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

• US 10,265,167 B2
• Filed: 01/18/2017
• Issued: 04/23/2019
• 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
• Primary Examiner(s): Prone, Christopher D.
• Assistant Examiner(s): Shipmon, Tiffany
• Application Number:
  US15/409,320
• Publication Number:
  US 20170189178A1
• Time in Patent Office: 825 Days
• Field of Search: None
• 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 method for implanting a stent-valve at an implantation site for cardiac valve replacement, comprising the steps of:

providing a stent-valve and a delivery device, the delivery device including a stent-holder and an outer-sheath;

removably attaching the stent-valve to the delivery device by way of the stent-holder and the outer sheath, wherein;

the stent-valve comprises a valve component, and a stent component including at least two integral attachment elements provided therewith,

the stent component and the valve component configured with a collapsed configuration for delivery and an expanded configuration after implantation,

the at least two attachment elements are matably attached to the stent-holder, such that the stent-valve is held in position with respect to the delivery device by the stent-holder,

in a closed position, the outer sheath encompasses the stent-valve and constrains expansion of the stent-valve, and

the outer sheath is configured for distal movement relative to the stent holder in order to transition from the closed position, to a partially-open position, to an open position;

delivering the stent-valve to the implantation site in the collapsed condition;

partially expanding the stent-valve while maintaining attachment of the at least two attachment elements to the stent-holder, such that the stent-holder holds the stent-valve in position with respect to the delivery device;

determining whether the partially expanded stent-valve is positioned correctly at the implantation site;

wherein upon the determination being positive, allowing the at least two attachment elements to detach from the stent-holder to cause the stent-valve to expand from the partially expanded configuration to the expanded configuration; and

wherein upon the determination being negative, returning the stent-valve to the collapsed configuration and repositioning the stent-valve at the implantation site.

2. The method of claim 1, wherein the at least two attachment elements are matably attached to a complimentary structure of the stent-holder, such that the stent-valve is held in position with respect to the delivery device by the stent-holder.

3. The method of claim 2, wherein allowing the at least two attachment elements to detach from the stent-holder comprise allowing the at least two attachment elements to detach from mateable engagement with the complimentary structure of the stent-holder.

4. The method of claim 2, wherein the stent-holder comprises a radial extending structure positioned towards the distal end of the delivery device.

5. The method of claim 4, wherein the complimentary structure comprises the radial extending structure, and wherein matably attached comprises removably attached to the radial extending structure.

6. The method of claim 1, wherein the stent-holder comprises a body positioned towards the distal end of the delivery device.

7. The method of claim 6, wherein matably attached comprises removably attached to the stent-holder body.

8. The method of claim 1, wherein the stent-component further comprises a lattice structure comprising closed cells configured to facilitate recapture of the stent-valve when partially expanded.

9. The method of claim 8, wherein matably attached comprises removably attached to the stent-holder.

10. The method of claim 1, wherein the at least two attachment elements are interconnected by bracing elements in a circular configuration, each bracing element comprising a plurality of peaks between the attachment elements.

11. The method of claim 10, wherein matably attached comprises removably attached to the stent-holder.