Lumen design for catheter

• US 6,379,378 B1
• Filed: 03/03/2000
• Issued: 04/30/2002
• Est. Priority Date: 03/03/2000
• Status: Expired due to Fees

• Current Assignee: Philips Electronics North America Corporation (Koninklijke Philips N.V.)
• Original Assignee: Innercool therapies Incorporated (Taxus Cardium Pharmaceuticals Group, Inc.)
• Inventors: Werneth, Randell L., Yon, Steven A., Gilmartin, Kevin P., Dobak, John D III, Lasheras, Juan C
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/519,022
• Time in Patent Office: 788 Days
• Field of Search: 607/96, 607/104, 607/105, 607/106, 606/20-23, 606/27, 606/28
• US Class Current: 607/105
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities

Abstract

The invention provides a device for heating or cooling a surrounding fluid in a feeding vessel and a method of manufacturing the same. The device includes a catheter assembly capable of insertion to a selected blood vessel in the vascular system of a patient. The assembly includes an elongated catheter body, a heat transfer element located at a distal portion of the catheter body and including an interior, an elongated supply lumen adapted to deliver a working fluid to the interior of the heat transfer element and having a hydraulic diameter, an elongated return lumen adapted to return a working fluid from the interior of the heat transfer element and having a hydraulic diameter, and wherein the ratio of the hydraulic diameter of the return lumen to the hydraulic diameter of the supply lumen is substantially equal to 0.75. The method of manufacturing the catheter assembly involves extruding an elongated catheter body; locating a heat transfer element including an interior at a distal portion of the catheter body; extruding an integrated elongated bi-lumen member including a first lumen adapted to receive a guide wire and a second lumen having a hydraulic diameter, the second lumen comprising either a supply lumen to deliver a working fluid to an interior of the heat transfer element or a return lumen to return a working fluid from the interior of the heat transfer element; and providing the integrated bi-lumen member substantially within the elongated catheter body so that a third lumen having a hydraulic diameter is formed, the third lumen comprising either a supply lumen to deliver a working fluid to an interior of the heat transfer element or a return lumen to return a working fluid from the interior of the heat transfer element and the ratio of the second lumen hydraulic diameter to the third lumen hydraulic diameter is substantially equal to 0.75.

Claims

1. A device for heating or cooling a surrounding fluid in a blood vessel, comprising:

an elongated catheter body;

a heat transfer element located at a distal portion of the catheter body and including an interior;

an elongated supply lumen having a cross-sectional area located within the catheter body and adapted to deliver a working fluid to the interior of the heat transfer element;

an elongated return lumen having a cross-sectional area located within the catheter body and adapted to return a working fluid from the interior of the heat transfer element; and

the ratio of the hydraulic diameter of the return lumen to the hydraulic diameter of the supply lumen being substantially equal to 0.75.

2. The device of claim 1, wherein the supply lumen is disposed substantially within the return lumen.

3. The device of claim 1, wherein one of the supply lumen and return lumen has a cross-sectional shape that is substantially luniform.

4. The device of claim 1, wherein one of the supply lumen and the return lumen has a cross-sectional shape that is annular.

5. The device of claim 1, wherein said heat transfer element includes an interior portion adapted to induce mixing of the working fluid and means for further enhancing mixing of said working fluid.

6. The device of claim 1, wherein the heat transfer element includes an interior distal portion, the supply lumen includes first means for delivering working fluid to the interior distal portion of the heat transfer element and second means for delivering working fluid to the interior of the heat transfer element at one or more points point proximal to the distal portion of the heat transfer element.

7. The device of claim 1, wherein the supply lumen has a general cross-sectional shape and the return lumen has a general cross-sectional shape different from the general cross-sectional shape of the supply lumen.

8. The device of claim 1, wherein said catheter assembly includes an integrated elongated bi-lumen member including a first lumen adapted to receive a guide wire and a second lumen, the second lumen comprising either said supply lumen or said return lumen.

9. The device of claim 8, wherein said bi-lumen member has a cross-sectional shape that is substantially in the shape of a figure eight.

10. The device of claim 8, wherein said first lumen has a cross-sectional shape that is substantially circular and the second lumen has a cross-sectional shape that is annular.

11. The device of claim 1, wherein the heating element includes means for inducing mixing in a surrounding fluid.

12. A catheter assembly capable of insertion into a selected blood vessel in the vascular system of a patient, comprising:

an elongated catheter body including an operative element having an interior at a distal portion of the catheter body;

an elongated supply lumen adapted to deliver a working fluid to the interior of said distal portion and having a hydraulic diameter;

an elongated return lumen adapted to return a working fluid from the interior of said operative element and having a hydraulic diameter; and

the ratio of the hydraulic diameter of the return lumen to the hydraulic diameter of the supply lumen being substantially equal to 0.75.

13. The catheter assembly of claim 12, wherein the supply lumen is disposed substantially within the return lumen.

14. The catheter assembly of claim 12, wherein one of the supply lumen and return lumen has a cross-sectional shape that is substantially luniform.

15. The catheter assembly of claim 12, wherein one of the supply lumen and the return lumen has a cross-sectional shape that is annular.

16. The catheter assembly of claim 12, wherein the supply lumen has a general cross-sectional shape and the return lumen has a general cross-sectional shape different from the general cross-sectional shape of the supply lumen.

17. The catheter assembly of claim 12, wherein said catheter assembly includes an integrated bi-lumen member including a first lumen adapted to receive a guide wire and a second lumen, the second lumen comprising either said supply lumen or said return lumen.

18. The catheter assembly of claim 17, wherein said bi-lumen member has a cross-sectional shape that is substantially in the shape of a figure eight.

19. The catheter assembly of claim 17, wherein said first lumen has a cross-sectional shape that is substantially circular and the second lumen has a cross-sectional shape that is substantially luniform.

20. The catheter assembly of claim 12, wherein said operative element includes a heat transfer element adapted to transfer heat to or from said working fluid.

21. The catheter assembly of claim 20, wherein said heat transfer element includes means for inducing mixing in a surrounding fluid.

22. The catheter assembly of claim 12, wherein said operative element includes a catheter balloon adapted to be inflated with said working fluid.

23. A device for heating or cooling a surrounding fluid in a blood vessel, comprising:

an elongated catheter body including an internal wall;

a heat transfer element located at a distal portion of the catheter body and including an interior;

an integrated elongated bi-lumen member located within said catheter body and including an external wall, a first lumen adapted to receive a guide wire and a second lumen, the second lumen comprising either a supply lumen to deliver a working fluid to an interior of the heat transfer element or a return lumen to return a working fluid from the interior of the heat transfer element; and

a third lumen comprising either a supply lumen to deliver a working fluid to an interior of the heat transfer element or a return lumen to return a working fluid from the interior of the heat transfer element, the third lumen substantially defined by said internal wall of the catheter body and the exterior wall of the bi-lumen member.

24. A device for heating or cooling a surrounding fluid in a blood vessel, comprising:

an elongated catheter body;

a heat transfer element located at a distal portion of the catheter body and including an interior;

an integrated elongated bi-lumen member located within said catheter body and including a first lumen adapted to receive a guide wire and a second lumen, the second lumen comprising either a supply lumen to deliver a working fluid to an interior of the heat transfer element or a return lumen to return a working fluid from the interior of the heat transfer element; and

a third lumen comprising either a supply lumen to deliver a working fluid to an interior of the heat transfer element or a return lumen to return a working fluid from the interior of the heat transfer element, the bi-lumen member disposed substantially within the third lumen.

25. A device for heating or cooling a surrounding fluid in a blood vessel, comprising:

an elongated catheter body;

a heat transfer element located at a distal portion of the catheter body and including an interior;

an integrated elongated bi-lumen member located within said catheter body and including a first lumen adapted to receive a guide wire and a second lumen, the second lumen comprising either a supply lumen to deliver a working fluid to an interior of the heat transfer element or a return lumen to return a working fluid from the interior of the heat transfer element; and

a third lumen comprising either a supply lumen to deliver a working fluid to an interior of the heat transfer element or a return lumen to return a working fluid from the interior of the heat transfer element the third lumen having a cross-sectional shape that is annular.

26. A device for heating or cooling a surrounding fluid in a blood vessel, comprising:

an elongated catheter body;

a heat transfer element located at a distal portion of the catheter body and including an interior portion adapted to induce mixing of the working fluid and means for further enhancing mixing of said working fluid;

an integrated elongated bi-lumen member located within said catheter body and including a first lumen adapted to receive a guide wire and a second lumen, the second lumen comprising either a supply lumen to deliver a working fluid to the interior portion of the heat transfer element or a return lumen to return a working fluid from the interior portion of the heat transfer element; and

a third lumen comprising either a supply lumen to deliver a working fluid to the interior portion of the heat transfer element or a return lumen to return a working fluid from the interior portion of the heat transfer element.

27. A device for heating or cooling a surrounding fluid in a blood vessel, comprising:

an elongated catheter body;

a heat transfer element located at a distal portion of the catheter body and including an interior and an interior distal portion;

an integrated elongated bi-lumen member located within said catheter body and including a first lumen adapted to receive a guide wire and a second lumen, the second lumen comprising either a supply lumen to deliver a working fluid to an interior of the heat transfer element or a return lumen to return a working fluid from the interior of the heat transfer element; and

a third lumen comprising either a supply lumen to deliver a working fluid to an interior of the heat transfer element or a return lumen to return a working fluid from the interior of the heat transfer element, the supply lumen including first means for delivering working fluid to the interior distal portion of the heat transfer element and second means for delivering working fluid to the interior of the heat transfer element at one or more points proximal to the distal portion of the heat transfer element.

28. A device for heating or cooling a surrounding fluid in a blood vessel, comprising:

an elongated catheter body;

a heat transfer element located at a distal portion of the catheter body and including an interior;

an integrated elongated bi-lumen member located within said catheter body and including a first lumen adapted to receive a guide wire and a second lumen, the second lumen comprising either a supply lumen to deliver a working fluid to an interior of the heat transfer element or a return lumen to return a working fluid from the interior of the heat transfer element, the second lumen having a general cross-sectional shape; and

a third lumen comprising either a supply lumen to deliver a working fluid to an interior of the heat transfer element or a return lumen to return a working fluid from the interior of the heat transfer element, the third lumen having a general cross-sectional shape different from the general cross-sectional shape of the second lumen.

29. A device for heating or cooling a surrounding fluid in a blood vessel, comprising:

an elongated catheter body;

a heat transfer element located at a distal portion of the catheter body and including an interior;

an integrated elongated bi-lumen member located within said catheter body and including a first lumen adapted to receive a guide wire and a second lumen, the second lumen comprising either a supply lumen to deliver a working fluid to an interior of the heat transfer element or a return lumen to return a working fluid from the interior of the heat transfer element, the bi-lumen member having a cross-sectional shape that is substantially in the shape of a figure eight; and

a third lumen comprising either a supply lumen to deliver a working fluid to an interior of the heat transfer element or a return lumen to return a working fluid from the interior of the heat transfer element.

30. A device for heating or cooling a surrounding fluid in a blood vessel, comprising:

an elongated catheter body;

a heat transfer element located at a distal portion of the catheter body and including an interior and means for inducing mixing in a surrounding fluid;

an integrated elongated bi-lumen member located within said catheter body and including a first lumen adapted to receive a guide wire and a second lumen, the second lumen comprising either a supply lumen to deliver a working fluid to an interior of the heat transfer element or a return lumen to return a working fluid from the interior of the heat transfer element; and

a third lumen comprising either a supply lumen to deliver a working fluid to an interior of the heat transfer element or a return lumen to return a working fluid from the interior of the heat transfer element.

31. The catheter assembly of claim 30, wherein the catheter body includes an internal wall and the integrated bi-lumen member includes an exterior wall, the third lumen substantially defined by said internal wall of the catheter body and the exterior wall of the bi-lumen member.

32. A catheter assembly capable of insertion into a selected blood vessel in the vascular system of a patient, including:

an elongated catheter body including an operative element having an interior at a distal portion of the catheter body;

an integrated elongated bi-lumen member located within said catheter body and including a first lumen adapted to receive a guide wire and a second lumen, the second lumen comprising either a supply lumen to deliver a working fluid to the interior of the operative element or a return lumen to return a working fluid from the interior of the operative element; and

a third lumen within said catheter body and comprising either a supply lumen to deliver a working fluid to an interior of the operative element or a return lumen to return a working fluid from the interior of the operative element, the bi-lumen member disposed substantially within the third lumen.

33. A catheter assembly capable of insertion into a selected blood vessel in the vascular system of a patient, including:

an elongated catheter body including an operative element having an interior at a distal portion of the catheter body;

an integrated elongated bi-lumen member located within said catheter body and including a first lumen adapted to receive a guide wire and a second lumen, the second lumen comprising either a supply lumen to deliver a working fluid to the interior of the operative element or a return lumen to return a working fluid from the interior of the operative element; and

a third lumen within said catheter body and comprising either a supply lumen to deliver a working fluid to an interior of the operative element or a return lumen to return a working fluid from the interior of the operative element, said third lumen having a cross-sectional shape that is annular.

34. A catheter assembly capable of insertion into a selected blood vessel in the vascular system of a patient, including:

an elongated catheter body including an operative element having an interior at a distal portion of the catheter body;

an integrated elongated bi-lumen member located within said catheter body and including a first lumen adapted to receive a guide wire and a second lumen, the second lumen comprising either a supply lumen to deliver a working fluid to the interior of the operative element or a return lumen to return a working fluid from the interior of the operative element, the second lumen having a general cross-sectional shape; and

a third lumen within said catheter body and comprising either a supply lumen to deliver a working fluid to an interior of the operative element or a return lumen to return a working fluid from the interior of the operative element, the third lumen having a general cross-sectional shape different from the general cross-sectional shape of the second lumen.

35. A catheter assembly capable of insertion into a selected blood vessel in the vascular system of a patient, including:

an elongated catheter body including an operative element having an interior at a distal portion of the catheter body;

an integrated elongated bi-lumen member located within said catheter body and including a first lumen adapted to receive a guide wire and a second lumen, the second lumen comprising either a supply lumen to deliver a working fluid to the interior of the operative element or a return lumen to return a working fluid from the interior of the operative element, said bi-lumen member having a cross-sectional shape that is substantially in the shape of a figure eight; and

a third lumen within said catheter body and comprising either a supply lumen to deliver a working fluid to an interior of the operative element or a return lumen to return a working fluid from the interior of the operative element.

36. A device for heating or cooling a surrounding fluid in a blood vessel, comprising:

an elongated catheter body;

a heat transfer element including at least a first heat transfer segment and a second heat transfer segment located at a distal portion of the catheter body and including an interior distal portion and an interior portion; and

a first elongated supply lumen located within the catheter body and terminating at the interior distal portion of the heat transfer element into first means for delivering working fluid to the interior distal portion of the heat transfer element; and

a second elongated supply lumen located within the catheter body and terminating at a point proximal to the distal portion of the heat transfer element into second means for delivering working fluid to the interior portion of the heat transfer element at a point proximal to the distal portion of the heat transfer element.

37. The device of claim 36, wherein the first working fluid delivering means is adapted to deliver working fluid to the interior distal portion of the heat transfer element and the second working fluid delivering means is adapted to deliver working fluid to the interior portion of the heat transfer element near a midpoint of the heat transfer element.

38. A device for heating or cooling a surrounding fluid in a blood vessel, comprising:

an elongated catheter body;

a heat transfer element including at least a first heat transfer segment and a second heat transfer segment located at a distal portion of the catheter body and including an interior distal portion and an interior portion; and

a first elongated supply lumen located within the catheter body and terminating at the interior distal portion of the first heat transfer segment into first means for delivering working fluid to the interior of the first heat transfer segment; and

a second elongated supply lumen located within the catheter body and terminating at a point proximal to the distal portion of the heat transfer element into second means for delivering working fluid to the interior portion of the second heat transfer segment.

39. The device of claim 38, wherein the second working fluid delivering means is adapted to deliver working fluid to the interior portion of the heat transfer element near a midpoint of the heat transfer element.

40. A device for heating or cooling a surrounding fluid in a blood vessel, comprising:

an elongated catheter body;

a heat transfer element located at a distal portion of the catheter body and including an interior portion adapted to induce mixing of a working fluid to effect heat transfer between the heat transfer element and working fluid, the heat transfer element including at least a first heat transfer segment, a second heat transfer segment, and an intermediate segment between the first heat transfer segment and the second heat transfer segment;

an elongated supply lumen member located within the catheter body and adapted to deliver the working fluid to the interior of the heat transfer element, said supply lumen member including a circular outer surface;

an elongated return lumen defined in part by the outer surface of the supply lumen member and the interior portion of the heat transfer element and adapted to return the working fluid from the interior of the heat transfer element; and

wherein the distance between the interior portion of the heat transfer element and the outer surface of the supply lumen member adjacent the intermediate segment is less than the distance between the interior portion of the heat transfer element and the outer surface of the supply lumen member adjacent the first heat transfer segment.

41. The device of claim 40, wherein the distance between the interior portion of the heat transfer element and the outer surface of the supply lumen member adjacent the intermediate segment is such that the characteristic flow resulting from a flow of working fluid is at least of a transitional nature.

42. The device of claim 40, wherein the intermediate segment includes an interior diameter that is less than the interior diameter of the first heat transfer segment or the second heat transfer segment.

43. The device of claim 40, wherein the supply lumen member includes an outer diameter adjacent the intermediate segment that is greater than its outer diameter adjacent the first heat transfer segment or the second heat transfer segment.

44. The device of claim 40, wherein the supply lumen member comprises a multiple-lumen member.

45. The device of claim 40, wherein the supply lumen member includes a supply lumen having a hydraulic diameter and the return lumen has a hydraulic diameter substantially equal to 0.75 of the hydraulic diameter of the supply lumen.

46. The device of claim 40, wherein the intermediate segment includes a flexible bellows joint.

47. The device of claim 40, wherein the intermediate segment includes a flexible tube.

48. A device for heating or cooling a surrounding fluid in a blood vessel, comprising:

an elongated catheter body;

a heat transfer element located at a distal portion of the catheter body and including an interior portion with first means for mixing a working fluid to effect heat transfer between the heat transfer element and working fluid;

an elongated supply lumen member located within the catheter body and adapted to deliver the working fluid to the interior of the heat transfer element;

an elongated return lumen member located within the catheter body and adapted to return the working fluid from the interior of the heat transfer element; and

second means located within said heat transfer element for further enhancing mixing of said working fluid to effect further heat transfer between the heat transfer element and working fluid, said second means being different from said first means.

49. A device for heating or cooling a surrounding fluid in a blood vessel, comprising:

an elongated catheter body;

a heat transfer element located at a distal portion of the catheter body and including an interior portion adapted to induce mixing of a working fluid to effect heat transfer between the heat transfer element and working fluid;

an elongated supply lumen member located within the catheter body and adapted to deliver the working fluid to the interior of the heat transfer element, the supply lumen member including a multiple-lumen member having a circular outer surface;

an elongated return lumen member located within the catheter body and adapted to return the working fluid from the interior of the heat transfer element; and

means located within said heat transfer element for further enhancing mixing of said working fluid to effect further heat transfer between the heat transfer element and working fluid.

50. A device for heating or cooling a surrounding fluid in a blood vessel, comprising:

an elongated catheter body;

a heat transfer element located at a distal portion of the catheter body and including an interior portion adapted to induce mixing of a working fluid to effect heat transfer between the heat transfer element and working fluid;

an elongated supply lumen member located within the catheter body and adapted to deliver the working fluid to the interior of the heat transfer element, the supply lumen member including a supply lumen having a hydraulic diameter;

an elongated return lumen member located within the catheter body and adapted to return the working fluid from the interior of the heat transfer element, the return lumen having a hydraulic diameter substantially equal to 0.75 of the hydraulic diameter of the supply lumen; and

means located within said heat transfer element for further enhancing mixing of said working fluid to effect further heat transfer between the heat transfer element and working fluid.

51. A device for heating or cooling a surrounding fluid in a blood vessel, comprising:

an elongated catheter body;

a heat transfer element located at a distal portion of the catheter body and including an interior portion adapted to induce mixing of a working fluid to effect heat transfer between the heat transfer element and working fluid;

an elongated supply lumen member located within the catheter body and adapted to deliver the working fluid to the interior of the heat transfer element, the supply lumen member including a multiple-lumen member having a circular outer surface;

an elongated return lumen member located within the catheter body and adapted to return the working fluid from the interior of the heat transfer element; and

a mixing-enhancing mechanism located within said heat transfer element and adapted to further mix said working fluid to effect further heat transfer between the heat transfer element and working fluid.

52. A device for heating or cooling a surrounding fluid in a blood vessel, comprising:

an elongated catheter body;

a heat transfer element located at a distal portion of the catheter body and including an interior portion adapted to induce mixing of a working fluid to effect heat transfer between the heat transfer element and working fluid;

an elongated supply lumen member located within the catheter body and adapted to deliver the working fluid to the interior of the heat transfer element, the supply lumen member including a supply lumen having a hydraulic diameter;

an elongated return lumen member located within the catheter body and adapted to return the working fluid from the interior of the heat transfer element, the return lumen having a hydraulic diameter substantially equal to 0.75 of the hydraulic diameter of the supply lumen; and

a mixing-enhancing mechanism located within said heat transfer element and adapted to further mix said working fluid to effect further heat transfer between the heat transfer element and working fluid.

53. A method of heating or cooling a surrounding fluid in a blood vessel, comprising:

providing a device for heating or cooling a surrounding fluid in a blood vessel within the blood stream of a blood vessel, the device including an elongated catheter body, a heat transfer element located at a distal portion of the catheter body and including an interior portion with first means for mixing a working fluid to effect heat transfer between the heat transfer element and working fluid, an elongated supply lumen member located within the catheter body and adapted to deliver the working fluid to the interior of the heat transfer element, an elongated return lumen member located within the catheter body and adapted to return the working fluid from the interior of the heat transfer element, and second means located within said heat transfer element for further enhancing mixing of said working fluid to effect further heat transfer between the heat transfer element and working fluid, said second means being different from said first means;

causing a working fluid to flow to and along the interior portion of the heat transfer element of the device using the supply lumen and return lumen;

facilitating the transfer of heat between the working fluid and the heat transfer element by effecting mixing of the working fluid with the first means for mixing the working fluid;

facilitating additional transfer of heat between the working fluid and the heat transfer element by effecting further mixing of the working fluid within the interior portion with the second means for further enhancing mixing of the working fluid;

causing heat to be transferred between the blood stream and the heat transfer element without ablating tissue by the heat transferred between the heat transfer element and working fluid.