Bone tissue treatment apparatus

Abstract

In particular, the invention relates to a bone tissue treatment apparatus for treating bone tissue damage / loss, collapses, cracks or fractures in the form of indentations, cavities or crevices on a bone surface, such as the jawbone, with the patient's own autogenous blood, allowing the formation of new bone tissue on the damaged bone surface and accelerating the formation of bone tissue by allowing the autogenous blood to reach areas remote from the bone.

Description

[0001] BONE TISSUE TREATMENT APPARATUS

[0002] Technical Field

[0003] The invention relates to a bone tissue treatment apparatus for treating indentation-shaped damage to the bone surface with patient's blood and accelerating the formation of new bone tissue.

[0004] In particular, the invention relates to a bone tissue treatment apparatus for treating bone tissue damage / loss, collapses, cracks or fractures in the form of indentations, cavities or crevices on a bone surface, such as the jawbone, with the patient's own autogenous blood, allowing the formation of new bone tissue on the damaged bone surface and accelerating the formation of bone tissue by allowing the autogenous blood to reach areas remote from the bone.

[0005] Background Art

[0006] The surface of bone structures such as the jawbone can be damaged in the form of indentations due to impact, operational procedures, tooth loss or old age. This damage in the form of indentation on the bone surface can be in the form of bone collapse, cleavage, fracture or crack and causes a decrease in the durability of the bone structure in which it occurs. In the treatment of this indentation-shaped damage on the bone surface, it is very difficult to treat naturally due to the fact that the living tissue structure is less than other fracture or crack-type damage and it is difficult to support the bone structure. In addition, if this type of bone damage is not treated in a short time, it can lead to more serious damage. In the jawbone, it causes inability to use prosthesis, and speech and chewing disorders. Damage, especially in the form of bone collapse, usually occurs as a result of old age and / or osteoporosis, causing the bone structure to become thinner, resulting in adverse effects such as fracture and damage to the soft tissue underneath or around it. In the state of the art, many different techniques such as bone grafts, distraction osteogenesis methods, membrane methods, free fibulae vascular grafts and biomaterials are used to repair bone damage. Among these, membranes, which are frequently preferred especially in bone surface damage, can be made of biodegradable (biodegradable) or non-biodegradable (non-biodegradable) materials and are generally used in the directed tissue generation method. The tissue integration feature, which is one of the first conditions for barrier membranes to be used as medical devices, stabilizes the healing process and prevents the fibrous connective tissue between the membrane and bone from reaching the damage site. The membrane structure is also expected to be biocompatible and easy for clinical use. However, biocompatible soft membranes do not have the strength to protect the space area formed between the bone under the effect of compressive force.

[0007] On the other hand, under a hermetically sealed rigid (titanium) membrane, an equal amount of bone tissue as the penetrable (permeable) membrane amount is formed. Therefore, a rigid and pore-free membrane can successfully provide bone regeneration through its cell-blocking properties. Cell inhibition is directly related to the porosity / meshness of the membrane and membrane pores facilitate the diffusion of fluids, oxygen, nutrients and bioactive substances necessary for cell growth. However, the large pores may allow fibroblast cells to pass through and may cause bacterial contamination. For this reason, the membrane should act as a barrier to prevent the formation of fibrous tissue that adversely affects bone formation. For example, a titanium membrane, which is shaped during the procedure and contains pores, causes adverse conditions such as mucosal irritation, growth of soft tissue through the membrane and microbial contamination during the removal process. However, in the case of the use of membranes with a rigid structure and / or without pores, the development of new bone tissue is not sufficient or the development time is quite long. This makes the treatment of depressions or clefts, especially in the jaw and skull bones, more difficult and leads to complications. The patent document US20190142996A1 , which is in the known state of the art, discloses an implantable apparatus configured to deliver components for revascularisation and bone repair to an injured bone site. Said apparatus comprises a first osteoconductive scaffold component adapted to engage the damaged bone site and deliver growth factors to induce cellular growth, and a second osteoconductive scaffold component adapted to engage and deliver viable autologous osteogenic and / or angiogenic cells to the injured bone site. Said apparatus also comprises a third scaffold component adapted to promote bone cell proliferation and vascularity. Scaffold components with mesh / porous structure create a stable mechanical environment to promote the proliferation and vascularity of bone cells. The document in question does not mention the treatment of bone tissue damage / loss, especially in the form of indentations, with the patient's own blood and the acceleration of the tissue formation process by allowing autogenous blood to reach areas remote from the bone during the formation of new bone tissue on the damaged bone surface.

[0008] In another patent document CN115607309A of the known state of the art, an apparatus for bone regeneration consisting of polyetheretherketone (PEEK) material and a method of manufacturing the layers of this apparatus are disclosed. The mentioned method is carried out by 3D printing of a guided bone regeneration membrane made of PEEK material and firstly, modelling is made specifically for the bone to be regenerated and then the bone regeneration membrane to be printed is designed as a double-layer structure, with the bottom layer being a support structure and the top layer being a film structure. PEEK material is used as 3D printing material. Heat treatment and sieving process is applied on this material. Laser powder bed fusion 3D printing is performed according to the model designed by mixing soluble particles. PEEK composite powder is used and layer-by-layer pelletisation is applied until the required guide bone regeneration layer is obtained. The document also describes a guided bone regeneration membrane product made of PEEK material. With the method described in the invention, a customised bone regeneration membrane is rapidly prepared. The document in question does not mention the treatment of bone tissue damage / loss, especially in the form of indentations, with the patient's own blood and the acceleration of the tissue formation process by allowing autogenous blood to reach areas remote from the bone during the formation of new bone tissue on the damaged bone surface

[0009] As a result, there is a need for the development of a bone tissue treatment apparatus that provides the treatment of bone tissue damage / losses, especially in the form of indentations formed on a bone surface such as the jawbone, with the patient's own blood, thickening the bone by form ing / growing new bone tissue on the damaged bone surface, and accelerating the formation of bone tissue and increasing the strength of the newly formed bone tissue by providing rapid access of the blood or blood-containing fluid used for treatment to areas remote from the bone.

[0010] Aim of the invention

[0011] The present invention relates to a bone tissue treatment apparatus which fulfils the above-mentioned requirements, eliminates possible disadvantages and provides some additional advantages.

[0012] The main purpose of the bone tissue treatment apparatus of the invention is to obtain a bone tissue treatment apparatus that provides the treatment of bone tissue damages / losses in the form of indentations on the bone surface with the patient's own blood and the strengthening of the bone by forming new bone tissue on the damaged bone surface.

[0013] Another aim of the invention is to provide an effective bone tissue treatment apparatus for accelerating the formation of bone tissue by providing rapid access of blood or blood-containing fluid used for treatment to areas remote from the bone.

[0014] A further aim of the invention is to provide a safe bone tissue treatment apparatus which prevents contamination and tissue damage during or after treatment. A further aim of the invention is to provide an efficient bone tissue treatment apparatus which supports the newly formed bone tissue and strengthens it by increasing its thickness.

[0015] A further aim of the invention is to provide a functional bone tissue treatment apparatus which prevents soft tissue growth during treatment and reduces the risk of infection after treatment.

[0016] Another aim of the invention is to provide a bone tissue treatment apparatus which is resistant to impact and / or compression force, which prevents disruption of the treatment process and increases the effectiveness of the treatment.

[0017] A further aim of the invention is to provide a bone tissue treatment apparatus which enables the regenerated bone tissue to grow with equal intensity in all areas of the bone surface damage in the form of indentation and to provide a balanced treatment.

[0018] Another aim of the invention is to provide a practical bone tissue treatment apparatus which is suitable for the biological structure of the patient and which is easily applicable and which facilitates the implant / placement process.

[0019] Another aim of the invention is to obtain an easy and harmless bone tissue treatment apparatus that allows the formation of new bone tissue by direct application to the bone surface to be treated without any drilling, carving, cutting, opening, etc.

[0020] Another aim of the invention is to provide a functional bone tissue treatment apparatus which allows the form of the new bone tissue to be preserved and the bone surface to be treated in accordance with its pre-damage state.

[0021] Another aim of the invention is to provide a bone tissue treatment apparatus which has antibacterial properties and prevents wound dehiscence. In order to achieve the above aims in the most general form, the bone tissue treatment apparatus, which provides the treatment of damage or loss of bone tissue in the form of indentation on the surface of at least one bone with repair material, increasing the rate of bone formation and strength, includes at least one first layer with hydrophilic properties, at least one second layer with hydrophobic properties, at least one body that allows the formation of at least one space between the damaged area and the first layer, suitable for the placement of repair material in it, and allows new bone tissue to grow in it, at least one hydrophilic delivery extension, which ensures that the repair material is distributed homogeneously and delivered to the area of the first layer which is furthest from the damaged area, and that the newly formed bone tissue is supported and its strength is increased.

[0022] The structural and characteristic features of the invention and all its advantages will be understood more clearly by the figures given below and the detailed description written with reference to these figures, and therefore and thus, the present disclosure should be evaluated by taking these figures and detailed description into consideration.

[0023] Figures to Help Understand the Invention

[0024] In order to best understand the embodiment and advantages of the present invention, it should be evaluated together with the figures described below.

[0025] Figure - 1 : A perspective view of the bone tissue treatment apparatus of the invention.

[0026] Figure - 2: A cross-sectional view of the bone tissue treatment apparatus of the invention.

[0027] Figure - 3: A front view of the bone tissue treatment apparatus of the invention.

[0028] Reference Numbers of Parts 1. Body la. First layer lb. Second layer lc. Space

[0029] 2. Delivery extension

[0030] 3. Fixing element

[0031] 4. Support element

[0032] 5. First opening

[0033] 6. Second opening

[0034] K. Bone surface

[0035] Detailed Description of the Invention

[0036] The preferred embodiments of the bone tissue treatment apparatus of the inventive subject, which are mentioned in this detailed description, are only intended for providing a better understanding of the subject-matter, and should not be construed in any restrictive sense.

[0037] A bone tissue treatment apparatus, the exemplary view of which is given in Figure 1 , developed with the present invention, which provides treatment of damage or loss of bone tissue in the form of indentation on the surface (K) of at least one bone, preferably the jaw bone and / or other body bones, with at least one repair material which is the patient's own blood or which contains the patient's own blood, preferably autogenous blood in gel form and autogenous graft, and which preferably contains bone morphogenic protein 2 and / or 7 and / or vascular endothelial growth factor and / or platelet-derived growth factor and / or platelet-rich fibrin / plasma and / or bisphosphonate (alendronate, etc.) in combination with autogenous blood, formation of new bone tissue on the damaged bone surface (K), increasing the rate and strength of bone formation includes at least one first layer (1a) which is positioned on the side close to the bone surface (K) to be treated, is hydrophilic and preferably contains poly(glycolic acid) (PGA), preferably containing an antimicrobial component such as Caffeic Acid Phenethyl Ester (CAPE), and is biodegradable after a first period of time, at least one second layer (1 b) which is positioned on the side distal to the bone surface (K) to be treated, is hydrophobic and preferably contains poly(lactic acid) (PLA) and / or poly(lactic-co- glycolic acid) (PLGA) and / or Polycaprolactone (PCL), and is biodegradable after a second period longer than the first mentioned period, at least one body (1 ) in the form of a indentation on the surface of bone tissue, preferably in the form of a cavity, fracture, crack or cavity structure, suitable for positioning over at least one damaged area and for covering said damaged area, which allows the formation of at least one space (1c) between said damaged area and the first layer (1a), suitable for the insertion of said repair material therein, and which allows the growth of new bone tissue within said space (1c), preferably in a semi-elliptical or semi-spherical form, preferably suitable to withstand a compressive force of at least 6 Newton I cm2; at least one delivery extension (2) which extends in said space (1c) towards said damaged area in connection with said first layer (1a), which is hydrophilic and preferably contains poly(glycolic acid) (PGA), which preferably contains an antimicrobial component such as Caffeic Acid Phenethyl Ester (CAPE), which is biodegradable after said first period of time, which allows the aforementioned repair material to be absorbed and homogeneously distributed in the aforementioned space (1c) and delivered to the region of the first layer (1a) furthest from the aforementioned damaged area, supporting the newly formed bone tissue and increasing its strength, which preferably have a beam structure comprising more than one bar or strip extending parallel to each other or intersecting one another.

[0038] In an exemplary embodiment of the bone tissue treatment apparatus according to the present invention, said body (1 ) is positioned and fixed on the damaged area on the bone surface (K) to be treated, and coating is provided on said damaged area. In this way, a space (1c) suitable for bone growth is formed between the body and the damaged area and the repair material in the space (1c) contacts the damaged area. In a preferred embodiment, decortication can be performed by drilling holes in the bone surface facing the damaged area. Thus, through the holes created in the cortical layer of the bone, bleeding from the spongy bone and filling of this blood into the space (1c) is provided. Due to the repair material in the space (1c), new bone tissue is formed on the damaged area and the damaged area is closed and treated. In the meantime, by means of the hydrophilic property of said delivery extension (2), the repair material is transferred and homogenously distributed in the space (1c) and delivered to the furthest point of said space (1c) to the damaged area. During the formation of new bone tissue, the delivery extension (2) supports the formed bone structure and at the same time increases the rate of bone formation due to the homogeneous distribution of the repair material. While the bone formation process is completed in the space (1c), the first layer (1a) is destroyed in the body by means of its biodegradable feature and the form of the newly formed bone tissue is completed properly and quickly. During the treatment period, the second layer (1b) provides a poreless (non- porous) and rigid closed environment suitable for bone growth, while at the same time ensuring the strength of the body (1 ) to withstand forces of at least 6 Newton I cm2pressure value and facilitating the disassembly of the apparatus after treatment.

[0039] In a preferred embodiment of the invention, said bone tissue treatment apparatus comprises at least one fixing element (3), preferably screws, nails / pins or bonding material, for fixing said body (1 ) to said bone surface (K).

[0040] In another preferred embodiment of the invention, said bone tissue treatment apparatus comprises at least one support element (4), preferably in the form of a belt, positioned on said body (1 ) and preventing deformation of said body (1 ) by increasing the physical strength of said body (1 ).

[0041] In another preferred embodiment of the invention, said bone tissue treatment apparatus comprises a first opening (5) positioned on said body (1 ) for transferring said repair material into said space (1c) and at least one second opening (6) for removing air from said space (1c) during filling of said space (1c) and repair material from said space (1c) after treatment.

[0042] In another preferred embodiment of the invention, said bone tissue treatment apparatus comprises at least one auxiliary element, preferably in the form of a mesh, which is positioned in said space (1c) and is made of a hydrophilic material suitable for production by electrowriting or electrospinning, which is biodegradable at the end of said first period of time, which enables said repair material to be homogeneously distributed in said space (1c) and to be transmitted to the areas furthest from said damaged area, and which enables the speed and efficiency of transmission to be increased and the strength to be increased.

[0043] The bone tissue treatment apparatus developed by the present invention enables the treatment of bone tissue damage / loss, in particular in the form of indentations on a bone surface (K) such as the jaw bone, with repair material containing or consisting of the patient's own blood. In addition, by providing new bone tissue growth on the damaged bone surface (K), the bone is thickened and the repair material used in the treatment is provided to reach the areas far from the bone quickly, thus obtaining a durable, functional, efficient and effective bone tissue treatment apparatus that accelerates the formation of bone tissue, increases the strength of the newly formed bone tissue, prevents the formation of soft tissue, infection and deformity during the treatment.

Claims

CLAIMS1. A bone tissue treatment apparatus for treating damage in the form of indentation or loss of bone tissue on the surface of at least one bone (K) with at least one repair material containing or consisting of the patient's own blood, creating new bone tissue on the damaged bone surface (K), increasing the rate and strength of bone formation, characterized in that it includes:- at least one first layer (1a) which is positioned on the side close to the bone surface (K) to be treated, is hydrophilic and biodegradable after a first period of time, at least one second layer (1 b) which is positioned on the side distal to the bone surface (K) to be treated, is hydrophobic and biodegradable after a second period of time longer than said first period of time, at least one body (1 ) suitable for positioning over at least one damaged area in the form of a indentation on the surface of the bone tissue and for covering said damaged area, which enables the formation of at least one space (1c) between said damaged area and the first layer (1a) suitable for the placement of said repair material therein, and which enables the growth of new bone tissue within said space (1c);- at least one delivery extension (2) which extends in said space (1c) towards said damaged area in connection with said first layer (1a), which is hydrophilic, which is biodegradable after said first period of time, which allows the aforementioned repair material to be absorbed and homogeneously distributed in the aforementioned space (1c) and delivered to the region of the first layer (1a) furthest from the aforementioned damaged area, supporting the newly formed bone tissue and increasing its strength.

2. A bone tissue treatment apparatus according to claim 1 , characterized in that said bone is the jawbone and / or another body bone.

3. A bone tissue treatment apparatus according to claim 1 , characterized in that said repair material includes autogenous blood and autogenous graft in gel form.

4. A bone tissue treatment apparatus according to claim 1 , characterized in that said repair material contains bone morphogenic protein 2 and / or 7 and / or vascular endothelial growth factor and / or platelet-derived growth factor and / or platelet-rich fibrin / plasma and / or bisphosphonate in combination with autogenous blood.

5. A bone tissue treatment apparatus according to claim 1 , characterized in that said first layer (1a) contains poly(glycolic acid) (PGA).

6. A bone tissue treatment apparatus according to claim 1 , characterized in that said first layer contains a component with antimicrobial properties such as Caffeic Acid Phenethyl Ester (CAPE).

7. A bone tissue treatment apparatus according to claim 1 , characterized in that said second layer (1 b) comprises poly(lactic acid) (PLA) and / or poly(lactic-co-glycolic acid) (PLGA) and / or Polycaprolactone (PCL).

8. A bone tissue treatment apparatus according to claim 1 , characterized in that said damaged area is in the form of a cavity, fracture, crack or cavity structure.

9. A bone tissue treatment apparatus according to claim 1 , characterized in that said body (1 ) is of semi-elliptical or semi-spherical form.

10. A bone tissue treatment apparatus according to claim 1 , characterized in that the body (1 ) is suitable to withstand a compressive force of at least 6 Newton / cm211. A bone tissue treatment apparatus according to claim 1 , characterized in that said delivery extension contains poly(glycolic acid) (PGA).

12. A bone tissue treatment apparatus according to claim 1 , characterized in that said delivery extension contains a component with antimicrobial properties such as Caffeic Acid Phenethyl Ester (CAPE).

13. A bone tissue treatment apparatus according to claim 1 , characterized in that; said delivery extension is in a beam structure consisting of more than one bar or strip extending parallel to each other or intersecting one another.

14. A bone tissue treatment apparatus according to claim 1 , characterized in that said bone tissue treatment apparatus comprises at least one fixing element (3), preferably screws, nails / pins or bonding material, for fixing said body (1) to said bone surface (K).

15. A bone tissue treatment apparatus according to claim 1 , characterized in that said bone tissue treatment apparatus comprises at least one support element (4), preferably in the form of a belt, positioned on said body (1 ) and preventing deformation of said body (1) by increasing the physical strength of said body (1 ).

16. A bone tissue treatment apparatus according to claim 1 , characterized in that said bone tissue treatment apparatus comprises a first opening (5) positioned on said body (1) for transferring said repair material into said space (1c) and at least one second opening (6) for removing air from said space (1c) during filling of said space (1c) and repair material from said space (1c) after treatment.

17. A bone tissue treatment apparatus according to claim 1 , characterized in that said bone tissue treatment apparatus comprises at least one auxiliary element, preferably in the form of a mesh, which is positioned in said space (1c) and is made of a hydrophilic material suitable for production by electrowriting or electrospinning, which is biodegradable at the end of said first period of time, which enables said repair material to be homogeneously distributed in said space (1c) and to be transmitted to the areas furthest from said damaged area, and which enables the speed and efficiency of transmission to be increased and the strength to be increased.

Images