GB2136533A - Artificial heart valve - Google Patents
Artificial heart valve Download PDFInfo
- Publication number
- GB2136533A GB2136533A GB08303479A GB8303479A GB2136533A GB 2136533 A GB2136533 A GB 2136533A GB 08303479 A GB08303479 A GB 08303479A GB 8303479 A GB8303479 A GB 8303479A GB 2136533 A GB2136533 A GB 2136533A
- Authority
- GB
- United Kingdom
- Prior art keywords
- valve
- avalve
- supportframe
- frame
- heart valve
- Prior art date
- Legal status (The legal status 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 status listed.)
- Granted
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
- A61L27/36—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
- 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
- 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
- A61L27/14—Macromolecular materials
- A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Dermatology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Cardiology (AREA)
- Vascular Medicine (AREA)
- Botany (AREA)
- Heart & Thoracic Surgery (AREA)
- Molecular Biology (AREA)
- Urology & Nephrology (AREA)
- Zoology (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Abstract
A bioprosthetic heart valve suitable for natural aortic, pulmonary, mitral or tricuspid valve replacement. The valve comprises cylindrical valvular tissue 1, for example a porcine valve, and a waisted cylindrical support frame 3 therefor, preferably covered with a biologically compatible material 7, in which the respective cylindrical walls of the valve and frame are substantially coincidentally arranged. Desirably the support frame has at least two integral commissure support loops and is machined from an acetal homo- or co-polymer plastics material. <IMAGE>
Description
SPECIFICATION
Artificial heart valve
The present invention relates to bioprosthetic heart valves suitable for, for example, natural aortic, pulmonary, mitral or tricuspid valve replacement.
Considerable effort has been expended in recent years to provide a bioprosthetic heart valve the performance and efficiency of which approaches those of a natural valve, and in the present invention notable progress has been made in meeting these requirements while atthe same time providing a valve which is also relatively cheap to produce.
until now many bioprosthetic heart valves have consisted essentially of a fabric-covered cylindrical supportframeorstenttowhich is attached, for example, a porcine heart valve. Avariety of such valves are at present commercially available and while some have had success in terms of extending the life of the recipient, they have all involved a method of construction in which the cylindrical wall of tissue of the "new" valve is located concentrically within the supporting frame, i.e. the cylindrical walls ofthe valvulartissue and the supporting frame are concentrically arranged with respect to one another.
Thus, when such a valve is implanted it effectively narrows the valve orifice through which blood must pass, which is generally considered to be an undesirable feature.
In the present invention this undesirable characteristic of known valves has been substantially eliminated by a novel method of construction.
Thus the present invention provides a bioprosthetic heartvalve comprising substantially cylindrical valvulartissue and a substantially cylindrical support frame therefor in which the respective cylindrical walls of the valve and frame are substantially coincidentally arranged.
The present invention also provides a method of manufacturing a bioprosthetic heart valve in which substantially cylindrical valvulartissue is supported on a substantially cylindrical frame with a waisted circumferential ring having at least two commissure support loops in the circumferential plane so that tissue located within the frame lies substantially coincidentallytherewith.
Preferably, the support loops are closed and integra with the skirt portion of the cylindrical frame.
Such an agreementofvalvulartissueand support frame has been found to offer noticeably reduced resistanceto the flow of blood therethroughwhen compared with earlier "concentrically" arranged valves.
Preferably, the supportframe is machined from a waisted, hollow cylinder of plastics material, such as anacetal homo-orcopolymer,forexample, as sold
underthe registered trade marks DELRIN and HOSTA
FORM respectively. The circumferential skirt portion oftheframebelowthewaistconfers rigidityonthe frameasawholewhileatthesametime permitting limitedflexibilityin orderthattheframecan be "naturally" accommodated bythe recipient vessel.
The valve commissure support loops of the support frame are usually slightly asymmetrical arranged in order to readily accommodate the natural asymmetry of, e.g. a porcine valve.
So that the tissue of the valve may be secured to the supportframe, the frame is covered, usually completely, with a biologically compatible textile fabric or film material which is stiched tothe frame, for example, a polyester or P.T.F.E. fibre velour, which also incorporates a "conventional" integral sewing ring. The integral seam ofthe sewing ring may
Incorporate a radio-opaque silicon rubbermarkerfor X-ray identification.
The material covering gives the supportframe a smooth liquid flow profile and facilitates tissue ingrowth as well as providing means for attaching valvulartissue.
The valve which has previously been fullyfixed (for example glutaraldehyde treated) is trimmed to fit insidethecylindrical coveredsupportframeandthe inflow aspect of the valve (below the waist of the frame) is sewn to the covering material in the customaryway.
The outflow aspect of the valve is sewn into the closed loops of the support frame through an inverted annulus or glycerol treated pericardium tissue, preferablyfrom the same animal species as the valvular tissue. Using pericardium tissue in this way has the advantage of spreading the load of the stitches and by sewing through an inverted annulusthe stitches and the cut edge of the valvularwall are hidden when the annulus is everted and the free edge of the pericardium is trimmed and oversewn to the edge of the frame. Thus, the use of an annulus of pericardium avoids any joints or seams and contributes to an efficient flow profile.
Afterfinal sewing the complete valve is fixed by immersion in a buffered solution ofglutaraldehyde, sterilized and stored in a 4% solution of buffered formaldehyde.
The invention may be further described, byway of example only (for a three cusp or leaflet valve suitable for implanting into the aortic position) by reference to the accompanying drawings in which:~
Figure 1 is a side perspective view of a waisted supportframe showing the location of valvulartissue within the commissure support loops (for claritythe supporting fabric (Figure 4) has not been shown);
Figure 2 is a plan view of Figure 1, illustrating the coincident arrangement of the frame and valve parts;
Figure 3 is a plan view similar to that of Figure 2 showing a conventional valve in which the same parts are arranged concentrically; and
Figure 4 is a cross-sectional side view of a valve according to the present invention showing the position of the constituent parts including the everted pericardium.
Figure 1 shows the position of cylindrical valvular tissue 1 which has been trimmed to fit inside the closed, inverted, substantially U-shaped upstanding (commissure support) loops 2 ofthe support frame generally indicated at 3. The lower circumferential edge ofthe valvulartissue being located inside the waisted portion 4 of the skirt 5 of the frame. The position of the valve cusps within the support frame is shown at6.
A plan view of the valve shown in Figure 1 is illustrated in Figure 2 where the coincident arrangement of valvulartissue 1 and supportframe 3 is clearly shown. Figure 3 is a similarviewofa conventional valvewherethevalvulartissue 1 and frame 3 are arranged concentrically.
In Figure 4the parts are shown in a slightly exploded arrangementso asto clearly identify their relative positions. Thus, the valvular wall 1 is shown separated from its supporting textile fabric 7 which overlays the waisted supportframe 3 and to which it is sewn. A sewing ring 8 containing, for example, a semi-rigid expanded P.T.F.E. foam material is also provided for assisting in implanting the valve in position in a recipient heart. An everted pericardium annulus 9 overlies the top circumferential edge ofthe valve to give the valve a neat and aesthetic appearance.
Typically,the inflow and outflow aspects ofthe valve are sewn to the adjacent textile fabric with a (compatible) white braided polyesterthread using a modified blanket stitch.
In an extensive in vitro assessment of aortic replacementvalves made according to the present invention, the hydro-dynamic performance of the valveintermsof(1)the pressure drop across the valves and (2) the volume of fluid refluxed by the valves per cycle (gross regurgitation) was found to be
satisfactory. Also, a high speed cine film taken of the valves in action (at 75 beats per minute) showed no
cusp instability and thatthe valve opened well to give
a good orifice area. The in vitro assessment gave
every indication that the valves would perform well when implanted clinically.
Seven animals successfully underwent implantation of valves made according to the present invention in the mitral position, and were long term survivors.
Mean survival to elective sacrifice was 5.47 months.
Haemodynamic results in terms of atrial pressure and cardiac output were good and the condition of the explanted valves was found to be excellent. There were no cusp tears or perforations and there was no evidence of endocarditis or of calcification. Paravalve fibrous tissue ingrowth was also found to be satisfactory and did not extend beyond the polyesterfabric.
Claims (17)
1. A bioprosthetic heart valve comprising substantially cylindrical valvulartissue and a substantially cylindrical supportframetherefor in which the respective cylindrical walls of the valve and frame are substantially coincidentally arranged.
2. Avalve according to Claim 1 in which the valvular tissue comprises a porcine heart valve.
3. Avalve according to Claim 1 or Claim 2 in which the supportframe has a waisted circumferential ring.
4. Avalve according to any one of Claim 1-3 in
which the supportframe has at leasttwo commissure
support loops in the circumferential plane.
5. Avalve according to Claim 4in which the
support loops are closed and integral with the support
frame.
6. A valve according to any one of the preceding claims in which the supportframe comprises a plastics material.
7. Avalve according to Claim 6 in which the plastics material is derived from an acetal homo- or co-polymer.
8. Avalve according to any one of the preceding claims in which the supportframe is covered with a biologically compatible material to which thevalvular tissue is attached.
9. Avalve according to Claim 8 in which the material comprisesatextilefabric.
10. Avalve according to Claim 9 in which the fabric comprises knitted polyester fibre.
11. A valve according to any one of the preceding claims in which the supportframe includes an integral sewing ring.
12. Avalve according to Claim 11 in which the sewing ring incorporates a radio-opaque marker.
13. Avalve according to any one of the preceding claims in which the outflow aspectthereof is covered by pericardial tissue.
14. A method of manufacturing a bioprosthetic heart valve in which substantially cylindrical valvular tissue is supported on a substantially cylindrical frame with a waisted circumferential ring having at Ieasttwo commissure support loops in the circumferential plane so thattissue located within theframe lies substantially coincidentally therewith.
15. A method according to Claim 14 in which the supportframe is first covered with a biologically compatible material to which thevalvulartissue is attached.
16. A bioprosthetic heart valve substantially as hereinbefore described with reference to figures 1, 2 and 4 ofthe accompanying drawings.
17. A method of manufacturing a bioprosthetic heartvalve substantially as hereinbefore described with reference to figures 1,2 and 4 of the accompany- ing drawings.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB08303479A GB2136533B (en) | 1983-02-08 | 1983-02-08 | Artifical heart valve |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB08303479A GB2136533B (en) | 1983-02-08 | 1983-02-08 | Artifical heart valve |
Publications (3)
Publication Number | Publication Date |
---|---|
GB8303479D0 GB8303479D0 (en) | 1983-03-16 |
GB2136533A true GB2136533A (en) | 1984-09-19 |
GB2136533B GB2136533B (en) | 1986-06-11 |
Family
ID=10537676
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
GB08303479A Expired GB2136533B (en) | 1983-02-08 | 1983-02-08 | Artifical heart valve |
Country Status (1)
Country | Link |
---|---|
GB (1) | GB2136533B (en) |
Cited By (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5192312A (en) * | 1991-03-05 | 1993-03-09 | Colorado State University Research Foundation | Treated tissue for implantation and methods of treatment and use |
US5613982A (en) * | 1994-03-14 | 1997-03-25 | Cryolife, Inc. | Method of preparing transplant tissue to reduce immunogenicity upon implantation |
WO1997024989A1 (en) * | 1996-01-04 | 1997-07-17 | Shelhigh, Inc. | Heart valve prosthesis and method for making same |
US5935163A (en) * | 1998-03-31 | 1999-08-10 | Shelhigh, Inc. | Natural tissue heart valve prosthesis |
US6165216A (en) * | 1995-06-20 | 2000-12-26 | Efstathios Andreas Agathos | Human cardiac valve placement with marine mammal ventricular outflow (aortic or pulmonary) valve |
US6350282B1 (en) * | 1994-04-22 | 2002-02-26 | Medtronic, Inc. | Stented bioprosthetic heart valve |
GB2405919A (en) * | 2003-09-12 | 2005-03-16 | Martin Lister | Artificial heart valve |
EP1878407A1 (en) | 2006-07-12 | 2008-01-16 | Efstathios-Andreas Agathos | Human cardiac valve replacement with seal heart valve (aortic or pulmonary) |
US7722667B1 (en) * | 1998-04-20 | 2010-05-25 | St. Jude Medical, Inc. | Two piece bioprosthetic heart valve with matching outer frame and inner valve |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB2056023A (en) * | 1979-08-06 | 1981-03-11 | Ross D N Bodnar E | Stent for a cardiac valve |
-
1983
- 1983-02-08 GB GB08303479A patent/GB2136533B/en not_active Expired
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB2056023A (en) * | 1979-08-06 | 1981-03-11 | Ross D N Bodnar E | Stent for a cardiac valve |
Cited By (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5772695A (en) * | 1991-03-05 | 1998-06-30 | Colorado State University Research Foundation | Treated tissue for implantation and methods of treatment and use |
US5192312A (en) * | 1991-03-05 | 1993-03-09 | Colorado State University Research Foundation | Treated tissue for implantation and methods of treatment and use |
US5863296A (en) * | 1991-03-05 | 1999-01-26 | Colorado State University Research Foundation | Treated tissue for implantation and methods of treatment and use |
US5855617A (en) * | 1991-03-05 | 1999-01-05 | Colorado State University Research Foundation | Treated tissue for implantation and methods of treatment and use |
US5899936A (en) * | 1994-03-14 | 1999-05-04 | Cryolife, Inc. | Treated tissue for implantation and methods of preparation |
US5843182A (en) * | 1994-03-14 | 1998-12-01 | Cryolife, Inc. | Treated tissue for implantation and methods of preparation |
US5632778A (en) * | 1994-03-14 | 1997-05-27 | Cryolife, Inc. | Treated tissue for implantation and methods of preparation |
US5613982A (en) * | 1994-03-14 | 1997-03-25 | Cryolife, Inc. | Method of preparing transplant tissue to reduce immunogenicity upon implantation |
US6350282B1 (en) * | 1994-04-22 | 2002-02-26 | Medtronic, Inc. | Stented bioprosthetic heart valve |
US6165216A (en) * | 1995-06-20 | 2000-12-26 | Efstathios Andreas Agathos | Human cardiac valve placement with marine mammal ventricular outflow (aortic or pulmonary) valve |
WO1997024989A1 (en) * | 1996-01-04 | 1997-07-17 | Shelhigh, Inc. | Heart valve prosthesis and method for making same |
US5935163A (en) * | 1998-03-31 | 1999-08-10 | Shelhigh, Inc. | Natural tissue heart valve prosthesis |
WO1999049817A1 (en) * | 1998-03-31 | 1999-10-07 | Shelhigh, Inc. | Natural tissue heart valve prosthesis |
US7722667B1 (en) * | 1998-04-20 | 2010-05-25 | St. Jude Medical, Inc. | Two piece bioprosthetic heart valve with matching outer frame and inner valve |
GB2405919A (en) * | 2003-09-12 | 2005-03-16 | Martin Lister | Artificial heart valve |
EP1878407A1 (en) | 2006-07-12 | 2008-01-16 | Efstathios-Andreas Agathos | Human cardiac valve replacement with seal heart valve (aortic or pulmonary) |
Also Published As
Publication number | Publication date |
---|---|
GB2136533B (en) | 1986-06-11 |
GB8303479D0 (en) | 1983-03-16 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
PCNP | Patent ceased through non-payment of renewal fee |