Implant

Abstract

The invention provides an implant for the simple and reliable treatment of a bladder neck. This is achieved by a removable implant in which a pressure-mediating structure is used to dilate the bladder neck. This structure exerts local pressure on the bladder neck tissue. The pressure-mediating structure can be connected to a retention element for handling. This retention element, which can be a wire, thread, or rod, serves to insert the implant or pressure-mediating structure through the urethra into the bladder neck and, if necessary, to remove the structure from the patient's body after the treatment is completed.

Description

[0001] The invention relates to an implant according to the preamble of claim 1.

[0002] Various methods and techniques are known for treating the urinary tract, particularly benign prostatic hyperplasia (BPH). In a minimally invasive, especially gentle treatment of BPH symptoms, a removable implant is temporarily placed in the urethra, specifically in the prostatic portion of the urethra. This implant is a wire structure made of a shape-memory alloy, such as nitinol. The wire structure is inserted into the correct position in a folded state via a catheter, where it unfolds into its predefined basic structure. This structure, which can be formed from three or four wires, is a basket-like structure. This basket-like structure dilates the urethra. Over the course of a few days, the expansion of the wire structure against the urethral tissue denatures the tissue.This tissue denaturation occurs due to ischemic pressure exerted by the individual wires on the tissue cells, leading to reduced or completely absent blood flow. Consequently, the lack of blood flow results in oxygen deprivation within the cells and ultimately cell death. Within a few days, the tissue can be reduced to such an extent that urine flow almost returns to normal. After completion of the treatment, the implant can be removed from the urethra using a catheter. Further details on such implants are described, for example, in DE 10 2021 133 394 A1.

[0003] The implant described above can also be used to treat a partially closed or blocked bladder neck; however, this treatment is more of a side effect of treating BPH symptoms, and therefore its effectiveness is very limited. Since an elevated bladder neck primarily results from overgrowth of the posterior or middle lobe and the prostate, this symptom cannot be treated by the tissue manipulation described above. In fact, using the implant described above to treat the bladder neck can even prove detrimental. Specifically, the use of the three wires, arranged at 120° intervals, and the resulting highly localized pressure on the tissue are unsuitable for treating a narrowed bladder neck.

[0004] Based on this, the invention aims to create an implant that allows for the treatment of a bladder neck in a simple and reliable manner.

[0005] A solution to this problem is described by the features of claim 1. Accordingly, it is provided that a particularly removable implant comprises a pressure-mediating structure for dilating the bladder neck of a person. This pressure-mediating structure exerts local pressure on the tissue of the bladder neck. The pressure-mediating structure can be connected to a retention element for handling. This retention element, which can be a wire, thread, or rod, can serve to insert the implant or the pressure-mediating structure through the urethra into the bladder neck and, if necessary, to retrieve the pressure-mediating structure from the patient's body after completion of the treatment.

[0006] A key feature of the invention is that the pressure medium structure comprises at least one planar pressure medium. This planar pressure medium allows the implant to exert local, yet widespread, pressure on the bladder neck tissue. For a given force, this planar pressure medium structure results in only a low surface pressure, which is significantly lower than the ischemic pressure, thus preventing deformation or denaturation of the tissue of the relevant lobe. Simultaneously, the implant can act on the posterior part of the bladder neck as well as on the middle lobe, thereby counteracting bladder neck narrowing.

[0007] Preferably, the surface of the pressure medium is convex or concave. Depending on the application and orientation of the planar, particularly plate-like, pressure medium, it can be advantageous for the surface in contact with the tissue to be concave or convex. The specific curvature of the surface allows the tissue to conform particularly well to the pressure medium structure, thereby generating a particularly beneficial pressure. The uniform pressure distribution makes the use of the implant especially efficient. However, it is also conceivable that the surface has a significantly more complex shape, such as a hyperbolic shape.

[0008] It can also be provided that the planar pressure medium has a closed or at least partially open, preferably net-like, surface. Furthermore, it is conceivable that the surface is designed as a grid of parallel or intersecting wires. These variations allow different effects, or pressures, to be exerted on the surrounding fabric.

[0009] Preferably, the pressure medium is designed in a scoop-like shape and serves to support edge areas of the bladder neck, in particular a posterior part of the bladder neck and / or a middle lobe.

[0010] A preferred embodiment of the invention provides that the length of the pressure medium is from 0.5 mm to 30 mm. Furthermore, it is conceivable that the width of the pressure medium is from 1 mm to 10 mm, or that the width of the pressure medium increases continuously from a first to a second end. It is also conceivable that the radius of curvature of the curved surface of the pressure medium is from 1 mm to 20 mm. Finally, it is conceivable that the surgeon has several different implants with varying geometries of the pressure medium available in order to respond appropriately to the respective situation and to apply the most homogeneous pressure possible to the affected tissue.

[0011] In particular, it is conceivable that the cross-section of the pressure medium is wedge-shaped, with one base of the wedge being convex. Preferably, the base is a closed surface, and the wedge shape is formed by a wire structure. This specific design can ensure the positioning of the implant within the bladder neck. Simultaneously, the flat base allows for a relatively broad but low pressure to be exerted on the tissue, while the wire structure exerts a highly localized, higher pressure on the opposing tissue. This combination of different pressure surfaces enables various tissue treatments to be achieved with a single implant.

[0012] Another possible embodiment of the implant can provide for an arc-shaped cross-section of the pressure medium, with the apex of the arc forming a closed surface. The shape of the arc, however, can be formed by a wire structure. This embodiment also allows for a more homogeneous and lower pressure to be exerted on the tissue through the flat apex area, and a highly localized, high pressure through the wire structure. Furthermore, numerous other embodiments are conceivable, which, through their specific shapes, can exert a virtually tailor-made pressure on the tissue to be treated.

[0013] A particularly advantageous embodiment of the invention may provide that a preferably leaf-shaped anchoring clamp is arranged on the holding or pressure means. This anchoring clamp can project into the bladder and, due to its curved structure, acts as a kind of clamp or return spring, which protects the implant from slipping into the bladder neck. It is conceivable that this clamp is inserted into the urethra through a tube and only pushed out of this tube at the correct position, thus allowing for precise positioning. Likewise, this clamp can be retracted into the tube after completion of the treatment. It is also conceivable that the clamp can be removed from the bladder neck by twisting or by some other movement. This anchoring clamp allows the treatment using the described implant to be carried out with particular precision and reliability.

[0014] According to the invention, the pressure medium can be foldable and unfold from its folded state into an active state. The implant can be inserted, for example, through the urethra, and in particular through a tube, using a retention device which is designed as a tube, wire, or thread, and positioned correctly. Once the pressure medium is in the correct position, it can unfold. After the treatment is completed, the pressure medium structure can be removed from the bladder neck in reverse order. In particularly specialized applications, it is also conceivable that the implant remains in the body.

[0015] Furthermore, according to the invention, the at least one holding element and / or the pressure element can be made of a metal, a plastic, a biodegradable material, or a shape-memory material, in particular nitinol. The embodiment made of a biodegradable material is particularly advantageous, as this material does not need to be recovered but decomposes after a certain period of time.

[0016] Finally, a particularly preferred embodiment of the invention is provided in which the surface of the pressure medium is formed with a coating for the absorption and, preferably, metered release of a drug into the surrounding environment. This coating can be designed as a reservoir that can be filled with the appropriate drug before treatment. This reservoir can be, for example, a flaky material, a foam, or another material through which the drug can be metered and released into the environment. In this way, the drug can be dosed and administered very precisely. The use of such a coating results in the implant having a dual effect. Firstly, pressure is exerted on the surrounding tissue, and secondly, the drug is delivered with pinpoint accuracy.

[0017] A preferred embodiment of the present invention is explained in more detail below with reference to the drawing. This shows: Fig. 1 a schematic representation of a possible embodiment of an implant, Fig. 2 a schematic representation of another embodiment of an implant, Fig. 3 a perspective view of another embodiment of an implant, Fig. 4 a perspective view of another embodiment of an implant, and Fig. 5 a perspective view of another embodiment of an implant.

[0018] In the Fig. Figure 1 is a highly schematic representation of a possible embodiment of an implant 10. The [missing information] Fig. The implant 10 shown is used to treat an elevated bladder neck 11. In this condition, the implant 10 is inserted through the patient's urethra 12 into the bladder neck 11, so that part of the implant 10 protrudes into the bladder 13. The implant 10 essentially consists of a retention element 14 and a pressure element 15. The pressure element 15, along with the retention element 14, which can be a thread, tube, wire, or rod, is inserted through the urethra 12. The retention element 14 allows the pressure element 15 to be maneuvered into the correct position in the bladder neck 11 and, if necessary, secured. After completion of the treatment, the pressure element 15 can be retrieved or withdrawn from the bladder neck 11 using the retention element 14.

[0019] The pressure medium structure 15 comprises a pressure medium 16. This pressure medium 16 is planar and exerts pressure on the fabric to be treated with a surface 17. The surface 17 of the pressure medium can be concave or convex. The purpose of using the pressure medium structure 15 is to exert planar pressure on the fabric without denaturing it, as would occur, for example, with the use of a wire. Depending on the circumstances, application, and the design of the fabric 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.

[0020] Preferably, the length of the pressure medium 16 is 0.5 mm to 20 mm and it has a width of 1 mm to 5 mm. However, it is also conceivable that the pressure medium 16 is fan-shaped and that its width increases continuously from the holding element 14.

[0021] It is intended that the retention element 14 and / or the pressure element 16 are made of a metal, a plastic, a biodegradable material, or a shape-memory material such as nitinol. A biodegradable implant 10, in particular, has the advantage of dissolving over time and not needing to be removed from the body. An implant 10, especially a pressure element 16, made of a shape-memory material can also prove advantageous, as the pressure element 16 can be positioned in a folded state and unfolds into its active shape. This folded insertion, in particular, is especially gentle on the body.

[0022] In the Fig. In the embodiment shown in Figure 2, the implant 10 or the pressure medium structure 15 is used for the treatment of a narrowed bladder neck 11. The pressure medium 16 is positioned within the narrowing so that the flat pressure medium 16 acts on the surrounding tissue. Depending on the nature of the narrowing, the curvature of the pressure medium 16 can be adjusted or selected accordingly by the patient.

[0023] In the Fig. Figure 3 shows another embodiment of an implant 10. In this embodiment, the pressure medium 16 has a wedge-shaped cross-section. This wedge shape is formed by a base with a closed surface 18 and an open wire structure 19, which forms the legs of the wedge. This embodiment of the implant 10 also has a retention element 14, as described above. The convex surface 18 exerts a homogeneous pressure on the surrounding tissue, whereas the wire structure 19 exerts a local pressure on the tissue, which leads to reduced blood flow and thus denaturation. This particular embodiment of the implant 10 can be used to treat both a high bladder neck 11 and a narrowed bladder neck 11.

[0024] Another embodiment of an implant 10 is provided by the Fig. Figure 4 is sketched. This embodiment also has a convex surface 18, to which, however, two parallel or at least nearly parallel sides 20, 21 are attached, so that a cross-section of the surface 18 and the sides 20, 21 forms an arc. The sides 20, 21 are also formed by a wire structure 22, which exerts a similar effect on the surrounding tissue as previously described in the embodiment according to Figure 4. Fig. 3 described. Also by this embodiment for an implant 10 according to Fig. 4. A uniform and homogeneous pressure can be exerted on the tissue over the area 18.

[0025] To fix the implant 10 in position in the bladder neck 11, the pressure medium structure 15 may be provided with an anchoring clamp 23. In the Fig. 5 is illustrated by the exemplary embodiment of an implant 10 according to the Fig. Figure 4 shows an example of an anchoring clamp 23. This anchoring clamp 23 is tab-shaped and has at least a slight spring force, so that after insertion into the bladder neck 11 it serves as an anchor or anchoring device. The anchoring clamp 23 projects into the bladder neck 11 and simultaneously presses the surface 18 against the opposite tissue of the bladder neck 11. After completion of the treatment, the anchoring clamp 23 can be removed or withdrawn from the bladder neck 11. It is also conceivable that the other embodiments of an implant 10 shown here also provide an anchor as described in Figure 4. Fig. 5 shown, exhibit. Reference symbol list: 10 implants 11 Bladder neck 12 Urethra 13 bladder 14 Holding devices 15 Pressure medium structure 16 Pressure instruments 17 Surface 18 area 19 wire structure Page 20 Page 21 22 wire structure 23 Anchoring clamp QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] DE 10 2021 133 394 A1

[0002]

Claims

[1] Implant (10), in particular a removable implant, with a pressure medium structure (15) attached to a retention means (14) for widening the bladder neck (11) of a person by applying local pressure to the tissue of the bladder neck (11), characterized by that the printing medium structure (15) has at least one planar printing medium (16). [2] Implant (10) according to claim 1, characterized by , that a surface (17) of the pressure medium (16) is convex or concave. [3] Implant (10) according to claim 1 or 2, characterized by that the planar printing medium (16) has a closed or at least partially open, preferably net-like, surface (17). [4] Implant (10) according to any of the preceding claims, characterized by, that the pressure medium (16) is shaped like a shovel and serves to support marginal areas of the bladder neck (11), in particular a posterior part of the bladder neck (11) and / or a middle lobe. [5] Implant (10) according to any of the preceding claims, characterized by , that the length of the pressure medium (16) is 0.5 mm to 30 mm. [6] Implant (10) according to any of the preceding claims, characterized by , that the width of the printing medium (16) is 1 mm to 10 mm or that the width of the printing medium (16) increases continuously from a first to a second end. [7] Implant (10) according to any of the preceding claims, characterized by , that the radius of curvature of the bent surface of the printing medium (16) is 1 mm to 20 mm. [8] Implant (10) according to any of the preceding claims, characterized by , that a cross-section of the pressure medium (16) is wedge-shaped, with a base of the wedge being convex. [9] Implant (10) according to claim 8, characterized by , that the base is a closed surface (18) and the wedge shape is formed by a wire structure (19). [10] Implant according to any of the preceding claims, characterized by , that a cross-section of the printing medium (16) is arc-shaped, wherein a vertex region of the arc is a closed surface (18) and the shape of the arc is formed by a wire structure (22). [11] Implant (10) according to any of the preceding claims, characterized by , that the retaining element (14) is designed as a tube, wire or thread. [12] Implant (10) according to any of the preceding claims, characterized by that an anchoring clamp (23), preferably leaf-shaped, is arranged on the holding means (14) or the pressure means (16). [13] Implant (10) according to any of the preceding claims, characterized by, that the pressure medium (16) is foldable and unfolds from the folded state into an active state. [14] Implant (10) according to any of the preceding claims, characterized by , that the at least one retaining means (14) and / or the pressure means (16) are made of a metal, a plastic or a biodegradable material or a shape memory material, in particular nitinol. [15] Implant (10) according to any of the preceding claims, characterized by , that the surface (17) of the pressure medium (16) is formed as a coating for the absorption and, preferably metered, release of a drug into an environment.

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