Implantable prosthetic valve

• US 7,393,360 B2
• Filed: 01/28/2005
• Issued: 07/01/2008
• Est. Priority Date: 10/11/2001
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Inventors: Benichu, Netanel, Spenser, Benjamin, Bash, Assaf, Zakai, Avraham
• Primary Examiner(s): Matthews; William H.
• Application Number:
  US11/045,773
• Publication Number:
  US 20050192665A1
• Time in Patent Office: 1,250 Days
• Field of Search: 623 111- 114, 623 123- 127, 623 21- 219
• US Class Current: 623/2.18
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2421 with non-pivoting rigid closure members
• 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 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9524 Iris-type crimpers
• 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 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers

Abstract

A valve prosthesis device is disclosed suitable for implantation in body ducts. The device comprises support stent, comprised of a deployable construction adapted to be initially crimped in a narrow configuration suitable for catheterization through the body duct to a target location and adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state in the target location, the support stent provided with a plurality of longitudinally rigid support beams of fixed length; valve assembly comprising a flexible conduit having an inlet end and an outlet, made of pliant material attached to the support beams providing collapsible slack portions of the conduit at the outlet. When flow is allowed to pass through the valve prosthesis device from the inlet to the outlet the valve assembly is kept in an open position, whereas a reverse flow is prevented as the collapsible slack portions of the valve assembly collapse inwardly providing blockage to the reverse flow.

Claims

1. A method for deploying a valve device at the natural aortic valve position at the entrance to the left ventricle of a myocardium of a patient, comprising:

radially collapsing a deployable implantable valve device having a collapsible and expandable support stent and a collapsible and expandable valve assembly, the support stent comprising a first portion configured to expand to a first diameter and a second portion configured to expand to a second diameter, the first diameter being smaller than the second diameter and wherein the valve assembly is sutured to the support stent;

advancing the collapsed valve device through the patient'"'"'s vasculature towards the natural aortic valve position via a catheterization technique;

positioning the valve device such that the valve assembly is located substantially within an annulus of a natural aortic valve; and

radially expanding the first and second portions such that the first portion engages leaflets of the natural aortic valve and the second portion engages an inner wall of an ascending aorta above the opening of the coronary arteries;

wherein, after implantation, the valve assembly allows blood to flow in a first direction and prevents blood from flowing in a second direction and wherein the first and second portions of the support stent are configured to resist migration of the valve assembly;

wherein, after implantation, the support stent has a third diameter positioned at the level of the coronary arteries, the third diameter being substantially less than an inner diameter of the ascending aorta such that a radial gap is provided between the support stent and the opening of the coronary arteries.

2. The method of claim 1, further comprising advancing a guidewire through the patient'"'"'s vasculature to facilitate advancement of the valve device via a catheterization technique.

3. The method of claim 2, wherein the valve device is advanced over the guidewire and around the aortic arch.

4. The method of claim 1, wherein a balloon catheter is used to assist in the radial expansion of the first and second portions of the support stent.

5. The method of claim 4, wherein the balloon catheter has a first inflatable portion for expanding the first portion of the support stent and a second inflatable portion for expanding the second portion of the support stent.

6. The method of claim 1, wherein the valve assembly is formed of natural tissue.

7. The method of claim 1, wherein the valve assembly is formed of pericardial tissue.

8. The method of claim 1, wherein the support stent is formed of a shape memory alloy.

9. The method of claim 1, wherein the valve assembly is adhered to the first portion of the support stent.

10. A method for deploying a valve device at the natural aortic valve position at the entrance to the left ventricle of a myocardium of a patient, comprising:

radially collapsing an implantable valve device having a collapsible and expandable support stent formed of a shape memory material and a collapsible and expandable valve assembly formed of pericardial tissue, the support stent comprising a lower portion configured to expand to a first diameter and an upper portion configured to expand to a second diameter, the first diameter being smaller than the second diameter and wherein the valve assembly is sutured to the support stent at an inlet end and is sutured to the support stent along three commissural points for support three valve leaflets;

advancing a guidewire through the patient'"'"'s vasculature and around the aortic arch;

advancing the collapsed valve device over the guidewire towards the natural aortic valve position via a catheterization technique;

positioning the valve device such that the valve assembly is located within an annulus of a natural aortic valve; and

radially expanding the support stent such that the lower portion engages leaflets of the natural aortic valve and the upper portion engages an inner wall of an ascending aorta;

wherein, after implantation, the valve assembly allows blood to flow in a first direction and prevents blood from flowing in a second direction and wherein the lower and upper portions of the support stent are configured to resist migration of the valve assembly;

wherein the support stent further comprises a central portion between the lower and upper portion, the central portion being shaped to provide a radial gap between the support stent and the inner wall of the ascending aorta at the openings of the coronary arteries.

11. The method of claim 10, further comprising inflating a balloon within the valve device to assist in the radial expansion of the lower and upper portions of the support stent.