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

• US 20090171447A1
• Filed: 03/10/2009
• Published: 07/02/2009
• Est. Priority Date: 12/22/2005
• Status: Abandoned Application

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: DELALOYE, Stephane, VON SEGESSER, Ludwig K.
• Application Number:
  US12/401,276
• Publication Number:
  US 20090171447A1
• Time in Patent Office: Days
• US Class Current: 623/1.240
• 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 replacement valve for use within a human body comprising:

a valve component;

a stent component comprising a first section, a second section for housing the valve component, and a third section, wherein the third section comprises at least one attachment element configured for removable attachment to a delivery device.

2. The replacement valve of claim 1, wherein the at least one attachment element comprises a geometric opening configured for removable attachment to a complimentary element of the delivery device.

3. The replacement valve of claim 1, wherein the at least one attachment element comprises a wire, hook, or strap configured for removable attachment to a complimentary element of the delivery device.

4. The replacement valve of claim 1, wherein the at least one attachment element comprises at least two attachment elements.

5. The replacement valve of claim 1, wherein the at least one attachment element comprises at least three attachment elements.

6. The replacement valve of claim 1, wherein the at least one attachment element comprises at least six attachment elements.

7. The replacement valve of claim 1, wherein the stent component comprises a lattice structure comprising:

at least one commissural post; and

the at least one attachment element.

8. The replacement valve of claim 7, wherein the lattice structure further comprises at least one supporting element for connecting the at least one commissural post to the at least one attachment element.

9. The replacement valve of claim 1, wherein the at least one attachment element projects at least partially inwardly toward a center axis of the stent component.

10. The replacement valve of claim 1, wherein the third section has a diameter that is less than a diameter of the second section.

11. A replacement valve for use within a human body comprising:

a valve component; and

a stent component comprising;

a first section comprising a fixation element;

a second section configured to house the valve component; and

a third section comprising at least one attachment element.

12. The replacement valve of claim 11, wherein the fixation element comprises an annular groove.

13. The replacement valve of claim 12, wherein the annular groove is formed from a plurality of independently bendable elements, wherein each bendable element comprises a bending deformation the location of which is determined by the lengths of an attached pair of struts.

14. The replacement valve of claim 11, wherein the attachment element comprises a wire that forms an opening, hook, or strap.

15. The replacement valve of claim 11, wherein the second region comprises at least one locking element protruding outwardly from an outer surface of the second region.

16. A replacement valve for use within a human body comprising:

a valve component; and

at least two stent components affixed to one another comprising;

a first section comprising a first cone or crown and a second stent structure collectively forming a fixation element; and

a second section configured to house the valve component;

wherein the at least two stent components further comprise a third section comprising at least one attachment element for removable attachment to a delivery device; and

at least one of the first cone or crown and the second cone or crown has cross-section substantially in the shape of a pyramid.

17. A method for delivering a cardiac stent-valve to an implantation site comprising:

removably attaching the stent-valve to a delivery device;

delivering the stent-valve to the implantation site in a collapsed configuration;

partially proximally expanding the stent-valve while maintaining the stent-valve attached to the delivery device; and

making a determination with respect to the stent-valve when the stent-valve is in the partially-expanded configuration.

18. The method of claim 17, wherein the making a determination comprises determining whether the stent-valve is positioned correctly at the implantation site.

19. The method of claim 18, further comprising returning the stent-valve to the collapsed configuration and repositioning the stent-valve when the stent-valve is not positioned correctly at the implantation site.

20. The method of claim 17, wherein the making a determination comprises determining whether a valve component of the stent-valve is functioning properly.

21. The method of claim 20, wherein determining whether the valve component is functioning properly comprises testing whether the valve component will permit sufficient blood-flow.

22. The method of claim 20, further comprising returning the stent-valve to the collapsed configuration and removing the stent-valve from a patient'"'"'s body when the stent-valve is not functioning properly.

23. The method of claim 17, further comprising causing the stent-valve to fully expand by causing the stent-valve to detach from the delivery device, when the making a determination yields a positive response.

24. The method of claim 17, wherein the delivering the stent-valve to the implantation site comprises delivering the stent-valve to the heart for replacement of a cardiac valve, wherein the delivering further comprises:

accessing a patient'"'"'s body through an intercostal space; and

penetrating the left ventricle at the apex of the heart.

25. The method of claim 24, wherein the accessing comprises accessing the patient'"'"'s body through a fifth intercostal space.