IMPLANT OR CATHETERS

Description

[0001] The invention relates to an implant or a catheter for insertion into the urethra of a patient, with a through-opening for the passage of urine, comprising the features of the preamble of claim 1.

[0002] Implants of this type are used, for example, in the treatment of urinary incontinence. They feature a controllable valve, allowing the user to regulate the release of urine. Examples of such implants are described in publications WO 2018 / 130358 A1 and WO 2019 / 243070 A1. A catheter of this type is known from US 5,656,528 A. Publications DE 10 2010 008070 A1, CN 108 339 163 A, and US 2008 / 208083 A1 also describe medical catheters.

[0003] Implants for the treatment of urinary incontinence, or other intraurethral implants such as stents and urinary catheters, have an opening to allow urine flow. However, the length of time such an implant or catheter can remain in a patient's urethra is limited by factors including the extent of biofilm and crystalline deposits forming in the opening. Replacement of the implant or catheter is usually necessary after a certain period to prevent infection of the patient by the biofilm. Therefore, it is desirable to extend the service life of such an implant or catheter by reducing or preventing biofilm or deposit formation.

[0004] The invention is therefore based on the objective of providing an implant or catheter for insertion into the urethra of a patient, the duration of which is extended.

[0005] To solve this problem, an implant or catheter with the features of claim 1 is provided.

[0006] In the tubular implant or catheter, according to the invention, a tube made of an elastomer, having a lumen for the passage of urine, is arranged in the opening. The tube's wall thickness is so thin that it vibrates when urine flows through it. This oscillation is caused exclusively by the urine flowing through the tube. The tube is fixed in the implant or catheter under torsional preload, and any biofilm on the tube's surface can be loosened by the generated vibrations and flushed away with urine. The geometric parameters of the tube, such as wall thickness, length, and the material selected, are coordinated to ensure that the desired vibrations occur when urine flows through it, reducing or preventing biofilm formation.

[0007] In this application, the term "lumen" is used to refer to a cavity, i.e., an interior space bounded by walls.

[0008] The invention is based on the finding that biofilm buildup in the lumen of a tube located in the through-hole of an implant or catheter can be prevented or significantly reduced by using an implant with a comparatively thin wall. This thin wall causes the implant to vibrate as urine flows through it, thereby flushing away the biofilm and any deposits that may be present. In many cases, these mechanical vibrations can also prevent biofilm formation altogether. The oscillation of the implant is caused solely by the flow of urine; that is, no electrical, mechanical, or electromechanical actuator is required. Accordingly, the implant is cleaned automatically by the urine flowing through the tube, without the need for an external energy source. The implant according to the invention...The catheter is therefore characterized by a particularly simple design and can be manufactured cost-effectively.

[0009] The effect of the implant or catheter according to the invention is based on the fact that a biofilm located in the lumen of the tube can be loosened and flushed away by the vibrations. For the function of the invention, it is therefore essential that the wall thickness and other geometric parameters of the tube are selected such that vibrations are generated when urine flows through the lumen of the tube. For this purpose, the tube has a particularly thin wall and is made of a flexible, elastic material.

[0010] Preferably, at least in sections, a radial clearance is provided between the outer surface of the tube and the inner surface of the through-hole of the implant or catheter, allowing the tube to oscillate. Since the tube is spaced apart from the through-hole of the implant or catheter, it can oscillate in the radial direction.

[0011] It has proven particularly advantageous for the wall thickness of the tube to be 200 to 600 µm, preferably 300 to 500 µm, and most preferably about 400 µm. With a tube of such a wall thickness, the flowing urine automatically generates the desired vibrations, causing the biofilm to be detached and removed from the surface of the tube.

[0012] With regard to the geometric parameters, it is preferred that the inner diameter of the hose be 2.5 to 3.5 mm. Preferably, the inner diameter can be approximately 3.0 mm.

[0013] A further development of the invention provides that the section set into vibration is a central section of the hose, the wall thickness of which is reduced compared to the end sections of the hose. Accordingly, the end sections of the hose can have a greater wall thickness. The central section, on the other hand, has a reduced wall thickness, so that it is set into vibration when urine flows through it. Alternatively, the hose can also have a constant wall thickness. Such a hose can be manufactured particularly easily.

[0014] According to the invention, the tube is attached to the implant or catheter under torsional preload by securing it with at least a slight twist about its longitudinal axis. This torsional attachment promotes the desired generation of vibrations in the tube when fluid flows through it.

[0015] An alternative embodiment of the invention provides that the tube is implanted within the implant or catheter between an upper and a lower attachment position, with the length of the implant being greater than the distance between the two attachment positions. It has been found that such an implant, which is slightly longer than necessary, also tends to vibrate when urine flows through it, thus favorably influencing the cleansing of the lumen. The tube can have a constant wall thickness or a central section with a reduced wall thickness.

[0016] Another alternative variant of the tubing of the implant or catheter according to the invention is shaped such that sections with an increased diameter alternate with sections with a decreased diameter. This design has a corrugated shape in the longitudinal direction. At each position in the longitudinal direction, the tubing has a circular cross-section, with the diameter continuously decreasing or increasing. Tests have shown that this tubing shape also stimulates the formation of turbulent flows, which loosen and flush away any biofilms or deposits that may be present from the surface of the lumen.

[0017] The tube of the implant or catheter according to the invention can be made of an elastomer; a silicone material is particularly preferred. The surface can be provided with an antibacterial coating.

[0018] The invention is explained below with reference to the drawings. The drawings are schematic representations and show: Fig. 1 a first embodiment of an implant according to the invention; Fig. 2 the one in Fig. 1 The implant shown in the flow state; Fig. 3 a second embodiment of an implant according to the invention; Fig. 4 the one in Fig. 3 The implant shown in the flow state; Fig. 5 a third embodiment of an implant according to the invention; and Fig. 6 the one shown in Fig. 5 Implant shown in the flow-through state.

[0019] Fig. 1 Figure 1 shows an implant 1 which, according to a first embodiment, is attached inside the urethra 2 of a patient. The implant 1 has a tubular base 3 with a through-opening 4 in which a tube 5 made of an elastomer is arranged, the tube having a lumen 6 for conducting urine. The tube 5 is attached at both ends 7, 8 to the base 3 of the implant 1 such that urine can flow exclusively through the lumen 6. A cylindrical space 9 is located between the outer surface of the tube 5, which has the lumen 6, and the inner surface of the base 3 of the implant. The geometric parameters of the tube 5, i.e., its wall thickness and length, are selected such that the tube 5 vibrates when urine flows through it. These vibrations prevent the formation of deposits such as a biofilm inside the tube 5.If a biofilm has already formed, it can be loosened by the movement of hose 5 and flushed away by the flowing liquid.

[0020] The tube 5, which has a lumen 6, is twisted at least slightly about its longitudinal axis, i.e., torsioned, and is arranged in the through-opening 4 of the base body 3 of the implant 1. This creates a slight torsional preload, which facilitates the generation of vibrations of the tube 5.

[0021] Fig. 2 This shows in Fig. 1 The implant 1 shown is in its flow state. When urine flows through the lumen 6 of the tube 5 of the implant 1, which is contained within the base body 3, vibrations or wave-like movements of the tube 5 are generated, causing any point on the surface of the tube 5 to move radially outwards and inwards. Experiments have shown that these wave-like movements are accompanied by turbulent flow of the fluid. The mechanical vibrations of the tube 5, in turn, cause deposits and biofilms on the surface of the lumen 3 to be loosened and flushed away. In this way, the inside of the tube 5 of the implant 1 is cleaned. Since the growth of biofilms is greatly reduced, the implant 1 with the tube 5 inside it can be used for a significantly longer period before it needs to be removed due to biofilm formation.

[0022] In the illustrated embodiment, the wall thickness of the tubular tube 5 is 400 µm, and the inner diameter of the lumen 6 of the tube 5 is 3.0 mm.

[0023] Fig. 3 Figure 1 is a second embodiment and shows an implant 10 inserted in the urethra of a patient, with a tube 11 attached at an upper position 12 and a lower position 13. The length of the tube 11 is greater than the distance between the upper position 12 and the lower position 13, so that the tube 11 is limp when at rest, when no urine is flowing through it.

[0024] Fig. 4 Figure 1 shows the implant 10 in its flow state. The tube 11 of the implant 10 is set into vibration by the flowing urine, causing biofilms or deposits to detach. This requires that the tube 11 is longer than the distance between the upper position 12 and the lower position 13. Accordingly, the tube 11 of the implant 10 also undergoes self-cleaning.

[0025] Fig. 5 Figure 1 is another embodiment and shows an implant 14 in whose through-hole a tube 15 is arranged, the tube being shaped such that sections 17 with an increased diameter alternate with sections 16 with a decreased diameter. Thus, in its resting state, i.e., when no urine flows through it, the implant 14 has a wavy outer contour. In a plane cut perpendicular to the longitudinal direction of the implant 14, the outer contour of the implant 14 is bounded by circles whose diameters change radially when urine flows through the lumen of the tube 15 of the implant 14.

[0026] Fig. 6 This shows that the implant 14 is excited to vibrate when fluid flows through it. The flow inside the tube 15 is turbulent, which generates forces acting on the tube 15 that cause the detachment of biofilms and the desired cleaning effect. Reference sign

[0027] 1 Implant 2 Urethra 3 Base 4 Passage 5 Tube 6 Lumen 7 End 8 End 9 Free space 10 Implant 11 Tube 12 Upper position 13 Lower position 14 Implant 15 Tube 16 Section 17 Section

Claims

1. Implant (1, 10, 14) or catheter for insertion into the urethra (2) of a patient, with a passage opening (4) for passing urine, wherein a tube (5, 11, 15) made of an elastomer and having a lumen (6) for passing urine is arranged in the passage opening (4), the wall thickness of which tube is so thin that the tube (5, 11, 15) is not obstructed when urine flows through it, characterized in that the oscillation of the tube (5, 11, 15) is caused exclusively by the urine flowing through the tube (5, 11, 15), wherein the tube (5, 11, 15) is fixed in the implant (1, 10, 14) or the catheter under torsional preload, whereby a biofilm located on the surface of the tube (5, 11, 15) can be loosened by the vibrations generated and washed away by urine.

2. Implant or catheter according to claim 1, wherein a cylindrical free space (9) enabling the tube (5, 11, 15) to vibrate is provided at least in sections between the outside of the tube (5, 11, 15) and the inside of the passage opening (4).

3. Implant or catheter according to claim 1 or 2, wherein the wall thickness of the tube (5, 11, 15) is 200 to 600 µm, preferably 300 to 500 µm, and particularly preferably about 400 µm.

4. Implant or catheter according to one of the preceding claims, wherein the inner diameter of the lumen (6) of the tube (5, 11, 15) is 2.5 to 3.5 mm and preferably about 3.0 mm.

5. Implant or catheter according to one of the preceding claims, wherein the section of the tube (5, 11, 15) that can be set into vibration is a middle section whose wall thickness is reduced in comparison to end sections of the tube (5, 11, 15).

6. Implant or catheter according to any of the preceding claims, wherein the tube (5, 11, 15) is attached at an upper position (12) and a lower position (13) in the implant (1, 10, 14) or the catheter, and the length of the tube (5, 11, 15) is greater than the distance between the upper position (12) and the lower position (13).

7. Implant or catheter according to any of the preceding claims, wherein the tube (5, 11, 15) is shaped such that sections (17) of increased diameter alternate with sections (16) of decreased diameter.

8. Implant or catheter according to one of the preceding claims, wherein the tube (5, 11, 15) is made of an elastomer, preferably a silicone material.