Surgical method and apparatus for positioning a diagnostic or therapeutic element within the body

• US 20020151889A1
• Filed: 05/30/2002
• Published: 10/17/2002
• Est. Priority Date: 10/07/1994
• Status: Active Grant

• Current Assignee: David K. Swanson, Edward J. Snyder, James G. Whayne, Josef V. Koblish, Russell B. Thompson, Sidney D. Fleischman, Thomas R. Jenkins
• Original Assignee: David K. Swanson, Edward J. Snyder, James G. Whayne, Josef V. Koblish, Russell B. Thompson, Sidney D. Fleischman, Thomas R. Jenkins
• Inventors: Swanson, David K., Snyder, Edward J., Fleischman, Sidney D., Whayne, James G., Jenkins, Thomas R., Thompson, Russell B., Koblish, Josef V.
• Granted Patent: US 6,786,905 B2
• Time in Patent Office: Days
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/2911 rings
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00101 low, i.e. thermally insulating
• CPC Class Codes: A61B 2018/00136 with polymer
• CPC Class Codes: A61B 2018/00148 with metal
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/0091 Handpieces of the surgical instrument or device
• CPC Class Codes: A61B 2018/00916 with means for switching or controlling the main function of the instrument or device
• CPC Class Codes: A61B 2018/00946 slidable
• CPC Class Codes: A61B 2018/00952 rotatable
• CPC Class Codes: A61B 2018/124 switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/1253 : monopolar
• CPC Class Codes: A61B 2018/126 : bipolar
• CPC Class Codes: A61B 2018/1407 : Loop
• CPC Class Codes: A61B 2018/142 : at least partly surrounding the target, e.g. concave, curved or in the form of a cave
• CPC Class Codes: A61B 2018/1475 : Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61N 1/056 : Transvascular endocardial electrode systems

Abstract

A surgical method and apparatus for positioning a diagnostic or therapeutic element within the body. The apparatus may be catheter-based or a probe including a relatively short shaft.

Claims

1. A surgical device, comprising:

a relatively short shaft defining a distal end and a proximal end;

a bendable spline assembly associated with the distal end of the shaft and having a predetermined configuration, the spline assembly being adapted to collapse in response to an application of an external force and to expand to the predetermined configuration in response to a withdrawal of the external force; and

an operative element associated with the bendable spline assembly.

2. A surgical device as claimed in claim 1, further comprising:

a substantially tubular member positioned around the shaft and slidable relative to the shaft;

wherein the spline assembly is adapted to collapse in response to movement of the substantially tubular member thereover and to expand to the predetermined configuration in response to a retraction of the substantially tubular member.

3. A surgical device as claimed in claim 2, wherein the substantially tubular member comprises a substantially cylindrical member.

4. A surgical device as claimed in claim 2, wherein the substantially tubular member comprises a sheath.

5. A surgical device as claimed in claim 2, wherein the tubular member is relatively stiff.

6. A surgical device as claimed in claim 2, wherein the tubular member is malleable.

7. A surgical device as claimed in claim 2, wherein the tubular member is somewhat flexible.

8. A surgical device as claimed in claim 2, wherein the tubular member defines a bending modulus between 3 lb.-in.² and 50 lb.-in.².

9. A surgical device as claimed in claim 1, wherein the bendable spline assembly includes a substantially annular portion.

10. A surgical device as claimed in claim 9, wherein the shaft defines a longitudinal axis and the substantially annular portion lies in a plane oriented substantially perpendicular to the longitudinal axis.

11. A surgical device as claimed in claim 1, wherein the bendable spline assembly comprises a substantially triangularly-shaped spline assembly.

12. A surgical device as claimed in claim 11, wherein the substantially triangularly-shaped spline assembly comprises a distal leg defining first and second ends, the distal leg being non-linear from the first end to the second end.

13. A surgical device as claimed in claim 12, wherein the distal leg comprises a first linear portion, a second linear portion and a non-linear portion therebetween.

14. A surgical device as claimed in claim 13, wherein the first linear portion defines a first length, the second linear portion defines a second length, and the first length is equal to the second length.

15. A surgical device as claimed in claim 11, wherein the substantially triangularly-shaped spline assembly comprises a distal leg, a first side leg and a second side leg, and at least one of the first and second side legs includes a guidewire.

16. A surgical device as claimed in claim 1, wherein the operative element comprises an electrode.

17. A surgical device as claimed in claim 1, wherein the operative element comprises a plurality of electrodes.

18. A surgical device as claimed in claim 1, wherein the operative element comprises an energy emitting element.

19. A surgical device as claimed in claim 1, further comprising:

a handle associated with the proximal end of the shaft.

20. A surgical device as claimed in claim 1, wherein the shaft is relatively stiff.

21. A surgical device as claimed in claim 1, wherein the shaft defines an overall length and the overall length is less than approximately 20 inches.

22. A surgical device as claimed in claim 1, wherein the shaft is malleable.

23. A surgical device as claimed in claim 1, wherein the shaft is somewhat flexible.

24. A surgical device as claimed in claim 1, wherein the shaft defines a bending modulus between 3 lb.-in.² and 50 lb.-in.².

25. A surgical device as claimed in claim 1, wherein the bendable spline assembly is in the form of a loop.

26. A surgical device as claimed in claim 1, wherein the bendable spline assembly comprises a spring member having a cross-section defining a length and a width, and the length is different than the width.

27. A surgical device as claimed in claim 1, wherein the bendable spline assembly comprises a spring member is in the form of a loop, the loop defining a plane and being adapted to bend in response to an in-plane force and resist bending in response to an equal out-of-plane force.

28. A surgical device as claimed in claim 1, further comprising a steering element operably connected to the bendable spline assembly.

30. A method as claimed in claim 29, further comprising the steps of:

establishing an opening into the heart; and

inserting at least a portion of the relatively short shaft of the surgical device into the heart;

wherein the step of bringing the coagulation electrode into contact with the heart tissue comprises bringing the coagulation electrode into contact with endocardial tissue.

31. A method as claimed in claim 29, further comprising the steps of:

collapsing the spline assembly prior to insertion of the surgical device into the chest cavity; and

expanding the spline assembly after the surgical device has been inserted into the chest cavity.

29. A method of coagulating heart tissue, comprising the steps of:

providing a surgical device including a relatively short shaft, a collapsible spline assembly associated with the distal end of the shaft, and an coagulation electrode mounted on the spline assembly;

establishing an opening through the exterior of the chest of a patient into the chest cavity;

inserting at least a portion of the relatively short shaft of the surgical device into the chest cavity;

bringing the coagulation electrode into contact with the heart tissue; and

supplying energy to the coagulation electrode sufficient to coagulate the heart tissue.

32. A soft tissue coagulation probe, comprising:

a relatively short shaft defining a distal end and a proximal end;

a handle associated with the proximal end of the shaft; and

at least two spaced soft tissue coagulation electrodes associated with the shaft and located in spaced relation to the handle, the respective size and spacing of the at least two soft tissue coagulation electrodes being such that simultaneous transmission of energy thereby to an indifferent electrode will produce an area of coagulated tissue that spans the at least two soft tissue coagulation electrodes.

33. A soft tissue coagulation probe as claimed in claim 32, wherein the soft tissue coagulation electrodes are associated with the distal end of the shaft.

34. A soft tissue coagulation probe as claimed in claim 32, further comprising:

a temperature sensor located at the longitudinal end edge of at least one of the soft tissue coagulation electrodes.

35. A soft tissue coagulation probe as claimed in claim 32, wherein the relatively short shaft is malleable.

37. A soft tissue coagulation probe as claimed in claim 36, wherein the at least one soft tissue coagulation electrode is associated with the distal end of the shaft.

38. A soft tissue coagulation probe as claimed in claim 36, wherein the at least one soft tissue coagulation electrode comprises a plurality of soft tissue coagulation electrodes.

39. A soft tissue coagulation probe as claimed in claim 32, wherein the relatively short shaft is malleable.

36. A soft tissue coagulation probe, comprising:

a relatively short shaft defining a distal end and a proximal end;

a handle associated with the proximal end of the shaft;

at least one soft tissue coagulation electrode associated with the shaft and located in spaced relation to the handle; and

a temperature sensor located at the longitudinal end edge of the at least one soft tissue coagulation electrode.

40. A surgical device, comprising:

a shaft defining a distal end and a proximal end, the shaft being at least relatively stiff;

a handle associated with the proximal end of the shaft; and

a distal tip assembly associated with the distal end of the shaft, the distal tip assembly including one of a distal member and an operative element carried by the distal member, the distal member being one of flexible, somewhat flexible and malleable.

41. A surgical device as claimed in claim 40, wherein the operative element comprises at least one electrode.

42. A surgical device as claimed in claim 40, wherein the operative element comprises at least one ablation electrode.

43. A surgical device as claimed in claim 40, wherein the distal tip assembly comprises a loop structure.

44. A surgical device as claimed in claim 40, wherein the distal tip assembly comprises a pull wire defining a distal end associated with the distal tip assembly and a proximal end associated with the handle.

45. A surgical device as claimed in claim 40, further comprising:

a tubular member positioned around a predetermined portion of the shaft and movable relative thereto, the tubular member defining a proximal end, a distal end and an opening between the distal and proximal ends;

wherein the distal tip assembly comprises a pivot assembly having a first pivot member connected to a distal portion of the distal member and a second pivot member connected to the tubular member.

46. A surgical device as claimed in claim 45, further comprising:

a locking device adapted to prevent relative movement of the shaft and tubular member when actuated.

47. A surgical device as claimed in claim 40, wherein the shaft is malleable.

48. A surgical device as claimed in claim 40, wherein the shaft is rigid.

49. A surgical device as claimed in claim 40, wherein the shaft is somewhat flexible.

50. A surgical device as claimed in claim 40, wherein the distal member comprises a spring member.

51. A surgical device as claimed in claim 40, wherein the distal member comprises a tube.

52. A surgical device as claimed in claim 40, wherein the distal member comprises a loop structure.

53. A surgical device as claimed in claim 40, wherein the distal member comprises a substantially triangularly-shaped structure.

54. A surgical device, comprising:

a shaft defining a distal end and a proximal end;

a handle associated with the proximal end of the shaft;

a relatively stiff tubular member positioned around a predetermined portion of the shaft and movable relative thereto, the tubular member defining a proximal end, a distal end and an opening between the distal and proximal ends;

a distal tip assembly associated with the distal end of the shaft, the distal tip assembly including a flexible distal member and an operative element carried by the distal member; and

a pivot assembly having a first pivot member associated with the distal end of the tubular member and a second pivot member associated with a distal portion of the tip assembly.

55. A surgical device as claimed in claim 54, wherein the operative element comprises at least one electrode.

56. A surgical device as claimed in claim 54, wherein the operative element comprises at least one ablation electrode.

57. A surgical device as claimed in claim 54, further comprising:

a locking device adapted to prevent relative movement of the shaft and tubular member when actuated.

58. A surgical device as claimed in claim 54, wherein the tubular member is malleable.

59. A surgical device as claimed in claim 54, wherein the tubular member is rigid.

60. A surgical device as claimed in claim 54, wherein the tubular member is somewhat flexible.

61. A surgical device as claimed in claim 54, wherein the distal member comprises a spring member.