Percutaneous placement valve stent

• US 5,957,949 A
• Filed: 05/01/1997
• Issued: 09/28/1999
• Est. Priority Date: 05/01/1997
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: World Medical Manufacturing Corp. (Medtronic Plc)
• Inventors: Greenan, Trevor, Leonhardt, Howard J.
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): Shai, Daphna
• Application Number:
  US08/848,892
• Time in Patent Office: 880 Days
• Field of Search: 606/108, 606/194, 606/195, 606/198, 606/200, 623/1, 623/2, 623/12
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/82 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 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

An artificial valve stent for maintaining patent one way flow within a biological passage is disclosed. The artificial valve includes a tubular graft having radially compressible annular spring portions for biasing proximal and distal ends of the graft into conforming fixed engagement with the interior surface of a generally tubular passage. Also disclosed is a deployment catheter including an inner catheter having a nitinol core wire, a controllable tip balloon at its the distal end for dilation and occlusion of the passage, and a controllable graft balloon in the vicinity of and proximal to the tip balloon for fixedly seating the spring portions in conformance with the interior surface of the passage. A spool apparatus for adjusting or removing an improperly placed or functioning artificial valve, and a microembolic filter tube are usable with the deployment catheter. The artificial valve may be completely sealed to the living tissue by light activated biocompatible tissue adhesive between the outside of the tubular graft and the living tissue. A method of implanting the artificial valve is also disclosed.

Claims

1. A percutaneously implanted valve stent comprising:

a tubular graft of bio-compatible material capable of conducting fluid, said graft capable of substantial deformation so as to conform to the interior surface of a patient'"'"'s internal passage, said graft having proximal and distal ends;

a radially compressible spring means for biasing said proximal and distal ends of said graft radially outward into dynamic conforming fixed engagement with said interior surface of said internal passage; and

a valve means capable of blocking flow in one direction, said valve means being sealingly and permanently attached to the internal tubular portion of said graft or said spring means or both;

wherein

said graft material being attached to said spring means and enclosing said spring means.

2. The valve stent of claim 1, wherein said graft includes a middle portion extending between said proximal and distal ends, and said graft material is tapered to define a smaller fluid conducting area through said middle portion.

3. The valve stent of claim 1, wherein at least one of said tubular graft and said spring means contains a radio opaque marker.

4. The valve stent of claim 1, wherein said spring means is a wire spring comprising a pair of annular spring portions, and at least one connecting bar extending between said spring portions for connecting said pair of spring portions to one another.

5. The valve stent of claim 4, wherein each of said annular spring portions comprises a continuous zig-zag pattern of straight spokes connected by alternating crests and troughs, and said crest and troughs are of a predetermined radius.

6. The valve stent of claim 5, wherein said graft material is cut out between said crests of at least one of said pair of spring portions to define a plurality of radially distensible fingers.

7. The valve stent of claim 1, further including tissue adhesive means on the outside of said graft for bonding said graft to said interior surface of said passage and forming a substantially fluid-tight seal therebetween.

8. The valve stent of claim 7, wherein said tissue adhesive means comprises a plurality of packets including a degradable photo-sensitive outer packet material enclosing tissue adhesive, whereby said tissue adhesive may be released by exposing said packets to a light beam.

9. The stent of claim 7, wherein said tissue adhesive means is biocompatible and biodegradable.

10. The valve stent of claim 7, wherein said tissue adhesive remains adhesively inert until said adhesive is exposed to a light beam.

11. The valve stent of claim 7, wherein said tissue adhesive is at least one of fibrin glue, isobutyl 2 cyanoacrylate, and cryroparticipate.

12. The valve stent of claim 1, further comprising a deployment means for deploying said valve stent.

13. The valve stent of claim 1, further comprising a retreival means for retreiving said valve stent after deployment from said deployment means for removal from the patient.

14. The retreival means of claim 13, wherein said retreival means also allows repositioning of said valve stent within the patient.

15. The valve stent of claim 1, further comprising a filter means for capturing particles during deployment of said valve stent.

16. The valve stent of claim 1, wherein said graft material prevents contact between said spring means and living tissue.

17. A percutaneously implanted valve stent comprising:

a tubular graft of bio-compatible material capable of conducting fluid, said graft capable of substantial deformation so as to conform to the interior surface of a patient'"'"'s internal passage, said graft having proximal and distal ends;

a radially compressible spring means for biasing said proximal and distal ends of said graft radially outward into dynamic conforming fixed engagement with said interior surface of said internal passage;

a valve means capable of blocking flow in one direction, said valve means being sealingly and permanently attached to the internal tubular portion of said graft or said spring means or both; and

tissue adhesive means on the outside of said graft for bonding said graft to said interior surface of said passage and forming a substantially fluid-tight seal therebetween;

wherein

said graft material is attached to said spring means and encloses said spring means; and

said tissue adhesive means is adhesively inert until said tissue adhesive means is exposed to light.