EP4284297A1

EP4284297A1 - Optimized implant system

Info

Publication number: EP4284297A1
Application number: EP22703566.4A
Authority: EP
Inventors: Adem Aksu; Frank Reinauer; Tobias Wolfram
Original assignee: Karl Leibinger Medizintechnik GmbH and Co KG
Current assignee: Karl Leibinger Medizintechnik GmbH and Co KG
Priority date: 2021-03-11
Filing date: 2022-01-24
Publication date: 2023-12-06
Also published as: WO2022189055A1; CN117015356A; DE102021202393A1; AU2022233419A1; JP2024509294A; US20240156601A1

Abstract

In order to improve local specificity and adjustability of the radiant power in radiation diagnostics and in post-operative radiation therapy, the invention devises an implant system (100, 100', 100", 100'") having a structural part (50, 50', 50", 50'") that can be implanted in a damaged tissue region (30) and has at least a first region (10a, 10b, 10c, 10d) made of a first material and at least a second region (20a, 20b, 20c, 20d) made of a second material, the first region (10a, 10b, 10c, 10d) being designed to support the structural part (50, 50', 50", 50'") and being substantially impermeable to a predetermined radiation for the purpose of diagnostics or for medical radiation therapy, and the second region (20a, 20b, 20c, 20d) being designed to complement the first region (10a, 10b, 10c, 10d) to the structural part (50, 50', 50", 50"') and further comprising at least one portion (22a, 2b, 22c, 22d) that is structurally modified. The portion (22a, 2b, 22c, 22d) of the second region (20a, 20b, 20c, 20d) is permeable to the predetermined radiation for the purpose of diagnostics or for medical radiation therapy.

Description

Optimized implant system

The present invention relates to an implant system with a structural part that can be implanted in a damaged tissue area, which has at least one first area made of a first material and at least one second area made of a second material, wherein the first and second material can be identical or different.

In the correction of bone defects caused by tumors, for example, which are surgically replaced by implants, the use of biocompatible materials, in which corresponding metals and their alloys are used, is known. Such implants are known, for example, from DE 102005 003 188 A1.

In radiation therapy, cancer cells are destroyed using ionizing radiation or particle radiation. The radiation damages the genetic material of the cells so that cell division stops and the cells perish. As a result, the tumors become smaller or disappear. For example, percutaneous radiation therapy uses radiation from outside the body at a distance. Here, very high-energy radiation is generated, for example by means of linear accelerators, which direct photon beams (here: hard X-rays) onto the tumor and destroy the cancer cells.

Radiation therapy can, however, be negatively influenced in terms of its site specificity and performance specificity by the shadowing or absorption effect of the implant systems used. This also applies to radiation diagnostic applications, which is why it often cannot be used in a defined, controlled manner if it is present. Accordingly, a defective or insufficient radiotherapeutic result is obtained. Frequently, however, there is no choice but to accept the negative effects of the deficits described as well as the associated problems. Otherwise, the necessary reconstruction may only be carried out temporarily, minimally or not at all, which in turn can lead to other problems. As a rule, the necessary operation can only be made up for after the completion of the radiotherapy. It is therefore the object of the present invention to provide an implant system which allows an improvement in the location determination and the setting of the radiation power both in radiation diagnostics and in the use of post-operative radiation therapy.

The task is solved by an implant system with the features of claim 1 . The solution according to the invention consists in particular in the fact that in an implant system of the type mentioned at the outset the first area is set up to support the structural part and is essentially impenetrable for a given radioactive radiation for medical radiotherapy. The second area is designed to complement the first area to form the structural part and is provided with at least one section that has a structural modification, the section of the second area being designed to be penetrable for the specified radioactive radiation for medical radiation therapy.

With the implant system according to the invention, an optimized radiation input can be achieved in that on the one hand a first area made of a first material and on the other hand a second area made of a second material is provided on the structural part, of which the first area forms the mechanical load-bearing component, for example , while the second area is an implant component, for example consisting of a raw material that promotes radiotherapy. This permits improved location accuracy and power adjustment for patient-specific improved radiotherapeutic or radiodiagnostic care.

Preferred developments of the implant system according to the invention can be found in the corresponding dependent claims.

In an advantageous development of the prosthesis part, the penetrability of the second area of the structural part can be achieved in a suitable manner by the second material being different from the first material. In this way, the optimum material selection can be made for the functional assignment of the respective area in interaction with the other area.

Another stable and easy-to-handle development can be designed in such a way that the first area completely encloses the second area and thereby stabilizes and protects it can, which is why in this development of the implant system the second area is designed as an insert in the first area.

A further preferred development can then consist in particular in the at least structurally modified section having a lower material density than its surroundings. It is also conceivable to provide several structurally modified sections which have the same material thicknesses or possibly different material thicknesses.

A particularly accurate irradiation of the tumor, in which the healthy tissue in the area can be better protected, is achieved with another development in which the second area is designed as a recess in the first area, so that in the second area a through the structural part completely unimpeded passage of radiation and its entry into the patient-specific tissue area is guaranteed.

In another advantageous development, the second area can have a regular or irregular 3-dimensional framework structure, so that an optimized radiation input is achieved in the same way as with a recess, but here on the one hand the stability of the structural part is improved and on the other hand a larger section with only a second area can be covered. Several second areas with a perforated grid structure are also conceivable on the structural part of the implant system according to the invention.

The structural part experiences a satisfactory supporting effect and rigidity in a preferred development in which the first material is a mechanically stable material. This can therefore include both metals and their alloys, as well as polymers or combinations of these. Particularly preferably, the metallic material of the first area can be titanium, titanium alloys, molybdenum, molybdenum alloys, magnesium, magnesium alloys, implantable stainless steel, or a combination of at least two of these materials.

An advantageous addition of the first area to the structural part, which allows an optimized introduction of radiation into tissue arranged behind it with respect to the radiation source, can be achieved with a development of the implant system according to the invention if the second material is designed as a plastic material or a ceramic material or at least one resorbable component. Combinations of materials are also conceivable here. The plastic material can particularly preferably be formed from at least one polymer, such as PEEK, PEKK, PE, PPSU or a combination of at least two of these materials. Equally preferred is a development in which the ceramic material is formed from aluminum oxide or zirconium oxide. The resorbable component can be equally preferred, without being limited to this, for example HA, β-TCP, a combination of HA/β-TCP, β-TCP/Mg, PDLLA/Mg, PDLLA/β-TCP, PDLLA/CaCC or similar materials may be formed.

Corpuscular radiation, in particular electron radiation, or wave radiation, in particular X-ray radiation, is preferably used as the radioactive radiation provided, which is capable of destroying cancer cells by means of radiation. Due to the formation in several areas of different permeability or penetrability for the intended radioactive radiation, this can be applied particularly accurately and limited to an area with the specifically required power.

In an advantageous development of the implant system, the structural part can be set up to replace, protect and/or cover a damaged bone area in the area of the cranium or the mandible. The implant system can preferably be precisely adapted to the patient-specific requirements and can include a large number of the areas that are necessary in each case.

The above configurations and developments can be combined with one another as desired, insofar as this is expedient. Further possible refinements, developments and implementations of the invention also include combinations of features of the invention described above or below with regard to the exemplary embodiments that are not explicitly mentioned.

The invention is explained in more detail below using exemplary embodiments in the figures of the drawing. The following are shown in a partially schematic representation:

1 shows a perspective side view of a first embodiment according to the invention of the implantable prosthesis part in the area of a mandible with a structural part having a first and a second area and a structurally modified section in the second area; 2 shows a perspective side view of a second embodiment of the implantable prosthesis part in the area of a cranium with a structural part with a first and a second area and a structurally modified section on the second area;

3a, 3b perspective side views of a third embodiment of the implantable prosthesis part for arrangement in the area of a mandible with a structural part with a first and a plurality of second areas and structurally modified sections on the second areas; and

4 shows a perspective side view of a fourth embodiment of the implantable prosthesis part in the area of the mandible with a structural part having a first and a second area and a structurally modified section.

In all figures, elements and devices that are the same or have the same function have been provided with the same reference symbols unless otherwise stated.

Fig. 1 shows a perspective side view of a first embodiment according to the invention of the implantable prosthesis part, designated as a whole by 100, in the area of the mandible 60 with a structural part 50 with a first area 10a and a second area 20a and a structurally modified section 22a arranged in the second area.

In the illustration of Fig. 1, the first area 10a of the structural part 50 is made of a titanium material in the manner of a clamp, which is adapted to the contour of the mandible and extends along it from a chin area shown in the left-hand section of the illustration to an ascending branch (ramus) of the mandible 60 in the right portion of the illustration. The first area 10a of the structural part 50 is fixed to the mandible 60 with fastening screws 12a.

Furthermore, recesses 14a are provided on the first region 10a, which engage around projections on the jawbone and thus additionally prevent a lateral displacement of the structural part and hold it in place. Due to their contact with bone areas, the respective recesses 14a are suitable for the passage of radioactive radiation from the bone material arranged in the recesses 14a is absorbed. In a middle section of the representation of Fig. 1, three equally spaced arms 24a, which are also made of a titanium material, protrude from the first region 10a in the direction of the maxillary sinus and carry with their ends an artificial dental prosthesis part 18a, which passes through the jaw Resection of a tumour, for example, closes a gap in the area of the teeth.

The arms 24a span the second region 20a above the mandible, which is designed as a recess 26 in the first region 10a. The second area 20a formed by the arms 24a is set up to complement the first area 10a to form the structural part and, with its solid structure protruding from the first area 10a and with a large clearance for the passage of radioactive radiation, has a structural modification such that that an essentially free passage is created through the relevant section of the mandible 60, which is traversed by a supporting structure formed by the arms 24a, which has sufficient stability to support or carry the dental prosthesis part 18a and at the same time allow a sufficiently large amount of radiation into allow the tissue to be irradiated in the maxillary sinus.

Fig. 2 shows a perspective side view of a second embodiment of the implantable prosthesis part 100' in the area of a cranium 62 with a structural part 50' with a first and a second area 10b, 20b and a structurally modified section 22b on the second area 20b. In this second embodiment, the first region 10b of the structural part 50' is formed by support parts arranged irregularly at the edge of an opening 34b created by surgical opening (trepanation) of the skullcap (decompressive craniectomy) and protruding essentially transversely to the edge into the opening 34b. The support parts are formed from a titanium material. In contrast, here the second area 20b is formed by a regular perforated grid structure which, held by the first area 10b, covers the opening 34b. At the same time, the perforated lattice structure of the second region 20b, which is also made of a titanium material, forms a section 22b with structural modification, supplements the first region 10b to form the structural part 50' and can be penetrated by the specified radioactive radiation.

3a, 3b show two perspective side views of a third embodiment of the implantable prosthesis part 100″ for arrangement in the area of a mandible 60 not shown in FIGS. 3a, 3b, each having a structural part 50″ with a first and several second regions 10c, 20c and structurally modified sections 22c on the second regions 20c. The structural parts 50' are rotated about their longitudinal axis by approximately 180° in the side views of FIGS. 3a and 3b. The structural part 50″ of FIGS. 3a, 3b has, in a middle section, a first region formed by two webs 42c running parallel to one another, the uniform spacing of which forms a narrow gap 44c. A second region 22c of the structural part 50" is arranged at the ends of the two webs 42c, which in the deployed position encompasses a region of the mandible (not shown) and which, like the first region 10c, is made of a metallic magnesium material.

The upper second region 20c of the structural part 50" in the illustrations in FIGS. 3a, 3b is intended for embracing a chin section from the front, while the lower second region 20c in the illustrations in FIGS. 3a, 3b is intended for embracing the mandible 60 in the side region provided from below. Both second areas 20c have a structural modification 22c and have an irregular perforated lattice structure through which the specified radioactive radiation for radiation therapy penetrates. The position of the perforated grid structure is specifically tailored to the absence of bone material and thus the possibilities for the radiation to be introduced into the tissue there as desired.

4 shows a perspective side view of a fourth embodiment of the implantable prosthesis part 100'' in the area of the mandible 60 with a structural part 50''' with a first and a second area 10d, 20d and a structurally modified section 22d. In this case, the first region 10d is made of a titanium material and is arranged on a side region of the mandible 60, along which it extends and which, in the course of the latter, it partially completely replaces. In a central section of the first area 10d, a second area 20d of the structural part 50'" is formed as an insert with an elongated diamond-shaped, i.e. square, cross-section on the first area 10d, the second area 20d being made of a plastic material, more precisely of a polymer, such as in this case PEEK is formed. The second area 20d thus supplements the first part 10d to form the structural part 50'" and has a structural modification with its section 22d such that the predetermined radioactive radiation, here X-ray radiation, penetrates the second area 20 and into the exposed soft tissue of the oral cavity can be introduced through the removed bone. With the invention described above with reference to preferred embodiments according to FIGS. 1 to 4, an implant system 100, 100′, 100”, 100′″ is created which allows an improvement in the location determination and the setting of the radiation power when using postoperative radiation therapy. For this purpose, the first region 10a, 10b, 10c, 10d of the structural part 50, 50', 50", 50"" is set up in the implantable prosthesis part 100, 100', 100", 100"', the structural part 50, 50', 50 ”, 50'” and to be essentially impenetrable for a given radioactive radiation for medical radiation therapy, while the second area 20a, 20b, 20c, 20d is set up, the first area 10a, 10b, 10c, lod to the structural part 50 , 50', 50”, 50”' and is provided with at least one portion 22a, 2b, 22c, 22d having a structural modification. The section 22a, 2b, 22c, 22d of the second region 20a, 20b, 20c, 20d is designed so that it can be penetrated by the specified radioactive radiation for medical radiation therapy. Although the present invention has been described above on the basis of preferred exemplary embodiments, it is not limited thereto but can be modified in a variety of ways. In particular, the invention can be changed or modified in many ways without departing from the core of the invention.

Claims

1. Implant system (100, 100', 100”, 100'”), comprising: a structural part (50, 50', 50”, 50'”) implantable in a damaged tissue region (30), which comprises at least one of a first material formed first region (10a, 10b, 10c, lOd) and at least one second region (20a, 20b, 20c, 20d) formed from a second material, wherein the first region (10a, 10b, 10c, lOd) is set up that structural part (50, 50', 50”,

50’”) and is substantially impenetrable to a given diagnostic or medical radiation therapy radiation; the second area (20a, 20b, 20c, 20d) is set up, the first area (10a, 10b,

10c, 10d) to the structural part (50, 50', 50", 50"') and is provided with at least one section (22a, 2b, 22c, 22d) which has a structural modification, and the section ( 22a, 2b, 22c, 22d) of the second region (20a, 20b, 20c, 20d) is designed so that it can be penetrated by the specified radiation for diagnostics or for medical radiation therapy.

2. The implant system (100, 100', 100", 100"") according to claim 1, wherein the second material is different from the first material.

3. The implant system (100, 100', 100", 100'") according to claim 1 or 2, wherein the second area (20d) is designed as an insert in the first area (10d).

4. The implant system (100, 100', 100", 100'") according to claim 1 or 2, wherein the second area (20d) is designed as a recess in the first area (10d).

5. The implant system (100, 100', 100", 100'") according to any one of claims 1 to 3, wherein the at least structurally modified section (22a, 2b, 22c, 22d) has a lower material density than its surroundings.

6. The implant system (100, 100′, 100″, 100′″) according to any one of claims 1 to 3, wherein the second region (20a, 20b) has a regular or irregular hole lattice structure.

7. The implant system (100, 100′, 100”, 100″) according to one of the preceding claims, wherein the first material is a mechanically stable material, in particular a metallic material.

8. The implant system (100, 100′, 100″, 100′″) according to claim 7, wherein the metallic material is formed from titanium, titanium alloys, molybdenum, molybdenum alloys, magnesium, magnesium alloys, implantable stainless steel or a combination of at least two of these materials.

9. The implant system (100, 100′, 100″, 100″) according to one of the preceding claims, wherein the second material is designed as a plastic material, ceramic material, composite or an absorbable combination of these.

10. The implant system (100, 100', 100", 100'") according to claim 9, wherein the plastic material is formed from at least one polymer such as PEEK, PEKK, PE, PPSU or a combination of at least two of these materials.

11. The implant system (100, 100', 100", 100'") according to claim 9, wherein the ceramic material is formed from aluminum oxide or zirconium oxide.

12. The implant system (100, 100', 100", 100"') according to claim 9, wherein the absorbable component consists of HA, β-TCP, combinations of HA/β-TCP, β-TCP/Mg, PDLLA/Mg, PDLLA /ß-TCP, PDLLA/CaCC or similar materials.

13. The implant system (100, 100′, 100″, 100′″) according to one of the preceding claims, wherein the radioactive radiation is corpuscular radiation, in particular electron radiation, or wave radiation, in particular X-ray radiation.

14. The implant system (100, 100', 100", 100"") according to one of the preceding claims, wherein the structural part (50, 50', 50", 50'") is designed to repair a damaged bone area in the area of the cranium (62 ) or the mandible (60).