Thermal treatment apparatus

• US RE37,704 E1
• Filed: 03/28/2000
• Issued: 05/14/2002
• Est. Priority Date: 03/22/1990
• Status: Expired due to Fees

• Current Assignee: Wit Ip Corporation
• Original Assignee: Argomed Limited
• Inventors: Eshel, Uzi
• Primary Examiner(s): NGUYEN, ANH TUAN TUONG
• Application Number:
  US09/534,842
• Time in Patent Office: 777 Days
• Field of Search: 604/27, 604/28, 604/48, 604/97.01, 604/101.01, 604/113, 604/114, 604/151-153, 606/27, 606/28, 606/194, 607/105, 607/126
• US Class Current: 604/113
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2018/00101 low, i.e. thermally insulating
• CPC Class Codes: A61B 2018/00166 Multiple lumina
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/0086 with a thermostat
• CPC Class Codes: A61F 2007/0095 with a temperature indicator
• CPC Class Codes: A61F 2007/025 retaining air or other gas
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: A61M 2205/366 by liquid heat exchangers
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: F04B 43/1253 by using two or more rollers as squeezing elements, the rollers moving on an arc of a circle during squeezing
• CPC Class Codes: F24H 1/121 using electric energy supply

Abstract

Thermal treatment apparatus for thermally treating selected tissues of a subject located in or near a body cavity, includes a catheter insertable into the subject'"'"'s body cavity and having a proximal end formed with an inflatable anchoring section for anchoring the catheter in the body cavity, a distal end to be located externally of the body cavity, and an inflatable heating section adjacent the proximal end to be located near the tissue to be heated. The catheter is formed with passageways extending from the distal end to the inflatable heating section for circulating heated fluid through the inflatable heating section but not through the inflatable anchoring section, and a further passageway from the distal end to the inflatable anchoring section for inflating the inflatable anchoring section with a non-heated fluid. The inflatable heating section and the tissue in its proximity may thus be heated to a desired high temperature without correspondingly heating the inflatable anchoring section and the tissue in its proximity.

Claims

1. Thermal treatment apparatus for thermally treating selected tissues of a subject located in or near a body cavity, comprising a catheter insertable into the subject'"'"'s body cavity and including a proximal end to be inserted into the body cavity, a distal end to be located externally of the body cavity, an inflatable anchoring balloon positioned adjacent said proximal end, and an inflatable heating section on said proximal end axially away from said inflatable anchoring balloon in a direction which is toward said distal end so as to be located near the tissue to be heated;

said catheter being formed with first and second passageways extending from said distal end to said inflatable heating section and in fluid communication with each other for circulating heated fluid through said inflatable heating section and a third anchoring inflation passageway extending from said distal end to said inflatable anchoring balloon, said anchoring inflation passageway configured separate from said first and second passageways, and thermal insulation, surrounding said first and second passageways from close to said distal end to close to said inflatable heating section, said thermal insulation including a plurality of separate compartments containing a non-heated fluid, said components extending axially along the catheter, whereby the inflatable heating section and the tissue in its proximity may be heated to a desired high temperature without correspondingly heating non-selected tissues.

2. The apparatus according to claim 1, further including a heater associated with said first passageway for heating a fluid, and a pump associated with said heater and said second passageway for circulating said fluid in a closed circuit through said heating section of the catheter.

3. The apparatus according to claim 2, wherein said heater includes:

a heating block formed with a smoothly curved cavity;

a container defining a liquid reservoir and formed with a complementary-curved wall removably receivable in said cavity;

a cover attached to said container;

a liquid inlet tube passing through said cover for inletting a liquid into said container to be heated by said heating block; and

a liquid outlet tube passing through said cover for outletting a liquid from said container after having been heated by said heating block.

4. The apparatus according to claim 3, wherein the dimensions of said curved wall of the container are slightly smaller than those of the smoothly curved cavity of the heating block, to provide a small gap for receiving a liquid having good thermal coupling characteristics.

5. The apparatus according to claim 3, wherein said smoothly-curved cavity of the heating block, and said complementary-curved wall of the container, are both of semi-spherical configuration.

6. The apparatus according to claim 3, wherein said heating block is made of a material having high thermal conductivity and includes at least one electrical heating element encased therein.

7. The apparatus according to claim 2, wherein said pump is a peristaltic pump for pumping fluid through a peristaltic tube, said pump including:

(a) a housing formed with a substantially cylindrical cavity having an inner surface, said housing provided with a lid, said lid having a depending skirt removably engagable within said cylindrical cavity so as to form an inset lining around a part of said inner surface; and

(b) a rotor rotatably mounted within said cylindrical cavity, said rotor carrying rollers,

such that, when said depending skirt is not engaged in said cylindrical cavity, the peristaltic tube may be easily inserted between said rollers and said inner surface and, when said depending skirt is engaged in said cylindrical cavity, the peristaltic tube is engaged between said rollers and said inset lining such that rotation of said rotor pumps fluid through the peristaltic tube.

8. The apparatus according to claim 7, wherein an inner surface of said depending skirt is formed with a groove to produce a pulsatile fluid flow.

9. The apparatus of claim 1, further including a first thermal sensor assembly associated with the inlet end of said first passageway for measuring the temperature of the heated fluid entering said first passageway;

and a second thermal sensor assembly associated with the outlet end of said second passageway for measuring the temperature of the heated fluid exiting from said second passageway.

10. The apparatus according to claim 9, wherein each of said thermal sensor assemblies includes:

a thermal sensor, a metal tube connectable to the respective end of the respective passageway of the catheter to receive the heated fluid flowing therethrough;

a metal thermal coupling member formed with a recess on one face for receiving the thermal sensor therein, a recess on the opposite face complementary to the shape of the metal tube for receiving the metal tube therein, and a relatively thin web between the two recesses; and

a cover pressing said metal tube to said thermal coupling member.

11. The apparatus according to claim 1, wherein said catheter includes a third fourth passageway extending centrally of the catheter and communicating with an opening in the proximal end of the catheter to drain liquid from the body cavity to said distal end or to introduce a drug into the body.

12. The apparatus according to claim 1, wherein said heating section of the catheter is of cylindrical configuration.

15. The apparatus of claim 1, wherein said body cavity is the urethra and the tissue proximity to said inflatable heating section is the prostate, and wherein, in position, said anchoring balloon resides in the bladder of the subject proximate to the bladder neck.

16. The apparatus of claim 15, wherein responsive to inflation of said heating section, said catheter inflatable heating section is configured to expand and press against the prostate to enhance the heating effects provided by exposing the tissue to heated fluid circulating therein.

17. The apparatus of claim 2, wherein said pump is configured to provide a pulsatile flow output.

18. The apparatus of claim 9, wherein said first and second thermal sensor assemblies each include a metal tube portion configured to allow the heated fluid to flow therethrough and which thermally heat up in response to the heated fluid traveling therethrough.

19. The apparatus of claim 11, wherein said anchoring balloon is inflated with air, and wherein the heated fluid circulating through said inflatable heating section comprises water.

13. Thermal treatment apparatus for thermally treating selected tissues of a subject located in or near a body cavity, comprising:

a catheter insertable into the subject'"'"'s body cavity and including a proximal end with a length which is to be inserted into the body cavity, a distal end to be located externally of the body cavity, and an inflatable heating section on located along a portion of the length of said proximal end to be located near the tissue to be heated such that it can be inserted and positioned in a desired location within a body cavity;

first and second passageways extending from said distal end to said inflatable heating section in fluid communication with each other are for circulating heated fluid through said inflatable heating section;

a first thermal sensor assembly associated with the inlet end of said first passageway for measuring the temperature of the heated fluid entering said first passageway;

a second thermal sensor assembly associated with the outlet end of said second passageway for measuring the temperature of the heated fluid exiting from said second passageway; and

thermal insulation surrounding said first and second passageways from close to said distal end to close to said inflatable heating section, said thermal insulation including a plurality of separate compartments containing a non-heated fluid, said compartments extending axially along the said catheter.

14. The apparatus according to claim 13, wherein each of said thermal sensor assembly includes:

a thermal sensor;

a metal tube connectable to the respective end of the respective passageway of the catheter to receive the heated fluid flowing therethrough;

a metal thermal coupling member formed with a recess on one face for receiving the thermal sensor therein, a recess on the opposite face complementary to the shape of the metal tube for receiving the metal tube therein, and a relatively thin web between the two recesses; and

a cover pressing said metal tube to said metal thermal coupling member.

20. The thermal treatment apparatus of claim 13, wherein each of said first and second thermal sensor assemblies includes:

21. The thermal treatment apparatus of claim 20, said catheter further comprising an anchoring balloon positioned on said catheter intermediate said inflatable heating section and said proximal end, and wherein said anchoring balloon is in fluid communication with a third passageway which is in fluid isolation from said first and second passageways.

22. The apparatus of claim 21, wherein said body cavity comprises the urethra, wherein the tissue in proximity to said inflatable heating section is the prostate, and wherein, in position, said anchoring balloon resides in the bladder of the subject proximate to the bladder neck.

23. The apparatus of claim 22, wherein, responsive to inflation of said inflatable heating section, said catheter inflatable heating section is configured to expand and press against the prostate to enhance the heating effects provided by exposing the tissue to heated fluid circulating therein.

24. The apparatus of claim 23, wherein said catheter further comprises a urinary drain port on said proximal end, said urinary drain port including a drain channel which extends from said proximal end to said distal end to allow urine to drain therethrough.

25. The apparatus of claim 24, wherein said thermal treatment apparatus further comprises a pump in fluid communication with said first and second passageways that circulates the heated fluid therethrough, and wherein said pump is configured to provide a pulsatile flow output.

26. The apparatus of claim 24, wherein said anchoring balloon is inflated with air, and wherein the heated fluid circulating through said inflatable heating section comprises water.

27. A thermal treatment system for thermally treating benign prostatic hyperplasia, comprising:

28. A thermal treatment system according to claim 27, further comprising first and second metal cylinder segments configured to allow the heated fluid to flow therethrough, said first metal cylinder in fluid communication with said first inlet passageway and said second metal cylinder in fluid communication with said second outlet passageway.

29. A thermal treatment system according to claim 27, wherein said inflatable heating section is configured as a cylindrical heating section to radially expand from a first collapsed position to a cylindrically shaped heating configuration having a first radial width during use.

30. A thermal treatment system according to claim 29, wherein said inflatable anchoring balloon expands to a shape which has a second radial width when inflated, said second radial width being larger than said first radial width of said cylindrically shaped heating section.

31. A thermal treatment system according to claim 30, wherein said catheter is configured to circulate heated water to thermally treat the prostate by exposing same to heated water circulating in said inflatable heating section without correspondingly heating non-selected tissues.

32. A thermal treatment system according to claim 31, wherein said inflatable anchoring balloon is inflated by introduction of air therein from said third passageway.