Artificial valve prosthesis with improved flow dynamics

• US 9,421,096 B2
• Filed: 07/16/2012
• Issued: 08/23/2016
• Est. Priority Date: 04/24/2003
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Case, Brian C., Garrison, Michael L., Hoffa, Andrew, Schaeffer, Darin G., Flagle, Jacob A.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): WOLF, MEGAN YARNALL
• Application Number:
  US13/550,229
• Publication Number:
  US 20130018453A1
• Time in Patent Office: 1,499 Days
• Field of Search: 623 124- 126, 623/2.14, 623/2.17, 623/2.18
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0037 differing in height or in length
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

An expandable venous valve having a support structure that is configured to enlarge the area adjacent to the valve structure such that the flow patterns of retrograde flow are modified in a way that facilitates the flushing of the pockets at the base of the valve area to prevent stagnation of bodily fluid, which in the venous system, can lead to thrombus formation. The enlarged pocket areas can be created by forming an artificial sinus adjacent the valve structure in an unsupported section of vessel wall between two support frame sections or the support frame can comprise an expanded-diameter intermediate or proximal section that forms an artificial sinus adjacent the valve structure.

Claims

1. An artificial valve prosthesis for implantation in a bodily passage, the artificial valve prosthesis extending between a proximal end and a distal end along a longitudinal axis and comprising:

a support structure having a support structure proximal end, a support structure distal end, and comprising;

a proximal section comprising a first radially expandable anchoring portion having a plurality of struts interconnected by bends, the proximal section comprising a first bend connecting first and second circumferentially adjacent struts and a second bend connecting third and fourth circumferentially adjacent struts, the proximal section having a proximal section length extending from the support structure proximal end to the first bend and a proximal section outer diameter that is constant along the proximal section length, each of the first and second circumferentially adjacent struts extending from the support structure proximal end to the first bend;

a distal section comprising a second radially expandable anchoring portion having a plurality of struts interconnected by bends, the distal section comprising a third bend connecting fifth and sixth circumferentially adjacent struts, a fourth bend connecting seventh and eighth circumferentially adjacent struts, and a fifth bend connecting ninth and tenth circumferentially adjacent struts, the fifth bend free of attachment to another strut between the ninth and tenth circumferentially adjacent struts, the distal section having a distal section length extending from the support structure distal end to the third bend and a distal section outer diameter that is constant along the distal section length, each of the fifth and sixth circumferentially adjacent struts extending from the support structure distal end to the third bend, each of the ninth and tenth circumferentially adjacent struts extending from the support structure distal end to the fifth bend;

the proximal and distal sections spaced apart from one another to define an intermediate section disposed between the proximal and distal sections, the intermediate section comprising a substantially open section of the support structure;

a first interconnecting member connected to the proximal and distal sections and spanning the intermediate section, the first interconnecting member extending from the first bend of the proximal section to the third bend of the distal section and from the third bend of the distal section to the second bend of the proximal section, the first interconnecting member free of attachment to another strut between the first bend of the proximal section and the third bend of the distal section; and

a second interconnecting member connected to the proximal and distal sections and spanning the intermediate section, the second interconnecting member extending from the first bend of the proximal section to the fourth bend of the distal section and from the fourth bend of the distal section to the second bend of the proximal section, the second interconnecting member free of attachment to another strut between the first bend of the proximal section and the fourth bend of the distal section and between the fourth bend of the distal section and the second bend of the proximal section; and

a valve structure attached to the support structure and configured to selectively restrict fluid flow through the support structure by closing with changes in the fluid pressure differential across said artificial valve prosthesis;

wherein the third bend is offset from the first bend and the second bend relative to said longitudinal axis of said artificial valve prosthesis; and

wherein the fourth bend is offset from the first bend and the second bend relative to said longitudinal axis of said artificial valve prosthesis.

2. The artificial valve prosthesis of claim 1, wherein the first interconnecting member is disposed substantially opposite the second interconnecting member relative to said longitudinal axis of said artificial valve prosthesis.

3. The artificial valve prosthesis of claim 1, wherein the artificial valve prosthesis is adapted to create an artificial sinus along the intermediate section.

4. The artificial valve prosthesis of claim 1, wherein the first interconnecting member and second interconnecting member comprise a material selected from the group consisting of fabrics and non-rigid materials.

5. The artificial valve prosthesis of claim 1, wherein the valve structure is attached to the first interconnecting member and second interconnecting member.

6. The artificial valve prosthesis of claim 1, wherein the valve structure comprises two leaflets.

7. The artificial valve prosthesis of claim 1, wherein the valve structure comprises a synthetic material.

8. The artificial valve prosthesis of claim 1, wherein the valve structure comprises a biologically-derived material.

9. The artificial valve prosthesis of claim 1, wherein the first bend and the second bend are substantially opposite each other relative to said longitudinal axis of said artificial valve prosthesis.

10. The artificial valve prosthesis of claim 1, wherein the third bend and the fourth bend are substantially opposite each other relative to said longitudinal axis of said artificial valve prosthesis.

11. The artificial valve prosthesis of claim 1, wherein the first interconnecting member has a first interconnecting member outer diameter that is equal to the proximal section outer diameter.

12. The artificial valve prosthesis of claim 1, wherein the first interconnecting member is free of attachment to another strut between the third bend of the distal section and the second bend of the proximal section.

13. An artificial valve prosthesis for implantation in a bodily passage, the artificial valve prosthesis extending between a proximal end and a distal end along a longitudinal axis and comprising:

a support structure having a support structure proximal end, a support structure distal end, and comprising;

a proximal section comprising a first radially expandable anchoring portion having a plurality of struts interconnected by bends, the proximal section comprising a first bend connecting first and second circumferentially adjacent struts and a second bend connecting third and fourth circumferentially adjacent struts, the proximal section having a proximal section length extending from the support structure proximal end to the first bend and a proximal section outer diameter that is constant along the proximal section length, each of the first and second circumferentially adjacent struts extending from the support structure proximal end to the first bend;

a distal section comprising a second radially expandable anchoring portion having a plurality of struts interconnected by bends, the distal section comprising a third bend connecting fifth and sixth circumferentially adjacent struts, a fourth bend connecting seventh and eighth circumferentially adjacent struts, and a fifth bend connecting ninth and tenth circumferentially adjacent struts, the fifth bend free of attachment to another strut between the ninth and tenth circumferentially adjacent struts, the distal section having a distal section length extending from the support structure distal end to the third bend and a distal section outer diameter that is constant along the distal section length, each of the fifth and sixth circumferentially adjacent struts extending from the support structure distal end to the third bend, each of the ninth and tenth circumferentially adjacent struts extending from the support structure distal end to the fifth bend;

the proximal and distal sections spaced apart from one another to define an intermediate section disposed between the proximal and distal sections, the intermediate section comprising a substantially open section of the support structure;

a first interconnecting member connected to the proximal and distal sections and spanning the intermediate section, the first interconnecting member extending from the first bend of the proximal section to the third bend of the distal section and from the third bend of the distal section to the second bend of the proximal section, the first interconnecting member free of attachment to another strut between the first bend of the proximal section and the third bend of the distal section; and

a second interconnecting member connected to the proximal and distal sections and spanning the intermediate section, the second interconnecting member extending from the first bend of the proximal section to the fourth bend of the distal section and from the fourth bend of the distal section to the second bend of the proximal section, the second interconnecting member free of attachment to another strut between the first bend of the proximal section and the fourth bend of the distal section and between the fourth bend of the distal section and the second bend of the proximal section; and

a valve structure attached to the support structure and configured to selectively restrict fluid flow through the support structure by closing with changes in the fluid pressure differential across said artificial valve prosthesis;

wherein the third bend is offset from the first bend and the second bend relative to said longitudinal axis of said artificial valve prosthesis;

wherein the fourth bend is offset from the first bend and the second bend relative to said longitudinal axis of said artificial valve prosthesis;

wherein the first bend and the second bend are substantially opposite each other relative to said longitudinal axis of said artificial valve prosthesis; and

wherein the third bend and the fourth bend are substantially opposite each other relative to said longitudinal axis of said artificial valve prosthesis.