GB2159242A - Improved bioprosthetic valve - Google Patents

Improved bioprosthetic valve Download PDF

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Publication number
GB2159242A
GB2159242A GB8332715A GB8332715A GB2159242A GB 2159242 A GB2159242 A GB 2159242A GB 8332715 A GB8332715 A GB 8332715A GB 8332715 A GB8332715 A GB 8332715A GB 2159242 A GB2159242 A GB 2159242A
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GB
United Kingdom
Prior art keywords
valve
part
bioprosthetic
outside
cardiac 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Withdrawn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
GB8332715A
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GB8332715D0 (en
Inventor
Endre Bodnar
Clara Bodnar
Original Assignee
Endre Bodnar
Clara Bodnar
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 Endre Bodnar, Clara Bodnar filed Critical Endre Bodnar
Priority to GB8332715A priority Critical patent/GB2159242A/en
Publication of GB8332715D0 publication Critical patent/GB8332715D0/en
Publication of GB2159242A publication Critical patent/GB2159242A/en
Application status is Withdrawn legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2412Heart 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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents

Abstract

A bioprosthetic valve is presented, in which the biological part is a natural aortic or pulmonary valve of human or animal origin, and the valve incorporates a primary cloth cover C, E of the supporting frame A, which cover is discontinuous both on the outside and the inside of the said frame. The biological part F is led through the resulting openings, part of it is, thus, mounted onto the inside, part of it onto the outside of the supporting frame. <IMAGE>

Description

SPECIFICATION Improved bioprosthetic cardiac valve This invention relates to a bioprosthetic replacement cardiac valve.

Replacement cardiac valves have been in clinical use for more than 20 years. Currently there are two main types known: mechanical and bioprosthetic. The bioprosthetic valves consist of three parts: the cusped member which is biological in origin, the support frame, or stent, which can be metal, plastic or the combination of the two, and the soft cloth cover on the support frame, to which the biological part is secured by means of sutures, and which is attached to the patient's heart when the valve is inserted. These bioprosthetic valves have the great advantage of being non-thrombogenic as opposed to the mechanical valves which may cause serious blood clotting and embolism. On the other hand, bioprosthetic valves tend to be more obstructive and less durable than the mechanical prostheses.It is of the utmost importance therefore, that the obstruction to blood flow is minimised in the bioprosthetic valves and that they are constructed for the longest possible life and reliability. Generally, the bioprosthetic valves are compared by comparing the degree of occlusion and the longevity of the valves.

Both factors depend on the method and design how the biological part is mounted on the support frame, especially when the biological part is a porcine aortic valve. The design and attachment of the cloth cover on the support frame is the major single determinant of the way the porcine aortic valve can be mounted on it.

The cloth cover of all known bioprosthetic valves represent a continuous layer of fabric, generally synthetic in origin, covering uninterruptedly both the inside and outside of the supporting frame (Fig. 1.B). Such a cover can comprise two tubes, ready knitted into tubular form or made during valve manufacture by sewing two free edges of a sheet together, in which case these tubes are joined together at the top end as well as at the bottom end of the support frame. Alternatively, a single tube can be folded over the frame from inside to outside, or vice versa, and joined with one single suture line. In any case the continuity of the cover on both outside and inside is preserved. The porcine aortic valve, therefore, has to be mounted entirely within the covered stent (Fig. 1.C).This mounting technique which is uniformly characteristic of all known porcine bioprosthetic valves has two major disadvantages. Firstly, the thickness of the porcine tissue, which is in the range of 1-2mm, occupies a considerable part of the potential diameter of the valve, creating, thus, undesirable additional obstruction. Secondly, the forces which develop during valve closure tend to pull the bioprosthetic part away and off the support frame, and if such an event occurs, it invariably heralds the ultimate failure of the valve.

The present invention provides major improvements in both regards.

According to the present invention there is a bioprosthetic valve in which the biological part is a natural aortic or pulmonary valve of human or animal origin, and the valve incorporates a primary cloth cover, which is completely discontinuous both on the outside as well as on the inside of the support frame, making it possible, that part of the biological part is mounted onto the inside, part of it onto the outside of the supporting frame to achieve maximum performance and durability.

An embodiment of the present invention will now be Hescribed by way of example only, by reference to the accompanying drawings, in which Figure 1 is the schematic representation of a pair art bioprosthetic valve, and Figure 2 is the schematic representation of a bioprosthetic valve according to the present invention.

A known valve, as drawn in Fig. 1, comprises stent, or support frame (A), sheathed completely in cloth, (B) and the biological part (C) attached to this cloth with two suture lines (D,E) in such a way that the entire biological part is located within the inside of the stent.

Referring now to Fig. 2, it will be seen that the supporting frame (A) is not enclosed into a continuous cloth cover before the biological part is mounted onto it. The highly scalloped outflow part of the stent comprising legs (B) and the sinuses between these legs (C) are covered with a tight tube of material, in this case polyester, whilst the base ring (D) is covered with a separate piece of material (E).

First the aortic or pulmonary valve is sewn to the base ring (F), so that it is accommodated within the stent. Next the outflow part of the biological part is tailored to a scalloped shape similar to that of the stent, and the "legs" of the tailored aortic valve (called commissural parts), are pulled onto the outside across the legs of the stent (B) and sewn onto their outside surface. Finally, the remaining part of the sheet (E) is tailored into an appropriate shape and sewn onto the tube covering the legs (B) and sinuses (C).

The result of the proposed method is a valve which has an unobstructed outflow aspect, and in which the forces during valve closure are not pulling the biological part away from the support stent; instead they are pulling it onto the stent thus increasing durability.

It is to be understood that the present invention is applicable to all bioprosthetic valves which do not comprise a support stent being a continuous layer of metal or plastic, and that the present invention embraces all those modifications and improvements which would be apparent to one skilled in the art.

Claims (6)

1. A bioprosthetic cardiac valve, incorporating a cloth cover of the supporting frame, which cover does not represent a fully continuous layer of material either on the inside or on the outside of the supporting frame when this frame is ready for valve mounting, and the biological part is led through the resulting openings so, that part of it is mounted onto the inside, part of it onto the outside of the supporting frame.
2. A bioprosthetic cardiac valve, as claimed in Claim 1, in which the biological part is of human or animal origin.
3. A bioprosthetic cardiac valve, as claimed in Claims 1 s 2, in which the biological part is natural aortic or pulmonary valve.
4. A bioprosthetic cardiac valve, as claimed in Claim 1, in which the cloth cover is made of synthetic material.
5. A bioprosthetic cardiac valve as claimed in Claim 1, in which the cloth cover of the support frame is completed only after the mounting of the biological part has been completed.
6. A bioprosthetic cardiac valve, substantially as described herein with reference to Fig. 1 8 2 of the accompanying drawing.
GB8332715A 1983-12-08 1983-12-08 Improved bioprosthetic valve Withdrawn GB2159242A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
GB8332715A GB2159242A (en) 1983-12-08 1983-12-08 Improved bioprosthetic valve

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
GB8332715A GB2159242A (en) 1983-12-08 1983-12-08 Improved bioprosthetic valve

Publications (2)

Publication Number Publication Date
GB8332715D0 GB8332715D0 (en) 1984-01-18
GB2159242A true GB2159242A (en) 1985-11-27

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
GB8332715A Withdrawn GB2159242A (en) 1983-12-08 1983-12-08 Improved bioprosthetic valve

Country Status (1)

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GB (1) GB2159242A (en)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992009247A1 (en) * 1990-11-29 1992-06-11 Anschütz & Co. Gmbh Support ring for a biological aortic-valve prosthesis
US5449385A (en) * 1991-05-08 1995-09-12 Nika Health Products Limited Support for a heart valve prosthesis
US6231602B1 (en) 1999-04-16 2001-05-15 Edwards Lifesciences Corporation Aortic annuloplasty ring
US8591575B2 (en) * 1996-12-31 2013-11-26 Edwards Lifesciences Pvt, Inc. Method of dilating a stenotic aortic valve and implanting a prosthetic valve

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1243293A (en) * 1968-09-16 1971-08-18 Warren Dale Hancock Improvements relating to stent's for heart valves
EP0116236A1 (en) * 1983-01-11 1984-08-22 The University Of Sheffield Heart valve replacements

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1243293A (en) * 1968-09-16 1971-08-18 Warren Dale Hancock Improvements relating to stent's for heart valves
EP0116236A1 (en) * 1983-01-11 1984-08-22 The University Of Sheffield Heart valve replacements

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992009247A1 (en) * 1990-11-29 1992-06-11 Anschütz & Co. Gmbh Support ring for a biological aortic-valve prosthesis
US5449385A (en) * 1991-05-08 1995-09-12 Nika Health Products Limited Support for a heart valve prosthesis
US8591575B2 (en) * 1996-12-31 2013-11-26 Edwards Lifesciences Pvt, Inc. Method of dilating a stenotic aortic valve and implanting a prosthetic valve
US6231602B1 (en) 1999-04-16 2001-05-15 Edwards Lifesciences Corporation Aortic annuloplasty ring

Also Published As

Publication number Publication date
GB8332715D0 (en) 1984-01-18

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Legal Events

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