MEDICAL SYSTEM AND METHOD OF USE

• US 20110077628A1
• Filed: 08/13/2010
• Published: 03/31/2011
• Est. Priority Date: 01/10/2006
• Status: Abandoned Application

• Current Assignee: Tsunami MedTech, LLC
• Original Assignee: Tsunami MedTech, LLC
• Inventors: HOEY, Michael, SHADDUCK, John H.
• Application Number:
  US12/856,339
• Publication Number:
  US 20110077628A1
• Time in Patent Office: Days
• US Class Current: 606/27
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2018/00619 Welding
• CPC Class Codes: A61B 2018/0063 Sealing
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2018/048 in gaseous form

Abstract

An instrument and method for tissue thermotherapy including an inductive heating means to generate a vapor phase media that is used for interstitial, intraluminal, intracavity or topical tissue treatment. In one method, the vapor phase media is propagated from a probe outlet to provide a controlled vapor-to-liquid phase change in an interface with tissue to thereby apply ablative thermal energy delivery.

Claims

11. A method of treating pain comprising:

applying energy to a flow media to produce a condensable vapor media;

introducing the condensable vapor media proximate to an intraosseal nerve and where the energy ablates the intraosseal.

12. A method of treating spinal pain comprising introducing a vapor delivery tool into the interior of a vertebral body and delivering a vapor media wherein condensation of the vapor applies energy sufficient to ablate a basivertebral nerve.

13. The method of claim 12 wherein the vapor media is substantially water vapor.

14. A method of treating spinal pain comprising introducing a condensable vapor media proximate to a nerve in at least one of the interior of a disc, the interior of a vertebral body, a zygapophyseal joint and a paravertebral region wherein condensation of the vapor media applies energy to ablate said nerve.

15. The method of claim 14 wherein the nerve comprises sinuvertebral nerves.

16. The method of claim 15 wherein the nerve comprises a basivertebral nerve.

17. The method of claim 15 wherein the vapor media is substantially water vapor.

18. The method of claim 15 wherein the vapor media is at least 80% water vapor.

19. A method of ablating a targeted tissue volume in a patient body comprising:

introducing an elongated probe into a patient body that includes at least one vapor delivery outlet for delivering a condensable thermal vapor to the targeted tissue;

deploying at least one needle member with a temperature sensor into region proximate a periphery of the targeted tissue and monitoring temperature;

delivering the condensable vapor through the probe and at least one outlet to apply ablative energy to the tissue, and

controlling the applied energy in response to the monitored temperature.

21. The method of claim 20 wherein monitoring temperature is performed with a thermocouple temperature sensor.

22. The method of claim 20 wherein monitoring temperature is performed with a fiber optic temperature sensor system.

23. A method of ablating a targeted tissue volume in a patient body comprising:

providing an elongated vapor delivery tool having a working end with at least one vapor outlet for delivering a condensable vapor flow to the targeted tissue;

delivering a vapor flow through the at least one outlet into the targeted tissue; and

allowing a flexible member disposed around a proximal tool portion to expand when contacted by vapor flow to thereby prevent unwanted retrograde vapor flow.

24. A system for ablating a tissue within a vertebral body or intervertebral disc, the system comprising:

an introducer having a blunt tip; and

a vapor delivery needle coupled to a fluid media source, where the vapor delivery needle is configured to apply a vaporization energy to the fluid media and where the vaporization energy exceeds a heat of vaporization of the fluid media therein to convert the fluid media to a vapor media, where the vapor delivery needle comprises at least one vapor delivery port to direct the vapor media to the tissue such that when the vapor media contacts the tissue energy transfer occurs from the vapor media to the tissue, the vapor delivery needle having a sharp tip sufficient to advance through the a vertebral body or intervertebral disc.

1. A method of treating discogenic pain comprising:

applying energy to a flow media produce a water vapor media;

introducing the water vapor media into an intervertebral disc such that the vapor media releases energy into a treatment site in the intervertebral disc during a vapor to liquid transition to produce a therapeutic effect in the treatment site in the disc.

2. The method of claim 1 wherein the water vapor media has a temperature of at least 60 degrees C.

3. The method of claim 1 wherein the water vapor media has a mass average temperature of at least 60 degrees C.

4. The method of claim 1 wherein the treatment site includes tissue proximate at least one of a disc bulge, a disc protrusion, a disc extrusion and an annular tear or defect.

5. The method of claim 1 wherein the treatment site includes tissue containing sinuvertebral nerves.

6. The method of claim 1 wherein the treatment site includes a portion of the annulus fibrosus containing sinuvertebral nerves.

7. The method of claim 1 wherein the water vapor media includes a pharmacological agent.

8. The method of claim 1 wherein the water vapor media includes an analgesic.

9. The method of claim 1 wherein the effects include at least one of ablation of nerves, reduction of intradiscal pressure and shrinkage of disc tissue.

10. The method of claim 1 further comprising applying aspiration forces within the disc.

25. The system of claim 24 further comprising a controller coupled to the vapor delivery needle, where the controller is configured to controlling delivery of the vaporization energy to maintain a treatment temperature of the tissue above an ablation temperature of the tissue and below a transformation temperature of the tissue, such that the energy ablates the tissue allowing the tissue to subsequently be resorbed by the body.

26. The system of claim 24, where the needle comprises a shape memory alloy material.

27. The system of claim 24, where a distal portion of the vapor delivery needle is curved.

28. The system of claim 27, where the at least one vapor delivery ports is located on an interior radius of the curved portion.

29. The system of claim 27, where the at least one vapor delivery port comprise a plurality of vapor delivery ports that are configured to emit vapor in a radial arc.

30. The system of claim 24, further comprising a negative pressure source coupled to a sleeve extending through the introducer and the vapor delivery needle is located within the sleeve.

31. The system of claim 30, where the sleeve further a lumen having dual-lead helical elements having an edge that contacts the vapor delivery needle, such that elements form at least one helical channel that winds around the vapor delivery needle.

32. The system of claim 31, further comprising a source of cooling fluid fluidly coupled to the helical channel.

33. The system of claim 30, further comprising an elastomeric sleeve having a proximal portion affixed to the vapor delivery needle, where a distal portion of the elastomeric sleeve is able to expand away from the vapor delivery needle.

34. The system of claim 24, further comprising a proximal handle having a hammering surface configured to allow application of an impact force theron to drive the sharp tip of the vapor delivery needle tipped through hard tissue.

35. The system of claim 34, where the deflectable working end comprises a pre-curved shape and where the extension member comprises a pre-curved shape, and where the extension member and vapor delivery needle are rotatable relative to each other such that rotation of the vapor delivery needle relative to the extension member deflects the deflectable working end of the vapor delivery needle.

36. The system of claim 24, further comprising at least one temperature sensing member extendable from the introducer.

37. The system of claim 36, where the at least one temperature sensing member comprises a plurality of temperature sensing members.

38. The system of claim 36, where the at least one temperature sensing is operatively connected to a controller to provide temperature feedback to the controller to terminate or modulate vapor delivery upon reaching a peak temperature or a rate or acceleration of temperature increase.

26-1. The system of claim 24, where the needle comprises a shape memory alloy material.

34-2. The system of claim 24, further comprising at least one radiopaque marking on the vapor delivery needle and proximate to the vapor delivery outlets.

34-3. The system of claim 24, further comprising an extension member located within the vapor delivery needle, where the vapor delivery needle member comprises a deflectable working end.