Selectable Eccentric Remodeling and/or Ablation of Atherosclerotic Material

• US 20080161801A1
• Filed: 09/28/2007
• Published: 07/03/2008
• Est. Priority Date: 09/12/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Vessix Vascular, Inc. (Boston Scientific Corporation)
• Inventors: Stone, Corbett W., Kelleher, Brian S., Koenig, Donald H., Steinke, Tom A., Michel, Raphael M., Ross, Stephen O.
• Granted Patent: US 9,125,666 B2
• Time in Patent Office: Days
• US Class Current: 606/41
• 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 2018/0016 Energy applicators arranged in a two- or three dimensional array
• 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 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/0041 Removal of thrombosis
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00601 Cutting
• CPC Class Codes: A61B 2018/00654 with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2090/373 using light, e.g. by using optical scanners
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 2218/007 Aspiration

Abstract

A catheter and catheter system for eccentric remodeling and/or removal of atherosclerotic material of a blood vessel of a patient include an elongate flexible catheter body with a radially expandable structure. A plurality of electrodes or other electrosurgical energy delivery surfaces can radially engage atherosclerotic material when the structure expands. An atherosclerotic material detector near the distal end of the catheter body may measure circumferential atherosclerotic material distribution, and a power source selectively energizes the electrodes to eccentrically remodel the measured atherosclerotic material.

Claims

1. A catheter system for eccentric removal of atherosclerotic material from a blood vessel of a patient, the system comprising:

an elongate flexible catheter body having a proximal end and a distal end with an axis therebetween;

a radially expandable structure near the distal end of the catheter body;

a plurality of electrodes oriented to be urged radially against atherosclerotic material when the expandable structure expands;

an atherosclerotic material detector disposed near the distal end of the catheter body for circumferential measurement of atherosclerotic material; and

a power source electrically coupled to the electrodes, the power source energizing the electrodes so as to eccentrically ablate the measured atherosclerotic material.

2. The catheter system of claim 1, wherein the catheter body has a lumen extending between the proximal end and the distal end.

3. The catheter system of claim 2, further comprising an aspiration connector in fluid communication with the lumen at the proximal end of the catheter body.

4. The catheter system of claim 3, further comprising proximal and distal ablation debris barriers disposed proximally and distally of the electrodes, respectively, and an aspiration port disposed between the proximal and distal barriers for removal of ablation debris during atherosclerotic material ablation.

5. The catheter system of claim 2, wherein the atherosclerotic material detector comprises an ultrasound transducer of an intravascular ultrasound catheter, the intravascular ultrasound catheter disposed in the lumen.

6. The catheter system of claim 2, further comprising an irrigation lumen extending between the proximal end of the catheter body and the distal end of the catheter body.

7. The catheter system of claim 2, further comprising a restenosis inhibitor advancable distally within the lumen so as to inhibit restenosis of the blood vessel.

8. The catheter system of claim 7, wherein the restenosis inhibitor comprises a brachytherapy catheter having a radiation source.

9. The catheter system of claim 1, wherein the radially expandable body comprises a plurality of flexible struts, and wherein the electrodes define a circumferentially oriented electrode array.

10. The catheter system of claim 9, wherein struts of the radially expandable structure have perforations disposed therebetween so as to define an expandable basket, wherein the basket has a proximal portion and a distal portion with an intermediate portion disposed therebetween, an array of electrodes supported along the intermediate portion so as to engage the adjacent atherosclerotic material when the basket is expanded within the blood vessel, and further comprising an aspiration port in fluid communication with an interior of the basket.

11. The catheter system of claim 10, further comprising a distal membrane deployable within the blood vessel distally of electrodes so as to inhibit distal movement of ablation debris, and a proximal membrane deployable proximally of the electrodes so as to inhibit proximal movement of the ablation debris, wherein the membranes inhibit blood interaction with the ablation process.

12. The catheter system of claim 11, wherein the distal membrane is supported by the distal portion of the basket so as to expand radially therewith, and wherein the proximal membrane is supported by the proximal portion of the basket so as to expand radially therewith.

13. The catheter system of claim 12, wherein at least one of the proximal and distal membranes comprises a balloon axially off-set from the basket.

14. The catheter system of claim 1, wherein the electrodes comprise an array of at least 6 alternatively selectable electrodes distributed circumferentially about the axis, and a controller coupling the power source to the electrode array for selectively energizing an eccentric subset of the electrode array in response to the measured atherosclerotic material.

15. The catheter system of claim 14, wherein each electrode comprises a metallic body affixed to an adjacent strut of the expandable structure by a polymer with an associated conductor extending proximally from the electrode so as to electrically couple the electrode surface to the controller.

16. The catheter system of claim 14, wherein the controller selectively energizes electrodes by directing RF energy thereto.

17. The catheter system of claim 1, wherein the atherosclerotic material detector comprises an ultrasound transducer or optical coherence reflectrometry.

18. The catheter system of claim 2, further comprising a display showing an image of circumferential atherosclerotic material thickness distributed about the catheter axis.

19. A catheter for remodeling of atherosclerotic material of a blood vessel of a patient, the catheter comprising:

an elongate flexible catheter body having a proximal end and a distal end with lumen therebetween;

a radially expandable basket near the distal end of the catheter body, the basket having a proximal portion and a distal portion with an intermediate portion disposed therebetween; and

a circumferential electrode array distributed circumferentially about the intermediate portion of the radially expandable basket so as to selectably remodel adjacent eccentric atherosclerotic material while the basket is expanded within the blood vessel;

an aspiration port providing fluid communication between the aspiration lumen and an interior of the basket.

20. The catheter of claim 19, wherein the catheter body has an aspiration lumen, and further comprising:

an aspiration port providing fluid communication between the aspiration lumen and an interior of the basket; and

a distal membrane supported by the distal portion of the basket so as to inhibit distal movement of debris when the basket is expanded within the blood vessel, and a proximal membrane supported by the proximal portion of the basket so as to inhibit proximal movement of debris when the basked is expanded within the blood vessel.

21. A catheter for atherosclerotic material removal from a blood vessel of a patient, the catheter comprising:

an elongate flexible catheter body having a proximal end and a distal end with an axial aspiration lumen therebetween;

a radially expandable basket near the distal end of the catheter body, the basket having a proximal portion and a distal portion with an intermediate portion disposed therebetween;

a circumferential electrode array distributed circumferentially about the intermediate portion of the radially expandable basket so as to ablate adjacent atherosclerotic material when the basket expands within the blood vessel;

an aspiration port providing fluid communication between the aspiration lumen and an interior of the basket; and

a distal membrane supported by the distal portion of the basket so as to inhibit distal movement of ablation debris when the basket is expanded within the blood vessel, and a proximal membrane supported by the proximal portion of the basket so as to inhibit proximal movement of ablation debris when the basked is expanded within the blood vessel.

22. A method for remodeling eccentric atherosclerotic material of a blood vessel of a patient, the method comprising:

positioning a working end of a catheter within the blood vessel and adjacent the atherosclerotic material, the catheter defining an axis radially expanding the catheter so as to engage at least one energy delivery surface of the catheter against the atherosclerotic material;

determining a circumferential distribution of the atherosclerotic material about the axis of the catheter;

directing electrosurgical energy from the at least one energy delivery surface eccentrically relative to the axis of the catheter in response to the determined atherosclerotic material distribution.

23. The method of claim 22, wherein the electrosurgical energy is directed eccentrically without rotating the energy delivery surfaces about the catheter axis by energizing a subset of the electrodes, and further comprising selecting the subset of electrodes in response to the determined atherosclerotic material distribution.

24. The method of claim 22, further comprising rotationally registering selected electrodes with the determined atherosclerotic material distribution.

25. The method of claim 24, wherein the registration is performed with reference to one or more structures of the expandable basket having a distinguishable image.

26. The method of claim 24, wherein the registration is performed automatically with reference to an electronic signal.

27. A method for eccentric atherosclerotic material removal from a blood vessel of a patient, the method comprising:

positioning a working end of a catheter within the blood vessel and adjacent the atherosclerotic material, the catheter defining an axis;

radially expanding the catheter so as to engage a plurality of electrodes of the catheter against the atherosclerotic material;

measuring a circumferential distribution of the atherosclerotic material about the axis of the catheter;

directing RF energy from the electrodes eccentrically relative to the axis of the catheter in response to the measured atherosclerotic material distribution.

28. The method of claim 27, further comprising rotationally registering selected electrode with the measured atherosclerotic material distribution.

29. The method of claim 28, wherein the registration is performed with reference to a asymmetric structure of the expandable basket having a distinguishable image.

30. The method of claim 28, wherein the registration is performed automatically with reference to an electronic signal.

31. A device for remodeling occlusive material of a body lumen of a patient, the device comprising:

an elongate body having a proximal end and a distal end with an axial aspiration lumen therebetween;

a radially expandable basket near the distal end of the body, the basket having a proximal portion and a distal portion with an intermediate portion disposed therebetween;

a circumferential electrode array distributed circumferentially about the intermediate portion of the radially expandable basket so as to remodel adjacent occlusive material when the basket expands within the body lumen;

an aspiration port providing fluid communication between the aspiration lumen and an interior of the basket; and

a distal membrane supported by the distal portion of the basket so as so expand the membrane when the basket is expanded within the body lumen, and a proximal membrane supported by the proximal portion of the basket so as to expand the membrane when the basket is expanded within the body lumen.

32. A system for eccentric removal of material from a body lumen of a patient, the system comprising:

an elongate body having a proximal end and a distal end with an axis therebetween;

a radially expandable structure near the distal end of the catheter body;

a plurality of electrodes oriented to be urged radially against the material when the expandable structure expands within the body lumen;

a material detector disposed near the distal end of the catheter body for circumferential measurement of the material; and

a power source electrically coupled to the electrodes, the power source energizing the electrodes so as to eccentrically ablate the measured material.

33. A device for occlusive material removal from a body lumen of a patient, the device comprising:

an elongate body having a proximal end and a distal end with an axial aspiration lumen therebetween;

a radially expandable basket near the distal end of the body, the basket having a proximal portion and a distal portion with an intermediate portion disposed therebetween;

a circumferential electrode array distributed circumferentially about the intermediate portion of the radially expandable basket so as to ablate adjacent occlusive material when the basket expands within the body lumen;

an aspiration port providing fluid communication between the aspiration lumen and an interior of the basket; and

a distal membrane supported by the distal portion of the basket so as to expand the membrane when the basket is expanded within the body lumen, and a proximal membrane supported by the proximal portion of the basket so as to expand the membrane when the basked is expanded within the body lumen.

34. A system for eccentric remodeling of material of a body lumen of a patient, the system comprising:

an elongate body having a proximal end and a distal end with an axis therebetween;

a radially expandable structure near the distal end of the catheter body;

a plurality of electrodes oriented to be urged radially against the material when the expandable structure expands within the body lumen;

a material detector disposed for circumferential detection of the material; and

a power source electrically coupled to the electrodes, the power source energizing the electrodes so as to eccentrically remodel the detected material.

35. A device for occlusive material remodeling in a body lumen of a patient, the device comprising:

an elongate body having a proximal end and a distal end with an axial aspiration lumen therebetween;

a radially expandable basket near the distal end of the body, the basket having a proximal portion and a distal portion with an intermediate portion disposed therebetween;

a circumferential electrode array distributed circumferentially about the intermediate portion of the radially expandable basket so as to engage adjacent occlusive material when the basket expands within the body lumen;

an aspiration port providing fluid communication between the aspiration lumen and an interior of the basket; and

a distal membrane supported by the distal portion of the basket so as so expand the membrane when the basket is expanded within the body lumen, and a proximal membrane supported by the proximal portion of the basket so as to expand the membrane when the basked is expanded within the body lumen.