Selectable eccentric remodeling and/or ablation of atherosclerotic material

• US 9,125,666 B2
• Filed: 09/28/2007
• Issued: 09/08/2015
• 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: Steinke, Tom A., Stone, Corbett W., Ross, Stephen O., Kelleher, Brian S., Michel, Raphael M., Koenig, Donald H.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US11/864,779
• Publication Number:
  US 20080161801A1
• Time in Patent Office: 2,902 Days
• Field of Search: 606/41, 606 47- 50, 607/101, 607/102, 607/122, 600/439
• US Class Current: 1/1
• 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, and a lumen extending between the proximal end and the distal end;

an aspiration source coupled with the lumen, wherein the lumen is configured for aspiration of debris from within the blood vessel when coupled to the aspiration source;

a restenosis inhibitor advanceable distally within the lumen so as to inhibit restenosis of the blood vessel, wherein the restenosis inhibitor comprises a brachytherapy catheter having a radiation source;

a radially expandable structure near the distal end of the catheter body, the radially expandable body including a plurality of flexible non-overlapping struts;

a plurality of electrodes supported by the radially expandable structure and oriented to be urged radially against atherosclerotic material when the expandable structure expands, the plurality of electrodes comprising a circumferentially distributed array of electrodes of which each electrode is selectively energizable, wherein adjacent electrodes are axially offset from one another;

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

a power source electrically coupled to the electrodes with a controller, the controller configured to selectively energize an eccentric subset of the electrode array in response to the measured atherosclerotic material so as to eccentrically ablate the measured atherosclerotic material.

2. The catheter system of claim 1, further comprising an aspiration connector in fluid communication with the lumen at the proximal end of the catheter body connecting the lumen to the aspiration source so as to allow aspiration of debris from within the blood vessel through the lumen.

3. The catheter system of claim 2, 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.

4. The catheter system of claim 1, wherein the atherosclerotic material detector comprises an ultrasound transducer of an intravascular ultrasound catheter, the intravascular ultrasound catheter disposed in the lumen.

5. The catheter system of claim 1, further comprising an irrigation lumen extending between the proximal end of the catheter body and the distal end of the catheter body that is coupled with an irrigation source, the irrigation lumen being separate from the aspiration lumen.

6. The catheter system of claim 1, wherein the electrodes define a circumferentially oriented electrode array.

7. The catheter system of claim 6, 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, the array of electrodes being 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.

8. The catheter system of claim 1, wherein the array of electrodes comprises at least 6 alternatively selectable electrodes distributed circumferentially about the axis.

9. The catheter system of claim 8, wherein the controller selectively energizes electrodes by directing RF energy thereto.

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

11. The catheter system of claim 1, further comprising a display showing an image of circumferential atherosclerotic material thickness distributed about the catheter axis.

12. 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 formed from a plurality of struts and the basket having a proximal portion and a distal portion with an intermediate portion disposed therebetween, wherein each strut includes a region of localized widening in a central portion of the strut; and

a circumferential electrode array supported by the radially expandable basket and distributed circumferentially about the intermediate portion of the radially expandable basket, wherein each electrode of the electrode array is selectively energizable, wherein each electrode is supported by one of the regions of localized widening, wherein each region of localized widening does not extend substantially beyond its associated electrode;

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

a power source electrically coupled to the electrodes with a controller, the controller configured to selectively energize an eccentric subset of the electrode array in response to a circumferential measurement of the atherosclerotic material so as to selectably remodel adjacent eccentric atherosclerotic material while the basket is expanded within the blood vessel.

13. 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, the radially expandable structure comprising a plurality of struts, each strut including a region of localized widening in a central portion of the strut;

a plurality of electrodes supported on the radially expandable structure and oriented to be urged radially against the material when the expandable structure expands within the body lumen, the plurality of electrodes comprising a circumferentially distributed array of electrodes of which each electrode is selectively energizable, wherein each electrode is supported by one of the regions of localized widening, wherein each region of localized widening does not extend substantially beyond its associated electrode;

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

a power source electrically coupled to the electrodes with a controller, the controller configured to selectively energize an eccentric subset of the electrodes in response to the circumferential measurement and detection of the material so as to eccentrically ablate the measured material.