Selectable eccentric remodeling and/or ablation of atherosclerotic material

• US 7,291,146 B2
• Filed: 09/10/2004
• Issued: 11/06/2007
• Est. Priority Date: 09/12/2003
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Minnow Medical Inc (Boston Scientific Corporation)
• Inventors: Stone, Corbett W., Kelleher, Brian S., Koenig, Donald H., Steinke, Tom A., Michel, Raphael M., Ross, Stephen O.
• Primary Examiner(s): Peffley; Michael
• Application Number:
  US10/938,138
• Publication Number:
  US 20050096647A1
• Time in Patent Office: 1,152 Days
• Field of Search: 606/41, 606 47- 50, 607/101, 607/102, 607/122, 600/439
• 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 remodeling of atherosclerotic material of 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 energy delivery surfaces, each energy delivery surface oriented radially when the expandable structure expands so as to provide an array of energy delivery surfaces distributed circumferentially about the axis of the blood vessel;

an atherosclerotic material detector coupled to the catheter body for circumferential atherosclerotic material detection along the blood vessel;

a power source electrically coupled to the energy delivery surfaces; and

a controller coupling the power source to the array for selectively energizing an eccentric subset of the energy delivery surfaces in response to the detected atherosclerotic material, the power source energizing the energy delivery surfaces so as to eccentrically remodel the detected atherosclerotic material along the blood vessel.

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 source 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 debris barriers disposed proximally and distally of the energy delivery surfaces, respectively, and an aspiration port disposed between the proximal and distal barriers for removal of debris during atherosclerotic material remodeling.

5. The catheter system of claim 3, further comprising an irrigation lumen extending between the proximal end of the catheter body and the distal end of the catheter body, and an irrigation source in fluid communication with the irrigation lumen.

6. The catheter system of claim 2, wherein the atherosclerotic material detector comprises at least one of:

an intravascular ultrasound catheter disposed in the lumen;

an intravascular optical coherence tomography catheter disposed in the lumen; and

an intravascular magnetic resonance imaging catheter disposed in the lumen.

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 energy delivery surfaces define a circumferentially oriented 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, the array of electrodes supported along the intermediate portion so as to engage 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 the electrodes so as to inhibit distal movement of debris, and a proximal membrane deployable proximally of the electrodes so as to inhibit proximal movement of the debris, wherein the membranes inhibit blood interaction with the remodeling 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 energy delivery surfaces comprise an array of at least 3 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 detected atherosclerotic material.

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

16. The catheter system of claim 1, wherein the controller selectively energizes a subset of the energy directing surfaces by directing at least one of RF energy and microwave energy thereto.

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

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

19. The catheter system of claim 1, wherein the atherosclerotic material detector comprises an electrical impedance measurement device, and wherein the power source can selectively energize an eccentric subset of the energy delivery surfaces with remodeling electrical energy in response to eccentric atherosclerotic material identified by the atherosclerotic material detector.

20. A system for eccentric remodeling of atherosclerotic material of a blood vessel 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 along the blood vessel against the material when the expandable structure expands within the body lumen so as to define an axisymmetric electrode array;

an atherosclerotic material detector coupled to the elongate body for ircumferential measurement of the material registered to the electrode array; and

a power source electrically coupled to the electrodes, the power source selectably energizing an eccentric subset of the electrodes so as to eccentrically remodel the measured material.