WO2000044312A1 - Cryopreserved homografts and other stentless bioprosthetic heart valves having natural tissue sewing rings - Google Patents
Cryopreserved homografts and other stentless bioprosthetic heart valves having natural tissue sewing rings Download PDFInfo
- Publication number
- WO2000044312A1 WO2000044312A1 PCT/US2000/001223 US0001223W WO0044312A1 WO 2000044312 A1 WO2000044312 A1 WO 2000044312A1 US 0001223 W US0001223 W US 0001223W WO 0044312 A1 WO0044312 A1 WO 0044312A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- tissue
- sewing ring
- homograft
- lip
- heart valve
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2415—Manufacturing methods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
Definitions
- heterograft heart valves are formed of tissue that has been harvested from the heart of an animal, such as a pig, and has been treated with a chemical fixative to preserve the tissue for subsequent implantation.
- homograft heart valves are formed of tissue that has been harvested from cadaveric human donors, or from the explanted hearts of a human heart transplant recipients who's ailing hearts had healthy valves despite the presence of cardiomyopathy or other cardiac pathology. The harvested homograft tissue is then treated chemically to kill any viruses or other microbes and subsequently cryopreserved (i.e., cooled to a very low temperature by immersion in liquid nitrogen) until the time of implantation.
- the chemical fixation of biological tissues contained in bioprosthetic heart valves can be accomplished by contacting the tissue with one or more chemicals which will crosslink collagen and elastin molecules which are present within the tissue. Such crosslinking of the collagen and elastin serves to preserve the tissue so that it may be stored until it is needed for implantation in a patient.
- Examples of the types of biological tissues that are suitable for chemical fixation include cardiac valvular tissue, blood vessels, skin, dura mater, pericardium, ligaments and tendons.
- These anatomical structures typically contain connective tissue matrices, formed of collagen and elastin, and the cellular parenchyma of each tissue is disposed within and supported by its connective tissue matrix.
- Each collagen molecule consists of three (3) polypeptide chains which are intertwined in a coiled helical confirmation.
- Chemical fixatives i.e., tanning agents
- used to preserve biological tissues generally form chemical cross-linkages between the amino groups on the polypeptide chains within a given collagen molecules, or between adjacent collagen molecules.
- factors which determine the rate at which chemically-fixed bioprosthetic grafts undergo calcification have not been fully elucidated.
- factors which are thought to influence the rate of calcification include: a) patient's age; b) existing metabolic disorders (i.e., hypercalcemia, diabetes, etc.); c) dietary factors; d) race; e) infection; f) parenteral calcium administration; g) dehydration; h) distortion/mechanical factors; i) inadequate coagulation therapy during initial period following surgical implantation; and j) host tissue responses.
- a proximal suture line attaching the homograft 10 to the left ventricular outflow tract is begun by placing simple interrupted or mattress stitches 34 of appropriate suture material (e.g., 4/0 Ethibond braided suture material) through the annular connective tissue ACT surrounding the patient's valve annulus AN, as shown in Figure 3A.
- appropriate suture material e.g., 4/0 Ethibond braided suture material
- these stitches 34 may be placed through septal myocardium and the unsupported anterior leaflet of the mitral valve and/or roof of left atrium to gain sufficient suture-holding capacity in the absence of sufficient annular connective tissue ACT.
- the repair is then completed by anastomosis of the ascending aorta to the aortic root, the patient is removed from cardiopulmonary bypass, and the thoracotomy (sternotomy) incision is closed.
- the sewing ring tissue strip 14 used to form the natural tissue sewing ring 14A need not necessarily be made of cryopreserved tissue harvested from the same donor as the valve itself, but rather may be a chemically fixed (“tanned") instead of cryopreserved and/or may have been harvested from any suitable human or animal (e.g., porcine, bovine) donor.
- this invention includes cryopreserved stented or stentless heterografts formed wholly or partially of tissues that have been harvested from non-human animal species (e.g., porcine, bovine), such as pigs that have been genetically altered or genetically engineered to produce tissue that is human-compatable and can be transplanted into human recipients without rejection or significant immunogenic reaction. Accordingly, it is intended that all such additions, deletions, changes and alterations be included within the scope of the following claims.
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA002360559A CA2360559A1 (en) | 1999-01-27 | 2000-01-18 | Cryopreserved homografts and other stentless bioprosthetic heart valves having natural tissue sewing rings |
JP2000595617A JP2003524457A (en) | 1999-01-27 | 2000-01-18 | Cryopreserved homografts and other stentless bioprosthetic heart valves with natural cell suture rings |
EP00904405A EP1154737A1 (en) | 1999-01-27 | 2000-01-18 | Cryopreserved homografts and other stentless bioprosthetic heart valves having natural tissue sewing rings |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/238,964 | 1999-01-27 | ||
US09/238,964 US6524339B1 (en) | 1999-01-27 | 1999-01-27 | Cryopreserved homografts and other stentless bioprosthetic heart valves having natural tissue sewing rings |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2000044312A1 true WO2000044312A1 (en) | 2000-08-03 |
Family
ID=22900061
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2000/001223 WO2000044312A1 (en) | 1999-01-27 | 2000-01-18 | Cryopreserved homografts and other stentless bioprosthetic heart valves having natural tissue sewing rings |
Country Status (5)
Country | Link |
---|---|
US (2) | US6524339B1 (en) |
EP (1) | EP1154737A1 (en) |
JP (1) | JP2003524457A (en) |
CA (1) | CA2360559A1 (en) |
WO (1) | WO2000044312A1 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2001049217A2 (en) * | 1999-12-30 | 2001-07-12 | St. Jude Medical, Inc. | Heart valve |
Families Citing this family (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1592367B1 (en) | 2002-08-28 | 2016-04-13 | HLT, Inc. | Method and device for treating diseased valve |
US6830585B1 (en) * | 2003-01-14 | 2004-12-14 | 3F Therapeutics, Inc. | Percutaneously deliverable heart valve and methods of implantation |
USRE44050E1 (en) | 2003-06-27 | 2013-03-05 | University Of South Florida | Vascular prosthesis |
US7488346B2 (en) * | 2004-01-21 | 2009-02-10 | The Cleveland Clinic Foundation | Method and apparatus for replacing a mitral valve and an aortic valve with a single homograft |
US20070038294A1 (en) * | 2004-01-21 | 2007-02-15 | Navia Jose L | Method and apparatus for replacing a mitral valve and an aortic valve with a homograft |
EP3072475B1 (en) | 2005-05-27 | 2018-10-03 | HLT, Inc. | Stentless support structure |
US7575592B2 (en) * | 2006-10-03 | 2009-08-18 | St. Jude Medical, Inc. | Synthetic blood vessel grafts |
US8163011B2 (en) * | 2006-10-06 | 2012-04-24 | BioStable Science & Engineering, Inc. | Intra-annular mounting frame for aortic valve repair |
US20090157176A1 (en) * | 2007-02-09 | 2009-06-18 | Alain Carpentier | Annuloplasty rings for correcting degenerative valvular diseases |
FR2951549B1 (en) | 2009-10-15 | 2013-08-23 | Olivier Schussler | PROCESS FOR OBTAINING IMPLANTABLE MEDICAL BIOPROTHESES |
EP2569043B1 (en) | 2010-05-10 | 2023-12-13 | Edwards Lifesciences Corporation | Stentless support structure |
US8696737B2 (en) | 2010-08-11 | 2014-04-15 | Hlt, Inc. | Reinforced commissural support structure |
US9522064B2 (en) | 2011-05-16 | 2016-12-20 | Hlt, Inc. | Inversion delivery device and method for a prosthesis |
US9301835B2 (en) * | 2012-06-04 | 2016-04-05 | Edwards Lifesciences Corporation | Pre-assembled bioprosthetic valve and sealed conduit |
US9486314B2 (en) | 2013-03-15 | 2016-11-08 | Hlt, Inc. | Low-profile prosthetic valve structure |
US9999504B2 (en) | 2014-10-13 | 2018-06-19 | Hlt, Inc. | Inversion delivery device and method for a prosthesis |
Citations (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4120649A (en) | 1975-04-10 | 1978-10-17 | Israel Schechter | Transplants |
EP0103947A2 (en) | 1982-08-25 | 1984-03-28 | McNeilab, Inc. | Method for inhibiting mineralization of natural tissue during implantation |
WO1984001879A1 (en) | 1982-11-12 | 1984-05-24 | American Hospital Supply Corp | Surfactant treatment of implantable biological tissue to inhibit calcification |
US4648881A (en) | 1982-03-23 | 1987-03-10 | American Hospital Supply Corporation | Implantable biological tissue and process for preparation thereof |
US4759758A (en) | 1984-12-07 | 1988-07-26 | Shlomo Gabbay | Prosthetic heart valve |
US4885005A (en) | 1982-11-12 | 1989-12-05 | Baxter International Inc. | Surfactant treatment of implantable biological tissue to inhibit calcification |
US4890457A (en) * | 1987-01-02 | 1990-01-02 | Cryolife, Inc. | Method for cryopreserving heart valves |
US4890437A (en) | 1987-07-09 | 1990-01-02 | Quaile Allan T | Segmented arch structure |
US4976733A (en) | 1988-02-03 | 1990-12-11 | Biomedical Design, Inc. | Prevention of prosthesis calcification |
US5156621A (en) * | 1988-03-22 | 1992-10-20 | Navia Jose A | Stentless bioprosthetic cardiac valve |
US5197979A (en) * | 1990-09-07 | 1993-03-30 | Baxter International Inc. | Stentless heart valve and holder |
US5509930A (en) * | 1993-12-17 | 1996-04-23 | Autogenics | Stentless heart valve |
US5632778A (en) * | 1994-03-14 | 1997-05-27 | Cryolife, Inc. | Treated tissue for implantation and methods of preparation |
US5662704A (en) * | 1995-12-01 | 1997-09-02 | Medtronic, Inc. | Physiologic mitral valve bioprosthesis |
US5733331A (en) * | 1992-07-28 | 1998-03-31 | Newcor Industrial S.A. | Total mitral heterologous bioprosthesis to be used in mitral or tricuspid heat replacement |
US5769780A (en) * | 1994-09-02 | 1998-06-23 | Baxter International Inc. | Method of manufacturing natural tissue valves having variably compliant leaflets |
US5843181A (en) * | 1994-04-18 | 1998-12-01 | Hancock Jaffe Laboratories | Biological material pre-fixation treatment |
US5910169A (en) * | 1992-07-28 | 1999-06-08 | Newcor Industrial S.A. | Total mitral heterologous bioprosthesis to be used in mitral tricuspid heart replacement |
Family Cites Families (17)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3548418A (en) | 1968-05-03 | 1970-12-22 | Cutter Lab | Graft valve transplantation for human hearts and graft-support ring therefor |
CA1232407A (en) | 1983-06-23 | 1988-02-09 | David K. Walker | Bubble heart valve |
GB2149062B (en) | 1983-09-08 | 1986-09-24 | Endre Bodnar | Improved cardiac valve |
US4629459A (en) | 1983-12-28 | 1986-12-16 | Shiley Inc. | Alternate stent covering for tissue valves |
US4790844A (en) | 1987-01-30 | 1988-12-13 | Yoel Ovil | Replacement of cardiac valves in heart surgery |
US5352240A (en) | 1989-05-31 | 1994-10-04 | Promedica International, Inc. | Human heart valve replacement with porcine pulmonary valve |
US5336616A (en) | 1990-09-12 | 1994-08-09 | Lifecell Corporation | Method for processing and preserving collagen-based tissues for transplantation |
IT1245750B (en) | 1991-05-24 | 1994-10-14 | Sorin Biomedica Emodialisi S R | CARDIAC VALVE PROSTHESIS, PARTICULARLY FOR REPLACING THE AORTIC VALVE |
EP0680291B1 (en) | 1991-08-29 | 1998-03-18 | Medtronic, Inc. | Natural tissue heart valve fixation |
US5449384A (en) | 1992-09-28 | 1995-09-12 | Medtronic, Inc. | Dynamic annulus heart valve employing preserved porcine valve leaflets |
US5480424A (en) | 1993-11-01 | 1996-01-02 | Cox; James L. | Heart valve replacement using flexible tubes |
US5713950A (en) | 1993-11-01 | 1998-02-03 | Cox; James L. | Method of replacing heart valves using flexible tubes |
WO1997024083A1 (en) | 1993-11-01 | 1997-07-10 | Cox James L | Method of replacing heart valves using flexible tubes |
US5593424A (en) | 1994-08-10 | 1997-01-14 | Segmed, Inc. | Apparatus and method for reducing and stabilizing the circumference of a vascular structure |
US5728152A (en) | 1995-06-07 | 1998-03-17 | St. Jude Medical, Inc. | Bioresorbable heart valve support |
WO1997000651A1 (en) | 1995-06-20 | 1997-01-09 | Agathos Efstathios A | Human valve replacement with marine mammal valve |
WO1997037618A1 (en) | 1996-04-08 | 1997-10-16 | Medtronic, Inc. | Method of fixing a physiologic mitral valve bioprosthesis |
-
1999
- 1999-01-27 US US09/238,964 patent/US6524339B1/en not_active Expired - Fee Related
-
2000
- 2000-01-18 WO PCT/US2000/001223 patent/WO2000044312A1/en not_active Application Discontinuation
- 2000-01-18 CA CA002360559A patent/CA2360559A1/en not_active Abandoned
- 2000-01-18 JP JP2000595617A patent/JP2003524457A/en active Pending
- 2000-01-18 EP EP00904405A patent/EP1154737A1/en not_active Withdrawn
- 2000-12-14 US US09/738,805 patent/US6540781B2/en not_active Expired - Fee Related
Patent Citations (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4120649A (en) | 1975-04-10 | 1978-10-17 | Israel Schechter | Transplants |
US4648881A (en) | 1982-03-23 | 1987-03-10 | American Hospital Supply Corporation | Implantable biological tissue and process for preparation thereof |
EP0103947A2 (en) | 1982-08-25 | 1984-03-28 | McNeilab, Inc. | Method for inhibiting mineralization of natural tissue during implantation |
WO1984001879A1 (en) | 1982-11-12 | 1984-05-24 | American Hospital Supply Corp | Surfactant treatment of implantable biological tissue to inhibit calcification |
US4885005A (en) | 1982-11-12 | 1989-12-05 | Baxter International Inc. | Surfactant treatment of implantable biological tissue to inhibit calcification |
US4759758A (en) | 1984-12-07 | 1988-07-26 | Shlomo Gabbay | Prosthetic heart valve |
US4890457A (en) * | 1987-01-02 | 1990-01-02 | Cryolife, Inc. | Method for cryopreserving heart valves |
US4890437A (en) | 1987-07-09 | 1990-01-02 | Quaile Allan T | Segmented arch structure |
US4976733A (en) | 1988-02-03 | 1990-12-11 | Biomedical Design, Inc. | Prevention of prosthesis calcification |
US5156621A (en) * | 1988-03-22 | 1992-10-20 | Navia Jose A | Stentless bioprosthetic cardiac valve |
US5197979A (en) * | 1990-09-07 | 1993-03-30 | Baxter International Inc. | Stentless heart valve and holder |
US5733331A (en) * | 1992-07-28 | 1998-03-31 | Newcor Industrial S.A. | Total mitral heterologous bioprosthesis to be used in mitral or tricuspid heat replacement |
US5910169A (en) * | 1992-07-28 | 1999-06-08 | Newcor Industrial S.A. | Total mitral heterologous bioprosthesis to be used in mitral tricuspid heart replacement |
US5509930A (en) * | 1993-12-17 | 1996-04-23 | Autogenics | Stentless heart valve |
US5632778A (en) * | 1994-03-14 | 1997-05-27 | Cryolife, Inc. | Treated tissue for implantation and methods of preparation |
US5843181A (en) * | 1994-04-18 | 1998-12-01 | Hancock Jaffe Laboratories | Biological material pre-fixation treatment |
US5769780A (en) * | 1994-09-02 | 1998-06-23 | Baxter International Inc. | Method of manufacturing natural tissue valves having variably compliant leaflets |
US5662704A (en) * | 1995-12-01 | 1997-09-02 | Medtronic, Inc. | Physiologic mitral valve bioprosthesis |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2001049217A2 (en) * | 1999-12-30 | 2001-07-12 | St. Jude Medical, Inc. | Heart valve |
WO2001049217A3 (en) * | 1999-12-30 | 2002-02-07 | St Jude Medical | Heart valve |
US6409759B1 (en) | 1999-12-30 | 2002-06-25 | St. Jude Medical, Inc. | Harvested tissue heart valve with sewing rim |
US7316712B2 (en) | 1999-12-30 | 2008-01-08 | St. Jude Medical, Inc. | Tissue heart valve with annulus support structure |
Also Published As
Publication number | Publication date |
---|---|
JP2003524457A (en) | 2003-08-19 |
EP1154737A1 (en) | 2001-11-21 |
CA2360559A1 (en) | 2000-08-03 |
US20010012963A1 (en) | 2001-08-09 |
US6540781B2 (en) | 2003-04-01 |
US6524339B1 (en) | 2003-02-25 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US6524339B1 (en) | Cryopreserved homografts and other stentless bioprosthetic heart valves having natural tissue sewing rings | |
US6342070B1 (en) | Stentless bioprosthetic heart valve with patent coronary protuberances and method of surgical use thereof | |
US6797000B2 (en) | Tri-composite, full root, stentless valve | |
US6409759B1 (en) | Harvested tissue heart valve with sewing rim | |
JP3797673B2 (en) | Method for treating implantable biological tissue to reduce calcification and bioprosthesis treated in such a manner | |
AU734858B2 (en) | System, apparatus and method for chemical fixation of stentless cardiac valvular bioprostheses | |
US7189259B2 (en) | Tissue material and process for bioprosthesis | |
US20070038294A1 (en) | Method and apparatus for replacing a mitral valve and an aortic valve with a homograft | |
EP1549257A4 (en) | Method and apparatus for replacing a mitral valve with a stentless bioprosthetic valve | |
JP2000502580A (en) | Heart valve replacement technology using flexible tubing | |
Butany et al. | The failure modes of biological prosthetic heart valves | |
Doty et al. | Medtronic Freestyle aortic root bioprosthesis: implant techniques | |
CN113423363A (en) | Self-expanding stent and stent set | |
Love | Cardiac prostheses | |
BR102022003145A2 (en) | MITRAL STEN |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AK | Designated states |
Kind code of ref document: A1 Designated state(s): CA JP |
|
AL | Designated countries for regional patents |
Kind code of ref document: A1 Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE |
|
121 | Ep: the epo has been informed by wipo that ep was designated in this application | ||
DFPE | Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101) | ||
ENP | Entry into the national phase |
Ref document number: 2360559 Country of ref document: CA Ref country code: CA Ref document number: 2360559 Kind code of ref document: A Format of ref document f/p: F |
|
WWE | Wipo information: entry into national phase |
Ref document number: 2000904405 Country of ref document: EP |
|
ENP | Entry into the national phase |
Ref country code: JP Ref document number: 2000 595617 Kind code of ref document: A Format of ref document f/p: F |
|
WWP | Wipo information: published in national office |
Ref document number: 2000904405 Country of ref document: EP |
|
WWW | Wipo information: withdrawn in national office |
Ref document number: 2000904405 Country of ref document: EP |