STENT-VALVES FOR VALVE REPLACEMENT AND ASSOCIATED METHODS AND SYSTEMS FOR SURGERY

• US 20090171432A1
• Filed: 03/10/2009
• Published: 07/02/2009
• 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, Stephane
• Granted Patent: US 9,216,082 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• 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 first assembly comprising an outer sheath and a guide wire tubing; and

a second assembly comprising a stent holder configured for removable attachment to at least one attachment element of a stent-valve, the stent-valve positioned over the guide wire tubing of the first assembly, 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 the stent-valve still attached to the stent holder and thus constrains expansion of the stent-valve, and such that in the open position the outer sheath does not constrain expansion of the stent-valve and thus the stent-valve detaches from the stent holder and expands to a fully expanded configuration.

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 stent-valve expands partially proximally 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 at least one balloon configured to cause at least one of valvuloplasty prior to implantation of the stent-valve and expansion or post-dilation of the stent-valve upon inflation of the at least one balloon.

5. The stent-valve delivery system of claim 4, wherein the at least one balloon is housed proximally to the stent-valve.

6. The stent-valve delivery system of claim 4, wherein the at least one balloon is housed distally to the stent-valve.

7. The stent-valve delivery system of claim 4, wherein the at least one balloon is housed at least partially within the stent valve.

8. 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.

9. 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.

10. 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 an implantation site, wherein the integrated introducer is configured to remain within a patient'"'"'s body even after the first assembly and the second assembly are removed.

11. The stent-valve delivery system of claim 1, wherein after expansion of the stent-valve to the fully expanded configuration, the delivery system is configured to return to the closed position by passing the second assembly through the stent-valve towards a distal end of the first assembly.

12. 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.

13. The stent-valve delivery system of claim 12, wherein the geometrical opening comprises a circular or ovular opening.

14. 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.

15. 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.

16. 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.

17. 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.

18. 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.

19. The stent-valve delivery system of claim 18, wherein the lattice structure of the stent-valve further comprises at least one supporting element for connecting the at least one commissural post to the at least one attachment element.