Tutoplast Sclera

Print This Post
patch grafts Category Tutoplast Sclera iopatch Category Tutoplast Sclera
The IOPatch Sclera patch graft is comprised of high profile collagen with a nominal thickness of 1 mm (photo: 1x3 cm configuration). It is a multi-directional matrix for superior surgical handling and suture utility. The IOPatch graft is the industry standard for glaucoma implant/valve surgery.

Since technology Tutoplast® Pericardium and Sclera allografts have been employed by ophthalmic surgeons throughout the world to treat a variety of ocular conditions. The surgical use of the Tutoplast® allografts as a tectonic support, epithelialization substrate or superficial patch graft has been well documented.

The Tutoplast® Process is scientific and technology based method of virally inactivating, preserving and sterilizing human tissue. The Tutoplast® benefits are vast:

  • Immunologically safe.
  • Biologically and mechanically stable.
  • Five year shelf life/Room temperature storage.
  • Uniform and consistent in tissue quality.
  • Improved suturability and handling.

During the last 30 years, over 1 million Tutoplast® Allografts have been surgically implanted without a single documented case of disease transmission.

Tutoplast® is a registered trademark of Tutogen Medical, USA.

Applications

Glaucoma

  • Drainage implant and, or valve implantation.1,4, 5
  • Repair of leaking and, or overfiltering bleb (trabeculectomy).3
  • Repair of corneo-scleral fistulas.9

Retina

  • Repair of exposed sclera buckles.6

Cataract

  • Phaco “burns.”7

Oculoplastics

  • Eyelid reconstruction.
  • Repair of exposed orbital implants.
  • Gold eyelid weight cover.

Introduction and History

The exclusive Tutoplast® Process is a scientific and technology based method of virally inactivating, preserving and sterilizing human tissue for transplantation.

During the past thirty years, over 1 million Tutoplast® Bioimplants have been surgically implanted without a single documented case of disease transmission.

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.

1. Brown P, et al. Sodium hydroxide decontamination of Creutzfeld-Jakob Disease virus. The New England Journal of Medicine. Vol. 310, No.11.

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

2. Hinton R, Jinnah RH, Johnson C, et al. A biomechanical analysis of solvent-dehydrated and freeze-dried human fascia lata allografts. Am J Sports Med 1992;20: 607-612.

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 Growth 3

  • 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, clera -shite sheet of collagenous tissue corresponding to viable endogenous connective tissue. No immunological rejection has been observed.

3. Hans-Jurgen Pesch. Solvent preserved grafts of dura mater and fascia lata (Membranous Collagen Graft) in animals. Facial Nerve 1984.

Additional Benefits

IOPatch Pericardium Patch Graft 1.5 cm

  • Low profile collagen with a nominal thickness of 400 microns.
  • Multi-directional matrix for superior surgical handling and suture utility.
  • Patch graft standard for glaucoma implant/valve surgery.

IOPatch Sclera Patch Graft 5x8 mm

  • High profile collagen with a nominal thickness of 1 mm (photo: 1x3 cm configuration).
  • Multi-directional matrix for superior surgical handling and suture utility.
  • Patch graft standard for glaucoma implant/valve surgery.

Glaucoma Implant Surgery (Marlene Moster, M.D.)

  • Surgical Pearl: Double-thickness Tutoplast® Pericardium.
  • To help prevent tube erosion, fold pericardium in half, while dry, to create a double-thickness patch graft. Suture in place with 10-0 nylon.

Glaucoma Implant Surgery (Marlene Moster, M.D.)

  • IOPatch Pericardium sutured in place over the tube.
  • The low profile nature of the pericardium prevents graft bulkiness over the implant.
  • Single layer tissue thickness can be maintained at the limbus to prevent dellen. Maintain double-thickness posterior to the limbus.

Repair of Exposed Scleral Buckle (David Weissgold, M.D.)

  • IOPatch Pericardium sutured in place over exposed clera buckle.
  • IOPatch promotes rapid epithelialization and a complete healing of conjunctiva over the graft within weeks.
  • The low profile nature of the pericardium prevents graft bulkiness over the implant.

Ordering

Tutoplast® Processed Sclera is a solvent dehydrated, gamma-irradiated preserved human sclera. Recovery: All tissue recovered meets stringent specifications during donor screening and laboratory testing to reduce the risk of transmitting infectious disease.

Precautions

  • Tutoplast® Processed Sclera remains sterile and non-pyrogenic as long as the package is not opened and/or damaged. The graft must be used before the expiration date.
  • Appropriate placement and fixation are critical factors in the avoidance of potentially adverse effects on graft service life.
  • The adsorption process and reformation of endogenous tissue begins one to two days after implantation and continues for weeks, months, or years, depending on the size of the graft and the responsiveness of the graft site.

Processing

The processing of all Tutoplast® tissue consists of a strict, quality-controlled procedure, which involves thorough cleaning, processing, dehydration, and preservation.

The process leaves no deleterious residue and minimizes antigenic potential. Additional assurance of sterility is achieved with the use of a target of 25 kGy (2.5 Mrads) of gamma radiation. Based on previous trials with gamma irradiation, the level used in the Tutoplast® process effectively significant adverse effect on the biomechanical properties of the tissue.

Indications

Tutoplast® Processed Sclera is indicated for implantation with a specific spectrum of indications. Collagenous connective tissue with multidirectional fibers retains the mechanical strength and elasticity of native pericardium, while providing the basic formative structure to support replacement by new endogenous tissue. This tissue is indicated for use in a variety of surgical applications, including duraplasty (as a substitute for human dura mater), and in abdominal, urological, ophthalmological, and vascular surgery.

Contraindications

  • Implantation into areas with active or latent infection or signs of tissue necrosis.
  • Implantation into areas with a compromised circulation.
  • Any disorder which would create an unacceptable risk of post-operative complications.

Adverse Effects

  • As with any surgical procedure, the possibility of infection exists.
  • Although the Tutoplast® process is designed to eliminate antigenic properties of the graft, the possibility of rejection is present in any allograft procedure.
  • Reoperation could be necessary to correct adverse effects.
  • Adverse reactions should be immediately reported to Tutogen Medical, U.S., Inc.

Steilization

  • This graft has been sterilized by a target of 25 kGy (2.5 Mrads) of gamma radiation to provide sterility throughout the unit.
  • The Packaging of all sterile products should be inspected for flaws in the sterile barrier before opening. In the presence of such a flaw, the product must be assumed nonsterile.
  • Care should be taken to prevent contamination of the graft. In the event of such contamination, this product must be discarded.
  • If the package has been opened, but the product is not used, the graft must not be resterilized and must therefore be discarded.

Utilization/Implantation

  • It is recommended that Tutoplast® Processed Sclera be rehydrated prior to use by soaking in 0.9% saline solution for 5 to 30 minutes, depending on the consistency desired, using aseptic/sterile technique.
  • Tutoplast® Processed Sclera is packaged in various sizes (length and width). The size of the section used should correspond to the size of the respective defect.
  • The surgeon should monitor the effect of rehydration by visual inspection after completing the rehydration and while cutting and shaping the allograft.
  • Implantation should be preformed in such a way that the free edges of the implant do not extend into areas where the possibility of adhesion may present a problem.
  • Absorbable or nonabsorbable suture material can be used to fix Tutoplast® Processed Sclera.
  • For a Continuous suture, absorbable suture material and round atraumatic needle are recommended.
  • Suture gauge depends on the surgical indication.
  • The suture should be located two to millimeters from the edge of the graft.
  • Better results are obtained by doubling the section at suture sites that are under moderate to high stress.

Storage

This product should be stored in a clean, dry place at controlled room temperature of 15*C to 30* C (59* to 86* F).

Warnings

  • Tutoplast® Processed tissues have been used for over 25 years in more than 750,000 surgical transplant cases with an outstanding safety record. As with all biological products, it is not possible to give an absolute guarantee of freedom of transmitting infectious diseases such as hepatitis and CJD. Processed treatments shown to be capable of reducing the risk of any transmission as well as strict donor screening and laboratory testing are used to decrease the risk.
  • The reaction of the body to any allograft is not completely understood.
  • Discard all damaged or mishandled grafts or when possible contamination of the graft has occurred.
  • Return all packages with flaws in the sterile barrier to the supplier.
  • Unused tissue should be properly discarded.
  • DO NOT RE-STERILIZE.
  • Single patient use only.

The relevance of the reimbursement codes depends on indications of use and geographic region.

Please use the hotline or email to determine what the guidelines are for your area.

IOP Reimbursement Hotline:    1.888.700.9005

IOP Reimbursement Email:      support@nmdhealthcare.com

Coming Soon

68332 Tutoplast Whole Sclera Register to See Pricing
68333 Tutoplast Sclera (0.5 x 0.8 cm.) Register to See Pricing
68337 Tutoplast Sclera (0.6 x 1.0 cm.) Register to See Pricing
68334 Tutoplast Sclera (1 x 3 cm.) Register to See Pricing
indicator Category Tutoplast ScleraUpdating…