US20030055495A1
Expired / Lapsed
US
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Rolled minimally-invasive heart valves and methods of manufacture
Assignee: Individual
•
Filing: 2002-11-01
•
Granted: —
•
Expires: 2022-11-01
Abstract
Abstract Expandable heart valves for minimally invasive valve replacement surgeries are disclosed. The valves are rolled into a first, contracted configuration for minimally invasive delivery using a catheter, and then unrolled or unfurled at the implantation site. One- and two-piece stents may be used in conjunction with a plurality of flexible leaflet-forming membranes. The stents may include an annulus section, a sinus section with the membranes attached over sinus apertures, and an outflow section. Lockout tabs and making slots secure the stents in their expanded shapes. Alignment structure ensures concentric unfurling of the stent. Anchoring elements at the stent edges or in the stent body secure the valve within the annulus. A method of manufacture includes shape setting the sheet-like stent to ensure an outward bias during deployment. The stent may also include dear tracks for engagement with a gear mechanism for deployment. The stent is desirably made of a superelastic material such as Nitinol and may have areas removed or thinned to reduce the bending stresses when rolled into its small spiral for catheter delivery.
Inventors
- 👤 Matthew Pease
- 👤 Brandon Walsh
- 👤 Jibin Yang
- 👤 Travis Rowe
- 👤 Gregory Mast
- 👤 Tyson Gustus
- 👤 David Forster
- 👤 John Muskivitch
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-22 23:06
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2412; A61F2/2418; A61F2/82; A61F2/848; A61F2/92; A61F2220/00; A61F2220/0008; A61F2220/0016; A61F2220/0025; A61F2220/0075
Claims Analysis
Total Claims: 71
Claim 1
Independent Claim
68 words
1 . A rolled prosthetic heart valve suitable for minimally invasive delivery and implantation in a heart valve annulus, comprising: a stent body that has a generally tubular shape set and is structured to be rolled into a spiral sized to pass through a patient's vasculature; and a plurality of flexible membranes fastened to the inside of the stent body to form occluding leaflets of the heart valve.
Claim 2
Dependent Claim
68 words
1 . A rolled prosthetic heart valve suitable for minimally invasive delivery and implantation in a heart valve annulus, comprising: a stent body that has a generally tubular shape set and is structured to be rolled into a spiral sized to pass through a patient's vasculature; and a plurality of flexible membranes fastened to the inside of the stent body to form occluding leaflets of the heart valve.
Claim 3
Dependent Claim
68 words
2 . The heart valve of claim 1 , wherein the stent body is adapted to conform to a first, contracted configuration in which the stent body is spirally rolled about an axis, and a second, expanded configuration in which the stent body is substantially unrolled and at least partly forms a tube centered about the axis and sized to engage an annulus of a patient's heart valve.
Claim 4
Dependent Claim
38 words
3 . The heart valve of claim 2 , further including at least one guide to insure the stent body expands evenly along the axis during a conversion between the first, contracted configuration to the second, expanded configuration.
Claim 5
Dependent Claim
60 words
4 . The heart valve of claim 3 , wherein the stent body defines a pair of opposed side edges that generally mate in the second, expanded configuration, and a pair of opposed end edges that extend between the side edges, and the at least one guide comprises a tab extending generally radially along each one of the end edges.
Claim 6
Dependent Claim
22 words
5 . The heart valve of claim 1 , wherein the stent body forms the only rolled structure in the heart valve.
Claim 7
Dependent Claim
50 words
6 . The heart valve of claim 1 , wherein the stent body has an annulus section on an inflow end, a sinus section, and an outflow section, the sinus section being between the annulus section and outflow section and having a plurality of sinus apertures outward of each membrane.
Claim 8
Dependent Claim
39 words
7 . The heart valve of claim 6 , wherein there are three generally semi-circular sinus apertures, and three separate membranes fastened around the edge of each except on one side which forms a free edge of each leaflet.
Claim 9
Dependent Claim
37 words
8 . The heart valve of claim 7 , wherein the outer edge of each membrane is folded over and fastened to an inner surface of the stent body adjacent an edge of the associated sinus aperture.
Claim 10
Dependent Claim
111 words
9 . The heart valve of claim 1 , wherein the stent body is adapted to conform to a first, contracted configuration in which the stent body is spirally rolled about an axis, and a second, expanded configuration in which the stent body is substantially unrolled and at least partly forms a tube centered about the axis and sized to engage an annulus of a patient's heart valve, the tube having a pair of end edges, and wherein the stent body has a pair of opposed side edges that mate in the second, expanded configuration, the stent body further including lockout structure to retain the opposed side edges in mating engagement.
Claim 11
Dependent Claim
54 words
10 . The heart valve of claim 9 , wherein the lockout structure comprises tabs formed on both of the end edges and adjacent one of the side edges, and slots formed in both of the end edges adjacent the other of the side edges that are sized to receive and retain the tabs.
Claim 12
Dependent Claim
28 words
11 . The heart valve of claim 9 , wherein the lockout structure both prevents further expansion of the stent body and contraction from the expanded tubular shape.
Claim 13
Dependent Claim
41 words
12 . The heart valve of claim 1 , further including at least one anchoring element comprising a curved strip extending radially outward from the stent body designed to prevent axial migration of the heart valve after implantation in the annulus.
Claim 14
Dependent Claim
16 words
13 . The heart valve of claim 1 , wherein the flexible membranes are bioprosthetic tissue.
Claim 15
Dependent Claim
19 words
14 . The heart valve of claim 13 , wherein the bioprosthetic tissue is compressed to reduce its thickness.
Claim 16
Dependent Claim
19 words
15 . The heart valve of claim 1 , wherein the stent body is made of a superelastic material.
Claim 17
Dependent Claim
60 words
16 . A prosthetic heart valve suitable for minimally invasive delivery and expansion against a heart valve annulus, comprising: a stent body that has a first, contracted configuration with a first diameter for delivery through the vasculature of a patient and a second, expanded configuration with a predetermined maximum second diameter regardless of the size of the heart valve annulus.
Claim 18
Dependent Claim
60 words
16 . A prosthetic heart valve suitable for minimally invasive delivery and expansion against a heart valve annulus, comprising: a stent body that has a first, contracted configuration with a first diameter for delivery through the vasculature of a patient and a second, expanded configuration with a predetermined maximum second diameter regardless of the size of the heart valve annulus.
Claim 19
Dependent Claim
37 words
17 . The heart valve of claim 16 , wherein the stent body is a sheet-like member having a generally tubular shape and adapted to be rolled into a spiral sized to pass through a patient's vasculature.
Claim 20
Dependent Claim
43 words
18 . The heart valve of claim 17 , wherein the stent body has a plurality of sinus apertures and the heart valve further includes a plurality of flexible membranes fastened around the sinus apertures to form occluding leaflets of the heart valve.
Claim 21
Dependent Claim
117 words
19 . The heart valve of claim 17 , wherein the stent body is adapted to conform to a first, contracted configuration in which the stent body is spirally rolled about an axis, and a second, expanded configuration in which the stent body is substantially unrolled and at least partly forms a tube centered about the axis and sized to engage an annulus of a patient's heart valve, the tube having a pair of end edges, wherein the stent body has a pair of opposed side edges that mate in the second, expanded configuration, the stent body further including lockout structure to retain the opposed side edges in mating engagement and define the predetermined maximum second diameter.
Claim 22
Dependent Claim
54 words
20 . The heart valve of claim 19 , wherein the lockout structure comprises tabs formed on both of the end edges and adjacent one of the side edges, and slots formed in both of the end edges adjacent the other of the side edges that are sized to receive and retain the tabs.
Claim 23
Dependent Claim
36 words
21 . The heart valve of claim 19 , wherein the lockout structure both defines the predetermined maximum second diameter thus preventing further expansion of the stent body, and prevents contraction from the expanded tubular shape.
Claim 24
Dependent Claim
41 words
22 . The heart valve of claim 16 , further including at least one anchoring element comprising a curved strip extending radially outward from the stent body designed to prevent axial migration of the heart valve after implantation in the annulus.
Claim 25
Dependent Claim
42 words
23 . A method of prosthetic heart valve implantation, comprising: positioning a rolled prosthetic heart valve at a heart valve annulus; and unfurling the prosthetic heart valve from a spirally-wound contracted, first configuration to an unwound expanded, second configuration at the annulus.
Claim 26
Dependent Claim
42 words
23 . A method of prosthetic heart valve implantation, comprising: positioning a rolled prosthetic heart valve at a heart valve annulus; and unfurling the prosthetic heart valve from a spirally-wound contracted, first configuration to an unwound expanded, second configuration at the annulus.
Claim 27
Dependent Claim
36 words
24 . The method of claim 23 , wherein the prosthetic heart valve comprises a single stent body having a plurality of flexible, biocompatible membranes incorporated therein that form heart valve leaflets in the expanded configuration.
Claim 28
Dependent Claim
24 words
25 . The method of claim 23 , further including anchoring the prosthetic heart valve in its expanded configuration to the heart valve annulus.
Claim 29
Dependent Claim
41 words
26 . The method of claim 23 , wherein the native heart valve leaflets of the heart valve annulus are left in place and the step of unfurling causes the prosthetic heart valve to contact and outwardly compress the native leaflets.
Claim 30
Dependent Claim
24 words
27 . The method of claim 23 , wherein the step of unfurling further includes ensuring that the prosthetic heart valve remains generally tubular.
Claim 31
Dependent Claim
22 words
28 . The method of claim 23 , further including the step of locking the prosthetic heart valve in its expanded configuration.
Claim 32
Dependent Claim
118 words
29 . A rolled prosthetic heart valve suitable for minimally invasive delivery and implantation in a heart valve annulus, comprising: a stent body that has a generally tubular shape set and is structured to be rolled about a first axis into a contracted spiral sized to pass through a patient's vasculature and substantially unrolled into an expanded tube centered about a second axis parallel to the first axis, the tube being sized to engage an annulus of a patient's heart valve and having a pair of opposed side edges and a pair of generally axially-oriented and mating end edges; lockout structure to retain the opposed side edges in mating engagement; and valve leaflets connected to the stent body.
Claim 33
Dependent Claim
118 words
29 . A rolled prosthetic heart valve suitable for minimally invasive delivery and implantation in a heart valve annulus, comprising: a stent body that has a generally tubular shape set and is structured to be rolled about a first axis into a contracted spiral sized to pass through a patient's vasculature and substantially unrolled into an expanded tube centered about a second axis parallel to the first axis, the tube being sized to engage an annulus of a patient's heart valve and having a pair of opposed side edges and a pair of generally axially-oriented and mating end edges; lockout structure to retain the opposed side edges in mating engagement; and valve leaflets connected to the stent body.
Claim 34
Dependent Claim
35 words
30 . The heart valve of claim 29 , wherein the valve leaflets comprise a plurality of flexible membranes fastened to the inside of the stent body to form occluding leaflets of the heart valve.
Claim 35
Dependent Claim
48 words
31 . The heart valve of claim 30 , wherein the stent body has an annulus section on an inflow end, a sinus section, and an outflow section, the sinus section being between the annulus section and outflow section and having a sinus aperture outward of each membrane.
Claim 36
Dependent Claim
39 words
32 . The heart valve of claim 31 , wherein there are three generally semi-circular sinus apertures, and three separate membranes fastened around the edge of each except on one side which forms a free edge of each leaflet.
Claim 37
Dependent Claim
37 words
33 . The heart valve of claim 32 , wherein the outer edge of each membrane is folded over and fastened to an inner surface of the stent body adjacent an edge of the associated sinus aperture.
Claim 38
Dependent Claim
46 words
34 . The heart valve of claim 29 , further including at least one guide to insure the stent body expands evenly along the axis during a conversion between the contracted spiral to the expanded tube and the first axis remains parallel to the second axis.
Claim 39
Dependent Claim
28 words
35 . The heart valve of claim 34 , wherein the at least one guide comprises a tab extending generally radially from each one of the end edges.
Claim 40
Dependent Claim
54 words
36 . The heart valve of claim 29 , wherein the lockout structure comprises tabs formed on both of the end edges and adjacent one of the side edges, and slots formed in both of the end edges adjacent the other of the side edges that are sized to receive and retain the tabs.
Claim 41
Dependent Claim
28 words
37 . The heart valve of claim 29 , wherein the lockout structure both prevents further expansion of the stent body and contraction from the expanded tubular shape.
Claim 42
Dependent Claim
36 words
38 . The heart valve of claim 29 , wherein the lockout structure ensures the stent body has an expanded tubular shape with a predetermined maximum diameter regardless of the size of the heart valve annulus.
Claim 43
Dependent Claim
41 words
39 . The heart valve of claim 29 , further including at least one anchoring element comprising a curved strip extending radially outward from the stent body designed to prevent axial migration of the heart valve after implantation in the annulus.
Claim 44
Dependent Claim
16 words
40 . The heart valve of claim 29 , wherein the flexible membranes are bioprosthetic tissue.
Claim 45
Dependent Claim
19 words
41 . The heart valve of claim 40 , wherein the bioprosthetic tissue is compressed to reduce its thickness.
Claim 46
Dependent Claim
35 words
42 . The heart valve of claim 29 , wherein the stent body is a sheet-like member having reduced thickness tabs on a first side edge that form the inner portion of the contracted spiral.
Claim 47
Dependent Claim
138 words
43 . A rolled prosthetic heart valve suitable for minimally invasive delivery and implantation in a heart valve annulus, comprising: a sheet-like stent body that has a generally tubular shape set and is structured to be rolled about a first axis into a contracted spiral sized to pass through a patient's vasculature and substantially unrolled into an expanded tube centered about a second axis parallel to the first axis, the tube being sized to engage an annulus of a patient's heart valve and having a pair of opposed side edges and a pair of generally axially-oriented and mating end edges; at least one anchoring element comprising a curved strip extending radially outward from the stent body designed to prevent axial migration of the heart valve after implantation in the annulus; and valve leaflets connected to the stent body.
Claim 48
Dependent Claim
138 words
43 . A rolled prosthetic heart valve suitable for minimally invasive delivery and implantation in a heart valve annulus, comprising: a sheet-like stent body that has a generally tubular shape set and is structured to be rolled about a first axis into a contracted spiral sized to pass through a patient's vasculature and substantially unrolled into an expanded tube centered about a second axis parallel to the first axis, the tube being sized to engage an annulus of a patient's heart valve and having a pair of opposed side edges and a pair of generally axially-oriented and mating end edges; at least one anchoring element comprising a curved strip extending radially outward from the stent body designed to prevent axial migration of the heart valve after implantation in the annulus; and valve leaflets connected to the stent body.
Claim 49
Dependent Claim
34 words
44 . The heart valve of claim 43 , wherein-the valve leaflets comprise a plurality of flexible membranes fastened to the inside of the stent body to form occluding leaflets of the heart valve.
Claim 50
Dependent Claim
48 words
45 . The heart valve of claim 44 , wherein the stent body has an annulus section on an inflow end, a sinus section, and an outflow section, the sinus section being between the annulus section and outflow section and having a sinus aperture outward of each membrane.
Claim 51
Dependent Claim
45 words
46 . The heart valve of claim 43 , wherein there are at least three anchoring elements each formed by a pair of parallel slits in the stent that are bent radially outward in an arcuate shape so as to form partial rings or loops.
Claim 52
Dependent Claim
57 words
47 . The heart valve of claim 43 , wherein the stent body has an annulus section on an inflow end, a sinus section, and an outflow section, the sinus section being between the annulus section and outflow section, and wherein there are at least three anchoring elements on both the annulus section and the outflow section.
Claim 53
Dependent Claim
46 words
48 . The heart valve of claim 43 , further including at least one guide to insure the stent body expands evenly along the axis during a conversion between the contracted spiral to the expanded tube and the first axis remains parallel to the second axis.
Claim 54
Dependent Claim
28 words
49 . The heart valve of claim 48 , wherein the at least one guide comprises a tab extending generally radially from each one of the end edges.
Claim 55
Dependent Claim
22 words
50 . The heart valve of claim 43 , further including lockout structure to retain the opposed side edges in mating engagement.
Claim 56
Dependent Claim
54 words
51 . The heart valve of claim 50 , wherein the lockout structure comprises tabs formed on both of the end edges and adjacent one of the side edges, and slots formed in both of the end edges adjacent the other of the side edges that are sized to receive and retain the tabs.
Claim 57
Dependent Claim
28 words
52 . The heart valve of claim 50 , wherein the lockout structure both prevents further expansion of the stent body and contraction from the expanded tubular shape.
Claim 58
Dependent Claim
36 words
53 . The heart valve of claim 50 , wherein the lockout structure ensures the stent body has an expanded tubular shape with a predetermined maximum diameter regardless of the size of the heart valve annulus.
Claim 59
Dependent Claim
16 words
54 . The heart valve of claim 43 , wherein the flexible membranes are bioprosthetic tissue.
Claim 60
Dependent Claim
19 words
55 . The heart valve of claim 54 , wherein the bioprosthetic tissue is compressed to reduce its thickness.
Claim 61
Dependent Claim
31 words
56 . The heart valve of claim 43 , wherein the stent body has reduced thickness tabs on a first side edge that form the inner portion of the contracted spiral.
Claim 62
Dependent Claim
130 words
57 . A rolled prosthetic heart valve suitable for minimally invasive delivery and implantation in a heart valve annulus, comprising: a sheet-like stent body that has a generally tubular shape set and is structured to be rolled about a first axis into a contracted spiral sized to pass through a patient's vasculature and substantially unrolled into an expanded tube centered about a second axis parallel to the first axis, the tube being sized to engage an annulus of a patient's heart valve and having a pair of opposed side edges and a pair of generally axially-oriented and mating end edges, wherein the stent body has reduced thickness tabs on a first side edge that form the inner portion of the contracted spiral; and valve leaflets connected to the stent body.
Claim 63
Dependent Claim
130 words
57 . A rolled prosthetic heart valve suitable for minimally invasive delivery and implantation in a heart valve annulus, comprising: a sheet-like stent body that has a generally tubular shape set and is structured to be rolled about a first axis into a contracted spiral sized to pass through a patient's vasculature and substantially unrolled into an expanded tube centered about a second axis parallel to the first axis, the tube being sized to engage an annulus of a patient's heart valve and having a pair of opposed side edges and a pair of generally axially-oriented and mating end edges, wherein the stent body has reduced thickness tabs on a first side edge that form the inner portion of the contracted spiral; and valve leaflets connected to the stent body.
Claim 64
Dependent Claim
35 words
58 . The heart valve of claim 57 , wherein the valve leaflets comprise a plurality of flexible membranes fastened to the inside of the stent body to form occluding leaflets of the heart valve.
Claim 65
Dependent Claim
48 words
59 . The heart valve of claim 58 , wherein the stent body has an annulus section on an inflow end, a sinus section, and an outflow section, the sinus section being between the annulus section and outflow section and having a sinus aperture outward of each membrane.
Claim 66
Dependent Claim
46 words
60 . The heart valve of claim 57 , further including at least one guide to insure the stent body expands evenly along the axis during a conversion between the contracted spiral to the expanded tube and the first axis remains parallel to the second axis.
Claim 67
Dependent Claim
22 words
61 . The heart valve of claim 57 , further including lockout structure to retain the opposed side edges in mating engagement.
Claim 68
Dependent Claim
28 words
62 . The heart valve of claim 61 , wherein the lockout structure both prevents further expansion of the stent body and contraction from the expanded tubular shape.
Claim 69
Dependent Claim
26 words
63 . The heart valve of claim 57 , wherein the sheet-like stent body further includes thinned bend relief regions in areas having the most material.
Claim 70
Dependent Claim
27 words
64 . The heart valve of claim 63 , wherein the thinned regions are between 25%-50% of the thickness of the rest of the sheet-like stent body.
Claim 71
Dependent Claim
27 words
65 . The heart valve of claim 64 , wherein the thinned regions are between 40%-50% of the thickness of the rest of the sheet-like stent body.
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