Introduction
The exclusive Tutoplast® Process is a scientific and
technology based method of virally inactivating, preserving
and sterilizing human tissue for transplantation.
History
During the past thirty years, over 1 million Tutoplast®
Bioimplants have been surgically implanted without a single
documented case of disease transmission.
Stage 1: Materials - Source Screening Tutoplast®
human tissues are obtained from tissue banks operating in
compliance with recovery standards set forth by the Food&
Drug Administration and the AATB (American Association of
Tissue Banks). Serological protocols are followed as consistent
with current U.S. FDA requirements (serological testing includes
HIV 1 and 2, Hepatitis B and C, among others). Source material
is rejected if medical and/or social history indicates risk
of infectious disease, malignancy or other disease. The tissues
are placed in prepared storage medium before the onset of
processing. All tissues are unambiguously labeled and must
pass standards for size, structure, cleanliness and quality.
No donor pooling is allowed.
Stage 2: Osmotic Cleaning and Acellularization Tissues
are cleaned with saline solution of various concentrations.
The result is the osmotic destruction of cells, reducing the
tissue to its fiber and mineral components. The results of
osmotic contrast bathing phase:
- Removal of bacteria
- Potential viruses are exposed and prepared for activation
in following phase
- Because the majority of antigens are bound to cell membranes,
most of the antigenicity is removed.
Stage 3: Viral Inactivation and Denaturization Inorganic
agents (hydrogen peroxide, sodium hydroxide) are employed
in specific concentrations during specific time intervals
shown to inactivate HIV and the agent responsible for Creutzfeldt-Jakob
Disease (CJD).1 This denaturization of soluble
proteins is achieved without significant alterations in the
collagenous structure of the tissue.
Stage 4: Tissue Preservation The tissue is preserved
by the extraction of water using organic solvents (acetone).
Through this gentle method of preservation, the dense collagenous
tissue matrix of the tissue is retained. The organic solvents
employed in Phase 1 and 2 of the tissue processing are completely
removed, resulting in a residue-free allograft. The organic
solvents employed during this stage also possess disinfectant
properties capable of inactivating HIV and other unconventional
viruses.2
Stage 5: Terminal Sterilization Following dehydration,
the tissue is configured to standard sizes and packaged in
transparent, double peel pouches. Finally, the each tissue
is terminally sterilized by gamma-irradiation. Since viral
inactivation is achieved during the previous stages, an appropriate
dosage is employed for effective terminal sterilization of
any remaining bacteria or bioburden without significant effects
on the collagenous, fibril structure of the tissue.
Histology
Tutoplast® Dura Mater - the Scaffold for Endogenous Tissue
Growth3
- 14 days post-op: The graft is incorporated at the level
of the skeletal striated muscle. It is surrounded by well-vascularized,
cell-rich, unspecified granulation tissue composed of macrophages
and fibroblasts.
- 6 weeks post-op: The margins of the graft have become
firmly incorporated in the host tissue where it has been
replaced be cell-rich, well-vascularized endogenous connective
tissue.
- 14 months post-op: The former graft site exhibits a defined,
irritation-free, greyish-shite sheet of collagenous tissue
corresponding to viable endogenous connective tissue. No
immunological rejection has been observed.
|
