Compliant blood vessel graft

• US 7,998,188 B2
• Filed: 05/04/2007
• Issued: 08/16/2011
• Est. Priority Date: 04/28/2003
• Status: Active Grant

• Current Assignee: Vascular Graft Solutions Ltd.
• Original Assignee: Kips Bay Medical, Inc.
• Inventors: Zilla, Peter Paul, Bezuidenhout, Deon, Yeoman, Mark, Bowles, Hellmut, Franz, Thomas, Wolf, Michael F., Douk, Nareak, Rafiee, Nasser, Human, Paul
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US11/797,648
• Publication Number:
  US 20070293932A1
• Time in Patent Office: 1,565 Days
• Field of Search: 600/587, 623/1.13, 623/1.36
• US Class Current: 623/1.13
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1132 End-to-end connections
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/856 Single tubular stent with a side portal passage
• 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 2240/002 Designing or making customized prostheses

Abstract

Stents and methods of using stents are provided. Stents of the invention provide external support structure for a blood vessel segment disposed within, wherein the stents are capable of resilient radial expansion in a manner mimicking the compliance properties of an artery. The stent may be formed of a knitted or braided mesh formed so as to provide the needed compliance properties. A venous graft with the stent and a vein segment disposed within is provided, wherein graft is capable of mimicking the compliance properties of an artery. Methods of selecting stents for downsizing and methods of using the stents of the invention in downsizing and smoothening are provided. Methods of replacing a section of an artery with a venous graft including a stent of the invention are provided. Methods of reducing intimal hyperplasia in implanted vein segment in a venous graft using stents of the invention are provided.

Claims

1. A method for selecting a stent for placement at an ablumenal surface of a vein of a venous graft, the method comprising:

providing the vein to be measured;

measuring a minimum outer diameter and a maximum outer diameter of the vein;

selecting a maximum amount of diametrical downsizing for the vein and a minimum amount of diametrical downsizing for the vein, the diametrical downsizing being effected by resilient compliance of the stent placed at the ablumenal surface, said stent providing resilient compliance in the range of 3 to 30%/100 mm Hg;

calculating a range of inner diameters of stents that provide an amount of diametrical downsizing between the selected maximum amount and the selected minimum amount;

selecting a single stent having an inner diameter that falls within the calculated range.

2. The method according to claim 1, further comprising calculating a degree of downsizing for smoothening the vein.

3. The method according to claim 2, wherein said smoothening comprises altering an outside diameter of at least one part of the vein to be substantially the same as another part of the vein.

4. The method according to claim 1, wherein the single stent is the smallest possible stent within the range, resulting in maximum downsizing.

5. The method according to claim 1, wherein the single stent is the largest possible stent within the range, resulting in minimum downsizing.

6. The method according to claim 5, wherein the stent has a diameter of between about 3.0 mm and 4.0 mm.

7. The method according to claim 1, wherein the stent has a diameter of between about 2.7 mm and about 4.0 mm.

8. The method according to claim 1, wherein the maximum amount of downsizing for the vein is the degree of downsizing for substantially smoothening the vein.

9. The method according to claim 8, wherein said substantially smoothening the vein includes smoothening irregularities in the vein.

10. The method according to claim 1 wherein the maximum amount of downsizing of the vein is up to about 40%.

11. The method according to claim 10 wherein a largest inner diameter of the range of stent inner diameters is smaller than or equal to the minimum outer diameter of the vein.