Method and device for delivering heat to hollow body organs

• US 5,188,602 A
• Filed: 06/08/1992
• Issued: 02/23/1993
• Est. Priority Date: 07/12/1990
• Status: Expired due to Term

• Current Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Original Assignee: Interventional Thermodynamics, Inc.
• Inventors: Nichols, Colin J.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Maglione, C.
• Application Number:
  US07/895,579
• Time in Patent Office: 260 Days
• Field of Search: 604/113-114, 604/96, 604/105-107, 604/49, 606/33, 606/49, 128/784-786, 128/804, 128/401
• US Class Current: 604/113
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• 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

Abstract

A catheter for thermally treating a hollow body organ includes a first flexible elongate member having a heater element at or near its distal end. A second flexible elongate member may be slidably disposed within a central lumen of the first flexible elongate member and may include an occluding means, such as an inflatable balloon, at its distal end. By first inserting the distal end of the second flexible elongate member within a hollow body organ or connecting region, the heater element on the first flexible elongate member may then be positioned and repositioned by axially translating the first flexible elongate member over the exterior of the second flexible elongate member. A collapsible shield may also be provided about the exposed heater element on the first flexible elongate member. The shield typically comprises a cylinder having a plurality of axial slots near its distal end. A plurality of ribs defined by the slots may be expanded radially outward by compressing the cylinder in the distal direction or by releasing tension which has maintained the shield in a radially collapsed configuration. Once expanded, the shield may be rotated to effect mixing of the fluid surrounding the catheter.

Claims

1. A catheter for heating a hollow body organ, said catheter comprising:

a first flexible elongate member having a proximal end, a distal end, and an axial lumen extending between said proximal and distal ends;

a second flexible elongate member slidably disposed within the axial lumen of the first flexible elongate member;

means disposed externally near the distal end of the first flexible elongate member for heating an environment surrounding the catheter; and

means on the second flexible elongate member for sealing a region connecting with the hollow body organ.

2. A catheter as in claim 1, wherein the means for sealing includes an inflatable balloon.

3. A catheter as in claim 1, having an annular lumen between the first and second flexible elongate members.

4. A catheter as in claim 1, further comprising a shield and means on the first flexible elongate member for expanding the shield about the heating means while the heating means is positioned within the hollow body organ.

5. A catheter as in claim 1, wherein the means for heating on the first flexible elongate member comprises a coil resistance heater disposed externally on the member.

6. A catheter as in claim 5, wherein the coil resistance heater extends over a length in the range from about 3 mm to 6 cm.

7. A catheter for heating a hollow body organ, said catheter comprising:

a first flexible elongate member having a proximal end, a distal end, and an axial lumen extending between said proximal and distal ends;

a second flexible elongate member slidably disposed within the axial lumen of the first flexible elongate member, said second flexible elongate member being a flexible tubular structure having an axial lumen available for perfusion or aspiration and having sufficient column strength to act as a guide for axially positioning the first flexible elongate member thereover;

means on the second flexible elongate member for sealing a region connecting with the hollow body organ; and

means disposed externally near the distal end of the first flexible elongate member for heating an environment surrounding the catheter.

8. A catheter as in claim 7, wherein the means for sealing includes an inflatable balloon.

9. A catheter as in claim 7, having an annular lumen between the first and second flexible elongate members.

10. A catheter as in claim 7, further comprising a shield and means on the first flexible elongate member for expanding the shield about the heating means while the heating means is positioned within the hollow body organ.

11. A catheter as in claim 7, wherein the means for heating on the first flexible elongate member comprises a coil resistance heater disposed externally on the member.

12. A catheter as in claim 11, wherein the coil resistance heater extends over a length in the range from about 3 mm to 6 cm.

13. A method for heating a hollow body organ, said method comprising:

(a) placing a distal end of a second flexible elongate member within the hollow body organ;

(b) positioning a first flexible elongate member over the second flexible elongate member so that a heater on said first flexible elongate member lies within a first desired region within the hollow body organ;

(c) heating the first desired region with the heater;

(d) repositioning the first flexible elongate member over the second flexible elongate member so that the heater lies within a second desired region within the hollow body organ; and

(e) heating the second desired region with the heater.

14. A method as in claim 13, further comprising repeating steps (d) and (e) for at least a third desired region within the hollow body organ.

15. A method as in claim 13, wherein the first desired region is a region connecting to the hollow body organ.

16. A method as in claim 15, wherein the hollow body organ is the gallbladder and the connecting region is the cystic duct.

17. A method as in claim 16, wherein a balloon at the distal end of the second flexible elongate member is inflated within the connecting region.

18. A catheter for heating a hollow body organ, said catheter comprising:

a first flexible elongate member having a proximal end, a distal end, and an axial lumen extending between said proximal and distal ends;

a second flexible elongate member slidably disposed within the axial lumen of the first flexible elongate member; and

means disposed externally near the distal end of the first flexible elongate member for heating an environment surrounding the catheter, said heating means comprising an exposed convective heating surface which is free from surrounding structure.

19. A catheter as in claim 18, wherein the second flexible elongate member further comprises a means for sealing a region connecting with the hollow body organ.

20. A catheter as in claim 19, wherein the means for sealing includes an inflatable balloon.

21. A catheter as in claim 18, having an annular lumen between the first and second flexible elongate members.

22. A catheter as in claim 18, wherein the means for heating on the first flexible elongate member comprises a coil resistance heater disposed externally on the member.

23. A catheter as in claim 22, wherein the coil resistance heater extends over a length in the range from about 3 mm to 6 cm.

24. A catheter for heating a hollow body organ, said catheter comprising:

a first flexible elongate member having a proximate end, a distal end, and an axial lumen extending between said proximal and distal ends;

a second flexible elongate member slidably received within the axial lumen of the first flexible elongate member;

means disposed on the second flexible elongate member for heating an environment surrounding the catheter;

a stop element disposed near the distal end of the second flexible elongate member;

a shield disposed about the heating means on the second flexible member; and

means on the first flexible elongate member for expanding the shield about the heating means on the second flexible elongate member by axially advancing the first member against the stop element on the second member;

whereby the second flexible elongate member may be rotated relative to the first in order to enhance mixing of a thermally conductive fluid within the hollow body organ.

25. A catheter as in claim 24, further comprising an inflatable balloon disposed distally of the stop element on the second flexible elongate member.

26. A catheter as in claim 24, wherein the means for heating on the first flexible elongate member comprises a coil resistance heater disposed externally on the member.

27. A method for heating a hollow body organ, said method comprising:

(a) placing a distal end of a flexible member within the hollow body organ;

(b) expanding a shield over the distal end of the flexible member;

(c) energizing a heating element within the expanded shield; and

(d) rotating the shield in order to enhance mixing of a thermally conductive fluid within the hollow body organ.

28. A method as in claim 27, further comprising positioning the flexible member over another flexible member which has been previously located within the hollow body organ.

29. A method as in claim 28, still further comprising expanding a balloon on said another flexible member to occlude a region connecting with the hollow body organ.

30. A catheter for heating a hollow body organ, said catheter comprising:

a first flexible elongate member having a proximal end, a distal end, and means for heating a fluid environment surrounding the catheter to a temperature sufficient to thermally ablate the internal surface of a body organ, said heating means being disposed externally near the distal end of the first flexible member;

an expandable shield disposed about the heating means which can assume a collapsed configuration and an expanded configuration and which possesses a plurality of large apertures, which, in the expanded configuration, the apertures are sufficiently large to permit free circulation of a fluid to and from the environment, whereby heated fluid in the environment surrounding the heating means can circulate and transfer heat to the body organ; and

means on the first flexible elongate member for expanding the shield about the heating means while the heating means is positioned within the hollow body organ.

31. A catheter as in claim 30, wherein the shield comprises a cylinder having a plurality of axial slits and the means for expanding the shield comprises means for compressing said cylinder to cause outward deformation thereof.

32. A catheter as in claim 31, wherein the means for compressing the cylinder comprises a flexible tubular member which extends over the length of the flexible elongate member.

33. A catheter as in claim 32, further comprising means on the first flexible elongate member for limiting movement of the flexible tubular member so that the cylinder can be compressed by pushing the tubular member in the distal direction relative to the elongate member.

34. A catheter as in claim 30, wherein the means for heating on the first flexible elongate member comprises a coil resistance heater disposed externally on the member.

35. A catheter as in claim 34, wherein the coil resistance heater extends over a length in the range from abut 3 mm to 6 cm.

36. A catheter as in claim 30, wherein the first flexible elongate member has an axial lumen extending from its proximal end to its distal end, said catheter further comprising:

a second flexible elongate member slidably disposed within the axial lumen of the first flexible elongate member; and

an inflatable balloon disposed near the distal end of the second flexible elongate member, whereby the heating means may be positioned by axially translating the first flexible elongate member over the second flexible elongate member.

37. A method for heating a hollow body organ, said method comprising:

introducing a distal end of a flexible elongate member to the interior of the hollow body organ;

expanding a shield about an external heating element near the distal end of the flexible elongate member after said member has been introduced, said shield having apertures to allow free circulation of fluid therethrough in both directions;

introducing a thermally conductive medium into and circulating said medium within the interior of the hollow body organ; and

raising the temperature of the heating element to heat the thermally conductive medium sufficiently to ablate an interior surface of the body organ, while the shield prevents contact between the external heating element and the interior surface of the organ.

38. A method as in claim 37, wherein the shield is a cylinder having a plurality of axial slits and the shield is expanded by compressing the length of the cylinder.

39. A method as in claim 38, wherein the cylinder is formed at the distal end of a flexible tubular ember which extends over the length of the flexible elongate member, whereby the cylinder may be compressed by pushing on a proximal end of the tubular member.

40. A method as in claim 37, wherein the shield is a cylinder having a plurality of axial slits and the shield is expanded by releasing tension which allows the shield to assume an unconstrained expanded configuration.

41. A catheter for heating a hollow body organ, said catheter comprising:

a first flexible elongate member having a proximal end, a distal end, and an axial lumen extending between said proximal and distal ends;

a second flexible elongate member slidably disposed within the axial lumen of the first flexible elongate member;

said first and second elongate members together defining an annular lumen which is open at its distal end to permit perfusion or aspiration of fluids therethrough;

means disposed externally near the distal end of the first flexible elongate member for heating an environment surrounding the catheter; and

a shield, comprising a plurality of expandable ribs disposed about the heating means and means on the first flexible elongate member for expanding the shield while the heating means is positioned within the hollow body organ.

42. A catheter as in claim 41, wherein the second flexible elongate member further comprises a means for sealing a region connecting with the hollow body organ.

43. A catheter as in claim 42, wherein the means for sealing includes an inflatable balloon.

44. A catheter as in claim 41, wherein the means for heating on the first flexible elongate member comprises a coil resistance heater disposed externally on the member.

45. A catheter as in claim 44, wherein the coil resistance heater extends over a length in the range from about 3 mm to 6 cm.