Infusion array ablation apparatus

• US 6,641,580 B1
• Filed: 02/24/2000
• Issued: 11/04/2003
• Est. Priority Date: 11/08/1993
• Status: Expired due to Fees

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: Rita Medical Systems Incorporated (AngioDynamics, Inc.)
• Inventors: Baker, James, Edwards, Stuart D., Lax, Ronald G., Sharkey, Hugh
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US09/513,725
• Time in Patent Office: 1,349 Days
• Field of Search: 606/41, 606/42, 606/45-50, 607/101, 607/102
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• 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 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00101 using an array of thermosensors
• 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 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00452 Skin
• CPC Class Codes: A61B 2018/00476 Hair follicles
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• 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 2018/00744 : Fluid flow
• CPC Class Codes: A61B 2018/00761 : Duration
• CPC Class Codes: A61B 2018/00779 : Power or energy
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00821 : measured by a thermocouple
• CPC Class Codes: A61B 2018/00827 : Current
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/00892 : Voltage
• 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 2018/1425 : Needle
• CPC Class Codes: A61B 2018/143 : multiple needles
• CPC Class Codes: A61B 2018/1432 : curved
• CPC Class Codes: A61B 2018/1435 : Spiral
• CPC Class Codes: A61B 2018/1472 : for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2018/162 : located on the probe body
• CPC Class Codes: A61B 2018/1861 : with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia
• CPC Class Codes: A61N 5/02 : using microwaves
• CPC Class Codes: A61N 5/04 : Radiators for near-field treatment
• CPC Class Codes: A61N 5/045 : specially adapted for treatment inside the body
• CPC Class Codes: B22F 2999/00 : Aspects linked to processes or compositions used in powder metallurgy
• CPC Class Codes: B22F 3/1216 : Container composition
• CPC Class Codes: C22C 1/047 : comprising intermetallic compounds C22C1/0441 takes precedence
• CPC Class Codes: C22C 14/00 : Alloys based on titanium
• CPC Class Codes: C22C 33/0285 : with Cr, Co, or Ni having a minimum content higher than 5%
• CPC Class Codes: C22F 1/183 : of titanium or alloys based thereon

Abstract

An infusion array ablation apparatus includes an elongated delivery device having a lumen and an infusion array positionable in the lumen. The infusion array includes an RF electrode and at least a first and a second infusion member. Each infusion member has a tissue piercing distal portion and an infusion lumen. At least one of the first or second infusion members is positionable in the elongated delivery device in a compacted state and deployable from the elongated delivery device with curvature in a deployed state. Also, at least one of the first or second infusion members exhibits a changing direction of travel when advanced from the elongated delivery device to a selected tissue site. At least one infusion port is coupled to one of the elongated delivery device, the infusion array, the first infusion member or the second infusion member.

Claims

1. A cell necrosis apparatus, comprising:

an elongated delivery device including a lumen;

an energy delivery device including at least a first and a second RF electrode, each electrode having a tissue piercing distal portion, the first and second electrodes (A) being positionable in the elongated delivery device in a compacted state and preformed to assume a curved shape when deployed, the first and second RF electrodes (B) exhibiting a changing direction of travel when advanced from the elongated delivery device to a selected tissue site, and (C) defining an ablation volume when in said deployed state; and

at least one of (a) the elongated delivery device, (b) the first RF electrode, or (c) the second RF electrode being adapted for fluid delivery therethrough to an infusion port disposed on at least one of (i) the elongated delivery device, (ii) the first RF electrode, or (iii) the second RF electrode.

2. The apparatus of claim 1, wherein the infusion port is positioned at a distal portion of at least one of (i) the elongated delivery device, (ii) the first RF electrode or (iii) the second RF electrode.

3. The apparatus of claim 1, wherein at least one of the first RF electrode or the second RF electrode has an infusion lumen that terminates at one or more infusion ports in the electrode;

and

wherein said at least one of the first RF electrode or the second RF electrode has a proximal end adapted to be operatively coupled to a source of fluid.

4. The apparatus of claim 3, wherein at least one of the first RF electrode or the second RF electrode further includes an infusion port in the electrode positioned at the distal end of at least one of the first RF electrode or the second RF electrode.

5. The apparatus of claim 3, where at least one of the first RF electrode or the second RF electrode has a series of end region infusion ports positioned at the distal end of the first RF electrode or the second RF electrode.

6. The apparatus of claim 1, further comprising:

a rigid electrode advancement member coupled to the energy delivery device.

7. The apparatus of claim 1, further comprising:

an insulator positioned in a surrounding relationship to at least a portion of at least one of (i) the elongated delivery device, (ii) the first RF electrode, or (iii) the second RF electrode.

8. The apparatus of claim 7, wherein said insulator is positioned at a distal portion of at least one of (i) the elongated delivery device, (ii) the first RF electrode, or (iii) the second RF electrode.

9. The apparatus of claim 7, further comprising:

a sensor positioned on the insulator.

10. The apparatus of claim 9, wherein said sensor is positioned at the distal portion of the insulator.

11. The apparatus of claim 10, wherein the sensor is a thermal sensor.

12. The apparatus of claim 1, further comprising:

a sensor positioned on at least one of (i) the elongated delivery device, (ii) the first RF electrode, or (iii) the second RF electrode.

13. The apparatus of claims 12, 9, or 10, wherein said sensor is positioned at the distal portion of (i) the elongated delivery device, (ii) the first RF electrode, (iii) the second RF electrode, or (iv) the insulator.

14. The apparatus of claim 13, wherein the sensor is a thermal sensor.

15. The apparatus of claim 13, further comprising:

feedback control resources coupled to at least one of (i) the sensor, (ii) the first RF electrode, or (iii) the second RF electrode.

16. The apparatus of claim 13, wherein the sensor is an optical sensor comprised of an imaging system selected from the group consisting of viewing optics and optical fibers.

17. The apparatus of claim 13, wherein the sensor is a thermal sensor.

18. The apparatus of claim 1, wherein the elongated delivery device includes a tapered distal end.

19. The apparatus of claim 1, wherein the apparatus is configured to have independent fluid delivery to the first and second RF electrodes.

20. The apparatus of claim 1, further comprising a fluid delivery device including a first infusion lumen extending through the first RF electrode and terminating at a first infusion port to define a first fluid path;

and

said fluid delivery device further comprises a second infusion lumen extending through the second RF electrode and terminating at a second infusion port to define a second fluid path.

21. The apparatus of claim 1, further comprising a return electrode adapted for contact with a patient'"'"'s skin.

22. The apparatus claim 1, further comprising control means coupled to an RF source for controlling process variables.

23. The apparatus of claim 22, wherein the process variables are at least one of:

(a) a power level;

(b) a duty cycle;

(c) an energy delivery;

(d) a fluid delivery flow rate or (e) a fluid pressure.

24. The apparatus of claim 22, wherein the control means includes at least one of:

(a) a digital controller, (b) an analog controller and (c) a programmed computer.

25. The apparatus of claim 22, further comprising an RF source coupled to the first RF electrode and the second RF electrode for providing RF energy to the first and second RF electrodes.

26. The apparatus of claim 25, wherein said control means are operatively connected to the first RF electrode and the second RF electrode and the RF source to control application of RF current to the electrodes.

27. The apparatus of claim 26, wherein the control means is a feedback control operatively coupled to a thermal sensor on any one of the RF electrodes, and the RF source.

28. The apparatus of claim 27, wherein the feedback control adjusts the RF energy delivered to the RF electrodes from the RF source.

29. The apparatus of claim 27, wherein the control means is a feedback control that adjusts the RF energy delivered to the RF electrodes from the RF source in response to impedance measured at one or more of said RF electrodes.

30. A cell necrosis apparatus, comprising:

an elongated delivery device including a lumen;

an energy delivery device including at least a first and a second RF electrode, each electrode having a tissue piercing distal portion, the first and second electrodes (A) being positionable in the elongated delivery device in a compacted state and preformed to assume a curved shape when deployed, the first and second RF electrodes (B) exhibiting a changing direction of travel when advanced from the elongated delivery device to a selected tissue site, and (C) defining an ablation volume when in said deployed state, said device being adapted for operative connection to a source of RF energy for applying RF energy to said first and second RF electrode in said deployed state; and

at least one of (a) the elongated delivery device, (b) the first RF electrode or (c) the second RF electrode being adapted for fluid delivery therethrough to an infusion port disposed on at least one of (i) the elongated delivery device, (ii) the first RF electrode or (iii) the second RF electrode.

31. The apparatus of claim 30, wherein said source of RF energy includes function for determining system impedance at the electrodes and controlling RF energy applied to the electrodes according to said system impedance.

32. The apparatus of claim 30, wherein the infusion port is positioned at a distal portion of (a) the elongated delivery device, (b) the first RF electrode or (c) the second RF electrode.

33. The apparatus of claim 30, wherein at least one of the first RF electrode or the second RF electrode has an infusion lumen that terminates at one or more infusion ports in the electrode;

and

wherein said at least one of the first RF electrode or the second RF electrode has a proximal end adapted to be operatively coupled to a source of fluid.

34. The apparatus of claim 33, wherein at least one of the first RF electrode or the second RF electrode further includes an infusion port in the electrode positioned at the distal end, of said at least one of the first RF electrode or the second RF electrode.

35. The apparatus of claim 33, where at least one of the first RF electrode or the second RF electrode has a series of end region infusion ports positioned at the distal end of the first RF electrode or the second RF electrode.

36. The apparatus of claim 30, further comprising:

a rigid advancement member coupled to the energy delivery device.

37. The apparatus of claim 30, further comprising:

an insulator positioned in a surrounding relationship to at least a portion of at least one of (i) the elongated delivery device, (ii) the first RF electrode, or (iii) the second RF electrode.

38. The apparatus of claim 37, wherein said insulator is positioned at a distal portion of at least one of (i) the elongated delivery device, (ii) the first RF electrode, or (iii) the second RF electrode.

39. The apparatus of claim 37, further comprising:

a sensor positioned on the insulator.

40. The apparatus of claim 30, further comprising:

a sensor positioned on at least one of (i) the elongated delivery device, (ii) the first RF electrode, or (iii) the second RF electrode.

41. The apparatus of claims 40 or 39, wherein said sensor is positioned at the distal portion of (i) the elongated delivery device, (ii) the first RF electrode, (iii) the second RF electrode, or (iv) the insulator.

42. The apparatus of claim 41, wherein the sensor is an optical sensor comprised of an imaging system selected from the group consisting of viewing optics and optical fibers.

43. The apparatus of claim 41, wherein the sensor is a thermal sensor.

44. The apparatus of claim 30, further comprising a return electrode adapted for contact with a patient'"'"'s skin.