Method and apparatus for thermally destroying a layer of an organ

• US 4,979,948 A
• Filed: 04/13/1989
• Issued: 12/25/1990
• Est. Priority Date: 04/13/1989
• Status: Expired due to Term

• Current Assignee: Medical Engineering And Development Institute Inc, Purdue Research Foundation West Lafayette In 47907
• Original Assignee: MED Institute, Inc. (Cook Group Incorporated), Purdue Research Foundation (The Trustees of Purdue University (d/b/a Purdue University))
• Inventors: Hinds, Marvin H., Voorhees, William D., Geddes, Leslie A., Bourland, Joe D.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US07/337,356
• Time in Patent Office: 621 Days
• Field of Search: 128/303.17, 128/303.13, 128/784, 128/785, 128/786, 128/804, 128/401, 606/33, 606/49
• US Class Current: 606/33
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2018/00077 high, i.e. electrically conducting
• CPC Class Codes: A61M 2205/0266 Shape memory materials

Abstract

Method and apparatus are disclosed for thermally destroying a layer of an organ such as the mucosal layer of the gallbladder. The apparatus includes a catheter having an elongated member having a plurality of lumens therein. At the distal end of the elongated member is an electrode for emitting radiofrequency current to the mucosal layer. Also at the distal end is a capacitive balloon electrode surrounding the current-emitting electrode for containing an electrolyte solution and for distributing the radiofrequency current to the mucosal layer. The balloon electrode is expanded with the electrolyte solution to conform and make contact with the mucosal layer. The electrolyte solution has a resistivity significantly less than the resistivity of the gallbladder wall, as well as the gallbladder bile, to cause a concentrated power deposition in the mucosal layer. The distal end of the catheter is endoscopically inserted into the body of the gallbladder by a retrograde route through the duodenum, common bile duct and cystic duct. While the balloon electrode is being expanded, the bile present in the gallbladder is drained through one of the lumens in the elongated member. The apparatus also includes a radiofrequency generator for supplying radiofrequency current to the current-emitting electrode. The current-emitting electrode is energized for a period of time to cause the mucosal layer to be heated for a predetermined period of time to thermally coagulate the mucosal layer of the gallbladder and cystic duct. A dispersive electrode is positioned on the skin of the patient'"'"'s body to facilitate a complete circuit back to the generator without causing trauma to the patient.

Claims

1. Apparatus for thermally destroying a layer of an organ comprising:

an elongated member including a single fluid-transporting lumen opening interior to a capacitive balloon electrode;

a current-emitting electrode positioned about a distal end of said member and connectable to a source of radiofrequency current for emitting radiofrequency current; and

said capacitive balloon electrode surrounding said current-emitting electrode for distributing said current to said layer and having a shape expandable in response to an electrolyte solution for conforming said layer thereto, whereby said balloon electrode and said electrolyte solution in a non-flowing state cooperate in response to said radiofrequency current for selectively depositing power in said layer when said layer is in contact with said balloon electrode.

2. The apparatus of claim 1 wherein said lumen includes a plurality of ports about said distal end of said elongated member for expanding said balloon electrode.

3. The apparatus of claim 1 wherein said member comprises a lumen opening exterior to said balloon electrode for draining fluid from said organ displaced by said balloon electrode.

4. The apparatus of claim 1 further comprising sensor means for sensing a temperature of an environment about said distal end of said member.

7. The apparatus of claim 1 wherein said elongated member includes a lumen in said elongated member leading to said current-emitting electrode.

8. The apparatus of claim 1 wherein said capacitive balloon electrode comprises a flexible material having a predetermined capacitance.

9. The apparatus of claim 1 further comprising said source of radiofrequency current connected to said current-emitting electrode.

10. The apparatus of claim 9 further comprising means responsive to a temperature of an environment about said distal end of said member for controlling said source of radiofrequency current.

11. The apparatus of claim 1 further comprising said electrolyte solution including a radio-opaque compound.

5. The apparatus of claim 5 wherein said sensor means includes a thermistor.

6. The apparatus of claim 5 wherein said member includes a lumen in said elongated member reading to said sensor means.

12. A catheter for thermally coagulating the mucosal layer of a gallbladder, said mucosal layer having a first predetermined resistivity, comprising:

an elongated member having a distal end and a plurality of lumens therein;

a capacitive balloon electrode attached about said distal end of said elongated member and including a flexible material having a predetermined capacitance for making contact with said mucosal layer and for containing an electrolyte solution;

a first one of said lumens having a plurality of ports opening interior to said balloon electrode for expanding said balloon electrode with said electrolyte solution;

said solution having a second predetermined resistivity less than said first predetermined resistivity of said mucosal layer for selectively heating said mucosal layer;

a current-emitting electrode positioned about said distal end of said elongated member for emitting radiofrequency current to said balloon electrode and said mucosal layer when said balloon electrode is in contact with said mucosal layer, said current for heating said mucosal layer to a predetermined temperature, the heating of said mucosal layer at said predetermined temperature for a predetermined time period thermally coagulating said mucosal layer;

an electrical conductor connected to said current-emitting electrode and in a second one of said lumens for conducting said current from a source of said current to said current-emitting electrode;

a thermistor positioned about said distal end for sensing a temperature of an environment about said distal end;

a pair of electrical conductors in a third one of said lumens and connected to said thermistor for sending said sensed temperature to a current control circuit; and

a fourth one of said lumens opening exterior to said balloon electrode for draining fluid from said gallbladder when said balloon electrode is being expanded with said electrolyte solution.

13. Apparatus for thermally destroying a layer of an organ, comprising:

an elongated member including first and second lumens therein, said first lumen opening interior to a capacitive balloon electrode, said second lumen opening exterior to said balloon electrode;

a current-emitting electrode positioned about a distal end of said member and connectable to a source of radiofrequency current for emitting radiofrequency current; and

said capacitive balloon electrode positioned about said distal end and surrounding said current-emitting electrode for distributing said current to said layer and expandable in response to an electrolyte solution for making contact with said layer and for containing said electrolyte solution, whereby said balloon electrode and said electrolyte solution cooperate in response to said radiofrequency current for selectively heating said layer of said organ.

14. A catheter for thermally destroying the mucosal layer of a gallbladder, comprising:

an elongated member including a single fluid-transporting lumen opening interior to a capacitive balloon electrode;

a current-emitting electrode positioned about a distal end of said member and connectable to a source of radiofrequency current for emitting radiofrequency current; and

said capacitive balloon electrode surrounding said current-emitting electrode and having a predetermined ellipsoidal shape expandable in response to an electrolyte solution for conforming said mucosal layer thereto, whereby said balloon electrode and said electrolyte solution in a non-flowing state cooperate in response to said radiofrequency current for selectively heating said mucosal layer.

15. A method for thermally destroying a layer of an organ comprising the steps of:

inserting into said organ next to said layer of expandable, capacitive balloon electrode positioned about a distal end of a catheter;

expanding said capacitive balloon electrode with an electrolyte solution for making contact with said layer;

maintaining said electrolyte solution in a nonflowing state;

distributing a radiofrequency current from said capacitive balloon electrode to said layer; and

responsive to said radiofrequency current, heating said layer to a predetermined temperature for a predetermined period of time for thermally destroying said layer.

16. The method of claim 15 wherein said heating includes selectively depositing power in said layer in response to said radiofrequency current.

17. The method of claim 16 wherein said depositing includes expanding said capacitive balloon electrode with an electrolyte solution having a predetermined resistivity less than the resistivity of said layer.

18. The method of claim 15 further comprising monitoring a temperature of an environment about said distal end and maintaining a temperature of said layer at said predetermined temperature for said predetermined period of time in response to said temperature of said environment.

19. The method of claim 15 wherein said expanding includes expanding said capacitive balloon electrode with an electrolyte solution having a second predetermined resistivity less than a first resistivity of said layer.

20. The method of claim 15 further comprising draining fluid from said organ displaced by said capacitive balloon electrode.

21. The method of claim 15 wherein said distributing includes emitting said radiofrequency current from a current-emitting electrode positioned within said capacitive balloon electrode.

22. The method of claim 15 further comprising verifying the position of said capacitive balloon electrode next to said layer.