US6524339B1
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: 1999-01-27
•
Granted: 2003-02-25
•
Expires: 2019-01-27
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
2026-11-02 07:06
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2412; A61F2/2415
Claims Analysis
Total Claims: 54
Claim 1
Independent Claim
98 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.
Claim 2
Dependent Claim
98 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.
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 donors 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
26 words
A homograft according to claim 1 wherein the sewing ring further comprises cryopreservable material that is captured between the subvalvular lip and said sewing ring tissue.
Claim 9
Dependent Claim
31 words
A homograft according to claim 7 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 10
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 11
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 12
Dependent Claim
107 words
A cryopreserved 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; 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; and a cryopreservable attachment component attaching the sewing ring to said subvalvular lip.
Claim 13
Dependent Claim
107 words
A cryopreserved 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; 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; and a cryopreservable attachment component attaching the sewing ring to said subvalvular lip.
Claim 14
Dependent Claim
31 words
A stentless heart valve bioprosthesis according to claim 11 wherein the sewing ring comprises a strip of pericardium that has been attached to the subvalvular lip of the generally tubular segment.
Claim 15
Dependent Claim
30 words
A stentless aortic valve bioprosthesis according to claim 11 wherein said generally tubular segment comprises a segment of the donor's aorta and said leaflets comprise the donor's aortic valve leaflets.
Claim 16
Dependent Claim
31 words
A stentless pulmonary valve bioprosthesis according to claim 11 wherein said generally tubular segment comprises a segment of the donor's pulmonary artery and said leaflets comprise the donors pulmonary valve leaflets.
Claim 17
Dependent Claim
41 words
A stentless heart valve bioprosthesis according to claim 11 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 18
Dependent Claim
39 words
A stentless heart valve bioprosthesis according to claim 11 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 19
Dependent Claim
36 words
A stentless heart valve bioprosthesis according to claim 11 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 20
Dependent Claim
17 words
A stentless heart valve bioprosthesis according to claim 11 formed entirely of biological tissue that is cryopreservable.
Claim 21
Dependent Claim
43 words
A stentless heart valve bioprosthesis according to claim 18 wherein the cryopreservable attachment component is 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 22
Dependent Claim
19 words
A stentless heart valve bioprosthesis according to claim 11 wherein the biological tissue thereof is preserved by chemical fixation.
Claim 23
Dependent Claim
31 words
A stentless heart valve bioprosthesis according to claim 11 wherein the sewing ring further comprises a quantity of material that is captured between the subvalvular lip and said sewing ring tissue.
Claim 24
Dependent Claim
35 words
A stentless heart valve bioprosthesis according to claim 21 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 25
Dependent Claim
14 words
A stentless heart valve prosthesis according to claim 11 formed entirely of cryopreservable material.
Claim 26
Dependent Claim
13 words
A stentless heart valve prosthesis according to claim 23 which has been cryopreserved.
Claim 27
Dependent Claim
23 words
A stentless heart valve prosthesis according to claim 24 wherein the bioprosthesis is a heterograft formed of tissue harvested from a non-human species.
Claim 28
Dependent Claim
35 words
A stentless heart valve prosthesis according to claim 25 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 29
Dependent Claim
120 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; a sewing ring formed of tissue harvested from a human donor; and a cryopreservable attachment component attaching the sewing ring to said subvalvular lip, said cryopreservable attachment component been selected from the group consisting of: a cryopreservable suture material; and a cryopreservable adhesive, said tubular segment having said sewing ring attached thereto using said cryopreservable attachment component been cryopreserved.
Claim 30
Dependent Claim
120 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; a sewing ring formed of tissue harvested from a human donor; and a cryopreservable attachment component attaching the sewing ring to said subvalvular lip, said cryopreservable attachment component been selected from the group consisting of: a cryopreservable suture material; and a cryopreservable adhesive, said tubular segment having said sewing ring attached thereto using said cryopreservable attachment component been cryopreserved.
Claim 31
Dependent Claim
12 words
A homograft according to claim 27 wherein the sewing ring comprises pericardium.
Claim 32
Dependent Claim
32 words
A homograft according to claim 27 wherein the sewing ring comprises a tissue that is selected from the group of tissues consisting of: dura mater; tendon sheath; fascia; and, possible combinations thereof.
Claim 33
Dependent Claim
27 words
A homograft according to claim 27 wherein said generally tubular segment comprises a segment of the donor's aorta and said leaflets comprise the donor's aortic valve leaflets.
Claim 34
Dependent Claim
28 words
A homograft according to claim 27 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 35
Dependent Claim
26 words
A homograft according to claim 27 wherein the sewing ring further comprises cryopreservable material that is captured between the subvalvular lip and said sewing ring tissue.
Claim 36
Dependent Claim
31 words
A homograft according to claim 32 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 37
Dependent Claim
54 words
A homograft according to claim 27 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 38
Dependent Claim
23 words
A homograft according to claim 27 wherein the subvalvular lip has been trimmed to provide a sewing ring of predetermined length and diameter.
Claim 39
Dependent Claim
120 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; 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; and, a cryopreservable attachment component attaching the sewing ring to said subvalvular lip selected from the group consisting of: a cryopreservable suture material; and a cryopreservable adhesive.
Claim 40
Dependent Claim
120 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; 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; and, a cryopreservable attachment component attaching the sewing ring to said subvalvular lip selected from the group consisting of: a cryopreservable suture material; and a cryopreservable adhesive.
Claim 41
Dependent Claim
31 words
A stentless heart valve bioprosthesis according to claim 36 wherein the sewing ring comprises a strip of pericardium that has been attached to the subvalvular lip of the generally tubular segment.
Claim 42
Dependent Claim
35 words
A stentless heart valve bioprosthesis according to claim 36 wherein the sewing ring comprises a tissue that is selected from the group of tissues consisting of: dura mater; tendon sheath; fascia; and, possible combinations thereof.
Claim 43
Dependent Claim
30 words
A stentless aortic valve bioprosthesis according to claim 36 wherein said generally tubular segment comprises a segment of the donor's aorta and said leaflets comprise the donor's aortic valve leaflets.
Claim 44
Dependent Claim
31 words
A stentless pulmonary valve bioprosthesis according to claim 36 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 45
Dependent Claim
41 words
A stentless heart valve bioprosthesis according to claim 36 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 46
Dependent Claim
39 words
A stentless heart valve bioprosthesis according to claim 36 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 47
Dependent Claim
17 words
A stentless heart valve bioprosthesis according to claim 36 formed entirely of biological tissue that is cryopreservable.
Claim 48
Dependent Claim
19 words
A stentless heart valve bioprosthesis according to claim 36 wherein the biological tissue thereof is preserved by chemical fixation.
Claim 49
Dependent Claim
31 words
A stentless heart valve bioprosthesis according to claim 36 wherein the sewing ring further comprises a quantity of material that is captured between the subvalvular lip and said sewing ring tissue.
Claim 50
Dependent Claim
35 words
A stentless heart valve bioprosthesis according to claim 45 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 51
Dependent Claim
14 words
A stentless heart valve prosthesis according to claim 36 formed entirely of cryopreservable material.
Claim 52
Dependent Claim
13 words
A stentless heart valve prosthesis according to claim 47 which has been cryopreserved.
Claim 53
Dependent Claim
23 words
A stentless heart valve prosthesis according to claim 48 wherein the bioprosthesis is a heterograft formed of tissue harvested from a non-human species.
Claim 54
Dependent Claim
35 words
A stentless heart valve prosthesis according to claim 49 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.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2006-02-24 | 2006-08-26 | 2007-02-25 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2010-02-24 | 2010-08-26 | 2011-02-25 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2014-02-24 | 2014-08-26 | 2015-02-25 | $7700.00 | Window Closed / Lapsed |