Systems and methods for adjusting the diameter of an endoluminal prosthesis and an endoluminal prosthesis configured for the same

• US 10,709,541 B2
• Filed: 04/24/2018
• Issued: 07/14/2020
• Est. Priority Date: 04/28/2017
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Bradway, Ryan C.
• Primary Examiner(s): Ganesan, Suba
• Application Number:
  US15/960,895
• Publication Number:
  US 20180311030A1
• Time in Patent Office: 812 Days
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/844 folded prior to deployment
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/962 having an outer sleeve
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• 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 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

Systems and methods of adjusting the diameter of an endoluminal prosthesis that allows for controlled radial deployment of the endoluminal prosthesis and the ability to revise the positioning of the endoluminal prosthesis after unsheathing. The endoluminal prosthesis includes a stent graft having a tubular graft wall, a stent, a main strand, a proximal strand, and a distal strand.

Claims

1. An endoluminal prosthesis comprising:

a stent graft comprising a tubular graft wall, a stent, a main strand, a proximal strand perpendicular to the main strand and having first and second ends, and a distal strand perpendicular to the main strand and having first and second ends;

wherein the tubular graft wall defines an internal lumen of the stent graft and comprises a first surface and a second surface;

wherein the stent is positioned on the first surface of the tubular graft wall and comprises at least two proximal apices and at least three distal apices;

wherein the proximal strand is positioned on at least the first surface of the tubular graft wall with the first end connected to one of the at least two proximal apices of the stent and the second end connected to another of the at least two proximal apices of the stent;

wherein the distal strand is positioned on at least the first surface of the tubular graft wall with the first end connected to one of the least three distal apices of the stent and the second end connected to an another of the least three distal apices of the stent;

wherein the main strand is positioned longitudinally along one of the first and second surfaces of the tubular graft wall and connected to the proximal strand and the distal strand on one of the first and second surfaces of the tubular graft wall and moveable in at least a distal direction;

wherein movement of the main strand in the distal direction pulls the proximal strand distally to cause the at least two proximal apices of the stent to move inwardly toward each other and reduce a diameter of the tubular graft at the at least two proximal apices of the stent.

2. The endoluminal prosthesis of claim 1, wherein the proximal strand is positioned on both of the first and second surfaces, and wherein the distal strand is positioned on both of the first and second surfaces.

3. The endoluminal prosthesis of claim 1, wherein movement of the main strand in the distal direction pulls the distal strand distally to cause at least two of the at least three distal apices of the stent to move inwardly toward each other and reduce the diameter of the tubular graft at the at least two distal apices of the stent.

4. The endoluminal prosthesis of claim 1, wherein the stent graft further comprises a second stent having at least two proximal apices and at least three distal apices, a second proximal strand having first and second ends with the first end connected to one of the at least two proximal apices of the second stent and the second end connected to another of the at least two proximal apices of the second stent, a second distal strand having first and second ends with the first end connected to one of the at least three distal apices of the second stent and a second end connected to another of the at least three distal apices of the second stent;

wherein the main strand is connected to the second proximal strand and the second distal strand on one of the first and second surfaces of the tubular graft;

wherein movement of the main strand in the distal direction pulls the second proximal strand distally to cause the at least two proximal apices of the second stent to move inwardly toward each other and reduce a diameter of the tubular graft at the at least two proximal apices of the second stent.

5. The endoluminal prosthesis of claim 4, wherein movement of the main strand in the distal direction pulls the second distal strand distally to cause the at least two of the at least three distal apices of the second stent to move inwardly toward each other and reduce a diameter of the tubular graft at the least two distal apices of the second stent.

6. The endoluminal prosthesis of claim 4, wherein the second proximal strand and the second distal strand extend through a wall of the tubular graft so that a length of both the first and second proximal strands extend over both of the first and second surfaces of the tubular graft.

7. The endoluminal prosthesis of claim 4, wherein the distal strand is a closed loop having a length that extends at least partially over an external surface of the tubular graft and a length that extends at least partially over an internal surface of the tubular graft.

8. The endoluminal prosthesis of claim 7, wherein the first end of the distal strand loops around the one of the at least three distal apices of the first stent and the second end of the distal strand loops around another of the at least three distal apices of the first stent.

9. The endoluminal prosthesis of claim 7, wherein the main strand extends along the internal surface of the tubular graft and is connected to the length of the distal strand that extends at least partially over the internal surface of the tubular graft.

10. The endoluminal prosthesis of claim 1, wherein the proximal strand is a closed loop having a length that extends at least partially over an external surface of the tubular graft and a length that extends at least partially over an internal surface of the tubular graft.

11. The endoluminal prosthesis of claim 10, wherein the first end of the proximal strand loops around the one of the at least two proximal apices of the first stent and the second end of the proximal strand loops around the other of the at least two proximal apices of the first stent.

12. The endoluminal prosthesis of claim 10, wherein the main strand extends along the internal surface of the tubular graft and is connected to the length of the proximal strand that extends at least partially over the internal surface of the tubular graft.

13. The endoluminal prosthesis of claim 1, wherein the stent graft further comprises a second stent having at least two proximal apices and at least three distal apices, a second main strand configured for proximal and distal movement independent of the main strand, a second proximal strand having first and second ends with the first end connected to one of the at least two proximal apices of the second stent and the second end connected to another of the at least two proximal apices of the second stent, a second distal strand having first and second ends with the first end connected to one of the at least three distal apices of the second stent and a second end connected to another of the at least three distal apices of the second stent;

wherein the second main strand is connected to the second proximal strand and the second distal strand on one of the first and second surfaces of the tubular graft;

wherein movement of the second main strand in the distal direction pulls the second proximal strand distally to cause the at least two proximal apices of the second stent to move inwardly toward each other and reduce a diameter of the tubular graft at the at least two proximal apices of the second stent.

14. An endoluminal prosthesis comprising:

a stent graft comprising a tubular graft wall, a stent, a main strand, a proximal strand perpendicular to the main strand and having first and second ends, and a distal strand perpendicular to the main strand and having first and second ends;

wherein the tubular graft wall defines an internal lumen of the stent graft and comprises a first surface and a second surface;

wherein the stent is positioned on the first surface of the tubular graft wall and comprises at least two proximal apices and at least three distal apices;

wherein the proximal strand is positioned on at least the first surface of the tubular graft wall with the first end connected to one of the at least two proximal apices of the stent and the second end connected to another of the at least two proximal apices of the stent;

wherein the distal strand is positioned on at least the first surface of the tubular graft wall with the first end connected to one of the least three distal apices of the stent and the second end connected to an another of the least three distal apices of the stent;

wherein the main strand is positioned longitudinally along one of the first and second surfaces of the tubular graft wall and connected to the proximal strand and the distal strand on one of the first and second surfaces of the tubular graft wall and moveable in both a distal direction and a proximal direction;

wherein movement of the main strand in the distal direction pulls the proximal strand distally to cause the at least two proximal apices of the stent to move inwardly toward each other and reduce a diameter of the tubular graft at the at least two proximal apices of the stent; and

wherein movement of the main strand in the proximal direction pushes the proximal strand proximally to cause the at least two proximal apices of the stent to move outwardly away each other and increase the diameter of the tubular graft at the at least two proximal apices of the stent.

15. The endoluminal prosthesis of claim 14, wherein movement of the main strand in the distal direction pulls the distal strand distally to cause at least two of the at least three distal apices of the stent to move inwardly toward each other and reduce a diameter of the tubular graft at the at least two distal apices of the stent;

and

wherein movement of the main strand in the proximal direction pushes the distal strand proximally to cause the at least two distal apices of the stent to move outwardly away each other and increase the diameter of the tubular graft at the at least two distal apices of the stent.

16. The endoluminal prosthesis of claim 14, wherein the stent graft further comprises a second stent having at least two proximal apices and at least three distal apices, a second main strand configured for proximal and distal movement independent of the main strand, a second proximal strand having first and second ends with the first end connected to one of the at least two proximal apices of the second stent and the second end connected to another of the at least two proximal apices of the second stent, a second distal strand having first and second ends with the first end connected to one of the at least three distal apices of the second stent and a second end connected to another of the at least three distal apices of the second stent;

wherein the second main strand is positioned longitudinally along one of the first and second surfaces of the tubular graft wall and connected to the proximal strand and the distal strand on one of the first and second surfaces of the tubular graft wall and moveable in both a distal direction and a proximal direction independently of the main strand;

wherein movement of the second main strand in the distal direction pulls the proximal strand distally to cause the at least two proximal apices of the second stent to move inwardly toward each other and reduce a diameter of the tubular graft at the at least two proximal apices of the second stent;

wherein movement of the second main strand in the proximal direction releases the second proximal strand to cause the at least two proximal apices of the second stent to move outwardly away each other and increase the diameter of the tubular graft at the at least two proximal apices of the second stent.

17. A system for controlled radial contraction and expansion of an endoluminal prosthesis, the system comprising:

a stent graft comprising a tubular graft, a stent connected to the tubular graft, a main strand, a proximal strand, and a distal strand;

wherein the tubular graft wall defines an internal lumen of the stent graft and comprises a first surface and a second surface;

wherein the stent is positioned on the first surface of the tubular graft wall and comprises at least two proximal apices and at least three distal apices;

wherein the proximal strand is positioned on at least the first surface of the tubular graft wall and connected to the two proximal apices of the stent;

wherein the distal strand is positioned on at least the first surface of the tubular graft wall and connected to at least two of the three distal apices of the stent;

wherein the main strand is positioned along one of the first and second surfaces of the tubular graft wall and connected to the proximal strand and the distal strand on one of the first and second surfaces of the tubular graft wall and is configured to move in a proximal direction and a distal direction;

wherein the main strand comprises a proximal end connected to the proximal strand and a distal manipulation end;

wherein movement of the main strand in the distal direction reduces the diameter of the stent and an associated portion of the tubular graft and movement of the main strand in the proximal direction increases the diameter of the stent and an associated portion of the tubular graft from the reduced diameter.

18. The system of claim 17, wherein the endoluminal prosthesis further comprises a second stent, a second proximal strand, and a second distal strand;

wherein the second proximal strand is connected to at least two proximal apices of the second stent; and

wherein the second distal strand is connected to at least two of three distal apices of the second stent.

19. The system of claim 18, wherein movement of the main strand in the distal direction reduces the diameter of the second stent and an associated portion of the tubular graft and movement of the main strand in the proximal direction increases the diameter of the second stent and an associated portion of the tubular graft from the reduced diameter.

20. The system of claim 17, wherein the stent graft further comprises a second stent having at least two proximal apices and at least three distal apices, a second main strand configured for proximal and distal movement independent of the main strand, a second proximal strand having first and second ends with the first end connected to one of the at least two proximal apices of the second stent and the second end connected to another of the at least two proximal apices of the second stent, a second distal strand having first and second ends with the first end connected to one of the at least three distal apices of the second stent and a second end connected to another of the at least three distal apices of the second stent;

wherein the second main strand is positioned longitudinally along one of the first and second surfaces of the tubular graft wall and connected to the proximal strand and the distal strand on one of the first and second surfaces of the tubular graft wall and moveable in both a distal direction and a proximal direction independently of the main strand;

wherein movement of the second main strand in the distal direction reduces the diameter of the stent and an associated portion of the tubular graft and movement of the second main strand in the proximal direction increases the diameter of the second stent and an associated portion of the tubular graft from the reduced diameter.