Systems, methods and devices for delivery systems, methods and devices for implanting prosthetic heart valves

• US 10,653,523 B2
• Filed: 01/18/2018
• Issued: 05/19/2020
• Est. Priority Date: 01/19/2017
• Status: Active Grant

• Current Assignee: 4C Medical Technologies, Inc.
• Original Assignee: 4C Medical Technologies, Inc.
• Inventors: Chambers, Jeffrey W., Brucker, Gregory G., Higgins, Joseph P., Kumar, Saravana B., Diedering, Jason S., Kabarowski, Karl A., Thatcher, Robert J., Flaherty, James E., Stone, Jeffrey R.
• Primary Examiner(s): Yabut, Diane D
• Application Number:
  US15/874,376
• Publication Number:
  US 20180200049A1
• Time in Patent Office: 852 Days
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

Embodiments of delivery systems, devices and methods for delivering a prosthetic heart valve device to a heart chamber for expanded implementation are disclosed. More specifically, methods, systems and devices are disclosed for delivering a self-expanding prosthetic mitral valve device to the left atrium, with no engagement of the left ventricle, the native mitral valve leaflets or the annular tissue downstream of the upper annular surface during delivery, and in some embodiments with no engagement of the ventricle, mitral valve leaflets and/or annular tissue located downstream of the upper annular surface by the delivered, positioned and expanded prosthetic mitral valve device.

Claims

1. A method of delivering a self-expanding prosthetic mitral valve device comprising prosthetic mitral valve leaflets to an implantation site within a left atrium of a patient'"'"'s heart, comprising:

accessing the left atrium with a delivery catheter having a proximal end, a distal end and a lumen therethrough;

loading the self-expanding prosthetic mitral valve device in a collapsed configuration into the lumen of the delivery catheter at the proximal end thereof, wherein the collapsed configuration of the prosthetic mitral valve device comprises a prosthetic mitral valve attached thereto;

delivering the collapsed prosthetic valve out of the distal end of the delivery catheter and into the left atrium at a location proximate the implantation site;

allowing the delivered self-expanding prosthetic mitral valve device to expand within the left atrium at the implantation site, wherein at least a portion of the expanded device engages at least a portion of the upper annular surface within the left atrium; and

ensuring that the left ventricle, the annular tissue below or downstream of the upper annular surface and the native mitral valve leaflets of the heart are not touched at any point in the delivery of the self-expanding prosthetic mitral valve device before the delivered self-expanding prosthetic mitral valve device is allowed to expand within the left atrium;

providing a plug attached directly to a side portion of the collapsed self-expanding prosthetic mitral valve device;

aligning the plug with the left atrial appendage; and

engaging the left atrial appendage with the plug when the self-expanding prosthetic mitral valve device is expanded.

2. The method of claim 1, wherein the collapsed self-expanding prosthetic mitral valve device further comprises a proximal portion and a distal portion, wherein the prosthetic mitral valve leaflets are disposed within the distal portion;

loading an inner sheath into the catheter lumen, the inner sheath having a distal end that engages the collapsed self-expanding prosthetic mitral valve, wherein translation of the inner sheath through the catheter lumen results in translation of the collapsed self-expanding stented valve through the catheter lumen.

3. The method of claim 2, wherein the inner sheath comprises a lumen therethrough sized to receive the proximal portion of the collapsed self-expanding prosthetic mitral valve device.

4. The method of claim 3, wherein the distal end of the inner sheath engages the distal portion of the collapsed self-expanding prosthetic mitral valve device, wherein the distal portion is not received within the lumen of the inner sheath.

5. The method of claim 2, wherein the distal portion is delivered, positioned proximate the implantation site and expanded before the proximal portion of the collapsed self-expanding prosthetic mitral valve device is delivered and expanded.

6. The method of claim 2, further comprising a central portion disposed between the proximal portion and the distal portion, the central portion having a maximum diameter that is smaller than a maximum diameter of the proximal portion and a maximum diameter of the distal portion.

7. The method of claim 6, further comprising:

providing a hinge on the central portion;

delivering the central portion out of the distal end of the delivery catheter lumen to expose the hinge to the left atrium; and

rotating the distal portion toward the upper annular surface of the left atrium; and

delivering the proximal portion out of the distal end of the delivery catheter lumen and into the left atrium.

8. The method of claim 2, further comprising:

translating an alignment wire disposed through the lumen of the delivery catheter;

engaging an open frame portion of the prosthetic mitral valve device with the alignment wire; and

engaging the left upper pulmonary vein with the alignment wire before delivering the prosthetic mitral valve device into the left atrium along the alignment wire.

9. The method of claim 1, wherein the plug further comprises a flange that engages and seals the atrial wall around the left atrial appendage.

10. The method of claim 1, further comprising:

providing a push rod that is connected to the collapsed prosthetic mitral valve device; and

pushing the collapsed prosthetic mitral valve device with the push rod through the lumen of the delivery catheter for delivery and expansion within the left atrium.

11. The method of claim 10, further comprising at least partially collapsing the expanded prosthetic mitral valve within the lumen of the delivery catheter by pulling proximally on the push rod.

12. The method of claim 10, further comprising:

translating a locating element through the lumen of the catheter;

engaging an open frame portion of the prosthetic mitral valve device with the locating element; and

engaging the lumen of the left upper pulmonary vein with a distal end of the locating element before delivering the prosthetic mitral valve device into the left atrium.

13. The method of claim 12, wherein the locating element extends through an open frame section of the prosthetic mitral valve device.

14. The method of claim 1, further comprising at least one capture wire extending through the delivery catheter lumen and engaging the self-expanding prosthetic mitral valve device adapted to restrain the expansion of the device to a partially expanded configuration.

15. The method of claim 14, further comprising the at least one capture wire further adapted to positionally orient the partially expanded device by manipulating the at least one capture wire at the proximal end of the delivery catheter.

16. The method of claim 15, further comprising:

positionally orienting the partially expanded device within the left atrium;

confirming proper orientation of the partially expanded device;

removing the at least one capture wire; and

allowing the partially expanded device to fully expand.

17. The method of claim 16, further comprising providing a push/pull rod through the lumen of the delivery catheter adapted to assist in positionally orienting the partially expanded device.

18. The method of claim 1, further comprising a lasso element attached to the prosthetic mitral valve device adapted to be manipulated at the proximal end of the delivery catheter;

manipulating the lasso element to positionally orient, prevent full expansion of the prosthetic mitral device and/or allow full expansion of the prosthetic mitral valve device within the left atrium.

19. The method of claim 1, wherein the self-expanding prosthetic mitral valve device further comprises an upper portion formed from a stent comprising at least two sets of opposing subsections, at least one set of the opposing subsections comprising a fabric covering.

20. The method of claim 19, further comprising using the fabric covering to capture blood flow to position the self-expanding prosthetic mitral valve device and expanding the positioned self-expanding prosthetic mitral valve device.