US20050075725A1
Expired / Lapsed
US
⏱️ 0.0 years remaining
Implantable prosthetic valve with non-laminar flow
Assignee: Edwards Lifesciences Corp
•
Filing: 2003-10-02
•
Granted: —
•
Expires: 2023-10-02
Abstract
Abstract A valve prosthesis device is disclosed suitable for implantation in body ducts. The device comprises a support stent, comprised of a deployable construction adapted to be initially crimped in a narrow configuration suitable for catheterization through the body duct to a target location and adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state in the target location, and a valve assembly comprising a flexible conduit having an inlet end and an outlet, made of pliant material attached to the support beams providing collapsible slack portions of the conduit at the outlet. The support stent is provided with a plurality of longitudinally rigid support beams of fixed length. When flow is allowed to pass through the valve prosthesis device from the inlet to the outlet, the valve assembly is kept in an open position, whereas a reverse flow is prevented as the collapsible slack portions of the valve assembly collapse inwardly providing blockage to the reverse flow. The device is configured so that retrograde flow will be altered from laminar flow and directed towards the leaflets to effect closing.
Inventors
- 👤 Stanton Rowe
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 12:45
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2412; A61F2/2418; A61F2/2427; A61F2/243; A61F2/2433; A61F2/2475; A61F2/82; A61F2/844; A61F2210/00; A61F2210/0014; A61F2220/00; A61F2220/0025; A61F2220/0041; A61F2220/0075; A61F2250/00; A61F2250/0014; A61F2250/0039; Y; Y10; Y10S; Y10S623/00; Y10S623/902; Y10S623/904
Claims Analysis
Total Claims: 80
Claim 1
Independent Claim
108 words
1 . A valve prosthesis device suitable for implantation in corporeal ducts, the device comprising: a support stent, and a valve assembly comprising a flexible conduit having an inlet end and an outlet end, wherein when flow is allowed to pass through the valve prosthesis device from the inlet to the outlet, the valve assembly is kept in an open position; wherein a reverse flow is prevented as the collapsible slack portions of the valve assembly collapse inwardly providing blockage to the reverse flow; and where the device is configured so that retrograde flow will be altered from laminar flow and directed towards the leaflets to effect closing.
Claim 2
Dependent Claim
108 words
1 . A valve prosthesis device suitable for implantation in corporeal ducts, the device comprising: a support stent, and a valve assembly comprising a flexible conduit having an inlet end and an outlet end, wherein when flow is allowed to pass through the valve prosthesis device from the inlet to the outlet, the valve assembly is kept in an open position; wherein a reverse flow is prevented as the collapsible slack portions of the valve assembly collapse inwardly providing blockage to the reverse flow; and where the device is configured so that retrograde flow will be altered from laminar flow and directed towards the leaflets to effect closing.
Claim 3
Dependent Claim
64 words
2 . The valve prosthesis device of claim 1 , wherein the support stent comprises a deployable construction adapted to be initially crimped in a narrow configuration suitable for catheterization through the body duct to a target location and adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state in the target location
Claim 4
Dependent Claim
27 words
3 . The valve prosthesis device of claim 1 , wherein the support stent is provided with a plurality of longitudinally rigid support beams of fixed length.
Claim 5
Dependent Claim
33 words
4 . The valve prosthesis device of claim 1 , wherein the valve assembly comprises pliant material attached to the support beams and provides collapsible slack portions of the conduit at the outlet.
Claim 6
Dependent Claim
26 words
5 . The valve prosthesis of claim 1 , wherein the device is configured so that an artificial sinus is formed adjacent to the valve assembly.
Claim 7
Dependent Claim
17 words
6 . The valve prosthesis of claim 1 , wherein the retrograde flow will be substantially non-laminar.
Claim 8
Dependent Claim
192 words
7 . A valve prosthesis device suitable for implantation in corporeal ducts, the device comprising: a support stent, comprised of a deployable construction adapted to be initially crimped in a narrow configuration suitable for catheterization through the body duct to a target location and adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state in the target location, the support stent provided with a plurality of longitudinally rigid support beams of fixed length; and a valve assembly comprising a flexible conduit having an inlet end and an outlet, made of pliant material attached to the support beams providing collapsible slack portions of the conduit at the outlet, wherein when flow is allowed to pass through the valve prosthesis device from the inlet to the outlet, the valve assembly is kept in an open position, wherein a reverse flow is prevented as the collapsible slack portions of the valve assembly collapse inwardly providing blockage to the reverse flow, and wherein the device is configured so that retrograde flow will be altered from laminar flow and directed towards the leaflets to effect closing.
Claim 9
Dependent Claim
192 words
7 . A valve prosthesis device suitable for implantation in corporeal ducts, the device comprising: a support stent, comprised of a deployable construction adapted to be initially crimped in a narrow configuration suitable for catheterization through the body duct to a target location and adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state in the target location, the support stent provided with a plurality of longitudinally rigid support beams of fixed length; and a valve assembly comprising a flexible conduit having an inlet end and an outlet, made of pliant material attached to the support beams providing collapsible slack portions of the conduit at the outlet, wherein when flow is allowed to pass through the valve prosthesis device from the inlet to the outlet, the valve assembly is kept in an open position, wherein a reverse flow is prevented as the collapsible slack portions of the valve assembly collapse inwardly providing blockage to the reverse flow, and wherein the device is configured so that retrograde flow will be altered from laminar flow and directed towards the leaflets to effect closing.
Claim 10
Dependent Claim
18 words
8 . The valve prosthesis device of claim 7 , wherein the support stent comprises an annular frame.
Claim 11
Dependent Claim
18 words
9 . The valve prosthesis device of claim 7 , wherein said valve assembly has a tricuspid configuration.
Claim 12
Dependent Claim
19 words
10 . The valve prosthesis device of claim 7 , wherein said valve assembly is made from biocompatible material.
Claim 13
Dependent Claim
23 words
11 . The valve prosthesis device of claim 10 , wherein the valve assembly is made from pericardial tissue, or other biological tissue.
Claim 14
Dependent Claim
19 words
12 . The valve prosthesis device of claim 7 , wherein said valve assembly is made from biocompatible polymers.
Claim 15
Dependent Claim
24 words
13 . The valve prosthesis device of claim 12 , wherein the valve assembly is made from materials selected from polyurethane and polyethylene terephthalate.
Claim 16
Dependent Claim
27 words
14 . The valve prosthesis device of claim 13 , wherein said valve assembly comprises a main body made from polyethylene terephthalate and leaflets made from polyurethane.
Claim 17
Dependent Claim
19 words
15 . The valve prosthesis device of claim 7 , wherein said support stent is made from nickel titanium.
Claim 18
Dependent Claim
29 words
16 . The valve prosthesis device of claim 7 , wherein the support beams are substantially equidistant and substantially parallel so as to provide anchorage for the valve assembly.
Claim 19
Dependent Claim
32 words
17 . The valve prosthesis device of claim 7 , wherein the support beams are provided with bores so as to allow stitching or tying of the valve assembly to the beams.
Claim 20
Dependent Claim
21 words
18 . The valve prosthesis device of claim 7 , wherein the support beams are chemically adhered to the support stent.
Claim 21
Dependent Claim
20 words
19 . The valve prosthesis device of claim 7 , wherein said valve assembly is riveted to the support beams.
Claim 22
Dependent Claim
20 words
20 . The valve prosthesis device of claim 7 , wherein said valve assembly is stitched to the support beams.
Claim 23
Dependent Claim
23 words
21 . The valve prosthesis device of claim 7 , wherein said beams are manufactured by injection using a mold, or by machining.
Claim 24
Dependent Claim
23 words
22 . The valve prosthesis device of claim 7 , wherein said valve assembly is rolled over the support stent at the inlet.
Claim 25
Dependent Claim
21 words
23 . The valve prosthesis device of claim 7 , wherein said valve device is manufactured using forging or dipping techniques.
Claim 26
Dependent Claim
44 words
24 . The valve prosthesis device of claim 7 , wherein said valve assembly leaflets are longer than needed to exactly close the outlet, thus when they are in the collapsed state substantial portions of the leaflets fall on each other creating better sealing.
Claim 27
Dependent Claim
29 words
25 . The valve prosthesis device of claim 7 , wherein said valve assembly is made from a coiled polymer, coated by a coating layer of the same polymer.
Claim 28
Dependent Claim
15 words
26 . The valve prosthesis device of claim 25 , wherein said polymer is polyurethane.
Claim 29
Dependent Claim
33 words
27 . The valve prosthesis device of claim 7 , wherein the support stent is provided with heavy metal markers so as to enable tracking and determining the valve device position and orientation.
Claim 30
Dependent Claim
26 words
28 . The valve prosthesis device of claim 27 , wherein the heavy metal markers are selected from the group consisting of gold, platinum-iridium, and tantalum.
Claim 31
Dependent Claim
34 words
29 . The valve prosthesis device of claim 7 , wherein the valve assembly leaflets are provided with radio-opaque material at the outlet, so as to help tracking the valve device operation in vivo.
Claim 32
Dependent Claim
17 words
30 . The valve prosthesis device of claim 29 , wherein said radio-opaque material comprises gold thread.
Claim 33
Dependent Claim
32 words
31 . The valve prosthesis device of claim 7 , wherein the diameter of said support stent, when fully deployed is in the range of from about 19 to about 26 mm.
Claim 34
Dependent Claim
27 words
32 . The valve prosthesis device of claim 7 , wherein the diameter of said support stent may be expanded from about 4 to about 26 mm.
Claim 35
Dependent Claim
58 words
33 . The valve prosthesis device of claim 7 , wherein the support beams are provided with bores and wherein the valve assembly is attached to the support beams by means of U-shaped rigid members that are fastened to the valve assembly and that are provided with extruding portions that fit into matching bores on the support beams.
Claim 36
Dependent Claim
61 words
34 . The valve prosthesis device of claim 7 , wherein the support beams comprise rigid support beams in the form of frame construction, and the valve assembly pliant material is inserted through a gap in the frame and a fastening rod is inserted through a pocket formed between the pliant material and the frame and holds the valve in position.
Claim 37
Dependent Claim
28 words
35 . The valve prosthesis device of claim 7 , wherein the main body of the valve assembly is made from coiled wire coated with a coating material.
Claim 38
Dependent Claim
22 words
36 . The valve prosthesis device of claim 35 , wherein the coiled wire and the coating material is made from polyurethane.
Claim 39
Dependent Claim
45 words
37 . The valve prosthesis device of claim 7 , wherein a strengthening wire is interlaced in the valve assembly at the outlet of the conduit so as to define a fault line about which the collapsible slack portion of the valve assembly may flap.
Claim 40
Dependent Claim
19 words
38 . The valve prosthesis device of claim 37 , wherein the strengthening-wire is made from nickel titanium alloy.
Claim 41
Dependent Claim
115 words
39 . A valve prosthesis device suitable for implantation in corporeal ducts, the device comprising a main conduit body having an inlet and an outlet and pliant leaflets attached at the outlet so that when flow passes through the conduit from the inlet to the outlet the leaflets are in an open position allowing the flow to exit the outlet, and when the flow is reversed the leaflets collapse so as to block the outlet, wherein the main body is made from polyethylene terephtalate and collapsible leaflets are made form polyurethane and wherein the device is configured so that retrograde flow will be altered from laminar flow and directed towards the leaflets to effect closing.
Claim 42
Dependent Claim
115 words
39 . A valve prosthesis device suitable for implantation in corporeal ducts, the device comprising a main conduit body having an inlet and an outlet and pliant leaflets attached at the outlet so that when flow passes through the conduit from the inlet to the outlet the leaflets are in an open position allowing the flow to exit the outlet, and when the flow is reversed the leaflets collapse so as to block the outlet, wherein the main body is made from polyethylene terephtalate and collapsible leaflets are made form polyurethane and wherein the device is configured so that retrograde flow will be altered from laminar flow and directed towards the leaflets to effect closing.
Claim 43
Dependent Claim
36 words
40 . The valve prosthesis device of claim 39 , wherein support beams made from polyurethane are provided on the main body and wherein the leaflets are attached to the main body at the support beams.
Claim 44
Dependent Claim
21 words
41 . The valve prosthesis device of claim 39 , wherein said support beams are chemically adhered to the main body.
Claim 45
Dependent Claim
160 words
42 . A valve prosthesis device suitable for implantation in corporeal ducts, the device comprising: a support stent, comprised of a deployable construction adapted to be initially crimped in a narrow configuration suitable for catheterization through the body duct to a target location and adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state in the target location, the support stent provided with a plurality of longitudinally rigid support beams of fixed length; a valve assembly comprising a flexible conduit having an inlet end and an outlet, made of pliant material attached to the support beams providing collapsible slack portions of the conduit at the outlet; and substantially equidistant rigid support beams interlaced or attached to the slack portion of the valve assembly material, arranged longitudinally, wherein the device is configured so that retrograde flow will be altered from laminar flow and directed towards the leaflets to effect closing.
Claim 46
Dependent Claim
160 words
42 . A valve prosthesis device suitable for implantation in corporeal ducts, the device comprising: a support stent, comprised of a deployable construction adapted to be initially crimped in a narrow configuration suitable for catheterization through the body duct to a target location and adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state in the target location, the support stent provided with a plurality of longitudinally rigid support beams of fixed length; a valve assembly comprising a flexible conduit having an inlet end and an outlet, made of pliant material attached to the support beams providing collapsible slack portions of the conduit at the outlet; and substantially equidistant rigid support beams interlaced or attached to the slack portion of the valve assembly material, arranged longitudinally, wherein the device is configured so that retrograde flow will be altered from laminar flow and directed towards the leaflets to effect closing.
Claim 47
Dependent Claim
142 words
43 . A valve prosthesis device suitable for implantation in corporeal ducts, the device comprising: an expandable support frame, the support frame provided with a plurality of longitudinally rigid support beams of fixed length; and a valve assembly comprising a flexible conduit having an inlet end and an outlet, made of pliant material attached to the support beams providing collapsible slack portions of the conduit at the outlet, wherein when flow is allowed to pass through the valve prosthesis device from the inlet to the outlet, the valve assembly is kept in an open position, wherein a reverse flow is prevented as the collapsible slack portions of the valve assembly collapse inwardly providing blockage to the reverse flow, and wherein the device is configured so that retrograde flow will be altered from laminar flow and directed towards the leaflets to effect closing.
Claim 48
Dependent Claim
142 words
43 . A valve prosthesis device suitable for implantation in corporeal ducts, the device comprising: an expandable support frame, the support frame provided with a plurality of longitudinally rigid support beams of fixed length; and a valve assembly comprising a flexible conduit having an inlet end and an outlet, made of pliant material attached to the support beams providing collapsible slack portions of the conduit at the outlet, wherein when flow is allowed to pass through the valve prosthesis device from the inlet to the outlet, the valve assembly is kept in an open position, wherein a reverse flow is prevented as the collapsible slack portions of the valve assembly collapse inwardly providing blockage to the reverse flow, and wherein the device is configured so that retrograde flow will be altered from laminar flow and directed towards the leaflets to effect closing.
Claim 49
Dependent Claim
65 words
44 . The valve prosthetic device of claim 43 , wherein the expandable support frame comprises a deployable construction adapted to be initially crimped in a narrow configuration suitable for catheterization through the corporeal duct to a target location and adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state in the target location.
Claim 50
Dependent Claim
19 words
45 . The valve prosthetic device of claim 43 , wherein the support beams have a U-shaped cross section.
Claim 51
Dependent Claim
24 words
46 . The valve prosthetic device of claim 45 , wherein a holder is used to secure the pliant material to the support beams.
Claim 52
Dependent Claim
24 words
47 . The valve prosthetic device of claim 43 , wherein the support frame comprises three segments that form a circular assembly when assembled.
Claim 53
Dependent Claim
26 words
48 . The valve prosthetic device of claim 43 , wherein the support beams point inwardly with respect to a central longitudinal axis of the device.
Claim 54
Dependent Claim
26 words
49 . The valve prosthetic device of claim 47 , wherein the support beams point outwardly with respect to a central longitudinal axis of the device.
Claim 55
Dependent Claim
24 words
50 . The valve prosthetic device of claim 43 , further provided with a restricting tapered housing, for housing it in a crimped state
Claim 56
Dependent Claim
24 words
51 . The valve prosthetic device of claim 43 , wherein hooks are provided to secure the device in position after it is deployed.
Claim 57
Dependent Claim
37 words
52 . The valve prosthetic device of claim 43 , wherein the support beams comprise longitudinal bars having a narrow slit used as the commissural attachment so that extensions the pliant material are tightly inserted through it.
Claim 58
Dependent Claim
26 words
53 . The valve prosthetic device of claim 52 , wherein the extensions of the pliant material are wrapped about rigid bars serving as anchorage means.
Claim 59
Dependent Claim
25 words
54 . The valve prosthetic device of claim 53 , wherein extensions of the pliant material are sutured to each other at the rigid bars.
Claim 60
Dependent Claim
23 words
55 . The valve prosthetic device of claim 54 , wherein a bottom portion of the pliant material is attached to the inlet.
Claim 61
Dependent Claim
31 words
56 . The valve prosthetic device of claim 43 , wherein the support beams are each provided with a rounded pole, forming a loop through which the pliant material is inserted.
Claim 62
Dependent Claim
41 words
57 . The valve prosthetic device of claim 43 , wherein the pliant material is provided with longitudinal bars attached to the pliant material at positions assigned for attachment to the support frame, in order to prevent localized stress from forming.
Claim 63
Dependent Claim
38 words
58 . The valve prosthetic device of claim 43 , further provided with longitudinal bars having protrusions that are inserted in bores in the pliant material, a sheet of PET and through bores provided on the support beams.
Claim 64
Dependent Claim
23 words
59 . The valve prosthetic device of claim 43 , wherein the pliant material is sutured leaving the slack portions free of sutures.
Claim 65
Dependent Claim
41 words
60 . The valve prosthetic device of claim 43 , wherein a connecting member with a split portion is used to connect leaflets of the pliant material to the support beams, the split connecting member compressing the pliant material in position.
Claim 66
Dependent Claim
23 words
61 . The valve prosthetic device of claim 60 , wherein a portion of the connecting member is perpendicular to the split portion.
Claim 67
Dependent Claim
57 words
62 . The valve prosthetic device of claim 43 , wherein the support frame is provided with metallic members coupled to the stent and rigid members are positioned on two opposite sides of the metallic member and held against each other, holding a portion of the pliant material between them, sutured, the metallic members wrapped with PET.
Claim 68
Dependent Claim
25 words
63 . The valve prosthetic device of claim 3 , wherein the device is further provided with spring to reduce wear of the pliant material.
Claim 69
Dependent Claim
18 words
64 . The valve prosthetic device of claim 63 , wherein the spring is provided with a spiral.
Claim 70
Dependent Claim
18 words
65 . The valve prosthetic device of claim 63 , wherein the spring is made from stainless steel.
Claim 71
Dependent Claim
22 words
66 . The valve prosthetic device of claim 63 , wherein the spring is attached to slots provided on the support frame.
Claim 72
Dependent Claim
22 words
67 . The valve prosthetic device of claim 43 , wherein the pliant material is sutured to the support frame forming pockets.
Claim 73
Dependent Claim
52 words
68 . The valve prosthetic device of claim 67 , wherein attachment bars are provided on the stent support at a portion of the stent close to the outlet, on which the pliant material is coupled to, and wherein the pliant material is attached circumferentially to the inlet, leaving slack pliant material.
Claim 74
Dependent Claim
20 words
69 . The valve prosthetic device of claim 43 , wherein the outlet is tapered with respect to the inlet.
Claim 75
Dependent Claim
28 words
70 . The valve prosthetic device of claim 69 , wherein the support frame at the outlet is wider in diameter than the pliant material forming the outlet.
Claim 76
Dependent Claim
18 words
71 . The valve prosthetic device of claim 43 , wherein the pliant material is reinforced using PET.
Claim 77
Dependent Claim
41 words
72 . The valve prosthetic device of claim 43 , wherein the support frame is a tube having an inner wall, having sinusoidal fold lines, wherein the pliant material is sutured to the inner wall of the tube along suture lines.
Claim 78
Dependent Claim
21 words
73 . The valve prosthetic device of claim 72 , wherein additional piece of PET is added below the suture lines.
Claim 79
Dependent Claim
19 words
74 . The valve prosthetic device of claim 43 , wherein the device is incorporated with an angioplasty balloon.
Claim 80
Dependent Claim
64 words
75 . The valve prosthetic device of claim 74 , wherein the balloon has a central longitudinal axis that runs along a flow path through the device, and a perimeter, the balloon comprising four inflatable portions, one portion located along a central axis and the other three located on the perimeter, the pliant material in the form of leaflets is distributed about the perimeter.
References Cited (Backward Citations)
No citation records indexed.
USPTO Annuity & Maintenance Windows
Maintenance schedule is calculated for granted US utility patents.