Devices, systems, and methods for reshaping a heart valve annulus, including the use of magnetic tools

• US 10,398,437 B2
• Filed: 11/11/2016
• Issued: 09/03/2019
• Est. Priority Date: 03/25/2005
• Status: Active Grant

• Current Assignee: MVRx, Inc.
• Original Assignee: MVRx, Inc.
• Inventors: Machold, Timothy R., Chang, Robert T., Rahdert, David A., Scott, David, Tholfsen, David R.
• Primary Examiner(s): Eiseman, Adam J
• Application Number:
  US15/349,968
• Publication Number:
  US 20170055969A1
• Time in Patent Office: 1,026 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 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00588 Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• 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 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00876 magnetic
• 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 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• 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 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/1132 : End-to-end connections
• CPC Class Codes: A61B 2017/1135 : End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61B 2017/1139 : Side-to-side connections, e.g. shunt or X-connections
• 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 2002/30079 : magnetic
• CPC Class Codes: A61F 2002/30668 : Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2210/009 : magnetic
• CPC Class Codes: A61F 2250/0001 : Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61M 2025/09175 : having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/09 : Guide wires

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 retrievability. 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 a bridge stop to secure the implant, and the methods of implantation employ various tools.

Claims

1. A method of establishing a pathway to a desired location within a body of a patient, the method comprising:

providing a first elongate member extending along a longitudinal axis and having a first magnetically attracting element along a distal portion thereof;

providing a second elongate member extending along a longitudinal axis and having a distal hole for passage of a guidewire therethrough, the second elongate member further including a second magnetically attracting element along a distal portion thereof and an interior channel extending to a side hole in the distal portion, wherein the side hole is axially spaced apart from the distal hole;

positioning the first elongate member at a first location within the body by advancing the first elongate member through a first vascular access point;

positioning the second elongate member at a second location within the body adjacent the first location with a layer of tissue therebetween by advancing the second elongate member through a second vascular access point;

aligning the distal portions of the first and second elongate member by magnetically coupling the first and second magnetically attracting elements on opposite sides of the layer of tissue;

passing a piercing element between the first and second elongate elements through the layer of tissue and through the side hole of the second elongate member while magnetically coupled, wherein the piercing element comprises a puncturing guidewire advanced from the first vascular access point and through the layer of tissue;

further advancing the puncturing guidewire until the puncturing guidewire exits the second vascular access site so as to define a loop guidewire, thereby allowing a physician to pull an implant or tool into the patient'"'"'s vasculature; and

advancing an exchange catheter over the puncturing guidewire through the first vascular access point until the exchange catheter exits at the second vascular access point to facilitate delivery of the implant or tool by pulling the puncturing guidewire without injuring tissues.

2. The method of claim 1, wherein aligning the distal portions comprises aligning the longitudinal axis of the distal portion of the first elongate member transverse to the longitudinal axis of the distal portion of the second elongate member when magnetically coupled across the layer of tissue.

3. The method of claim 2, wherein aligning the distal portions comprises aligning the longitudinal axis of the distal portion of the first elongate member substantially perpendicular to the longitudinal axis of the distal portion of the second elongate member when magnetically coupled across the layer of tissue.

4. The method of claim 1, wherein the first elongate member comprises a first catheter having an elongated shaft with an interior channel such that passing the penetrating element comprises advancing the penetrating element through the interior channel of the first catheter.

5. The method of claim 4, wherein the second elongate member comprises a second catheter having an elongated shaft with the interior channel.

6. The method of claim 5, wherein the second catheter comprises a flexible region adjacent the distal portion to facilitate transverse alignment between the distal portions of the first and second catheters.

7. The method of claim 5, wherein passing the penetrating member comprises advancing the penetrating element distally through the interior channel of the first catheter, exiting a distal opening of the interior channel of the first catheter and entering the side hole of the second catheter.

8. The method of claim 5, wherein passing the penetrating member comprises advancing the penetrating element distally through the interior channel of the second catheter, exiting the side hole of the second catheter and entering a distal opening of the first catheter.

9. The method of claim 8, wherein the interior channel of the second catheter extends to a radially curved side hole lumen adjacent the side hole to direct passage of the piercing element into the distal opening of the first catheter.

10. The method of claim 9, wherein the distal opening of the first catheter is funnel shaped to facilitate entry of the penetrating element.

11. The method of claim 9, wherein the penetrating element comprises a flattened bendable tip to facilitate passage of the penetrating element through the side hole into the interior channel of the second elongate member.

12. The method of claim 5, wherein the first catheter includes a side hole in communication with the interior channel such that aligning the distal portions comprises a side-by-side alignment of the longitudinal axes of the distal portions with the side holes facing each other.

13. The method of claim 12, wherein passing the penetrating element comprises distally advancing the penetrating element through the second catheter so as to exit the side hole of the second catheter and enter the side hole of the first catheter.

14. The method of claim 13, wherein the side hole of the first catheter is larger than the side hole of the second catheter so as to funnel the penetrating element into the side hole of the first catheter.

15. The method of claim 1, wherein the penetrating element comprises a sharpened tip of a guidewire passed through the first or second elongate member.

16. The method of claim 1, wherein the first vascular access point comprises a femoral access site.

17. The method of claim 16, wherein the second vascular access point comprises a jugular access site.

18. The method of claim 1, wherein the first location and/or the second location comprises a body structure and/or body lumen within the patient.

19. The method of claim 18, wherein the first location and the second location comprise adjacent body structures within the patient.

20. The method according to claim 1, further comprising:

advancing at least a portion of the implant to the desired location by passing the at least a portion of the implant through an interior lumen of the exchange catheter by pulling the puncturing guidewire along the pathway.

21. The method according to claim 1, wherein the first and second magnetically attracting elements comprise permanent magnets.

22. The method according to claim 1, wherein positioning the second elongate member comprises positioning the second magnetically attracting element within the great cardiac vein and positioning the first elongate member comprises positioning the first magnetically attracting element within a chamber of the heart adjacent the great cardiac vein.

23. The method according to claim 1, wherein the second elongate member comprises a guidewire lumen in communication with the distal opening and a separate side hole lumen in communication with the side hole to direct the piercing element through the side hole and toward the first elongate element.

24. The method of claim 20, wherein the at least a portion of the implant comprises a bridging element attached at one end to the puncturing guidewire and attached at an opposite end to a posterior bridge stop, the method further comprising:

pulling the puncturing guidewire through the first vascular access point until the bridging element extends through the first vascular access point and the posterior bridge stop is delivered within a great cardiac vein of a heart of the patient; and

advancing an anterior bridge stop along the bridging element through the first vascular access point and delivering the anterior bridge stop along a septal wall of the heart to facilitate deployment of the implant.