BR202018077249Y1 - FULLY EFFECTIVE ARTIFICIAL SPHINCTER - Google Patents

Abstract

The present utility model patent relates to an artificial sphincter for the treatment of urinary incontinence and, more specifically, to an artificial sphincter to be implanted in a living being, particularly a male human being, for the treatment of incontinence. urinary. According to an aspect of the present patent, the artificial sphincter comprising a cuff (b), intended to bypass at least part of the urethra of an individual, said cuff being in fluid communication with a reservoir (d) of unidirectional displacement, characterized by the fact that said sphincter further comprises a reservoir (a) in fluid communication with (d) and said cuff (b), and a pump (c) in fluid communication with said cuff.

Description

[001] The present utility model patent relates, in general, to an artificial sphincter for the treatment of urinary incontinence. More specifically, the present patent relates to an artificial sphincter to be implanted in a living being, particularly a male human being, for the treatment of urinary incontinence.

BACKGROUND OF THE PATENT

[002] The act of urinating is a complex human function that is carried out through the interrelationship of parts of the nervous and muscular systems, forming a system not yet fully understood by science. The loss of the ability to control the act of urinating, whether by permission or involuntary interruption, in different degrees, is called urinary incontinence. The publication Fourth Report on the Standardization of Terminology of Lower Urinary Tract Function, International Continence Society Standardization Committee, 1949, defines urinary incontinence as the involuntary loss of urine that can be objectively demonstrated, causing a hygienic and/or social problem.

[003] In summary, the urinary system can be outlined as smooth and striated muscle fibers that promote contraction and relaxation with the purpose of maintaining a pressure gradient that ensures the storage of urine in the bladder, and its release at a convenient time.

[004] Although there are sympathetic and parasympathetic endings distributed throughout the bladder and sphincter region, it is known that the bladder muscle (detrusor) is rich in cholinergic receptors, with the sphincter region controlled mainly by alpha-adrenergic receptors. 1. Integration with the voluntary nervous system occurs through the pudendal nerve, which would initially have as its main activity the voluntary interruption of urination.

[005] The failure of this mechanism, which was called the sphincter, produces the most varied degrees of urinary incontinence. Changes in the functioning of the sphincter, particularly in males, can be caused by neurological disorders, such as Parkinson's disease, spinal cord trauma and stroke; birth defects, or even chronic diseases such as diabetes.

[006] Mild changes in the functioning of the sphincter complex can be treated through the use of drugs that inhibit or stimulate the endings of the sympathetic and parasympathetic system. Intermediate processes, when there are basically anatomical defects, as in the case of the exstrophy-epispadias complex, involve surgical procedures that aim to reinforce these mechanisms, lengthening or angling the posterior urethra and bladder neck.

[007] The use of urethral “Slings” to support the urethra is also effective in treating urinary incontinence, however there is a high rate of erosion of the urethra.

[008] The injection of gelatinous substances around the urethra is another method used, but high rates of infection, rejection and the development of safer methods have reduced the application of gelatinous substances.

[009] Prostate diseases and their treatments are the most frequent causes of urinary incontinence in individuals, particularly males, with prostate cancer standing out. The prostate removal procedure (radical prostatectomy) is the main cause of incontinence. Urinary incontinence is believed to occur in 2 to 60 percent of males who have undergone radical prostatectomy surgery.

[010] Although the state of the art presents some treatments to try to reverse the problem of urinary incontinence, as described above, situations often occur in which the problem persists, presenting the individual, particularly a male individual, with failures of the sphincter mechanism, resulting in the persistence of urinary incontinence.

[011] In these cases, the alternative to strengthening urination control mechanisms is the use of an artificial sphincter, also called mechanical sphincter.

[012] The state of the art reveals a series of artificial sphincters, with the aim of reversing the problem of urinary incontinence, particularly in males.

[013] Scott et al, 1973, describe an artificial sphincter composed, basically, of a pressure regulating reservoir, which is placed in the abdominal cavity, connected to a pump that transfers liquid contained therein to a cuff placed around the urethra. The pressure generated by the balloon is exerted on the cuff that keeps the urethra occluded in the intervals between urination. When urinating, the patient presses the pump that transfers the liquid from the cuff to the abdominal reservoir, which in turn slowly returns it to the cuff, thus occluding the urethra again, maintaining the same pressure gradient. The problem with this type of artificial sphincter is the frequent necrosis of regions of the urethra, due to the great pressure exerted by the cuff.

[014] The model AS-800 sphincter, sold by American Medical System, Minnesota, USA, partially solves the problem of necrosis in regions of the urethra. However, this device is relatively expensive due to the use of a large number of components.

[015] Patent PI 0706143-9 owned by the same inventors of the present patent features an artificial sphincter, however the main focus of the patent sought here is on the exclusion of a component that connected from the subcutaneous space in the abdominal skin to the reservoir. The exclusion of this component significantly reduces the possibility of erosion through the skin over time, as well as simplifying the surgical procedure itself. At the same time, it reduces the number of device connections, reinforcing its effectiveness. The puncture made in C (fig.01) which is inside the scrotum is less invasive and therefore makes the activation procedure simpler and safer.

[016] Therefore, the present patent aims to overcome the problems encountered in treatment methods and artificial sphincters found in the prior art.

[017] More specifically, the present patent aims at an artificial sphincter that solves the problems found in prior art sphincters, particularly for the treatment of urinary incontinence in a male individual.

[018] Even more particularly, the present patent aims at an artificial sphincter that is relatively cheaper in relation to prior art sphincters, as it comprises a smaller number of components or less complex components, reducing costs and facilitating its manufacture. .

[019] Yet another objective of the present patent is an artificial sphincter that prevents, or at least prevents, the involuntary loss of urine when occasional abdominal effort is made by the individual.

PATENT DESCRIPTION

[020] The objectives mentioned above, among others, are achieved with the present patent.

[021] According to a first aspect, the present patent relates to an artificial sphincter comprising a cuff (B), intended to contour the urethra of an individual, said cuff being in fluid communication with a unidirectional displacement pump ( C), characterized by the fact that said sphincter additionally comprises a reservoir (D) in fluid communication with another reservoir (A) and the cuff (B). The cuff (B) communicates with the pump (C).

[022] The present patent may include one or more of the following aspects:

[023] A reservoir is in fluid communication with said third pump;

[024] Said second pump is a unidirectional displacement pump;

[025] Said second pump comprises a restrictor for slow release of fluid back to the cuff;

[026] Slow release represents a time period between 10s and 3 min, particularly between 20s and 2 min, more particularly between 30s and 1 min, even more particularly about 45s;

[027] Said cuff is implanted in the posterior urethra next to the bladder neck;

[028] Said cuff is implanted at the level of the bulbar urethra;

[029] Said first pump is implanted in the scrotum of a male individual;

[030] Said second pump is implanted in the inguinal canal of a male individual;

[031] Said third pump is implanted in the abdominal cavity of a male individual;

[032] Said reservoir is implanted in the retropubic space or abdominal cavity of a male individual.

[033] Fluid communication between said pumps, the cuff and, eventually, the reservoir is carried out by conduits;

[034] Said fluid is distilled water;

[035] The pressure of the system, when filled with fluid, is between approximately 20 and 150 cmH»0, more particularly between approximately 40 and 100 cmH,0, even more particularly between 50 and 90 cmH>0, more particularly around of 70 cmH.0.

[036] The patent sphincter is made of medical grade silicone.

[037] The sphincter of the present patent can also be implanted in females and children, making common adaptations within the reach of any person skilled in the art.

BRIEF DESCRIPTION OF THE FIGURE

[038] These and other objectives, improvements and effects of the sphincter of the present patent will become apparent to those skilled in the art from the detailed description presented below, with reference to the attached figures, given only by way of illustration of a particular embodiment of the invention. Such figures are schematic, and their dimensions or proportions may not correspond to reality, since they only aim to illustrate the invention in a didactic way, without imposing any limitations other than those of the claims presented below, being that:

[039] Figure 1 is a schematic representation of the artificial sphincter according to an embodiment of the present patent, being:

[040] “A” Reservoir 1;

[041] “B” the Cuff;

[042] “C” the Pump (approximately 4 mm thick)

[043] “D” Reservoir 2;

[044] I - approximately 10 cm; II - approximately 10 cm; III - approximately 20 cm; IV - approximately 15 cm; V - approximately 5 cm.

[045] Figures 2 and 3 are details of the cuff included in the sphincter of figure 1, showing its closed and open positions, respectively.

[046] Figure 4 shows the invention implanted in the male body.

DESCRIPTION OF PARTICULAR ACHIEVEMENTS

[047] Figure 1 schematically illustrates an artificial sphincter according to an embodiment of the present patent. The patent sphincter comprises a cuff (B), intended to bypass an individual's urethra. According to the embodiment represented here, and according to figures 2 and 3, the cuff (B) is intended to contour the entire urethra of an individual.

[048] Such cuff (B) comprises opening and closing means so that it can be opened, bypassed the urethra, and closed to remain around the urethra of an individual. Said cuff comprises a pocket that can be filled or emptied with a fluid. When filled with fluid under a certain pressure, the cuff remains in the occluded position, as illustrated in figure 2, and when emptied, it opens, reducing the pressure around the urethra and, thus, allowing urine to pass through it.

[049] The cuff must be implanted around the posterior urethra, next to the bladder neck, or at the level of the bulbar urethra.

[050] The cuff can be made of flexible medical grade silicone material covered on the inner side by a strip of polyurethane foam and, on the outer side, reinforced by a polyester strap. Typically, the cuff is adjustable and, commonly on the market, there are three different sizes of 55, 65 and 75 mm in internal perimeter.

[051] Further details of the cuff are unnecessary in the present description, since this device is well known to those skilled in the art.

[052] The cuff is in fluid communication with the reservoir (D). This reservoir is preferably unidirectional, that is, when activated, the fluid contained in the sphincter can only move in one direction (represented by the arrows in figure 1), towards the second reservoir (A) and the cuff. (B).

[053] The purpose of the reservoir (D) is to empty the cuff, that is, to release the fluid contained therein and, consequently, the pressure exerted by the fluid on its walls, thus allowing the disocclusion of the cuff and the passage of urine from the bladder through the urethra.

[054] The reservoir (C) is, preferably, implanted in the scrotum of a male individual, and is activated by finger pressure on its walls. This reservoir is in fluid communication with the pump (D) with the second reservoir (A) and the cuff (B). It receives the fluid from the cuff (C), when it is activated, and its purpose is to return the fluid to the cuff to fill it again, but slowly. In other words, the fluid from the cuff, which passes through (C) when it is activated, and lodges in (D) and (A), is not immediately returned to the cuff. This way, the fluid is slowly returned to the cuff. This slower return can be achieved, for example, by reducing the diameter at the outlet (D), reducing the fluid flow and, consequently, allowing the cuff to fill slowly.

[055] This feature is advantageous so that the individual equipped with the artificial sphincter as described here can only activate the reservoir (D) once, to empty the cuff and allow urination. As the cuff refills slowly, the individual can perform the entire act of urinating, without needing to activate the reservoir (C) again, until the bladder is emptied.

[056] By “slow” or “slow release” in the present specification, it should be interpreted as a time lapse comprised between 10s and 3 min, particularly between 20s and 2 min, more particularly between 30s and 1 min, even more particularly about 45s.

[057] Another reservoir (A) is in fluid communication with the cuff (B). This other reservoir (A) is preferably implanted in the abdominal cavity of an individual. The purpose of using this other reservoir (A) is to increase the pressure of the cuff when pressed, particularly when there is occasional effort by the individual's abdomen, as is the case, for example, in moments of coughing or when the individual bends down, contracting the abdomen. The additional pressure exerted by (A) on the cuff only occurs when pressed, that is, when there is occasional abdominal effort, preventing this greater abdominal pressure, also exerted on the bladder, from causing an involuntary passage of urine through the cuff that is occluding the urethra. As this greater pressure exerted by the third pump (A) on the cuff is only occasional, that is, when greater abdominal effort occurs, the problem of urethral necrosis is less likely.

[058] This reservoir (A) is preferably implanted in the rero-pubic space or peritoneal cavity, particularly in a male individual.

[059] The functioning of the sphincter of the present patent is now explained in greater detail.

[060] During rest, the entire system remains filled with fluid at a pre-established pressure, which allows continence. When pressed, the reservoir (C) allows the cuff to be emptied, and consequently, opened, by moving the fluid contained therein towards it. As the cuff deflates and opens, urination occurs.

[061] The fluid contained in (D) is transferred to (A) and (D), where it is stored while it is slowly released back into the cuff, which is gradually being filled with fluid again and occluding, pressing the urethra , allowing continence again.

[062] The reservoir (A) aims to activate and deactivate the system, as mentioned above. When surgery to implant an artificial sphincter is performed, it is filled with a small amount of fluid immediately, which will not generate significant pressure within the system. It is necessary for the body to regenerate before definitively activating it. Thus, the system is only filled with fluid in an adequate quantity, and, consequently, its activation will typically only occur after 6 to 8 weeks after the implantation surgery.

[063] In this sense, there must be a convenient means of accessing the artificial sphincter to fill it with fluid and provide the system with adequate pressure. With the reservoir implanted inside the scrotum here named C, the doctor who will fill it with fluid has easy access to the system, without the need for new surgical intervention to fill the fluid. Particularly, a device used for infusing serum can be used to fill fluid into the sphincter of the present patent. The fluid is exclusively distilled water.

[064] Filling with fluid must be sufficient to exert a pressure on the system between approximately 20 and 150 cmH20, more particularly between approximately 40 and 100 cmH;0, even more particularly between 50 and 90 cmHz,0, more particularly around of 70 cmH20.

[065] Fluid communication between (D), the cuff (M) and the reservoir (A) can be carried out through conduits that allow the passage of fluid. The conduit between (C) and (D) (fig.1 - IV) measures between 2 and 30 cm (preferably 15 cm). The conduit between (D) and the connection of (A) (fig.1 - V) measures between 2 and 30 cm (preferably 5 cm). The conduit in A (fig.1 - I) measures between 2 and 30 cm (preferably 10 cm). The conduit between the connection of (A) and (B) (fig.1 - II) measures between 2 and 30 cm (preferably 10 cm). The conduit between (B) and (C) (fig.1 - III) measures between 2 and 30 cm (preferably 20 cm).

[066] Both (A and D) and (C) and the conduits can be made of medical grade silicone.

[067] Although the description of the particular embodiment carried out above is directed to the implantation of the sphincter in a male individual, it should be clear that the sphincter of the present patent can also be implanted in female individuals and children, making it the necessary adaptations are within the reach of any technical person.

[068] It must be recognized that, although the present patent has been described with respect to a particular embodiment, those skilled in the art will be able to develop a wide variation of details and expand the above-exposed sphincter to other types of applications without, however, deviate from the principles of the invention. For example, the various elements shown in the embodiment may be combined in a manner not illustrated above and in accordance with the accompanying drawings. Therefore, the claims below should be interpreted as covering all equivalents that fall within the scope and character of the invention.

ADVANTAGES OF THE PATENT

[069] The exclusion of this component significantly reduces the possibility of erosion through the skin over time, as well as simplifying the surgical procedure itself. At the same time, it reduces the number of device connections, reinforcing its effectiveness. The puncture made in C (fig.01) which is inside the scrotum is less invasive and therefore makes the activation procedure simpler and safer.

Claims (7)

1. Artificial sphincter comprising a cuff (B), intended to bypass at least part of the urethra of an individual, said cuff being in fluid communication with a reservoir (D) of unidirectional displacement, characterized by the fact that said sphincter additionally comprises a reservoir (A) in fluid communication with (D) and the cuff (B), and a pump (C) in fluid communication with said cuff (B) and the reservoir (D) and (C) being within the scrotum and be unidirectional and (D) comprise a restrictor for slow release of fluid back to the cuff (B). 2. Artificial ester, according to claim 1, characterized in that (C) it is approximately 4 mm thick. 3. Artificial sphincter, according to claim 1 and 2, characterized in that said slow release represents a time period comprised between 10s and 3 min, particularly between 20s and 2 min, more particularly between 30s and 1 min, even more particularly about of 43s. 4. Artificial sphincter, according to claim 1, characterized by the fact that fluid communication between A, B, C and D is carried out by conduits. 5. Artificial sphincter, according to claims 1 to 4, characterized by the fact that the conduit between (C) and (D) (IV) measures between 2 and 30 cm (preferably 15 cm), the conduit between (D) and the connection of (A) (V) measures between 2 and 30 cm (preferably 5 cm), the conduit of A (I) measures between 2 and 30 cm (preferably 10 cm), the conduit between the connection of (A) and ( B) (II) measures between 2 and 30 cm (preferably 10 cm), the conduit between (B) and (C) (III) measures between 2 and 30 cm (preferably 20 cm). 6. Artificial sphincter according to claim 1, characterized in that the fluid is distilled water. 7. Artificial sphincter, according to claim 1, characterized in that the system pressure is comprised between approximately 20 and 150 cmH,0, more particularly between approximately 40 and 100 cmH>0, even more particularly between 50 and 90 emH, 0, more particularly about 70 cmH.0.