Devices and methods for transcatheter valve loading and implantation
The present disclosure relates to numerous devices and methods for transcatheter stented prosthetic heart valve loading and delivery. Such devices and methods reduce suture tangling and also provide the ability to adjust the stented prosthetic heart valve expansion and contraction prior to the final release of the stented prosthetic heart valve from the delivery device.
1. A combination delivery device and prosthetic heart valve, the combination comprising:
a prosthetic heart valve having a stent frame and a suture positioned around the stent frame; and
a delivery device including:
a catheter having a lumen and an access port, and
a continuous suture actuation member extending from a proximal end to a distal end, the suture actuation member positioned within the lumen, the suture actuation member forming a plurality of sinuous engagement sections between the proximal end and the distal end, each sinuous engagement section forming a plurality of teeth and having no free ends, each of the plurality of teeth being angled in a proximal direction with respect to a central axis of the lumen; the suture engaged with one tooth of one of the plurality of sinuous engagement sections proximate the access port;
wherein the suture actuation member can be pulled proximally to place tension in the suture and correspondingly compress the prosthetic heart valve.
2. The combination of claim 1 , wherein the plurality of engagement sections and the plurality of teeth are continuously formed in a material of the suture actuation member.
3. The combination of claim 2 , wherein the suture is one of a plurality of sutures positioned around the stent frame and a plurality of access ports within the catheter, each suture being engaged with one of the plurality of teeth.
4. The combination of claim 2 , wherein the plurality of engagement sections are separated from each other by sections of the suture actuation member that do not include teeth.
5. The combination of claim 1 , wherein the suture actuation member includes three engagement sections.
6. The combination of claim 1 , wherein a maximum height of the plurality of teeth and a diameter of the lumen are configured to prevent the suture from disengaging from the suture actuation member when the suture actuation member is pulled proximally.
7. A method of adjusting expansion and contraction of a prosthetic heart valve prior to deployment, the method comprising the steps of:
providing a prosthetic heart valve;
providing a suture positioned around the prosthetic heart valve;
providing a delivery device including:
a catheter having a lumen and an access port, and
a continuous suture actuation member extending from a proximal end to a distal end, the suture actuation member positioned within the lumen, the suture actuation member forming a plurality of sinuous engagement sections between the proximal end and the distal end, each sinuous engagement sections forming a plurality of teeth and having no free ends, each of the plurality of teeth being angled in a proximal direction with respect to a central axis of the lumen; the suture engaged with at least one tooth of the plurality of teeth proximate the access port;
engaging the suture with one of the plurality of teeth; and
pulling the suture actuation member proximally to place tension in the suture to correspondingly compress the prosthetic heart valve.
8. The method of claim 7 , further comprising the step of moving the suture actuation member distally to release tension in the suture.
9. The method of claim 7 , wherein the plurality of engagement sections and the plurality of teeth are continuously formed in a material of the suture actuation member.
10. The method of claim 9 , wherein the suture is one of a plurality of sutures positioned around a stent frame of the prosthetic heart valve and the catheter incudes a plurality of access ports, the method further comprising engaging each suture with one of the plurality of teeth.
11. The method of claim 10 , wherein the step of pulling the suture actuation member proximally correspondingly tensions each of the plurality of sutures.
12. The method of claim 9 , wherein the plurality of engagement sections are separated from each other by sections of the suture actuation member that do not include teeth.
13. The method of claim 7 , wherein a maximum height of the plurality of teeth and a diameter of the lumen are configured to prevent the suture from disengaging from the suture actuation member during the step of pulling the suture actuation member proximally.
14. The method of claim 7 , wherein the prosthetic heart valve includes a proximal end and a distal end; wherein each of the plurality of teeth are angled with respect to a central axis of the lumen in a direction of the proximal end of the prosthetic heart valve.
15. The combination of claim 1 , wherein the prosthetic heart valve includes a proximal end and a distal end; wherein each of the plurality of teeth are angled with respect to a central axis of the lumen in a direction of the proximal suture.
16. A method of adjusting at least one of expansion and contraction of a prosthesis comprising:
engaging a suture, which extends at least partially around a prosthesis, with a sinuous engagement section of a continuous elongated suture actuation member, which is positioned in a catheter having an end; wherein the suture actuation member forming a plurality of sinuous engagement sections, each sinuous engagement section forming a plurality of teeth and having no free ends, each of the plurality of teeth being angled in a proximal direction with respect to a central axis of the catheter; the suture engaged with one tooth of one of the plurality of sinuous engagement sections; and
moving the suture actuation member to move the suture and compress the prosthesis or allow
the prosthesis to expand.
17. The method of claim 16 , wherein the prosthesis is a self-expanding prosthesis.
18. The method of claim 16 , wherein the sinuous engagement sections engage the suture through a respective catheter access port.