Catheter for obstructed stent

• US 5,749,914 A
• Filed: 05/28/1996
• Issued: 05/12/1998
• Est. Priority Date: 01/06/1989
• Status: Expired due to Fees

• Current Assignee: Walter Wilson
• Original Assignee: Advanced Coronary Intervention, Inc.
• Inventors: Janssen, Michael
• Primary Examiner(s): JAWORSKI, FRANCIS J
• Application Number:
  US08/654,146
• Time in Patent Office: 714 Days
• Field of Search: 623/1, 128/660.03, 128/642, 606/39-41, 607/122, 607/116
• US Class Current: 607/116
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/1206 Generators therefor
• 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 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00386 Coronary vessels
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/0041 Removal of thrombosis
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/0066 without feedback, i.e. open loop control
• CPC Class Codes: A61B 2018/0075 Phase
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/1213 creating an arc
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1497 Electrodes covering only part of the probe circumference
• CPC Class Codes: A61B 2018/162 located on the probe body
• 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 5/06 : Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/062 : using magnetic field
• CPC Class Codes: A61B 5/066 : Superposing sensor position on an image of the patient, e.g. obtained by ultrasound or x-ray imaging
• CPC Class Codes: A61B 5/068 : using impedance sensors
• CPC Class Codes: A61F 2/82 : Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61N 1/056 : Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia

Abstract

Obstructive material is removed from a stent by modified electrosurgical ablation. A modified electrosurgical device having at least one electrode is positioned within the stent, and current is supplied to the electrode. The electrode is prevented from physically contacting the stent, such as by being situated within a groove on the device. The stent may, but need not be, grounded to the current source. The device may be properly positioned within the stent by using ultrasound transducers, fiber optics, or other means. Additionally, the device may be positioned by including at least two electrodes, and measuring the impedance therebetween, as the impedance will be relatively low when both electrodes are within a conductive stent. Therapeutic fluid may be supplied through the catheter, and energy may be supplied to increase the activity of the fluid.

Claims

1. A device for ablation of obstructive material within a stent, the device comprising:

an elongate flexible tube having a distal end and a proximal end and an interior surface therebetween, the tube defining an axial direction along a length of the tube and a radial direction radially away from the tube;

a first ablation electrode positioned within said interior surface proximate the distal end;

an ablation power supply in electrical communication with said ablation electrode;

wherein said first ablation electrode is shielded from physical contact with the stent by said tube when the first ablation electrode is positioned within the stent; and

wherein said first ablation electrode is positioned so that it is electrically unobstructed in the radial direction by the tube while being shielded from physical contact with the stent, thereby being electrically operative in the radial direction with respect to its position along the axial direction.

2. The device of claim 1, wherein said first electrode is located on the interior surface of said elongate flexible tube, and said elongate tube has a lip extending distal to said first electrode.

3. The device of claim 2, further comprising a first plurality of electrodes on the interior of said elongate flexible tube proximate the distal end, said electrodes being circumferentially spaced about the interior of the tube;

and the power supply allowing current to be selectively supplied to any of the plurality of electrodes.

4. The device of claim 3, further comprising a return electrode in electrical communication with the current supply, the return electrode being attachable to a patient.

5. The device of claim 3, further comprising means for visualizing the location of said distal end of said elongate tube and determining the composition and amount of the obstructive material.

6. The device of claim 5, wherein the means for visualizing include an ultrasound transducer.

7. The device of claim 5, wherein the means for visualizing include fiber optics.

8. The device of claim 5, wherein the means for visualizing include a fluoroscopic device.

9. The device of claim 1, wherein said tube has a groove proximate said distal end, said groove being formed within an exterior surface of said tube;

said first electrode being situated within said groove; and

said first electrode being sized so that it is recessed within the groove, whereby said electrode is unobstructed in the radial direction.

10. The device of claim 9, further comprising a return electrode located on said tube.

11. The device of claim 10, wherein said return electrode may be positioned so as to physically contact said stent.

12. The device of claim 1, further comprising a plurality of grooves within said tube, each of said grooves being formed within an exterior surface of said tube, and a plurality of electrodes, wherein at least one of said plurality of electrodes is recessed within each of said plurality of grooves, and whereby said electrodes are unobstructed in the radial direction.

13. The device of claim 1, further comprising a plurality of electrodes located on said tube, at least some of the plurality of electrodes being located further distal on the catheter than other of the plurality of electrodes;

and the power supply allowing each of the plurality of electrodes to independently receive current.

14. The device of claim 13, wherein at least one of the plurality of electrodes may be alternately made a supply or return electrode by the current source.

15. The device of claim 13, further comprising means for sensing the impedance between at least two of said electrodes, the impedance sensing means detecting whether one or both of the at least two electrodes are within the stent so that only an electrode within the stent is suppled with ablative current.

16. The device of claim 15, further comprising spacers disposed about said tube proximate said electrodes, said spacers projecting radially further from the tube than said electrodes, said spacers projecting a distance sufficient to prevent said electrodes from contacting the stent.

17. The device of claim 16, wherein said plurality of electrodes are arranged in a series of rings located around said tube.

18. The device of claim 1 wherein the electrode directs current distal to the distal end of the device.

19. The device of claim 1, further comprising a second electrode, the second electrode projecting radially further from the axis of tube than the first electrode.

20. The device of claim 19, further comprising a first plurality of electrodes and a second plurality of electrodes;

each of the first plurality of electrodes being shielded from contact with the stent when each of the first plurality of electrodes are positioned within the stent; and

each of the second plurality of electrodes extending further from the tube axis than each of the first plurality of electrodes.

21. The device of claim 1, further comprising means for delivering bioactive fluid exterior to the tube.

22. The device of claim 21, further comprising means for delivering energy to increase the bioactivity of the fluid.

23. The device of claim 22, wherein the energy to increase the bioactivity of the fluid consists of electrical energy, optical energy, mechanical energy, or acoustical energy.

24. The device of claim 1, further comprising at least two sensing electrodes proximate the distal end, and means to sense the impedance between the sensing electrodes.

25. The device of claim of claim 1, further comprising insulating material that partially covers the electrode, said insulating material separating the electrode from the stent.

26. The device of claim 25, wherein the insulating material is perforated.

27. The device of claim 25, wherein the insulating material is cross hatched.

28. The device of claim 1, further comprising:

a first plurality of electrodes including the first electrode, the first plurality of electrodes being disposed about the distal end of the catheter;

a second plurality of electrodes, each of the second plurality of electrodes being disposed about the distal end of the catheter;

the first plurality of electrodes being interspaced with the second plurality so that members of the first plurality alternate with members of the second plurality across a portion of the distal end of the catheter; and

wherein the first plurality are electrically interconnected in parallel to a first polarity and the second plurality are electrically interconnected in parallel to an opposite polarity.

29. The device of 28, wherein the first plurality of electrodes and the second plurality of electrodes are arranged in a series of spaced rings.

30. A method of removing obstructive material from the interior of an axially extending stent implanted in a subject, comprising:

engaging said subject with an elongate electrosurgical device including a tube having a proximal end and a distal end and an interior surface therebetween, said device having an ablation electrode proximate said distal end, said ablation electrode being positioned within said interior surface such that it is prevented from contacting the stent by said tube and is electrically unobstructed in a radial direction in relation to an axial direction defined by said stent while being shielded from physical contact with the stent;

positioning said device so that the ablation electrode is at least partially with the stent; and

supplying current from a current source to said ablation electrode to ablate said obstructive material.

31. The method of claim 30, wherein the positioning step includes using visualization means to visualize the position of the distal end in relation to said stent.

32. The method of claim 30, wherein the visualization means include ultrasound transducers.

33. The method of claim 30, wherein the visualization means include fiber optics.

34. The method of claim 30, wherein said device contains at least two electrodes proximate said distal end, and the positioning step includes determining the position of the distal end in relation to the stent by establishing current flow between at least two of said electrodes and determining the impedance therebetween.

35. The method of claim 34, further comprising the step of establishing direct electrical communication between said stent and said current source.

36. The method of claim 30, further comprising the step of supplying bioactive fluid through the device to medicate said subject.

37. The method of claim 36, further comprising supplying energy to increase the bioactivity of the fluid.

38. The method of claim 37, wherein the energy to increase the bioactivity of the fluid consists of electrical energy, optical energy, mechanical energy, or acoustical energy.

39. The method of claim 30 further comprising the step of ablating material exterior to said stent, the step of ablating material exterior to said stent being performed by a second electrode.

40. The method of claim 30, wherein the positioning step includes measuring the impedance between at least two sensing electrodes located on said device.

41. A therapeutic method to increase flow through an at least partially obstructed lumen, comprising the steps of:

deploying a stent with the abstract lumen;

inserting an ablation device within the stent, the device having

(a) an elongate flexible tube having a distal end and a proximal end and an interior surface therebetween, the tube defining an axial direction along a length of the tube and a radial direction radially away from the tube;

(b) a first ablation electrode positioned within said interior surface proximate the distal end;

(c) an ablation power supply in electrical communication with said ablation electrode;

(d) wherein said first ablation electrode is shielded from physical contact with the stent by said tube when the first ablation electrode is positioned within the stent; and

wherein said first ablation electrode is positioned so that it is electrically unobstructed in the radial direction by the tube while being shielded from physical contact with the stent, thereby being electrically operative in the radial direction with respect to its position along the axial direction; and

using said ablation device to ablate obstructions from the stent.