Implantable catheter assembly

• US 20090018493A1
• Filed: 07/10/2007
• Published: 01/15/2009
• Est. Priority Date: 07/10/2007
• Status: Abandoned Application

• Current Assignee: AAT Catheter Technologies, LLC
• Original Assignee: AAT Catheter Technologies, LLC
• Inventors: Brown, Kenneth E., Ash, Stephen R.
• Application Number:
  US11/827,025
• Publication Number:
  US 20090018493A1
• Time in Patent Office: Days
• US Class Current: 604/29
• CPC Class Codes: A61M 1/284 Continuous flow peritoneal dialysis [CFPD]
• CPC Class Codes: A61M 1/285 Catheters therefor

Abstract

Assemblies, kits and methods are provided for catheter assemblies that include a coupling member with first and second access ports to which first and second intrabody members are coupled. The coupling member defines an internal chamber which is in communication with lumens of the first and second intrabody members. In an implantation orientation each of the first and second intrabody members is in a straightened configuration relative to the coupling member and in an implanted orientation each of the first and second intrabody members is in a contracted configuration relative to the coupling member.

Claims

1. A catheter assembly for use in peritoneal dialysis, comprising:

a first intraperitoneal member including a first coiled portion at a distal end thereof and defining a first lumen extending from a proximal end toward said distal end;

a second intraperitoneal member including a second coiled portion at a distal end thereof and defining a second lumen extending from a proximal end toward said distal end;

a coupling member including first and second access ports and a transabdominal member defining a third lumen; and

wherein said proximal end of said first intraperitoneal member extends from said coupling member at said first access port and said proximal end of said second intraperitoneal member extends from said coupling member at said second access port with said first and second lumens in fluid communication with said third lumen.

2. The assembly of claim 1, wherein said second coiled portion is more tightly coiled than said first coiled portion.

3. The assembly of claim 2, wherein said first intraperitoneal member further includes a first length between a proximal end and said distal end thereof and said second intraperitoneal member further includes a second length between a proximal end and said distal end thereof, said second length being smaller than said first length.

4. The assembly of claim 3, wherein said coupling member defines an internal chamber and said first, second and third lumens are in fluid communication with said internal chamber.

5. The assembly of claim 4, wherein said proximal ends of said first and second intraperitoneal members extend substantially along a common longitudinal axis.

6. The assembly of claim 5, wherein said first and second intraperitoneal members and said coupling member lie substantially in a common plane.

7. The assembly of claim 6, wherein said first coiled portion is positioned on a first side of said longitudinal axis and said second coiled portion is positioned on a substantially opposite second side of said longitudinal axis.

8. The assembly of claim 7, wherein said transabdominal member is positioned on said second side of said longitudinal axis.

9. The assembly of claim 8, wherein said first and second intraperitoneal members are straightened when in an implantation orientation.

10. The assembly of claim 9, wherein in said implantation orientation said coupling member is folded with said first and second access ports positioned adjacent one another.

11. The assembly of claim 10, wherein in said implantation orientation each of said first and second intraperitoneal members includes a substantially linear profile between said proximal and distal ends thereof.

12. The assembly of claim 3, further comprising a radiopaque marker disposed on an exterior surface of at least one of said first and second intraperitoneal members and said transabdominal member.

13. The assembly of claim 12, wherein said radiopaque marker is barium sulfate.

14. The assembly of claim 3, wherein each of said first and second lumens includes a substantially circular cross-sectional shape.

15. The assembly of claim 14, wherein each of said first and second lumens includes a diameter in the range from about 3 to about 5 millimeters.

16. The assembly of claim 14, wherein each of said first and second lumens is compressible to transition said circular shape to a flattened shape.

17. The assembly of claim 4, further comprising a partition in said internal chamber and said third lumen, said partition dividing said internal chamber and said third lumen into first and second pathways.

18. The assembly of claim 17, wherein said first pathway is in fluid communication with said first lumen and said second pathway is in fluid communication with said second lumen.

19. The assembly of claim 1, wherein each of said first and second intraperitoneal members includes a plurality of openings in communication with said lumen thereof.

20. The assembly of claim 19, wherein said plurality of openings includes a number of oppositely disposed openings spaced apart along respective ones of said first and second intraperitoneal members.

21. The assembly of claim 20, wherein a perimetrical position of said pairs of openings varies between adjacent ones of said pairs of openings.

22. The assembly of claim 1, further comprising a first tissue ingrowth promoting cuff positioned around said transabdominal member adjacent a distal end thereof.

23. The assembly of claim 22, further comprising a second tissue ingrowth promoting cuff positioned around said transabdominal member and spaced proximally from said first cuff.

24. The assembly of claim 1 wherein said first intraperitoneal member includes a first length between said coupling member and said distal end thereof and said second intraperitoneal member includes a second length between said coupling member and said distal end thereof which is shorter than said first length.

25. The assembly of claim 24, further comprising a transabdominal member extending from said coupling member.

26. The assembly of claim 24, wherein each of said first and second intraperitoneal members is structured to infuse a dialysate into the peritoneal cavity of a patient and drain a spent dialysate from the peritoneal cavity of the patient.

27. The assembly of claim 1 wherein:

said first coiled portion includes a first dimension corresponding to an outer diameter thereof;

said second coiled portion includes a second dimension corresponding to an outer diameter thereof; and

said second dimension is smaller than said first dimension.

28. The assembly of claim 27, wherein said first and second intraperitoneal members and said transabdominal member lie substantially in a common plane.

29. The assembly of claim 28, wherein said transabdominal member extends along a first longitudinal axis and each of said first and second intraperitoneal members are positioned on opposite sides of said longitudinal axis.

30. The assembly of claim 29, wherein said coupling member includes a first portion from which said first and second intraperitoneal members extend, said first portion extending along a second longitudinal axis positioned substantially transversely to said first longitudinal axis.

31. The assembly of claim 30, wherein each of said first and second coiled portions are positioned substantially on opposite sides of said second longitudinal axis.

32. A catheter assembly, comprising:

a resilient, pliable coupling member defining an internal chamber, said coupling member including a first portion with a first access port and a second access port and a second portion defining a third access port, said first, second and third access ports being in communication with said internal chamber;

a first intrabody member extending from said first access port and a second intrabody member extending from said second access port, wherein each of said first and second intrabody members defines a lumen in communication with said internal chamber; and

wherein the catheter assembly is configurable to an implantation orientation wherein each of said first and second intrabody members is in a straightened configuration and an implanted orientation wherein each of said first and second intrabody members is in a contracted configuration.

33. The assembly of claim 32, further comprising a main member extending from said third access port along a first longitudinal axis, said main member defining a lumen in communication with said internal chamber.

34. The assembly of claim 33, wherein said coupling member is foldable between said implantation orientation and said implanted orientation.

35. The assembly of claim 34, wherein in said implantation orientation said first and second access ports are juxtaposed and in said implanted orientation said first and second access ports lie along a second longitudinal axis transversely oriented to said first longitudinal axis.

36. The assembly of claim 33, wherein in said contracted configuration each of said first and second intrabody members includes a coiled portion.

37. The assembly of claim 36, wherein in said implanted orientation said first portion of said coupling member extends along a second longitudinal axis and said coiled portion of said first intrabody member is positioned on a first side of said second longitudinal axis and said coiled portion of said second intrabody member is positioned on an opposite side of said second longitudinal axis.

38. The assembly of claim 37, wherein in said implanted orientation said first and second intrabody members, said coupling member and said main member are positioned substantially in a common plane.

39. The assembly of claim 36, wherein said coiled portion of said second intrabody member is more tightly coiled than said coiled portion of said first intrabody member.

40. The assembly of claim 39, wherein each of said first and second intrabody members includes a distal end spaced apart from respective ones of said first and second access ports and wherein in said contracted configuration said distal end is positioned adjacent a center of said coiled portion of said corresponding intrabody member.

41. The assembly of claim 40, wherein said first intrabody member has a length between said first access port and said distal end which is greater than a length of said second intrabody member between said second access port and said distal end thereof.

42. The assembly of claim 33, further comprising a radiopaque marker disposed on an exterior surface of at least one of said first and second intrabody members and said main member.

43. The assembly of claim 42, wherein said radiopaque marker is barium sulfate.

44. The assembly of claim 33, wherein said lumens of said first and second intrabody members define a substantially circular cross-section.

45. The assembly of claim 44, wherein said lumens of said first and second intrabody members include a diameter in the range from about 3 to about 5 millimeters.

46. The assembly of claim 45, wherein said diameter of said lumens of said first and second intrabody members is about 4 millimeters.

47. The assembly of claim 44, wherein each of said first and second intrabody members includes a plurality of openings in communication with said lumen thereof.

48. The assembly of claim 47, wherein said plurality of openings includes a number of pairs of oppositely disposed openings spaced apart along respective ones of said first and second intrabody members.

49. The assembly of claim 48, wherein adjacent ones of said pairs of opposite openings open at circumferentially offset locations.

50. The assembly of claim 33, further comprising a first tissue ingrowth promoting cuff positioned around said main member adjacent to said third access port.

51. The assembly of claim 50, further comprising a second tissue ingrowth promoting cuff positioned around said main member and spaced apart from said first cuff.

52. The assembly of claim 33, further comprising a partition positioned in said internal chamber and in said lumen of said main member, said partition dividing said internal chamber and said lumen of said main member into first and second pathways.

53. The assembly of claim 52, wherein said first pathway is in fluid communication with said lumen of said first intrabody member and said second pathway is in fluid communication with said lumen of said second intrabody member.

54. A catheter assembly comprising:

an elongated main member including a coupling portion disposed at a distal end thereof;

a first intrabody member including a proximal portion and a distal portion, said distal portion defining a first coiled section;

a second intrabody member including a proximal portion and a distal portion, said distal portion defining a second coiled section; and

wherein said proximal portions of said first and second intrabody members extend from said coupling portion along a first longitudinal axis and said first and second coiled sections are positioned on substantially opposite sides of said first longitudinal axis.

55. The catheter assembly of claim 54, wherein said main member is positioned on the same side of said longitudinal axis as said second coiled section.

56. The assembly of claim 54, wherein each of said first and second intrabody members and said main member defines a lumen in communication with an internal chamber defined by said coupling portion.

57. The assembly of claim 56, wherein each of said lumens of said first and second intrabody members includes a plurality of openings in fluid communication therewith.

58. The assembly of claim 56, further comprising a partition in said coupling portion and said lumen of said main member, said partition dividing said coupling portion and said lumen of said main member into a first pathway in fluid communication with said lumen of said first intrabody member and a second pathway in fluid communication with said lumen of said second intrabody member.

59. The assembly of claim 57, wherein said plurality of openings is structured to dispense a liquid from said lumens into a patient.

60. The assembly of claim 59, wherein said plurality of openings is further structured to drain a liquid from the patient.

61. The assembly of claim 54, wherein said first intrabody member includes a first length between a proximal end and a distal end thereof that is greater than a second length of said second intrabody member between a proximal and a distal end thereof.

62. The assembly of claim 54, wherein said main member extends along a second longitudinal axis oriented transversely to said first longitudinal axis.

63. The assembly of claim 54, wherein said second coiled section is more tightly coiled than said first coiled section.

64. The assembly of claim 54, wherein said main member includes a first tissue ingrowth promoting cuff positioned adjacent to said distal end thereof and a second tissue ingrowth promoting cuff spaced proximally from said first cuff.

65. A system for performing peritoneal dialysis, comprising;

an intraperitoneal supply member structured to infuse the peritoneal cavity with a dialysate; and

an intraperitoneal drain member spaced from said supply member, said drain member including a first collecting member including a first coiled section and a second collecting member including a second coiled section, said collecting members being structured to remove said dialysate from the peritoneal cavity.

66. The system of claim 65, further comprising a drainage conduit coupled with said drain member, said drainage conduit being structured to deliver said dialysate from said first and second collecting members to a location external to a patient.

67. The system of claim 66, wherein said drainage conduit is sized to extend beyond the epidermis of a patient.

68. The system of claim 67, wherein said drainage conduit includes a first tissue ingrowth promoting cuff and a second tissue ingrowth promoting cuff spaced apart from said first cuff.

69. The system of claim 65, further comprising a transcutaneous member including an intrabody coupling portion defining a first access port and a second access port, said transcutaneous member and said coupling portion being partitioned into first and second pathways and wherein said first pathway is in fluid communication with said first access port to which said supply member is coupled and said second pathway is in fluid communication with said second access port to which a drainage conduit extending from said drainage member is coupled.

70. The system of claim 69, wherein said transcutaneous member includes a first tissue ingrowth promoting cuff positioned adjacent to said intrabody coupling portion and a second tissue ingrowth promoting cuff spaced apart from said first cuff.

71. The system of claim 70, wherein said transcutaneous member is divided into first and second conduit members at a position external to the body and said first conduit member is coupled with a dialysate source and said second conduit member is coupled to a receptacle for spent dialysate.

72. The system of claim 65, wherein said first collecting member includes a first length between a proximal end and a distal end thereof and said second collecting member includes a second length between a proximal end and a distal end thereof which is shorter than said first length.

73. The system of claim 72, wherein said first collecting member and said second collecting member extend in opposite directions from one another.

85. The method of claim 72, wherein inserting said first and second stylets includes inserting said stylets into said transabdominal member until a stop on each of said stylets contacts a proximal end of said transabdominal member.

74. A method for positioning a catheter assembly for peritoneal dialysis, comprising:

providing a catheter assembly including a coupling member, said coupling member including a transabdominal member and first and second intraperitoneal members extending therefrom, said first and second intraperitoneal members including distal coiled sections;

providing a pair of stylets configured to pass through said coupling member and into communication with lumens of said first and second intraperitoneal members;

inserting a first one of said stylets into said lumen of said first intraperitoneal member and thereby substantially straightening said distal coiled section thereof;

inserting a second one of said stylets into said lumen of said second intraperitoneal member and thereby substantially straightening said distal coiled section thereof;

implanting said catheter assembly at a prepared surgical location with said coiled sections substantially straightened; and

removing said first and second stylets from said lumens of said intraperitoneal members and thereby reforming said distal coiled sections to a coiled configuration.

75. The method of claim 74, further comprising folding said coupling member and wherein inserting said stylets includes inserting said first and second stylets through said transabdominal member and into said lumens.

76. The method of claim 74, wherein said coiled section of said second intraperitoneal member is more tightly coiled than said coiled section of said first intraperitoneal member.

77. The method of claim 76, wherein each of said first and second intraperitoneal members has a length between a proximal and a distal end and wherein said length of said first intraperitoneal member is greater than said length of said second intraperitoneal member.

78. The method of claim 74, wherein said catheter assembly includes a radiopaque marker on an exterior portion thereof and said implanting includes radiographically monitoring the position of said radiopaque marker.

79. The method of claim 74, wherein said transabdominal member includes a first cuff portion and a second cuff portion spaced apart from said first cuff portion.

80. The method of claim 79, further comprising positioning said first and second cuffs at said surgical site to promote tissue ingrowth between said first and second cuffs and around said transabdominal member.

81. The method of claim 74, wherein removing said first and second stylets includes incrementally withdrawing said first and second stylets from said lumens of said first and second intraperitoneal members to gradually reform said coiled sections.

82. The method of claim 74, wherein implanting said catheter assembly includes passing said catheter assembly through a retractor sleeve.

83. The method of claim 82, wherein passing said catheter assembly further includes compressing the lumens of said first and second intraperitoneal members and positioning said stylets in a side-by-side relationship.

84. The method of claim 82, wherein implanting said catheter assembly further comprises positioning said first intraperitoneal member inferiorly of said second intraperitoneal member at the surgical location.

86. The method of claim 83, wherein said first stylet includes a length between a distal end and said stop thereof which is greater than a length of said second stylet between a distal end and said stop thereof.

87. A kit for implanting a catheter assembly, comprising:

a catheter assembly including a main member and first and second intrabody members extending from a coupling member, said first and second intrabody members each including a coiled portion positioned at a distal end thereof;

a first stylet and a second stylet, wherein each of said first and second stylets includes an elongated shaft portion and an enlarged head portion at a distal end of said shaft portion; and

packaging for holding said catheter assembly and said first and second stylets in a sterilized condition until implantation of said catheter assembly.

88. The kit of claim 87, wherein each of said first and second intrabody members and said main member defines a lumen and said enlarged head portion of said first and second stylets is structured to pass through said lumen of each of said first and second intrabody members and said main member.

89. The kit of claim 88, wherein each of said first and second stylets further includes a stop portion spaced proximally from said enlarged head portion.

90. The kit of claim 89, wherein said first stylet includes a length between said enlarged head portion and said stop portion thereof which is greater than a length of said second stylet between said enlarged head portion and said stop portion thereof.

91. The kit of claim 90, wherein said length of said first stylet corresponds to a combined length of said first intrabody member and said main member to control an insertion distance of said first stylet into said first intrabody member.

92. The kit of claim 90, wherein said length of said second stylet corresponds to a combined length of said second intrabody member and said main member to control an insertion distance of said second stylet into said second intrabody member.

93. The kit of claim 87, further comprising a surgical aide selected from the group consisting of:

retractors, dilators, tissue promoting cuffs, sutures, needles, syringes, scalpels, scissors, forceps, hemostats, sponges, bandages, ointments, lubricating gels, antiseptics, antimicrobials, antibiotics, analgesics and instructions for implanting said catheter assembly.