Medical instruments and techniques for thermally-mediated therapies

• US 7,674,259 B2
• Filed: 10/07/2003
• Issued: 03/09/2010
• Est. Priority Date: 12/09/2000
• Status: Expired due to Term

• Current Assignee: Tsunami Medtech
• Original Assignee: Tsunami Medtech
• Inventors: Shadduck, John H.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US10/681,625
• Publication Number:
  US 20040068306A1
• Time in Patent Office: 2,345 Days
• Field of Search: 606 27- 31, 606/41, 606 45- 50, 607101-105
• US Class Current: 606/41
• 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 2017/00504 Tissue welding
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• 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
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension

Abstract

A surgical instrument for thermally-mediated therapies in targeted tissue volumes and for causing thermal effects in polymer tissue-contacting members. In one embodiment, the instrument has a working end with an interior chamber that is supplied with a biocompatible liquid. An energy source causes a liquid-to-vapor phase change within the interior of the instrument. The vapor phase media then is ejected from the working surface of the instrument, and a controlled vapor-to-liquid phase change in an interface with tissue applies thermal energy substantially equal to the heat of vaporization to ablate tissue. The vapor-to-liquid phase transitions, or internal energy releases, can be provided about thin-film flexible structures for engaging body lumens and cavities. An exemplary embodiment can be used for shrinking, sealing, welding or creating lesions in tissue—while causing limited collateral thermal damage and while totally eliminating electrical current flow in the engaged tissue.

Claims

1. A surgical thermally-mediated therapy for treating tissue comprising causing a controlled vapor-to-liquid phase state change of a selected media in a tissue site by causing a sufficient amount of energy to conduct through the selected media when contained within an instrument such that the selected media increases in volume causing pressurized ejection of the selected media from the instrument into the tissue site thereby applying thermal energy substantially equal to the heat of vaporization of the media to said tissue site causing the vapor media to propagate extracellularly in tissue when in a vapor state and allowing the media to undergo a vapor-to-liquid phase state change and release thermal energy to the tissue and further introducing the vapor media into an interior of a patient'"'"'s body through an expandable member by engaging a body structure with the expandable member.

2. A surgical thermally-mediated therapy as in claim 1 wherein the heat of vaporization is in excess of about 500 calories per gram of the selected media.

3. A surgical thermally-mediated therapy as in claim 1 wherein the vapor-to-liquid phase state change is created within a patient'"'"'s body after pressurized ejection of the selected media from at least one port of the instrument.

4. A surgical thermally-mediated therapy as in claim 1 wherein the vapor-to-liquid phase state change is created at a selected depth in tissue after pressurized ejection of the media from the instrument.

5. A surgical thermally-mediated therapy as in claim 1 wherein the vapor-to-liquid phase state change is created about a flexible working surface deployed in the interior of a body cavity or lumen.

6. A surgical thermally-mediated therapy as in claim 1 further comprising the step of controlling a parameter of the causing step selected from the class of parameters consisting of controlling the temperature of the vapor-to-liquid phase state change in the selected media, controlling the pressure of the media ejected from a working surface of the instrument, controlling the volume of the media being ejected from the working surface, and controlling the rate of delivery of the media volume being ejected from the working surface.

7. The method of claim 1 wherein the vapor media collapses in volume upon the vapor-to-liquid phase state change.

8. The method of claim 1 wherein the vapor-to-liquid phase state change applies thermal energy capable of modifying tissue.

9. The method of claim 1 wherein the vapor-to-liquid phase state change applies thermal energy capable of at least one of shrinking, sealing, welding and creating lesions in tissue.

10. The method of claim 1 wherein the vapor media has a temperature of at least 100°

C.

11. The method of claim 1 including controlling at least one of the pressure of the vapor media, the volume of the vapor media, and the duration of a flow of the vapor media.

12. A method for thermally treating tissue comprising applying a first energy density to a fluid media when contained within a device such that the fluid media increases in volume causing a vapor media and subsequently providing a second energy density being lesser than the first energy density to maintain the vapor media;

and

expelling the vapor media from the device causing the vapor media to propagate extracellularly in tissue and allow the vapor media to undergo a vapor-to liquid phase state change and release thermal energy in the tissue.

13. A surgical thermally-mediated therapy for treating tissue comprising causing a controlled vapor-to-liquid phase state change of a selected media in a targeted tissue by modulating energy to apply a first amount of energy to the selected media when contained within an instrument such that the selected media increases in volume and transforms into a vapor media, and subsequently applying a second amount of energy being lesser than the first amount to maintain the vapor media;

and

controlling propagation of the vapor media using a pressure control system coupled to the instrument to cause pressurized ejection of the selected media from the instrument at a sufficiently high velocity to penetrate the targeted tissue and propagate within extracellular spaces of the targeted tissue to create a lesion in the targeted tissue.