Intraurethral sphincter prosthesis

Abstract

The invention relates to an intraurethral sphincter prosthesis (1) comprising: a tubular housing (2) having an inlet (3) and an outlet (4); a balloon (5) which is made of an elastic material and is received and held in the housing (2); and a high-viscosity fluid (6) contained in the balloon (5), wherein the balloon (5) has an inlet-side sealing-balloon portion (7) and an outlet-side compensation-reservoir portion (8) which is fluidically connected to the inlet-side sealing-balloon portion, a throttle (10) being arranged between these portions, wherein, in a rest state in which no external pressure is exerted on the inlet side, the sealing-balloon portion (7) bears circumferentially against the inner wall of the housing (2) and seals the inlet (3), wherein, under the action of a sustained external pressure on the inlet side, the high-viscosity fluid (6) can be moved from the sealing-balloon portion (7) through the throttle (10) into the compensation-reservoir portion (8), wherein the sealing-balloon portion (7) moves away from the inner wall of the housing (2) and the housing (2) can be traversed by a flow.

Description

[0001] Intraurethral sphincter prosthesis

[0002] The invention relates to an intraurethral sphincter prosthesis.

[0003] An intraurethral sphincter prosthesis is used in patients suffering from urinary incontinence. The sphincter prosthesis is inserted into the patient's urethra and has an opening equipped with a controllable valve. In one position of the valve, the opening is open. In the second position, the opening is closed.

[0004] A growing number of people suffer from some form of urinary incontinence. Urinary incontinence is a significant psychological burden and considerably impairs a patient's quality of life. Stress incontinence refers to the involuntary loss of urine that occurs during exertion or physical activity. The cause of this incontinence is an insufficient closure of the bladder. Urine loss occurs during brief spikes in bladder pressure, such as when standing up, coughing, laughing, or lifting objects. In women, this form of incontinence often occurs due to reduced pelvic floor integrity after childbirth, while in men it most commonly occurs after prostate surgery. For milder cases of stress incontinence, conservative measures can be taken initially, such as pelvic floor exercises, magnetic field therapy, biofeedback training, electrical stimulation training, or vibration therapy.In more severe cases, however, only surgical therapies are an option. The most common procedures include intraurethral submucosal injections of fillers, implantation of a pelvic floor mesh, or paraurethral balloon compression in men. These conventional treatment methods do not always guarantee complete continence. Furthermore, the implantation of an artificial sphincter system involves a major surgical procedure, which carries an increased risk of postoperative complications. Additionally, some of the devices available on the market require...

[0005] The systems located at the University of Erlangen-near 2 require a certain level of dexterity from the patients. Conventional mechatronic systems have high energy consumption. Therefore, they must be replaced regularly or require the charging of an energy storage device.

[0006] The invention is therefore based on the objective of providing an intraurethral sphincter prosthesis that can be operated without mechatronic components and without energy storage.

[0007] To solve this problem, an intraurethral sphincter prosthesis with the features of claim 1 is provided.

[0008] The intraurethral sphincter prosthesis according to the invention comprises a tubular housing with an inlet and an outlet, a balloon made of an elastic material received and held in the housing, a highly viscous fluid contained in the balloon, wherein the balloon has an inlet-side sealing balloon section and a fluid-connected outlet-side reservoir section, between which a throttle is located, wherein the sealing balloon section, in a resting state in which no inlet-side external pressure is exerted, rests circumferentially against the inner wall of the housing and seals the inlet, wherein under the influence of a sustained inlet-side external pressure, the highly viscous fluid from the sealing balloon section can be moved through the throttle into the reservoir section, wherein the sealing balloon section is moved away from the inner wall of the housing and the housing can be permeated by flow.

[0009] The invention is based on the idea that an intraurethral sphincter prosthesis can be controlled purely mechanically via bladder pressure. The bladder pressure, intuitively generated by the patient, enables micturition corresponding to the normal physiological process. At the same time, continence is ensured during brief pressure spikes in bladder pressure, which can occur, for example, when standing up, coughing, laughing, or lifting objects.

[0010] The sphincter prosthesis, developed at the University of Erlangen-Nuremberg (Uni Erlangen-Nuremberg-an-2), can be implanted using minimally invasive techniques and results in less stress on the human body compared to other conventional systems. The smaller dimensions of the sphincter prosthesis according to the invention allow for gender-independent application. The completely intraurethral placement of the system reduces the risk of tissue erosion and urinary tract infections.

[0011] The intraurethral sphincter prosthesis according to the invention essentially consists of the following components: the tubular housing, which is anchored in the urethra, the balloon made of an elastic material, and the highly viscous fluid contained within the balloon. In the resting state, the patient does not generate any intravesical pressure in the bladder. In this case, the pressures in the inlet-side sealing balloon section and the outlet-side reservoir section are equal. There is no flow of the highly viscous fluid. The sealing balloon section seals the opening of the tubular housing. In the resting state, no urine can flow from the bladder.

[0012] If there is a brief but significant increase in intravesical pressure in the bladder, this pressure also acts on the fluid in the inlet-side sealing balloon section. However, the restrictor positioned between the sealing balloon section and the reservoir section prevents rapid outflow of the highly viscous fluid, ensuring that the intraurethral sphincter prosthesis continues to close the patient's lower urinary tract. Urine flow is thus prevented, ensuring continence.

[0013] When the patient voluntarily initiates urination, the intravesical pressure in the bladder increases. This sustained pressure increase acts on the proximal part of the sphincter prosthesis, i.e., on the inlet-side sealing balloon section, resulting in a slow flow of the highly viscous fluid from the sealing balloon section into the fluid-connected outlet-side reservoir section. If, after a short period, typically a few seconds,

[0014] At the University of Erlangen-near 2, once a sufficient amount of fluid has passed through the throttle, the sealing balloon section no longer rests against the inner wall of the tubular housing. In this state, urine can flow from the bladder through the sphincter prosthesis, allowing the bladder to be emptied.

[0015] To prevent the flow of urine when at rest, it is preferred that a seal be arranged at the axial position of the housing where the sealing balloon section is located.

[0016] The seal extends circumferentially along the inside of the housing. It is also possible, in principle, for the seal to be located on the outside of the inlet-side sealing balloon section.

[0017] The seal preferably has an approximately hemispherical cross-section. This shape ensures a reliable seal of the housing's through-hole when at rest.

[0018] Within the scope of the invention, it is preferred that the housing has a holder for the outer end of the sealing balloon section near its inlet and / or a holder for the outer end of the expansion tank section near its outlet. Preferably, a holder is located at both axial ends of the housing.

[0019] A holder is preferably arranged near the center of the inlet or outlet. In this design, a substantially ring-shaped opening is formed between the holder and the housing, through which urine can flow.

[0020] In the intraurethral sphincter prosthesis according to the invention, it is preferred that the restrictor has an opening whose cross-section is smaller than the cross-section of the sealing balloon section. The restrictor thus forms a constriction that the highly viscous fluid can only pass through slowly.

[0021] Uni Erlangen-an-2 With regard to the balloon, it is preferred that it be made of a silicone material.

[0022] Silicone oil is particularly well-suited as the fluid. The viscosity of the highly viscous fluid is preferably in the range of 30,000 to 50,000 mPa s. Within this range, the fluid is highly viscous, resulting in the desired effect that, during short pressure surges, there is no or only a negligible flow through the restrictor. Conversely, the patient can initiate fluid flow by applying a sustained increase in pressure.

[0023] The invention is explained below with reference to an exemplary embodiment and the drawings. The drawings are schematic representations and show:

[0024] Fig. 1 shows a cutaway view of an intraurethral sphincter prosthesis according to the invention in its resting state;

[0025] Fig. 2 shows the sphincter prosthesis from Fig. 1 during short-term pressure spikes; and

[0026] Fig. 3 shows the sphincter prosthesis in the context of persistently elevated intravesical pressure.

[0027] The intraurethral sphincter prosthesis 1, shown in a sectional view in Fig. 1, is designed for implantation into the urethra of a male or female patient. The sphincter prosthesis 1 comprises a tubular housing 2 with an inlet 3 and an outlet 4. A balloon 5, made of an elastic material, is contained within the tubular housing 2. In the illustrated embodiment, this material is silicone. The balloon 5 is filled with a highly viscous fluid 6, which is silicone oil. The viscosity of the fluid 6 is 40,000 mPa s; in other embodiments, the viscosity may range from 30,000 to 50,000 mPa s.

[0028] The balloon 5 comprises an inlet-side sealing balloon section 7 and a fluid-connected outlet-side expansion tank section 8. The sealing balloon section 7 extends from an inlet-side support 9 along the longitudinal direction of the housing 2 to a throttle 10. The support 9 comprises a circular area that is held in the center of the opening of the housing 2. The support 9 can be connected to the housing 2, for example, by radially extending struts. The opposite inner end of the sealing balloon section 7 is formed by the throttle 10. Similar to the support 9, the throttle 10 is connected to the housing 2 by means not shown, for example, by radially extending struts. The throttle 10 is designed as an orifice with a defined opening (not shown). The throttle limits the flow of fluid between the sealing balloon section 7 and the expansion tank section 8.The inlet-side sealing balloon section 7 and the outlet-side expansion tank section 8 are formed in one piece and together form the balloon 5. The outlet-side expansion tank section 8 extends from the throttle 10 to an outlet-side bracket 11.

[0029] The inlet-side sealing balloon section 7 is surrounded by a circumferential seal 12, which is arranged on the inner wall of the housing 2 and is located approximately halfway along the length of the sealing balloon section 7.

[0030] The left side of the intraurethral sphincter prosthesis 1 in Fig. 1 is the proximal end, which points towards the patient's bladder. The right side in Fig. 1 is the distal end.

[0031] Fig. 1 shows the resting state, in which only a constant low intravesical pressure prevails in the bladder. The sealing balloon section 7 rests in a form-fitting manner against the circumferential seal 12 over its entire circumference, so that the through-opening of the housing 2 is closed. The same pressure then prevails in the sealing balloon section 7 and the expansion tank section 8; accordingly, no flow of the highly viscous fluid 6 occurs.

[0032] Uni Erlangen-an-2 the Drossel 10 instead. An unwanted leakage of urine from the bladder is prevented in the resting state.

[0033] Fig. 2 shows the intraurethral sphincter prosthesis 1 during brief intravesical pressure spikes. Typical incontinence scenarios include standing up, coughing, laughing, or lifting objects. These events cause brief, significantly increased pressures in the body, including the lower urinary tract. The increased pressure acts on the annular space between the inlet-side holder 9 and the inner wall of the housing 2. In this state, however, the highly viscous fluid cannot flow quickly from the inlet-side sealing balloon section 7, through the restrictor 10, into the outlet-side reservoir section 8. The small opening of the restrictor 10 prevents rapid flow of the highly viscous fluid, so the sealing balloon section 7 remains in contact with the circumferential seal 12. The increased pressure in the inlet-side sealing balloon section 7 cannot be quickly relieved.Accordingly, even in the case of intravesical pressure peaks, an unwanted flow of urine is blocked, thus ensuring the desired continence.

[0034] Fig. 3 shows the sphincter prosthesis 1 during sustained elevated intravesical pressure. When the patient voluntarily initiates urination, the bladder muscle (detrusor muscle) contracts, thereby increasing the intravesical pressure in the bladder, partly supported by the abdominal muscles. This prolonged pressure increase, compared to the pressure peaks described, causes the highly viscous fluid 6 to flow slowly through the opening of the throttle 10. The fluid 6 then passes from the sealing balloon section 7 into the reservoir section 8, which is elastically stretched in the process. When the sealing balloon section 7 is deflated, it no longer rests against the seal 12 on its outer surface, allowing urine to flow from the bladder through the intraurethral sphincter prosthesis 1.An annular space is formed between the inner wall of the housing 2 and the outer surface of the sealing balloon section 7, extending further around the outer surface of the expansion tank section 8 to the outlet 4. Urine can pass through the sphincter prosthesis 1 via this opening.

[0035] The fluid flows through the sphincter section of the balloon at the University of Erlangen-near 2, allowing the bladder to empty similarly to natural urination. The time required for enough fluid to flow out of section 1 of the balloon for urine to pass through the sphincter prosthesis is only a few seconds. The patient must therefore maintain the increased pressure for a few seconds.

[0036] After the bladder empties, the highly viscous fluid 6 is forced back through the 10 into the sealing balloon section 7 by the elasticity of the expansion chamber section 8 until equilibrium is reached. In this state, the sealing balloon section 7 rests with its circumference against the seal again.

[0037] 12, which prevents the flow of urine.

[0038] University of Erlangen-near 2 Reference list

[0039] 1 intraurethral sphincter prosthesis

[0040] 2 Housing 3 Inlet

[0041] 4 outlets

[0042] 5 Balloon

[0043] 6 Fluid

[0044] 7 Sealing balloon section 8 Expansion tank section

[0045] 9 inlet-side bracket

[0046] 10 throttles

[0047] 11 outlet-side bracket

[0048] 12 Seal

[0049] University of Erlangen-near 2

Claims

Patent claims 1. Intraurethral sphincter prosthesis (1 ), comprising: - a tubular housing (2) with an inlet (3) and an outlet (4), - a balloon (5) made of an elastic material, which is received and held in the housing (2), - a highly viscous fluid (6) contained in the balloon (5), wherein the balloon (5) has an inlet-side sealing balloon section (7) and a fluid-connected outlet-side expansion tank section (8), between which a throttle (10) is located, wherein the sealing balloon section (7) in a rest state in which no inlet-side external pressure is exerted bears circumferentially against the inner wall of the housing (2) and seals the inlet (3), wherein under the influence of a sustained inlet-side external pressure the highly viscous fluid (6) from the sealing balloon section (7) through the throttle (10) into the expansion tank section (8), wherein the sealing balloon section (7) is moved away from the inner wall of the housing (2) and the housing (2) is open to flow.

2. Intraurethral sphincter prosthesis according to claim 1, wherein a seal (12) circumferentially surrounding the housing (2) is arranged at the axial position of the housing (2) where the sealing balloon section (7) is located.

3. Intraurethral sphincter prosthesis according to claim 2, wherein the seal (12) has a cross-section that is at least approximately hemispherical.

4. Intraurethral sphincter prosthesis according to one of the preceding claims, wherein the housing (2) has a holder (9) near its inlet (3) for the outer end of the sealing balloon section (7) and / or a holder (11) near its outlet (4) for the outer end of the reservoir section (8). University of Erlangen-near 2 5. Intraurethral sphincter prosthesis according to claim 4, wherein a holder (9, 11) is arranged near the center of the inlet (3) or the outlet (4).

6. An intraurethral sphincter prosthesis according to any one of the preceding claims, wherein the throttle (10) has an opening whose cross-section is smaller than the cross-section of the sealing balloon section (7).

7. An intraurethral sphincter prosthesis according to any one of the preceding claims, wherein the balloon (5) is made of a silicone material.

8. Intraurethral sphincter prosthesis according to any of the preceding claims, wherein the fluid (6) is silicone oil.

9. Intraurethral sphincter prosthesis according to any of the preceding claims, wherein the fluid (6) has a viscosity in the range of 30,000 to 50,000 mPa s. University of Erlangen-near 2

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