A GRAFT FOR MAXILLARY SINUS LIFTING TREATMENT AND PRODUCTION THEREOF

TECHNICAL FIELD

The invention relates to a novel graft suitable for use in maxillary sinus lifting procedure, which enables the elevation of the sinus membrane with external or internal approach and placement the graft material to the created space.

PRIOR ART

The maxillary sinus is the anatomical cavity filled with air, located symmetrically on both sides of the nasal cavity in the maxilla. Also known as the Antrum of Highmore since it was first defined by Nathaniel Highmore first, the maxillary sinus starts to form in the mother’s womb and assumes a pyramid shape from birth to adulthood by expanding into the bone in a downward and forward manner.

Maxillary sinuses located in the maxilla and generally hag down due to the loss of teeth and cause inadequate bone volume in posterior maxilla. The role of the maxillary sinus cavities located particularly in the alignment of the root apex of molar teeth is very important, and they provide for voice creation and decreasing of the head weight.

The trough created at the maxillary sinus base can be lifted using various surgical operations. The purpose of maxillary sinus lifting is to lift the sinus membrane with external or internal methods and then place bone materials (grafts) into the surgically created space, providing new bone creation. The said grafts can be provided for treatment in three categories as the autogenous graft obtained from the patient, allogenic graft obtained from different human (cadaver or living donor), and xenogenous graft obtained from animals.

The highest yield among the indicated graft types is the autogenous grafts obtained from the person themselves and accepted as the golden standard. However, for obtaining the autogenous grafts, there are disadvantages such as the requirement for a second operation, the amount of bone to be obtained being restricted, and the obligation for general anaesthesia for the procedure. Today, aside from autogenous bones, allogenic, xenogenous, synthetic graft materials and recombinant human bone proteins have been using in sinus lifting surgery.

Additionally, it is known that xenogenous grafts which usually originate from bovine or horse and the synthetic hydroxyapatite (HAP) grafts are known to show close similarity to human bone, and these grafts are frequently used in sinus lifting surgeries. However, there are disadvantages of these materials being rather expensive and showing only osteoconductive effects.

Consequently, it has become a necessity to make an innovation in the related technical field for obtaining grafts usable in the treatment of maxillary sinus lifting procedures. Within this context, the subject of the invention is related to a new graft suitable for use in maxillary sinus lifting surgery and production thereof.

BRIEF DESCRIPTION OF THE INVENTION

The present invention relates to a biocompatible xenogenous graft for eliminating the disadvantages in the related technical field and providing additional advantages.

The object of the invention is to put forth a graft suitable for use in maxillary sinus lift procedure. The graft obtained with the invention has more affordable prices and high biocompatibility with the patient’s bone. Thereby, it is possible to obtain a biomaterial that shows rapid development at lower costs.

An object of the invention is to put forth a graft which comprises minerals such as magnesium, zinc, and strontium. As different from synthetic grafts, comprising said minerals for bone development, the graft provides that the patient recovers faster.

An object of the invention is to put forth a graft that has calcium minerals in high amounts, which have great importance in bone health.

BRIEF DESCRIPTION OF THE FIGURES

Figure 1 : The view of the xenogenous graft of the invention obtained from the FE-SEM device.

Figure 2: The EDX analysis result of the xenogenous graft of the invention. Figure 3: The illustration of cell viability test results of the xenogenous graft of the invention.

Figure 4: The analysis result of the xenogenous graft of the invention obtained from the XRD device

DETAILED DESCRIPTION OF THE INVENTION

In this detailed description, the subject of the invention relates to a new graft suitable for use in maxillary sinus lifting surgery, which provides for the lifting of sinus membrane with internal or external methods and placing of the graft material in surgically created space; and it is described by means of examples only for the better understanding of the subject in the way to create no limiting effect whatsoever.

The graft of the invention is a xenogenous graft. Preferably, in the invention, the bones obtained from marine species that have high amounts of calcium are used as xenogenous graft sources. The amount of calcium between 70-90% by weight in the bones of marine species provides that the patients gain their bone health rapidly. Preferably, it is provided to obtain the xenogenous grafts provided from the vertebra section where marine species have higher numbers of bones.

In the invention, lepidote or alepidote fish can be used as a xenogenous graft source. Preferably, it can be obtained from bones combined from at least one or a few, or all of the fish species of trout, leer, merling, red mullet, tabby, hake, brushtooth lizardfish, sea bream, flounder, halibut, john dory, sea bass, angler, rockling, whiting, turbot, shipshead bream, mullet, swallow, bogue, grooper, and bluefish. As the xenogenous graft source of the invention, the bones obtained from at least one of the trout, sea bass, and sea bream are used. As the most preferred xenogenous graft source, the bones obtained from trout are used. The most preferred in the invention is the use of bones obtained from the vertebra section of trout to be used as xenogenous graft raw material in maxillary sinus lifting surgery.

In the invention, the bones obtained from the vertebra of trout are used as xenogenous graft source. The obtained trout bones have hydroxyapatite compounds with high calcium contents. The biggest advantage of grafts containing these compounds is that they are similar to human bone composition. Grafts having a similar structure to human bone provide their use in bone diseases, faster recovery of the patients, and forming a whole by combining with autogenous graft by presenting high biocompatibility. As mentioned previously, calcium at a value between 70-90% is present in fish bones. Additionally, unlike the synthetic grafts, the natural grafts obtained from fish bones comprise minerals such as magnesium, zinc, and strontium that provide fast improvement of the patient's bone health.

In the invention, the bones obtained from marine species are used as xenogenous graft raw material. Here, the said bones can be used in obtaining graft with methods recommended in the invention, for example by using fish scraps whose meat has been removed in restaurants, save the bones. Thereby, by using scrap fish as a graft source, the costs can be lowered and it can be provided that waste products are included in the sustainable production flow.

The xenogenous graft obtained from marine species of the invention, in the case that it is preferred, may contain at least one of autogenous graft, allogenic graft and/or synthetic graft with high biocompatibility.

The xenogenous graft obtained from the marine species of the invention, in the case that it is preferred, may contain at least one of the additives, drugs with healing properties, hormones, vitamins and/or minerals which can speed the treatment of the surgical operation area and contribute to bone growth.

In the invention, the xenogenous graft obtained from marine species can be used as a biomaterial in tissue engineering, orthopedics, and dentistry. Essentially, the xenogenous graft of the invention is used as a biomaterial in surgical operations essentially for maxillary sinus lifting procedures.

The invention relates to a xenogenous graft production suitable for use as a biomaterial in surgical operations for maxillary sinus lifting, characterized in that it comprises the following process steps; i. separating the meat of the fish that has the vertebra bones mechanically by means of a cutter, ii. boiling the bone separated from the meat at 50 to 150°C temperatures for a period between 30 minutes to 180 minutes and cooling at the end of the period, iii. treating with 1% NaOH solution in an ultrasonic water bath, iv. drying the bones obtained after the process (iii), v. pulverizing the dried bones and sieving, vi. thermally processing the bone powder sieved. The said process step i) is preferably a mechanical method, however, in case it is preferred, chemical separation techniques which will provide that the fish meat is separated more easily from the bone can also be used. The said cutter can be a knife and similar tools.

In the said process step ii), the boiling is performed for 45 to 75 minutes. The preferred boiling process duration is 60 minutes.

The boiling in the process step ii) is essentially performed at 100°C. Then, the cleaning process can be performed, with hot or cold water. Preferably, it is performed with cold water. The said cooling process is performed at room temperature.

In the said process step iii), the obtained bones are preferably treated with NaOH for 10 minutes to 45 minutes. The preferred treatment duration is 30 minutes. At the end of this process, the tissue bits remaining on the bones can be removed with ultra-pure water.

In the said process step iv), the drying process is performed for 1 to 10 hours at a constant temperature. The preferred drying process duration is 2 to 7 hours. The most preferred drying process is 6 hours. The temperature of the drying process is at a value between 50 to 65°C. The preferred drying process temperature is 60°C.

The said process step vi) is performed in the thermal treatment oven. The said oven temperature is preferably increased by 2°C per minute and provided that it reaches a value determined at 600 to 700°C. Preferably, the thermal treatment is performed for 4 to 6 hours.

Following the thermal treatment, the fish bones are left to cool. The cooling process is preferably performed slowly at room temperature.

The image of the xenogenous graft from the FE-SEM device obtained by performing the process steps is given in Figure 1. As can be seen, the obtained xenogenous graft has a view similar to synthetic grafts comprising hydroxyapatite.

In Figure 2, the results of the obtained xenogenous graft from the EDX device are given. It can be seen clearly that the main building elements of the examined sample are calcium (Ca), phosphorus (P), and oxygen (O). In Figure 3, the results of the cell viability tests of the xenogenous graft of the invention are shown. It is concluded that the obtained graft does not affect cell proliferation and is not cytotoxic since the cell viability test result does not fall under 50% (73%, 18±1 ,04). In Figure 4, the analysis of the xenogenous graft of the invention obtained from the XRD device is given. Then the XRD graph is examined to determine the structure and phase purity of the graft obtained from fish vertebrae, 8 clean and intense peaks have been defined between 20-60° 20 values. 6 of these peaks ((002), (211 ), (310), (222), (213) and (004)) have been matched with the 00-009-0432 (HAP) standard of the “Joint Committee of Powder Diffraction Standards (JCPDS)”. The sharp peaks show that the graft comprises HAP in the crystalline structure. According to the graph, the peak with the highest density has been observed at 31 .7 20 value and (211 ) plane. This points out the presence of pure HAP.

The protection scope of the invention is given in the attached claims, and it cannot be limited to what has been described as an example in this detailed description under any circumstances. It is understood that a person with the skill in the related technique can put forth similar embodiments in the light of what has been described above, without departing from the main theme of the invention.