Stent-valves for valve replacement and associated methods and systems for surgery

• US 9,216,082 B2
• Filed: 03/10/2009
• Issued: 12/22/2015
• Est. Priority Date: 12/22/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Symetis SA (Boston Scientific Corporation)
• Inventors: Von Segesser, Ludwig K., Delaloye, Stphane
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US12/401,329
• Publication Number:
  US 20090171432A1
• Time in Patent Office: 2,478 Days
• Field of Search: 623/1.11, 623/1.12, 623 211- 219
• US Class Current: 1/1
• 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 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• 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 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2472 Devices for testing
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0042 : using a fluid, e.g. circulating
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0083 : using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/001 : Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2250/006 : modular

Abstract

Stent-valves (e.g., single-stent-valves and double-stent-valves), associated methods and systems for their delivery via minimally-invasive surgery, and guide-wire compatible closure devices for sealing access orifices are provided.

Claims

1. A cardiac stent-valve delivery system comprising:

a stent-valve having a proximal section and at least one attachment element at a distal section and the stent-valve configured to be expandable between a first constrained, collapsed configuration and a second unconstrained expanded configuration;

a first assembly comprising an outer sheath and a guide wire tube;

a tip at a distal end of the delivery system, for passing a guide wire through the length of the delivery system and out of the tip via the guide wire tubing, the distal end of the delivery system configured for introduction in a patient'"'"'s body along the guide wire so that the tip at the distal end passes through a failed valve at an implantation site for the stent-valve; and

a second assembly comprising a stent holder configured for removable attachment to the at least one attachment element of the stent-valve, the stent-valve positioned over the guide wire tube of the first assembly and having the proximal section arranged toward a proximal end of the delivery system, and the distal section arranged toward the distal end of the delivery system,

wherein

the first assembly and the second assembly are configured for relative movement with respect to one another in order to transition from a closed position to an open position, such that in the closed position, the outer sheath encompasses and constrains an entirety of the stent-valve in the first constrained, collapsed configuration,

in the open position the outer sheath does not constrain the stent-valve and the stent-valve is released and detaches from the stent holder and expands to the second unconstrained expanded configuration, and

relative movement between the first assembly and the second assembly is configured such that upon transition from the closed position to the open position, the outer sheath is translated in a distal direction such that the proximal section of the stent-valve is released prior to release of the distal section of the stent-valve.

2. The stent-valve delivery system of claim 1, wherein the first assembly and the second assembly are configured to transition from the closed position, to a partially-open position, to the open position, wherein in the partially-open position, the proximal section of the stent-valve expands partially but does not detach from the stent holder because the outer sheath still encompasses the at least one attachment element of the stent-valve and the stent holder.

3. The stent-valve delivery system of claim 2, further comprising a flush mechanism.

4. The stent-valve delivery system of claim 1, further comprising a push handle for causing the relative movement of the first assembly and the second assembly.

5. The stent-valve delivery system of claim 1, further comprising a screw mechanism for translating rotational movement of a handle into the relative movement of the first assembly and the second assembly.

6. The stent-valve delivery system of claim 1, further comprising an integrated introducer within which the first assembly and the second assembly are positioned during delivery of the stent-valve to the implantation site, wherein the integrated introducer is configured to remain within the patient'"'"'s body even after the first assembly and the second assembly are removed.

7. The stent-valve delivery system of claim 1, wherein after expansion of the stent-valve to the second unconstrained expanded configuration, the second assembly is configured to be passed through the stent-valve towards a distal end of the first assembly.

8. The stent-valve delivery system of claim 7, wherein the first assembly and the second assembly are configured to be passed through the stent-valve in a proximal direction after expansion and release of the stent-valve before exiting the patient'"'"'s body.

9. The stent-valve delivery system of claim 1, wherein the at least one attachment element of the stent-valve comprises a geometrical opening configured for removable attachment to a complimentary structure of the stent holder.

10. The stent-valve delivery system of claim 9, wherein the geometrical opening comprises a circular or ovular opening.

11. The stent-valve delivery system of claim 1, wherein the at least one attachment element of the stent-valve comprises a wire, hook, or strap configured for removable attachment to a complimentary structure of the stent holder.

12. The stent-valve delivery system of claim 1, wherein the at least one attachment element of the stent-valve comprises at least two attachment elements configured for removable attachment to corresponding number of complimentary structures of the stent holder.

13. The stent-valve delivery system of claim 1, wherein the at least one attachment element of the stent-valve comprises at least three attachment elements configured for removable attachment to corresponding number of complimentary structures of the stent holder.

14. The stent-valve delivery system of claim 1, wherein the at least one attachment element of the stent-valve comprises at least six attachment elements configured for removable attachment to corresponding number of complimentary structures of the stent holder.

15. The stent-valve delivery system of claim 1, wherein the stent-valve comprises a lattice structure comprising:

at least one commissural post; and

the at least one attachment element.

16. The stent-valve delivery system of claim 15, wherein the lattice structure of the stent-valve further comprises a supporting element for connecting the at least one commissural post to the at least one attachment element.

17. The stent-valve delivery system of claim 1, wherein the stent-valve includes a stent component which comprises a lattice structure with a plurality of cells, all of the cells being closed cells to facilitate recapture of the stent-valve from a partially expanded configuration to a collapsed condition by sliding the outer sheath in a proximal direction over the proximal section of the stent-valve.

18. The stent-valve delivery system of claim 1, wherein the first assembly and the second assembly are configured for accessing the patient'"'"'s body through an intercostal space and penetrating the left ventricle at the apex of the heart.

19. The stent-valve delivery system of claim 1, wherein the stent-valve comprises a stent component and a valve component, the stent component comprising a first section including a fixation element, a second section for housing the valve component, and a third section, wherein the third section includes the at least one attachment element configured for removable attachment to the stent holder.

20. The stent-valve delivery system of claim 19, wherein the third section has a diameter that is less than a diameter of the second section.

21. The stent-valve delivery system of claim 19, wherein the fixation element comprises an annular groove.

22. The stent-valve delivery system of claim 21, wherein the annular groove is formed from a plurality of independently bendable elements, wherein each bendable element comprises a bending deformation, a location of which is determined by the lengths of an attached pair of struts.

23. A cardiac stent-valve delivery system comprising:

a stent-valve having a proximal section and at least one attachment element at a distal section, and the stent-valve configured to be expandable between a first constrained collapsed configuration and a second unconstrained expanded configuration;

a first assembly comprising an outer sheath and a guide wire tube;

a tip at a distal end of the delivery system, for passing a guide wire through the length of the delivery system and out of the tip via the guide wire tube, the distal end of the delivery system configured for introduction in a patient'"'"'s body along the guide wire so that the tip at the distal end passes through a failed valve at an implantation site for the stent-valve; and

a second assembly comprising a stent holder configured for removable attachment to the at least one attachment element of the stent-valve, the stent-valve positioned over the guide wire tube of the first assembly and having the proximal section arranged toward a proximal end of the delivery system, and the distal section arranged toward the distal end of the delivery system,

wherein

the first assembly and the second assembly are configured for relative movement with respect to one another in order to transition from a closed position to a partially-open position, to an open position, such that in the closed position, the outer sheath encompasses and constrains an entirety of the stent-valve in the first constrained, collapsed configuration,

in the open position the outer sheath does not constrain the stent-valve and the stent-valve is released and detaches from the stent holder and expands to the second unconstrained expanded configuration, and

relative movement between the first assembly and the second assembly is configured such that

upon transition from the closed position towards the open position, the proximal section of the stent-valve is released first, and

in the partially-open position, the proximal section of the stent-valve expands partially but does not detach from the stent holder due to the outer sheath still encompassing the at least one attachment element of the stent-valve and the stent holder.

24. The stent-valve delivery system of claim 23, further comprising a flush mechanism.

25. The stent-valve delivery system of claim 23, further comprising a push handle for causing the relative movement of the first assembly and the second assembly.

26. The stent-valve delivery system of claim 23, further comprising a screw mechanism for translating rotational movement of a handle into the relative movement of the first assembly and the second assembly.

27. The stent-valve delivery system of claim 23, wherein after expansion of the stent-valve to the second unconstrained expanded configuration, second assembly is configured to be passed through the stent-valve towards a distal end of the first assembly.

28. The stent-valve delivery system of claim 27, wherein the first assembly and the second assembly are configured to be passed through the stent-valve in a proximal direction before exiting the patient'"'"'s body.

29. The stent-valve delivery system of claim 23, wherein the at least one attachment element of the stent-valve comprises a geometrical opening configured for removable attachment to a complimentary structure of the stent holder.

30. The stent-valve delivery system of claim 29, wherein the geometrical opening comprises a circular or ovular opening.

31. The stent-valve delivery system of claim 23, wherein the at least one attachment element of the stent-valve comprises at least two attachment elements configured for removable attachment to corresponding number of complimentary structures of the stent holder.

32. The stent-valve delivery system of claim 23, wherein the at least one attachment element of the stent-valve comprises at least three attachment elements configured for removable attachment to corresponding number of complimentary structures of the stent holder.

33. The stent-valve delivery system of claim 23, wherein the stent-valve comprises a lattice structure comprising:

at least one commissural post; and

the at least one attachment element.

34. The stent-valve delivery system of claim 33, wherein the lattice structure of the stent-valve further comprises a supporting element for connecting the at least one commissural post to the at least one attachment element.

35. The stent-valve delivery system of claim 23, wherein the stent-valve includes a stent component which comprises a lattice structure with a plurality of cells, all of the cells being closed cells to facilitate recapture of the stent-valve from partially expanded configuration to a collapsed condition by sliding the outer sheath in a proximal direction over the proximal section of the stent-valve.

36. The stent-valve delivery system of claim 23, wherein the first assembly and the second assembly are configured for accessing the patient'"'"'s body through an intercostal space and penetrating the left ventricle at the apex of the heart.

37. The stent-valve delivery system of claim 23, wherein the stent-valve comprises a stent component and a valve component, the stent component comprising a first section including a fixation element, a second section for housing the valve component, and a third section, wherein the third section includes the at least one attachment element configured for removable attachment to the stent holder.