Thin layer ablation apparatus

• US 5,575,788 A
• Filed: 10/06/1994
• Issued: 11/19/1996
• Est. Priority Date: 06/24/1994
• Status: Expired due to Term

• Current Assignee: Stuart D. Edwards
• Original Assignee: Stuart D. Edwards
• Inventors: Jones, Chris, Sommer, Phillip, Baker, James, Edwards, Stuart D., Strul, Bruno, Lee, Kee S.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US08/319,373
• Time in Patent Office: 775 Days
• Field of Search: 606/7, 606/13-15, 606/27-34, 606/41, 606/42, 606/45-50, 606/191-193, 607/98-102, 604/53, 604/21, 604/22, 604/94-102
• US Class Current: 606/41
• CPC Class Codes: A61B 18/148 having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• 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 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00065 porous
• CPC Class Codes: A61B 2018/00077 high, i.e. electrically conducting
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00113 with foam
• CPC Class Codes: A61B 2018/00148 with metal
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00494 Stomach, intestines or bowel
• CPC Class Codes: A61B 2018/00559 : Female reproductive organs
• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61B 2018/00654 : with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/00666 : using a threshold value
• CPC Class Codes: A61B 2018/00678 : upper
• CPC Class Codes: A61B 2018/00702 : Power or energy
• CPC Class Codes: A61B 2018/00708 : switching the power on or off
• CPC Class Codes: A61B 2018/00726 : Duty cycle
• CPC Class Codes: A61B 2018/00755 : Resistance or impedance
• CPC Class Codes: A61B 2018/00761 : Duration
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00815 : measured by a thermistor
• CPC Class Codes: A61B 2018/00821 : measured by a thermocouple
• CPC Class Codes: A61B 2018/00827 : Current
• CPC Class Codes: A61B 2018/00869 : Phase
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/00886 : Duration
• CPC Class Codes: A61B 2018/00892 : Voltage
• CPC Class Codes: A61B 2018/00898 : Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/0091 : Handpieces of the surgical instrument or device
• CPC Class Codes: A61B 2018/00916 : with means for switching or controlling the main function of the instrument or device
• 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 2018/0262 : using a circulating cryogenic fluid
• CPC Class Codes: A61B 2018/046 : in liquid form
• CPC Class Codes: A61B 2018/124 : switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/1253 : monopolar
• CPC Class Codes: A61B 2018/126 : bipolar
• CPC Class Codes: A61B 2018/1273 : including multiple generators in one device
• CPC Class Codes: A61B 2018/1467 : using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1472 : for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2090/3614 : using optical fibre
• CPC Class Codes: A61B 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 8/00 : Diagnosis using ultrasonic, sonic or infrasonic waves imaging of objects using sonar G01S15/00
• CPC Class Codes: A61M 16/0481 : through the cuff wall
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1086 : having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61N 1/056 : Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 1/40 : Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals

Abstract

An ablation apparatus for ablating an inner layer in an organ or lumen of a body, or any desired thin layer, includes an expandable member made of a material with a porous exterior surface. An electrolytic solution, housed in an interior of the expandable member, releases electrolytic solution through the porous exterior surface. A conforming member, which can be an open cell foam material, has an RF conductive surface, and a back side in a surrounding relationship to an exterior surface of the expandable member. Further, the conforming member includes non-zone areas that have a first porosity rate for delivering electrolytic solution to the inner layer. The conforming member also includes a zone for housing each RF electrode and electrolytic solution. Zones have a second porosity rate that is less than the first porosity rate, thus permitting electrolytic solution to pass through the non-zone areas at a faster rate than in the zones. The zones provide an area where electrolytic solution is heated to a higher temperature, due to the differences in porosity with the non-zones. With the combination of the electrode and the heated electrolytic solution in each zone, a larger electrode is created, and there is a more effective, and even application of both RF and thermal energy to the tissue site, such as the endometrium.

Claims

1. An oblation apparatus for ablating an inner layer in an organ or lumen of a body, comprising:

an expandable member, made of a material with a porous exterior surface. defining an expandable member interior that contains an electrolytic solution, the expandable member releasing the electrolytic solution through the porous exterior surface;

an RF electrode;

a conforming member, with an RF conductive surface and a back side in a surrounding relationship to an exterior surface of the expandable member, made of a material that provides substantial conformity between the RF conductive surface and the inner layer, the conforming member including non-zone areas with a first porosity rate for delivering electrolytic solution to the inner layer and a zone for housing an electrode and receiving at least some of the electrolytic solution delivered to the inner layer, the zone having a second porosity rate that is less than the first porosity rate with electrolytic solution passing through the zone at a slower rate than electrolytic solution passing through non-zone areas of the conforming member; and

an RF power source coupled to the electrode.

2. The ablation apparatus of claim 1, wherein the conforming member is made of an open cell material.

3. The ablation apparatus of claim 1, wherein the conforming member is made of an open cell material, and the zone areas have less open cells than the non-zone areas.

4. The ablation apparatus of claim 3, wherein the conforming member is made of an open cell foam.

5. The ablation apparatus of claim 1, wherein the conforming member is two pieces of open cell foam material that are sealed together in the non-zone areas.

6. The ablation apparatus of claim 1, wherein the conforming member is two pieces of open cell foam material that are sealed together in the zone.

7. The ablation apparatus of claim 1, wherein the ablation apparatus includes a plurality of electrodes positioned in one of an interior or exterior of the conforming member.

8. The ablation apparatus of claim 7, wherein each electrode in the plurality of electrodes has an associated zone.

9. The ablation apparatus of claim 1, further comprising:

a groundpad electrode attached to an exterior surface of a patient.

10. The ablation apparatus of claim 1, further comprising:

an electrolytic solution source; and

a fluid delivery device for delivering electrolytic solution from the electrolytic solution source to the interior of the expandable member.

11. The ablation apparatus of claim 10 further comprising:

a device for heating the electrolytic solution coupled to the electrolytic solution source.

12. The ablation apparatus of claim 1 further comprising,

a heating device positioned in an interior of the expandable member to heat the electrolytic solution in the expandable member is heated to a desired temperature.

13. The ablation apparatus of claim 1 further comprising,

a mechanical expansion member positioned in an interior of the expandable member to mechanically expand the expandable member.

14. The ablation apparatus of claim 1, wherein the expandable member is expandable by a fluidic medium introduced into an interior of the expandable member.

15. The ablation apparatus of claim 14, wherein the fluid medium is the electrolytic solution.

16. The ablation apparatus of claim 1, wherein the expandable member is expanded mechanically with a mechanical expansion member positioned in an interior of the expandable member and with a fiuidic medium introduced into the interior of the expandable member.

17. An oblation apparatus for ablating an inner layer in an organ or lumen of a body, comprising:

an expandable member, made of a material with a porous exterior surface, defining an expandable member interior that contains a heated electrolytic solution, the expandable member releasing electrolytic solution through the porous exterior surface;

a device coupled to the expandable member interior for heating the electrolytic solution to a selected temperature;

a fluid conduit with a conductive surface and a back side in a surrounding relationship to the expandable member, the fluid conduit being made of a material that provides substantial conformity between the conductive surface and the inner layer of the organ, the fluid conduit delivering heated electrolytic solution received from the interior of the expandable member to the inner layer;

a plurality of electrodes positioned in one of the fluid conduit or between the expandable member and the fluid conduit; and

an RF power source coupled to the plurality of electrodes.

18. The ablation apparatus of claim 17, further comprising:

a patient return electrode coupled to the RF power source.

19. The ablation apparatus of claim 17, further comprising:

an electrolytic solution source; and

a fluid delivery device for delivering the electrolytic solution from the electrolytic solution source to the interior of the expandable member.

20. The ablation apparatus of claim 19, wherein the device for heating the electrolytic solution is associated with the electrolytic solution source.

21. The ablation apparatus of claim 19, wherein the device for heating the electrolytic solution is positioned in the interior of the expandable member.

22. The ablation apparatus of claim 17, wherein the expandable member is a mechanical expansion member positioned in an interior of the expandable member.

23. The ablation apparatus of claim 17, wherein the expandable member is a balloon.

24. The ablation apparatus of claim 17, wherein the fluid conduit is made of an open cell foam.

25. The ablation apparatus of claim 17, wherein the plurality of electrodes comprises a flexible circuit.

26. The ablation apparatus of claim 25, wherein the flexible circuit forms segments.

27. The ablation apparatus of claim 17, wherein the plurality of electrodes is positioned in the fluid conduit.

28. The ablation apparatus of claim 17, further comprising:

a feedback device coupled to the plurality of electrodes and responsive to a detected characteristic of the inner layer that provides a controlled delivery of RF energy to the plurality of electrodes.

29. An ablation apparatus for ablating an inner layer in an organ of a body comprising:

a first expandable member;

a second expandable member surrounding the first expandable member and attached thereto, the second expandable member having a porous structure to deliver an electrolytic solution to the inner layer of the organ, the second expandable member including non-zone areas with a first porosity rate for delivering electrolytic solution to the inner layer and one or more zones each housing an electrode and receiving at least some of the electrolytic solution delivered to the inner layer, each zone having a second porosity rate that is less than the first porosity rate with electrolytic solution passing through each zone at a slower rate than electrolytic solution passing through non-zone areas of the second expandable member;

an electrical connector device connecting each electrode to an RF energy source; and

an electrolytic solution delivery device coupled to one of an interior of the first or second expandable members to deliver electrolytic solution to the interior of the second expandable member and wherein the second expandable member expands to conform to at least a portion of the inner layer of the organ.

30. The apparatus as recited in claim 29 wherein the second expandable member expands in response to the delivery of the electrolytic solution to the second expandable member.