Stent-grafts with post-deployment variable radial displacement

• US 9,839,510 B2
• Filed: 04/04/2012
• Issued: 12/12/2017
• Est. Priority Date: 08/28/2011
• Status: Active Grant

• Current Assignee: Endospan Ltd.
• Original Assignee: Endospan Ltd.
• Inventors: Shalev, Alon
• Primary Examiner(s): Schillinger, Ann
• Application Number:
  US14/240,600
• Publication Number:
  US 20140324154A1
• Time in Patent Office: 2,078 Days
• 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 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2210/0057 stretchable
• CPC Class Codes: A61F 2210/0066 shrinkable
• 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 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0007 for adjusting length
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0013 for adjusting fluid pressure
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

An endovascular stent-graft includes a generally tubular body configured to assume a radially-compressed delivery state and a radially-expanded deployment state. The body includes a flexible stent member, and a tubular fluid flow guide attached to the stent member. The body includes a compliance-restoration body portion extending axially along a portion of the body, and including portions of the stent member and fluid flow guide. When the body is in the radially-expanded deployment state, the compliance-restoration body portion characterized by a greatest diastolic outer radius when the body is internally pressurized by fluid having a pressure of 80 mmHg, and radially expandable to a greatest systolic outer radius when the body is internally pressurized by fluid having a pressure of 120 mmHg. The greatest systolic outer radius (R_S) is at least 5% greater than the greatest diastolic outer radius.

Claims

1. Apparatus comprising an endovascular stent-graft, which comprises a generally tubular body, which body (a) is configured to assume a radially-compressed delivery state and a radially-expanded deployment state, and (b) comprises:

a flexible stent member; and

a tubular fluid flow guide, which comprises a graft material, and is attached to the stent member, the graft material comprising one or more of the following materials;

a polyester, a polyethylene, a polymeric film material, a polymeric textile material, woven polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), ePTFE, a woven graft material, and a medical-grade textile,

wherein the body includes a compliance-restoration body portion, which extends axially along a portion of the body, and which comprises a portion of the stent member and a portion of the fluid flow guide,

wherein, when the body is in the radially-expanded deployment state, the compliance-restoration body portion, including the portion of the stent member, is (a) configured to assume a greatest diastolic outer radius when the body is internally pressurized by fluid having a pressure of 80 mmHg, and (b) configured to assume a greatest systolic outer radius when the body is internally pressurized by fluid having a pressure of 120 mmHg, and

wherein the greatest systolic outer radius is at least 5% greater than the greatest diastolic outer radius.

2. The apparatus according to claim 1, wherein the greatest systolic outer radius is at least 10% greater than the greatest diastolic outer radius.

3. The apparatus according to claim 1, wherein the stent member is heat-set to cause the compliance-restoration body portion to assume the greatest diastolic outer radius when the body is internally pressurized by the fluid having the pressure of 80 mmHg.

4. The apparatus according to claim 1, wherein, when the body is in the radially-expanded deployment state, the compliance-restoration body portion is configured to assume a greatest relaxed outer radius when the body is not internally pressurized by fluid, which greatest relaxed outer radius is no more than 95% of the greatest diastolic outer radius.

5. The apparatus according to claim 4, wherein the stent member is heat-set to cause the compliance-restoration body portion to assume the greatest relaxed outer radius when unconstrained.

6. The apparatus according to claim 1, wherein the fluid flow guide alone is configured to assume first and second perimeters when internally pressurized by fluid having a pressure of 80 and 120 mmHg, respectively, the second perimeter being no more than 10% greater than the first perimeter.

7. The apparatus according to claim 1, wherein the fluid flow guide alone is configured to assume first and second perimeters when internally pressurized by fluid having a pressure of 80 and 120 mmHg, respectively, the second perimeter being between 0.5% and 5% greater than the first perimeter.

8. The apparatus according to claim 1, wherein the greatest systolic outer radius is no more than 30% greater than the greatest diastolic outer radius.

9. The apparatus according to claim 1, wherein the greatest diastolic outer radius is between 7.5 mm and 25 mm, when the body is in the radially-expanded deployment state.

10. The apparatus according to claim 1, wherein the greatest systolic outer radius is between 8.5 mm and 30 mm, when the body is in the radially-expanded deployment state.

11. The apparatus according to claim 1, wherein the body further includes distal and proximal portions, wherein the compliance-restoration body portion is disposed longitudinally between the distal portion and the proximal portion, and wherein respective greatest radii of the distal and the proximal portions are each at least 5% greater than a greatest relaxed outer radius of the compliance-restoration body portion, when the body is unconstrained in the radially-expanded deployment state.

12. The apparatus according to claim 1, wherein the body further includes distal and proximal portions, wherein the compliance-restoration body portion is disposed longitudinally between the distal portion and the proximal portion, and wherein respective greatest radii of the distal and the proximal portions are each at least 5% greater than the greatest diastolic outer radius, when the body is in the radially-expanded deployment state.

13. The apparatus according to claim 1, wherein the body further includes distal and proximal portions, wherein the compliance-restoration body portion is disposed longitudinally between the distal portion and the proximal portion, and wherein a greatest outer radius of the distal portion, when unconstrained, is between 2 and 10 mm greater than the greatest systolic outer radius, when the body is in the radially-expanded deployment state.

14. Apparatus comprising an endovascular stent-graft, which comprises a generally tubular body, which body (a) is configured to assume a radially-compressed delivery state and a radially-expanded deployment state, and (b) comprises:

a flexible stent member; and

a tubular fluid flow guide, which comprises a graft material, and is attached to the stent member,

wherein the body includes a compliance-restoration body portion, which extends axially along a portion of the body, and which comprises a portion of the stent member and a portion of the fluid flow guide,

wherein, when the body is in the radially-expanded deployment state, the compliance-restoration body portion, including the portion of the stent member, is (a) configured to assume a greatest diastolic outer radius when the body is internally pressurized by fluid having a pressure of 80 mmHg, and (b) configured to assume a greatest systolic outer radius when the body is internally pressurized by fluid having a pressure of 120 mmHg,

wherein the greatest systolic outer radius is at least 5% greater than the greatest diastolic outer radius,

wherein the graft material of the fluid flow guide of the compliance-restoration body portion is shaped so as to be expandable to a maximum greatest outer radius, and

wherein the maximum greatest outer radius of the graft material of the fluid flow guide of the compliance-restoration body portion is equal to the greatest systolic outer radius of the compliance-restoration body portion, such that the compliance-restoration body portion is limited by the graft material of the fluid flow guide from assuming an outer radius that is greater than the maximum greatest outer radius.

15. The apparatus according to claim 14, wherein the flexible stent member is attached to an internal surface of the tubular fluid flow guide.

16. The apparatus according to claim 14, wherein the flexible stent member comprises a plurality of structural stent elements, and wherein a portion of the structural stent elements are attached to an internal surface of the fluid flow guide, and another portion of the structural stent elements are attached to an external surface of the fluid flow guide.

17. Apparatus comprising an endovascular stent-graft, which comprises a generally tubular body, which body (a) is configured to assume a radially-compressed delivery state and a radially-expanded deployment state, and (b) comprises:

a flexible stent member; and

a tubular fluid flow guide, which comprises a graft material, and is attached to the stent member,

wherein the body includes a compliance-restoration body portion, which extends axially along a portion of the body, and which comprises a portion of the stent member and a portion of the fluid flow guide,

wherein, when the body is in the radially-expanded deployment state, the compliance-restoration body portion, including the portion of the stent member, is (a) configured to assume a greatest diastolic outer radius when the body is internally pressurized by fluid having a pressure of 80 mmHg, and (b) configured to assume a greatest systolic outer radius when the body is internally pressurized by fluid having a pressure of 120 mmHg,

wherein the greatest systolic outer radius is at least 5% greater than the greatest diastolic outer radius, and

wherein the graft material of the portion of the fluid flow guide is at least partially folded when the body is in the radially-expanded deployment state and is internally pressured by the fluid having the pressure of 80 mmHg.

18. Apparatus comprising an endovascular stent-graft, which comprises a generally tubular body, which body (a) is configured to assume a radially-compressed delivery state and a radially-expanded deployment state, and (b) comprises:

a flexible stent member; and

a tubular fluid flow guide, which comprises a graft material, and is attached to the stent member,

wherein the body includes a compliance-restoration body portion, which extends axially along a portion of the body, and which comprises a portion of the stent member and a portion of the fluid flow guide,

wherein, when the body is in the radially-expanded deployment state, the compliance-restoration body portion, including the portion of the stent member, is (a) configured to assume a greatest diastolic outer radius when the body is internally pressurized by fluid having a pressure of 80 mmHg, and (b) configured to assume a greatest systolic outer radius when the body is internally pressurized by fluid having a pressure of 120 mmHg,

wherein the greatest systolic outer radius is at least 5% greater than the greatest diastolic outer radius, and

wherein the body further includes distal and proximal portions, and wherein the compliance-restoration body portion is disposed longitudinally between the distal portion and the proximal portion,

wherein, when the body is in the radially-expanded deployment state, the distal and proximal portions are (a) configured to assume greatest diastolic distal- and proximal-end-portion radii, respectively, when the body is internally pressurized by fluid having a pressure of 80 mmHg, and (b) configured to assume greatest systolic distal- and proximal-end-portion radii, respectively, when the body is internally pressurized by fluid having a pressure of 120 mmHg,

wherein the greatest systolic distal-end-portion outer radius is less than 2% greater than the greatest diastolic distal-end-portion outer radius, and

wherein the greatest systolic proximal-end-portion outer radius is less than 2% greater than the greatest diastolic proximal-end-portion outer radius.