Implant

Abstract

The invention relates to an implant by means of which the bladder neck can be treated in a simple and reliable manner. This is achieved by an implant, in particular a removable implant, having a pressure device structure for expanding the bladder neck of a person. The pressure device structure applies local pressure to the tissue of the bladder neck. The pressure device structure may be connected to a holding device for operation. The retaining device may be a wire, a yarn or a rod, and may be used to introduce the implant or the pressure device structure through the urethra into the bladder neck and to remove the pressure device structure again from the patient's body if necessary after the end of the treatment.

Description

TECHNICAL FIELD

[0001] The present invention relates to an implant. BACKGROUND

[0002] For the treatment of the urinary tract, in particular of benigne Prostatahyperplasie, BPH, various methods or techniques are known. In the treatment of the symptoms of BPH in a minimally invasive, in particular gentle, manner, a removable implant is temporarily placed in the urethra or in the prostatic part of the urethra of the patient. This implant is a wire structure made of a shape memory alloy, for example Nitinol. The wire structure is pushed in the folded state through a catheter into the correct position, where it unfolds into its predetermined basic structure. This structure, which can be formed by three or four wires, is a basket-like structure. This basket-like structure expands the urethra. Due to the expansion of the urethral tissue by the wire structure, the urethral tissue is denatured within a few days. This denaturation of the tissue occurs due to the ischemic pressure of the individual wires on the tissue cells, which leads to a reduction or complete interruption of the blood flow. As a result, the cells are starved of oxygen due to the insufficient blood flow and ultimately die. Within a few days, the tissue can be reduced to such an extent that the urine flow is almost restored to normal. At the end of the treatment, the implant can be removed from the urethra by means of a catheter. Further details about such implants are described, for example, in DE 102021 133 394 A1.

[0003] The previously described implant can also be used to treat an at least partially closed or obstructed bladder neck, however this treatment is more of a side effect of the treatment of the symptoms of BPH and therefore its effectiveness is also very limited. Since the elevated bladder neck is caused in particular by the overgrowth of the posterior or median lobe and the prostate, this symptom cannot be treated by the tissue manipulation described above. In fact, the treatment of the bladder neck using the implant described above can also prove to be disadvantageous. In particular, the use of three wires arranged at an angle of 120° to each other and the resulting highly localized pressure on the tissue are not suitable for treating a constricted bladder neck. SUMMARY

[0004] On the basis of this, the present invention is based on the problem of providing an implant with which a bladder neck can be treated in a simple and reliable manner.

[0005] The solution to this problem is described by the features of the invention. According to this, a removable implant, in particular, is specified which has a pressure device structure for expanding the bladder neck of a person. The pressure device structure exerts a localized pressure on the tissue of the bladder neck. The pressure device structure can be connected to a holding device for the operation. The holding device can be a wire, a thread or a rod, which can be used to introduce the implant or the pressure device structure through the urethra into the bladder neck and, if necessary, to remove the pressure device structure from the patient's body again after the end of the treatment.

[0006] A key feature of this invention is that the pressure device structure has at least one planar or flat pressure device. Through this planar pressure device, the implant can apply localized but large-area pressure to the tissue of the bladder neck. Under a given force, the planar pressure device structure results only in a small area pressure, which does not correspond to ischemic pressure, thus preventing deformation or degeneration of the tissue of the relevant lobe. However, the implant can simultaneously act on the posterior and middle lobe of the bladder neck, resisting stenosis of the bladder neck.

[0007] Preferably, one surface of the pressure device is configured to be convex or concave. Depending on the application or orientation of the planar, particularly plate-shaped, pressure device, it may be advantageous if the surface in contact with the tissue is configured to be concave or convex. Due to the particular curvature of said surface, tissue can conform particularly well to the structure of the pressure device, thereby establishing a particularly advantageous pressure. The use of the implant to be protected is particularly efficient due to the uniform pressure distribution. However, it is also conceivable that the surface has a much more complex shape, such as a hyperbolic shape.

[0008] The planar pressure device may also have a closed or at least partially open surface, preferably a mesh surface. It is also conceivable that the surface is designed as a mesh composed of parallel or intersecting wires. These variations allow for the application of different influences or pressures to surrounding tissues. Preferably, the pressure device is envisioned as shaped like a shovel and used to support the marginal region of the bladder neck, particularly the posterior and / or middle lobe of the bladder neck.

[0009] In a preferred embodiment of the invention, the length of the pressure device may be specified to be 0.5 mm to 30 mm. Furthermore, it is conceivable that the width of the pressure device is 1 mm to 10 mm, or that the width of the pressure device increases continuously from the first end to the second end. It is also conceivable that the radius of curvature of the curved surface of the pressure device is 1 mm to 20 mm. Finally, it is conceivable that surgeons can use several different implants of pressure devices with different geometries to be able to respond appropriately to corresponding situations and apply pressure to the affected tissue as uniformly as possible.

[0010] In particular, it is conceivable that the cross-section of the pressure device is wedge-shaped, with the base of the wedge being constructed to be convex. Preferably, this base represents a closed surface, and the wedge shape is formed by a wire structure. This specific design ensures the implant's positioning within the bladder neck. Simultaneously, the flat base applies a large area of ​​low pressure to the tissue, while the wire structure applies highly localized, higher pressure to the opposing tissue. This combination of different pressure surfaces allows for different tissue treatments with a single implant.

[0011] Another possible implementation of the implant could be that the cross-section of the pressure device is arc-shaped, with the apex region of the arc forming a closed surface. The arc shape can be formed by a wire structure. This implementation also allows for more uniform and lower pressure to be applied to the tissue through the flat apex region, and a highly localized high pressure through the wire structure. Furthermore, a multitude of other implementations are conceivable, which, due to their specific shapes, can apply almost tailor-made pressure to the tissue to be treated.

[0012] A particularly advantageous embodiment of the invention may specify that an anchoring clip, preferably plate-shaped, may be arranged on the retaining or pressure device. This anchoring clip can extend into the bladder and, due to its curved structure, acts as a clamp or return spring, protecting the implant from slipping into the bladder neck. It is conceivable that the clip is inserted into the urethra through a tube and withdrawn from the tube only when in the correct position, thus allowing for precise positioning. Similarly, the clip can be pulled back into the tube after treatment. It is also conceivable that the clip can be removed from the bladder neck by rotation or other movement. This anchoring clip allows for particularly precise and reliable treatment using the described implant.

[0013] According to the invention, the pressure device can be foldable and unfolded from a folded state to an active state. The implant can be inserted and positioned correctly, for example, through a retaining device configured as a tube, wire, or yarn, passing through the urethra and, in particular, through a tube. Once in the correct position, the pressure device can be unfolded. Once treatment is complete, the pressure device structure can be removed from the bladder neck in reverse order. In particularly specific applications, it is also conceivable that the implant remain in the body.

[0014] Furthermore, according to the invention, the at least one holding device and / or pressure device may be made of metal, plastic, or a biodegradable material or a material with shape memory (especially nitinol). In particular, embodiments made of biodegradable materials are especially advantageous because the material does not need to be recycled but decomposes after a period of time.

[0015] Finally, a particularly preferred embodiment of the invention involves a coating on the surface of the pressure device for absorbing and preferably quantitatively releasing a drug into the environment. This coating can be designed as a reservoir that can be filled with the appropriate drug prior to treatment. For example, the reservoir could be fire, foam, or other materials through which the drug can be dosed and dispensed into the environment. In this way, the drug can be administered and used in a highly targeted manner. Using this coating means the implant has a dual effect: first, pressure is applied to the surrounding tissue; second, the drug is precisely administered. Attached Figure Description

[0016] A preferred embodiment of the invention will now be explained in more detail with reference to the accompanying drawings. In the drawings:

[0017] Figure 1 A schematic diagram showing one possible embodiment of the implant is provided.

[0018] Figure 2 A schematic diagram showing another embodiment of the implant is provided.

[0019] Figure 3 A perspective view showing another embodiment of the implant,

[0020] Figure 4 A perspective view showing another embodiment of the implant, and

[0021] Figure 5 A perspective view showing another embodiment of the implant.

[0022] List of reference numerals in the attached diagram:

[0023] 10 Implants

[0024] 11 Bladder neck

[0025] 12. Urethral

[0026] 13 Bladder

[0027] 14 Holding device

[0028] 15. Pressure Device Structure

[0029] 16 Pressure device

[0030] 17 Surface

[0031] 18 sides

[0032] 19. Metal wire structure

[0033] 20 Side

[0034] 21 Side

[0035] 22. Metal wire structure

[0036] 23 Anchoring clamps Detailed Implementation

[0037] Figure 1 A possible embodiment of the implant 10 is shown schematically. Figure 1The implant 10 shown is for an elevated bladder neck 11. For this symptom, the implant 10 is pushed into the bladder neck 11 through the patient's urethra 12, such that a portion of the implant 10 extends into the bladder 13. The implant 10 mainly consists of a retaining device 14 and a pressure device structure 15. The pressure device structure 15, together with the retaining device 14 (which may be yarn, tube, wire, or rod), is pushed through the urethra 12. The retaining device 14 can be used to manipulate the pressure device structure 15 to the correct position in the bladder neck 11 and, if necessary, to secure it. At the end of treatment, the pressure device structure 15 can be removed or pulled out of the bladder neck 11 through the retaining device 14.

[0038] The pressure device structure 15 includes a pressure device 16. This pressure device 16 is planar and presses against the tissue to be treated with a surface 17. It is conceivable that the surface 17 of the pressure device is concave or convex. The purpose of using the pressure device structure 15 is to apply two-dimensional pressure to the tissue without causing tissue denaturation as would occur, for example, when using a metal wire. Depending on the specific circumstances or application and the design of the tissue to be treated, it may be advantageous for the surface 17 to be concave or convex to achieve optimal surface contact.

[0039] Preferably, the pressure device 16 has a length of 0.5 mm to 20 mm and a width of 1 mm to 5 mm. However, it is also conceivable that the pressure device 16 is configured in a fan shape, and its width increases continuously from the holding device 14.

[0040] The retention device 14 and / or pressure device 16 are specified to be made of metal, plastic, or biodegradable materials or materials with shape memory (e.g., nitinol). In particular, the advantage of a biodegradable implant 10 is that it dissolves over time without needing to be removed from the body. Implants 10 made of shape memory materials, especially the pressure device 16, can also prove advantageous because the pressure device 16 can be brought into position in a folded state and unfolded there into its active form. This folded insertion is particularly gentle on the human body.

[0041] exist Figure 2 In the illustrated embodiment, the implant 10 or pressure device structure 15 is used to treat a narrowed bladder neck 11. There, a pressure device 16 is positioned at the narrowing, such that the planar pressure device 16 acts on the surrounding tissue. Depending on the condition of the narrowing, the curvature of the pressure device 16 can be adjusted or selected accordingly by the treating physician.

[0042] Figure 3Another embodiment for implant 10 is shown. In this embodiment, the pressure device 16 has a wedge-shaped cross-section. This wedge shape is formed by a base having a closed face 18 and an open wire structure 19 through which the legs of the wedge are formed. This embodiment of implant 10 also has a retaining device 14 as previously described. The convex face 18 applies uniform pressure to the surrounding tissue, while the wire structure 19 applies localized pressure to the tissue, resulting in insufficient blood supply and thus denaturation of the tissue. This particular embodiment of implant 10 can treat high bladder neck 11 or stenotic bladder neck 11.

[0043] pass Figure 4 Another embodiment for implant 10 is illustrated. This embodiment also has a convex surface 18, but connected to the surface 18 are two parallel or at least nearly parallel sides 20, 21, such that the cross-sections of the surface 18 and the sides 20, 21 form an arc shape. The sides 20, 21 are also formed of a wire structure 22, which applies pressure to the surrounding tissue as previously described. Figure 3 Similar effects to those described in the embodiments. According to the embodiments for implant 10 Figure 4 This embodiment can also apply planar and uniform pressure to the tissue through surface 18.

[0044] To secure the implant 10 in place within the bladder neck 11, the pressure device structure 15 may be configured to have an anchoring clip 23. Figure 5 In the middle, using according to Figure 4 An embodiment of implant 10 illustrates an example of an anchor clip 23. This anchor clip 23 is designed as a tab and has at least one small elasticity, allowing it to function as an anchor or anchoring device after insertion into the bladder neck 11. The anchor clip 23 extends into the bladder neck 11 and similarly presses its face 18 against the opposing tissue of the bladder neck 11. After treatment, the anchor clip 23 can be removed or pulled out of the bladder neck 11. Similarly, other embodiments of implant 10 shown herein are conceivable to also have such features. Figure 5 The anchor shown.

Claims

1. An implant (10), in particular a removable implant, having a pressure device structure (15) fixed on a holding device (14) for dilating a human urinary bladder neck (11) by exerting local pressure on the tissue of the urinary bladder neck (11), characterized in that The pressure device structure (15) has at least one planar pressure device (16).

2. Implant (10) according to claim 1, characterized in that The surface (17) of the pressure device (16) is configured convexly or concavely.

3. Implant (10) according to claim 1 or 2, characterized in that The planar pressure device (16) has a closed or at least partially open, preferably mesh-like surface (17).

4. Implant (10) according to any one of the preceding claims, characterized in that The pressure device (16) is configured leaf-like and serves to support the edge region of the bladder neck (11), in particular the posterior and / or median lobe of the bladder neck (11).

5. Implant (10) according to any one of the preceding claims, characterized in that The pressure device (16) has a length of 0.5 mm to 30 mm.

6. Implant (10) according to any one of the preceding claims, characterized in that The pressure device (16) has a width of 1 mm to 10 mm, or the width of the pressure device (16) increases continuously from a first end to a second end.

7. Implant (10) according to any one of the preceding claims, characterized in that The pressure device (16) has a curved surface with a radius of curvature of 1 mm to 20 mm.

8. Implant (10) according to any one of the preceding claims, characterized in that The pressure device (16) has a cross section that is wedge-shaped, wherein the base of the wedge is configured convexly.

9. Implant (10) according to claim 8, characterized in 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 in that The pressure device (16) has a cross section that is arcuate, wherein the apex 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 one of the preceding claims, characterized in that The holding device (14) is designed as a tube, wire or thread.

12. Implant (10) according to any one of the preceding claims, characterized in that An anchoring clip (23), preferably in the shape of a leaf, is arranged on the holding device (14) or the pressure device (16).

13. Implant (10) according to any one of the preceding claims, characterized in that The pressure device (16) is foldable and unfolds from a folded state into an active state.

14. Implant (10) according to any one of the preceding claims, characterized in that The at least one holding device (14) and / or the pressure device (16) is made of metal, plastic or biodegradable material or a material with shape memory, in particular Nitinol.

15. Implant (10) according to any one of the preceding claims, characterized in that The surface (17) of the pressure device (16) is formed with a coating for the absorption and preferably the metered release of a medicament into the environment.

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