Transurethral ablation catheter

• US 5,304,214 A
• Filed: 01/21/1992
• Issued: 04/19/1994
• Est. Priority Date: 01/21/1992
• Status: Expired due to Term

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: MED Institute, Inc. (Cook Group Incorporated)
• Inventors: DeFord, John A., Fearnot, Neal E., Ely, Joseph F.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US07/823,318
• Time in Patent Office: 819 Days
• Field of Search: 128/400, 128/401, 128/785, 128/786, 128/804, 606/28, 606/29, 606/31, 606/5, 607/101, 607/102, 607/105, 607/113, 607/116, 607/154, 607/156
• US Class Current: 607/105
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00101 using an array of thermosensors
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00547 Prostate
• 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: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A catheter, system, and method for selectively ablating prostatic tissue about the prostatic urethra. The catheter includes an elongated member having distal, proximal, and intermediate portions, the intermediate portion being shaped and sized for intimate contact with the prostatic urethra. The distal and proximal portions of the catheter include fixation and cooling balloons having an annular recess therein for positioning the internal and external sphincters therein and for maintaining the longitudinal position of the catheter in the prostatic urethra. A thermally conducted, heat-emitting element is positioned in the intermediate portion for producing a thermally conductive heat distribution to ablate the prostatic tissue. The catheter also includes irrigation and aspiration passageways therein for communicating with the interior of the distal and proximal cooling balloons. A circulating pump of the ablation system circulates coolant through the balloons to maintain the temperature of the sphincters below an injurious temperature. Sensors are positioned about the heat-emitting element as well as in the cooling balloons for supplying information to the controller of the system. The controller in response to the temperature information and the energy supplied to the heat-emitting element controls the supply of energy to the catheter as well as the pump circulating the coolant.

Claims

1. A transurethral ablation catheter for ablating prostatic tissue about a prostatic urethra positioned between internal and external sphincters, comprising:

an elongated member having a distal portion, a proximal portion, and an intermediate portion, said intermediate portion being positioned between said distal and proximal portions and shaped and sized for intimate contact with said prostatic urethra, at least one of said distal and proximal portions including fixation means positionable about at least one of said internal and external sphincters, respectively, for maintaining longitudinally said intermediate portion in said prostatic urethra; and

a thermally conductive heat-emitting element positioned in said intermediate portion and responsive to energy supplied thereto for producing a predetermined thermally conductive heat distribution in said tissue to ablate said tissue.

2. The ablation catheter of claim 1 wherein said fixation means comprises a first inflatable balloon positioned about at least one of said distal and proximal portions.

3. The ablation catheter of claim 2 wherein said first inflatable balloon when inflated includes a first annular recess for positioning at least one of said internal and external sphincters therein.

4. The ablation catheter of claim 2 wherein said elongated member further includes supply means communicating with said first inflatable balloon for inflating said first inflatable balloon.

5. The ablation catheter of claim 4 wherein said supply means further includes means for circulating a coolant in said first inflatable balloon.

6. The ablation catheter of claim 5 further comprising a temperature sensor means for measuring the temperature of said coolant.

7. The ablation catheter of claim 2 wherein said fixation means comprises a second inflatable balloon positioned about the other of said distal and proximal portions.

8. The ablation catheter of claim 7 wherein said elongated member further includes supply means communicating with said first and said second inflatable balloons for inflating said first and said second inflatable balloons.

9. The ablation catheter of claim 8 wherein said supply means further includes means for circulating a coolant in said first and second inflatable balloons.

10. The ablation catheter of claim 9 wherein said supply means includes first and second passageways in said elongated member communicating with said first and second inflatable balloons.

11. The ablation catheter of claim 9 wherein each of said first and second passageways includes a plurality of ports communicating with an interior of said first and second inflatable balloons.

12. The ablation catheter of claim 11 wherein the ports of each of said plurality of ports include different cross-sectional areas.

13. The ablation catheter of claim 7 wherein said second inflatable balloon includes an annular recess for positioning the other of said internal and external sphincters therein.

14. The ablation catheter of claim 7 further comprising first annular means for forming a first annular recess about said first inflatable balloon to position at least one of said internal and external sphincters therein.

15. The ablation catheter of claim 14 further comprising second annular means for forming a second annular recess about said second inflatable balloon to position the other of said internal and external sphincters therein.

16. The ablation catheter of claim 7 further comprising means for adjusting a spacing between said first and second inflatable balloons.

17. The ablation catheter of claim 1 wherein said fixation means includes recess means for positioning said at least one of said sphincters therein.

18. The ablation catheter of claim 17 wherein said fixation means includes second recess means for positioning the other of said sphincters therein.

19. The ablation catheter of claim 1 wherein said heat-emitting element comprises a helically wound coil of electrically semiconductive material.

20. The ablation catheter of claim 1 wherein said heat-emitting element is serpentine shaped and is positioned longitudinally along and partially circumferentially about said intermediate portion.

21. The ablation catheter of claim 1 further comprising a temperature sensor in said intermediate portion.

22. The ablation catheter of claim 21 wherein said temperature sensor comprises a thermistor.

23. The ablation catheter of claim 1 wherein said elongated member includes a passageway extending longitudinally therein.

24. A transurethral ablation catheter for ablating prostatic tissue positioned between internal and external sphincters, comprising:

an elongated member having a distal portion, a proximal portion, and an intermediate portion positioned between said distal and proximal portions, said distal and proximal portions including cooling means positionable about at least one of said internal and external sphincters for cooling said at least one of said internal and external sphincters; and

a heating element positioned about said intermediate portion and responsive to energy supplied thereto for producing a temperature in said tissue to ablate said tissue.

25. A transurethral catheter for ablating prostatic tissue between internal and external sphincters, comprising:

first and second elongated coaxial members longitudinally movable relative to each other, said first member having first fixation means for positioning said internal sphincter thereabout, said second member having second fixation means for positioning said external sphincter thereabout; and

one of said members including a thermally conductive heat-emitting element positioned between said first and second fixation means and responsive to energy supplied thereto for producing a predetermined, thermally conductive heat distribution in said prostatic tissue.

26. The catheter of claim 25 wherein said first and second fixation means includes respective first and second annular recesses for positioning said internal and external sphincters therein, respectively.

27. The catheter of claim 26 wherein said first and second fixation means includes respective first and second inflatable balloons responsive to coolant supplied thereto for maintaining a temperature of said internal and external sphincters below a predetermined maximum temperature.

28. A system for ablating prostatic tissue between internal and external sphincters, comprising:

heat-emitting catheter means transurethrally positionable in said prostatic tissue through at least one of said internal and external sphincters and responsive to energy supplied thereto for producing a predetermined, thermally conductive heat distribution in said prostatic tissue to ablate said prostatic tissue, said heat-emitting catheter means including sphincter cooling means positionable about at least one of said internal and external sphincters and responsive to a coolant supplied thereto for maintaining said at least one of said sphincters below a predetermined maximum temperature;

said heat-emitting catheter means including temperature sensor means for measuring temperature thereabout; and

control means responsive to said temperature measured about said sensor means and said energy supplied to said heat-emitting catheter means for controlling the energy supplied to said heat-emitting catheter means to produce said predetermined, heat distribution in said prostatic tissue.

29. The system of claim 28 wherein said heat-emitting catheter means further includes second temperature sensor means positioned about said sphincter cooling means for determining a temperature of said at least one of said sphincters and wherein said control means is responsive to the temperature of said at least one of said sphincters for controlling the coolant supplied to said cooling means.

30. The system of claim 28 wherein said sphincter cooling means includes first cooling means positionable about said internal sphincter and responsive to a coolant supplied thereto for maintaining said internal sphincter below a predetermined maximum temperature and a second cooling means positionable about said external sphincter and responsive to a coolant supplied thereto for maintaining said external sphincter below a predetermined maximum temperature.

31. The system of claim 30 wherein said heat-emitting catheter means further includes second temperature sensor means positioned about said first cooling means for determining a temperature of said internal sphincter and third temperature sensor means positioned about said second cooling means for determining a temperature of said external sphincter and wherein said control means is responsive to the temperatures of said internal and external sphincters and to the coolant supplied to said first and second cooling means for controlling the coolant supplied to said first and second cooling means.

32. The system of claim 31 further comprising means responsive to said control means for supplying the coolant to said first and second cooling means.

33. The system of claim 32 further comprising means responsive to said control means for supplying the energy to said heat-emitting catheter means.

34. A system for ablating prostatic tissue between internal and external sphincters comprising:

catheter means transurethrally positionable in said prostatic tissue through at least one of said internal and external sphincters and responsive to energy supplied thereto for producing a temperature in said tissue to ablate said tissue between said internal and external sphincters, said catheter means including cooling means positionable about at least one of said internal and external sphincters and responsive to a coolant supplied thereto for maintaining said at least one of said sphincters below a predetermined maximum temperature;

said catheter means including sensor mean for sensing temperature thereabout; and

control means responsive to said temperature sensed about said sensor means and said energy supplied to said catheter means for controlling the energy supplied to said catheter means to ablate said tissue.

35. The system of claim 34 further comprising means responsive to said control means for supplying the coolant to said cooling means.

36. A method for treating prostatic hyperplasia comprising:

positioning a heat-emitting catheter transurethrally into a prostatic urethra;

selectively applying heat to said prostatic urethra between internal and external sphincters for producing an ablative temperature in said prostatic urethra; and

cooling at least one of said internal and external sphincters to below a predetermined maximum temperature.

37. The method of claim 36 wherein the step of positioning said catheter includes positioning said catheter relative to at least one of said internal and external sphincters.

38. The method of claim 36 further comprising coagulating blood perfusing about said prostatic urethra in response to said ablative temperature.