implants

Abstract

To create an implant that allows for easy and reliable treatment of the bladder neck. [Solution] This is achieved by an implant having a pressurizing means structure for expanding the bladder neck of a person, particularly a removable implant. This pressurizing means structure applies local pressure to the tissue of the bladder neck. The pressurizing means structure may be connected to a retaining means for operation. This retaining means may be a wire, thread, or rod, and the retaining means is used to insert the implant or pressurizing means structure into the bladder neck via the urethra, and, if necessary, to retrieve the pressurizing means structure from the patient's body after the treatment is completed.

Description

Technical Field

[0004] , , , , ,

[0001] The present invention relates to an implant.

Background Art

[0002] Various methods and techniques for the treatment of the urinary tract, particularly benign prostatic hyperplasia (BPH), are known. In minimally invasive treatment of BPH symptoms that are particularly gentle on the body, a removable implant is temporarily placed in the urethra or the prostatic part of the patient's urethra. Such an implant is a wire structure made of a shape memory alloy such as nitinol. The wire structure, in a folded state, is pushed through a catheter to the correct position and deployed there into a predetermined basic structure. This structure can be formed from three or four wires and is a basket structure. This basket structure expands the urethra. By expanding the wire structure against the urethral tissue, the urethral tissue degenerates over several days. This tissue degeneration is caused by the ischemic pressure of the tissue on the individual wires, which results in a reduction or complete loss of blood flow. As a result, the lack of blood flow causes a lack of oxygen in the cells, ultimately leading to cell death. The tissue can shrink within a few days to such an extent that the urine flow is almost normalized. At the end of the treatment, the implant can be removed from the urethra using a catheter. Further details regarding such implants are described, for example, in German Patent Application Publication No. 102021133394.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] While the aforementioned implants can also be used to treat at least partially closed or obstructed bladder necks, their effectiveness is very limited, as this treatment is largely a secondary effect of treating BPH symptoms. Since elevated bladder necks are caused by overgrowth of the posterior or middle lobe and prostate, this condition cannot be treated by manipulating the tissue as described above. In fact, the use of the above-mentioned implants to treat the bladder neck can also be harmful. In particular, the use of three wires positioned 120° apart from each other, and the resulting high local pressure on the tissue, is unsuitable for treating narrowed bladder necks.

[0005] Based on this, the present invention is based on the objective of creating an implant that can easily and reliably treat the bladder neck. [Means for solving the problem]

[0006] A solution to this problem is described by the features of claim 1. Accordingly, the implant, in particular a removable implant, is said to have a pressurizing means structure for expanding the bladder neck of a person. This pressurizing means structure applies local pressure to the tissue of the bladder neck. The pressurizing means structure may be connected to a retaining means for operation. This retaining means may be a wire, thread, or rod, and the retaining means is used to insert the implant or pressurizing means structure into the bladder neck via the urethra and, if necessary, to retrieve the pressurizing means structure from the patient's body after the completion of the treatment.

[0007] An essential feature of the present invention is that the pressurizing means structure has at least one planar or flat planar pressurizing means. The implant can apply localized but large-area pressure to the tissue of the bladder neck by this planar pressurizing means. At a given force, this planar pressurizing means produces only low surface pressure that does not correspond to ischemic pressure, and for this reason the tissue of the valve in question is not deformed or degenerated. However, at the same time, the implant can act on the posterior and middle lobes of the bladder neck, thereby preventing stenosis of the bladder neck.

[0008] It is preferable that one surface of the planar pressurizing means is convex or concave. Depending on the application or orientation of the planar, particularly plate-shaped, planar pressurizing means, it may be advantageous for the surface in contact with the tissue to be concave or convex. Due to the special curvature of the surface, the tissue can be positioned particularly well within the pressurizing means structure, thereby accumulating particularly favorable pressure. The use of the claimed implant is particularly efficient for uniform pressure distribution. However, it is also conceivable that the surface may have a much more complex shape, such as a hyperbolic shape.

[0009] The planar pressurizing means may also have a closed, or at least partially open, preferably mesh-like, surface. The surface may also be designed as a grid of parallel or intersecting wires. These variations allow for different effects or pressures to be exerted on the surrounding tissue.

[0010] Preferably, the planar pressing means is shovel-shaped and is thought to function to support the marginal region of the bladder neck, particularly the posterior and / or middle lobe of the bladder neck.

[0011] In a preferred embodiment of the present invention, the length of the planar pressing means may be 0.5 mm to 30 mm. Furthermore, the width of the planar pressing means may be 1 mm to 10 mm, or the width of the planar pressing means may increase continuously from the first end to the second end. In addition, the radius of curvature of the curved surface of the planar pressing means may be 1 mm to 20 mm. Finally, it is conceivable that several different implants with varying shapes of planar pressing means may be available to surgeons to appropriately address individual situations and to apply the most uniform pressure possible to the affected tissue.

[0012] In particular, the cross-section of the planar pressurizing means is wedge-shaped, and the base of the wedge is convex. Preferably, the base is a closed surface, and the wedge shape is formed by a wire structure. This special design ensures the positioning of the implant within the bladder neck. At the same time, the flat base allows for a relatively large area of ​​low pressure on the tissue, while the wire structure allows for very localized, higher pressure on the opposing tissue. This combination of different pressure surfaces makes it possible to perform different tissue treatments with a single implant.

[0013] In another possible embodiment of the implant, the cross-section of the planar pressurizing means may be arc-shaped, with the apex region of the arc being a closed surface. Alternatively, the arc shape can be formed by a wire structure. This embodiment allows for more uniform and lower pressure to be applied to the tissue through the flat apex region, and also allows for very localized and high pressure through the wire structure. Numerous other embodiments are conceivable, and their specific shapes allow for nearly customized pressure to be applied to the tissue being treated.

[0014] A particularly advantageous embodiment of the present invention may provide a preferably sheet-like fixing clamp positioned on a retaining means or planar pressing means. This fixing clamp protrudes into the bladder and, by its curved structure, acts as a kind of clamp or return spring to protect the implant from sliding into the bladder neck. The clamp may be inserted into the urethra through a tube and pushed out of the tube only when in the correct position, thus allowing for pinpoint positioning. Similarly, the clamp can be retracted into the tube at the end of treatment. The clamp may also be removable from the bladder neck by rotation or other movement. This fixing clamp makes it possible to perform treatment with a certain degree of precision and reliability using the aforementioned implant.

[0015] According to the present invention, the planar pressurizing means is foldable and can be unfolded from a folded state to an operational state. For example, the implant can be pushed through the urethra, particularly through a tube, by a retaining means designed as a tube, wire, or thread, and positioned correctly. The planar pressurizing means can be unfolded as soon as it is positioned correctly. Once treatment is complete, the pressurizing means structure can be removed from the bladder neck in the reverse order. In particularly special applications, the implant can also remain in the body.

[0016] Furthermore, according to the present invention, at least one holding means and / or planar pressing means may be made of metal, plastic, or a biodegradable material, or a shape-memory material, particularly nitinol. Embodiments made of a biodegradable material are particularly advantageous because there is no need to recover the material, as it decomposes over time.

[0017] Finally, in a particularly preferred embodiment of the present invention, the surface of the planar pressurizing means is provided with a coating for drug absorption and release into the environment, preferably for administration. This coating can be designed as a reservoir that can be filled with the corresponding drug before treatment. This reservoir may be, for example, fire, foam, or another material that can administer the drug into the environment in several stages. In this way, the drug can be administered and used in a highly targeted manner. The use of such a coating means that the implant has a dual effect: firstly, pressure is applied to the surrounding tissue, and secondly, the drug is applied with pinpoint accuracy.

[0018] Preferred embodiments of the present invention will be described in more detail below with reference to the drawings. The drawings are shown below. [Brief explanation of the drawing]

[0019] [Figure 1] This is a schematic diagram of a possible embodiment of the implant. [Figure 2] This is a schematic diagram of a further embodiment of the implant. [Figure 3] It is a perspective view of a further embodiment of the implant. [Figure 4] It is a perspective view of a further embodiment of the implant. [Figure 5] It is a perspective view of a further embodiment of the implant.

Mode for Carrying Out the Invention

[0020] FIG. 1 is a highly schematic view of a possible embodiment of an implant 10. The implant 10 shown in FIG. 1 is used for the elevated bladder neck 11. For this condition, the implant 10 is pushed into the bladder neck 11 through the patient's urethra 12 such that a part of the implant 10 protrudes into the bladder 13. The implant 10 essentially consists of a holding means 14 and a pressurizing means structure 15. The pressurizing means structure 15 is pushed through the urethra 12 together with the holding means 14 which may be a thread, a tube, a wire or a rod. The holding means 14 can be used to move the pressurizing means structure 15 to the correct position within the bladder neck 11 and fix it if necessary. At the end of the treatment, the pressurizing means structure 15 can be retrieved or pulled out from the bladder neck 11 via the holding means 14.

[0021] The pressurizing means structure 15 comprises a planar pressurizing means 16. This planar pressurizing means 16 is planar and applies pressure on the surface 17 against the tissue to be treated. The surface 17 of the planar pressurizing means 16 can be considered concave or convex. The purpose of using the pressurizing means structure 15 is to apply a two-dimensional pressure to the tissue without denaturing the tissue, for example by using a wire. Depending on the condition or application and structure of the tissue to be treated, it may be advantageous for the surface 17 to be concave or convex in order to achieve the best possible surface contact.

[0022] Preferably, the length of the planar pressurizing means 16 is 0.5 mm to 20 mm and it has a width of 1 mm to 5 mm. However, the planar pressurizing means 16 can be fan-shaped and its width can be considered to increase continuously from the holding means 14.

[0023] The retaining means 14 and / or the planar pressing means 16 are assumed to be made of metal, plastic, or biodegradable material, or a material having shape memory such as nitinol. In particular, the biodegradable implant 10 has the advantage that it dissolves over time and does not need to be removed from the body. The implant 10 made of shape memory material, particularly the planar pressing means 16, is also proven to be advantageous because the planar pressing means 16 can be brought to a predetermined position in a folded state and deployed there into an operating form. This folded insertion is particularly gentle on the human body.

[0024] In the example of the embodiment shown in FIG. 2, the implant 10 or the pressing means structure 15 is used to treat the narrowed bladder neck 11. There, the planar pressing means 16 is arranged at the stenosis so that the flat planar pressing means 16 acts on the surrounding tissue. Depending on the nature of the stenosis, the curvature of the planar pressing means 16 can be adjusted or selected as appropriate by the person undergoing treatment.

[0025] FIG. 3 shows an example of a further embodiment of the implant 10. In the example of this embodiment, the planar pressing means 16 has a wedge-shaped cross section. This wedge shape is formed by a base having a closed surface 18 and an open wire structure 19 in which the legs of the wedge are formed. The example of this embodiment of the implant 10 also has the retaining means 14 as described above. The convex surface 18 applies a uniform pressure to the surrounding tissue, while on the other hand, the wire structure 19 applies a local pressure to the tissue, as a result of which the tissue degenerates without sufficient blood supply. This particular embodiment of the implant 10 can treat both the elevated bladder neck 11 and the narrowed bladder neck 11.

[0026] Figure 4 schematically shows an example of a further embodiment of the implant 10. This example also has a convex surface 18 to which two parallel or at least substantially parallel side surfaces 20, 21 are connected, so that the cross-section of the surface 18 and the side surfaces 20, 21 forms an arc. The side surfaces 20, 21 are also formed by a wire structure 22 that has a similar effect on the surrounding tissue as described above for the example of the embodiment in Figure 3. This example of the implant 10 in Figure 4 can also apply flat and uniform pressure to the tissue through the surface 18.

[0027] The pressurized media structure 15 may have a fixing clamp 23 to secure the implant 10 in a predetermined position within the bladder neck 11. Figure 5 shows an example of a fixing clamp 23 using an embodiment of the implant 10 according to Figure 4. This fixing clamp 23 is designed in a tab shape, has at least low spring force, and functions as a fixation part or fixing means after insertion into the bladder neck 11. The fixing clamp 23 protrudes into the bladder neck 11 and also pressurizes its surface 18 against the opposing tissue of the bladder neck 11. After the completion of treatment, the fixing clamp 23 can be removed or withdrawn from the bladder neck 11. Similarly, other embodiments of the implant 10 shown herein may also have a fixation part as shown in Figure 5. [Explanation of Symbols]

[0028] 10 Implants 11 Bladder neck 12 Urethra 13 Bladder 14 Retention means 15 Pressurization means structure 16 Pressurizing means 17 Surface 18 areas 19 Wire Structures 20 Side view 21 Side view 22 Wire Structures 23 Fixing clamp

Claims

1. A removable implant having a pressurizing means structure attached to a retaining means for expanding the bladder neck by applying local pressure to the tissue of the bladder neck, An implant in which the pressurizing means structure has at least one planar pressurizing means.

2. The implant according to claim 1, wherein the surface of the planar pressing means is convex or concave.

3. The implant according to claim 1, wherein the planar pressing means has a closed or at least partially open mesh surface.

4. The implant according to claim 1, wherein the planar pressurizing means is designed in a blade shape and functions to support the posterior and / or middle lobe of the bladder neck, which is the marginal region of the bladder neck.

5. The implant according to claim 1, wherein the length of the planar pressing means is 0.5 mm to 30 mm.

6. The implant according to claim 1, wherein the width of the planar pressing means is 1 mm to 10 mm, or the width of the planar pressing means increases continuously from the first end to the second end.

7. The implant according to claim 1, wherein the radius of curvature of the curved surface of the planar pressing means is 1 mm to 20 mm.

8. The implant according to claim 1, wherein the cross-section of the planar pressing means is wedge-shaped, and the base of the wedge shape is convex.

9. The implant according to claim 8, wherein the base is a closed region and the wedge shape is formed by a wire structure.

10. The implant according to claim 1, wherein the cross-section of the planar pressing means is arc-shaped, the vertex region of the arc shape is a closed region, and the arc shape is formed by a wire structure.

11. The implant according to claim 1, wherein the retaining means is designed as a tube, wire, or thread.

12. The implant according to claim 1, wherein a leaf-shaped fixing clamp is positioned on the holding means or the planar pressing means.

13. The implant according to claim 1, wherein the planar pressing means is foldable and unfolds from a folded state to an operational state.

14. The implant according to claim 1, wherein at least one of the retaining means and / or the planar pressing means is made of nitinol, which is a metal, plastic, biodegradable material, or shape memory material.

15. The implant according to claim 1, wherein a coating for drug absorption and release into the environment is formed on the surface of the planar pressurizing means.

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