Reinforced graft and method of deployment

• US 7,520,890 B2
• Filed: 02/04/2005
• Issued: 04/21/2009
• Est. Priority Date: 01/26/1998
• Status: Expired due to Fees

• Current Assignee: Anson Medical Limited
• Original Assignee: Peter W. Phillips
• Inventors: Phillips, Peter W.
• Primary Examiner(s): Stewart; Alvin J.
• Application Number:
  US11/051,614
• Publication Number:
  US 20050143806A1
• Time in Patent Office: 1,537 Days
• Field of Search: 623/1.11, 623/1.13, 623/1.35, 623/903, 606191-195
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0008 for adjusting a position by translation along an axis or two perpendicular axes
• CPC Class Codes: A61F 2250/0037 differing in height or in length

Abstract

A graft is provided with a flexible sheet (10) of graft material to which is sewn a reinforcing wire (12), preferably of shape-memory alloy. Sewing of the wire (12) is carried out while the sheet (10) is substantially planar, thus by conventional embroidery machines. The sheet (10) is subsequently rolled into a tubular shape.

Claims

1. A method of deploying a stent graft between proximal and distal landing sites axially spaced along the lumen of a patient, the method comprising the following steps:

a. selecting a flexible stent graft having spaced proximal and distal ends, the proximal and distal ends being spaced further apart than the proximal and distal landing sites,

b. situating the stent graft within a deployment sheath,

c introducing the proximal end of the stent graft into the lumen of the patient, with the distal end trailing, while the stent graft is within the deployment sheath,

d. situating;

(1) the proximal end of the stent graft at the proximal landing site, the proximal end being ejected from the deployment sheath, and

(2) the distal end of the stent graft away from the distal landing site within the deployment sheath, such that the distal landing site is between the proximal landing site and the distal end of the stent graft; and

e. subsequently moving the distal end of the stent graft by moving the deployment sheath toward the proximal end until the distal end is situated at the distal landing site, thereby compressing the stent graft along at least a portion of its length, while maintaining the diameter of the stent graft at least substantially unchanged at the compressed portion of the stent graft length, and

f. ejecting the distal end of the stent graft at the distal landing site.

2. The method of claim 1 wherein the distance between the proximal and distal ends of the stent graft is at least 15% greater than the distance between the proximal and distal landing sites.

3. The method of claim 1 wherein the stent graft is formed of:

a. flexible sheet material which defines a tubular shape; and

b. resiliently flexible supports spaced along the axial length of the tubular shape, wherein;

(1) the supports bias the tubular shape from a radially compacted form to a radially expanded form; and

(2) the supports are spaced by distances less than one-third of the diameter of the tubular shape.

4. The method of claim 3 wherein the spacing of the supports varies along the axial length of the tubular shape, thereby forming regions of varying axial extensibility of the tubular shape.

5. The method of claim 1 wherein the stent graft is furcated.

6. The method of claim 1:

a. wherein the stent graft includes;

(1) an interior axial passage extending between its proximal and distal ends, and

(2) a side aperture opening onto the interior axial passage between the proximal and distal ends;

b. further comprising the step of rotating the stent graft to align the side aperture with a lumen branch extending from the patient'"'"'s lumen.

7. The method of claim 1 wherein:

the step of situating the proximal end of the stent graft at the proximal landing site includes the substeps of;

(1) holding the proximal end of the stent graft at the proximal landing site; and

(2) simultaneously withdrawing the deployment sheath from the proximal end.

8. The method of claim 7 wherein the proximal end of the stent graft is restrained at the proximal landing site by a pushing member extending along the lumen.

9. The method of claim 7 wherein the proximal end of the stent graft is restrained at the proximal landing site by a pushing member which extends through a wall of the stent graft.

10. The method of claim 1 wherein:

(1) the stent graft may be situated within the deployment sheath with the stent graft being radially compressed, the stent graft radially expanding when released from the deployment sheath;

(2) the stent graft is provided in combination with proximal attachment means for releasably engaging the proximal end of the stent graft, the distal attachment means extending along the deployment sheath;

(3) the stent graft is provided in combination with distal attachment means for releasably engaging the distal end of the stent graft, the distal attachment means extending along the deployment sheath;

wherein;

a. the proximal end of the stent graft is situated at the proximal landing site by the proximal attachment means; and

b. the distal end of the stent graft is situated at the distal landing site by the distal attachment means.

11. The method of claim 10 wherein the step of situating the proximal end of the stent graft at the proximal landing site includes withdrawing the deployment sheath from the proximal end of the stent graft while the proximal attachment means maintains the proximal end of the stent graft at the proximal landing site.

12. The method of claim 11 wherein the step of situating the distal end of the stent graft at the distal landing site includes withdrawing the deployment sheath from the distal end of the stent graft while the distal attachment means maintains the distal end of the stent graft at the distal landing site.

13. The method of claim 10 wherein the proximal attachment means includes:

a. a first elongated member terminating in a pocket, and

b. a second elongated member adapted to extend alongside the first elongated member, the second elongated member terminating in an end sized to be received within the pocket of the first elongated member.

14. The method of claim 10 wherein:

a. the stent graft has an at least substantially tubular sidewall extending between its proximal and distal ends; and

b. at least a portion of the proximal attachment means extends through the sidewall when the proximal end of the stent graft is situated at the proximal landing site.

15. The method of claim 1 wherein the step of moving the distal end of the stent graft toward the proximal end until it is situated at the distal landing site is followed by the steps of:

a. continuing the motion of the distal end of the stent graft toward the proximal end until it is situated past the distal landing site; and

b. reversing the motion of the distal end of the stent graft until it is situated at the distal landing site.

16. A method of deploying a stent graft between proximal and distal landing sites axially spaced along the lumen of a patient, wherein the stent graft:

(1) has spaced proximal and distal ends, the proximal and distal ends being spaced further apart than the proximal and distal landing sites, and

(2) is axially compressible to allow the proximal and distal ends to be more closely spaced,and wherein the diameter of the stent graft is at least substantially constant during such compression,

the method comprising the following steps;

a. firstly introducing the proximal end of the stent graft into the lumen of a patient, with the distal end trailing behind, while the stent graft is whithin a deployment sheath;

b. secondly situating the proximal end of the stent graft at the proximal landing site;

c. thirdly advancing the distal end of the stent graft by moving the deployment sheath toward the proximal landing site, with the distal end being within the deployment sheath, until the distal end is situated at the distal landing site, with such advancing axially compressing the stent graft; and

d. fourthly releasing the distal end of the stent graft from the deployment sheath at the distal landing site.

17. A method of deploying a stent graft between proximal and distal landing sites axially spaced along the lumen of a patient, wherein the stent graft:

I. has spaced proximal and distal ends, the proximal and distal ends being spaced further apart than the proximal and distal landing sites;

II. is axially compressible to allow the proximal and distal ends to be more closely spaced; and

III. is provided in combination with;

i. a deployment sheath wherein the stent graft may be situated with the stent graft being radially compressed, the stent graft radially expanding when released from the deployment sheath;

ii. proximal attachment means for releasably engaging the proximal end of the stent graft, the proximal attachment means extending along the deployment sheath;

iii. distal attachment means for releasably engaging the distal end of the stent graft, the distal attachment means extending along the deployment sheath;

the method comprising the following steps;

a. introducing the deployment sheath into the lumen of a patient with;

(1) the deployment sheath having the stent graft therein, and

(2) the proximal end of the stent graft leading the distal end;

b. locating the deployment sheath within the lumen such that the proximal end of the stent graft is situated at the proximal landing site;

c. withdrawing the deployment sheath from the proximal end of the stent graft while the proximal attachment means maintains the proximal end of the stent graft at the proximal landing site;

d. axially compressing at least a portion of the stent graft to move the distal end of the stent graft by moving the deployment sheath toward the proximal end, with the distal end being within the deployment sheath, and with the compressed portion having at least substantially the same diameter before and after compression; and

e. withdrawing the deployment sheath from the distal end of the stent graft while the distal attachment means maintains the distal end of the stent graft at the distal landing site.

18. The method of claim 17 further comprising the steps of:

a. moving the distal end of the stent graft toward the proximal landing site to axially compress the length of the stent graft;

b. continuing such motion until the distal end of the stent graft is situated at the distal landing site; and

c. releasing the distal end of the stent graft to remain at the distal landing site.

19. The method of claim 17 further comprising the steps of:

a. after withdrawing the deployment sheath from the proximal end of the stent graft, engaging the distal end of the stent graft with the distal attachment means; and

b. moving the distal attachment means toward the proximal landing site to axially compress the length of the stent graft.

20. The method of claim 19 wherein the step of moving the distal attachment means toward the proximal landing site is followed by the step of releasing the distal attachment means from the distal end of the stent graft when the distal end of the stent graft is at the distal landing site.