Devices, systems, and methods for reshaping a heart valve annulus, including the use of a bridge implant having an adjustable bridge stop

• US 9,597,184 B2
• Filed: 06/26/2015
• Issued: 03/21/2017
• Est. Priority Date: 05/14/2004
• Status: Active Grant

• Current Assignee: MVRx, Inc.
• Original Assignee: MVRx, Inc.
• Inventors: Machold, Timothy R., Scott, David J., Rahdert, David A., Tholfsen, David R., Chang, Robert T., Macoviak, John A.
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US14/751,574
• Publication Number:
  US 20150289976A1
• Time in Patent Office: 634 Days
• US Class Current: 1/1
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• 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 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0451 Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0453 threaded elements, e.g. set screws
• 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 2017/0462 : One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06176 : with protrusions, e.g. barbs
• CPC Class Codes: A61F 2/2442 : Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• 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 2/2466 : Delivery devices therefor
• CPC Class Codes: A61F 2/2487 : Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2210/009 : magnetic
• CPC Class Codes: A61F 2250/0012 : for adjusting elasticity, flexibility, spring rate or mechanical tension

Abstract

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial adjustability and retrievability years after implant. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize an adjustable bridge stop to secure the implant, and the methods of implantation employ various tools.

Claims

1. A bridge stop apparatus comprising:

a bridge stop housing having a length and a width;

an aperture extending through the length of the bridge stop housing, the aperture sized and configured to allow at least a portion of a bridging element to extend through at least a portion of the length of the aperture, the bridging element having a length capable of bridging at least a portion of the interior of an atrium of a human heart;

a septal member, the septal member having an orifice formed therein, said orifice of sufficient diameter to receive the bridging element slidingly therein; and

an adjustment mechanism coupled to the bridge stop housing said adjustment mechanism having a restrained configuration wherein movement of said bridging element is restrained relative to said bridge stop, and an unrestrained configuration wherein movement of said bridging element is unrestrained relative to said bridge stop, said adjustment mechanism movable between said unrestrained and said restrained configuration; and

an activation mechanism, said activation mechanism capable of activating said adjustment mechanism to move said adjustment mechanism from said unrestrained configuration to said restrained configuration and from said restrained configuration to said unrestrained configuration.

2. A bridge stop according to claim 1

wherein the adjustment mechanism includes a catheter releasably coupled to the bridge stop to manipulate said activation mechanism.

3. A bridge stop according to claim 1

wherein the adjustment mechanism is located within the aperture within the bridge stop housing.

4. A bridge stop according to claim 1

wherein the adjustment mechanism comprises a locking collar.

5. A bridge stop according to claim 1

wherein the adjustment mechanism further comprises a toothed ribbon located within the bridge stop housing.

6. A bridge stop according to claim 1

wherein the adjustment mechanism further comprises an adjustment screw threaded into the bridge lock housing;

and a clamp;

wherein the adjustment screw is capable of exerting a force on the clamp that allows for both lengthening and shortening of the bridging element.

7. A bridge stop according to claim 1

wherein the bridge stop adjustment mechanism includes a static state, and the bridge stop adjustment mechanism restrains the bridging element in the adjustment mechanism'"'"'s static state, thereby requiring a positive activation force necessary to allow the bridging element to be adjusted.

8. A bridge stop according to claim 1

wherein the bridging element includes discrete stop beads to allow the bridging element to be adjusted in discrete lengths.

9. A bridge stop according to claim 1

wherein the bridging element includes a toothed ribbon portion or a perforated ribbon portion or a threaded shaft portion extending through at least a portion of the aperture in the bridge stop housing.

10. A bridge stop according to claim 1

wherein the length of the bridge stop housing is greater than the width of the bridge stop housing.

11. A bridge stop according to claim 1

wherein the bridge stop housing further includes at least one radio-opaque marker.

12. A bridge stop according to claim 1

wherein the bridge stop includes a relocation element.

13. A bridge stop according to claim 12

the relocation element further including at least one radio-opaque marker.

14. A bridge stop apparatus comprising:

a bridge stop housing, the housing comprising an inner portion and an outer portion, the housing having a length and a width;

a bridging element having a length capable of bridging at least a portion of the interior of an atrium of a human heart;

a septal member located on or abutting said bridge stop housing;

an aperture extending through the length of the bridge stop housing, the aperture sized and configured to allow the bridging element to extend through at least a portion of the length of the aperture, said aperture forming a relatively blood tight seal with said bridging element when a portion of said bridging element is located within said aperture; and

an adjustment mechanism coupled to the bridge stop housing, said adjustment mechanism having a restrained configuration wherein movement of said bridging element is restrained relative to said bridge stop, and an unrestrained configuration wherein movement of said bridging element is unrestrained relative to said bridge stop, said adjustment mechanism movable between said unrestrained and said restrained configuration, and subsequently from said restrained configuration back to said unrestrained configuration, wherein said adjustment mechanism comprises rotation of either the inner portion or the outer portion relative to the other, said rotation allowing for engagement and disengagement of the bridging element to thereby allow for tensioning and repositioning of the bridging element.

15. A bridge stop apparatus comprising:

a bridge stop housing, the housing comprising an inner portion and an outer portion, the housing having a length and a width, wherein the inner portion extends partially outside the outer portion;

a bridging element having a length capable of bridging at least a portion of the interior of an atrium of a human heart;

a septal member located on or abutting said bridge stop housing;

an aperture extending through the length of the bridge stop housing, the aperture sized and configured to allow the bridging element to extend through at least a portion of the length of the aperture, said aperture forming a relatively blood tight seal with said bridging element when a portion of said bridging element is located within said aperture; and

an adjustment mechanism coupled to the bridge stop housing, said adjustment mechanism having a restrained configuration wherein movement of said bridging element is restrained relative to said bridge stop, and an unrestrained configuration wherein movement of said bridging element is unrestrained relative to said bridge stop, said adjustment mechanism movable between said unrestrained and said restrained configuration, and subsequently from said restrained configuration back to said unrestrained configuration.

16. An implant system for use in a human atrium comprising:

a bridging element sized and configured to span a left atrium between a portion of the atrium wall contiguous with a great cardiac vein and an interatrial septum;

a septal member slideable onto said bridging element;

a first bridge stop coupled to the bridging element and abutting said septal member;

a second bridge stop coupled to the bridging element, the second bridge stop comprising;

a bridge stop housing, the housing comprising an inner portion and an outer portion, the housing having a length and a width;

an aperture extending through the length of the bridge stop housing, the aperture sized and configured to allow the bridging element to extend through at least a portion of the length of the aperture; and

an adjustment mechanism coupled to the bridge stop housing, said adjustment mechanism having a restrained configuration wherein movement of said bridging element is restrained relative to said bridge stop, and an unrestrained configuration wherein movement of said bridging element is unrestrained relative to said bridge stop, said adjustment mechanism movable between said unrestrained and said restrained configuration, and subsequently from said restrained configuration back to said unrestrained configuration, wherein the adjustment mechanism comprises rotation of either the inner portion or the outer portion to allow the bridging element to be lengthened or shortened.