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For Veterinary Professionals
FAQ
(1) Autogenetic bone grafting
Definition : Harvesting of bone from one site of the patient’s body and placing it in another site
Advantages : Relatively good healing since it causes no antigen-antibody reaction.
Disadvantages : Harvesting bone requires additional surgery and involves pain. It allows only limited amounts of bone to be harvested and requires a lot of time and cost.
(2) Allogenic bone grafting
Definition : Grafting of bone tissue harvested from an animal of the same species
Advantages : Excellent healing effect since the bone is harvested from a donor of the same species. Relatively sufficient amounts of bone graft material available compared with autogenic bone grafting. It’s possible to reduce time and costs without requiring additional surgery for harvesting bone. Allows for various types of bone grafting
Disadvantages : Despite graft products being processed by sterilization, refrigeration, and/or chemical treatment, it is still possible for the animal’s immune system to reject the product or develop an infection.
(1) Osteoinduction
The process by which bone formation is induced by stimulating the differentiation into osteoblasts of the neighboring stem cells in which there are such growth factors as bone morphogenetic protein (BMP), among the organic components of bone.
(2) Osteoconduction
The process by which bone cells produced through osteoinduction and the blood vessels that assist in the growth of those cells are proliferated and serve as a scaffold to create an environment for bone formation.
Orthopedic
On many occasions, bone loss occurs in various regions due to accidents or diseases. If such surgical procedures as TTA and TPLO are necessary for fractures, lost bone, or broken joints caused by accidents, or if a variety of forms of lost bone occurs, such as inflammation and bone cysts, bone grafts suitable for the locations in question can save the lives of animals and keep them healthy
Periodontal
Because animal teeth have much longer roots than human teeth, missing teeth leave much deeper voids behind. If exposed roots are left untreated, the animal will chew food using its gums, causing bacterial infection and inflammation, which can lead to more severe diseases. It is crucial to rebuild a healthy gum by filling the voids left by tooth extractions through bone grafting.
(1) Xenogenic bone grafting
Definition : Grafting of bone harvested from an animal of another species that allows for easy harvesting
Advantages : Bone graft material is readily available.
Disadvantages : Inherited transplantation antigens between animals due to difference of species.
(2) Synthetic bone grafting
Definition : Grafting of calcium, etc. derived from chemical treatment
Advantages : Relatively inexpensive
Disadvantages : Since it is not bio-friendly, it makes it more difficult to expect a good prognosis than bone grafting of the same species.
1. Cortical Bone
The cortical bone is the outer surface of bone. It is very hard and has high strength and density, which provides the ability to maintain its volume and withstand great loads. These properties allow the bone to serve as a support during the formation of new bone.
2. Cancellous Bone
The cancellous bone makes up the interior of bone and, unlike the cortical bone, has a spongy appearance in the highly porous, three-dimensional form of spicules crisscrossing the bone. Therefore, it serves as a scaffold that helps new bone cells attach, proliferate, and differentiate when new bone is being formed and provides exceptional osteoconductive properties that help create an ideal environment for revascularization.
3. Demineralized Bone
The bone consists of approximately 70% inorganic matter and 30% organic matter. The organic matter surrounded by this inorganic matter contains such growth factors as bone morphogenetic proteins (BMP). Through the demineralization process by which inorganic compounds are removed, growth factors such as BMP, which assist in bone repair, are quickly released and promote osteoinduction, contributing to the quality of bone repair.
Product components
※ These products are available in putty form for surgeon convenience and they have been optimized for room temperature operation.
These products should be stored in room temperature. Do not refrigerate or freeze.
Tissue suppliers and users should store the products at an appropriate condition before using them. Avoid high temperature and high humidity during transportation.
In case of return, please contact the distributor and send the products following the distributor's instructions.
The expiration period is 2 years from the manufacturing date. The expiration date is marked on the outer packages of products.
Our products are sterilized by Electron-beam irradiation after packing. The sterilization procedure is confirmed to be effective for eliminating bacteria and fungi. Radiation sterilization indicator labels that attached on the outer packages will turn to red from yellow after effective Electron-beam sterilization. Sometimes the labels will turn to orange from red due to high temperature and humidity during transport, but the product quality won't be affected. Do not re-sterilize.
1. Aseptic technique must be observed at all times to minimize surgical complications. These kinds of products are ready to use and then there is no need to rehydrate.
2. The packaging of our products are designed for easy to use and protect the product inside. The product should be opened in an aseptic condition.
3. How to use
(1) Take out the inner pouch package from the outer package. (2) Using aseptic technique, remove the first pouch and take out the product from the second vacuum-packed pouch. (3) Bone grafts are contained in a syringe with a green silicon cap, remove the cap by pulling it gently. There is a small adaptor on the nozzle, the contents can be transferred to a small defect site through the adaptor by pulling the plunger gently. (4) In case of big defect, the adaptor should be removed first by screwing it, and the contents can be easy squeezed out and transferred into the big defect. |
4. Apply the bone graft products into the injury sites with good blood supply will achieve the best bone regenerative effect.
Product components
These products should be stored in room temperature. Do not refrigerate or freeze.
Tissue suppliers and users should store the products at an appropriate condition before using them. Avoid high temperature and high humidity during transportation.
In case of return, please contact the distributor and send the products following the distributor's instructions.
The expiration period is 5 years from the manufacturing date.
The expiration date is marked on the outer packages of products.
Our products are sterilized by Electron-beam irradiation after packing. The sterilization procedure is confirmed to be effective for eliminating bacteria and fungi. Radiation sterilization indicator labels that attached on the outer packages will turn to red from yellow after effective Electron-beam sterilization. Sometimes the labels will turn to orange from red due to high temperature and humidity during transport, but the product quality won't be affected. Do not re-sterilize.
1. Aseptic technique must be observed at all times to minimize surgical complications.
2. The packaging of our products are designed for easy to use and protect the product inside. The product should be opened in an aseptic condition and rehydrated within 24 hours. After being rehydrated, the product must be used within 4 hours, otherwise it must be discarded.
3. How to apply bone grafts contained in a syringe to injury sites.
(1) Take out the inner pouch package from the outer package in an aseptic condition. (2) Using aseptic technique, remove the first pouch and take out the product from the second vacuum-packed pouch. (3) Bone grafts are contained in a syringe with a green silicon cap, remove the cap by pulling it gently, and put the cap on the thumb rest to use it as a stopper (The cap can prevent the rubber bulb from getting out of the barrel) (4) There is a transparent mesh cap under the green cap. Put the syringe tip into animal blood or saline with the mesh cap on, simply push and pull the plunger covered with the green silicon cap several times to rehydrate the contents. (5) After rehydration, squeeze out excess blood or saline by pushing the plunger covered with the green silicon cap gently. (6) Remove the mesh cap by screwing it, push the plunger covered with the green silicon cap gently to transfer the bone grafts into the injury sites. |
Through the demineralization process by which the inorganic matter in bone is removed to a certain ratio, growth factors like bone morphogenetic proteins (BMP), which assist in bone repair, are released, increasing osteoinduction and contributing to faster and higher quality bone repair.
When a highly viscous water-soluble composite is added to this bone powder, the product gains high viscosity. Without requiring extra rehydration, the product can be immediately molded to the desired shape, or mixed with other powder bone.
The highly viscous water-soluble composite assists in the action of BMPs released from the demineralized bone and prevents reduction in the particle size of demineralized bone, collagen decomposition, and breakdown of growth factors during radiation sterilization, which contributes to higher quality bone repair.
Such a product is called Demineralized Bone Matrix (DBM).
For veterinary use only. Our products would be toxic if consumed by humans.
1. General cautions
(1) For single use only. Do not reuse. (2) All products are sterilized by Electron-beam irradiation. (3) Check package integrity before use to ensure that the product has remained sterile. Do not resterilize. (4) Do not use the product that has past its expiration date. (5) Our products must be used by licensed veterinarians. Do not use them for other than the purpose intended. |
2. Improper use can cause severe adverse effects
(1) Calculating the necessary amount of grafts. Exceed amount of grafts may penetrate into other tissue adjacent to the defect and cause inflammatory response. (2) Immune rejection response may occur in the case of using these products to immune deficiency patients. (3) Our products are intended for filling bone defects caused by surgical procedures or traumatic injuries. Any other administration routes (oral, IV, IM, SC et al.) would cause serious problems, such as inflammation or even death by thrombosis. (4) Our products can be rehydrated by animal blood and saline. But if mix the products with bone cement, the release of the active components of the products can be inhibited, and the heat generated by the cement's hydration may cause tissue injury. (5) Products must be handled in an aseptic environment. Otherwise they may be contaminated and cause adverse effects such as fever and inflammation. |
3. Possibilities of infections
Although donor eligibility has been determined and the materials has been tested prior to manufacturing, there is still an inherent risk of disease transmission in the use of the bone graft for any purpose. |
An implant tracking card has been included with the product and should be completed at the time of surgery. Record the name and address of the medical facility, the name of the veterinarian, implant information and comments regarding the use of the implant on the tracking card. The completed original form should be returned to the distributor by post, or simply send it by FAX or E-mail. Copies should be retained by the medical facility in the animal medical record for tracking tissue post-transplantation.
* All details of the products (type, size, weight, et al.) can be found in the label attacked on the packages.
