Apparatus and methods for treating tissue

• US 20030018358A1
• Filed: 07/03/2002
• Published: 01/23/2003
• Est. Priority Date: 06/25/1999
• Status: Active Grant

• Current Assignee: Auris Health, Inc. (Johnson & Johnson)
• Original Assignee: Nidus Medical LLC
• Inventors: Saadat, Vahid
• Granted Patent: US 7,186,262 B2
• Time in Patent Office: Days
• US Class Current: 606/232
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/1442 Probes having pivoting end effectors, e.g. forceps
• CPC Class Codes: A61B 18/1477 Needle-like probes
• 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 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0451 : Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0454 : the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0458 : Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0461 : with features cooperating with special features on the suture, e.g. protrusions on the suture
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/2945 : Curved jaws
• CPC Class Codes: A61B 2018/00023 : closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00083 : low, i.e. electrically insulating
• 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 2018/00232 : having an irregular shape
• CPC Class Codes: A61B 2018/00273 : Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00369 : Heart valves
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/1253 : monopolar
• CPC Class Codes: A61B 2018/126 : bipolar
• CPC Class Codes: A61B 2018/1432 : curved
• CPC Class Codes: A61B 2018/1435 : Spiral
• CPC Class Codes: A61B 2090/064 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/2445 : Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2451 : Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2454 : Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61N 7/00 : Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

Apparatus and methods are provided for thermally and/or mechanically treating tissue, such as valvular structures, to reconfigure or shrink the tissue in a controlled manner. Mechanical clips are implanted over the leaflets of a valve, e.g., in the heart, either alone or after thermal treatment to cause the valve to close more tightly. The clips are delivered by a catheter and may be configured to traverse directly over the valve itself or to lie partially over the periphery of the valve to prevent obstruction of the valve channel. The clips can be coated with drugs or a radiopaque coating. Alternatively, individual anchors with a tensioning element, like a suture, may be used to approximate the valves towards each other. The catheter can also incorporate sensors or energy delivery devices, e.g., transducers, on its distal end.

Claims

1. An assembly for treating tissue near a valve to modify flow through the valve, comprising:

a plurality of anchor members each having a distal end adapted for insertion into the tissue surrounding the valve and a proximal end defining an opening therethrough; and

a tensioning element for passage through each opening of the plurality of anchor members,

wherein the plurality of anchor members is adapted to be deployed sequentially with the tensioning element into the tissue through a catheter.

2. The assembly of claim 1 wherein the distal end of each of the anchor members is barbed.

3. The assembly of claim 1 wherein the proximal end of each of the anchor members is indented.

4. The assembly of claim 1 wherein the anchor members each define at least one notch along a length of the member adjacent to the opening.

5. The assembly of claim 1 wherein the anchor members each define a sharpened edge at least partially around the opening.

6. The assembly of claim 1 wherein the distal end of the anchor members is bioabsorbable.

7. The assembly of claim 1 wherein the distal end of the anchor members is rotatable relative to the proximal end of the anchor members.

8. The assembly of claim 1 wherein the anchor members each define at least one retractable arm which is adapted to pivot radially when deployed from the catheter.

9. The assembly of claim 8 wherein a ratio of a diameter of the deployed anchor member to a diameter of the anchor member is between about 2:

1 to 50;

1.

10. The assembly of claim 1 wherein the catheter further comprises an elongate cartridge therewithin, the cartridge having a proximal end, a distal end, and a length therebetween and adapted to deliver and deploy the plurality of anchor members.

11. The assembly of claim 10 wherein the plurality of anchor members is disposed longitudinally adjacent to one another within the cartridge.

12. The assembly of claim 10 wherein the cartridge further comprises a release port at the distal end of the cartridge, the release port being adapted to deploy a single anchor member at a time.

13. The assembly of claim 10 wherein the cartridge further defines a pushing surface at the distal end which is adapted to deploy the anchor members.

14. The assembly of claim 10 wherein the cartridge defines a longitudinal slot formed along the length of the cartridge.

15. The assembly of claim 1 further comprising a fastener adapted to maintain a tensile force within the tensioning element.

16. The assembly of claim 15 wherein the fastener is adapted to allow uni-directional tensioning within the tensioning element.

17. The assembly of claim 15 wherein the fastener comprises a ratchet biased to remain in contact with the tensioning element.

18. The assembly of claim 1 further comprising a heating element in selective contact with a portion of the tensioning element for severing the tensioning element.

19. The assembly of claim 1 wherein the tensioning element comprises a suture or a wire.

20. The assembly of claim 1 wherein each of the anchor members is at least partially coated with a coating layer.

21. The assembly of claim 20 wherein the coating layer comprises a therapeutic or antimicrobial agent.

22. The assembly of claim 20 wherein the coating layer comprises a radiopaque layer.

23. The assembly of claim 22 wherein the radiopaque layer is selected from the group consisting of Nickel-Titanium alloy, Platinum, Palladium, Gold, and Tantalum.

25. The method of claim 24 wherein advancing the catheter comprises intralumenally advancing the catheter to the valve.

26. The method of claim 25 wherein advancing the catheter comprises intralumenally advancing the catheter into a heart.

27. The method of claim 24 wherein deploying the plurality of anchor members comprises sequentially advancing each of the anchor members from the catheter distal end via an actuator.

28. The method of claim 24 wherein tightening the tensioning element comprises pulling the tensioning element from a proximal end of the element.

29. The method of claim 24 further comprising severing the tensioning element.

24. A method of treating tissue near a valve to modify flow through the valve, comprising:

advancing a catheter to the tissue near the valve;

deploying a plurality of anchor members from a distal end of the catheter selectively around a perimeter of the valve, each of the anchor members being connected sequentially via a tensioning element passed through an opening defined in each member;

tightening the tensioning element such that the perimeter of the valve is approximated towards one another; and

securing the tensioning element such that the perimeter of the valve remains approximated.