RU2387410C1 - Device for elimination of defects and deformities of lower jaw bone - Google Patents

Abstract

FIELD: medicine. ^ SUBSTANCE: device includes elongated body with through longitudinal holes on at least part of length, binding means, representing bone material, and screws for connecting elongated body to lower jaw bone. Elongated body is provided with perforated element of flute-like shape. Binding substance in fixing position is located inside perforated element of flute-like shape. ^ EFFECT: invention allows to restore integrity of lower jaw reliably, without repeating operation. ^ 19 cl, 1 ex, 8 dwg

Description

The invention relates to medicine, namely to maxillofacial surgery, and can be used to replace congenital and acquired defects of the lower jaw resulting from underdevelopment of the facial skeleton, surgical interventions for tumors and traumatic injuries of the lower jaw.

The lower jaw - the only mobile and most massive bone of the facial skeleton is the support and the place of attachment of various muscle groups. Having a complex anatomical shape, it plays one of the main roles in providing the functions of chewing, swallowing, articulation and breathing. In the event of segmental defects of the lower jaw of various etiologies, the surgeon is faced with the task of choosing a reconstructive operation that allows you to restore vital functions and provide an acceptable cosmetic result, restoring the patient the ability to communicate normally with people. Of particular difficulty for surgeons involved in the reconstruction of the lower jaw are patients with radiation osteomyelitis and cancer patients.

The most common methods for eliminating these disorders are bone grafting using various grafts: autografts, allografts, combined; replacement of defects with biocompatible materials (synthetic materials) (hereinafter referred to as biocomposite materials).

However, these methods have several disadvantages:

- simultaneous elimination of defects of the lower jaw after removal of the swollen using a biograft is not always possible;

- the tendency of the transplant to rejection and encapsulation;

- resorption of the bone graft;

- the use of an autograft is associated with additional trauma for the patient;

- the use of allografts implies the availability of an accessible bank of such tissues and at the same time does not reduce the problems of tissue incompatibility, resorption of the graft and HIV infection.

The most promising of the currently used biological, semi-synthetic and synthetic materials for bone grafting are implants based on hydroxyappatite and collagen, acrylates and polylactates, implants based on carbon and silicon. These materials fully meet the requirements for biocomposite materials. They are biocompatible, non-toxic, do not cause an immunological rejection reaction. But low biomechanical characteristics limit the use of these materials to eliminate segmental defects of the lower jaw.

In recent years, biologically inert constructions of titanium and its alloys have found quite wide application in medicine. Their main advantages are:

- lack of biological incompatibility factor;

- high biomechanical characteristics;

- comparative ease of manufacture;

- ease of storage and sterilization and the possibility of standardized manufacturing.

Currently, reconstructive titanium meshes 0.6-1 mm thick and titanium plates of a larger thickness are used to eliminate segmental defects of the lower jaw and are subsequently removed if they do not break due to dynamic loads.

Indications for their use are extensive defects of the lower jaw in the region of the angle, as well as defects of the lower jaw with exarticulation that occur after gunshot wounds, oncological diseases, when simultaneous bone grafting to eliminate bone defect is impossible due to several circumstances (inflammatory process in the operation area cancer disease). With caution, it is necessary to use reconstructive plates in patients who undergo resection of the lower jaw for radiation osteomelitis, since as a result of inflammatory necrotic processes in the soft tissues, tissue failure around the titanium structure is possible.

Let's consider these constructions in more detail.

Known titanium mesh tray-like structure to replace the defect of the lower jaw. It is a mesh, curved in the shape of a tray, resembling the shape of the corresponding section of the lower jaw, that is, they make a mesh tray-like structure (advertising brochure of the company Oswald Leibinger GmbH (Germany), TITAN-Mesh-System (DTM), 1990, p.3, 4, 12). The mesh has a thickness, for example, in the range of 0.6 mm - 1 mm, but may also have other thicknesses. The device is installed and fixed in that place on the jaw, where there is no bone, and allows you to restore the continuity of the lower jaw.

Specifically, its installation is as follows.

The mesh structure is attached with titanium screws to the ends of the fragments of the lower jaw, between which there is no bone, forming a jumper between the fragments in this place. Since it is installed so that the tray is open upwards, after installation, the cavity of the mesh structure is filled with various auto- and / or allografts or biocomposite materials. Over time, this filling due to germination by its blood vessels grows together and the continuity of the bone of the lower jaw is restored.

However, if the continuity of bone tissue is not restored over time, then the mesh structure fractures due to significant dynamic loads, for example, when eating food or talking. The grid in its design does not allow long-term use and its installation is temporary. After bone fusion, the mesh structure is removed. In addition, this design does not allow the simultaneous installation (that is, immediately) of dental implants. These disadvantages limit its use.

It is also known with these defects in the lower jaw to install, instead of the mesh, a device for eliminating defects and deformations of the bone of the lower jaw, including an elongated body with through transverse openings, at least for a part of the length, a bonding agent representing bone material, and screws for attaching the elongated body to the bone of the lower jaw (see application WO 2007/106358, priority 09/20/2007). Before the operation, the elongated body can bend in the shape of the lower jaw, or rather its part, which it must replace. For bending, for example, during surgery, the elongated body has recesses along the sides opposite each other. During the operation, a curved or rectilinear oblong body is attached at the ends to the ends of the fragments of the lower jaw, forming a jumper between these fragments. After that, one or several block-shaped elements made of bone, for example, of auto- or allosty, with the formation of continuity of the lower jaw, can be screwed to the elongated body. Over time, these bone blocks are fused and the continuity of the lower jaw bone is restored. The oblong body, at the request of the patient, after bone fusion can be removed.

This technical solution was made as a prototype of the claimed invention, since it is closest to it in the aggregate of common essential features and the achieved technical result.

The disadvantage of it, as well as the above analogue, is the following.

If the bone tissue does not grow together, a structural fracture can occur due to significant static and dynamic loads, for example, when eating food or talking, and also due to the "fatigue" of the metal. Typically, a fracture occurs in the bending region of an elongated body, since in these places the greatest stresses occur inside it. This entails the need for additional surgery to remove the elongated body and replace it with another. A fracture occurs after about three years. Although the oblong body is stiffer compared to the mesh tray-like structure, however, it does not allow prolonged use under load and its installation is temporary. As in the previous case, this design does not allow the installation of dental implants simultaneously (that is, immediately with the installation of an elongated body). This limits its use.

An object of the present invention is to provide a device for eliminating defects and deformations of the lower jaw of various origins, avoiding repeated operations after the initial replacement of the defect as a result of manufacturing a reconstructive individual titanium plate together with a mesh to strengthen the structure, so that the resulting structure is not temporary and does not required additional surgical intervention to remove it in the event of a breakdown (known devices through def The selected time interval must either be replaced, or they break, which is a correctable drawback).

In addition, to ensure the possibility of rehabilitation of patients with defects in the deformation of the lower jaw at the same time, this device can be equipped with implants to compensate for tooth loss.

Before describing how the task was solved, the applicant considers it necessary to pay particular attention to the following important circumstance.

The mesh structure and the elongated body with through transverse holes (individual reconstructive plate) are self-sufficient in the sense that each of them, when used separately in some cases, allows to obtain a positive result. And their combination does not seem appropriate.

However, the prolonged use of a separate mesh structure and a separately elongated body with through transverse openings (individual reconstructive plate) showed that they have significant drawbacks that were previously described.

If a mesh structure is used separately, then, in addition to supporting bone tissue, it must absorb the loads that arise when chewing food, when pronouncing, then to increase its rigidity, it must have a sufficient wall thickness and relatively small holes (perforations). The reduction of the holes negatively affects the vascularization of the tissues, in other words, negatively affects the healing, in particular, prevents the growth of tissue by the vessels. Under such conditions, the mesh structure does not have the ability to carry the means for tooth restoration, which is at least one implant, because it simply “crack” (“burst”).

If an elongated body with through transverse openings (an individual reconstructive plate) is used separately, then it does not support bone blocks well and, as a result, the creation of sufficient optimal conditions for fusion (to create continuity of these bone fragments) is not ensured.

The combination of the mesh structure with an elongated body (individual reconstructive plate) allows you to create optimal conditions for bone fusion and to provide the ability to carry a means to restore teeth, which is, for example, at least one implant.

According to the invention, the oblong body (the individual reconstructive plate, for example, reinforced, i.e., made of increased thickness) takes up the main load, and the mesh structure of a certain shape provides optimal conditions for bone fusion. Since the mesh structure is unloaded from external forces, the holes in it can be made large, it is thinner in thickness, it is possible to fit components of a bonding agent containing bone material rather tightly into each other, for example, to lay fragments of auto- and / or allosty with bone chips and recreate the required width and height of the bone. And since the elongated body is not intended to ensure the continuity of bone fragments, it can be effectively used as a support for tooth restoration, which is, for example, at least one implant.

It should be noted that a design combining an elongated body with through transverse holes and a mesh cannot be made by hand during the operation, which involves the manufacture of an individual model of the lower jaw or skull of the patient before the operation (see the description of the operation below).

After this important point, the applicant goes back to how the problem described above has been solved.

The stated technical problem is solved in that the device for eliminating defects and deformations of the bone of the lower jaw includes an elongated body with through transverse holes, at least on a part of the length, a connecting means, which is a bone material, and screws for attaching the elongated body to the bone of the lower jaw moreover, according to the invention, the elongated body is provided with a perforated element of a grooved shape, and the bonding means in a fixed position is located inside perforated zhelobchatoobraznoy element of form.

This set of common essential features is the essence of the claimed device. It is necessary and sufficient in all cases of its implementation.

Thus, if a fracture of a mesh structure or an elongated body occurs in known structures with bone non-growth, then in the claimed structure, on the one hand, optimal conditions are created for bone growth in a groove-shaped element, and on the other hand, failure of the claimed structure is prevented (which allows provide a longer period for bone fusion). As noted above, this is achieved as a result of the fact that the oblong body takes up the main load (an individual reconstructive plate, for example, reinforced, i.e., made of increased thickness), and the mesh-like structure is optimal for bone splicing. Since the mesh structure is unloaded from external forces, the holes in it can be made large, it is thinner in thickness, it is possible to fit components of a bonding agent containing bone material rather tightly into each other, for example, to lay fragments of auto- and / or allosty with bone chips and recreate the required width and height of the bone. And since the elongated body is not intended to ensure the continuity of bone fragments, it can be effectively used as a support for tooth restoration, which is, for example, at least one implant.

As a result, it becomes possible to create a permanent structure for replacing a defect in the jaw and avoid re-operation after the initial replacement of the defect (by manufacturing a reconstructive individual titanium plate together with a mesh to strengthen the structure, so that the resulting structure is not temporary and does not require additional surgical intervention for its removal in case of breakage).

In addition, there is the possibility of rehabilitation of patients with simultaneous restoration of masticatory functions due to the installation of implants.

The applicant has developed many variants of the claimed device relating to the design of the device as a whole, and its individual components.

At the same time, he considers it necessary to single out the following developments and / or clarifications of the set of essential features relating to some particular cases of performance or use.

The claimed device can be equipped with a means for restoring teeth attached to an elongated body. This will allow the full rehabilitation of patients with defects in the deformation of the lower jaw. Such a tool may be at least one implant made, for example, of titanium.

In this case, numerous modifications are possible.

For example, an additional perforated element can be made with a recess, and a means for restoring teeth is attached to an elongated body at the site of the recess.

The tooth restoration agent may have various designs. For example, it may be at least one implant made in particular of titanium or an alloy thereof.

If the patient does not have a condylar process of the lower jaw, then the condylar endoprosthesis can be attached to the elongated body.

Various means, for example, a perforated plate, can be used to make the perforated element in a grooved shape. However, it is preferable to use a perforated element representing a grid, for example, of titanium.

The binding agent should contain at least bone material. Moreover, depending on the specific situation, numerous combinations of bone materials of various types are possible, namely, a binding agent can be:

bone chips;

at least one bone block;

at least one bone block and bone chips;

autograft;

allograft;

a combination of auto and allografts.

In addition, the binding agent, in addition to the bone material, may additionally contain a biocomposite material, for example, “valve”, “BCS”, etc.

Various combinations are also possible, for example, a binding agent may contain at least one bone block, bone chips and biocomposite material.

The elongated body and the perforated grooved element can be made of various materials, however, most preferably, they are made from titanium alloys.

The perforated grooved element can be rigidly connected to an elongated body, for example, by welding, and can be cast integrally with an elongated body, which depends, in particular, on the type of material, the selected manufacturing technology, etc.

The invention is illustrated in the drawing.

Figure 1 shows a device for eliminating defects and deformations of the bone of the lower jaw, a general view of the skull for the right side of the lower jaw (the binding agent in figure 1 is not shown so as not to overload the figure);

figure 2 is the same, section aa of figure 1 of the claimed device (the skull is not shown, but a binding agent is shown);

figure 3 shows a device for eliminating defects and deformations of the bone of the lower jaw, an external view, a perspective view;

figure 4 is a device for eliminating defects and deformations of the bone of the lower jaw, an inside view, a perspective view;

figure 5 - a device for eliminating defects and deformations of the bone of the lower jaw, top view, axonometry;

figure 6 - shows a device for eliminating defects and deformations of the bone of the lower jaw, fixed on the model of the lower jaw, side view, an option in which the perforated element of the groove-shaped form is made with a recess in the area of the implants, axonometry;

Fig.7 is the same, a top view, a perspective view.

Photo 1 shows a stereolithographic model of a skull with a device fixed on it, characterized in FIGS. 6 and 7.

The device 1 for eliminating defects and deformations of the bone of the lower jaw includes an elongated body 2 with through transverse holes 3, at least in part of the length, screws 4 for attaching the elongated body 2 to the lower jaw 5 and a bonding agent 6, representing at least bone material (figure 1). The elongated body 2 is provided with a perforated element of a grooved shape 7, and the bonding agent 6 in a fixed position (figure 2) is located inside the perforated element of a grooved shape 7.

The device 1 may be equipped with a means for restoring teeth attached to the elongated body 2, for example, an implant 8 connected to the elongated body with screws 9.

Figure 1-5 shows a variant in which the perforated element of the grooved shape 7 is made of relatively small length to restore the continuity of the lower jaw, with a segmental defect 10, which is the missing part of the lower jaw (the space between the remaining parts of the lower jaw). The segmental defect 10 is relatively small and the perforated element of the groove-shaped form slightly exceeds its boundaries so that the binding agent is tightly fixed.

Figures 6-7 show another embodiment in which the perforated element of the grooved shape 7 is made almost equal in length to the elongated body. It is used for significant defects in the bone tissue of the lower jaw.

In this case, if tooth restoration is necessary, the perforated element of the grooved shape 7 is made with a recess 11, which in this example is a cutout in the side wall of the perforated element of the grooved shape (the recess can have other shapes depending on the specific situation, in particular, on the type of tool for restoration of teeth (an implant or other means)), and a means for restoration of teeth, for example, implants 8, is attached to an elongated body 2 at the site of extraction. The recess 11 is formed only at the place where the means for restoring teeth should be installed, for example implants 8, in the rest of the perforated element of the groove-shaped form 7 is stored for laying the binding means, as is clearly seen in Fig.7.

To use the claimed device in the absence of the condylar process, an endoprosthesis of the condylar process (not shown in FIG.) Can be attached to the end part of the medulla oblongata.

The implant may be made of titanium or an alloy thereof or other suitable materials.

The perforated element grooved shape 7 can be made of mesh (Fig.1-7) or perforated curved plate made of titanium or its alloy or other suitable materials.

Note: in Fig.6-7, the perforated groove-shaped element is also made in the form of a mesh.

As noted above, the binding agent 6 must contain at least bone material. Moreover, depending on the specific situation, numerous combinations of materials are possible.

A binding agent may be:

bone chips;

at least one bone block;

at least one bone block and bone chips;

autograft;

allograft;

a combination of auto and allografts.

In addition, the binding agent, in addition to the bone material, may additionally contain a biocomposite material, for example, “valve”, “BCS”, etc.

Various combinations are also possible, for example, a binding agent may contain at least one bone block, bone chips and biocomposite material.

The elongated body 2, the screws 4 and 9, the perforated element of the groove-shaped form 7 can be made of titanium or its alloy or other suitable materials.

The perforated element of the groove-shaped form 7 can be fixed on the elongated body 2 for welding. At the same time, it can be cast integrally with an elongated body. This depends, in particular, on the type of material, the selected manufacturing technology, etc.

This is the design of the device in statics.

Treatment using the claimed invention consists of two stages.

Planning the operation for installing the claimed device

(first stage of treatment)

In recent years, surgeons have developed techniques that allow them to simulate an operation using an individual, artificial model of the patient’s skull, which corresponds to the structure of the bones of his face to the nearest millimeter. Making a skull model is the first step in treatment. The skull model is made of plastic by laser stereolithography using computer data, which is obtained after the patient undergoes a spiral computed tomography in 3D projection with the data stored on a digital medium. In computer simulation, an individually declared device is manufactured to eliminate defects and deformations of the lower jaw bone (in other words, an individual endoprosthesis is made) based on a healthy area of the lower jaw on the other hand. Subsequently, after the manufacture of an individual endoprosthesis, it is preliminarily applied to a stereolithographic model of the patient’s skull (photo 1). If necessary, the endoprosthesis is refined. If the endoprosthesis is fully consistent with the patient’s skull model, the second stage of treatment begins. This technique is well known, is not the subject of this application and therefore is not considered in detail.

The methodology of the operation to install the claimed device to eliminate defects and deformations of the bone of the lower jaw (endoprosthesis)

(second stage of treatment)

Consider it for the case when the perforated element of the groove-shaped form 7 is made of relatively small length to restore the continuity of the lower jaw, with a segmental defect.

Under general anesthesia with intubation of the patient through the nose, a skin incision is made in the submandibular region bordering the angle of the lower jaw, tissues are dissected in layers to the bone. Bone fragments of the lower jaw are refreshed with a drill. Trying on a previously manufactured device to eliminate defects and deformities of the lower jaw bone (hereinafter referred to as the individual endoprosthesis) together with implants already mounted on it.

After this, an autograft is made from the iliac scallop.

Autograft Fence:

The skin incision is made above the edge of the ilium to the width of one finger laterally to the bone ridge, starting from the front upper edge of the iliac crest. An acute dissection is performed through the skin and fascial leaves to the periosteum. The periosteum of the ridge is dissected as posteriorly as possible along the ridge, starting from a point about one centimeter in the back of the superior anterior iliac crest. Then the periosteum flakes and the iliac crest is exposed.

When the ilium is skeletonized, a transplant of the desired size and size of the defect is outlined with a series of small perforations using round boron. A disk cutter connects the perforations in the cortical bone and spongy bone is osteotomized.

To mobilize the transplant, an osteotomy is done in parallel and within the opposite borders of the iliac crest with a circular saw or fissure boron. After the autograft is completely separated, the edges of the cortical bone are usually smoothed with a milling cutter to eliminate sharp corners.

Before suturing the wound in the iliac region, an additional spongy bone and bone marrow are taken between the cortical plates of the ilium with a large curettage spoon or a grooved chisel, followed by the replacement of the defect with osteoplastic material. After careful hemostasis of the iliac region, the wound is sutured in layers. Between the joints, drainage is introduced, which is removed after 48 hours. A pressure dressing is applied to the wound to prevent hematoma formation and reduce pain.

While the ileal wound is sutured, the autograft is stored in bone marrow-enriched blood.

After that, the autograft is placed in the perforated element of the groove-shaped form 7 and fixed in it with screws through perforations (holes) in the perforated element of the groove-shaped form 7. The remaining shavings during sampling of the autograft are placed around the implants 8. Then the endoprosthesis with the autograft is fixed with 4 titanium screws to the lower bone so that they pass through both cortical layers. A tightly adapted graft prevents the ingrowth of soft tissue between the bone bed and the graft. In this case, the patient's bite in the correct position is fixed in advance. Wounds are carefully treated with an antiseptic solution. The next step is the suturing of the wound. Fabrics are layered in layers and sutured. For 2-3 days, drainage is introduced, which is subsequently removed.

Consider it for another case in which the perforated element of the groove-shaped form 7 is made along the length almost equal to the elongated body. It is used for significant defects in the bone tissue of the lower jaw. The difference in the operation in this case is that since the patient has a pronounced half defect and deformation of the branch and lateral part of the lower jaw on the right, the perforated element of the groove-like shape 7 is made for the entire length of the elongated body 2. During the operation, an autobone is also taken ( ilium scallop), which is subsequently placed in a perforated element groove-shaped 7 to create continuity of bone tissue.

As in the previous case, the implant prosthesis with implants and a perforated groove-shaped element 7 filled with autobone is fixed (attached) with screws 4 to the healthy bone of the lower jaw 5. After this, the final stages of the operation are carried out, similar to the previous example.

Clinical example.

Patient M., born in 1956 I went to the MONIKA maxillofacial surgery clinic with a defect and deformation of the branch and lateral part of the lower jaw on the right, malocclusion and difficulty in chewing food.

From the anamnesis: was repeatedly operated on for ameloblastoma of the lower jaw on the right with subsequent unsuccessful bone grafting by the iliac crest and rib.

In the preoperative period, she was treated by an orthodontist. The patient underwent a computer examination followed by the manufacture of a sterolithographic model of the skull.

We give a treatment plan:

1. To develop and create an endoprosthesis corresponding to individual characteristics of the patient, make a stereolithographic model of the patient’s skull based on the data of spiral computed tomography in 3D projection.

2. On the obtained model of the skull, conduct a simulation of the operation and make an individual endoprosthesis.

3. Prepare an orthodontic treatment plan to correct the occlusal relationship in the postoperative period.

4. Conduct a complete preoperative clinical and laboratory examination of the patient.

Endoprosthesis replacement of the right half of the lower jaw was carried out using the present invention with an individually manufactured endoprosthesis according to the method described above.

Received positive results. Significantly increased movement of the lower jaw. Deformation of the lower zone of the face, and with it cosmetic defects, decreased.

The invention allows reliably, without repeated operations, to restore the integrity of the lower jaw. An additional advantage of the claimed technical solution is the ability to equip it with implants to compensate for tooth loss.

In addition to the above variants of the invention, numerous other modifications are possible.

All of them are covered by the following claims.

Claims (19)

1. A device for eliminating defects and deformations of the bone of the lower jaw, including an elongated body with through transverse holes, at least on a part of the length, a bonding agent representing bone material, and screws for attaching the elongated body to the bone of the lower jaw, characterized in that the elongated body is provided with a perforated element of a grooved shape, and the bonding agent in a fixed position is located inside the perforated element of a grooved shape. 2. The device according to claim 1, characterized in that it is equipped with a means for restoring teeth attached to the elongated body. 3. The device according to claim 2, characterized in that the perforated element of the groove-shaped form is made with a recess, and a means for restoring teeth is attached to an elongated body at the site of the recess. 4. The device according to claim 2, characterized in that the means for restoring teeth are at least one implant. 5. The device according to claim 4, characterized in that the implant is made of titanium. 6. The device according to claim 1, characterized in that the endoprosthesis of the condylar process is attached to the end part of the elongated body. 7. The device according to claim 1, characterized in that the perforated element of the grooved shape is a grid. 8. The device according to claim 7, characterized in that the mesh is made of titanium. 9. The device according to claim 1, characterized in that the binding agent is a bone chip. 10. The device according to claim 1, characterized in that the binding agent is at least one bone block. 11. The device according to claim 1, characterized in that the bonding agent contains at least one bone block and bone chips. 12. The device according to claim 1, characterized in that the binding agent is an autograft. 13. The device according to claim 1, characterized in that the binding agent is an allograft. 14. The device according to claim 1, characterized in that the binding agent contains auto- and allografts. 15. The device according to claim 1, characterized in that the binding agent further comprises a biocomposite material. 16. The device according to claim 1, characterized in that the bonding agent contains at least one bone block, bone chips and biocomposite material. 17. The device according to claim 1, characterized in that the elongated body and the perforated element of the channel shape are made of titanium. 18. The device according to claim 1, characterized in that the perforated element is fluted-shaped mounted on an elongated body for welding. 19. The device according to claim 1, characterized in that the perforated element of the grooved shape is molded integrally with an elongated body.

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