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

• US 10,172,621 B2
• Filed: 09/12/2016
• Issued: 01/08/2019
• Est. Priority Date: 09/21/2007
• 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:
  US15/262,974
• Publication Number:
  US 20160374812A1
• Time in Patent Office: 848 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
• 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
• 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 treatment a human or veterinary patient involving two adjacent bodily structures comprising:

providing a first catheter having a first interior channel, the first catheter having a first orifice between said first interior channel and an exterior of the catheter, said first catheter having a first magnetically attracting tip, said first magnetically attracting tip comprising a ferromagnetic material located in a length of said first catheter that includes said first orifice, said first magnetically attracting tip having a polarity parallel to said first interior channel;

providing a second catheter having a second interior channel, the second catheter having a second orifice between said second interior channel and an exterior of the second catheter through a side wall of said second catheter, said second catheter having a second magnetically attracting tip, said second magnetically attracting tip comprising a ferromagnetic material, located in a length of said second catheter that includes said second orifice, said second magnetically attracting tip comprised of three magnetic sections, a first magnetic section, a middle magnetic section and a third magnetic section, said first and third magnetic sections having opposing polarity, and said middle magnetic section having its polarity oriented perpendicular to the polarity of said first and second section, said second orifice located in said middle magnetic section, wherein the second catheter includes a radio-opaque marker disposed along a distal portion thereof to indicate a rotational orientation of the second orifice;

locating said first catheter within a first body structure;

locating said second catheter within a second body structure adjacent the first body structure;

positioning the second catheter to rotationally align the second orifice of the second catheter with the first orifice of the first catheter by observing the radio-opaque marker on the second catheter under image guidance;

placing said first magnetically attracting tip within said first body structure adjacent said second magnetically attracting tip with a layer of tissue between said first magnetically and second magnetically attracting tips such that said first and second magnetically attracting tips align and magnetically couple to each other with first and second orifices opposed to each other but separated by the layer of tissue between them; and

passing a piercing device through the first orifice, through the layer of tissue, and into the second orifice.

2. The method according to claim 1 wherein the first catheter magnetically attracting tip and the second catheter magnetically attracting tip are arranged so that when they are brought into close proximity but on opposite sides of a layer of tissue they align with sufficient stability to remain aligned even should the body structure encounter movement.

3. The method according to claim 2 wherein the body structure is the human heart and the movement is the beating of the heart.

4. The method according to claim 1, wherein the piercing device is a needle with a suture.

5. The method according to claim 1, wherein the piercing device is a sharpened tip guide wire.

6. The method according to claim 1, wherein the piercing device is a hollow coring tip.

7. The method according to claim 1, wherein the piercing device is a multi-bladed cutting tip.

8. The method according to claim 1, wherein the piercing device is a flattened puncturing wire.

9. The method according to claim 1, wherein the first orifice has a funnel shape, whereby the piercing structure passing through the layer of tissue would be directed into the first catheter channel.

10. The method according to claim 9 wherein said first location and said second location are at a location on the same part of on the body of the patient.

11. The method according to claim 1 wherein the layer of tissue includes the tissue between the interior of the left atrium and the interior of the great cardiac vein.

12. The method according to claim 1 wherein said first catheter has a first proximal end exiting the body of the patient at a first location;

said second catheter has a second proximal end exiting the body of the patient at a second location; and

said method further comprises passing a guide wire into said first proximal end, through first catheter channel, out said first orifice, through said layer of tissue, into said second orifice, through said second catheter channel out said second proximal end and thus out of the body of the patient at said second location.

13. The method according to claim 12 wherein the said first and said second locations are at a location on the same part of the body of the patient.

14. The method according to claim 1 wherein the distal portion of said second interior channel forms of a ramp between said second interior channel and said second orifice.

15. The method according to claim 1, wherein positioning the second catheter comprises rotating the second catheter until the radio-opaque marker indicates rotational alignment of the second orifice with the first orifice.