Patent US2854425A successfully refreshed from Google Patents.
US6540781B2
Expired / Lapsed
US
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Cryopreserved homografts and other stentless bioprosthetic heart valves having natural tissue sewing rings
Assignee: The Brigham and Women's Hospital Inc
•
Filing: 2000-12-14
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Granted: 2003-04-01
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Expires: 2020-12-14
Abstract
Abstract Pre-trimmed, cryopreserved homografts and other stentless bioprosthetic heart valves having natural tissue sewing rings formed thereon. The sewing ring may be formed of strip of pericardium or other suitable tissue. Material may be captured between the natural tissue sewing ring and a sub-valvular lip formed on the valve to impart a desired size or shape to the sewing ring. In the case of cryopreserved embodiments of the invention (e.g., cryopreserved human homografts) the sewing ring is attached to the valve by way of a natural tissue suture, biological glue or other attachment component that is capable of undergoing cryopreservation without breaking, excessive weakening, or other changes that prevent it from performing its attachment function.
Inventors
- 👤 David H. Adams
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-24 15:48
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2412; A61F2/2415
Claims Analysis
Total Claims: 59
Claim 1
Independent Claim
127 words
A cryopreserved heart valve homograft comprising: a generally tubular segment of vascular tissue harvested from a mammalian donor, said tubular segment having an inflow end and an outflow end and a plurality of valve leaflets disposed within said tubular segment a spaced distance above the inflow end, the inflow end of said tubular segment being trimmed to form a subvalvular lip; and, a sewing ring formed of tissue harvested from a human donor, and comprising a cryopreservable material that is captured between the subvalvular lip and said sewing ring tissue, and is located to impart a desired shape to said sewing ring, said sewing ring being attached by a cryopreservable attachment component to said subvalvular lip; said tubular segment having said sewing ring attached thereto being cryopreserved.
Claim 2
Dependent Claim
127 words
A cryopreserved heart valve homograft comprising: a generally tubular segment of vascular tissue harvested from a mammalian donor, said tubular segment having an inflow end and an outflow end and a plurality of valve leaflets disposed within said tubular segment a spaced distance above the inflow end, the inflow end of said tubular segment being trimmed to form a subvalvular lip; and, a sewing ring formed of tissue harvested from a human donor, and comprising a cryopreservable material that is captured between the subvalvular lip and said sewing ring tissue, and is located to impart a desired shape to said sewing ring, said sewing ring being attached by a cryopreservable attachment component to said subvalvular lip; said tubular segment having said sewing ring attached thereto being cryopreserved.
Claim 3
Dependent Claim
12 words
A homograft according to claim 1 wherein the sewing ring comprises pericardium.
Claim 4
Dependent Claim
27 words
A homograft according to claim 1 wherein said generally tubular segment comprises a segment of the donor's aorta and said leaflets comprise the donors aortic valve leaflets.
Claim 5
Dependent Claim
28 words
A homograft according to claim 1 wherein said generally tubular segment comprises a segment of the donor's pulmonary artery and said leaflets comprise the donor's pulmonary valve leaflets.
Claim 6
Dependent Claim
43 words
A homograft according to claim 1 wherein the cryopreservable attachment component is selected from the group consisting of: a cryopreservable suture material; catgut suture material; suture material prepared from natural tissue; a cryopreservable adhesive; a biological adhesive; a fibrin glue; possible combinations thereof.
Claim 7
Dependent Claim
33 words
A homograft according to claim 1 wherein the sewing ring comprises a tissue that is selected from the group of tissues consisting of: pericardium; dura mater; tendon sheath; fascia; and, possible combinations thereof.
Claim 8
Dependent Claim
54 words
A homograft according to claim 1 wherein the subvalvular lip has an upper portion formed substantially of connective tissue and a lower portion formed substantially of other than connective tissue, and wherein the homograft further comprises marking formed on the sewing ring to denote the location of said upper portion of the, subvalvular lip.
Claim 9
Dependent Claim
23 words
A homograft according to claim 1 wherein the subvalvular lip has been trimmed to provide a sewing ring of predetermined length and diameter.
Claim 10
Dependent Claim
146 words
A cryopreserved heart valve homograft comprising: a generally tubular segment of vascular tissue harvested from a mammalian donor, said tubular segment having an inflow end and an outflow end and a plurality of valve leaflets disposed within said tubular segment a spaced distance above the inflow end, the inflow end of said tubular segment being trimmed to form a subvalvular lip; and, a sewing ring formed of tissue harvested from a human donor, said sewing ring being attached by a cryopreservable attachment component to said subvalvular lip; said tubular segment having said sewing ring attached thereto being cryopreserved; wherein the subvalvular lip has an upper portion formed substantially of connective tissue and a lower portion formed substantially of other than connective tissue, and wherein the homograft further comprises markings formed on the sewing ring to denote the location of said upper portion of the subvalvular lip.
Claim 11
Dependent Claim
146 words
A cryopreserved heart valve homograft comprising: a generally tubular segment of vascular tissue harvested from a mammalian donor, said tubular segment having an inflow end and an outflow end and a plurality of valve leaflets disposed within said tubular segment a spaced distance above the inflow end, the inflow end of said tubular segment being trimmed to form a subvalvular lip; and, a sewing ring formed of tissue harvested from a human donor, said sewing ring being attached by a cryopreservable attachment component to said subvalvular lip; said tubular segment having said sewing ring attached thereto being cryopreserved; wherein the subvalvular lip has an upper portion formed substantially of connective tissue and a lower portion formed substantially of other than connective tissue, and wherein the homograft further comprises markings formed on the sewing ring to denote the location of said upper portion of the subvalvular lip.
Claim 12
Dependent Claim
12 words
A homograft according to claim 9 wherein the sewing ring comprises pericardium.
Claim 13
Dependent Claim
27 words
A homograft according to claim 9 wherein said generally tubular segment comprises a segment of the donor's aorta and said leaflets comprise the donor's aortic valve leaflets.
Claim 14
Dependent Claim
28 words
A homograft according to claim 9 wherein said generally tubular segment comprises a segment of the donor's pulmonary artery and said leaflets comprise the donor's pulmonary valve leaflets.
Claim 15
Dependent Claim
43 words
A homograft according to claim 9 wherein the cryopreservable attachment component is selected from the group consisting of: a cryopreservable suture material; catgut suture material; suture material prepared from natural tissue; a cryopreservable adhesive; a biological adhesive; a fibrin glue; possible combinations thereof.
Claim 16
Dependent Claim
33 words
A homograft according to claim 9 wherein the sewing ring comprises a tissue that is selected from the group of tissues consisting of: pericardium; dura mater; tendon sheath; fascia; and, possible combinations thereof.
Claim 17
Dependent Claim
26 words
A homograft according to claim 9 wherein the sewing ring further comprises cryopreservable material that is captured between the subvalvular lip and said sewing ring tissue.
Claim 18
Dependent Claim
31 words
A homograft according to claim 15 wherein the cryopreservable material captured between the subvalvular lip and said sewing ring tissue is located to impart a desired shape to said sewing ring.
Claim 19
Dependent Claim
23 words
A homograft according to claim 9 wherein the subvalvular lip has been trimmed to provide a sewing ring of predetermined length and diameter.
Claim 20
Dependent Claim
115 words
A cryopreserved heart valve homograft comprising: a generally tubular segment of vascular tissue harvested from a mammalian donor, said tubular segment having an inflow end and an outflow end and a plurality of valve leaflets disposed within said tubular segment a spaced distance above the Inflow end, the inflow end of said tubular segment being trimmed to form a subvalvular lip; and, a sewing ring formed of tissue harvested from a human donor, said sewing ring being attached by a cryopreservable attachment component to said subvalvular lip; said tubular segment having said sewing ring attached thereto being cryopreserved; wherein the subvalvular lip has been trimmed to provide a sewing ring of predetermined length and diameter.
Claim 21
Dependent Claim
115 words
A cryopreserved heart valve homograft comprising: a generally tubular segment of vascular tissue harvested from a mammalian donor, said tubular segment having an inflow end and an outflow end and a plurality of valve leaflets disposed within said tubular segment a spaced distance above the Inflow end, the inflow end of said tubular segment being trimmed to form a subvalvular lip; and, a sewing ring formed of tissue harvested from a human donor, said sewing ring being attached by a cryopreservable attachment component to said subvalvular lip; said tubular segment having said sewing ring attached thereto being cryopreserved; wherein the subvalvular lip has been trimmed to provide a sewing ring of predetermined length and diameter.
Claim 22
Dependent Claim
12 words
A homograft according to claim 18 wherein the sewing ring comprises pericardium.
Claim 23
Dependent Claim
27 words
A homograft according to claim 18 wherein said generally tubular segment comprises a segment of the donor's aorta and said leaflets comprise the donor's aortic valve leaflets.
Claim 24
Dependent Claim
28 words
A homograft according to claim 18 wherein said generally tubular segment comprises a segment of the donor's pulmonary artery and said leaflets comprise the donor's pulmonary valve leaflets.
Claim 25
Dependent Claim
43 words
A homograft according to claim 18 wherein the cryopreservable attachment component is selected from the group consisting of: a cryopreservable suture material; catgut suture material; suture material prepared from natural tissue; a cryopreservable adhesive; a biological adhesive; a fibrin glue; possible combinations thereof.
Claim 26
Dependent Claim
33 words
A homograft according to claim 18 wherein the sewing ring comprises a tissue that is selected from the group of tissues consisting of: pericardium; dura mater; tendon sheath; fascia; and, possible combinations thereof.
Claim 27
Dependent Claim
26 words
A homograft according to claim 18 wherein the sewing ring further comprises cryopreservable material that is captured between the subvalvular lip and said sewing ring tissue.
Claim 28
Dependent Claim
31 words
A homograft according to claim 24 wherein the cryopreservable material captured between the subvalvular lip and said sewing ring tissue is located to impart a desired shape to said sewing ring.
Claim 29
Dependent Claim
54 words
A homograft according to claim 18 wherein the subvalvular lip has an upper portion formed substantially of connective tissue and a lower portion formed substantially of other than connective tissue, and wherein the homograft further comprises marking formed on the sewing ring to denote the location of said upper portion of the subvalvular lip.
Claim 30
Dependent Claim
115 words
A stentless heart valve bioprosthesis comprising: a generally tubular segment of vascular tissue that has an inflow end and an outflow end; a plurality of valve leaflets disposed within said tubular segment a spaced distance above the inflow end such that a subvalvular lip exists at the inflow end of the tubular segment beneath the valve leaflets; and, a sewing ring that has been attached to and extends at least partially about the subvalvular lip of said tubular segment, said sewing ring comprising sewing ring tissue that has been harvested from a mammalian donor; wherein said generally tubular segment comprises a segment of the donor's aorta and said leaflets comprise the donor's aortic valve leaflets.
Claim 31
Dependent Claim
115 words
A stentless heart valve bioprosthesis comprising: a generally tubular segment of vascular tissue that has an inflow end and an outflow end; a plurality of valve leaflets disposed within said tubular segment a spaced distance above the inflow end such that a subvalvular lip exists at the inflow end of the tubular segment beneath the valve leaflets; and, a sewing ring that has been attached to and extends at least partially about the subvalvular lip of said tubular segment, said sewing ring comprising sewing ring tissue that has been harvested from a mammalian donor; wherein said generally tubular segment comprises a segment of the donor's aorta and said leaflets comprise the donor's aortic valve leaflets.
Claim 32
Dependent Claim
31 words
A stentless heart valve bioprosthesis according to claim 27 wherein the sewing ring comprises a strip of pericardium that has been attached to the subvalvular lip of the generally tubular segment.
Claim 33
Dependent Claim
41 words
A stentless heart valve bioprosthesis according to claim 27 wherein at least the tubular segment and the leaflets were harvested from a donor of the same species as the recipient into whom the stentless heart valve homograft is to be implanted.
Claim 34
Dependent Claim
39 words
A stentless heart valve bioprosthesis according to claim 27 wherein the sewing ring comprises tissue that was harvested from a donor of the same species as the recipient into whom the stentless heart valve homograft is to be implanted.
Claim 35
Dependent Claim
36 words
A stentless heart valve bioprosthesis according to claim 27 wherein the sewing ring comprises a tissue that is selected from the group of tissues consisting of: pericardium; dura mater; tendon sheath; fascia; and, possible combinations thereof.
Claim 36
Dependent Claim
17 words
A stentless heart valve bioprosthesis according to claim 27 formed entirely of biological tissue that is cryopreservable.
Claim 37
Dependent Claim
53 words
A stentless heart valve bioprosthesis according to claim 27 wherein the sewing ring is attached to said subvalvular tissue lip by a cryopreservable attachment component selected from the group consisting of: a cryopreservable suture material; suture material prepared from natural tissue; a cryopreservable adhesive; a biological adhesive; a fibrin glue; possible combinations thereof.
Claim 38
Dependent Claim
19 words
A stentless heart valve bioprosthesis according to claim 27 wherein the biological tissue thereof is preserved by chemical fixation.
Claim 39
Dependent Claim
31 words
A stentless heart valve bioprosthesis according to claim 27 wherein the sewing ring further comprises a quantity of material that is captured between the subvalvular lip and said sewing ring tissue.
Claim 40
Dependent Claim
35 words
A stentless heart valve bioprosthesis according to claim 35 wherein the material captured between the subvalvular lip and said sewing ring tissue is sized and located to impart a desired shape to said sewing ring.
Claim 41
Dependent Claim
14 words
A stentless heart valve prosthesis according to claim 27 formed entirely of cryopreservable material.
Claim 42
Dependent Claim
13 words
A stentless heart valve prosthesis according to claim 37 which has been cryopreserved.
Claim 43
Dependent Claim
23 words
A stentless heart valve prosthesis according to claim 38 wherein the bioprosthesis is a heterograft formed of tissue harvested from a non-human species.
Claim 44
Dependent Claim
35 words
A stentless heart valve prosthesis according to claim 39 wherein the animal from which the tissue is harvested was genetically engineered to produce tissue suitable for transplantation into a human recipient without substantial immunogenic rejection.
Claim 45
Dependent Claim
116 words
A stentless heart valve bioprosthesis comprising: a generally tubular segment of vascular tissue that has an inflow end and an outflow end; a plurality of valve leaflets disposed within said tubular segment a spaced distance above the inflow end such that a subvalvular lip exists at the inflow end of the tubular segment beneath the valve leaflets; and, a sewing ring that has been attached to and extends at least partially about the subvalvular lip of said tubular segment, said sewing ring comprising sewing ring tissue that has been harvested from a mammalian donor; wherein said generally tubular segment comprises a segment of the donor's pulmonary artery and said leaflets comprise the donor's pulmonary valve leaflets.
Claim 46
Dependent Claim
116 words
A stentless heart valve bioprosthesis comprising: a generally tubular segment of vascular tissue that has an inflow end and an outflow end; a plurality of valve leaflets disposed within said tubular segment a spaced distance above the inflow end such that a subvalvular lip exists at the inflow end of the tubular segment beneath the valve leaflets; and, a sewing ring that has been attached to and extends at least partially about the subvalvular lip of said tubular segment, said sewing ring comprising sewing ring tissue that has been harvested from a mammalian donor; wherein said generally tubular segment comprises a segment of the donor's pulmonary artery and said leaflets comprise the donor's pulmonary valve leaflets.
Claim 47
Dependent Claim
31 words
A stentless heart valve bioprosthesis according to claim 41 wherein the sewing ring comprises a strip of pericardium that has been attached to the subvalvular lip of the generally tubular segment.
Claim 48
Dependent Claim
41 words
A stentless heart valve bioprosthesis according to claim 41 wherein at least the tubular segment and the leaflets were harvested from a donor of the same species as the recipient into whom the stentless heart valve homograft is to be implanted.
Claim 49
Dependent Claim
39 words
A stentless heart valve bioprosthesis according to claim 41 wherein the sewing ring comprises tissue that was harvested from a donor of the same species as the recipient into whom the stentless heart valve homograft is to be implanted.
Claim 50
Dependent Claim
36 words
A stentless heart valve bioprosthesis according to claim 41 wherein the sewing ring comprises a tissue that is selected from the group of tissues consisting of: pericardium; dura mater; tendon sheath; fascia; and, possible combinations thereof.
Claim 51
Dependent Claim
17 words
A stentless heart valve bioprosthesis according to claim 41 formed entirely of biological tissue that is cryopreservable.
Claim 52
Dependent Claim
53 words
A stentless heart valve bioprosthesis according to claim 46 wherein the sewing ring is attached to said subvalvular tissue lip by a cryopreservable attachment component selected from the group consisting of: a cryopreservable suture material; suture material prepared from natural tissue; a cryopreservable adhesive; a biological adhesive; a fibrin glue; possible combinations thereof.
Claim 53
Dependent Claim
19 words
A stentless heart valve bioprosthesis according to claim 41 wherein the biological tissue thereof is preserved by chemical fixation.
Claim 54
Dependent Claim
31 words
A stentless heart valve bioprosthesis according to claim 41 wherein the sewing ring further comprises a quantity of material that is captured between the subvalvular lip and said sewing ring tissue.
Claim 55
Dependent Claim
35 words
A stentless heart valve bioprosthesis according to claim 49 wherein the material captured between the subvalvular lip and said sewing ring tissue is sized and located to impart a desired shape to said sewing ring.
Claim 56
Dependent Claim
14 words
A stentless heart valve prosthesis according to claim 41 formed entirely of cryopreservable material.
Claim 57
Dependent Claim
13 words
A stentless heart valve prosthesis according to claim 51 which has been cryopreserved.
Claim 58
Dependent Claim
23 words
A stentless heart valve prosthesis according to claim 52 wherein the bioprosthesis is a heterograft formed of tissue harvested from a non-human species.
Claim 59
Dependent Claim
35 words
A stentless heart valve prosthesis according to claim 53 wherein the animal from which the tissue is harvested was genetically engineered to produce tissue suitable for transplantation into a human recipient without substantial immunogenic rejection.
References Cited (Backward Citations)
US3548418A
Cited
US4759759A
Cited
GB2149062A
Cited
US4629459A
Cited
EP0183904A2
Cited
US4890457A
Cited
EP0276975A1
Cited
US5156621A
Cited
EP0402036A1
Cited
US5352240A
Cited
WO1992003990A1
Cited
US5197979A
Cited
US5336616A
Cited
US5713953A
Cited
WO1993004643A1
Cited
WO1996040007A1
Cited
US5910169A
Cited
US5733331A
Cited
EP0581233A1
Cited
WO1994007437A1
Cited
WO1997024083A1
Cited
WO1997024082A1
Cited
US5824063A
Cited
WO1995016411A1
Cited
US5509930A
Cited
US5632778A
Cited
US5843182A
Cited
WO1995024873A1
Cited
US5843180A
Cited
US5843181A
Cited
US5593424A
Cited
WO1996007373A1
Cited
US5769780A
Cited
WO1996040012A1
Cited
WO1997000651A1
Cited
US5824065A
Cited
US5824067A
Cited
US5662704A
Cited
WO1997020524A1
Cited
WO1997037618A1
Cited
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