Devices and methods for heart valve repair

• US 10,092,402 B2
• Filed: 09/14/2016
• Issued: 10/09/2018
• Est. Priority Date: 06/13/2002
• Status: Expired due to Term

• Current Assignee: Ancora Heart, Inc.
• Original Assignee: Ancora Heart, Inc.
• Inventors: Starksen, Niel F., To, John
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US15/265,781
• Publication Number:
  US 20170224489A1
• Time in Patent Office: 755 Days
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 6/487 involving fluoroscopy
• CPC Class Codes: A61B 6/504 for diagnosis of blood vessels, e.g. by angiography
• CPC Class Codes: A61B 8/0883 for diagnosis of the heart
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

Devices and methods provide enhanced treatment of a cardiac valve annulus. Methods generally involve contacting an anchor delivery device with the valve annulus and releasing a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus. Anchors, which in some embodiments are super-elastic or shape memory self-securing anchors, are then drawn together to tighten the annulus. Devices generally include an elongate catheter having a housing at or near the distal end for releasably housing a plurality of coupled anchors. The housing may be flexible, may conform to a valve annulus, and in some embodiments may be coupled with an expandable member to enhance contact of the housing with annular tissue. In one embodiment, self-securing anchors lie approximately flat within the delivery device housing, allowing anchors with relatively large deployed shapes to be housed in and deployed from a relatively narrow delivery device.

Claims

1. A method of constricting tissue in a heart, the method comprising:

advancing an operational device to contact tissue of a tricuspid valve annulus of the heart, wherein the operational device comprises a lumen and a plurality of apertures in communication with the lumen for delivering a plurality of anchors therethrough;

delivering a plurality of tethered, self-securing anchors from the lumen of the operational device through the plurality of apertures to secure the anchors to the tissue of the tricuspid valve annulus; and

drawing the tethered, self-securing anchors together to constrict the tissue of the tricuspid valve annulus.

2. The method of claim 1, wherein each of the self-securing anchors has a straight undeployed configuration and a curved deployed configuration.

3. The method of claim 2, wherein each of the self-securing anchors comprises two sharpened tips and a loop therebetween, and when the anchor is in the deployed configuration, the two sharpened tips curve in opposite directions.

4. The method of claim 1, wherein delivering the plurality of tethered, self-securing anchors comprises sequentially releasing each self-securing anchor from the operational device.

5. The method of claim 1, wherein advancing an operational device to contact tissue of a tricuspid valve annulus comprises contacting tissue adjacent a tricuspid valve leaflet.

6. The method of claim 1, wherein advancing, delivering and drawing are performed as part of an open heart surgical procedure.

7. The method of claim 1, wherein advancing, delivering and drawing are performed without stopping the heart.

8. The method of claim 1, wherein advancing, delivering and drawing are performed through one or more minimally invasive incisions.

9. The method of claim 1, wherein drawing the anchors together comprises allowing a self-deforming coupling member coupled with the anchors to deform to constrict the tissue.

10. The method of claim 1, wherein delivering the plurality of anchors from the operational device acts to secure at least one heart valve prosthesis to the tissue.

11. The method of claim 1, wherein advancing, delivering and drawing are performed via intravascular access to the heart.

12. The method of claim 1, further comprising deforming a flexible distal portion of the operational device to conform a distal portion of the operational device to a length of tricuspid annulus tissue prior to contacting the operational device with the length of tricuspid annulus tissue.

13. The method of claim 1, wherein drawing the anchors together comprises cinching a tether coupled with the anchors.

14. The method of claim 13, further comprising:

securing the tether to at least a terminal anchor of the plurality of anchors; and

cutting the tether to leave the cinched anchors secured to the tissue.

15. The method of claim 1, further comprising visualizing the tissue of the tricuspid valve annulus.

16. The method of claim 15, wherein visualizing is performed using a visualization device selected from the group consisting of an ultrasound device, an angioscopic device, a transesophageal echocardiogram device and a fluoroscopic device.