WO2020132731A1

WO2020132731A1 - Fully effective artificial sphincter

Info

Publication number: WO2020132731A1
Application number: PCT/BR2019/050560
Authority: WO
Inventors: Salvador Vilar Correia Lima; Fábio DE OLIVEIRA VILAR
Original assignee: Salvador Vilar Correia Lima; De Oliveira Vilar Fabio
Priority date: 2018-12-27
Filing date: 2019-12-23
Publication date: 2020-07-02
Also published as: BR202018077249Y1; BR202018077249U2

Abstract

The present utility model patent relates to an artificial sphincter for treating urinary incontinence and, more specifically, to an artificial sphincter designed to be implanted in a living being, in particular a male human being, for treating urinary incontinence. According to one aspect of the present patent, the artificial sphincter has a cuff (B) that is designed to at least partially encircle the urethra of a person, said cuff being in fluid communication with a one-way reservoir (D), characterized in that said sphincter also has a reservoir (A) in fluid communication with (D) and said cuff (B), and a pump (C) in fluid communication with said cuff.

Description

“FULL EFFICIENCY ARTIFICIAL SPHERIN”

[001] The present utility model refers, 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.

PATENT BACKGROUND

[002] The act of urinating is a complex function of the human being that takes place through the interrelationship of parts of the nervous and muscular system, forming a system not yet fully understood by science. The loss of the ability to control the act of urination, whether by permission or involuntary interruption, in different degrees, is called urinary incontinence. The 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 in order to maintain a pressure gradient that ensures the storage of urine in the bladder, and its release at the appropriate 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, the sphincter region being controlled mainly by alpha-adrenergic receptors 1 . Integration with the voluntary nervous system occurs through the pudendal nerve, which at first would have as its main activity the voluntary interruption of urination.

REPLACEMENT SHEETS (RULE 26) [005] The failure of this mechanism, which was called 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 chronic diseases like 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 flaws, as in the case of the extrophy-epispadias complex, involve surgical procedures that aim to reinforce these mechanisms, lengthening or angulating the posterior urethra and the bladder neck.

[007] The use of urethral slings to support the urethra is also effective in the treatment of urinary incontinence, but there is a high rate of erosion of the urethra.

[008] The injection of gelatinous substances around the urethra is another method used, but the 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, especially prostate cancer. The prostate removal procedure (radical prostatectomy) is the main cause of incontinence. Urinary incontinence is believed to occur in 2 to 60 percent of male individuals who have undergone radical prostatectomy surgery.

[010] Although the state of the art has some treatments to try to reverse the problem of urinary incontinence, as described above, there are often situations in which the problem persists, presenting the individual,

REPLACEMENT SHEETS (RULE 26) particularly a male, sphincter mechanism failures, resulting in persistent urinary incontinence.

[01 1] In these cases, the alternative to reinforce urination control mechanisms is the use of an artificial sphincter, also called a mechanical sphincter.

[012] The state of the art reveals a series of artificial sphincters, in order to reverse 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 in it 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. During urination, the patient presses the pump that transfers the liquid from the cuff to the abdominal reservoir, which in turn returns it slowly to the cuff, thus re-occluding the urethra, maintaining the same pressure gradient. The problem in 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 sphincter model AS-800, sold by the 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] The patent PI 0706143-9 owned by the same inventors of the present patent brings 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 skin of the abdomen 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 in

REPLACEMENT SHEETS (RULE 26) itself. At the same time, it reduces the number of connections of the device reinforcing its effectiveness. The puncture made in C (fig.01) that is inside the scrotum is less invasive and consequently makes the activation procedure simpler and safer.

[016] Therefore, the aim of the present patent is to circumvent the problems found in the treatment methods and artificial sphincters found in the state of the art.

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

[018] Even more particularly, the present patent aims at an artificial sphincter that is relatively cheaper compared to the sphincters of the prior art, as it comprises a smaller number of less complex components or components, reducing costs and facilitating their 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 an eventual abdominal effort is performed 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 refers to an artificial sphincter comprising a cuff (B), intended to bypass an individual's urethra, 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) has communication with the pump (C).

REPLACEMENT SHEETS (RULE 26) [022] The present patent may comprise 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 the fluid back to the cuff;

[026] Slow release represents a time lag 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 close to the bladder neck;

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

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

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

[031] The said third pump is implanted in the abdominal cavity of a male person;

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

[033] The fluid communication between said pumps, the cuff and, eventually, the reservoir is carried out by ducts;

[034] Said fluid is distilled water;

[035] At system pressure, when filled with fluid, it 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 cmH> 0, more particularly still about of 70 cmH, 0.

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

REPLACEMENT SHEETS (RULE 26) [037] The sphincter of the present patent can also be implanted in female individuals and in children, making common adaptations available to any man of the technique.

BRIEF DESCRIPTION OF THE FIGURE

[038] These and other objectives, improvements and effects of the sphincter of the present patent will become apparent to the technicians in the subject from the detailed description presented below, making reference to the attached figures, given only for illustrative purposes. 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" o Reservoir 1;

[041] "B" the Cuff;

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

[043] “D” o 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 PRIVATE ACHIEVEMENTS

REPLACEMENT SHEETS (RULE 26) [047] Figure 1 schematically illustrates an artificial sphincter according to an embodiment of the present patent. The patent sphincter comprises a cuff (B), designed to bypass an individual's urethra. According to the embodiment shown here, and according to figures 2 and 3, the cuff (B) is intended to circumvent the entire urethra of an individual.

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

[049] The cuff should be implanted around the posterior urethra, close 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 inside by a polyurethane foam strip and on the outside, 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 of internal perimeter.

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

[052] The cuff is in fluid communication with the reservoir (D). This reservoir is preferably unidirectional displacement, that is, when activated, the fluid condict 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

REPLACEMENT SHEETS (RULE 26) fluid on its walls, thus allowing the cuff to disclose 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 its activation is done by the pressure of the fingers 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 refill it, however slowly. In other words, the fluid coming from the cuff, which passes through (C) when it is activated, and gets into (D) and (A), is not immediately returned to the cuff. In 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 of (D), decreasing the fluid flow and, consequently, allowing a slow filling of the cuff.

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

[056] By "slow" or "slow release" in this specification, it should be interpreted as a time lag 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 an individual's abdominal cavity. The purpose of using this other reservoir (A) is to increase the cuff pressure when pressed, narticularly when there is an occasional effort in the individual's abdomen, as is the case, for example, in coughing moments or when the individual lowers, contracting the

REPLACEMENT SHEETS (RULE 26) abdomen. The additional pressure exerted by (A) on the cuff only occurs when pressed, that is, when there is an occasional abdominal effort, preventing this greater abdominal pressure also exerted on the bladder, causing an involuntary passage of urine through the cuff that is to occlude the urethra. As this greater pressure exerted by the third pump (A) on the cuff is only occasional, that is, when a greater abdominal effort occurs, the problem of necrosis of the urethra is less likely.

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

[059] The operation of the sphincter of the present patent is now explained in more detail.

[060] During rest, the entire system remains filled with fluid at a pre-established pressure, which allows continence. When the reservoir (C) is pressed, it allows the cuff to empty, and consequently, to open, by displacing the fluid contained therein. With the cuff deflating and opening, urination occurs.

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

[062] The reservoir (A) aims to activate and deactivate the system, as mentioned above. When surgery for implantation of 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 that the body regenerates itself before activating it definitively. Thus, the system is only filled with fluid in an adequate amount, and, consequently, its activation will only occur, typically, after 6 to 8 weeks after the implantation surgery has been performed.

REPLACEMENT SHEETS (RULE 26) [063] In this sense, there needs to 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 further surgical intervention to perform the fluid filling. In particular, a device used for the infusion of serum can be used to fill fluid in the sphincter of the present patent. The fluid is exclusively distilled water.

[064] Filling with fluid should be enough to exert 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 still about 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 of 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 conduits can be made of medical grade silicone.

[067] Although the description of the particular realization that was performed 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 in children, making it necessary adaptations to the reach of any man of the art.

REPLACEMENT SHEETS (RULE 26) [068] It should be recognized that, although the present patent has been described with respect to a particular embodiment, those skilled in the art can develop a wide range of details and expand the sphincter exposed above to other types of applications without, however, deviate from the principles of the invention. For example, the various elements shown in the realization may be combined in a manner not illustrated above and in accordance with the accompanying drawings. Therefore, the claims below must be interpreted as covering all equivalents that fall within the scope and character of the invention.

PATENT ADVANTAGES

[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 connections of the device reinforcing its effectiveness. The puncture made in C (fig.01) that is inside the scrotum is less invasive and consequently makes the activation procedure simpler and safer.

REPLACEMENT SHEETS (RULE 26)

Claims

1. Artificial sphincter (fig.1) comprising a cuff (B), intended to bypass at least part of an individual's urethra, said cuff being in fluid communication with a unidirectional displacement reservoir (D), 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).

2. Artificial sphincter, according to claim 1, characterized by the fact that the pump (C) is inside the scrotum and is unidirectional.

Artificial ester according to claim 2, characterized in that (C) is approximately 4 mm thick.

4. Artificial sphincter according to one of claims 1 and 2, characterized in that (D) comprises a restrictor for slow release of the fluid back to the cuff (B).

5. Artificial sphincter, according to claim 4, characterized in that said slow release represents a time lapse between 10s and 3 min, particularly between 20s and 2 min, more particularly between 30s and 1 min, even more particularly about 43s.

6. Artificial sphincter, according to claim 1, characterized by the fact that the fluid communication between A, B, C and D are carried out by conduits.

7. Artificial sphincter, according to claim 6, characterized by the fact that 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 of A (fig.1 - I) measures between 2 and 30 cm (preferably 10 cm), 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).

8. Artificial sphincter, according to claim 1, characterized by the fact that the fluid is distilled water.

9. Artificial sphincter according to claim 1, characterized in that the system pressure is 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.