DIRECT VISION CRYOSURGICAL PROBE AND METHODS OF USE

• US 20150031946A1
• Filed: 07/23/2014
• Published: 01/29/2015
• Est. Priority Date: 07/24/2013
• Status: Abandoned Application

• Current Assignee: Arrinex, Inc. (Stryker Corporation)
• Original Assignee: Nidus Medical LLC
• Inventors: SAADAT, Vahid, Ewers, Richard C., Herron, Matthew
• Application Number:
  US14/339,024
• Publication Number:
  US 20150031946A1
• Time in Patent Office: Days
• US Class Current: 600/104
• CPC Class Codes: A61B 1/00042 for mechanical operation
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00087 Tools A61B17/00234 takes precedence
• CPC Class Codes: A61B 1/00177 for 90 degrees side-viewing
• CPC Class Codes: A61B 1/00179 for off-axis viewing
• CPC Class Codes: A61B 1/00183 for variable viewing angles
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 1/0615 for radial illumination
• CPC Class Codes: A61B 1/0623 for off-axis illumination
• CPC Class Codes: A61B 1/233 for the nose, i.e. nasoscopes , e.g. testing of patency of Eustachian tubes
• 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 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• 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
• CPC Class Codes: A61B 2018/0293 using an instrument interstitially inserted into the body, e.g. needle

Abstract

A direct vision cryosurgical and methods of use are described herein where the device may generally comprise an elongated rigid structure with a distal end, a proximal end, and a central lumen. The distal end may comprise a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen. The distal end may also house at least one imaging device configured for distal imaging. A proximal end of the device may comprise a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end with a cryo-ablation probe through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes.

Claims

1. A cryosurgical apparatus, comprising:

an elongated rigid structure having a distal end, a proximal end, and a lumen defined through the structure;

a non-coring optically transparent tip located at the distal end, wherein the tip presents a curved distal surface which curves to a side of the tip and terminates in at least one opening defined along a side relative to the structure such that the at least one opening is in communication with the lumen;

at least one imaging device positioned proximal or adjacent to the tip and angled to image through the tip and along a region coincident with the at least one opening; and

,

a cryo-ablation probe positioned through the lumen with a distal probe tip in proximity to the at least one opening.

2. The apparatus of claim 1 further comprising a lateral tissue thermal protection barrier located in apposition to the cryo-ablation probe.

3. The apparatus of claim 1 wherein the tip is configured for blunt atraumatic dissection between tissue fascia.

4. The apparatus of claim 3 wherein a distal edge of the at least one opening defines a radius which is configured to smooth the curved distal surface and the at least one opening.

5. The apparatus of claim 1 wherein the tip comprises a polycarbonate or glass material.

6. The apparatus of claim 1 wherein the at least one imaging device comprises a CMOS camera or fiberscope.

7. The apparatus of claim 1 wherein the cryo-ablation probe comprises a lumen configured to spray a liquid refrigerant through a tip of the probe.

8. The apparatus of claim 1 wherein the cryo-ablation probe comprises an inflatable balloon member configured to inflate upon introduction of a liquid refrigerant into an interior of balloon.

9. The apparatus of claim 1 wherein the cryo-ablation probe comprises an enclosed probe member.

10. A cryosurgical apparatus, comprising:

an elongated structure having a distal end, a proximal end, and a lumen defined through the structure;

an outer balloon positioned near or at the distal end, wherein the outer balloon is comprised of an optically transparent material;

at least one imaging device adjustably positioned within the outer balloon; and

at least one cryogenic probe positioned within the lumen such that one or more openings defined along the cryogenic probe are directed to a treatment region defined along an inner surface of the outer balloon; and

at least one inner balloon positioned within the outer balloon such that inflation of the inner balloon expands the inner balloon into conformance against the inner surface of the outer balloon at a location opposite to the treatment region to thermally insulate areas adjacent to the treatment region.

11. The apparatus of claim 10 further comprising a relief valve in fluid communication with the lumen, wherein the relief valve is configured to open at a predetermined pressure.

12. The apparatus of claim 10 wherein the outer balloon is configured to have a burst strength of between 4 and 12 atmospheres of pressure and at a cryogenic temperature between 0°

and −

100°

C.

13. The apparatus of claim 10 further comprising an inner cryo balloon positioned within the outer balloon and enclosing the at least one cryogenic probe.

14. The apparatus of claim 13 wherein the inner cryo balloon is configured to expand into conformance against the inner surface of the outer balloon.

15. The apparatus of claim 10 wherein the outer balloon is inflatable via a liquid refrigerate.

16. The apparatus of claim 10 wherein the outer balloon is inflatable to have an outer diameter between 6 mm and 20 mm or more.

17. The apparatus of claim 16 wherein the outer balloon has a length between 1 cm and 6 cm or more.

18. The apparatus of claim 10 wherein the at least one imaging device is removably insertable within the outer balloon.

19. The apparatus of claim 10 wherein the one or more openings are defined in a linear array along the cryogenic probe.

20. The apparatus of claim 19 wherein the one or more openings each have a diameter of between 50 and 150 microns.

21. The apparatus of claim 19 wherein the one or more openings number between 1 and 20 or more.

22. A method for cryosurgical ablation of an anatomical structure in the body of a patient comprising the steps of:

a. inserting a cryosurgical apparatus into the body of the patient, with said cryosurgical apparatus comprising an elongated structure with a distal end, a proximal end, a means for lateral tissue freezing disposed in the vicinity of the distal end, a means for lateral tissue thermal protection disposed in the vicinity of the distal end in diametric opposition to said lateral freezing means, an imaging device mounted in the vicinity of the distal end configured for distal imaging, a means for connecting the lateral freezing means to a source of cryogenic fluid, and a means for connecting the imaging device to an imaging console disposed in the vicinity of the proximal end;

b. advancing said distal end into close proximity of the target anatomical structure;

c. imaging distal tissue with said imaging device, and using said imaging to orient the lateral freezing means adjacent to the target anatomical structure;

d. freezing the anatomical structure with said lateral freezing means,

whereby said lateral tissue thermal protection means prevents cryogenic injury to tissue adjacent to the target anatomical structure.

23. The method of claim 22 wherein the target anatomical structure is a nerve associated with chronic pain, and said adjacent tissue comprises blood vessels associated with said nerve.

24. The method of claim 22 wherein the target anatomical structure comprises a facial boundary separating one or more anatomical structures.

25. The method of claim 22 wherein the cryosurgical apparatus comprises an elongated rigid structure with a distal end, a proximal end, and a central lumen;

with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging;

said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end with a cryo-ablation probe through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes.

26. The method of claim 25 wherein tissue diametrically opposed to the lateral fenestration is thermally protected from cryogenic injury due to the distance created between the target tissue and the opposing tissue by the intervening apparatus.

27. The method of claim 22 wherein the cryosurgical apparatus comprises an elongated structure with a distal end, a proximal end, and at least one central lumen;

with said distal end comprising an inflatable balloon structure configured as a refrigerant evaporation chamber, and as an optical imaging window, enclosing at least one optical imaging device;

with said proximal end comprising a means for introducing a liquid refrigerant into the distal balloon through a central lumen, a means of removing evaporated refrigerant from the cryosurgical apparatus at a predetermined pressure, a means for connecting the optical imaging device(s) to an imaging display, a means for inflating the balloon with a liquid or a gas, and a means spraying liquid refrigerant at a lateral interior portion of the balloon for the purpose of lateral tissue freezing.

28. The method of claim 27 wherein tissue diametrically opposed to the lateral tissue freezing is thermally protected from cryogenic injury due to the distance created between the target tissue and the opposing tissue by the balloon, or the thermal insulating properties of the refrigerant gas within the balloon.

29. The method of claim 22 wherein the cryosurgical apparatus comprises an elongated structure with a distal end, a proximal end, and at least one central lumen;

with said distal end comprising an outer inflatable balloon structure configured as an optical imaging window, and as a tissue dilator enclosing at least one optical imaging device, at least one inner cryogenic evaporator balloon, and at least one inner thermal insulation balloon;

with said proximal end comprising a means for introducing a liquid refrigerant into the cryogenic evaporator balloon through a central lumen, a means of removing evaporated refrigerant from the cryogenic evaporator balloon through a central lumen at a predetermined pressure, a means for inflating the thermal insulation balloon with the pressurized evaporated refrigerant gas, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the outer balloon with a liquid or a gas, and a means spraying liquid refrigerant at a lateral interior portion of the inner cryogenic evaporator balloon for the purpose of lateral tissue freezing.

30. The method of claim 29 wherein tissue diametrically opposed to the lateral tissue freezing is thermally protected from cryogenic injury due to the distance created between the target tissue and the opposing tissue by the outer balloon, or the thermal insulating properties of the refrigerant gas within the inner thermal insulation balloon.

31. A cryosurgical apparatus comprising:

a. an elongated rigid structure with a distal end, a proximal end, and a central lumen;

b. a non-coring optically transparent needle tip located at the distal end and having at least one lateral fenestration in communication with the central lumen, and housing at least one imaging device configured for distal imaging;

c. a handle located at the proximal end and having a means for connecting the imaging device(s) to an imaging display(s); and

d. a means for accessing bodily tissue in the vicinity of the distal end with a cryo-ablation probe through the central lumen and the lateral fenestration(s).

32. A cryosurgical apparatus comprising:

a. an elongated structure with a distal end, a proximal end, and at least one central lumen;

b. an inflatable balloon structure located at the distal end and configured as a refrigerant evaporation chamber, and as an optical imaging window, enclosing at least one optical imaging device;

c. an introducing means located at the proximal end for introducing a liquid refrigerant into the distal balloon through a central lumen;

d. a removal means located at the proximal end for removing evaporated refrigerant from the cryosurgical apparatus at a predetermined pressure;

e. a connecting means located at the proximal end for connecting the optical imaging device(s) to an imaging display;

f. an inflation means located at the proximal end for inflating the balloon with a liquid or a gas; and

g. a spraying means located at the proximal end for spraying liquid refrigerant at a lateral interior portion of the balloon for the purpose of lateral tissue freezing.

33. A cryosurgical apparatus comprising:

a. an elongated structure with a distal end, a proximal end, and at least one central lumen,

b. an outer inflatable balloon structure located at the distal end and configured as an optical imaging window, and as a tissue dilator enclosing at least one optical imaging device, at least one inner cryogenic evaporator balloon, and at least one inner thermal insulation balloon;

c. an introducing means located at the proximal end for introducing a liquid refrigerant into the inner cryogenic evaporator balloon through a central lumen, a means of removing evaporated refrigerant from the cryogenic evaporator balloon through a central lumen at a predetermined pressure, a means for inflating the thermal insulation balloon with the pressurized evaporated refrigerant gas, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the outer balloon with a liquid or a gas; and

d. a spraying means located at the proximal end for spraying liquid refrigerant at a lateral interior portion of the inner cryogenic evaporator balloon for the purpose of lateral tissue freezing.