Closed circulation tissue warming apparatus and method of using the same in prostate surgery

• US 5,437,673 A
• Filed: 02/04/1993
• Issued: 08/01/1995
• Est. Priority Date: 02/04/1993
• Status: Expired due to Term

• Current Assignee: Endocare Inc. (Siemens AG)
• Original Assignee: Cryomedical Sciences Inc.
• Inventors: Chang, Zhao H., Baust, John G., Cohen, Jeffrey, Onik, Gary, Reyes, George
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/013,307
• Time in Patent Office: 908 Days
• Field of Search: 604/96, 604/113, 606/23, 606/108, 606/191, 606/280, 606/264, 606/24
• US Class Current: 606/23
• 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 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• 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 7/12 Devices for heating or cooling internal body cavities

Abstract

The present invention is directed to a closed circulation tissue warming apparatus for use during surgery to maintain the temperature of tissues at a desired level and to a method of using the apparatus in prostate surgery particularly during transperineal cryoablation of the prostate gland in human males to maintain the temperature of the urethral tissues and thereby prevent urethral sloughing. It may also have utility where it is desired to lower the temperature of surrounding tissues, such as during laser ablation. The apparatus includes a multi-lumen catheter inserted into the urethra and connected to a fluid warming and circulation control means whereby warmed water is circulated through the lumens at a controlled flow rate and temperature. The concentric lumen structure of the catheter provides improved flow and even temperature maintenance along the length of the catheter and the urethra.

Claims

1. A method for performing cryoablation of the prostate while maintaining the temperature of surrounding healthy tissue, including urethral tissues, at near normal body temperature, said method comprising:

inserting a multi-lumen catheter through the urethra into the bladder,

allowing body liquids to drain from the bladder through a central lumen of said catheter,

pumping a temperature controlled warm liquid from a source of said warm liquid countercurrently through first and second communicating concentric passageways surrounding said central lumen of said catheter and back to said source,

performing transperineal cryoablation of the prostate at a temperature of less than about -60°

C. until the undesired tissue is destroyed, and

maintaining the flow of said warm liquid at a temperature and flow rate through said passageways sufficient to maintain the temperature of the bladder and surrounding healthy tissue at a temperature of about normal body temperature.

2. The method of claim 1 further comprising providing said source of warm liquid as a reservoir of physiological saline or sterile water within a reservoir, connecting said reservoir to said first and second communicating concentric passageways to form a closed loop circulation system and heating said liquid in said reservoir.

3. A method for performing cryoablation of the prostate while maintaining the temperature of surrounding urethral tissues comprising:

passing a multi-lumen catheter through the urethra into the bladder wherein said multi-lumen catheter comprises an elongated urethral catheter having a distal end, a proximal end and a central drainage lumen, a circulating fluid inflow block positioned concentrically on said catheter adjacent said proximal end thereof and having a fluid inflow chamber with a fluid inlet port, a circulating fluid outflow block positioned concentrically on said catheter and distally adjacent to said inflow block and having a fluid outflow chamber with a fluid outlet port, a first elongated sleeve concentric to said catheter forming a first lumen therebetween and having a proximal end extending through said outflow chamber and connected to said inflow block, and a second elongated sleeve concentric to said first sleeve forming a second lumen therebetween and having a proximal end connected to said outflow block, wherein said first sleeve terminates at a distal end proximal to said distal end of said catheter and said second sleeve terminates at a distal end between said distal end of said first sleeve and said distal end of said catheter, said distal end of said second sleeve being sealed to said catheter, said first lumen and said second lumen cooperating to form a closed loop, countercurrent flow, fluid conduit concentrically disposed along said catheter,

activating a warming system to circulate warm fluid through said first and second lumens to maintain the temperature of said urethra at up to 42°

C., and

performing transperineal cryoablation of the prostate followed by deactivation of said warming system and removal of said multi-lumen catheter.

4. The method of claim 3 wherein the step of activating said warming system comprises connecting a first fluid conduit from a reservoir in said warming system to said inflow port and a second fluid conduit from said reservoir to said outflow port, heating a fluid in said reservoir and pumping said fluid from said reservoir through said first conduit to said first lumen, through said first lumen to said second lumen, through said second lumen to said second conduit and through said second conduit to return to said reservoir.

5. The method of claim 4 comprising providing said reservoir as a disposable container and said fluid as a sterile biocompatible fluid in said reservoir, placing said reservoir within a heating block, heating said fluid to a temperature of up to 42°

C. and maintaining said temperature while said fluid is circulated through said first and second lumens.

6. The method of claim 5 wherein said sterile biocompatible fluid is sterile water or physiological saline solution.