WO2000059379A1 - Bioprotheses valvulaires cardiaques sans stent et procede de fabrication - Google Patents

Bioprotheses valvulaires cardiaques sans stent et procede de fabrication Download PDF

Info

Publication number
WO2000059379A1
WO2000059379A1 PCT/US2000/008558 US0008558W WO0059379A1 WO 2000059379 A1 WO2000059379 A1 WO 2000059379A1 US 0008558 W US0008558 W US 0008558W WO 0059379 A1 WO0059379 A1 WO 0059379A1
Authority
WO
WIPO (PCT)
Prior art keywords
noncoronary
sections
heart valve
tissue
outflow
Prior art date
Application number
PCT/US2000/008558
Other languages
English (en)
Inventor
David R. Clarke
E. Christopher Orton
Steven Goldstein
Kiby Black
Stacey Bode
Original Assignee
Cryolife, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cryolife, Inc. filed Critical Cryolife, Inc.
Priority to CA002366767A priority Critical patent/CA2366767A1/fr
Priority to EP00919941A priority patent/EP1175178A1/fr
Priority to AU40548/00A priority patent/AU4054800A/en
Priority to JP2000608947A priority patent/JP2002540832A/ja
Publication of WO2000059379A1 publication Critical patent/WO2000059379A1/fr
Priority to HK02105627.8A priority patent/HK1046353A1/zh

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/507—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials for artificial blood vessels
    • 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
    • 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
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A61L27/3625—Vascular tissue, e.g. heart valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
    • A61L27/3645—Connective tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/20—Materials or treatment for tissue regeneration for reconstruction of the heart, e.g. heart valves

Definitions

  • the present invention relates generally to bioprostheses and methods of making the same.
  • the present invention is embodied in unstented heart valve bioprostheses and methods of making the same.
  • Bioprosthetic porcine xenograft valves have been employed in the past for the successful treatment of human heart valve disease. More specifically, atrioventricular valve replacements have occurred in the past using stent mounting and glutaraldehyde fixation of porcine valves. More recently, stentless porcine xenograft valves, such as the O'Brien-Angell stentless valve, have been used with considerable success. Notwithstanding the clinical successes of such stentless porcine xenograft valves, improvements are still desirable.
  • bioprosthetic valves were provided with integral inflow and/or outflow conduits. Such an improvement would thereby allow the bioprosthetic valve to be used as a root valve to replace the entirety of a patient's native aortic valve or the pulmonary valve and its outflow tract. Alternatively, such a valve would be suitable for use as an inclusion-type valve following appropriate trimming.
  • a bioprosthetic valve could be provided which is potentially less immunogenic than other unfixed tissue grafts since it is capable of being decellularized to leave primarily the extracellular matrix of the leaflets, aortic wall and mitral leaflets.
  • the present invention is embodied in stentless heart valve bioprosthesis comprised of multiple noncoronary sections sutured together along lengthwise commissure lines. These sutured noncoronary sections establish a generally tubular bioprosthetic structure having an inflow conduit, an outflow conduit and a valve section intermediate to the inflow and outflow sections. Most preferably three noncoronary leaflet sections are employed to establish a trileaflet valve section intermediate to the inflow and outflow sections.
  • the heart valve bioprosthesis of the present invention is a composite structure formed of the noncoronary sections of unfixed heart valve tissue.
  • all myocardium is omitted from the valve components and the finished bioprosthesis in order to produce a structure with low antigenicity and maximal integrity of suturable tissue.
  • FIGURE 1 is a perspective view of a stentless heart valve bioprosthesis in accordance with the present invention
  • FIGURES 2A-2F represent a presently preferred technique for fabricating the stentless heart valve bioprosthesis depicted in FIGURE 1 as viewed from the exterior of the tissue segments;
  • FIGURES 3A and 3B schematically depict a preferred suturing technique using horizontal mattress sutures for joining adjacent noncoronary tissue segments during the fabrication of the bioprosthetic heart valve of this invention
  • FIGURE 4A is a photograph of one embodiment of a completed bioprosthetic heart valve according to this invention using the mattress sutures exemplified by FIGURES 3A and 3B;
  • FIGURE 4B is a photograph of another embodiment of a completed bioprosthetic heart valve according to this invention using conventional interrupted sutures.
  • FIGURE 5 depicts a modification of the heart valve bioprosthesis depicted in FIGURE 1 which is particularly useful for aortic valve repair.
  • FIGURE 1 shows a stentless bioprosthetic heart valve 10 in accordance with the present invention.
  • the heart valve 10 is fabricated from three noncoronary aortic leaflet sections 10-1 , 10-2 and 10-3, most preferably dissected from porcine heart tissue.
  • Adjacent noncoronary sections 10-1 , 10-2 and 10-3 are sutured together along commissure lines 12-1 , 12-2 and 12-3. That is, noncoronary section 10-1 is sutured to noncoronary sections 10-2 and 10-3 along commissure lines 12-1 and 12-3, respectively, while noncoronary sections 10-2 and 10-3 are sutured together along commissure line 12-2.
  • the sutured noncoronary sections 10-1 , 10-2 and 10-3 thereby form a generally tubular structure having an outflow conduit 14, an inflow conduit 16 formed of mitral leaflets 16-1 , 16-2 and 16-3, and a sinus section 18, distally of the annulus 20, intermediate to the inflow and outflow conduits 14, 16, respectively.
  • the arterial conduit 19 is thus comprised of the outflow conduit 14 and the sinus region 18.
  • the sinus section 18 interiorly includes three leaflet cusps (not shown in FIGURE 1 , but see the exemplary leaflet cusps 104-1 , 104-2 and 104-3 in the bioprosthetic heart valve 100 depicted in FIGURE 5) which collectively form the trileaflet valve in the complete bioprosthetic heart valve 10.
  • the inflow section 16 is formed of the individual anterior mitral leaflets associated with each of the noncoronary sections 10-1 , 10-2 and 10-3. The completed trileaflet bioprosthetic heart valve 10 will thereby approximate a patient's natural, but diseased, heart valve.
  • porcine heart tissue is procured and dissected fresh leaving only the aortic valve, the mitral leaflet and a lengthwise segment (preferably approximately 3 mm from the leaflet base) of myocardium. More specifically, the porcine heart tissue is first cut longitudinally between the left and right coronary arteries and placed flat on a dissection area with the lumenal surface of the valve tissue facing upwardly. The myocardium is then cut away so that only about
  • tissue is then cut longitudinally on either side of the noncoronary leaflet along the commissures from the free edge of the outflow conduit to approximately 2-3 mm below the base of the noncoronary leaflet.
  • the cut is most preferably made slightly broader (e.g., from about 1 to about 1.5 mm wider than the natural commissure line) near the outflow free edge in order to allow for histology samples to be taken.
  • the valve conduit is cut along the commissure lines just prior to assembly. In this regard, care should be taken so that the conduit is not more narrow than the widest portion of the leaflet.
  • the tissue is next cut at an angle from left to right (usually an angle between about 30° to about 50°, and more preferably an angle of about 45°, depending on the natural anatomy of the distal myocardium) starting from the end of the first vertical cuts (near the plane of the leaflet base) to the free end of the mitral leaflet, thus removing most of the myocardium as well as the right and left coronary leaflets and conduit.
  • This trimming is performed on either side of the noncoronary section. It should be noted here that the chordae tendineae of the mitral leaflet are not removed until the valve 10 is assembled (as will be discussed in greater detail below).
  • chordae tendineae are cut around the circumference of the inflow region 16 about 1.5 mm proximal to the final interrupted suture along the free edge of the mitral valve in a manner that is parallel to the presumptive annulus of the composite.
  • the noncoronary tissue segment may then be subjected to a conventional decellularization process.
  • the tissue may be subjected to one or more of the treatments by which the tissue may be decellularized, soluble proteins removed, tissue constituent covalently or ionically modified, chemical or biochemical substituents added, or tissue crosslinked.
  • the tissue is stored in a suitable medium and temperature (e.g., at about 4°C in an aqueous medium) to stabilize the tissue and/or modification until completion of the valve.
  • the noncoronary sections 10-1 , 10-2 and 10-3 are selected from tissue storage due to their approximate similar size (e.g., ⁇ 2 mm) and are measured for purposes of such matching.
  • the measurements include the distance and/or dimensions (i) between commissures, (ii) from the anterior of the leaflet (point of coaptation) to the posterior (base) of the leaflet, (iii) from the top of the commissure on either side of the leaflet to the center of the base of the leaflet, and (iv) from the free edge of the leaflet to the base of the coaptive margin.
  • the noncoronary sections 10-1 , 10-2 and 10-3 are then filled with storage solution (e.g., saline) in order to observe the shape and extension of the leaflet.
  • storage solution e.g., saline
  • the three noncoronary sections 10-1 , 10-2 and 10-3 are subjected to further dissection and inspection to assure optimal alignment for suturing.
  • Straight cuts are made along each commissure line of the non-coronary segment.
  • the cuts should be made as close to the leaflets and commissure tips as possible without causing any damage.
  • the cuts are performed at a slight angle toward the right, which should follow the angle at the point of coaptation (approximately 10° to 15° to the right of the vertical leaflet/commissure line).
  • the commissures should also not have any remaining leaflet tissue from the discarded left or right coronary sections, and the non-coronary leaflet and commissures should be inspected for damage after trimming this area.
  • the free edges along the commissure lines 12-1 , 12-2 and 12-3 should also be smooth to avoid gaps between tissue sections following suture placement. Any variance in the thickness of the outflow free edges 10-1 a, 10-2a and 10-3a of the outflow conduit sections 14-1 , 14-2 and 14-3 (which ultimately will collectively form the outflow conduit 14 of the valve 10) should be trimmed carefully to a substantially uniform thickness without leaving any jagged areas. This trimming should, however, only be done if the variance is less than or equal to about 1mm. If the variance is greater than about 1mm, the tissues should not be matched for assembly.
  • any remaining myocardium is also removed and the annulus 20 bladed to a smooth finish of substantially constant thickness.
  • the noncoronary sections 10-1 , 10-2 and 10-3 are frequently inspected for any damage, such as tears, holes or cuts that rendered an area too thin, and are discarded if any such defects are present.
  • the initial pair of noncoronary sections 10-1 and 10-2 are sutured together beginning generally at the base of the sinuses 18-1 , 18-2 of each tissue segment as depicted in accompanying FIGURE 2B.
  • the first joining stitch 22-1 a' is a basic interrupted suture placed through the arterial conduit with entry and exit points approximately 1.5 mm from the free edges of the commissure lines 12-1 on the exterior of the noncoronary sections using suitable suture material and needle (e.g., 6-0 Prolene monofilament polypropylene sterile suture with 3/8 inch tapered needle).
  • the depth of the suture 22-1 a' through the tissue thickness should be about 0.5 mm from the lumenal surface of each conduit, without penetrating any interior surface of the tissue, particularly the leaflet.
  • the suture 22-1 a is completed using a triple surgeon's knot and the free ends of the suture should be cut to less than about 1 mm in length.
  • the next interrupted suture 22-1 a in the suture line 22-1 is placed about 1.5 mm from the initial suture 22-1 a' in the direction of the mitral leaflets 16-1 , 16-2.
  • Four or five of these interrupted sutures 22-1 a in the suture line 22-1 should be completed for the purpose of easing the later placement of the horizontal mattress sutures (a few of which are identified in FIGURE 1 , for example, by reference numeral 24-1 a and collectively form the suture line 24-1) by having a joined section to grasp and anchor the tissue.
  • the remainder of the interrupted sutures 22-1 a of the suture line 22-1 are placed once the entire line of mattress sutures 24-1 a forming suture line 24-1 are completed, as will now be described.
  • the first horizontal mattress suture 24-1 a' is positioned approximately 0.5 mm distal to the initial interrupted suture 22-1 a' (i.e., toward the outflow) using the same Prolene material and needle as for the interrupted sutures forming the suture line 22-1 discussed previously.
  • the needle is inserted approximately 1 mm from the free edge of the conduit exterior.
  • the depth of the suture is the same as for the interrupted sutures (that is, less than or equal to about 0.5 mm from the lumenal surface).
  • the first exit point of the suture is approximately 1 mm from the free edge of the adjacent tissue's conduit exterior. The suture is pulled through the tissue, leaving about a 2 cm tail of suture extending out of the entry point to allow the suture to be tied off.
  • the needle is then inserted between about 1 mm to about 1.5 mm from the first exit point in a direction parallel to the commissure line and towards the outflow tissue, leaving the tissue about 0.5 mm from the lumenal surface and a distance of between about 1 mm to about 1.5 mm from the first half-loop of the suture.
  • the suture is placed through the thickness of the opposing tissue and exits the tissue no more than about 1 mm from the free edge 12-1 of the conduit exterior.
  • the final exit point should be 1 to 1.5 mm from the initial entry point (where the tail of the suture is protruding).
  • the suture should be tied off using a triple surgeons knot and the free ends should be trimmed to less than about 1 mm in length.
  • the angle of the mattress sutures 24-1 a causes a minor eversion (depicted by tissue mounds 30-1 and 30-2 in FIGURE 3B) between the connected tissues.
  • tissue mounds 30-1 , 30-2 should not protrude more than 1 mm outwardly from the external surface of the conduit to avoid causing an obstructive surface.
  • the next mattress suture 24-1 a in the suture line 24-1 should be initiated on the opposite tissue from that which had the knot for the initial suture 24-1 a'.
  • Each mattress suture 24-1 a is begun on the opposite tissue from the suture 24-1 a before it.
  • This alternating method reduces the puckering on the lumenal side of the tissue.
  • Each mattress suture should be positioned approximately 0.5 mm to 1 mm from the external loop of the previous suture.
  • the alternating mattress sutures in the suture line 24-1 should be completed from the base of the sinus region to the free edge of the outflow conduit (see FIGURE 2D).
  • the width of the eversion mounds 30-1 and 30-2 between tissues for the entire suture line should be no more than 3 mm for size 19 to 23 mm InOD and no more than 4 mm for size 25 to 29 mm InOD valves.
  • the interrupted sutures forming the suture line 22-1 along the mitral leaflets should be finished as depicted in FIGURE 2E.
  • the interrupted sutures of suture line 22-1 should extend as far along the mitral leaflets 16-1 , 16-2 as possible until the chordae tendineae begin to proliferate.
  • the length of the inflow must extend at least 4 mm beyond the base of each leaflet.
  • One final interrupted suture 22-1 b is placed 1 to 1.5 mm from the free edge of the outflow proximal to the final mattress suture in suture line 24-1. This procedure aids the cylindrical shaping of the outflow region.
  • the outflow conduit section 14 is trimmed along the circumference of its free edges 10-1 a, 10- 2a and 10-3a so as to present a substantially level border around the circumference of the outflow conduit section 14.
  • the inflow region fashioned with the mitral leaflets 16-1 , 16-2 and 16-3 is also trimmed approximately 1.5 mm beyond the final interrupted mitral suture.
  • mitral leaflets 16-1 , 16-2 and 16-3 should be trimmed substantially parallel to the annulus 20 and all chordae tendineae must be removed.
  • FIGURE 4A is a photograph of an exemplary bioprosthetic heart valve in accordance with the present invention.
  • a suture line comprised of horizontal mattress sutures is clearly visible in FIGURE 4A between the bases of the leaflet sections to the distal outflow free edges of the joined tissue segments.
  • FIGURE 4A visibly reveals a line of everted tissue which protrudes outwardly from the noncoronary sections formed by the mattress sutures.
  • the suture lines 22-1 and/or 24-1 can be formed from any type and/or combination of sutures suitable for the tissue involved and/or the ultimate placement of the bioprosthetic valve 10.
  • the sutures used for the suture lines should not tear the tissue and should accommodate relatively compliant tissue.
  • the sutures should also form a substantially leak-free juncture between the tissue segments.
  • Suitable sutures that may be employed in the practice of this invention include continuous sutures, lock-stitch sutures, interrupted sutures, mattress and the like.
  • FIGURE 4B another embodiment of a bioprosthetic heart valve in accordance with the present invention is depicted in FIGURE 4B as having noncoronary tissue sections joined together by interrupted sutures.
  • valve 10 may be surgically implanted as a total replacement for a patient's native aortic valve or the pulmonary valve and its outflow tract.
  • the attending surgeon may modify the bioprosthetic heart valve 10 to suit the particular anatomy of the patient.
  • the inflow and/or outflow conduits 16, 14, respectively may be trimmed in their lengthwise direction between adjacent sutures prior to surgical implantation so as to provide an overall lengthwise size suitable for the patient only if a continuous suture line has not been used to from the valve.
  • FIGURE 5 depicts a modified bioprosthetic heart valve (designated by reference numeral 100) in accordance with the present invention.
  • the heart valve 100 depicted in FIGURE 5 is a surgically modified version of the valve 10 discussed previously in that noncoronary tissue segments 100-1 , 100-2 and 100-3 have been sutured together to form a trileaflet valve structure.
  • the valve 100 includes scallop regions 102-1 and 102-2 defined by excised tissue from the outflow conduit region of joined tissue segments 100-1 and 100-2.
  • scallop regions 102-1 and 102-2 thereby allow fluid communication between the outflow side of the trileaflet valve structure 104 (formed by the juncture of leaflet cusps 104-1 , 104-2 and 104-3) and the patient's native coronary arteries.
  • FIGURE 5 is especially useful as an inclusion valve for aortic valve repair. It will be understood that, although two such scallop regions 102-1 and 102-2 are depicted in FIGURE 5, more or less scallop regions could be provided in the surgeon's discretion to suit particular aortic valve repairs. Thus, a single scallop region, or three scallop regions in each of the tissue segments 100-1 , 100-2 and 100-3 could be provided in the valve 100.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Botany (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Zoology (AREA)
  • Manufacturing & Machinery (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne des bioprothèses valvulaires cardiaques sans stent, qui sont formées comme des valvules d'origine au moyen d'une partie de la valvule antéro mitrale (16-1, 16-2, 16-3) fixée à plusieurs (trois de préférence) sections de la valvule non coronaires (10-1, 10-2, 10-3). De cette manière, les bioprothèse valvulaires cardiaques (10) peuvent comporter des tubes d'arrivée (16) et/ou d'évacuation (14) qui permettent de remplacer la valvule aortique malade d'origine d'un patient dans son intégralité ou la valvule pulmonaire et sa voie d'évacuation.
PCT/US2000/008558 1999-04-02 2000-03-31 Bioprotheses valvulaires cardiaques sans stent et procede de fabrication WO2000059379A1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CA002366767A CA2366767A1 (fr) 1999-04-02 2000-03-31 Bioprotheses valvulaires cardiaques sans stent et procede de fabrication
EP00919941A EP1175178A1 (fr) 1999-04-02 2000-03-31 Bioprotheses valvulaires cardiaques sans stent et procede de fabrication
AU40548/00A AU4054800A (en) 1999-04-02 2000-03-31 Unstented heart valve bioprostheses and methods of making the same
JP2000608947A JP2002540832A (ja) 1999-04-02 2000-03-31 非ステント型バイオ人工心臓弁およびその製造方法
HK02105627.8A HK1046353A1 (zh) 1999-04-02 2002-07-30 無支架的心臟瓣膜生物修補及其製造方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US12747999P 1999-04-02 1999-04-02
US60/127,479 1999-04-02

Publications (1)

Publication Number Publication Date
WO2000059379A1 true WO2000059379A1 (fr) 2000-10-12

Family

ID=22430350

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2000/008558 WO2000059379A1 (fr) 1999-04-02 2000-03-31 Bioprotheses valvulaires cardiaques sans stent et procede de fabrication

Country Status (6)

Country Link
EP (1) EP1175178A1 (fr)
JP (1) JP2002540832A (fr)
AU (1) AU4054800A (fr)
CA (1) CA2366767A1 (fr)
HK (1) HK1046353A1 (fr)
WO (1) WO2000059379A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002087474A1 (fr) 2001-05-01 2002-11-07 Imperial Medical Devices Limited Prothese de valvule
CN100405991C (zh) * 2005-07-08 2008-07-30 北京佰仁医疗科技有限公司 心脏流出道带瓣补片
WO2020092456A3 (fr) * 2018-11-02 2020-08-13 Aziyo Med, Llc Structure de poche de matrice extracellulaire et ses utilisations
US11045580B2 (en) 2011-12-16 2021-06-29 Aziyo Med, Llc Extracellular matrix sheet structures

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5595571A (en) * 1994-04-18 1997-01-21 Hancock Jaffe Laboratories Biological material pre-fixation treatment
US5709695A (en) * 1994-08-10 1998-01-20 Segmed, Inc. Apparatus for reducing the circumference of a vascular structure
US5861028A (en) * 1996-09-09 1999-01-19 Shelhigh Inc Natural tissue heart valve and stent prosthesis and method for making the same

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5595571A (en) * 1994-04-18 1997-01-21 Hancock Jaffe Laboratories Biological material pre-fixation treatment
US5709695A (en) * 1994-08-10 1998-01-20 Segmed, Inc. Apparatus for reducing the circumference of a vascular structure
US5861028A (en) * 1996-09-09 1999-01-19 Shelhigh Inc Natural tissue heart valve and stent prosthesis and method for making the same

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002087474A1 (fr) 2001-05-01 2002-11-07 Imperial Medical Devices Limited Prothese de valvule
CN100405991C (zh) * 2005-07-08 2008-07-30 北京佰仁医疗科技有限公司 心脏流出道带瓣补片
US11045580B2 (en) 2011-12-16 2021-06-29 Aziyo Med, Llc Extracellular matrix sheet structures
WO2020092456A3 (fr) * 2018-11-02 2020-08-13 Aziyo Med, Llc Structure de poche de matrice extracellulaire et ses utilisations

Also Published As

Publication number Publication date
EP1175178A1 (fr) 2002-01-30
JP2002540832A (ja) 2002-12-03
HK1046353A1 (zh) 2003-01-10
CA2366767A1 (fr) 2000-10-12
AU4054800A (en) 2000-10-23

Similar Documents

Publication Publication Date Title
EP1560545B1 (fr) Appareil de remplacement d'une valvule mitrale par une bioprothese de valvule sans extenseur dotee de cordages
US7488346B2 (en) Method and apparatus for replacing a mitral valve and an aortic valve with a single homograft
AU728106B2 (en) Stentless bioprosthetic heart valve with coronary protuberances
US5509930A (en) Stentless heart valve
CA2521896C (fr) Valvule souple concue pour etre implantee dans des vaisseaux sanguins mammaliens et dans le coeur et dotee d'un support temporaire ou permanent assure par deux stents
US6129758A (en) Products and methods for circulatory system valve repair
JP4057783B2 (ja) カットゾーンを備えた環状成形リング
US20070038294A1 (en) Method and apparatus for replacing a mitral valve and an aortic valve with a homograft
US20060195182A1 (en) Method and apparatus for replacing a mitral valve with a stentless bioprosthetic valve
JP5122584B2 (ja) 個別大動脈人工弁膜葉及びそれを製造するためのテンプレート
EP1175178A1 (fr) Bioprotheses valvulaires cardiaques sans stent et procede de fabrication
Raffa et al. Superimposition of a mechanical valve on an impacted aortic bioprosthesis
Misfeld et al. Types of reconstructive surgery of the aortic valve
WO2024054794A2 (fr) Dispositifs médicaux et méthode de reconstruction de valvules cardiaques semi-lunaires
Rabelo et al. Aortic valve replacement with the Labcor stentless porcine bioprosthesis

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AE AL AM AT AU AZ BA BB BG BR BY CA CH CN CR CU CZ DE DK DM EE ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX NO NZ PL PT RO RU SD SE SG SI SK SL TJ TM TR TT TZ UA UG UZ VN YU ZA ZW

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): GH GM KE LS MW SD SL SZ TZ UG ZW AM AZ BY KG KZ MD RU TJ TM AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE BF BJ CF CG CI CM GA GN GW ML MR NE SN TD TG

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)
REG Reference to national code

Ref country code: DE

Ref legal event code: 8642

ENP Entry into the national phase

Ref document number: 2366767

Country of ref document: CA

Ref country code: CA

Ref document number: 2366767

Kind code of ref document: A

Format of ref document f/p: F

ENP Entry into the national phase

Ref country code: JP

Ref document number: 2000 608947

Kind code of ref document: A

Format of ref document f/p: F

WWE Wipo information: entry into national phase

Ref document number: 2000919941

Country of ref document: EP

WWP Wipo information: published in national office

Ref document number: 2000919941

Country of ref document: EP

WWW Wipo information: withdrawn in national office

Ref document number: 2000919941

Country of ref document: EP