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The Tutoplast™ Benefits......
Immunologically safe
Problem:
HIV/CJD/Pathogens - A recent clinical report identified polymerase chain reaction evidence of the HIV genome in sclera sourced from HIV-1 seropositive donors.¹
Solution:
The patented Tutoplast® process meticulously eliminates or inactivates pathogens of major concern to you and your patients.²
Increased Fibrovascularization
Our process not only assures the safest tissue possible, but may also allow for a more rapid and complete
vascularization of the orbital implant.
“In the histological study described herein and in our prior study.... Tutoplast human sclera-wrapped implants demonstrated earlier amd more extensive fibrovascularization
than implants covered with remaining wraps.”³
Simple
- Single use, sterile packaging
- Activates in simple saline within minutes
- Five (5) year shelf life
- Reduced O.R. time/No autografts or secondary surgical sites required
“These wraps have a 5-year shelf life, which in many situations may be more convenient than obtaining donor
tissue from a regional eye or tissue bank.” ³
During the past 30 years, over 1 million Tutoplast® Bioimplants have been surgically implanted without a single documented case of disease transmission.
Screening
U.S. FDA serological testing protocols are followed. No donor pooling is allowed. Tissue is rejected if the donor has a medical or social history that indicates risk of infectious disease or malignancy.
Tissue Processing– Phase 1
Tissues are cleaned with a saline solution of various concentrations.This process results in the osmotic destruction of cells, reducing the tissue to its fiber and mineral components.
Osmotic Treatment
- Cells and bacteria are removed.
- Potential viruses are isolated for subsequent Phase 2 inactivation.
- Amajority of antigens are destroyed.
Tissue Processing – Phase 2
Inorganic agents are employed in specific concentrations to inactivate HIV, hepatitis and Creutzfeldt-Jakob Disease (CJD). This denaturization is achieved without significant alterations in the collagenous tissue structure.
NaOH Treatment
- Prions inactivation
- Virus destruction
- Collagenous preservation
H2O2 Treatment
- Antigen removal
- Collagenous preservation
Preservation
Non-caustic, organic solvents with disinfectant properties are employed to gently extract the water from the tissue. No chemical residue remains and the inherent collagenous matrix is preserved.
Final Packaging
The tissue is cut to specified sizes and packaged in transparent, double-peel pouches. The grafts are then terminally sterilized
by 2.5 mRads of gamma-irradiation.
The Tutoplast Process is a fully integrated science and
technology-based method of
virally inactivating and
preserving human tissue for surgical implantation.
1. Seiff SR, Chang JSJ, Hurt MH, Khayam-Bashi H. Polymerase chain reaction identification of human immunodeficiency virus-1 in preserved human sclera. Am J Ophthalmol 1994: 118: 528-30.
2. Simonds R.J., et al. Transmission of human immunodeficiency virus type 1 from a seronegative
organ and tissue donor. The New England Journal of Medicine. 1992. Vol. 326, No.11.
3. Brown P, et al. Sodium hydroxide decontamination of Creutzfeld-Jakob Disease virus. The New
England Journal of Medicine. Vol. 310, No.11.
4. Abe S., et al. “Clinical experiences with solvent dehydrated fascia lata in plastic surgery”. Jap Journal
Plast Reconst Surg. 1991. Vol 11, 721-730.
5. Hinton R, Jinnah RH, Johnson C, et al. A biomechanical analysis of solvent-dehydrated and freezedried
human fascia lata allografts. Am J Sports Med 1992;20: 607-612.
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