Apparatus and methods for treating tissue

• US 8,333,204 B2
• Filed: 06/22/2009
• Issued: 12/18/2012
• Est. Priority Date: 06/25/1999
• Status: Expired due to Term

• Current Assignee: Auris Health, Inc. (Johnson & Johnson)
• Original Assignee: Hansen Medical Incorporated (Johnson & Johnson)
• Inventors: Saadat, Vahid
• Primary Examiner(s): FARAH, AHMED M
• Application Number:
  US12/489,258
• Publication Number:
  US 20090264994A1
• Time in Patent Office: 1,275 Days
• Field of Search: 606/151, 606/153, 606/232, 623/1.24, 623/1.26, 128/898
• US Class Current: 128/898
• 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. A method of treating a target biological valve, comprising:

advancing a catheter to a location near the target biological valve;

delivering a first implant and a second implant from a distal end of the catheter selectively into a tissue near the target biological valve wherein the first and second implants are connectable via a tensioning element; and

cinching the tensioning element to affect the target biological valve wherein cinching the tensioning element approximates opposing sides of the valve to draw or close the opening of the valve.

2. The method of claim 1, further comprising securing the tensioning element to maintain tension across the tensioning element and the first and second implants.

3. The method of claim 1, wherein the tissue near the target tissue is a muscle around a perimeter of a valve and cinching the tensioning element approximates opposing sides of the valve to draw or close the opening of the valve.

4. The method of claim 1, wherein the catheter is advanced endoluminally and/or percutaneously.

5. The method of claim 1, wherein a first implant is inserted into tissue near a biological valve and the second implant is inserted into a heart chamber wall.

6. The method of claim 1, wherein tissue near the first implant is adjusted by cinching the tensioning element at the second implant.

7. The method of claim 1, wherein delivering the first and second implants comprises sequentially advancing each of the implants from the catheter distal end via an actuator.

8. The method of claim 1, wherein the tissue is near a valve selected from the group consisting of a tricuspid valve, a mitral valve, and an aortic valve.

9. A method of treating a target biological valve, comprising:

steering a catheter to a target biological valve;

delivering a first implant and a second implant from a distal end of the catheter selectively into tissue near the target biological valve;

connecting the first and second implants; and

displacing the first implant relative to the second implant to alter the target biological valve.

10. The method of claim 9, wherein the implants are delivered into tissue that surrounds a perimeter of a valve.

11. The method of claim 9, wherein the first and second implants are connected by a tensioning element.

12. The method of claim 11, wherein the target tissue comprises a first tissue component and a second tissue component, wherein cinching the tensioning element causes the tissue components to be drawn together.

13. The method of claim 9, wherein the catheter is steered within an endoluminal body along a periphery of the target biological valve.

14. The method of claim 9, wherein the catheter is advanced endoluminally and/or percutaneously.