Device, method and system for reshaping a heart valve annulus
Delivery systems, methods and associated devices to facilitate delivery and deployment of a heart implant. Such delivery systems and methods of delivery include use of a pair of magnetic catheters, including an anchor delivery catheter carrying an anchor, which can be stacked with or can be axially offset from the magnetic head. Such systems further include use of a puncturing guidewire advanceable through the magnetic head of the anchor delivery catheter to establish access to a chamber of a heart and which is attached to a bridging element such that continued advancement of the guidewire draws a bridging element attached to the first anchor across the chamber of the heart while the bridging element remains covered by the magnetically coupled catheters. Methods and devices herein also allow for cutting and removal of a bridge element of a deployed heart implant.
1. A system for delivering a heart implant comprising:
a) a first catheter having a proximal end and a distal end, wherein the first catheter comprises:
i) a first lumen extending through a length of the first catheter;
ii) a first magnet disposed along a distal portion of the first catheter, wherein the first magnet includes a first magnetic pole and a second magnetic pole; and
iii) a first guide channel disposed in the distal portion of the first catheter and extending along a first longitudinal axis, the first guide channel being coextensive with the first lumen and having a first side hole located proximal along the distal portion of the first catheter relative to the first magnetic pole; and
b) a second catheter having a proximal end and a distal end, wherein the second catheter comprises:
i) a second lumen extending through a length of the second catheter;
ii) a second magnet disposed at the distal end of the second catheter, wherein the second magnet includes a third magnetic pole and a fourth magnetic pole; and
iii) a second guide channel disposed at the distal end of the second catheter and extending along a second longitudinal axis, the second guide channel being coextensive with the second lumen and having a second side hole on a side wall of the second catheter and adjacent the second magnet,
wherein the first side hole and the second side hole are aligned in a plane parallel to the first longitudinal axis and the second longitudinal axis, and the second side hole is oriented distal along the distal portion of the first catheter relative to the first side hole, when the first magnet and the second magnet are magnetically coupled.
2. The system of claim 1 , wherein the first side hole and second side hole are at an angle of about 90 degrees with respect to one another when the first magnet and second magnet are magnetically coupled.
3. The system of claim 1 , wherein the distal portion of the first catheter and the distal end of the second catheter are at an angle of about 90 degrees with respect to one another when the first magnet and second magnet are magnetically coupled.
4. The system of claim 1 , wherein the first magnetic pole and the second magnetic pole are disposed perpendicular with respect to the first longitudinal axis.
5. The system of claim 1 , wherein the third magnetic pole and the fourth magnetic pole are disposed parallel with respect to the second longitudinal axis with the third magnetic pole being distal to the fourth magnetic pole along the distal end of the second catheter.
6. The system of claim 1 , wherein the first magnetic pole and the third magnetic pole are adjacent each other when the first magnet and the second magnet are magnetically coupled.
7. The system of claim 1 , wherein the second magnet comprises a contoured recess having an arcuate or sloped surface oriented towards the second guide channel and defining a surface of the second guide channel, the surface of the second guide channel being configured to guide a guidewire extending from the first guide channel through the second guide channel when the first magnet and the second magnet are magnetically coupled.
8. The system of claim 7 , wherein the contoured recess extends from a distal portion of the second magnet to a proximal portion of the second magnet.
9. The system of claim 7 , further comprising a penetrating member or guidewire advanceable through the first guide channel and the second guide channel via the first side hole and the second side hole when the first magnet and second magnet are magnetically coupled, and wherein the penetrating member or guidewire has a sharpened distal end to facilitate penetration of tissue.
10. The system of claim 1 , further comprising a radiopaque marker disposed at the distal end of the first catheter or the distal end of the second catheter.
11. The system of claim 10 , wherein the radiopaque marker is disposed at the distal end of the first catheter distal to the first magnet.
12. The system of claim 1 , wherein the first catheter comprises radiopaque markers disposed along a length of the first catheter to determine a depth of insertion.
13. The system of claim 1 , wherein the second catheter comprises radiopaque markers disposed along a length of the second catheter to determine a depth of insertion.
14. The system of claim 1 , wherein the first catheter includes a plurality of radiopaque markers disposed along the distal portion of the first catheter that are arranged asymmetrically about the longitudinal axis of the first guide channel to facilitate alignment of rotational orientation of the first catheter relative to the second catheter before magnetically coupling.
15. The system of claim 14 , wherein the the plurality radiopaque markers comprise first and second markers, the first marker being disposed on a same side of the first catheter as the first side hole and being different than the second marker under fluoroscopy.
16. A method of performing a surgical procedure on a subject, the method comprising:
inserting, through a first vascular access site, the first catheter of the system of claim 1 , and advancing the first catheter to a first location in or proximate a heart of the subject;
inserting the second catheter of the system of claim 1 through a second vascular access site and advancing the second catheter to a second location in or proximate the heart, the first and second locations being separated by a tissue wall of the heart;
positioning the first catheter and the second catheter such that the first magnet and the second magnet magnetically couple across the tissue wall; wherein the first side hole and the second side hole are aligned in a plane parallel to the first longitudinal axis and the second longitudinal axis, and the second side hole is oriented distal along the distal portion of the first catheter relative to the first side hole; and
penetrating the tissue wall with a penetrating member advanced through the first catheter or the second catheter and across the tissue wall while the first and second catheters are magnetically coupled, thereby performing a surgical procedure on the subject.
17. The method of claim 16 , further comprising: determining a depth of insertion of the first catheter via radiopaque markers disposed along the length of the first catheter before magnetic coupling of the first magnet and the second magnet.
18. The method of claim 16 , further comprising: determining a depth of insertion of the second catheter via radiopaque markers disposed along the length of the second catheter before magnetic coupling of the first magnet and the second magnet.
19. The method of claim 16 , further comprising: determining proper alignment of the first catheter and the second catheter via one or more radiopaque markers disposed along the distal portion of the first catheter before the first magnet and the second magnet are magnetically coupled.
20. The method of claim 16 , further comprising:
advancing a posterior anchor and a bridging element coupled at a first end of the bridging element to the posterior anchor to the first location from the first vascular access site while the first magnet and the second magnet are magnetically coupled;
advancing a second end of the bridging element through the penetrated tissue wall and into the second catheter; and
advancing an anterior anchor along the bridging element from the second vascular access site and deploying the anterior anchor at a third location in the heart, the bridging element spanning across a chamber of the heart.
21. The method of claim 20 , wherein the posterior anchor is an elongate member having strain relief portions that flex during advancement to the first location so as to accommodate curvature of the vasculature and avoid crimping of the posterior anchor.
22. The method of claim 20 , further comprising shortening a length of the bridging element thereby reshaping the chamber of the heart.
23. The method of claim 22 , wherein shortening the length of the bridging element comprises advancing the second end of the bridging element through or across the deployed anterior anchor.
24. The method of claim 22 , further comprising: coupling the bridging element to the deployed anterior anchor while the chamber of the heart is reshaped so that the chamber of the heart remains reshaped.
25. The method of claim 24 , wherein the bridging element is attached to the posterior anchor at the first end of the bridging element and attached to the anterior anchor at the second end of the bridging element.
26. The method of claim 20 , wherein the chamber of the heart is the left atrium.
27. The method of claim 16 , wherein the subject has, or is at risk of, mitral valve regurgitation.
28. The method of claim 27 , wherein the subject has congestive heart failure.
29. A method of treating mitral valve regurgitation in a subject by reshaping a heart chamber of a subject comprising:
inserting, through a first vascular access site, the first catheter of the system of claim 1 , and advancing the first catheter to a first location in or proximate a heart of the subject;
inserting the second catheter of the system of claim 1 through a second vascular access site and advancing the second catheter to a second location in or proximate the heart, the first and second locations being separated by a tissue wall of the heart;
positioning the first catheter and the second catheter such that the first magnet and the second magnet magnetically couple across the tissue wall;
wherein the first side hole and the second side hole are aligned in a plane parallel to the first longitudinal axis and the second longitudinal axis, and the second side hole is oriented distal along the distal portion of the first catheter relative to the first side hole;
penetrating the tissue wall with a penetrating member advanced through the first catheter or the second catheter and across the tissue wall while the first and second catheters are magnetically coupled;
advancing a posterior anchor and a bridging element coupled at a first end of the bridging element to the posterior anchor to the first location while the first magnet and the second magnet are magnetically coupled;
advancing a second end of the bridging element through the penetrated tissue wall when the posterior anchor is advanced through the first catheter; advancing an anterior anchor along the bridging element and deploying the anterior anchor at a third location in the heart, the bridging element spanning across a chamber of the heart;
and shortening a length of the bridging element thereby reshaping the chamber of the heart and coupling the second end of the bridging element to the deployed anterior anchor while the chamber of the heart is reshaped so that the chamber of the heart remains reshaped, thereby treating mitral valve regurgitation in the subject.
30. The method of claim 29 , wherein shortening the length of the bridging element comprises advancing the second end of the bridging element through or across the deployed anterior anchor.
31. The method of claim 29 , further comprising: determining a depth of insertion of the first catheter via radiopaque markers disposed along the length of the first catheter before magnetic coupling of the first magnet and the second magnet.
32. The method of claim 29 , further comprising: determining a depth of insertion of the second catheter via radiopaque markers disposed along the length of the second catheter before magnetic coupling of the first magnet and the second magnet.
33. The method of claim 29 , further comprising: determining proper alignment of the first catheter and the second catheter via one or more radiopaque markers disposed along the distal portion of the first catheter before the first magnet and the second magnet are magnetically coupled.
34. The method of claim 29 , wherein the chamber of the heart is the left atrium.