Biomaterial

Details Biomaterial Biomaterial

1985-06-17

1987-07-21

Apley, Richard J.

Prosthesis (i.e., artificial body members), parts thereof, or ai

Implantable prosthesis

623 1, 623 66, 128 1R, 8 9411, A61F 202, A61F 206, A61B 1900, A61L 1700

Patent

active

046815880

DESCRIPTION:

BRIEF SUMMARY
TECHNICAL FIELD

This invention provides a novel kind of material for use in a biological environment. More particularly this material may be used in treatments of the human body for example as a surgical dressing or for the repair of herniae, heart valves, holes in the heart or other defects. In some cases the material produced in accordance with the present invention may be used for dialysis and other filtering procedures.


DISCLOSURE OF INVENTION

The material of the present invention comprises a sheet of an animal parietal pleura which has been subjected to glutaraldehyde tanning. The invention also extends to the use of such material as a surgical graft or as a dressing applied to a living human patient.
The invention also provides a method of producing a biocompatible material comprising subjecting a sheet of animal parietal pleura to glutaraldehyde tanning.
The material may be subjected to irradiation before or after the glutaraldehyde tanning treatment. It may for example be subjected to 0.2 to 5.0 megarads of irradiation.
To be of maximum value, a biomaterial should be:


______________________________________ 1. Shelf storable. 2. Available in a wide range of sizes and shapes. 3. Sterile. 4. Non-antigenic. 5. Available in biodegradable or non- biodegradable form as the situation demands. 6. Able to support epithelial or endothelial growth as the situation demands. ______________________________________
By treating parietal pleura in accordance with the present invention it is possible to produce biomaterial meeting the above requirements.
Pleura is a thin membranous lining of the thoracic cavity and lungs. The pleura covering the thoracic cavity is termed parietal pleura and that covering the lungs is termed visceral. The invention makes use of the parietal pleura which consists of loose connective tissue covered with a single layer of mesothelial cells. The other components that are found in the connective tissue are macrophages, blood vessels, lymphatics, nerve fibres and fat cells.
In some circumstances human pleura may be available but more generally parietal pleura will be obtained from freshly slaughtered carcasses of animals such as cattle, sheep and pigs. In this way it has been possible to obtain sheets of pleura that measure as much as 60 cm.times.60 cm square. For special uses pleura can also be obtained from foetal calves.


BRIEF DESCRIPTION OF DRAWINGS

In the following detailed description of examples of clinical use of material prepared in accordance with the invention, reference will be made to the accompanying illustrations in which:
FIG. 1 shows the parietal side of a sheet of tanned bovine pleura produced in accordance with the invention;
FIG. 2 shows the visceral side of the same sheet of material;
FIG. 3 is a reproduction of a photomicrograph showing a section through a sheet of tanned bovine pleura;
FIG. 4 shows a pericardial patch recovered after six months implantation in a first dog;
FIG. 5 illustrates a pericardial patch recovered after three months implantation in another dog;
FIGS. 6 and 7 show a left atrial patch and a pulmonary outflow patch recovered after three months implantation in another dog;
FIG. 8 illustrates a pulmonary outflow patch recovered after three months implantation in a further dog;
FIG. 9 is a reproduction of a photomicrograph through the junction of the pulmonary artery and the pulmonary outflow patch of FIG. 7; and
FIG. 10 is a reproduction of a photomicrograph showing a section through the junction of the left atrium and the atrial patch of Figure.


BEST MODES OF CARRYING OUT THE INVENTION

In a typical process for producing a biomaterial in accordance with the invention, a sheet of parietal pleura obtained fresh from an abattoir is laid out flat with a single layer of gauze covering its smooth (visceral) surface. The pleura is transported in saline to a laboratory where it is stretched and cleansed of all excessive tissue to result in a uniform membrane 50-150 micron in thickness. This may be achieved by stretchin

REFERENCES:
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patent: 3974526 (1976-08-01), Dardik et al.
patent: 3988782 (1976-11-01), Dardik et al.
patent: 4120649 (1978-10-01), Schechter
patent: 4275469 (1981-06-01), Gabbay
patent: 4466139 (1984-08-01), Ketharanathan
patent: 4477930 (1984-10-01), Totten et al.
Stedman's Medical Dictionary, 24th ed., 1982, Williams & Wilkins Co. Baltimore, p. 1053.

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