GB2206395A - Bioprosthetic heart valve - Google Patents

Bioprosthetic heart valve Download PDF

Info

Publication number
GB2206395A
GB2206395A GB8711436A GB8711436A GB2206395A GB 2206395 A GB2206395 A GB 2206395A GB 8711436 A GB8711436 A GB 8711436A GB 8711436 A GB8711436 A GB 8711436A GB 2206395 A GB2206395 A GB 2206395A
Authority
GB
United Kingdom
Prior art keywords
stent
waist
prongs
bovine
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.)
Withdrawn
Application number
GB8711436A
Other versions
GB8711436D0 (en
Inventor
Dr Dhani Ram Baruah
Nirala Baruah
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to GB8711436A priority Critical patent/GB2206395A/en
Publication of GB8711436D0 publication Critical patent/GB8711436D0/en
Publication of GB2206395A publication Critical patent/GB2206395A/en
Withdrawn legal-status Critical Current

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
    • A61F2/2418—Scaffolds therefor, e.g. support stents

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

A bovine bioprosthetic heart valve comprising a stent 1 made of a biocompetent and fatigue resistance material, said stent comprising a waist 1a and three spaced apart prongs 16 projecting therefrom, said waist having three curvatures vertically consecutively and said prongs being at the mounts formed at the junctions of said curvatures, said stent being covered with a biocompetent and durable polymer cloth (1d) stitched thereto, and three leaflets 3 of bovine pericardium mechanically cleaned and shaped and treated with anticalcific solution and preserved in a preservative solution, said leaflets each being disposed on the outer surface of said stent between adjacent prongs and stitched (1e) to the waist and prongs, and a sewing ring (4) of a biocompetent and durable polymer cloth located over said waist and stitched thereto. <IMAGE>

Description

BIOPROSTHETIC HEART VALVE This invention relates to a bioprosthetic heart valve.
Bovine bioprosthetic heart valves are used as replacements for diseased natural aortic, mitral, tricuspid and pulmonary heart valves. A typical conventional bovine bionrosthetic heart valve comprises a stent consisting of a straight waist nrovided with three spaced apart prongs projecting therefrom and three leaflets of bovine pericardium mechanically cleaned and shaped and treated with anticalcific solution and preserved in a preservative solution. The leaflets are disposed on the inner surface of the stent between the prongs and stitched on to the waist and prongs. The stent is usual made of biocomoetent f#eyi#ie plastic material ends such as nolypronylene. The adjoining free / of the leaflets are provided with commissural stitches.Such a valve also includes a sewing ring of biocompetent and durable polymer cloth such as dacron cloth provided over the waist and stitched thereto. A disadvantage of such a valve is that the stent being flexible leakage of blood may occur between the outer surface of the waist and the implantation site (paravalvular leakage). Another disadvantage of such valve is that with time the plastic stent may become brittle and break. In fact there are known instances where the valve has become disfunctional due to fracture of the stent.
Anothe#r disadvantage of such valve is that since the leaflets are disposed on the inner surface of the stent ends and the adjoining free/cf the leaflets are provided with commissural stitches, the primary opening provided by the waist is larger than the secondary opening provided by the free ends of the leaflets. This will cause pressure drop when blood flows- through the valve. Another disadvantage of such a valve is that it has been found to calcify particularly in younger patients. Another disadvantage of such a valve is that the waist being straight the orongs are long and there are chances of the prongs rupturing small left ventricle of the heart and the ascending aorta when implanted at the aortic position.
The object of the present invention is to obviate the above disadvantages and prove an improved bovine bioprosthetic heart valve.
Accordina to the present invention there is thus provided a bovine bioprosthetic heart valve comprising a stent made of a biocompetent and fatigue resistant material, such as zirconium, said stent comprising a waist and three spaced apart prongs projecting therefrom, said waist having three curvatures vertically consecutively and said prongs being at the mounts formed at the junctions of said curvatures, said stent being covered with a biocompetent and durable polymer cloth, such as dacron cloth,stitched thereto, and three leaflets of bovine pericardium mechanically cleaned and shaped and treated with anticalcific solution and preserved in a preservative solution said leaflets each being disposed on the outer surface of said stent between adjacent prongs and stitched to the waist and prongs and a sewing ring of a biocompetent and durable polymer cloth, such as dacron cloth, located over said waist and stitched thereto.
An embodiment of the invention is described hereinbelow with reference to the accompanying drawings, in which : Fig. 1 is isometric view of the stent; Fig. 2 is isometric view of the stent after covering it with a biocompetent and durable polymer cloth such as dacron cloth; Fig. 3 is elevation of the bovine bioprosthetic heart valve without the sewing ring; and Fig. 4 is plan of the valve of Fig. 3 including the sewing ring.
Referring to the drawings, 1 is a zirconium stent comprising a waist la and three spaced apart prongs lb projecting therefrom (See Fig.1 ). Stitchwna holes nrovided in stent 1 are marked I c. The waist la is provided with three curvatures vertically consecutively (not marked but can be seen in Fig. 1) and the prongs 1b are at the mounts (not marked but can be seen in Fig. 1) formed at the junctions of the curvatures.
The stent 1 is covered with a biocompetent and durable polymer cloth such as dacron cloth id (See Fig.2). Three leaflets marked 2 of bovine pericardium merchanically cleaned such as polyoxy sorbitan monooleate ('Tween 80') and shaoed and treated wlth anticalcific solution/and preserved in a preservative solution such as glutaraldehyde are disposed on the outer surface of the stent between the prongs and stitched on to the waist and prongs (See Figs.
3 and 4). The stitches are marked le. 4 is a sewing ring of biocompetent and durable polymer cloth such as dacron cloth located on the waist and stitched thereto. At the time of implantation, the valve is stitched on to the site of implantation through th-sewin ring.
The above embodiment is by way of examnle and should not be considered to be limitative of the scope of the present invention.
An advantage of the improved valve is that zirconium being biocompatable and very fatigue resistant and rigid there are no chances of paravalvular leakage at implantation site and failure of the valve due to brittleness of the stent.
The improved valve is, therefore, safe and reliable and has longer life.
Another advantage of the improved valve is that since the leaflets are mounted on the outer surface of the stent and since there are no commissural stitches at the ends adjoining free /of the leaflets the secondary omening provided by the free ends of the leaflets is larger than the primary opening provided by the waist. Conseauently there will not be any pressure drop when blood flows through the valve and comparatively more blood will flow through the valve and the ventricle will not be subjected to undesirable. excess pressure.
Another advantage of the improved valve is that since the waist is provided with curvatures with mounts at the junctions thereof and since the orongs are orovided at the mounts, the orongs can be shorter. Therefore, there are no chances of the prongs rupturing the small left ventricle of the heart and the ascending aorta when it is implanted at the aortic position.
Another advantage of the improved valve is that by treating the leaflets with an effective selected anticalcific solution chances of decalcification can be eliminated thereby increasing the life of the valve.

Claims (4)

CLAIMS:
1. A bovine bioprosthetic heart valve comprising a stent made of a biocompetent and fatigue resistance material, said stent comprising a waist and three spaced apart prongs projecting therefrom, said waist having three curvatures vertically consecutively and said prongs being at the mounts formed at the junctions of said curvatures, said stent being covered with a biocompetent and durable polymer cloth stitched thereto, and three leaflets of bovine pericardium mechanically cleaned and shaped and treated with anticalcific solution and preserved in a preservative solution said leaflets each being disposed on the outer surface of said stent between adjacent prongs and stitched to the waist and prongs and a sewing ring of a biocompetent and durable polymer cloth located over said waist and stitched thereto.
2. A bovine bioprosthetic heart valve according to Claim 1, wherein the stent is made of zirconium.
3. A bovine bioprosthetic heart valve according to Claim 1 or Claim 2, wherein the polymer cloth with which the stent is covered is dacron cloth.
3. A bovine bioprosthetic heart valve according to any one of claims 1 to 3, wherein the sewing ring is made of dacron cloth.
4. A bovine bioprosthetic heart valve substantially as hereinbefore described with reference to the accompanying drawings.
GB8711436A 1987-05-14 1987-05-14 Bioprosthetic heart valve Withdrawn GB2206395A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
GB8711436A GB2206395A (en) 1987-05-14 1987-05-14 Bioprosthetic heart valve

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
GB8711436A GB2206395A (en) 1987-05-14 1987-05-14 Bioprosthetic heart valve

Publications (2)

Publication Number Publication Date
GB8711436D0 GB8711436D0 (en) 1987-07-22
GB2206395A true GB2206395A (en) 1989-01-05

Family

ID=10617349

Family Applications (1)

Application Number Title Priority Date Filing Date
GB8711436A Withdrawn GB2206395A (en) 1987-05-14 1987-05-14 Bioprosthetic heart valve

Country Status (1)

Country Link
GB (1) GB2206395A (en)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5554184A (en) * 1994-07-27 1996-09-10 Machiraju; Venkat R. Heart valve
WO1996040012A1 (en) * 1995-06-07 1996-12-19 St. Jude Medical, Inc. Bioresorbable heart valve support
US5782931A (en) * 1996-07-30 1998-07-21 Baxter International Inc. Methods for mitigating calcification and improving durability in glutaraldehyde-fixed bioprostheses and articles manufactured by such methods
US5861028A (en) * 1996-09-09 1999-01-19 Shelhigh Inc Natural tissue heart valve and stent prosthesis and method for making the same
US6231602B1 (en) 1999-04-16 2001-05-15 Edwards Lifesciences Corporation Aortic annuloplasty ring

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1264472A (en) * 1969-09-25 1972-02-23
US4172295A (en) * 1978-01-27 1979-10-30 Shiley Scientific, Inc. Tri-cuspid three-tissue prosthetic heart valve
EP0150608A1 (en) * 1983-12-28 1985-08-07 Shiley Inc. Stent covering for tissue valves
EP0125393B1 (en) * 1980-11-03 1987-12-09 Shiley Incorporated Prosthetic heart valve

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1264472A (en) * 1969-09-25 1972-02-23
US4172295A (en) * 1978-01-27 1979-10-30 Shiley Scientific, Inc. Tri-cuspid three-tissue prosthetic heart valve
EP0125393B1 (en) * 1980-11-03 1987-12-09 Shiley Incorporated Prosthetic heart valve
EP0150608A1 (en) * 1983-12-28 1985-08-07 Shiley Inc. Stent covering for tissue valves

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
WO 83/00617 *
WO 83/02225 *

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5554184A (en) * 1994-07-27 1996-09-10 Machiraju; Venkat R. Heart valve
WO1996040012A1 (en) * 1995-06-07 1996-12-19 St. Jude Medical, Inc. Bioresorbable heart valve support
US5728152A (en) * 1995-06-07 1998-03-17 St. Jude Medical, Inc. Bioresorbable heart valve support
US5895420A (en) * 1995-06-07 1999-04-20 St. Jude Medical, Inc. Bioresorbable heart valve support
US5782931A (en) * 1996-07-30 1998-07-21 Baxter International Inc. Methods for mitigating calcification and improving durability in glutaraldehyde-fixed bioprostheses and articles manufactured by such methods
US5861028A (en) * 1996-09-09 1999-01-19 Shelhigh Inc Natural tissue heart valve and stent prosthesis and method for making the same
US6231602B1 (en) 1999-04-16 2001-05-15 Edwards Lifesciences Corporation Aortic annuloplasty ring

Also Published As

Publication number Publication date
GB8711436D0 (en) 1987-07-22

Similar Documents

Publication Publication Date Title
CA1229202A (en) Stent covering for tissue valves
US6610088B1 (en) Biologically covered heart valve prosthesis
US9510944B2 (en) Prosthetic heart valve including stent structure and tissue leaflets, and related methods
US5935163A (en) Natural tissue heart valve prosthesis
US6797000B2 (en) Tri-composite, full root, stentless valve
CA2265754C (en) Prosthetic heart valve with suturing member having non-uniform radial width
EP1328215B1 (en) Flexible heart valve having moveable commissures
US5156621A (en) Stentless bioprosthetic cardiac valve
US6270527B1 (en) Elastic valve with partially exposed stent
US4388735A (en) Low profile prosthetic xenograft heart valve
US10028829B2 (en) Valve holder with leaflet protection
EP0086213A1 (en) Leaflet attachment and method of attachment for prosthetic heart valves.
EP3563799B1 (en) Heart valve holder
US20110000073A1 (en) Leaflet Alignment Fixture and Methods Therefor
GB2206395A (en) Bioprosthetic heart valve
CA2407200C (en) Method and system for providing a biologically covered heart valve prosthesis
US20030109921A1 (en) System for implanting prosthetic heart valves
RU99125557A (en) METHOD OF PLASTIC MITRAL-AORTAL CONTACT IN AORTAL-MITRAL PROSTHETICS.
WO2001056511A1 (en) Stentless heart valve bioprosthesis

Legal Events

Date Code Title Description
WAP Application withdrawn, taken to be withdrawn or refused ** after publication under section 16(1)