Implantable infusion apparatus

• US 4,978,338 A
• Filed: 06/20/1988
• Issued: 12/18/1990
• Est. Priority Date: 04/21/1988
• Status: Expired due to Term

• Current Assignee: Therex Limited Partnership
• Original Assignee: Therex Corp. (Teleflex Incorporated)
• Inventors: Prosl, Frank R., Melsky, Gerald S.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): DeFranco, Denise W.
• Application Number:
  US07/184,244
• Time in Patent Office: 911 Days
• Field of Search: 604/93, 604/175, 604/131, 604/132, 604/140, 604/141, 604/86, 604/83, 604/82, 604/43
• US Class Current: 604/288.02
• CPC Class Codes: A61M 5/14276 specially adapted for implantation

Abstract

Implantable infusion apparatus includes a housing with an inlet passage extending into the housing at a pronounced promontory on the housing wall. The passage has an outer end at the top of the promontory and an inner end defined by a needle stop positioned inside the housing. Self-sealing septa mounted in the passage at selected spacings from the needle stop divide the passage into a plurality of aligned inlet ports each of which has its own fluid outlet. One of the outlets leads to a pumpable infusate reservoir having an outlet conduit connected to a catheter that extends outside the housing; another leads directly to the outlet conduit so that while a first fluid is being pumped from the reservoir to the catheter, a second fluid can be introduced into the other inlet port for mixing with the first fluid flowing to the catheter. Several different infusate flow configurations are also disclosed.

Claims

1. Implantable infusion apparatus comprising

a hermetically sealed housing, said housing including a pronounced outwardly projecting promontory positioned at or near the center of the housing away from the periphery thereof;

a passage into said housing at said promontory;

needle stop means at the end of said passage inside said housing;

a first needle-penetrable, self-sealing septum mounted in said passage at a selected spacing from said needle stop means, said first septum being located at the outer surface of said housing at the top of said promontory;

a second septum mounted in said passage at a selected spacing from said first septum thereby to divide said passage into a first segment extending between said needle stop means and said first septum and a second aligned segment extending between said first septum and said second septum;

first and second fluid outlets from said first and second passage segments;

a pumpable infusate reservoir inside said housing in fluid communication with one of said fluid outlets, the other of said fluid outlets being in fluid communication with fluid flow means extending within said housing;

a catheter extending from the housing for conducting fluid from said apparatus to an infusion site; and

a conduit in said housing for conducting fluid from said reservoir to said catheter.

2. The apparatus defined in claim 1 wherein the other of said fluid outlets is also in fluid communication with said catheter.

3. The apparatus defined in claim 2 wherein

A. said catheter is a dual lumen catheter;

B. said conduit is in fluid communication with one lumen of said catheter; and

C. said other of said outlets conducts fluid to the other lumen of said catheter.

4. The infusion apparatus defined in claim 2 wherein said conduit from said reservoir to said catheter includes a filter and a fluid flow restrictor.

5. The infusion apparatus defined in claim 4 wherein the flow restrictor comprises a length of glass capillary tubing.

6. The infusion apparatus defined in claim 4 wherein

A. said conduit also includes a mixing chamber downstream from said flow restrictor;

and

B. the other of said fluid outlets leads to said mixing chamber, so that while a first fluid is being expelled from said pumpable reservoir to said mixing chamber, a second fluid introduced into said second passage segment will flow to and be mixed in said mixing chamber with said first fluid so that a fluid mixture will be conducted to the catheter.

9. The apparatus defined in claim 1 wherein said housing is generally circular and said catheter exits said housing substantially tangentially.

10. The apparatus defined in claim 1 and further including

A. a second catheter, said second catheter exiting said housing substantially tangentially and collinearly to said catheter;

and

B. means for conducting fluid from the other of said fluid outlets to said second catheter.

11. The apparatus defined in claim 1 wherein said pumpable infusate reservoir comprises

A. rigid manifold means inside the housing;

B. a collapsible metal bellows capsule having an open end mounted to the manifold means, the opposite end of the capsule being closed; and

C. means in the housing for collapsing the bellows capsule.

12. The apparatus defined in claim 1 wherein

A. said passage, said outlets and at least a portion of said conduit are formed in said manifold means;

and

B. said needle stop, septa and catheter are all mounted to said manifold means adjacent to the open end of said bellows capsule.

13. The apparatus defined in claim 12 wherein the open end of the bellows capsule is recessed into a circular groove with an open edge formed in said manifold means.

16. The apparatus defined in claim 1 and further including flow check means for preventing fluid flow from said other of said fluid outlets to said second passage segment.

7. The apparatus defined in claim 7 wherein said pumpable infusate reservoir includes

A. a collapsible infusate chamber;

and

B. means for collapsing the chamber to force infusate from the chamber through said conduit to said catheter.

8. The apparatus defined in claim 7 wherein the collapsing means comprise a two-phase fluid confined inside said housing adjacent to said chamber, said fluid exerting sufficient vapor pressure at physiological temperatures to collapse said chamber.

14. Implantable infusion apparatus comprising:

a hermetically sealed housing;

a passage into said housing;

needle stop means at the end of said passage inside said housing;

a first needle-penetrable, self-sealing septum mounted in said passage at a selected spacing from said needle stop means;

a second septum mounted in said passage at a selected spacing from said first septum thereby to divide said passage into a first segment extending between said needle stop means and said first septum and a second aligned segment extending between said first septum and said second septum;

first and second fluid outlets from said first and second passage segments;

a pumpable infusate reservoir inside said housing in fluid communication with one of said fluid outlets, said reservoir including rigid manifold means inside the housing, means defining a circular groove with an open edge in said manifold means, a collapsible metal bellows capsule having an open end recessed into said groove, the opposite end of said capsule being closed, and means for mounting said bellows open end to said manifold means, said mounting means comprising a

bracket including an annular body having an inner edge seated in said groove and a cylindrical flange having a free edge extending from the periphery of said body to the open edge of said groove,

the inner edge of said body being connected by a continuous weld to the open end of said bellows capsule and

the free edge of said flange being connected by a continuous weld to said open edge of said groove in the manifold means,

means in said housing for collapsing the bellows capsule;

a catheter extending from the housing for conducting fluid from said apparatus to an infusion site, and

a conduit in said housing for conducting fluid from said reservoir to said catheter, said passage, said outlets and at least a portion of said conduit being formed in said manifold means, and said needle stop, septa and catheter all being mounted to said manifold means adjacent to the open end of said bellows capsule.

15. Implantable infusion apparatus comprising:

a hermetically sealed housing;

a passage into said housing;

needle stop means at the end of said passage inside said housing;

a first needle-penetrable, self-sealing septum mounted in said passage at a selected spacing from said needle stop means;

a second septum mounted in said passage at a selected spacing from said first septum thereby to divide said passage into a first segment extending between said needle stop means and said first septum and a second aligned segment extending between said first septum and said second septum;

first and second fluid outlets from said first and second passage segments;

a pumpable infusate reservoir inside said housing in fluid communication with one of said fluid outlets, said reservoir including rigid manifold means inside the housing, means defining a circular groove with one open edge in said manifold means, a collapsible metal bellows capsule having an open end recessed into said groove, the opposite end of the capsule being closed, and means for mounting said bellows open end to said manifold means at said groove;

means in the housing for collapsing the bellows capsule;

a catheter extending from the housing for conducting fluid from said apparatus to an infusion site,

said manifold means being disk-shaped and

said circular groove being located eccentric to the circular periphery of said manifold means so that the groove is displaced away from said catheter,

and a conduit in said housing for conducting fluid from said reservoir to said catheter, said passage, said outlets and at least a portion of said conduit being formed in said manifold means and said needle stop, septa and catheter all being mounted to said manifold means adjacent to the open end of said bellows capsule.

17. Implantable infusion apparatus comprising:

a rigid discoid header having opposite first and second surfaces;

A circular groove in said header second surface;

a collapsible bellows capsule having a closed end and an open end;

mounting means for mounting said bellows open end to said header second surface, said mounting means including an annular bracket having a peripheral flange and radially inner and outer edges, the inner edge of said bracket being connected along its entire circular length to the capsule open end, said bracket and said capsule open end being seated in said groove so that said flange extends adjacent to the radially outer wall of said groove and connecting means connecting said bracket outer edge along its entire circular length to said header all around said groove;

a first passage in said header extending between said header surfaces opposite the bellows capsule;

a second passage extending into said header from the periphery thereof;

a liquid conduit extending from said first passage to said second passage;

a self-sealing inlet port in said header opposite the bellows capsule, said inlet port being accessible from said header first surface, and fluid conduit means extending between said inlet port and the interior of said capsule.

18. The apparatus defined in claim 17 wherein said capsule is made of a biocompatible metal and said connections are welds.

19. The apparatus defined in claim 17 wherein said liquid conduit includes a length of flow-restricting glass tubing.

20. The apparatus defined in claim 17

A. wherein said second passage extends along a chord of said header;

and

B. further including a flexible catheter having one end secured in a fluid-tight manner in said passage so that the catheter extends from the periphery of the apparatus more or less tangentially.

21. The apparatus defined in claim 17 wherein

A. said header includes a central mesa at said header first surface, said mesa having a central perpendicular axis;

and

B. said inlet port is located in said mesa.

22. The apparatus defined in claim 21 further including

A. a smoothly contoured cup-like first shell mounted to said header second surface at the periphery thereof, said first shell defining with said header a first fluid-tight compartment that contains said capsule;

and

B. a second smoothly contoured annular shell mounted to said header first surface, said second shell covering said second surface except at said inlet port and defining with said header a second fluid-tight compartment that overlies said first and second passages and said conduit.

23. The apparatus defined in claim 22 wherein said liquid conduit includes a length of flow restricting glass tubing wound around said mesa in said second compartment.

24. The apparatus defined in claim 23 wherein

A. said liquid conduit also includes a third passage in said header extending between said second passage and a location at said header first surface in said second compartment;

and

B. said tubing is connected between said first and said third passages.

25. The apparatus defined claim 22

A. wherein said second passage extends along a chord of said header spaced from the outer edge of said second shell and has opposite ends spaced apart on the header periphery;

and

B. further including a first catheter having one end in fluid-tight communication with one end of said second passage and a second catheter having one end in fluid-tight communication with the other end of said second passage so that said catheters extend more or less tangentially from the apparatus in opposite directions.

26. The apparatus defined in claim 22 and further including

A. a second self-sealing inlet port in said header, said second port being aligned along said axis in said mesa with said first port;

and

B. liquid conducting means in said header extending from said second inlet port to said liquid conduit.

27. The apparatus defined in claim 26 wherein

A. said conduit includes a liquid flow restriction;

and

B. said conducting means join said liquid conduit downstream from said flow restriction.

28. The apparatus defined in claim 27 and further including a check valve in said conducting means to prevent back flow into said second inlet port.

29. The apparatus defined in claim 26 and further including a check valve in said conducting means to prevent back flow into said second inlet port.

30. The apparatus defined in claim 22 and further including means accessible at said header second surface for flowing a two-phase fluid that vaporizes at physiological temperatures into said second compartment.

31. The apparatus defined in claim 22 and further including a plurality of suture loops attached to the outside of said header periphery at spaced apart locations therearound.

32. The apparatus defined in claim 17 and further including

A. a second self-sealing inlet port in said header, said second port being vertically aligned with said first port and accessible from the header second surface;

B. a liquid passage in said header extending from said second inlet port to the periphery of the header;

C. a first catheter having one end in fluid tight communication with said second passage at the header periphery; and

D. a second catheter having one end in fluid tight communication with said liquid passage at the header periphery.

33. The apparatus defined in claim 32 and further including a standing column of a biocompatible liquid filling said second inlet port, said liquid passage and said second catheter for transmitting pressure pulses from the opposite end of said catheter to said second inlet port for sensing by a needle-like pressure transducer inserted into said second inlet port.

45. The apparatus defined in claim 33 and further including

A. a smoothly contoured cup-like first shell mounted to said header first surface at the periphery thereof, said first shell defining with said header a first fluid-tight compartment that contains said infusate chamber;

and

B. a second smoothly contoured annular shell covering said manifold second surface except that the access to said inlet ports, said second shell being connected to said manifold periphery and said mesa so that the second shell defines with said manifold a second fluid-tight compartment that overlies said first and second outlet conduits.

34. Implantable infusion apparatus comprising

a rigid manifold having opposite first and second surfaces and a pronounced outwardly projecting mesa positioned at or near the center of said second surface away from the periphery thereof, said mesa having a central perpendicular axis;

a collapsible fluid-tight infusate chamber having a closed end and an open end;

means for mounting the chamber open end in a fluid-tight manner to the manifold first surface opposite said mesa;

a self-sealing inlet port in said manifold mesa, said inlet port being accessible from the manifold second surface at the top of said mesa;

fluid conduit means extending between said inlet port and the interior of said chamber; and

a first outlet conduit communicating between said manifold first surface inside said chamber and the manifold periphery.

35. Implantable infusion apparatus comprising

a rigid manifold having opposite first and second surfaces and a central mesa at said second surface, said mesa having a central perpendicular axis;

a collapsible fluid-tight infusate chamber having a closed end and an open end;

means for mounting the chamber open end in a fluid-tight manner to the manifold first surface opposite said mesa;

a self-sealing inlet port in said manifold mesa, said inlet port being accessible from the header second surface at the top of said mesa;

fluid conduit means extending between said inlet port and the interior of said chamber;

a first outlet conduit communicating between said manifold first surface inside said chamber and the manifold periphery;

a second self-sealing inlet port in said manifold mesa, said second inlet port being in alignment along said axis with said first inlet port and accessible from the manifold second surface at the top of said mesa; and

a second outlet conduit in said manifold communicating between said second inlet port and the periphery of said manifold.

36. The apparatus defined in claim 35 wherein first and second outlet conduits join in said manifold to form a Y-conduit that has a single outlet at the periphery of the manifold and which receives fluid from both said chamber and said second inlet port.

37. The apparatus defined in claim 36 and further including a check valve in said Y-conduit downstream from the joint with said first outlet conduit to prevent fluid back flow into said second inlet port.

38. The apparatus defined in claim 37 and further including a fluid flow restrictor in said Y-conduit upstream from the joint with said second outlet conduit.

39. The apparatus defined in claim 38 wherein said Y-conduit includes

A. a first manifold passage extending into said chamber;

B. a second manifold passage extending into the manifold from the periphery thereof; and

C. a flow-restricting glass capillary tube wound around said mesa and connected between said first and second passages.

40. The apparatus defined in claim 35

A. wherein first and second outlet conduits have separate outlets located adjacent to the periphery of said manifold;

and

B. further including first and second catheters having corresponding first ends connected to said first and second conduits respectively.

41. The apparatus defined in claim 35 and further including a dual-lumen catheter having a first end connected to the periphery of said manifold, the two lumens of said catheter being in fluid communication with different ones of said outlet conduits.

42. The apparatus defined in claim 35

A. wherein said first outlet conduit branches to form a Y-conduit that has first and second outlets at spaced-apart locations on the periphery of said manifold;

and

B. further including a pair of catheters having corresponding first ends connected to said header periphery and being in fluid communication with said first and second outlets respectively, a first check valve connected between said second outlet conduit and one branch of said Y-conduit, and a second check valve connected between said second outlet conduit and the other branch of said Y-conduit, both of said valves preventing back flow from the Y-conduit into said second conduit.

43. The apparatus defined in claim 42 and further including a flow restrictor in each branch of said Y-conduit upstream from the said check valve connected thereto.

44. The apparatus defined in claim 42 wherein said catheters are connected to the header so that they extend more or less tangentially from the apparatus.