TWI475985B - Device for covering and/or reconstructing a bone defect site; method of manufacturing an attachment for a covering device for a bone defect site - Google Patents

Description

Device for shielding and/or reconstructing a bone defect location and manufacturing method thereof

The present invention is based on a occlusion and/or reconstruction device for a bone defect position as described in the first reference of the scope of the patent application, and a skeletal defect according to the type mentioned in the fifteenth article of the patent application. The method of locating the cover of the visor is the starting point.

In human skeletal tissue, the location of skeletal defects in the form of voids or voids is often filled with bone building materials on bone surgery, such as in orthopedics, neurosurgery or cosmetic surgery or sacral surgery. Usually the bone building material consists of a mixture of synthetic bone substitute materials (such as hydroxyapatite particles, Hydroxylapatitgranulat) and the body's own bone particles. In order to allow the bone building material to substantially accumulate bone from the skeletal side, the recess is closed with a viscous membrane, as described in German patent document DE 43 02 708 C2. The opaque film is fixed on the original bone of the human body by the fixing nail. Since the opaque film is made of an elastic material, it requires a high degree of surgical skill for fixation.

In order to overcome the disadvantages of the lack of support function of the viscous film, a visor is proposed in US Pat. No. 4,816,339, which is composed of multiple layers, but the layer is not composed of a resorbable film material. In the meantime, after the bone defect has healed, it sometimes needs to be treated again to remove the material that is heterogeneous to the body.

A biodegradable, decomposed hollow body is proposed in the German patent document DE 10 2005 039 382 B4, which has in particular a hollow cylindrical or conical shape. The hollow body has a number of openings in its wall that accommodate blood and provide autologous bone hyperplasia. The disadvantage is that a cylindrical hole must be drilled into the existing bone with a drill bit when installing the hollow body.

An implant base is proposed in German laid-open document DE 10 2006 047 054 A1 The implant (Implantatlager) is characterized by high precision and stability, making it easy for the surgeon to perform the operation and implantation. The implant pile consists of hydroxyapatite with a film on the side facing the mucosa, preferably made of a resorbable material, to protect the mucous membrane from mechanical action, and to protect the implant pile. Without being affected by the hyperplastic tissue from the mucosal side, the implant pile is fabricated by a construction process that causes the material properties to form a "gradient structure" whose density, in particular, decreases inward. In the meantime, a loose structure is disposed on the side facing the bone, and a reduced structure is disposed outside the implant pile, and a structure for maintaining the implant and/or a tooth substitute is provided on the outer side.

The device of the present invention is used for occluding and/or reconstructing a bone defect position, and has the feature of claim 1 wherein "skeletal defect position" refers to the position of a (sick) bone, which is different in shape from health. The bone, and the method of the present invention, are used to manufacture a hood of a bone defect position shielding device, and have the features of claim 15 of the patent application. The invention has the advantage of shielding and/or reconstructing a bone defect location. The device is composed of a cover (for example, a shell, a hard shell, a body) and at least one fixing member for fixing the cover to a bone, the cover having a stable shape (hard) and a bone facing The wall of the cover of the defect or the wall of the cover away from the bone defect corresponds to the reconstructed bone, and after accretion, the bone re-shapes the shape of the healthy bone.

According to an advantageous embodiment of the device according to the invention, the cover and/or the fastening element are at least partially composed of a biocompatible material. Biocompatible materials can be bioreceptive, bioinert, and/or bioactive.

According to a related advantageous embodiment of the device according to the invention, the biocompatible material is at least partly an autogener, a syngener, an allogener, a xenogener, a synthetic or an artificial (alloplastischer) material.

According to a further advantageous embodiment of the device according to the invention, the cover and/or the fastening element are at least partially formed from a biodegradable material.

According to a further advantageous embodiment of the device according to the invention, the cover and/or the fastening element are at least partially formed from a resorbable material. Advantageously, the resorption time of the hard shell can be controlled by its resorption gradient, and/or the resorption time is less than six months, so that the implant can be put in time.

According to a further advantageous embodiment of the device according to the invention, the cover and/or the fastening element are at least partially composed of a polymer or a polymeric connecting material.

According to a further advantageous embodiment of the device according to the invention, the cover and/or the fastening element are at least partially composed of polylactide. Polylactide is composed of a plurality of chemically linked lactic acid molecules and belongs to a polymer. Polylactide plastic, also known as polylactic acid (PLA), has the advantage that it becomes a deformable plastic via heating and is biocompatible.

According to a further advantageous embodiment of the device according to the invention, the cover has a uniform or varying wall thickness.

According to a further advantageous embodiment of the device according to the invention, the wall thickness is at least 0.2 mm, preferably 0.5 mm, but at least the thickness is such that the profile has a dimensional stability.

According to a further advantageous embodiment of the device according to the invention, the fixing element is a pin, a screw, a nail and/or a bone adhesive.

According to a further advantageous embodiment of the device according to the invention, the cover has at least one milling process (drilling holes for the fixing elements).

According to a further advantageous embodiment of the device according to the invention, the milling process corresponds to a fixing element.

According to a further advantageous embodiment of the device according to the invention, the wall portion facing the skeleton has a surface treatment.

According to still another related advantageous embodiment of the device of the present invention, the surface may have a microstructure, a loose pore, an osteoblast-inducing substance (Osteoblastenlockstoffe), a bone A booster (Mittel), and/or a BMP-containing bone supplement.

In an advantageous embodiment of the method of the invention for manufacturing a cover for a skeletal defect position shield, a computer-aided forming design (CAD) of the cover is combined with a computer-aided manufacturing (CAM) into a computer-aided design and manufacturing (CAD) /CAM), which allows the development of the cover design model developed on the computer to be directly electronically manufactured, consisting of the following steps: - accepting a three-dimensional space representing the skeleton of the bone defect by tomography or similar imaging method - using data The cover is designed to have a wall portion away from the bone defect and a wall portion facing the bone defect, and the at least one fixing component can be fixed on a bone, converting the cover design into a design data set, and - Passing the design data set to a computer-controlled manufacturing process in which the cover is constructed of a material that is dimensionally stable and that faces the wall of the skeleton or its wall away from the skeleton to correspond to the shape of the regenerated bone, and by A computerized tomographic or digital volumetric fault accepts a data set that represents the skeleton in three dimensions.

In a further advantageous embodiment of the method according to the invention for producing a cover for a bone defect position screening device, the cover is formed by milling in the manufacturing method.

In a further advantageous embodiment of the method of the invention for manufacturing a cover for a bone defect position shield, a cleaning procedure and/or a sterilization procedure is carried out after the cover is manufactured.

In a further advantageous embodiment of the method of the invention for manufacturing a cover for a skeletal defect occlusion device, the cover can be used for occluding and/or reconstructing a bone according to the scope of claims 1 to 14. In the device of the defect location. This may result in a device for occluding and/or reconstructing a location of a bone defect, such as a cover material and/or a fixation element such as an artificial material and/or an autologous, homogenous, heterologous or heterogeneous ( Xenogener) material, human and/or animal skeleton, or human, moving The material or plastic matrix, the area between the bone and the desired shape of the proliferating bone is completely or nearly completely filled with these materials. To this end, the donor takes out, for example, a bone piece, which is then modeled by CAD/CAM.

Further advantages of the preferred embodiment of the invention are apparent from the following description, drawings and claims.

1 shows a device 1 of the present invention for occluding and/or reconstructing a bone defect location 2 (skeletal defect) of a bone, particularly the tibia 3. The device 1 consists of a cover 4 and a fixing element 5, which in Fig. 1 is shown as a latch. The cover 4 is constructed of a material that is dimensionally stable so that it can carry itself without the need for additional support. In order to fix the cover 4 (shell, hard case), the fixing element 5 is pushed into the cover 4 through an opening 6 and introduced into the bore 7 provided in the tibia 3. Next, the cover 4 is fixed by ultrasonic welding. In ultrasonic welding, it is preferred to generate an accurate frequency by an ultrasonic generator which is concentrated via an upper acoustic pole (sound discharge terminal, Sonotrode). After the resorbable fixing element 5 (plug) is placed in one of the bone holes (drill hole 7) pre-drilled in the bone, the vibration generated causes the surface of the pin to liquefy on its edge, allowing the pin to slide into the hole . Through the change of the assembly state (Aggregatzustand), the bolt is drilled into the skeleton empty chamber and implanted where the general bone screw cannot reach, achieving a very high initial strength. In addition, the latch head is coupled to the cover 4 to provide a stable three-degree space structure by a locking mechanism. At the time of ultrasonic welding, the fixing member 5 is softened so that it is connected to the tibia 3 and the cover 4. A sealed inner space 8 is created between the tibia 3 and the cover 4 via the fixed cover 4, and the space is proliferated by the bone and/or placed into the same body, the same species, the same heterogeneous, heterogeneous, synthetic And/or the artificial material is filled such that the proliferating bone or filling material corresponds to the wall portion 9 facing the bone defect location 2 of the cover 4 . In order to accelerate the process of patella 3 hyperplasia, the wall portion 9 of the cover 4 facing the skeleton can have a surface treatment (for example, a microstructure, loose porous, osteoblast-inducing substance, bone growth) Accelerators and/or bone supplements containing BMP).

2 shows another form of the device 1 for occluding and/or reconstructing a bone, in particular a tibia 3, with a bone defect location 2 (skeletal defect). The gums 10 are additionally shown in this figure.

Figure 3 shows the occlusion and/or reconstruction of a bone of the present invention, particularly the skeletal defect location 2 (skeletal defect) of a tibia 3. In this figure, the cover 4 is formed as a profile, for example of a human or animal bone, and has a wall portion 9 facing the skeleton, which cooperates with the contour of the bone defect position 2 and has a distance away from the skeleton. The wall portion 11 corresponds to the shape of the proliferating bone.

Figure 4 shows the occlusion and/or reconstruction of a bone of the present invention, particularly the skeletal defect location 2 (skeletal defect) of a tibia 3. In this figure, the cover 4 is formed as a body, for example, from a human or animal bone, and has a wall portion 9 facing the skeleton and a wall portion 11 remote from the skeleton, which corresponds to the shape of the proliferating bone. There is an internal space 8 between the wall portion 9 and the bone defect location 2, which will be filled with bones and/or filled with self, homogenous, heterologous, synthetic and/or artificial materials. .

The features of the invention shown in this description can be combined individually or arbitrarily.

1‧‧‧ device

2‧‧‧Bone defect location

3‧‧‧颚骨骨

4‧‧‧ Cover

5‧‧‧Fixed components

6‧‧‧Opening

7‧‧‧Drilling

8‧‧‧Internal space

9‧‧‧ wall

10‧‧‧ teeth

11‧‧‧ wall

Examples of the subject matter of the present invention are shown in the drawings and will be described in detail below. The figure shows: FIG. 1 is a device for shielding and/or reconstructing a bone defect position of the present invention, FIG. 2 is a device for shielding and/or reconstructing another shape of a bone defect position of the present invention, FIG. 3 A device for protecting and/or reconstructing another shape of a bone defect location, FIG. 4 is a cover of the present invention and/or reconstructing another shape of a bone defect location Device.

1‧‧‧ device

2‧‧‧Bone defect location

3‧‧‧颚骨骨

4‧‧‧ Cover

5‧‧‧Fixed components

8‧‧‧Internal space

9‧‧‧ wall

10‧‧‧ teeth

Claims (19)

A device (1) for covering and/or reconstructing a bone defect location (2), having a cover (4) having a wall portion (11) remote from the bone defect and a wall facing the bone defect Part (9), having at least one fixing element (5) for fixing the cover (4) to a bone, characterized in that the cover (4) is made of a material having a stable shape and a cover ( 4) The entire wall portion (9) or the entire wall portion (11) of the cover (4) corresponds to the shape of the proliferating bone. The device (1) according to item 1 of the patent application, characterized in that the cover (4) and/or the fixing element (5) are at least partially composed of a biocompatible material. The device (1) according to claim 2, wherein the biocompatible material is at least partially an autologous, homogenous, heterologous, heterogeneous, synthetic or artificial material. The device (1) according to the first aspect of the invention, characterized in that the cover (4) and/or the fixing element (5) are at least partially composed of a biodegradable material. The device (1) according to item 1 of the patent application, characterized in that the cover (4) and/or the fixing element (5) are at least partially composed of a material which can be resorbed. The device (1) according to the first aspect of the invention, characterized in that the cover (4) and/or the fixing element (5) are at least partially composed of a polymer or a polymer-bonded material. The device (1) according to item 1 of the patent application, characterized in that the cover (4) and/or the fixing element (5) are at least partially composed of polylactide. The device (1) according to the first aspect of the patent application, characterized in that the cover (4) Has a fixed or a varying wall thickness. The device (1) according to item 8 of the patent application, characterized in that the wall thickness is at least 0.2 mm. The device (1) according to claim 1, wherein the fixing member (5) is a pin, a screw, a nail and/or a bone adhesive. The device (1) according to the first aspect of the patent application, characterized in that the cover (4) has at least one milled bore. The device (1) according to claim 11 is characterized in that the milled bore corresponds to a fixing element (5). The device (1) according to the first aspect of the invention is characterized in that the wall portion (9) facing the bone defect has a surface treatment. The device (1) according to claim 13, wherein the surface treatment has a microstructured, porous, osteoblast-inducing substance, a bone growth promoter, and/or a bone supplement containing BMP. . A method for manufacturing a hood defect location (2) mask (4) of a visor, consisting of: - accepting a three-dimensional space representing a skeletal defect location by tomography or similar imaging method (2) The data set, the data set is used to design the cover (4), the cover has a wall portion (11) away from the bone defect and a wall portion (9) facing the bone defect, and the at least one fixing element (5) can be Fixed on a bone, converting the cover (4) design into a design data set, and - transferring the design data set to a computer controlled manufacturing process, characterized in that the cover (4) consists of a material that is dimensionally stable Composed, and its entire wall (9) or its The entire wall portion (11) corresponds to the shape of the proliferating bone. A method of manufacturing a cover (4) according to the fifteenth aspect of the patent application, characterized in that the data set representing the position of the bone defect (2) in a three-dimensional space is accepted by computer tomography or digital volume tomography. A method of manufacturing a cover (4) according to claim 15 wherein the cover (4) is formed by milling during the manufacturing process. A method of manufacturing a cover (4) according to the fifteenth aspect of the patent application, characterized in that after the cover (4) is manufactured, a cleaning procedure and/or a disinfection procedure is carried out. A method of manufacturing a cover (4) according to claim 15 of the invention, characterized in that the cover (4) is usable for a bone defect position according to items 1 to 14 of the patent application scope ( 2) Shielding or reconstruction device (1).