Devices and methods for effectuating percutaneous Glenn and Fontan procedures

• US 10,426,482 B2
• Filed: 09/15/2016
• Issued: 10/01/2019
• Est. Priority Date: 09/15/2015
• Status: Active Grant

• Current Assignee: US Department of Health and Human Services (Government of the United States of America), Transmural Systems LLC
• Original Assignee: United States Department Of Health And Human Services
• Inventors: Rafiee, Nasser, MacDonald, Stuart, Lederman, Robert J., Ratnayaka, Kanishka, MacDonald, Biwei, Rafiee, Alana
• Primary Examiner(s): Nguyen, Vi X
• Application Number:
  US15/267,075
• Publication Number:
  US 20170071722A1
• Time in Patent Office: 1,111 Days
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0082 specially designed for children, e.g. having means for adjusting to their growth
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00

Abstract

In some implementations, a radially self-expanding endograft prosthesis is provided that includes (i) distal flange that is self-expanding and configured to flip generally perpendicularly with respect to a body of the prosthesis to help seat the prosthesis against a tissue wall, (ii) a distal segment extending proximally from the distal flange that has sufficient stiffness to maintain a puncture open that is formed through a vessel wall (iii) a compliant middle segment extending proximally from the distal segment, the middle segment being more compliant than the distal segment, and having independently movable undulating strut rings attached to a tubular fabric, the combined structure providing flexibility and compliance to allow for full patency while flexed, the segment being configured to accommodate up to a 90 degree bend, (iv) a proximal segment having a plurality of adjacent undulating strut rings that are connected to each other.

Claims

1. A reinforced endograft shunt prosthesis, comprising:

a distal flange configured to help seat the prosthesis when it is pulled proximally;

a distal segment extending proximally from the distal flange that has sufficient stiffness to maintain a puncture in an open condition that is formed through a first vessel wall through which the distal segment passes;

a compliant middle segment extending proximally from the distal segment, the compliant middle segment being more compliant than the distal segment, and including a plurality of undulating strut rings attached to at least one of an inner tubular fabric and an outer tubular fabric, the combined structure providing flexibility and compliance to allow for full patency while flexed, the segment being further configured to accommodate up to a 90 degree bend;

a proximal segment having a plurality of adjacent undulating strut rings that are connected to each other, the proximal segment being sufficiently stiff to seat within and urge against a second vessel wall; and

an undulating proximal end including a tether that is threaded through the openings to cause the proximal end of the prosthesis to collapse radially inwardly when tension is applied to the tether.

2. The prosthesis of claim 1, wherein the proximal segment is flared or bell-shaped to enhance apposition against the interior wall of the second vessel.

3. The prosthesis of claim 1, wherein the distal flange is the shape of a multi-pointed star.

4. The prosthesis of claim 1, wherein the distal flange is configured to self-expand and flip from a first direction that is generally parallel to a central longitudinal axis of the prosthesis, and relaxes into a bent over flange having a tip that is generally perpendicular to the longitudinal axis of the prosthesis when permitted to expand.

5. The prosthesis of claim 1, wherein the distal flange is configured to self-expand and flip from a first direction that is generally parallel to a central longitudinal axis of the prosthesis, and relaxes into a bent over flange having a tip that forms an acute angle with respect to a wall of the prosthesis between 70 and 90 degrees.

6. The prosthesis of claim 1, wherein the prosthesis defines at least one fenestration through a sidewall thereof to permit leakage of bodily fluid through the fenestration.

7. The prosthesis of claim 1, wherein the prosthesis includes an inner tubular layer of fabric disposed inside of said struts and an outer tubular layer disposed outside of said struts.

8. The prosthesis of claim 1, wherein the prosthesis further includes a flange at the proximal end of the prosthesis, wherein each flanged end is configured to urge against an inner surface of a first body lumen and a second body lumen when the prosthesis is mounted through openings formed into the walls of the first body lumen and second body lumen.

9. The prosthesis of claim 8, wherein each of the flanged ends is attached to respective tubular structural regions that are in turn structurally joined in a central region by an elastic member, wherein tension can be maintained on the prosthesis by way of the elastic member to help the flanged ends to seat against the inner walls of the first vessel and second vessel.

10. The prosthesis of claim 1, wherein the prosthesis is of adjustable telescoping length.

11. The prosthesis of claim 10, wherein the inside diameter of the prosthesis remains substantially unchanged when the prosthesis is adjusted in length.

12. A delivery system including a prosthesis according to claim 1 mounted thereon, wherein the prosthesis is mounted on a longitudinal inner member and inside of a retractable sheath.

13. The delivery system of claim 12, wherein both ends of the tether that is routed through the prosthesis extend proximally through and out of a proximal region of the delivery system.

14. The delivery system of claim 13, further comprising a first set of radiopaque markers near the distal end of the delivery system, and a second set of markers that are visible outside the patient during a procedure that indicates the relative position of the delivery system and prosthesis, wherein the first and second set of markers are configured to be maintained in registration with each other during the procedure.

15. The delivery system of claim 14, wherein the first set of markers is located on a distal atraumatic tip of the delivery system made of iron oxide to facilitate navigation under MRI or other imaging modality to position the delivery system accurately, and wherein the second set of markers indicates the relative longitudinal position of the portions of the delivery system.

16. The delivery system of claim 14, wherein the markers are configured to indicate when the distal flange of the prosthesis is suitably configured to pull against an inner face of the wall of a lumen.

17. The prosthesis of claim 1, wherein the distal segment is formed at least in part from at least two further undulating strut rings that are attached to each other at aligned apices, and further wherein the distal flange is formed from an undulating wire ring that is attached to one of said further undulating strut rings of said distal segment.