Optimized implant system

Abstract

To improve positioning and radiation output control in radiodiagnosis and post-operative radiotherapy, the present invention contemplates an implant system (100, 100', 100'', 100''') comprising a structural component (50, 50', 50'', 50''') capable of being implanted in a damaged tissue site (30), said structural component having one or more first portions (10a, 10b, 10c, 10d) made of a first material and one or more second portions (20a, 20b, 20c, 20d) made of a second material. The first portion (10a, 10b, 10c, 10d) is designed to support the structural component (50, 50', 50'', 50''') and is substantially impermeable to a predetermined radiation for diagnostic purposes or medical radiation therapy, and the second portion (20a, 20b, 20c, 20d) is designed to complement the first portion (10a, 10b, 10c, 10d) with respect to the structural component (50, 50', 50'', 50''') and further comprises one or more structurally modified portions (22a, 2b, 22c, 22d). The portions (22a, 2b, 22c, 22d) of the second portion (20a, 20b, 20c, 20d) are permeable to the predetermined radiation for diagnostic purposes or medical radiation therapy.

Description

[Technical field]

[0001] The present invention relates to an implant system comprising a structural component implantable in a damaged tissue region, said structural component having one or more first portions formed from a first material and one or more second portions formed from a second material, the first material and the second material being capable of being the same or different. [Background technology]

[0002] In the case of the correction of defects in the bone, for example caused by a tumor, which are surgically replaced by an implant, it is known to use biocompatible materials, whereby suitable metals and their alloys are used. Such an implant is known, for example, from US Pat. No. 5,399,633.

[0003] In radiation therapy, cancer cells are destroyed by ionizing radiation or particle beams. The radiation damages the genetic material of the cells, so that cell division stops and the cells die. As a result, the tumor shrinks or disappears. For example, in percutaneous radiation therapy, irradiation is performed from outside the body, from a certain distance. In such cases, very high energy radiation is generated, for example, by a linear accelerator, which directs a photon beam (here, hard X-rays) onto the tumor to destroy the cancer cells.

[0004] However, with regard to its specificity in terms of location and power, radiation therapy can be adversely affected by the shielding or absorption effects of the implant system used. This also applies to radiodiagnostic applications, which are therefore often not available in a defined and controlled manner when an implant system is present. The results obtained in radiation therapy are therefore insufficient or inappropriate. In many cases, however, there is no choice but to accept the adverse effects of the abovementioned deficiencies and the associated problems that result. In other cases, the necessary reconstructions are only performed temporarily, minimally or not at all, which in turn can lead to other problems. Generally, the necessary surgery can only be performed after the completion of the radiation therapy. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] DE 102005003188 A1 Summary of the Invention [Problem to be solved by the invention]

[0006] It is therefore an object of the present invention to provide an implant system that allows improved positioning and setting of radiation power, both in diagnostic radiology and in post-operative radiotherapy uses. [Means for solving the problem]

[0007] The object is achieved by an implant system having the features of claim 1. In particular, the solution according to the invention consists in that in the case of an implant system of the type mentioned in the introduction, a first part is arranged to support a structural part and is substantially impermeable to specific radioactive radiation for medical radiotherapy, while a second part is arranged to complement the first part to form the structural part and comprises one or more sections with structural modifications, the sections of the second part being permeable to specific radioactive radiation for medical radiotherapy.

[0008] With the implant system according to the invention, therefore, an optimized radiation input can be achieved by providing on the structural part a first section made of a first material and a second section made of a second material, the first section forming for example a mechanical load-bearing component, while the second section is for example in the form of an implant component made of a material supporting the radiation treatment, which allows improved positional accuracy and power adjustment for improved radiation therapy or radiodiagnostic care in a patient-specific manner.

[0009] Preferred developments of the implant system according to the invention can be found in the associated dependent claims. In an advantageous development of the prosthetic part, the permeability of the second region of the structural part can be achieved expediently by means of a second material different from the first material, thus allowing the allocation of functions of a particular region to be achieved by an optimal selection of the material in conjunction with the other regions.

[0010] A further stable and easy to handle development can be designed in such a way that the first part completely covers the second part, thereby stabilizing and protecting the first part, so that in such a development of the implant system the second part is in the form of an insert in the first part.

[0011] A further preferred development may then in particular be present at least one structurally modified section which has a lower material density than its surrounding areas. It is also conceivable to provide a plurality of structurally modified sections with the same or, if necessary, different material thicknesses.

[0012] Particularly precise irradiation of the tumor, with which healthy tissue in the surrounding area can be better protected, is achieved by a further development in which the second section is in the form of a cutout in the first section, so that the second section ensures completely unhindered passage of the radiation through the structural component and input of the radiation into the patient-specific tissue area.

[0013] In another advantageous development, the second region can have a regular or irregular three-dimensional scaffold structure, so that an optimized radiation input is achieved similarly to the case of cutouts, but in such a case the stability of the structural part is improved and relatively large sections can be covered only by the second region. Also conceivable are a plurality of second regions with a perforated lattice structure on the structural part of the implant system according to the invention.

[0014] A sufficient support effect and rigidity is experienced by the structural part in a preferred development in which the first material is a mechanically stable material, which can therefore comprise a metal, an alloy thereof, a polymer, or a combination thereof. Particularly preferably, the metallic material of the first part can be titanium, a titanium alloy, molybdenum, a molybdenum alloy, magnesium, a magnesium alloy, an implantable stainless steel, or a combination of two or more of these materials.

[0015] The advantageous supplementation of the first region for forming a structural part, which is an optimized radiation input into the tissue arranged behind it with respect to the radiation source, can be achieved by one development of the implant system according to the invention when the second material is in the form of a plastic material, a ceramic material or one or more absorbent components. Material combinations are also conceivable here.

[0016] Particularly preferably, the plastic material can be made of one or more polymers such as PEEK, PEKK, PE, PPSU, or a combination of two or more of these materials. A development in which the ceramic material is made of aluminum oxide or zirconium oxide is also preferred. Also preferably, but not limited to, the absorbent component can be composed of HA, β-TCP, or a combination of materials such as HA / β-TCP, β-TCP / Mg, PDLLA / Mg, PDLLA / β-TCP, PDLLA / CACC, or similar.

[0017] As intended radioactive radiation capable of destroying cancer cells by radiation, it is preferable to use particle beams (particularly electron beams) or wave radiation (particularly X-rays).Due to the design at multiple sites with different permeability and penetration of intended radioactive radiation, said radiation can be irradiated in a particularly precise and localized manner at the site with a particularly required power.

[0018] In one advantageous development of the implant system, the structural equipment can be arranged to replace, protect and / or cover damaged bone areas in the region of the skull or mandible. The implant system can preferably be precisely adapted to the patient's specific requirements and can include the specific region variety required.

[0019] The above configurations and developments can be combined with one another, if necessary, as desired, and further possible configurations, developments and implementations of the invention also encompass combinations of features of the invention not explicitly mentioned, which features may be described above or below in relation to the exemplary embodiments.

[0020] The invention will be explained in more detail below on the basis of exemplary embodiments in the drawing figures. [Brief description of the drawings]

[0021] [Figure 1] FIG. 1 is a perspective side view of a first embodiment of an implantable prosthetic component in a mandibular region, comprising a structural component having a first region, a second region, and a structurally modified section on the second region, in accordance with the present invention; [Diagram 2] FIG. 2 is a perspective side view of a second embodiment of an implantable prosthetic component in a cranial region, the prosthetic component comprising a structural component having a first region, a second region, and a structurally modified section on the second region. [Figure 3a] FIG. 13 is a perspective side view of a third embodiment of an implantable prosthetic component for placement in a mandibular region, the prosthetic component comprising a structural component having a first region, a plurality of second regions, and a structurally modified section on the second regions. [Figure 3b] FIG. 13 is a perspective side view of a third embodiment of an implantable prosthetic component for placement in a mandibular region, the prosthetic component comprising a structural component having a first region, a plurality of second regions, and a structurally modified section on the second regions. [Figure 4] A perspective side view of a fourth embodiment of an implantable prosthetic component in the region of the mandible, comprising a structural component having a first portion, a second portion, and a structurally modified section. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] In all the figures, identical or functionally identical elements and devices are provided with the same reference numbers unless otherwise stated. 1 shows a perspective side view of a first embodiment of an implantable prosthetic component, generally identified by 100, in the region of a mandible 60 according to the present invention. The prosthetic component comprises a structural component 50 having a first region 10a, a second region 20a, and a structurally modified section 22a disposed in the second region.

[0023] 1, the first portion 10a of the structural component 50 is constructed from a titanium material in the form of a clamp that conforms to the contour of the mandibular jaw, extending from the chin portion depicted in the left section of the illustration to the ramus (ramus) extending above the mandibular jaw 60 in the right section of the illustration, where the first portion 10a of the structural component 50 is fixed onto the mandibular jaw 60 using a fastening screw 12a.

[0024] Furthermore, a cutout 14a is provided on the first part 10a, which surrounds the protrusion on the jawbone and thus additionally prevents lateral displacement of the structural part and keeps it stationary. Due to the application of the cutout 14a to the bone area, said cutout 14a is suitable for the passage of radioactive radiation, which is absorbed by the bone material placed in the cutout 14a. In the exemplary middle section of Fig. 1, three equally spaced arms 24a, also made of titanium material, protrude from the first part 10a in the direction of the maxillary sinus and support at their ends the denture part 18a which closes the gap at the tooth site. Said gap is present in the jaw, for example as a result of the removal of a tumor.

[0025] The second section 20a overhangs the mandible through the arms 24a and is in the form of a cutout 26 in the first section 10a. The second section 20a formed by the arms 24a is arranged to form a structural part complementary to the first section 10a. The second section 20a then has a structural modification which, projecting from the first section 10a, provides a substantially free passage through the relevant section of the mandible 60 by its solid structure with a large gap size for the passage of radioactive radiation. The mandible 60 is traversed by a support structure formed by the arms 24a and having sufficient stability to support or bear the denture part 18a, while at the same time allowing a sufficiently large input of radiation into the tissue to be irradiated present in the maxillary sinus.

[0026] FIG. 2 shows a perspective side view of a second embodiment of an implantable prosthetic component 100' in a region of the skull 62. The prosthetic component 100' comprises a structural component 50' having a first region 10b, a second region 20b and a structurally modified section 22b on the second region 20b. In this second embodiment, the first region 10b of the structural component 50' is formed by a support component that is irregularly arranged at the edge of an opening 34b formed by a surgical incision (burr hole) in the calvarium (decompressive craniotomy) and that protrudes into the opening 34b in a direction generally transverse to said edge. The support component is made of titanium material. In contrast, the second region 20b is now formed by a regular perforated lattice structure that covers the opening 34b and is held by the first region 10b. At the same time, the perforated lattice structure of the second portion 20b, also made of titanium material, forms a section 22b having a structural modification and complements the first portion 10b to form a structural component 50', which is permeable to certain radioactive radiation.

[0027] 3a and 3b show two perspective side views of a third embodiment of an implantable prosthetic component 100″ for placement in a region of the mandible 60 (not shown in FIGS. 3a and 3b). The prosthetic component 100″ comprises in each case a structural component 50″ having a first region 10c, a number of second regions 20c and a structurally modified section 22c on the second region 20c. In the side views of FIGS. 3a and 3b, the structural components 50′ are rotated about 180° about their longitudinal axis. The structural component 50″ in FIGS. 3a and 3b comprises, in the middle section, a first region formed by two parallel bridge portions 42c, the uniform distance of which forms a narrow gap 44c. In each case, the second region 22c of the structural component 50″ is arranged at the end of the two bridge portions 42c. The second part, in the position of use, in each case grips the part of the lower jaw (not shown) and, like the first part 10c, is made of metallic magnesium material.

[0028] The upper second part 20c of the structural part 50'' in Figs. 3a and 3b is intended to grip the chin section from the front, while the lower second part 20c in Figs. 3a and 3b is intended to grip the mandible 60 in the outer part from below. The two second parts 20c have a structural modification 22c and have an irregular perforated lattice structure through which the specific radioactive radiation for radiation therapy is transmitted. The position of the perforated lattice structure is specifically adjusted according to the lack of bone material and therefore the possibility of radiation being input into the tissue at that position as desired.

[0029] FIG. 4 shows a perspective side view of a fourth embodiment of an implantable prosthetic component 100''' in the region of the mandible 60. The prosthetic component 100''' comprises a structural component 50''' having a first portion 10d, a second portion 20d and a structurally modified section 22d. In the said case, the first portion 10d is made of titanium material and is placed on the outer region of the mandible 60, extends along it and completely replaces it in some parts of its path. In the middle section of the first portion 10d, the second portion 20d of the structural component 50''' is formed on the first portion 10d as an insert with an elongated rhomboidal cross section (i.e. square cross section), the second portion 20d being made of a plastic material, more precisely a polymer (PEEK, in the said case, etc.). The second part 20d therefore complements the first part 10d to form a structural part 50''' and has a structural modification by its section 22d such that a specific radioactive radiation (here, X-rays) can penetrate the second part 20 and enter into the soft tissue of the oral cavity located behind it and exposed by the removal of the bone.

[0030] The present invention as described above based on the preferred embodiment according to Figures 1 to 4 therefore provides an implant system 100, 100', 100'', 100''' which allows improved positioning and radiation power setting for post-operative radiation therapy use. For such purpose, in the case of the implantable prosthetic component 100, 100', 100'', 100''', the first portion 10a, 10b, 10c, 10d of the structural component 50, 50', 50'', 50''' is arranged to support the structural component 50, 50', 50'', 50''' and to be substantially impermeable to a specific radioactive radiation for medical radiotherapy, while the second portion 20a, 20b, 20c, 20d comprises one or more sections 22a, 2b, 22c, 22d with structural modifications arranged to complement the first portion 10a, 10b, 10c, 10d to form the structural component 50, 50', 50'', 50''''. The sections 22a, 2b, 22c, 22d of the second portion 20a, 20b, 20c, 20d are permeable to a specific radioactive radiation for medical radiotherapy.

[0031] Although the present invention has been described above based on preferred exemplary embodiments, the present invention is not limited thereto and can be modified in various ways. In particular, the present invention can be changed or modified in many ways without departing from its essence.

Claims

1. An implant system (100''), a structural component (50''') implantable within the damaged tissue region, said structural component having one or more first portions (10d) formed from a first material and one or more second portions (20d) formed from a second material; the first portion (10d) is arranged to support the structural component (50''') and is substantially impermeable to certain radioactive radiation for medical radiation therapy; the second portion (20d) is arranged to complement the first portion (10d) to form the structural component (50''') and comprises one or more sections (22d) having structural modifications; the section (22d) of the second portion (20d) being transmissible to the specific radioactive radiation for medical radiotherapy; The second portion (20d) is formed as an insert in the first portion (10d).

2. The implant system (100''') of claim 1, wherein at least the structurally modified section (22d) has a lower material density than surrounding areas.

3. An implant system (100''') according to claim 1 or 2, wherein the first material is a mechanically stable material, in particular a metallic material.

4. 4. The implant system (100'') of claim 3, wherein the metallic material is formed from titanium, a titanium alloy, molybdenum, a molybdenum alloy, magnesium, a magnesium alloy, implantable stainless steel, or a combination of two or more of the foregoing materials.

5. An implant system (100'') according to any one of claims 1 to 4, wherein the second material is in the form of a plastic material, a ceramic material, a composite material, a resorbable component, or a combination thereof.

6. The implant system (100'') of claim 5, wherein the plastic material is formed from one or more polymers such as PEEK, PEKK, PE, PPSU, or a combination of two or more of these materials.

7. The implant system (100''') of claim 5, wherein the ceramic material is formed from aluminum oxide or zirconium oxide.

8. 6. The implant system (100''') of claim 5, wherein the absorbable component is composed of HA, β-TCP, or a combination of HA / β-TCP, β-TCP / Mg, PDLLA / Mg, PDLLA / β-TCP, PDLLA / CaCC, or similar materials.

9. An implant system (100'') described in any one of claims 1 to 8, wherein the specific radioactive radiation is a particle beam, in particular an electron beam, or a wave radiation, in particular an X-ray.

10. An implant system (100'') according to any one of the preceding claims, wherein said structural component (50''') is designed to replace a damaged bone area in the region of a mandible (60).

11. An implant system (100''') as described in claim 10, wherein the first portion (10d) is formed from a titanium material, the first portion (10d) is designed to be arranged on a lateral portion of the mandible (60), the first portion (10d) extends along the mandible (60) and is partially replaced in its extending portion, and in an intermediate section of the first portion (10d), the second portion (20d) of the structural part (50''') is formed as an insert in the first portion (10d), and the second portion (20d) is formed from a plastic material, in particular PEEK.

12. An implant system (100''') as described in claim 11, wherein the insert includes an elongated rectangular cross-section.

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