to claim 19, wherein the pressure source comprises one or more of the group consisting of multiple-phase fluids, springs, shape memory metal alloys, Belville washers, and compressible materials.

26. An implantable infusion device according to claim 19, wherein a multiple-phase fluid propellant is present in at least one of a liquid phase and a gas phase within said variable volume region of said bellows 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 bellows in the interior region of the housing, thereby exerting a force on a fluid external to said bellows in said housing so as to provide a substantially constant flow rate of said fluid through said fluid exit flow path.

27. An implantable infusion device according to claim 26, wherein said propellant is disposed in said variable volume region of said bellows at a pressure which is not less than atmospheric pressure at ambient temperature.

28. An implantable infusion device according to claim 19, wherein said bellows is made of a substantially rigid, gas-impermeable material.

29. An implantable infusion device according to claim 19, wherein said bellows is hermetically sealed.

30. An implantable infusion device according to claim 19, wherein said central portion of at least one of the top and bottom members of said bellows is offset from the plane of said annular peripheral portion of said top and bottom members of said bellows.

31. An implantable infusion device according to claim 30, wherein a central region of said portion of said housing coupled to the bellows is correspondingly offset from the plane of the annular portion of the housing, wherein the offset central region of said portion of the housing coupled to the bellows substantially nests within said central portion of the coupled portion of said bellows.

32. An implantable infusion device according to claim 19, wherein the bellows is coupled to the top portion of the housing.

33. An implantable infusion device according to claim 19, wherein the bellows is coupled to the bottom portion of the housing.

34. An implantable infusion device according to claim 19, wherein the fluid dispersal flow path includes regions of increased surface contact area in the coupled region between the housing and the bellows.

35. An implantable infusion device according to claim 19, wherein the housing and bellows are cylindrical.

36. An implantable infusion device according to claim 19, further comprising a separate bolus port in fluid communication with said fluid exit flow path.

37. An implantable infusion device according to claim 36, further comprising a pair of septa disposed in said bolus port, wherein the septa ape spaced apart to define a bolus reservoir therebetween, wherein a delivery needle having an opening near the center of its length is required to deliver infusate to the bolus reservoir.

38. An implantable infusion device, comprising:

A. a housing having (a) an annular portion with an inner wall defining an interior region having a width dimension D and extending along a central axis, (b) a bottom portion extending from said annular portion and spanning a first end of said interior region, and (c) a top portion extending from said annular portion and spanning a second end of said interior region, said top portion being opposite said bottom portion, wherein said interior region is substantially closed;

B. a closed fluid-impermeable hollow bellows extending from one of the top and bottom portions of the housing and defining a variable volume- region therein and having a plurality of serially coupled annular members extending between top and bottom portions of the bellows, wherein junctions of said coupled annular members are coupled with flexures, said bellows having a maximum outer width dimension D′

where D′

is less than D, wherein the portion of the housing from which the bellows extends includes a substantially planar annular peripheral portion disposed about a central portion, wherein a pressure source is contained within said variable volume region of said bellows, and wherein said bellows is disposed within said interior region of said housing and rigidly coupled to said portion of the housing from which the bellows extends, whereby said annular members of said bellows are spaced apart from said annular portion of said housing, wherein said housing includes a recharging fluid flow path from points external to said housing to a region adjacent to said central portion of said portion of said housing from which the bellows extends, and wherein said housing further defines a fluid exit flow path extending from the region between said bellows and said annular portion of said housing to points external to said housing; and

C. a separate bolus port in fluid communication with said fluid exit flow path, wherein said bolus port includes a pair of septa disposed therein and spaced apart to define a bolus reservoir therebetween, wherein a delivery needle having an opening near the center of its length is required to deliver infusate to the bolus reservoir.

39. An implantable infusion device, comprising:

A. a housing having (a) an annular portion with an inner wall defining an interior region having a width dimension D and extending along a central axis, (b) a bottom portion extending from said annular portion and spanning a first end of said interior region, and (c) a top portion extending from said annular portion and spanning a second end of said interior region, said top portion being opposite said bottom portion, wherein said interior region is substantially closed;

B. a closed fluid-impermeable hollow bellows disposed about a variable volume region and having a top member, a bottom member, and a plurality of serially coupled annular members extending therebetween, wherein junctions of said coupled annular members are coupled with flexures, said bellows having a maximum outer width dimension D′

where D′

is less than D, wherein at least one of said top and bottom members includes a substantially planar annular peripheral portion disposed about a central portion, wherein a pressure source is contained within said variable volume region of said bellows, and wherein said bellows is disposed within said interior region of said housing with one of said top and bottom members facing and rigidly coupled to a corresponding portion of said housing, whereby said annular members of said bellows are spaced apart from said annular portion of said housing, wherein said housing includes a recharging fluid flow path from points external to said housing to a region adjacent to said central portion of one of said top and bottom members of said bellows, and wherein the region of coupling between said housing and said bellows defines a fluid dispersal flow path from said region adjacent to said central portion of said coupled member of said bellows to a region between said annular members of said bellows and said annular portion of said housing, and wherein said housing further defines a fluid exit flow path extending from the region between said bellows and said annular portion of said housing to points external to said housing; and

C. a separate bolus port in fluid communication with said fluid exit flow path, wherein said bolus port includes a pair of septa disposed therein and spaced apart to define a bolus reservoir therebetween, wherein a delivery needle having an opening near the center of its length is required to deliver infusate to the bolus reservoir.

40. A septum replacement kit for an enclosed device which is sealed with a septum,

wherein the enclosed device defines a fluid reservoir, a fluid flow inlet and a fluid flow outlet, the kit comprising:

a compressible septum adapted to sealingly engage in the fluid flow inlet of the reservoir; and

a septum installation tool adapted to compress the septum to a nominal insertion size, maintain said nominal insertion size of said septum prior to installation of the septum, and install the septum in the fluid flow inlet of the reservoir.

41. A septum replacement kit according to claim 40, wherein the septum installation tool comprises a tubular member adapted for insertion into the fluid flow inlet of the reservoir, an opening in the tubular member for insertion and retention of said septum therein, and a plunger member disposable in said tubular member for expulsion of said septum from the tubular member, wherein insertion of the septum into the tubular member compresses the septum, and wherein expulsion of the septum from the tubular member into the fluid inlet reservoir permits the septum to expand to fill in and seal the fluid inlet reservoir.

42. A septum replacement kit according to claim 40, wherein the septum is made of a self-sealing elastomeric material.