HEMOSTATIC TISSUE TUNNEL GENERATOR FOR INSERTING TREATMENT APPARATUS INTO TISSUE OF A PATIENT

• US 20090118725A1
• Filed: 04/30/2008
• Published: 05/07/2009
• Est. Priority Date: 11/07/2007
• Status: Active Grant

• Current Assignee: Mirabilis Medica, Inc.
• Original Assignee: Mirabilis Medica, Inc.
• Inventors: Auth, David C., Connolly, Michael J., Lebedev, Alexander
• Granted Patent: US 8,439,907 B2
• Time in Patent Office: Days
• US Class Current: 606/33
• 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 2018/00791 Temperature
• CPC Class Codes: A61B 2018/1213 creating an arc
• CPC Class Codes: A61B 2018/1472 for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 2218/007 Aspiration
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00

Abstract

A catheter for insertion into and treatment of tissue in a patient comprises a radio frequency (RF) electrode having an elongated body that conducts electrical RF energy to a conductive tip. An insulating sleeve surrounds the elongated body. In a first mode of operation, the conductive tip is exposed outside the insulating sleeve and the RF electrode delivers RF energy that erodes the tissue of the patient and creates a tunnel through which the catheter can advance into the tissue of the patient. In a second mode of operation, the insulating sleeve and/or the RF electrode is retracted and a second treatment apparatus treats the tissue.

Claims

1. A system for inserting treatment apparatus into tissue of a patient, comprising:

a first treatment apparatus including a radio frequency (RF) electrode having an elongated body and a conductive tip at a distal end of the elongated body, wherein the elongated body is configured to conduct electrical RF energy to the conductive tip;

an insulating sleeve surrounding the elongated body of the RF electrode; and

a second treatment apparatus for treating the tissue,

wherein, in a first mode of operation for insertion of the catheter into the tissue of the patient, the conductive tip of the RF electrode is configured to deliver, via the conductive tip, RF energy that erodes the tissue of the patient and generates a tunnel through which the catheter can advance into the tissue of the patient, and

wherein, in a second mode of operation for treatment of the tissue in the patient, one of the insulating sleeve or the RF electrode is retracted and the second treatment apparatus is configured to treat the tissue of the patient.

2. The system of claim 1, wherein the insulating sleeve is retracted from the distal tip of the RF electrode to expose the tissue of the patient to the second treatment apparatus.

3. The system of claim 2, wherein the second treatment apparatus comprises a linear array of ultrasound transducers configured to rotate about a longitudinal axis of the second treatment apparatus and emit ultrasound energy for treating the tissue of the patient.

4. The system of claim 3, wherein the linear array is further configured to emit and receive ultrasound energy for imaging the tissue of the patient.

5. The system of claim 2, wherein the second treatment apparatus comprises one or more cylindrical ultrasound transducers configured to emit ultrasound energy for treating the tissue of the patient.

6. The system of claim 2, wherein the second treatment apparatus comprises a spherical ultrasound transducer configured to emit ultrasound energy for treating the tissue of the patient.

7. The system of claim 2, wherein the second treatment apparatus includes a fluid delivery catheter with an internal lumen in fluid connection with one or more exit ports.

8. The system of claim 7, wherein the fluid delivery catheter is configured to deliver a hyperthermic fluid to the tissue of the patient for treatment.

9. The system of claim 7, wherein the fluid delivery catheter is configured to deliver a hypothermic fluid to the tissue of the patient for treatment.

10. The system of claim 2, wherein the second treatment apparatus includes a microwave catheter that is configured to deliver microwave energy to the tissue of the patient.

11. The system of claim 10, wherein the microwave catheter comprises an inner conductor in coaxial arrangement with an outer conductor and a dielectric material disposed therebetween, the inner conductor extending beyond the distal end of the outer conductor to form a microwave antenna, and wherein the dielectric material includes one or more channels for the passage of a deionized fluid to cool the microwave catheter.

12. The system of claim 1, wherein the RF electrode is retracted from the insulating sleeve to allow the second treatment apparatus to be advanced through the insulating sleeve.

13. The catheter of claim 12, wherein the second treatment apparatus comprises a linear array of ultrasound transducers configured to rotate about a longitudinal axis of the second treatment apparatus and emit ultrasound energy for treating the tissue of the patient.

14. The system of claim 13, wherein the linear array of ultrasound transducers is further configured to emit and receive ultrasound energy for imaging the tissue of the patient.

15. The system of claim 12, wherein the second treatment apparatus comprises one or more cylindrical ultrasound transducers configured to emit ultrasound energy for treating the tissue of the patient.

16. The system of claim 12, wherein the second treatment apparatus comprises a spherical ultrasound transducer configured to emit ultrasound energy for treating the tissue of the patient.

17. The system of claim 12, wherein the second treatment apparatus includes a fluid catheter with an internal lumen in fluid connection with one or more exit ports.

18. The system of claim 17, wherein the fluid catheter is configured to deliver a hyperthermic fluid to the tissue of the patient for treatment.

19. The system of claim 17, wherein the fluid catheter is configured to deliver a hypothermic fluid to the tissue of the patient for treatment.

20. The system of claim 12, wherein the second treatment apparatus includes a microwave catheter configured to deliver microwave energy to the tissue of the patient.

21. The system of claim 20, wherein the microwave catheter comprises an inner conductor in coaxial arrangement with an outer conductor and a dielectric material disposed therebetween, the inner conductor extending beyond the distal end of the outer conductor to form a microwave antenna, and wherein the dielectric material includes one or more passages for the passage of a deionized fluid that cools the microwave catheter.

30. The method of claim 21, wherein retracting one of the RF electrode or the insulating sleeve comprises retracting the RF electrode to allow the second treatment apparatus to be advanced through the insulating sleeve.

31. The method of claim 30, further comprising treating the tissue of the patient in the second mode of operation by emitting ultrasound energy from one or more ultrasound transducers in the second treatment apparatus.

32. The method of claim 31, further comprising imaging the tissue of the patient using the one or more ultrasound transducers in the second treatment apparatus.

33. The method of claim 30, wherein the second treatment apparatus includes a fluid catheter with an internal lumen in fluid connection with one or more exit ports in the fluid catheter, the method further comprising treating the tissue of the patient by delivering a hyperthermic fluid via the fluid catheter to the tissue of the patient.

34. The method of claim 30, wherein the second treatment apparatus includes a fluid catheter with an internal lumen in fluid connection with one or more exit ports in the fluid catheter, the method further comprising treating the tissue of the patient by delivering a hypothermic fluid via the fluid catheter to the tissue of the patient.

35. The method of claim 30, further comprising treating the tissue of the patient by emitting microwave energy from a microwave antenna positioned at a distal end of the second treatment apparatus.

36. The method of claim 35, further comprising cooling the microwave antenna by supplying a deionized fluid that fills a space between an inner conductor in coaxial arrangement with an outer conductor, the inner conductor extending beyond the distal end of the outer conductor to form the microwave antenna.

22. A method for inserting treatment apparatus into tissue of a patient, comprising:

positioning a catheter with respect to tissue of the patient, wherein the catheter includes;

a radio frequency (RF) electrode having an elongated body and a conductive tip at a distal end of the elongated body, wherein the elongated body is configured to conduct electrical RF energy to the conductive tip;

an insulating sleeve surrounding the elongated body of the RF electrode; and

a second treatment apparatus;

delivering RF energy to the conductive tip in a first mode of operation for insertion of the catheter into the tissue of the patient, wherein the RF energy erodes the tissue of the patient and generates a tunnel through which the catheter advances into the tissue of the patient, and

retracting one of the RF electrode or the insulating sleeve and treating the tissue with the second treatment apparatus while in a second mode of operation.

23. The method of claim 22, wherein retracting one or the RF electrode or the insulating sleeve comprises retracting the insulating sleeve to expose the tissue to the second treatment apparatus.

24. The method of claim 23, wherein the tissue is treated in the second mode of operation by emitting ultrasound energy from one or more ultrasound transducers in the second treatment apparatus.

25. The method of claim 24, further comprising imaging the tissue of the patient using the one or more ultrasound transducers in the second treatment apparatus.

26. The method of claim 23, wherein the second treatment apparatus includes a fluid catheter with an internal lumen in fluid connection with one or more exit ports in the fluid catheter, the method further comprising treating the tissue of the patient by delivering a hyperthermic fluid via the fluid catheter to the tissue of the patient.

27. The method of claim 23, wherein the second treatment apparatus includes a fluid catheter with an internal lumen in fluid connection with one or more exit ports in the fluid catheter, the method further comprising treating the tissue of the patient by delivering a hypothermic fluid via the fluid catheter to the tissue of the patient.

28. The method of claim 23, further comprising treating the tissue of the patient by emitting microwave energy from a microwave antenna positioned at a distal end of the second treatment apparatus.

29. The method of claim 28, further comprising cooling the microwave antenna by supplying a deionized fluid that fills a space between an inner conductor in coaxial arrangement with an outer conductor, the inner conductor extending beyond the distal end of the outer conductor to form the microwave antenna.

37. A system for inserting treatment apparatus into tissue of a patient, comprising:

a radio frequency (RF) electrode having an elongated body and a conductive tip at a distal end of the elongated body, wherein the elongated body is configured to conduct electrical RF energy to the conductive tip; and

an insulating sleeve surrounding the elongated body of the RF electrode,

wherein, in a first mode of operation for insertion of the catheter into the tissue of the patient, the conductive tip of the RF electrode is exposed outside the insulating sleeve and the RF electrode is configured to deliver, via the conductive tip, RF energy that erodes the tissue of the patient and generates a tunnel through which the catheter can advance into the tissue of the patient, and

wherein, in a second mode of operation for treatment of the tissue in the patient, the insulating sleeve is configured to be withdrawn, leaving the RF electrode in the tunnel, and a second treatment apparatus is configured to be inserted through the tunnel into the patient using the elongated body of the RF electrode as a guidewire.

38. The system of claim 37, wherein the second treatment apparatus comprises a linear array of ultrasound transducers configured to rotate about a longitudinal axis of the second treatment apparatus and emit ultrasound energy for treating the tissue of the patient.

39. The system of claim 38, wherein the linear array is further configured to emit and receive ultrasound energy for imaging the tissue of the patient.

40. The system of claim 37, wherein the second treatment apparatus comprises one or more cylindrical ultrasound transducers configured to emit ultrasound energy for treating the tissue of the patient.

41. The system of claim 37, wherein the second treatment apparatus comprises a spherical ultrasound transducer configured to emit ultrasound energy for treating the tissue of the patient.

42. The system of claim 37, wherein the second treatment apparatus includes a fluid catheter with an internal lumen in fluid connection with one or more exit ports in the fluid catheter that is configured to deliver a hyperthermic fluid to the tissue of the patient for treatment.

43. The system of claim 37, wherein the second treatment apparatus includes a fluid catheter with an internal lumen in fluid connection with one or more exit ports in the fluid catheter that is configured to deliver a hypothermic fluid to the tissue of the patient for treatment.

44. The catheter of claim 37, wherein the second treatment apparatus includes a microwave catheter that is configured to deliver microwave energy the tissue of the patient.

45. The catheter of claim 44, wherein the microwave catheter comprises an inner conductor in coaxial arrangement with an outer conductor and a dielectric material disposed therebetween, the inner conductor extending beyond the distal end of the outer conductor to form a microwave antenna, and one or more channels in the dielectric material for the passage of a deionized fluid that cools the microwave catheter.

46. A method for inserting treatment apparatus into tissue of a patient, comprising:

positioning a catheter with respect to tissue of the patient, wherein the catheter includes;

a radio frequency (RF) electrode having an elongated body and a conductive tip at a distal end of the elongated body, wherein the elongated body is configured to conduct electrical RF energy to the conductive tip; and

an insulating sleeve surrounding the elongated body of the RF electrode;

delivering RF energy to the conductive tip in a first mode of operation for insertion of the catheter into the tissue of the patient, wherein the RF energy erodes the tissue of the patient and generates a tunnel through which the catheter advances into the tissue of the patient, and

while in a second mode of operation for treatment of the tissue in the patient, withdrawing the insulating sleeve, leaving the RF electrode in the tunnel, and inserting a second treatment apparatus through the tunnel into the patient using the elongated body of the RF electrode as a guidewire.

47. The method of claim 46, further comprising treating the tissue of the patient by emitting ultrasound energy from one or more ultrasound transducers in the second treatment apparatus.

48. The method of claim 46, further comprising imaging the tissue of the patient using the one or more ultrasound transducers in the second treatment apparatus.

49. The method of claim 46, wherein the second treatment apparatus includes a fluid catheter with an internal lumen in fluid connection with one or more exit ports in the fluid catheter, the method further comprising treating the tissue of the patient by delivering a hyperthermic fluid via the fluid catheter to the tissue of the patient.

50. The method of claim 46, wherein the second treatment apparatus includes a fluid catheter with an internal lumen in fluid connection with one or more exit ports in the fluid catheter, the method further comprising treating the tissue of the patient by delivering a hypothermic fluid via the fluid catheter to the tissue of the patient.

51. The method of claim 46, further comprising treating the tissue of the patient by emitting microwave energy from a microwave antenna positioned at a distal end of the second treatment apparatus.

52. The method of claim 51, further comprising cooling the microwave antenna by supplying a deionized fluid that fills a space between an inner conductor in coaxial arrangement with an outer conductor, the inner conductor extending beyond the distal end of the outer conductor to form the microwave antenna.

53. A catheter for inserting treatment apparatus into tissue of a patient, comprising:

a radio frequency (RF) electrode having an elongated body and a conductive tip at a distal end of the elongated body, wherein the elongated body is configured to conduct electrical RF energy to the conductive tip; and

an insulating sleeve surrounding the elongated body of the RF electrode,

wherein, in a first mode of operation for insertion of the catheter into the tissue of the patient, the conductive tip of the RF electrode is exposed outside the insulating sleeve and the RF electrode is configured to deliver, via the conductive tip, RF energy that erodes the tissue of the patient and generates a tunnel through which the catheter can advance into the tissue of the patient, and

wherein, in a second mode of operation for treatment of the tissue in the patient, the insulating sleeve and RF electrode are configured to be withdrawn from the patient, leaving the tunnel generated in the patient, and a second treatment apparatus is configured to be inserted into the tissue of the patient via the tunnel.

54. The catheter of claim 53, wherein the second treatment apparatus comprises a linear array of ultrasound transducers configured to rotate about a longitudinal axis of the second treatment apparatus and emit ultrasound energy for treating the tissue of the patient.

55. The catheter of claim 54, wherein the linear array is further configured to emit and receive ultrasound energy for imaging the tissue of the patient.

56. The catheter of claim 53, wherein the second treatment apparatus comprises one or more cylindrical ultrasound transducers configured to emit ultrasound energy for treating the tissue of the patient.

57. The catheter of claim 53, wherein the second treatment apparatus comprises a spherical ultrasound transducer configured to emit ultrasound energy for treating the tissue of the patient.

58. The catheter of claim 53, wherein the second treatment apparatus includes a fluid catheter with an internal lumen in fluid connection with one or more exit ports in the fluid catheter that deliver a hyperthermic fluid to the tissue of the patient for treatment.

59. The catheter of claim 53, wherein the second treatment apparatus includes a fluid catheter with an internal lumen in fluid connection with one or more exit ports in the fluid catheter that deliver a hypothermic fluid to the tissue of the patient for treatment.

60. The catheter of claim 53, wherein the second treatment apparatus includes a microwave catheter configured to conduct microwave energy to an antenna at a distal end of the microwave catheter for treating the tissue of the patient.

61. The catheter of claim 60, wherein the microwave catheter comprises an inner conductor in coaxial arrangement with an outer conductor and a dielectric material disposed therebetween, the inner conductor extending beyond the distal end of the outer conductor to form the microwave antenna, and wherein the dielectric material includes one or more channels for the passage of a deionized fluid to cool the microwave catheter.

62. A method for inserting treatment apparatus into tissue of a patient, comprising:

positioning a catheter with respect to tissue of the patient, wherein the catheter includes;

a radio frequency (RF) electrode having an elongated body and a conductive tip at a distal end of the elongated body, wherein the elongated body is configured to conduct electrical RF energy to the conductive tip; and

an insulating sleeve surrounding the elongated body of the RF electrode;

delivering RF energy to the conductive tip in a first mode of operation for insertion of the catheter into the tissue of the patient, wherein the RF energy erodes the tissue of the patient and generates a tunnel through which the catheter advances into the tissue of the patient, and

while in a second mode of operation for treatment of the tissue in the patient, withdrawing the insulating sleeve and RF electrode from the patient, leaving the tunnel generated in the patient, and inserting a second treatment apparatus through the tunnel into the tissue of the patient.

63. The method of claim 62, further comprising treating the tissue of the patient by emitting ultrasound energy from one or more ultrasound transducers in the second treatment apparatus.

64. The method of claim 63, further comprising imaging the tissue of the patient using the one or more ultrasound transducers in the treatment apparatus.

65. The method of claim 62, wherein the second treatment apparatus includes a fluid catheter with an internal lumen in fluid connection with one or more exit ports in the fluid catheter, the method further comprising treating the tissue of the patient by delivering a hyperthermic fluid via the fluid catheter to the tissue of the patient.

66. The method of claim 65, wherein the treatment apparatus includes a fluid catheter with an internal lumen in fluid connection with one or more exit ports in the fluid catheter, the method further comprising treating the tissue of the patient by delivering a hypothermic fluid via the fluid catheter to the tissue of the patient.

67. The method of claim 62, further comprising treating the tissue of the patient by emitting microwave energy from a microwave antenna positioned at a distal end of the second treatment apparatus.

68. The method of claim 67, further comprising cooling the microwave antenna by supplying a deionized fluid that fills a space between an inner conductor in coaxial arrangement with an outer conductor, the inner conductor extending beyond the distal end of the outer conductor to form the microwave antenna.