Percutaneous heart valve, system, and method

• US 20090171456A1
• Filed: 12/28/2007
• Published: 07/02/2009
• Est. Priority Date: 12/28/2007
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Jenson, Mark L., Kveen, Graig L., Drasler, William J., Thielen, Joseph M., Eidenschink, Tracee E.J.
• Application Number:
  US12/005,881
• Publication Number:
  US 20090171456A1
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity

Abstract

Devices, systems, and methods are provided to treat diseased cardiac valves. The device includes a percutaneous heart valve having an expandable valve frame including valve frame members, a valve leaflet coupled to the valve frame, and an expandable stent anchoring frame coupled to the valve frame including stent frame members defining a first portion and a second portion having greater flexibility than the first portion, where the first portion and the valve frame define a length, and where the stent frame members and the valve frame members along the length provide a contiguous surface over which a delivery device can repeatedly slide over the length in its entirety in two longitudinal directions when the first portion and the valve frame are in a partially expanded state during delivery from the delivery device.

Claims

1. A percutaneous prosthetic heart valve, comprising:

an expandable valve frame including valve frame members;

a valve leaflet coupled to the valve frame; and

an expandable stent anchoring frame coupled to the valve frame including stent frame members defining a first portion and a second portion having greater flexibility than the first portion, where the first portion and the valve frame define a length, and where the stent frame members and the valve frame members along the length provide a contiguous surface over which a delivery device can repeatedly slide over the length in its entirety in two longitudinal directions when the first portion and the valve frame are in a partially expanded state during delivery from the delivery device.

2. The valve of claim 1, where the valve frame includes a transition zone, where the transition zone is positioned at a proximal end of the valve frame.

3. The valve of claim 2, where the transition zone includes transition zone members coupled to a distal end of the stent anchoring frame.

4. The valve of claim 3, where the transition zone members are coupled to the first portion of the stent anchoring frame.

5. The valve of claim 1, where the valve frame includes a support ring at the distal end of the valve frame.

6. The valve of claim 1, where the valve frame and the stent anchoring frame are cylindrical and a distal end of the valve frame and a proximal end of the stent anchoring frame flare in an outward direction.

7. The valve of claim 1, where the second portion of the stent anchoring frame is positioned proximal to the first portion of the stent anchoring frame in a longitudinal direction.

8. The valve of claim 1, where the stent frame members are annular stent frame members having apexes and connectors coupling the annular stent frame members, and where in the first portion the connectors are positioned between each apex formed by the annular frame member and in the second portion the connectors are positioned between less than each apex formed by the annular frame member.

9. A system, comprising:

an elongate delivery catheter;

a first retractable sheath positioned around at least a portion of the elongate delivery catheter, where the first retractable sheath moves longitudinally relative the elongate delivery catheter;

a second retractable sheath, where the second retractable sheath moves longitudinally relative the elongate delivery catheter;

a prosthetic valve positioned between the elongate delivery catheter and the first retractable sheath, where the prosthetic valve includes;

a valve frame including valve frame members and a valve leaflet coupled to the valve frame; and

a stent anchoring frame coupled to the valve frame including frame members in at least a first portion of the stent anchoring frame, where the frame members in at least the first portion and the valve frame members provide a contiguous surface over which the second sheath can repeatedly slide longitudinally over at least the first portion and the valve frame in their entirety in two directions when the first portion and the valve frame are in a partially expanded state during delivery from the elongate delivery catheter.

10. The system of claim 9, where the valve frame is positioned between the elongate delivery catheter and the first retractable sheath in a delivery state.

11. The system of claim 10, where the valve frame is in a deployed state when the first sheath is retracted from the valve frame and the first portion of the stent anchoring frame.

12. The system of claim 10, including a stopper to hold the valve in place when the first retractable sheath is retracted.

13. The system of claim 9, including a cable member to hold the prosthetic valve in place when the second retractable sheath is moved toward a distal end of the elongate delivery catheter.

14. The system of claim 9, where at least a portion of the first retractable sheath is slotted to provide flexibility.

15. The system of claim 9, where the valve frame includes a transition zone, where the transition zone includes transition zone members coupling the valve frame to a distal end of the stent anchoring frame.

16. The system of claim 15, where the transition zone members are formed of a rigid material to keep the distance between the valve frame and the stent anchoring frame approximately static.

17. The system of claim 9, where the second retractable sheath is expandable and positioned proximal to the first retractable sheath in a compressed state.

18. A method, comprising:

positioning a prosthetic valve in a delivery state between an elongate delivery catheter and a first retractable sheath, where the first retractable sheath moves longitudinally relative the elongate delivery catheter;

advancing the elongate delivery catheter to a delivery site;

retracting the first retractable sheath to expose a valve frame included in the prosthetic valve at the delivery sight, where the valve frame expands to a deployed state;

advancing a second retractable sheath over the first retractable sheath and the deployed valve frame to at least partially compress the valve frame;

repositioning the prosthetic valve;

retracting the second retractable sheath to expose the valve frame; and

retracting the second retractable sheath and the first retractable sheath to expose a stent anchoring frame included in the prosthetic valve coupled to the valve frame, where the valve frame and the stent anchoring frame expand to a deployed state to anchor the prosthetic valve at the delivery sight.

19. The method of claim 18, where the method includes repeating the steps of retracting the first retractable sheath, advancing the second retractable sheath, and repositioning the prosthetic valve until the position, stability, and functioning of the prosthetic valve are satisfactory.

20. The method of claim 18, where advancing the second retractable sheath over the first retractable sheath and the deployed valve frame to at least partially compress the valve frame includes expanding the second retractable sheath.

21. A method, comprising:

forming an expandable valve frame including valve frame members;

coupling a valve leaflet to the valve frame;

forming a stent anchoring frame including stent frame members defining a first portion and a second portion having greater flexibility than the first portion; and

coupling the stent anchoring frame to the valve frame, where the first portion and the valve frame define a length, and where the stent frame members and the valve frame members along the length provide a contiguous surface over which a retractable sheath can repeatedly slide longitudinally over the length in its entirety in two directions when the first portion and the valve frame are in a partially expanded state during delivery from a delivery device.

22. The method of claim 21, where the method includes positioning the valve frame coupled to the stent anchoring frame on the delivery device between an elongate delivery catheter and the first retractable sheath, where the first retractable sheath moves longitudinally relative the elongate delivery catheter.

23. The method of claim 22, where the method includes retracting the first retractable sheath towards a proximal end of the elongate delivery catheter to expose the valve frame and the first portion of the stent anchoring frame, where the valve frame expands to a deployed state and the first portion of the stent anchoring frame expands to a partially-deployed state.

24. The method of claim 23, where the method includes advancing a second retractable sheath on the delivery device toward a distal end of the elongate delivery catheter to contract the valve frame and the first portion of the stent anchoring frame.

25. The method of claim 24, where the method includes:

retracting the second retractable sheath toward the proximal end of the elongate delivery catheter to expose the valve frame and the first portion of the stent anchoring frame; and

retracting the first retractable sheath toward the proximal end of the elongate delivery catheter to expose the valve frame and the stent anchoring frame, where the valve frame and stent anchoring frame expand to a deployed state.