US20030130726A1 — Combination valve and stent for treating vascular…

Claim 1

Independent Claim 58 words

1 . A self-expanding replacement valve assembly configured for implantation within a vascular lumen, the valve assembly comprising a plurality of flexible members, each flexible member conformed to cooperate with at least one other flexible member to unidirectionally admit vascular fluid through the valve assembly and to prevent retrograde flow of the vascular fluid through the valve assembly.

Claim 2

Dependent Claim 58 words

1 . A self-expanding replacement valve assembly configured for implantation within a vascular lumen, the valve assembly comprising a plurality of flexible members, each flexible member conformed to cooperate with at least one other flexible member to unidirectionally admit vascular fluid through the valve assembly and to prevent retrograde flow of the vascular fluid through the valve assembly.

Claim 3

Dependent Claim 27 words

2 . The assembly of claim 1 , wherein at least a portion of one of said flexible members includes either sclera or small intestine sub-mucosa material.

Claim 4

Dependent Claim 27 words

3 . The assembly of claim 1 , in which the flexible members are supported by flexible and resilient struts configured for use in a vascular lumen.

Claim 5

Dependent Claim 19 words

4 . The assembly of claim 3 , in which the struts are manufactured with a resilient metallic material.

Claim 6

Dependent Claim 21 words

5 . The assembly of claim 4 , in which the struts material is selected from either nitinol or stainless steel.

Claim 7

Dependent Claim 30 words

6 . The assembly of claim 3 , in which the struts are manufactured from a biodegradable-like material designed to dissolve in a patient after a certain period of time.

Claim 8

Dependent Claim 54 words

7 . The assembly of claim 3 , in which the flexible members are cusps of a valve having edge portions configured for attachment to the struts, and edge portions configured to form free ends capable of reshaping to selectively form an opening through the valve assembly or an obstruction in the valve assembly.

Claim 9

Dependent Claim 15 words

8 . The assembly of claim 1 , in which the flexible members are bicusps.

Claim 10

Dependent Claim 17 words

9 . The assembly of claim 1 , in which the flexible members generally semi-elliptical in shape.

Claim 11

Dependent Claim 27 words

10 . The assembly of claim 1 , shaped as a generally tubular flexible member conformed to be implanted in a venous lumen in a fixed location.

Claim 12

Dependent Claim 45 words

11 . The assembly of claim 3 , in which the struts are connected to form a tubular shape and are flexible in a direction generally transverse to a longitudinal axis of the tubular shape, the flexible members being operably disposed in the tubular member.

Claim 13

Dependent Claim 56 words

12 . The assembly of claim 11 , in which each flexible member defines a first edge portion conformable to said tubular member and a second edge portion, the second edge portion of each flexible member cooperating to enable said unidirectional flow by forming a plurality of free ends which selectively engage and disengage each other.

Claim 14

Dependent Claim 77 words

13 . A stent and valve assembly for use in a vascular lumen, comprising: a. a flexible and resilient structure of a plurality of struts designed as a variably diametered tubular shape; and b. a plurality of valve leaflets formed from either SIS or sclera material and attached along designated edge portions to a plurality of said struts to enable opening and closing of free edge portions to emulate the operation of a naturally occuring vascualr valve.

Claim 15

Dependent Claim 77 words

13 . A stent and valve assembly for use in a vascular lumen, comprising: a. a flexible and resilient structure of a plurality of struts designed as a variably diametered tubular shape; and b. a plurality of valve leaflets formed from either SIS or sclera material and attached along designated edge portions to a plurality of said struts to enable opening and closing of free edge portions to emulate the operation of a naturally occuring vascualr valve.

Claim 16

Dependent Claim 21 words

14 . The assembly of claim 13 , having a two stage design of at least six struts in each stage.

Claim 17

Dependent Claim 34 words

15 . The assembly of claim 13 , in which the total length of the assembly is between about 1 and 2 cm, and the diameter of any stage is between about 8-20 mm.

Claim 18

Dependent Claim 99 words

16 . A method of making a replacement valve assembly for implantation into a vascular lumen and to function as a check valve, the valve assembly comprising a plurality of flexible members, each flexible member conformed to cooperate with the other at least one flexible member to unidirectionally admit vascular fluid through the valve assembly, the method comprising the steps of: providing a flexible biocompatible material; constructing a plurality of flexible members from the flexible material; and disposing the flexible members in a tubular member having at least one stage so as to function as a unidirectional flow valve.

Claim 19

Dependent Claim 99 words

16 . A method of making a replacement valve assembly for implantation into a vascular lumen and to function as a check valve, the valve assembly comprising a plurality of flexible members, each flexible member conformed to cooperate with the other at least one flexible member to unidirectionally admit vascular fluid through the valve assembly, the method comprising the steps of: providing a flexible biocompatible material; constructing a plurality of flexible members from the flexible material; and disposing the flexible members in a tubular member having at least one stage so as to function as a unidirectional flow valve.

Claim 20

Dependent Claim 20 words

17 . The method of claim 16 , in which sclera or SIS material is provided as the flexible material.

Claim 21

Dependent Claim 29 words

18 . The method of claim 17 , in which the tubular member is constructed as a two stage member to enhance stability during employment in a vascular lumen.

Claim 22

Dependent Claim 107 words

19 . A method of treating chronic vascular insufficiency, the method comprising the steps of: providing a replacement valve assembly shaped for implantation within a venous lumen, the valve assembly comprising a plurality of flexible members, each flexible member shaped to cooperate with the other at least one flexible member to unidirectionally admit vascular fluid through the valve assembly; introducing at least one of said replacement valve assemblies into a venous lumen generally proximate an insufficient vascular valve; and fixing said replacement valve assembly in said venous lumen by actuating a self-expanding portion of the valve assembly to engage the inner lumenal wall of the venous lumen.

Claim 23

Dependent Claim 107 words

19 . A method of treating chronic vascular insufficiency, the method comprising the steps of: providing a replacement valve assembly shaped for implantation within a venous lumen, the valve assembly comprising a plurality of flexible members, each flexible member shaped to cooperate with the other at least one flexible member to unidirectionally admit vascular fluid through the valve assembly; introducing at least one of said replacement valve assemblies into a venous lumen generally proximate an insufficient vascular valve; and fixing said replacement valve assembly in said venous lumen by actuating a self-expanding portion of the valve assembly to engage the inner lumenal wall of the venous lumen.

Claim 24

Dependent Claim 21 words

20 . The method of claim 19 , in which the replacement valve assembly is introduced into the venous lumen percutaneously.

Claim 25

Dependent Claim 31 words

21 . The method of claim 20 , in which the replacement valve assembly is introduced into the vascular lumen by a catheter with the replacement valve assembly within the catheter.

Claim 26

Dependent Claim 22 words

22 . The method of claim 19 , in which the venous replacement valve is made, at least partially, from mammalian tissue.

Claim 27

Dependent Claim 47 words

23 . A method of making a vascular valve member assembly from mammalian sclera or small intestine sub-mucosa (SIS), the method comprising the steps of: providing a mammalian tissue source; removing said tissue from the tissue source; and fashioning the valve member from the sclera or SIS.

Claim 28

Dependent Claim 47 words

23 . A method of making a vascular valve member assembly from mammalian sclera or small intestine sub-mucosa (SIS), the method comprising the steps of: providing a mammalian tissue source; removing said tissue from the tissue source; and fashioning the valve member from the sclera or SIS.

Claim 29

Dependent Claim 35 words

24 . The method of claim 23 , in which a plurality of the valve members are attached at least in part to an inner portion of a self-expanding and generally tubular shaped strut assembly.

Combination valve and stent for treating vascular reflux

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