Apparatus and methods for treating tissue

• US 8,523,883 B2
• Filed: 08/18/2011
• Issued: 09/03/2013
• Est. Priority Date: 06/25/1999
• Status: Expired due to Fees

• 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:
  US13/212,842
• Publication Number:
  US 20110301699A1
• Time in Patent Office: 747 Days
• Field of Search: 606/1, 606/139, 606/144, 606/148, 606/149, 606151-159, 606/232, 623/1.26, 623 21- 214, 128/898
• US Class Current: 606/144
• 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 reducing a diameter of a mitral valve of a heart to reduce regurgitation of blood across the mitral valve, the method comprising:

providing a plurality of anchors coupleable to a tensioning element;

advancing a catheter into a left ventricle of the heard and delivering the plurality of anchors through the catheter;

deploying a plurality of anchors into heart tissue around the periphery of the mitral valve where the plurality of anchors are connectable to the tensioning element;

cinching the tensioning element once connected to the plurality of anchors to approximate opposing sides of the mitral valve to draw or close the opening of the valve;

securing the tensioning element to maintain tension across the tensioning element and plurality of anchors; and

removing the catheter from the left ventricle.

2. The method of claim 1, where the tensioning element is sequentially coupled to each anchor.

3. The method of claim 1, where deploying, the plurality of anchors into heart tissue comprises deploying the plurality of anchors with the tensioning element pre-threaded through the anchors.

4. The method of claim 1, where deploying the plurality of anchors into heart tissue further comprises threading the tensioning element with the anchors after the anchors are positioned in tissue.

5. The method of claim 1, where securing the tensioning element to maintain tension comprises affixing a fastener to the tensioning element.

6. The method of claim 1, where the tensioning element comprises a suture or wire.

7. The method of claim 1, where advancing the catheter into the left ventrical comprises advancing the catheter through the vasculature.

8. The method of claim 1, where deploying the plurality of anchor comprises sequentially advancing each of the anchor from the catheter into heart tissue.

9. An assembly for reducing a diameter of a mitral valve of a heart to reduce regurgitation of blood across the mitral valve, the assembly comprising:

a plurality of anchors configured to be implanted within muscle around a perimeter of the mitral valve through a catheter;

a tensioning member sequentially connectible to each anchor, the tensioning member having sufficient strength for cinching the tensioning element once sequentially connected to the plurality of anchors to approximate opposing sides of the mitral valve to draw or close the opening of the valve; and

a catheter containing the plurality of anchors and the tensioning element, where the catheter is sufficiently flexible to navigate through the vasculature and into a left atrium.

10. The assembly of claim 9, where the distal end of each of the anchors is barbed.

11. The assembly of claim 9, where the proximal end of each of the anchors is indented.

12. The assembly of claim 9, where the anchors each define at least one notch along a length of the member adjacent to the opening.

13. The assembly of claim 9, where the anchor embers each define a sharpened edge at least partially around the opening.

14. The assembly of claim 9, where the distal end of the anchors is bioabsorbable.

15. The assembly of claim 9, further comprising a fastener adapted to maintain a tensile force within the tensioning element once the tensioning element cinches the anchors and tissues.

16. The assembly of claim 15, where the fastener is adapted to allow unidirectional tensioning within the tensioning element.

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

18. The assembly of claim 9, where the tensioning element comprises a suture or a wire.