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

• US 10,219,902 B2
• Filed: 02/13/2017
• Issued: 03/05/2019
• Est. Priority Date: 03/25/2005
• 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
• Application Number:
  US15/431,450
• Publication Number:
  US 20170216031A1
• Time in Patent Office: 750 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 17/0487 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 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• 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 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0453 threaded elements, e.g. set screws
• 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 2017/06176 with protrusions, e.g. barbs
• 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 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0083 : using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/001 : Figure-8-shaped, e.g. hourglass-shaped
• 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 method of adjusting a length of a bridging element of an implant comprising:

providing a bridge stop having a housing with a length and a width and an aperture extending through the length of the bridge stop housing, the aperture sized and configured to allow a bridging element to extend through at least a portion of the length of the aperture, and an adjustment mechanism coupled to the bridge stop to allow adjustment of the length of the bridging element;

operating the adjustment mechanism to lengthen or to shorten the bridging element;

repeating the operating the adjustment mechanism to lengthen or shorten the bridging element until a desired length of the bridging element is achieved; and

allowing the bridging element to settle for at least a predetermined time before repeating the operating the adjustment mechanism step.

2. The method of claim 1 further including:

repeating the operating the adjustment mechanism to lengthen or shorten the bridging element until a desired length of the bridging element is achieved.

3. The method of claim 1 further comprising:

placing the bridging element across a chamber of a human heart; and

adjusting the bridge stop to place the bridging element in tension.

4. A method of adjusting a length of a bridging element of an implant comprising:

providing a bridge stop having a housing with a length and a width and an aperture extending through the length of the bridge stop housing, the aperture sized and configured to allow a bridging element to extend through at least a portion of the length of the aperture, and an adjustment mechanism coupled to the bridge stop to allow adjustment of the length of the bridging element;

operating the adjustment mechanism to lengthen or to shorten the bridging element; and

coupling a catheter to the bridge stop, the catheter being used to operate the adjustment mechanism.

5. A method of adjusting a length of a bridging element of an implant comprising:

providing a bridge stop having a housing with a length and a width and an aperture extending through the length of the bridge stop housing, the aperture sized and configured to allow a bridging element to extend through at least a portion of the length of the aperture, and an adjustment mechanism coupled to the bridge stop to allow adjustment of the length of the bridging element;

operating the adjustment mechanism to lengthen or to shorten the bridging element;

placing the bridging element across a chamber of a human heart;

adjusting the bridge stop to place the bridging element in tension;

allowing the heart to settle for at least a period of time after adjusting the bridge stop to place the bridging element in tension; and

imaging the heart to determine heart function.

6. The method of claim 5 further comprising:

securing the adjustment mechanism to fix the bridge stop to the bridging element based on the imaging of the heart indicating a desired heart function.

7. The method of claim 5 further comprising:

adjusting the bridge stop to shorten or lengthen the bridging element based on the imaging of the heart; and

allowing the heart to settle for at least the period of time after adjusting the bridge stop to shorten or lengthen the bridging element; and

imaging the heart to determine heart function after allowing the heart to settle for at least the period of time.

8. The method of claim 7 further comprising:

secure the adjustment mechanism to fix the bridge stop to the bridging element based on the imaging of the heart indicating a desired heart function.

9. The method of claim 5 wherein imaging the heart comprises any of:

fluoroscopy, ultrasound, magnetic resonance, computed tomography, or any combination thereof.

10. A method of adjusting a bridge stop in deployment of an implant in a heart of a patient, the heart having a valve annulus, the method comprising:

placing the implant in the heart of the patient such that a bridging element spans at least a portion of a chamber of the patient'"'"'s heart between a posterior anchor and an anterior anchor, the anterior anchor having the bridge stop with an adjustment mechanism being operable between a restrained configuration that restrains movement of the bridging element through the bridge stop and an unrestrained configuration that allows movement of the bridging element through the bridge stop;

adjusting a length of the bridging element between the anterior and posterior anchors while the adjustment mechanism is in the unrestrained configuration;

activating the adjustment mechanism from the unrestrained configuration to the restrained configuration while the bridging element is in tension to fix the length of the bridging element at a first length;

allowing passage of at least a period of time for the heart to settle after adjusting the length of the bridging element to the first length while the adjustment mechanism is in the restrained configuration; and

imaging the heart after the period of time while the adjustment mechanism is in the restrained configuration at the first length of the bridging element so as to determine heart function.

11. The method of claim 10, further comprising:

locking the bridge stop when the determined heart function corresponds to a desired heart function.

12. The method of claim 10, further comprising:

releasing the adjustment mechanism from the restrained to the unrestrained configuration, re-adjusting the length of the bridging element to a second length different from the first length when the determined heart function does not correspond to a desired heart function;

allowing passage of at least the period of time for the heart to settle after adjusting the length of the bridging element to the second length while the adjustment mechanism is in the restrained configuration; and

imaging the heart after the period of time while the adjustment mechanism is in the restrained configuration at the second length of the bridging element so as to determine heart function.

13. The method of claim 10 wherein activating the adjustment mechanism comprises operating a catheter releasably coupled to the bridge stop.

14. The method of claim 10 further comprising deploying the bridge stop, at least in part, in a chamber adjacent to the chamber which the bridging element spans.

15. The method of claim 10 further comprising:

deploying the bridge stop at least in part in the right atrium and deploying the posterior anchor at least in part within the great cardiac vein so that the bridging mechanism spans at least a portion of the left atrium so as to reshape the left atrium for treatment of a mitral valve annulus.

16. The method of claim 15 wherein the bridge stop is deployed at least in part in contact with a septum between the left and the right atrium.

17. The method of claim 16 wherein the bridge stop is deployed in contact with a fossa ovalis portion of the septum.

18. The method of claim 10 wherein the adjustment mechanism comprises a clamp engageable with a plurality of stop elements disposed along an anterior portion of the bridging element such that activating the adjustment mechanism from the unrestrained configuration to the restrained configuration comprises activating the clamp to clamp down on the anterior portion of the bridging element posterior along or adjacent to at least one stop element of the plurality of stop elements.

19. The method of claim 18 further comprising:

releasing the adjustment mechanism from the restrained configuration to the unrestrained configuration by releasing the clamp from the anterior portion of the bridging element to facilitate re-adjusting the length of the bridging element.

20. The method of claim 10 wherein the adjustment mechanism comprises a toothed ribbon in conjunction with a locking collar, the locking collar being adjustable between a locked position wherein the collar is locked against the teeth in the ribbon and an unlocked position wherein the ribbon is free to slide within the locking collar.

21. The method of claim 10 wherein the adjustment mechanism comprises a locking collar engageable with a plurality of discrete stops of an anterior portion of the bridging element, the locking collar having a ramp therein with a slot therethrough, the slot having a narrow section and an enlarged section, the enlarged section sized for passage of the discrete to allow shortening or lengthening of the bridging element and the narrow section sized to inhibit passage of the discrete stops to lock the length of the bridging element, wherein the step of activating the adjustment mechanism from the unrestrained configuration to the restrained configuration comprising moving the anterior portion of the bridging element from the enlarged section to the narrow section.

22. The method of claim 10 wherein the heart of the patient includes a great cardiac vein, and the posterior anchor comprises a T-bar such that placing the implant in the heart of the patient comprises placing the posterior anchor within the great cardiac vein.

23. The method of claim 10 wherein the heart of the patient has a great cardiac vein, and the posterior anchor comprises a stent such placing the implant in the heart comprises deploying the stent in the great cardiac vein.

24. A method of adjusting a bridge stop in deployment of an implant in a heart of a patient, the heart having a valve annulus, the method comprising:

placing the implant in the heart of the patient such that a bridging element spans at least a portion of a chamber of the patient'"'"'s heart between a posterior anchor and an anterior anchor, the anterior anchor having the bridge stop with an adjustment mechanism being operable between a restrained configuration that restrains movement of the bridging element through the bridge stop and an unrestrained configuration that allows movement of the bridging element through the bridge stop;

adjusting a length of the bridging element between the anterior and posterior anchors while the adjustment mechanism is in the unrestrained configuration; and

activating the adjustment mechanism from the unrestrained configuration to the restrained configuration while the bridging element is in tension to fix the length of the bridging element at a first length, wherein the adjustment mechanism comprises a toothed ribbon in conjunction with a locking collar, the locking collar being adjustable between a locked position wherein the collar is locked against the teeth in the ribbon and an unlocked position wherein the ribbon is free to slide within the locking collar, wherein the locking collar is changed from the unlocked position to the locked position by means of rotating at least a portion of the locking collar.

25. A method of adjusting a bridge stop in deployment of an implant in a heart of a patient, the heart having a valve annulus, the method comprising:

placing the implant in the heart of the patient such that a bridging element spans at least a portion of a chamber of the patient'"'"'s heart between a posterior anchor and an anterior anchor, the anterior anchor having the bridge stop with an adjustment mechanism being operable between a restrained configuration that restrains movement of the bridging element through the bridge stop and an unrestrained configuration that allows movement of the bridging element through the bridge stop;

adjusting a length of the bridging element between the anterior and posterior anchors while the adjustment mechanism is in the unrestrained configuration; and

activating the adjustment mechanism from the unrestrained configuration to the restrained configuration while the bridging element is in tension to fix the length of the bridging element at a first length, wherein the adjustment mechanism comprises an anterior portion of the bridging element having toothed projections and a bridge lock adjustment screw, the bridge lock adjustment screw having an interior bore with helical grooves thereon that mate with the toothed projections, wherein the step of activating the adjustment mechanism comprises rotating the bridge lock adjustment screw relative to the toothed portion of the bridging element.