Dual action cryoprobe and methods of using the same

• US 6,551,309 B1
• Filed: 09/14/2000
• Issued: 04/22/2003
• Est. Priority Date: 09/14/2000
• Status: Expired due to Term

• Current Assignee: Nuvue Therapeutics, Inc.
• Original Assignee: Cryoflex, Inc.
• Inventors: LePivert, Patrick J. M.
• Primary Examiner(s): Peffley, Michael
• Application Number:
  US09/662,213
• Time in Patent Office: 950 Days
• Field of Search: 606/20, 606/21, 606/22, 606/23, 606/24, 606/25, 606/26
• US Class Current: 606/20
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/0218 with open-end cryogenic probe, e.g. for spraying fluid directly on tissue or via a tissue-contacting porous tip
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid

Abstract

Cryosurgery is performed with cryosurgical probe tips either contacting the tissue or by tips which deliver refrigerant onto the tissue. A dual action probe tip can be used to perform either operation separately or may be used for application of both methods. Various method steps define the procedures for use of the probe tips.

Claims

1. A dual action ablation probe for necrosis of tissue by spray and contact comprising a tubular shaft for delivery of a cryogen, said shaft having a first end and a second end, an elongated hollow tip having a proximal end and a distal end and an interior space surrounded by a continuous sidewall, said proximal end of said tip connected to said first end of said tubular shaft, and said tip including at least one aperture whereby said cryogen lowers the temperature of said tip to ablate tissue by contact and said cryogen passing through said at least one aperture ablates tissue directly by spray.

2. A dual action ablation probe of claim 1 wherein a matrix is disposed in said hollow tip and contacts said sidewall, said matrix enhancing the heat exchange between the cryogen and said sidewall and providing a complex flow path within said tip.

3. A dual action ablation probe of claim 2 wherein said matrix is any one of the group of materials consisting of filaments, porous three dimensional structure, or microspheres.

4. A dual action ablation probe of claim 1 wherein said shaft has a liquifier means disposed on said shaft between said first and second ends for reducing the temperature in said shaft.

5. A dual action ablation probe of claim 1 wherein said distal end of said tip has a plurality of apertures in a portion of said distal end for direct contact of the cryogen.

6. A dual action ablation probe of claim 5 wherein an inflatable and deflatable balloon is connected to said distal end of said tip opposite said apertures.

7. A dual action ablation probe of claim 1 wherein said tip has an inner smaller hollow dome-shape cooling chamber, said tip and said chamber rotatably mounted with respect to each other, and said at least one aperture through said hollow dome-shape chamber, whereby said at least one aperture in said tip may be opened and closed by rotation of said cooling chamber.

8. A dual action ablation probe of claim 7 wherein said cooling chamber has a plurality of apertures therethrough whereby a plurality of said apertures in said tip may be opened and closed by rotation of said cooling chamber.

13. A dual action ablation probe of claim 1 wherein said elongated hollow tip includes at least one electrode for applying an electrical current across said tissue.

14. A dual action ablation probe of claim 13 wherein said at least one aperture in said elongated hollow tip has a grid extending across said aperture, said grid forming a sensor means for monitoring the changes in said tissue.

15. A dual action ablation probe of claim 13 wherein a plurality of sensor means are mounted on said elongated hollow tip and exposed to said tissue for monitoring electrical changes in said tissue.

16. A dual action ablation probe of claim 15 wherein said distal end includes a closed done-shape area, said continuous sidewall and said dome-shape area having a plurality of apertures.

17. A dual action ablation probe of claim 16 wherein a matrix is disposed in and contacts said distal end, said matrix being one of the group consisting of filaments, three dimensional porous material, or microspheres.

18. A dual action ablation probe of claim 17 wherein said shaft has at least two lumen, one lumen for cryogen supply and one lumen for cryogen exhaust, said distal end forming a Joule/Thomson cooling chamber.

19. A dual action ablation probe of claim 13 wherein said elongated hollow probe contains a reference electrode for completing an electrical circuit through said tissue.

28. A probe of claim 13 wherein said elongated hollow tip includes at least one electro-surgical electrode.

9. A dual action ablation probe for necrosis of tissue comprising a tubular shaft for delivery of a cryogen, said shaft having a first end and a second end, an elongated hollow tip having a proximal end and a distal end and an interior space surrounded by a continuous sidewall, said proximal end of said tip connected to said first end of said tubular shaft, and said tip including at least one aperture wherein said shaft comprises at least two lumen, one lumen for cryogen supply to said tip and another lumen for cryogen exhaust from said tip.

10. A dual action ablation probe of claim 9 wherein said elongated hollow tip is formed with a Joule/Thomson heat exchange chamber therein.

11. A dual action ablation probe of claim 10 wherein said Joule/Thomson heat exchange chamber contains a matrix.

12. A dual action ablation probe of claim 10 wherein said shaft has a liquifier disposed on said shaft between said ends for additional cooling of said shaft.

20. A cryosurgical system for necrosis of tissue by hypothermia comprising at least one cryoprobe, said cryoprobe having a tubular shaft with a first end and a second end, said second end of said shaft connected to a console, said console containing valves for controlling flow of cryogenic fluid, a source of electrical power and electrical instruments for monitoring necrosis, said console adapted for connection to said source of cryogenic fluid through said valves, said first end of said shaft connected to the proximal end of a hollow elongated tip, wherein said shaft has a supply lumen and an exhaust lumen, the distal end of said tip having at least one exposed electrode for conducting an electric current, said tip having a plurality of exposed electrical sensors for monitoring electrical changes, said electrode and said sensors electrically connected to said console.

21. A cryosurgical system of claim 20 wherein said supply and said exhaust lumen are concentric.

22. A cryosurgical system of claim 20 wherein said distal end of said cryoprobe has a hollow dome-shape with at least one aperture, said hollow dome-shape forming a Joule/Thomson cooling chamber.

23. A cryosurgical system of claim 22 wherein said distal end of said tip contains a matrix.

24. A cryosurgical system of claim 20 wherein a liquifier means for reducing shaft temperature is located on said shaft between said first and second ends, said liquifier means adapted to be connected to a source of cryogenic fluid.

25. A cryosurgical system of claim 20 wherein said electrical sensors have pre-set conditions and said sensors are electrically connected in said console to a control means for actuating said valves to open and close whereby when said pre-set conditions are met said valves are automatically actuated.

29. A cryosurgical system of claim 20 wherein said electrical instruments for monitoring necrosis detect changes in impedance, said console includes a dispatcher/scanner electrically connected to said electrical instruments and said distal end of said tip to obtain electrical signals indicating a change in impedance, said electrical instruments for monitoring necrosis include at least one remote electrode adapted to be attached to the skin, a plurality of tissue sensors adapted to be inserted into the area adjacent the necrosis, said dispatcher/scanner obtaining said electrical signals from said electrical instruments and said distal end of said tip and said remote electrode.

26. A dual action ablation method of necrosis of tissue by freezing comprising the steps of

(A) providing an elongated tubular cryoprobe operatively connected at the proximal end to a source of cryogen, the distal end of said cryoprobe forming a cooling chamber, said cooling chamber having at least one aperture therethrough,

(B) operatively placing said cryoprobe in tissue,

(C) as a first action initiating flow of said cryogen to said cryoprobe to reduce the temperature of said cryoprobe and freeze a thin layer of tissue in contact with said cryoprobe,

(D) as a second action continuing flow of said cryogen through said aperture as a spray onto said frozen tissue,

(E) ceasing cryogen flow,

(F) heating said cryoprobe and removing said cryoprobe from said tissue.

27. A dual action ablation method of claim 26 wherein said cooling chamber of said cryoprobe includes an inner and outer walls, each with a plurality of apertures, said inner and outer walls being relatively movable in regard to each other, said relative movement bringing said plurality of apertures into and out of registry with each other, including the steps of

(A) relatively moving said inner and outer wall so that said plurality of apertures is out of registry,

(B) inserting said cryoprobe in tissue,

(C) initiating flow of said cryogen to freeze a thin layer of said tissue by contact with said cryoprobe,

(D) relatively moving said inner and outer wall to bring said plurality of apertures into registry, and

(E) continuing flow of said cryogen through said apertures onto said tissue.