Medical implant for filling a cavity in ganular tissue and method for manufacturing

Abstract

The invention relates to a medical implant for filling cavities in gland tissue and a method for producing the same, the medical implant (1) for filling cavities in gland tissue, in particular in gland tissue of a human breast, the medical implant (1) consisting of a titanized polymer and being designed in a mesh structure to cover the cavity to be filled. The invention relates to a method for manufacturing a medical implant (1), comprising the steps of providing a mesh structure (2) made of a titanized polymer, the size of the mesh structure being larger than that of the medical implant to be manufactured, cutting each region of the provided mesh structure in order to obtain the medical implant (1), the shape of the desired medical implant obtained remaining connected to the provided mesh structure (2) at predetermined connection points (3).

Description

Technical Field

[0001] The present invention relates to a medical implant for filling a cavity in glandular tissue, in particular glandular tissue of the human breast. The present invention also relates to a method for making a medical implant for filling a cavity in glandular tissue. Background Art

[0002] The implant according to the invention is particularly useful for filling the cavity in the human breast after breast-conserving surgery for breast cancer. In breast-conserving surgery, the surgeon completely removes the tumor tissue from the mammary tissue (glandular tissue). When the tumor is removed, the margin of surrounding healthy tissue is as small as possible. After the operation, in the laboratory, the edges of the removed tissue (resection margins) and / or the tumor bed (the area of ​​the breast where the tumor is located) are examined for cancer cells. In addition, the new method allows the edges of the removed tissue to be examined during surgery. If the histological examination shows that the cancerous tissue has not been completely removed, it must be re-resected during surgery, or a new operation must be performed to re-remove the tissue.

[0003] However, after the tumor is removed from the breast tissue, a cavity is created which is visible from the outside. This cavity is preferably filled so that it is not visible from the outside. However, especially small implants often cause encapsulation, inflammation, growth or even rejection reactions.

[0004] Another alternative to breast-conserving surgery for breast cancer is total removal of the breast (mastectomy). The removed breast can then be reconstructed (breast reconstruction). For this purpose, for example, WO 2013 / 148719 A1 discloses a mesh implant for placing a breast implant. The mesh implant is fixed to the pectoralis muscle so that the implant cannot slide. In order to improve biocompatibility, the mesh implant is preferably surface coated, in particular titanium treated. Summary of the invention

[0005] Based on this prior art, the object of the present invention is to provide a medical implant for filling cavities in glandular tissue while preventing encapsulation, inflammation, vegetation or rejection reactions.

[0006] According to the invention, this problem is solved by a medical implant for filling a cavity in glandular tissue, in particular glandular tissue of the human breast, wherein the medical implant consists of a titaniumized polymer and is formed into a mesh for covering the cavity to be filled.

[0007] According to the invention, the mesh structure of the medical implant ensures that the surrounding glandular tissue (breast tissue) can grow into the mesh structure. At the same time, the use of the titaniumized polymer prevents the formation of entrapments, inflammation, vegetation or rejection reactions. To this end, the medical implant according to the invention allows the surrounding tissue (especially the surrounding tumor bed) to grow into the mesh structure of the implant, so that the cavity is filled with the patient's own tissue. Due to the biocompatibility of the titaniumized polymer, this newly grown tissue does not contain any entrapments or vegetation, especially these are caused by inflammatory processes or rejection reactions.

[0008] By titaniumized polymer according to the invention is meant a polymer fibre coated with titanium. Conveniently, the titanium coating applied is very thin so as not to affect the elasticity and flexibility of the polymer fibre. Preferably, the medical implant is made of a polymer mesh which is subsequently titaniumized. This has the advantage that the subsequently applied titanium coating fixes the mesh so that the medical implant can later be cut to size without the mesh dissolving.

[0009] According to a convenient embodiment of the invention, the medical implant consists of a titanated polypropylene.

[0010] According to a preferred embodiment of the present invention, the medical implant is in the shape of a plus sign (+). The intersection of the two legs of the plus sign can be located at the deepest part of the cavity to be filled, so that the legs extending therefrom at least partially, preferably completely, cover the side walls of the cavity to be filled. If individual parts of the legs extend from the cavity to be filled, they can be removed after the medical implant of the present invention is inserted. According to this form, the implant of the present invention can be particularly easily adapted to the size of the cavity to be filled, in particular the depth.

[0011] According to one embodiment of the present invention, the mesh width of the mesh structure is less than 2 mm, preferably 1 mm. Such a mesh size is particularly conducive to the ingrowth of surrounding tissues, especially glandular tissue or breast tissue.

[0012] According to a convenient embodiment of the present invention, the weight of the medical implant is less than 50 g / m 2 , especially 16g / m 2 or 35 g / m 2 .

[0013] According to a particularly useful embodiment of the present invention, the thickness of the titanium coating is selected so that the elasticity and flexibility of the polymer network structure are not compromised. For example, the diameter of the polymer fibers of the network structure is 50-100 μm and the thickness of the titanium coating is 15-75 nm.

[0014] This problem can be further solved by a method for making a medical implant of the present invention, comprising the following steps: - providing a mesh structure made of a titaniumized polymer, the dimensions of the mesh structure being larger than the medical implant to be manufactured, - Cutting individual areas of the provided mesh structure to obtain the desired shape of the medical implant, the desired implant shape obtained remaining connected to the offcuts of the provided mesh structure at predetermined locations.

[0015] Thus, the medical implant according to the invention is a component of a provided mesh structure, which until shortly before the actual implantation is larger than the actual medical implant. Only immediately before the implantation are the predetermined connection points separated, thereby releasing the medical implant from the surrounding mesh structure. This improves the manageability of the medical implant until it is actually implanted.

[0016] According to a preferred embodiment of the method of the present invention, in the mesh structure provided, at least two medical implants of different sizes are cut out. In this way, several medical implants of different sizes are provided in the mesh structure, and the surgeon can separate the medical implant from the mesh structure during surgery, and the medical implant corresponds to the size of the cavity to be filled. As described at the beginning of this article, when the tumor tissue is excised, the surrounding tissue edges are also excised together. It is impossible to accurately predict in advance how big the cavity to be filled is, especially if it is necessary to re-excise during surgery, for example, because the fine tissue checked during surgery has shown that not all tumor tissue has been excised. By cutting out a plurality of medical implants of different sizes from the mesh structure, the surgeon can select the medical implant by separating the determined connection points, which is the ideal size to fill the cavity. In addition, before deciding on the medical implant, the surgeon can test the matching of different medical implants with the cavity to be filled. Providing several medical implants of different sizes in one mesh structure is more economical than providing several separate mesh structures (one mesh structure with one medical implant) which must be individually packaged, sterilized, stored, etc.

[0017] According to a suitable embodiment of the invention, the method comprises the steps of packaging and sterilizing the provided mesh structure and cutting out at least one medical implant therein.

[0018] According to a preferred embodiment of the present invention, the titanium mesh structure is manufactured by the following steps: - provide a polymer network structure, and - Apply a titanium layer on the provided polymer mesh.

[0019] The subsequent application of the titanium layer can better secure the mesh structure so that the mesh structure can be cut without adversely affecting the mesh structure.

[0020] According to a particularly useful embodiment of the present invention, the thickness of the titanium coating is selected so that the elasticity and flexibility of the polymer network structure are not compromised. For example, the diameter of the polymer fibers of the network structure is 50-100 μm and the thickness of the titanium coating is 15-75 nm. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The present invention will be described in more detail below with reference to the embodiments shown in the accompanying drawings. The accompanying drawings are as follows:

[0022] Figure 1 is a schematic diagram of a medical implant according to the present invention, Figure 2 is a schematic diagram of a titaniumized polymer mesh structure with two medical implants of the present invention cut out therein, and Figure 3 is a flow chart of a method of the present invention for making a medical implant of the present invention. DETAILED DESCRIPTION

[0023] Figure 1 A schematic diagram of a medical implant 1 according to the invention is shown for filling a cavity in glandular tissue, in particular glandular tissue in the human breast. Figure 1 The medical implant 1 in the present invention is composed of a titanium-containing polymer and is designed in the form of a mesh structure to cover a cavity to be filled.

[0024] Since the medical implant 1 according to the invention is designed as a mesh structure, which covers the cavity to be filled in the implanted state, the surrounding glandular tissue (breast tissue) can grow into the mesh structure of the medical implant 1. At the same time, the use of the titanium polymer can prevent the formation of encapsulation, inflammation, vegetation or rejection reactions. The medical implant 1 according to the invention promotes the extension of the surrounding tissue into the mesh structure of the medical implant 1, which is covered by the medical implant 1 in the implanted state. The growth of the surrounding tissue allows the cavity to be filled with the patient's own tissue. The biocompatibility of the titanium polymer prevents the formation of encapsulation or vegetation in the newly grown tissue, especially these are caused by inflammatory processes or rejection reactions.

[0025] Titanized polymers according to the invention mean a polymer fiber coated with titanium. Conveniently, the titanium coating applied is very thin and does not restrict the elasticity and flexibility of the polymer fiber. Preferably, the medical implant 1 is made of a polymer mesh which is subsequently titaniumized. Advantageously, the subsequently applied titanium coating fixes the mesh so that the medical implant 1 can be cut to size later without the mesh dissolving.

[0026] Preferably, the medical implant 1 consists of titanium-treated polypropylene. The mesh size of the mesh structure of the medical implant 1 is preferably less than 2 mm, in particular a mesh size of about 1 mm. The weight of the medical implant 1 is preferably less than 50 g / m 2 , especially 16g / m 2 or 35 g / m 2 .

[0027] like Figure 1 As shown, the medical implant 1 is in the shape of a plus sign or, after a rotation of 45°, in the shape of an X. The intersection of the two legs of the plus sign is located at the deepest point of the cavity to be filled during the implantation of the medical implant 1, and the legs extending therefrom at least partially, preferably completely, cover the side walls of the cavity to be filled. In order to make the implant of the invention particularly easy to adapt to the size of the cavity to be filled, in particular the depth, it is possible to cut off individual parts of the legs extending from the cavity to be filled.

[0028] Figure 2 A schematic diagram of a titaniumized polymer mesh structure 2 is shown, from which two medical implants 1 of the present invention are cut. The two medical implants 1 are connected to the mesh structure 2 at predetermined connection points 3 and can be separated (cut away) from the mesh structure 2 before implantation.

[0029] The sizes of the two medical implants 1 cut out of the mesh structure 2 are different, so the surgeon can select the medical implant 1 of the appropriate size during the operation. The surgeon can also compare the fit of the two medical implants 1 with each other and determine the appropriate size of the medical implant 1 based on this.

[0030] Figure 3 1 is a flow chart of the method of the present invention, which is used to make the medical implant 1 of the present invention. In the first step, a mesh structure 2 of polymer fibers is provided. For example, the diameter of the polymer fibers is 50 to 100 μm. The size of the mesh structure 2 is larger than the medical implant 1 to be made or the medical implant 1 to be made therefrom.

[0031] Next, a titanium layer is applied to the prepared mesh structure. For example, the thickness of the titanium layer is in the range of 15 to 75 nm. Conveniently, the applied titanium layer does not impair the elasticity and flexibility of the polymer mesh structure 2.

[0032] In the final step of the manufacturing process, areas of the prepared and titaniumized mesh structure 2 are cut out to obtain the desired shape of the medical implant 1. Figure 2 As shown, it is also possible to cut the medical implant 1 of several different sizes from the mesh structure 2 .

[0033] The desired implant 1 in its final shape remains connected to the offcuts of the provided mesh structure 2 at predetermined connection points 3 .

[0034] Finally, the prepared mesh structure 2, including the medical implant 1 cut therefrom, can be packaged and sterilized. In this state, the packaged mesh structure 2 is transported and stored until the surgeon inserts it into the cavity to be filled during breast-conserving surgery. During the operation, the surgeon can separate the medical implant 1 from the surrounding mesh structure 2 by separating (especially cutting) the predetermined area.

[0035] Meaning of reference numerals in the accompanying drawings 1Medical Implants 2. Mesh structure 3 Predetermined connection points

Claims

1. A medical implant (1) for filling a cavity in glandular tissue, for filling a cavity in glandular tissue, in particular in glandular tissue of the human breast, in, The medical implant (1) is made of a titanium polymer and is formed into a mesh structure to cover the cavity to be filled.

2. The medical implant (1) according to claim 1, wherein The medical implant (1) consists of titanium-treated polypropylene.

3. The medical implant (1) according to claim 1 or 2, wherein: The medical implant (1) is in the shape of a plus sign.

4. The medical implant (1) according to any one of claims 1 to 3, wherein: The mesh size of the mesh structure is less than 2 mm, preferably 1 mm.

5. The medical implant (1) according to any one of claims 1 to 4, wherein: The weight of the medical implant (1) is less than 50 g / m 2 , especially 16 g / m 2 or 35 g / m 2 .

6. A method for producing a medical implant (1) according to any one of claims 1 to 5, comprising the following steps: A titanium-polymer mesh structure (2) is provided, wherein the size of the mesh structure (2) is larger than the medical implant (1) to be manufactured, Areas of the provided mesh structure (2) are cut out to obtain the desired shape of the medical implant (1), wherein the obtained shape of the desired implant (1) remains connected to the edge material of the provided mesh structure (2) at predetermined connection points (3).

7. The method according to claim 6, wherein: At least two medical implants (1) of different sizes are cut out of the provided mesh structure (2).

8. The method according to claim 6 or claim 7, comprising the steps of packaging and sterilizing the provided mesh structure (2) and cutting at least one of the medical implants (1) therefrom.

9. The method according to any one of claims 6 to 8, wherein: The titanium network structure (2) is manufactured by the following steps: providing a polymer network structure, and A titanium layer is applied to the provided polymer mesh.

10. The method according to claim 9, wherein: The thickness of the titanium layer is selected such that the elasticity and flexibility of the polymer network are not impaired.

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