Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Heart valve – Having rigid or semirigid pivoting occluder
Patent
1996-08-22
1998-03-17
Jackson, Gary
Prosthesis (i.e., artificial body members), parts thereof, or ai
Heart valve
Having rigid or semirigid pivoting occluder
606139, A61F 224
Patent
active
057281530
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
This invention relates in general to surgical devices, and more particularly to a stentless heart valve surgical support device.
BACKGROUND OF THE INVENTION
Heart valve disfunction can usually be corrected with surgery, involving repair or replacement of the diseased valves. The very best replacement for such a valve is a homograph, which is another human valve. Nevertheless, the availability of these valves is limited, so generally two types of replacement valves are currently used; mechanical and bioprosthetic (i.e. tissue). Mechanical valves are typically composed of tough, rigid materials, and usually do not fail structurally. However, mechanical valves require that the patient receive chronic anticoagulation therapy. Bioprosthetic valves are structured of chemically preserved animal tissue, usually from porcine or bovine sources. Tissue valves, because of their soft tissue composition, do not require chronic anticoagulation therapy. However, the tissue valves deteriorate in a similar manner to the patient's original valve, such that the survival rate is approximately 95% at five years, but only 40% at 15 years. Failure of the valve is usually a result of inadequate mechanical durability, atypical loading conditions and calcification.
Currently, bioprosthetic valve leaflets are made of tanned porcine aortic valves or calf pericardium, mounted on a rigid or pliable frame (also known as a stent). The purpose of the stent is to make it easier for the surgeon to implant the valve, since it allows the valve to retain its shape during surgery. Recently, using pathological and engineering analysis methods, it has been determined that the rigid stents themselves change the way in which the leaflets deform and carry load. To alleviate this problem, some valve manufacturers have begun producing stentless bioprosthetic valves. The lack of a stent and rigid cloth-covered ring, however, makes implantation of stentless valves difficult and time consuming. Several assistants are usually needed to hold the stentless valve in position with sutures and/or forceps or haemostats. This procedure is awkward for both the assistants and the surgeon performing the suturing. It is clearly advantageous to perform the valve surgery as quickly as possible, in order to ensure patient survival and rapid recovery.
To this end, at least one prior art holding device is known to facilitate surgical implantation of a heart valve. A stentless heart valve and holder is described in U.S. Pat. No. 5,197,979. This stentless heart valve holder is disposable and is detachably affixed to a suturable covering on the aortic segment of a heart valve, preferably via sutures which pass through holes in the holder.
However, this prior art holder suffers from the disadvantage that it cannot be thoroughly cleaned after use, due to the inclusion of internal threads for attaching a handle portion of the holder to a main body portion thereof. A further disadvantage of this prior art holder is that the holder is affixed to the valve via sutures, which necessitates time consuming connection. The prior art also does not provide space between the valve and holder for suturing of the valve to the patient's heart.
SUMMARY OF THE INVENTION
According to the present invention, a holding device for stentless valves is provided that allows accurate and easy positioning of the valve and facilitates suturing by adding rigidity to the valve structure. By utilizing the valve holding device of the present invention, surgery is made less complicated and faster.
Unlike U.S. Pat. No. '979, the valve holding device of the present invention is reusable with the exception of a detachable handle. A further advantage of the present invention is that it does not require the aortic segment of the valve to be enclosed by a suturable covering, as required in the prior art '979 patent. The present invention is not attached via sutures, but rather is preferably affixed by a tie wrap being wound around the valve. Furthermore, according to an aspect of the p
REFERENCES:
patent: 4702250 (1987-10-01), Ovil et al.
patent: 5053043 (1991-10-01), Gottesman et al.
patent: 5197979 (1993-03-01), Quintero et al.
patent: 5236450 (1993-08-01), Scott
Menkis Alan
Scott Michael
Vesely Ivan
Jackson Gary
London Health Sciences Centre
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