Multi-lumen heat transfer catheters

• US 7,811,249 B2
• Filed: 06/24/2005
• Issued: 10/12/2010
• Est. Priority Date: 08/13/1992
• Status: Expired due to Fees

• Current Assignee: Vention Medical Advanced Components, Inc. (Nordson Corporation)
• Original Assignee: Advanced Polymers Incorporated
• Inventors: Saab, Mark A.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US11/167,036
• Publication Number:
  US 20050273145A1
• Time in Patent Office: 1,936 Days
• Field of Search: 128/6, 128/713, 128/720, 128/724, 128/725, 600/466, 604/96, 604/508, 604 9501- 9505, 604 9601-10314
• US Class Current: 604/96.01
• CPC Class Codes: A61B 2018/00166 Multiple lumina
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: A61M 2025/0025 having a collapsible lumen
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Heat transfer catheter apparatus and methods of making and using same are disclosed wherein fluid connection means is provided between the distal portions of two adjacent, thin-walled, high strength fluid lumens to define a closed loop fluid circulation system capable of controlled delivery of thermal energy to or withdrawal of thermal energy from remote internal body locations.

Claims

1. Fluid circulation catheter apparatus for circulating a heat transfer fluid along a closed path from a proximal region of said catheter apparatus, to a distal region of said apparatus, and returning said fluid to a proximal region of said apparatus, said apparatus comprising a multi-lumen catheter comprising wall portions along at least a first section of said catheter, said first section consisting essentially of an orientable thermoplastic polymer, at least a portion of which has been at least partially oriented so as to be very thin-walled, high tensile strength, flexible, readily inflatable under fluid pressure and readily collapsible under vacuum, said first section of said catheter comprising three or more first section lumens wherein at least three of said first section lumens are common-wall-sharing lumens each of which shares a common, very thin, integrally-formed wall portion with at least one adjacent common-wall-sharing lumen along at least a section of their respective axial lengths, and further wherein:

(a) at least one of said common-wall-sharing lumens is a fluid inflow-lumen having inflow-lumen proximal and distal ends, an inflow-lumen fluid inlet proximate to the inflow-lumen proximal end, and an inflow-lumen fluid outlet between the inflow-lumen fluid inlet and the inflow-lumen distal end;

(b) at least one of said common-wall-sharing lumens is a fluid outflow-lumen having outflow-lumen proximal and distal ends, an outflow-lumen fluid outlet proximate to the outflow-lumen proximal end, and an outflow-lumen fluid inlet between the outflow-lumen fluid outlet and the outflow-lumen distal end; and

,

(c) the common wall portion between said inflow-lumen and said outflow-lumen includes at least an aperture that serves as an inflow-lumen fluid outlet and an outflow-lumen fluid inlet.

2. Fluid circulation catheter apparatus according to claim 1 comprising at least two inflow-lumens.

3. Fluid circulation catheter apparatus according to claim 1 comprising at least two outflow-lumens.

4. Fluid circulation catheter apparatus according to claim 1 comprising at least two inflow-lumens and at least two outflow-lumens.

5. Fluid circulation catheter apparatus according to claim 1 further wherein said fluid inflow- and fluid outflow-lumens are adapted in size and shape for circulating a heat transfer fluid through said fluid inflow- and fluid outflow-lumens.

6. Fluid circulation catheter apparatus according to claim 1 wherein at least three common-wall-sharing lumens are peripheral lumens, each having at least an exterior wall portion or a wall portion adjacent to an exterior wall, further wherein said peripheral lumens surround at least one common-wall-sharing interior lumen, which has no exterior wall portion and no wall portion adjacent to an exterior wall along said first section of said catheter.

7. Fluid circulation catheter apparatus according to claim 6 wherein at least one of said peripheral or interior lumens is adapted in size and shape to house a medical instrument.

8. Fluid circulation catheter apparatus according to claim 6 wherein said interior lumen is adapted in size and shape to house a medical instrument.

9. Fluid circulation catheter apparatus according to claim 6 wherein at least one of said peripheral or interior lumens is adapted in size and shape to provide a passageway for medicine delivery.

10. Fluid circulation catheter apparatus according to claim 6 wherein said interior lumen is adapted in size and shape to provide a passageway for medicine delivery.

11. Fluid circulation catheter apparatus according to claim 6 wherein at least one of said peripheral or interior lumens is adapted in size and shape to provide a passageway for fluid drainage.

12. Fluid circulation catheter apparatus according to claim 6 wherein said interior lumen is adapted in size and shape to provide a passageway for fluid drainage.

13. Fluid circulation catheter apparatus according to claim 6 wherein said peripheral and interior lumens have been biaxially oriented.

14. Fluid circulation catheter apparatus according to claim 6 wherein said peripheral and interior lumens consist essentially of biaxially-oriented polyethylene terephthalate.

15. Fluid circulation catheter apparatus according to claim 6 wherein at least three peripheral lumens surround a central interior lumen.

16. Fluid circulation catheter apparatus according to claim 15 wherein said central lumen is adapted in size and shape to provide a passageway for medicine delivery.

17. Fluid circulation catheter apparatus according to claim 15 wherein said central lumen is adapted in size and shape to house a diagnostic or therapeutic instrument.

27. Fluid circulation catheter apparatus according to claim 1 wherein said common-wall-sharing lumens have been biaxially oriented.

28. Fluid circulation catheter apparatus according to claim 1 wherein said common-wall-sharing lumens consist essentially of biaxially-oriented polyethylene terephthalate.

46. Fluid circulation catheter apparatus according to claim 1 wherein a wall portion of at least a fluid inflow-lumen or of a fluid outflow-lumen is formed so as to have a varying cross-sectional diameter along its length in order to cause turbulent fluid flow for purposes of increased heat transfer.

18. Catheter apparatus for adding or removing heat from an internal body region, said apparatus comprising a multi-lumen catheter comprising wall portions along at least a first section of said catheter, said first section consisting essentially of an orientable thermoplastic polymer, at least a portion of which has been at least partially oriented so as to be very thin-walled, high tensile strength, flexible, readily inflatable under fluid pressure and readily collapsible under vacuum, said first section of said catheter comprising three or more first section lumens wherein each of at least three of said first section lumens shares a common, very thin, integrally-formed wall portion with at least one adjacent first section lumen along at least a section of their respective axial lengths, and further wherein:

(a) at least one of said first section lumens is a heat transfer fluid inflow-lumen having a heat transfer fluid inlet;

(b) at least one of said first section lumens is a heat transfer fluid outflow-lumen having a heat transfer fluid outlet, said outflow-lumen being in fluid communication with said inflow-lumen for circulation of a heat transfer fluid; and

,

(c) at least one of said first section lumens is a perfusion lumen having a body fluid inlet and a body fluid outlet, wherein at least one of said inflow- and outflow-lumens has a heat transfer region therealong adjacent to a wall of said perfusion lumen.

19. Catheter apparatus according to claim 18 further comprising a heat transfer fluid circulating through said inflow- and outflow-lumens.

20. Catheter apparatus according to claim 18 further comprising blood flowing through said perfusion lumen.

21. Catheter apparatus according to claim 18 wherein at least three of said first section lumens are peripheral lumens which surround a central lumen.

22. Catheter apparatus according to claim 21 wherein said central lumen is adapted in size and shape to provide a passageway for medicine delivery or to house a diagnostic or therapeutic instrument.

29. Catheter apparatus according to claim 18 further wherein the common wall portion between at least two of said first section lumens includes at least an aperture for fluid flow between the two first section lumens.

30. Catheter apparatus according to claim 18 wherein said first section lumens have been biaxially oriented.

31. Catheter apparatus according to claim 18 wherein said first section lumens consist essentially of biaxially-oriented polyethylene terephthalate.

23. Fluid circulation catheter apparatus for circulating a heat transfer fluid along a closed path from a proximal region of said catheter apparatus, to a distal region of said apparatus, and returning said fluid to a proximal region of said apparatus, said apparatus comprising a multi-lumen catheter comprising wall portions along at least a first section of said catheter, said first section consisting essentially of an orientable thermoplastic polymer, at least a portion of which has been at least partially oriented so as to be very thin-walled, high tensile strength, flexible, readily inflatable under fluid pressure and readily collapsible under vacuum, said first section of said catheter comprising three or more first section lumens wherein at least three of said first section lumens are common-wall-sharing lumens each of which shares a common, very thin, integrally-formed wall portion with at least one adjacent common-wall-sharing lumen along at least a section of their respective axial lengths, and further wherein:

(a) at least two of said common-wall-sharing lumens are fluid inflow-lumens, each having inflow-lumen proximal and distal ends, an inflow-lumen fluid inlet proximate to the inflow-lumen proximal end, and an inflow-lumen fluid outlet between the inflow-lumen fluid inlet and the inflow-lumen distal end;

(b) at least two of said common-wall-sharing lumens are fluid outflow-lumens, each having outflow-lumen proximal and distal ends, an outflow-lumen fluid outlet proximate to the outflow-lumen proximal end, and an outflow-lumen fluid inlet between the outflow-lumen fluid outlet and the outflow-lumen distal end; and

,

(c) the common wall portions between respective sets of inflow-lumens and the associated outflow-lumens each include at least an aperture that serves as an inflow-lumen fluid outlet and an outflow-lumen fluid inlet.

32. Fluid circulation catheter apparatus according to claim 23 wherein said common-wall-sharing lumens have been biaxially oriented.

33. Fluid circulation catheter apparatus according to claim 23 wherein said common-wall-sharing lumens consist essentially of biaxially-oriented polyethylene terephthalate.

24. Fluid circulation catheter apparatus for circulating a heat transfer fluid along a closed path from a proximal region of said catheter apparatus, to a distal region of said apparatus, and returning said fluid to a proximal region of said apparatus, said apparatus comprising a multi-lumen catheter comprising wall portions along at least a first section of said catheter, said first section consisting essentially of an orientable thermoplastic polymer, at least a portion of which has been at least partially oriented so as to be very thin-walled, high tensile strength, flexible, readily inflatable under fluid pressure and readily collapsible under vacuum, said first section of said catheter comprising three or more first section lumens wherein at least three of said first section lumens are common-wall-sharing lumens each of which shares a common, very thin, integrally-formed wall portion with at least one adjacent common-wall-sharing lumen along at least a section of their respective axial lengths, and further wherein:

(a) at least one of said common-wall-sharing lumens is a fluid inflow-lumen having inflow-lumen proximal and distal ends, an inflow-lumen fluid inlet proximate to the inflow-lumen proximal end, and an inflow-lumen fluid outlet between the inflow-lumen fluid inlet and the inflow-lumen distal end;

(b) at least one of said common-wall-sharing lumens is a fluid outflow-lumen having outflow-lumen proximal and distal ends, an outflow-lumen fluid outlet proximate to the outflow-lumen proximal end, and an outflow-lumen fluid inlet between the outflow-lumen fluid outlet and the outflow-lumen distal end; and

,

(c) the common wall portion between said inflow-lumen and said outflow-lumen includes at least an aperture that serves as an inflow-lumen fluid outlet and an outflow-lumen fluid inlet;

further wherein at least three common-wall-sharing lumens are peripheral lumens, each having at least an exterior wall portion or a wall portion adjacent to an exterior wall, and further wherein said peripheral lumens surround at least one common-wall-sharing interior lumen, which has no exterior wall portions and no wall portions adjacent to an exterior wall along said first section of said catheter.

34. Fluid circulation catheter apparatus according to claim 24 wherein said peripheral and interior lumens have been biaxially oriented.

35. Fluid circulation catheter apparatus according to claim 24 wherein said peripheral and interior lumens consist essentially of biaxially-oriented polyethylene terephthalate.

36. Fluid circulation catheter apparatus according to claim 24 comprising at least two inflow-lumens and at least two outflow-lumens.

37. Fluid circulation catheter apparatus according to claim 36 wherein at least three peripheral lumens surround a central interior lumen.

25. Catheter apparatus for adding or removing heat from an internal body region, said apparatus comprising a multi-lumen catheter comprising wall portions along at least a first section of said catheter, said first section consisting essentially of an orientable thermoplastic polymer, at least a portion of which has been at least partially oriented so as to be very thin-walled, high tensile strength, flexible, readily inflatable under fluid pressure and readily collapsible under vacuum, said first section of said catheter comprising three or more first section lumens wherein each of at least three of said first section lumens shares a common, very thin, integrally-formed wall portion with at least one adjacent first section lumen along at least a section of their respective axial lengths, and further wherein:

(a) at least two of said first section lumens are heat transfer fluid inflow-lumens, each having a heat transfer fluid inlet;

(b) at least two of said first section lumens are heat transfer fluid outflow-lumens, each having a heat transfer fluid outlet, each said outflow-lumen being in fluid communication with at least one associated inflow-lumen for circulation of a heat transfer fluid; and

,

(c) at least one of said first section lumens is a perfusion lumen having a body fluid inlet and a body fluid outlet, wherein at least one set of associated inflow- and outflow-lumens has a heat transfer region therealong adjacent to a wall of said perfusion lumen.

38. Catheter apparatus according to claim 25 wherein said first section lumens have been biaxially oriented.

39. Catheter apparatus according to claim 25 wherein said first section lumens consist essentially of biaxially-oriented polyethylene terephthalate.

40. Catheter apparatus according to claim 25 wherein for at least two lumen sets, each comprising an inflow-lumen and an associated outflow lumen, the common wall portion between an inflow-lumen and an associated outflow-lumen includes at least an aperture that serves as an inflow-lumen fluid outlet and an outflow-lumen fluid inlet.

26. Catheter apparatus for adding or removing heat from an internal body region, said apparatus comprising a multi-lumen catheter comprising wall portions along at least a first section of said catheter, said first section consisting essentially of an orientable thermoplastic polymer, at least a portion of which has been at least partially oriented so as to be very thin-walled, high tensile strength, flexible, readily inflatable under fluid pressure and readily collapsible under vacuum, said first section of said catheter comprising three or more first section lumens wherein each of at least three of said first section lumens shares a common, very thin, integrally-formed wall portion with at least one adjacent first section lumen along at least a section of their respective axial lengths, and further wherein:

(a) at least one of said first section lumens is a heat transfer fluid inflow-lumen having a heat transfer fluid inlet;

(b) at least one of said first section lumens is a heat transfer fluid outflow-lumen having a heat transfer fluid outlet, said outflow-lumen being in fluid communication with said inflow-lumen for circulation of a heat transfer fluid; and

,

(c) at least one of said first section lumens is a perfusion lumen having a body fluid inlet and a body fluid outlet, wherein at least one of said inflow- and outflow-lumens has a heat transfer region therealong adjacent to a wall of said perfusion lumen;

further wherein at least three first section lumens are peripheral lumens, each having at least an exterior wall portion or a wall portion adjacent to an exterior wall, and further wherein said peripheral lumens surround at least one interior first section lumen, which has no exterior wall portions and no wall portions adjacent to an exterior wall along said first section of said catheter.

41. Catheter apparatus according to claim 26 wherein said peripheral and interior lumens have been biaxially oriented.

42. Catheter apparatus according to claim 26 wherein said peripheral and interior lumens consist essentially of biaxially-oriented polyethylene terephthalate.

43. Catheter apparatus according to claim 26 further wherein the common wall portion between said inflow-lumen and said outflow-lumen includes at least an aperture that serves as an inflow-lumen fluid outlet and as an outflow-lumen fluid inlet.

44. Catheter apparatus according to claim 26 comprising at least two inflow-lumens and at least two outflow-lumens.

45. Catheter apparatus according to claim 44 wherein at least three peripheral lumens surround a central interior lumen.

47. Fluid circulation catheter apparatus for circulating a heat transfer fluid along a closed path from a proximal region of said catheter apparatus, to a distal region of said apparatus, and returning said fluid to a proximal region of said apparatus, said apparatus comprising a multi-lumen catheter comprising wall portions along at least a first section of said catheter, said first section of said catheter comprising three or more first section lumens at least one of which is formed to have a varying cross-sectional diameter along its length in order to cause turbulent fluid flow along its length for purposes of increased heat transfer, and wherein at least three of said first section lumens are common-wall-sharing lumens and further wherein:

(a) at least one of said common-wall-sharing lumens is a fluid inflow-lumen having inflow-lumen proximal and distal ends, an inflow-lumen fluid outlet proximate to the inflow-lumen distal end;

(b) at least one of said common-wall-sharing lumens is a fluid outflow-lumen having outflow-lumen proximal and distal ends, an outflow-lumen fluid inlet proximate to the outflow-lumen distal end; and

,

(c) an aperture between the inflow-lumen fluid outlet and an outflow-lumen fluid inlet.