METHODS AND APPARATUS FOR PERCUTANEOUS PATIENT ACCESS AND SUBCUTANEOUS TISSUE TUNNELING

• US 20080119846A1
• Filed: 10/11/2007
• Published: 05/22/2008
• Est. Priority Date: 10/11/2006
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Rioux, Robert F.
• Application Number:
  US11/871,089
• Publication Number:
  US 20080119846A1
• Time in Patent Office: Days
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1477 Needle-like probes
• 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 2017/22038 with a guide wire
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 25/0612 Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders

Abstract

Methods and apparatus for percutaneous blood vessel access and tissue tunneling, including guidewire placement, are provided. In one embodiment, an atraumatic distal tip of a tissue tunneling, medical probe is pressed against the derma, and electrical energy (e.g., radio frequency (RF) energy) is conveyed to or from the distal tip to ablate tissue immediately adjacent the distal tip, thereby advancing the probe through the derma while the tissue immediately adjacent the distal tip is ablated. In one embodiment, the medical probe comprises an elongated, rigid, electrically conductive, shaft, and an electrically insulative sheath disposed on the shaft to form an exposed tip electrode configured for electrosurgically ablating solid tissue located immediately axial to the tip electrode to facilitate rapid advancement of the medical probe through solid tissue. The probe may include an axially extending lumen through which an elongated guidewire may be introduced.

Claims

1. A method of percutaneously accessing a patient with an elongated probe, comprising:

placing an atraumatic distal tip of the probe against the derma of the patient;

conveying electrical energy to or from the distal tip to ablate tissue immediately adjacent the distal tip; and

advancing the probe through the derma while the tissue immediately adjacent the distal tip is ablated.

2. The method of claim 1, wherein the electrical energy is only conveyed to or from the distal tip.

3. The method of claim 1, further comprising introducing a medical agent into the patient using the probe.

4. The method of claim 1, wherein the electrical energy is radio frequency (RF) energy having a power level equal to or less than 30 W.

5. The method of claim 1, wherein tissue immediately axial to the distal tip is ablated.

6. The method of claim 1, further comprising introducing a cannula over the probe.

7. The method of claim 1, further comprising introducing a guidewire through the probe.

8. The method of claim 7, wherein the electrical energy is conveyed between the distal tip and a catheter having the guidewire disposed therethrough, the method further comprising advancing the catheter with the guidewire through the derma while the tissue immediately adjacent the distal tip is ablated.

9. The method of claim 1, wherein the probe includes an outer cannula and an inner member, the method further comprising:

removing the inner member from the cannula; and

introducing a medical probe through the cannula into the patient.

10. The method of claim 1, further comprising introducing fluid into the patient or removing fluid from the patient through the probe.

11. The method of claim 1, further comprising intravascularly advancing the distal tip into the patient.

12. The method of claim 1, further comprising:

sensing physiological information adjacent the distal tip of the probe; and

determining the nature of tissue in which the distal tip is located based on the sensed physiological information.

13. A method of subcutaneously creating a tunnel through tissue with an elongated tunneling probe, comprising:

conveying electrical energy to or from an atraumatic distal tip of the tunneling probe to ablate tissue immediately adjacent the distal tip; and

subcutaneously advancing the tunneling probe within the patient while the tissue immediately adjacent the distal tip is ablated.

14. The method of claim 13, wherein the electrical energy is only conveyed to or from the distal tip.

15. The method of claim 13, wherein the electrical energy comprises radio frequency (RF) energy having a power level equal to 30 W or less.

16. The method of claim 13, further comprising:

sensing physiological information adjacent the distal tip of the tunneling probe; and

determining the nature of tissue in which the distal tip is located based on the sensed physiological information.

17. A medical probe, comprising:

an elongated, rigid, electrically conductive, shaft; and

an electrically insulative sheath disposed on the shaft to form an exposed atraumatic tip electrode configured for electrosurgically ablating solid tissue located immediately axial to the tip electrode to facilitate rapid advancement of the medical probe through the solid tissue without substantially ablating solid tissue immediately radial to the tip electrode.

18. The medical probe of claim 17, wherein the exposed tip electrode is confined to a distal-facing surface of the shaft.

19. The medical probe of claim 17, wherein the combination of the shaft and sheath has a size between 27 gauge and 8 Fr, and wherein the tip electrode is configured for ablating the solid tissue distal to the tip electrode when electrical energy at a power level of 30 W or less is applied to a proximal end of the shaft.

20. The medical probe of claim 17, further comprising a sensor carried by the shaft adjacent the tip electrode, the sensor configured for sensing a physiological parameter indicative of a tissue characteristic.

21. The medical probe of claim 17, wherein the probe defines a lumen for introducing a guidewire.

22. A percutaneous access system, comprising:

a catheter having a lumen; and

a guidewire configured for being introduced through the catheter lumen, wherein the guidewire includes an electrically conductive, shaft and an electrically insulative sheath disposed on the shaft to form an exposed atraumatic tip electrode configured for electrosurgically ablating solid tissue located immediately axial to the tip electrode to facilitate rapid advancement of the guidewire through the solid tissue without substantially ablating solid tissue immediately radial to the tip electrode.

23. The system of claim 22, wherein the exposed tip electrode is confined to a distal-facing surface of the guidewire shaft.

24. The medical probe of claim 22, wherein the tip electrode is configured for ablating the solid tissue distal to the tip electrode when electrical energy at a power level of 10 W or less is applied to a proximal end of the guidewire shaft, and wherein the combination of the shaft and sheath has a size between 27 gauge and 8 Fr.

25. The medical probe of claim 24, further comprising an electrical connector electrically coupled to the shaft.

26. The medical probe of claim 22, further comprising a sensor carried by the shaft adjacent the tip electrode, the sensor configured for sensing a physiological parameter indicative of a tissue characteristic.

27. A catheter assembly, comprising:

a flexible therapeutic or diagnostic catheter having an elongated shaft and a lumen axially extending through the catheter shaft; and

a flexible guidewire configured for being removably introduced through the catheter lumen, the guidewire having an elongated, electrically conductive, shaft and an electrically insulative sheath disposed on the guidewire shaft to form an exposed atraumatic tip electrode that extends from a distal end of the catheter shaft when the guidewire is inserted within the catheter lumen, the tip electrode configured for electrosurgically ablating solid tissue located immediately axial to the tip electrode to facilitate rapid advancement of the catheter through solid tissue.

28. The catheter assembly of claim 27, wherein the tip electrode is configured for electrosurgically ablating solid tissue located immediately axial to the tip electrode without substantially ablating solid tissue immediately radial to the tip electrode.

29. The catheter assembly of claim 27, wherein the tip electrode is confined to a distal-facing surface of the guidewire shaft.

30. The catheter assembly of claim 27, wherein the tip electrode is configured for ablating the solid tissue distal to the tip electrode when electrical energy at a power level of 30 W or less is applied to a proximal end of the guidewire shaft.

31. The catheter assembly of claim 27, further comprising an electrical connector electrically coupled to the guidewire shaft.

32. The catheter assembly of claim 31, further comprising a handle carrying the electrical connector and removably mounted to the guidewire shaft.

33. The catheter assembly of claim 27, further comprising a locking mechanism configured for alternately affixing the guidewire relative to the catheter and allowing the guidewire to move relative to the catheter.

34. The catheter assembly of claim 27, further comprising a sensor carried by the guidewire shaft adjacent the tip electrode, the sensor configured for sensing a physiological parameter indicative of a tissue characteristic.

35. A medical probe, comprising:

an elongated, electrically conductive, shaft;

a lumen extending through the shaft; and

an electrically insulative sheath disposed on the shaft to form an exposed atraumatic tip electrode configured for electrosurgically ablating solid tissue located immediately axial to the tip electrode to facilitate rapid advancement of the medical probe through the solid tissue.

36. The medical probe of claim 35, wherein the exposed tip electrode is confined to a distal-facing surface of the shaft.

37. The medical probe of claim 35, further comprising an electrical connector electrically coupled to the shaft.

38. The medical probe of claim 35, further comprising a sensor carried by the shaft adjacent the tip electrode, the sensor configured for sensing a physiological parameter indicative of a tissue characteristic.

39. The medical probe of claim 35, wherein the shaft is rigid.

40. A method of percutaneously introducing a guidewire into a patient, comprising:

placing an atraumatic distal tip of the guidewire against the derma of the patient;

conveying electrical energy to or from the distal tip to ablate tissue immediately adjacent the distal tip; and

advancing the catheter with the guidewire through the derma while the tissue immediately adjacent the distal tip is ablated.

41. The method of claim 40, wherein the electrical energy is only conveyed to or from the distal tip.

42. The method of claim 40, further comprising advancing the catheter with the guidewire into a blood vessel of the patient.

43. The method of claim 40, wherein the electrical energy is radio frequency (RF) energy having a power level equal to or less than 30 W.

44. The method of claim 40, wherein tissue immediately axial to the distal tip is ablated to a depth of no greater than 1 mm from the surface of the distal tip.

45. The method of claim 40, further comprising:

sensing physiological information adjacent the distal tip of the guidewire; and

determining the nature of tissue in which the distal tip is located based on the sensed physiological information.

46. A catheter assembly, comprising:

a flexible therapeutic or diagnostic catheter having an elongated shaft and a lumen axially extending through the catheter shaft;

a flexible guidewire configured for being removably introduced through the catheter lumen, the guidewire having an elongated, electrically conductive, shaft and an electrically insulative sheath disposed on the guidewire shaft to form an exposed atraumatic tip electrode that extends from a distal end of the catheter shaft when the guidewire is inserted within the catheter lumen; and

an electrical connector electrically coupled to the guidewire shaft,

wherein the tip electrode is configured for electrosurgically ablating solid tissue located immediately axial to the tip electrode without substantially ablating solid tissue immediately radial to the tip electrode.