ES2669197T3 - Urethra cuff that includes a tube - Google Patents

Abstract

An artificial urinary sphincter system (20), comprising: a reservoir (28) for containing a fluid; a sleeve (22, 300) that includes a previously formed spiral tube (302) configured to be wound around a urethra and a connector (304); and a control device (26) adapted to be hydraulically coupled to the tank (28) and the sleeve (22, 300) by a pipe (30) and to regulate the transfer of fluid between the tank (28) and the sleeve (22 , 300) such that the sleeve (22, 300) receives and sends the fluid to dilate and contract the previously shaped spiral tube (302) and to close the urethra to ensure continence and open the urethra to ensure urination, characterized in that the connector (304) comprises a first connector (304a) and a second connector (304b) and that the connector (304) is formed in the spiral tube (302) previously formed in a first end (302a) and in a first part (302c) of tube end (302), which is adjacent to the first end (302a), and in which the first connector (304a) is suitable for attachment to a second end (302b) of the tube (302), such that the second end (302b) and a second part (302d) of extr The tube (302), which is adjacent to the second end (302b), is adapted to be applied to the first connector (304a) to provide a tight, fluid tight fit, and the second connector (304b) is suitable for its pipe joint (30).

Description

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DESCRIPTION

Urethra cuff that includes a tube BACKGROUND

Urinary incontinence affects many people and is a worldwide health problem. Published research indicates that urinary incontinence has a substantial social and economic burden worldwide, affecting up to an average of approximately 16% of the global population.

Urinary incontinence in women may be associated with a prolapse of one or more pelvic organs, which may occur from the birth of a child or a weakness in the tissues / muscle of the pelvic floor. Urinary incontinence in men may occur after surgical treatment of the prostate gland, the treatment of which may include the removal or weakening of the prostate sphincter from the urinary urethra.

A treatment for urinary incontinence includes the placement of an artificial sphincter around a circumference of a part of the urethra. The artificial sphincter works to compress the urethra to selectively close or stop the flow of urine through the urethra, thus providing the user with a continent state. The artificial sphincter can be activated to a position opened by the user, which opens the urethra and allows the user to pass urine selectively.

US 4881939 describes a helical sleeve that can be implanted that is adapted to be wound around a tubular member in a pressure transfer relationship. The sleeve can be fully inflated to function as an occluder, or partially inflated to function as a pressure sensor or transducer in an appropriate system.

Surgeons and patients would welcome advances in the treatment of urinary incontinence.

SUMMARY

Some embodiments of the exposure provide an artificial urinary sphincter system (AUS) that includes a reservoir for containing a fluid, a sleeve that includes a spiral tube previously formed to be wound around the urethra, and a control device to be coupled hydraulically to the tank and the sleeve. The control device regulates the transfer of fluid between the reservoir and the sleeve. The sleeve receives and sends the fluid to dilate and contract the previously shaped spiral tube and to close the urethra to ensure continence and open the urethra to ensure urination.

Some embodiments of the description provide an AUS system that includes a reservoir for containing a fluid, a sleeve that includes twist-resistant tubing to be wound around a urethra, and a control device to be hydraulically coupled to the reservoir and sleeve. The control device regulates the movement of the fluid between the reservoir and the sleeve. The sleeve receives and sends the fluid to dilate and contract the twist-resistant tubing and close the urethra to ensure continence and open the urethra to ensure urination.

Although multiple embodiments have been described, still other embodiments will be apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments. Therefore, the drawings and detailed description should be considered as illustrative and not restrictive in nature.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide an additional understanding of embodiments and are incorporated into this specification and constitute a part thereof. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated and will be better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Similar reference numbers designate corresponding similar parts.

Fig. 1 is a diagram illustrating an embodiment of an AUS system implanted in the male urogenital region environment.

Fig. 2A is a diagram illustrating an example of a sleeve, which includes a previously formed spiral tube and a connector, on the urethra.

Fig. 2B is a cross-sectional diagram of the previously formed spiral tube taken along line B2-B2 in fig. 2A.

Fig. 2C is a diagram illustrating the previously shaped spiral tube located around the urethra, where the previously shaped spiral tube is deflated and the urethra is open to ensure urination.

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Fig. 2D is a diagram illustrating the previously shaped spiral tube located around the urethra, where the previously shaped spiral tube is inflated and the urethra is closed to prevent incontinence.

Fig. 3A is a diagram illustrating the previously shaped spiral tube located around the urethra, wherein the previously shaped spiral tube is deflated and contracted to crush or close the urethra to prevent incontinence.

Fig. 3B is a diagram illustrating the previously shaped spiral tube located around the urethra, where the previously shaped spiral tube is inflated and dilated to allow the urethra to open to ensure urination.

Fig. 4 is a diagram illustrating an embodiment of a sleeve that includes a previously formed spiral tube having a connector that is integrated into the previously formed spiral tube.

Fig. 5 is a diagram illustrating an embodiment of a sleeve that includes a previously formed spiral tube wound around the urethra and having multiple turns located side by side in the urethra.

Fig. 6A is a diagram illustrating an embodiment of a tube resistant to the twisting of a sleeve.

Fig. 6B is a diagram illustrating an embodiment of a twist-resistant tube wrapped around the urethra.

Fig. 6C is a diagram illustrating an example of the sleeve, which includes the twist-resistant tube and the connector, on the urethra.

Fig. 7 is a schematic view of a scalpel and a dissection tool used to dissect tissue through the perineum.

Fig. 8 is a schematic view of a sleeve located around the urethral bulb.

Fig. 9 is a schematic view of the cuff in place around the patient's urethral bulb and connected to an AUS system.

DETAILED DESCRIPTION

In the following detailed description, reference has been made to the accompanying drawings, which form a part thereof, and in which embodiments have been shown by way of illustration. In this regard, directional terminology has been used, such as "top", "bottom", "front", "back", "front", "rear", etc., with reference to orientation of the figure or figures that have been described. Because the components of embodiments can be positioned in several different orientations, directional terminology has been used for purposes of illustration and not in a limiting manner. It should be understood that other embodiments can be used and that structural or logical changes can be made without departing from the scope of the description. The following detailed description, therefore, should not be taken in a limiting sense.

The characteristics of the different exemplary embodiments described in this exhibition can be combined with each other ("mixed and matched"), unless specifically indicated otherwise.

Extremity means the most extreme. A distal limb is the most extreme location furthest from a distal portion of a thing that has been described, while a proximal limb is the closest extreme location of a proximal portion of the thing that has been described. The portion adjacent or adjacent to a limb is a limb portion. Also, the soft tissue includes dermal tissue, subdermal tissue, ligaments, tendons, or membranes but does not include bone.

Artificial urinary sphincters have proven useful in the treatment of urinary incontinence. An AUS is implanted around the urethra and can be operated to selectively close the urethral orifice to allow the user to move the artificial sphincter from an open state that allows urine to pass to a closed state that provides continence to the user.

A urinary control system that has been well received by the medical community includes three components cooperatively connected with tubing. The three components include an occlusive sleeve, a control pump, and a pressure regulating balloon reservoir. The cuff is implanted around the urethra, the control pump is implanted in the scrotum of a male user, and the pressure regulating balloon reservoir is implanted in the pre-bladder space. The three components are filled with a liquid to provide a closed system filled with liquid that is maintained at an equilibrium pressure that closes the sleeve around the urethra. When the user wishes to urinate, squeeze and release the pump several times to move the fluid from the sleeve to the pressure regulating balloon reservoir. The cuff "deflates" and opens, allowing the urethra to open and pass urine. The pressure regulating ball tank, which has been pressurized at a pressure above the equilibrium pressure by

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When the pump is activated, it automatically re-pressurizes the cuff at equilibrium pressure over the course of several minutes to inflate the cuff again and close the urethra. The sleeve is manufactured from sheets of film that are sealed to provide one or more inflatable cushions. The sleeve is provided in a rectangular shape and intended to be placed around the urethra, with the ends of the rectangular sleeve secured together. However, observers have seen that the sleeve of this system has a tendency to twist when it is inflated, particularly at the junction where rectangular balloon cushions are formed in a circular sleeve. The location of this twist may wear out over time and create a leak in the sleeve.

Embodiments described in this discussion provide an AUS system that includes a sleeve that includes a tube that is to be wound around the urethra. In some embodiments, the tube is a previously formed spiral tube to be wound around the urethra. In some embodiments, the tube includes twist resistant tubing that is to be wound around the urethra.

Embodiments described in this disclosure further include a fluid reservoir containing fluid, such as a saline solution, and a control device that is configured to be hydraulically coupled to the reservoir and sleeve. The control device regulates the movement of the fluid between the reservoir and the sleeve, such that the sleeve receives and sends the fluid to dilate and contract the tube. In some embodiments, the tube is inflated to dilate and close the urethra to maintain continence and deflated to contract and open the urethra to ensure urination. In some embodiments, the tube is inflated to dilate and open the urethra to ensure urination and deflated to contract and close the urethra to maintain continence or prevent incontinence.

The AUS systems described in this exposure are suitable for use in both female and male patients, where the cuff is placed around a portion of the urethra. Female patients may have the component of the control device implanted in one of the lips or in an abdominal area. Male patients may have the control device component implanted in the scrotum.

Fig. 1 is a diagram illustrating an embodiment of an AUS system 20 implanted in the environment of the male urogenital region. The AUS system 20 includes a sleeve 22 located around the urethra 24. The AUS system 20 also includes a control device 26 that is hydraulically connected to the sleeve 22 and a fluid reservoir 28 through the pipe 30, such as twist resistant pipe.

The sleeve 22 includes an elastic tube that is wound around or rotated around the urethra 24 and a connector that connects the elastic tube to the control device 26. In some embodiments, the sleeve 22 is inflated to dilate the elastic tube and close the urethra 24 to prevent incontinence and deflation to contract the elastic tube and open urethra 24 to ensure urination. In some embodiments, the sleeve 22 is inflated to dilate the elastic tube and open the urethra 24 to ensure urination and deflation to contract the elastic tube and close the urethra 24 to maintain continence.

The control device 26 and the fluid reservoir 28 are operable to inflate and deflate the sleeve 22. The fluid reservoir 28 is sized to retain a volume of the liquid, such as a saline solution, which can be moved to the sleeve 22 to dilate the elastic tube.

In some embodiments, the fluid reservoir 28 provides a regulated fluid pressure and the control device 26 includes a control valve that, upon activation, allows the fluid to move from the fluid reservoir 28 to the sleeve 22, which dilate cuff 22 to close urethra 24 and maintain continence. In some of these embodiments, the control device 26 includes a pump bulb which, when tightened, moves the fluid from the sleeve 22 to the fluid reservoir 28 to deflate the sleeve 22, where the load of the elastic tube in the sleeve 22 helps deflate the cuff 22. The deflated cuff 22 allows the urethra 24 to open to ensure urination. In some embodiments, the fluid reservoir 28 that provides a regulated fluid pressure automatically inflates the sleeve 22 over time, such as 2 or 3 minutes or less, through a leakage valve arrangement in the flow device. control 26 and sleeve 22, which expands sleeve 22 to close urethra 24 and prevent incontinence. In some embodiments, other suitable pumps are used, such as electromechanical pumps, electronic pumps, and button-style cavity pumps.

In some embodiments, the fluid reservoir 28 provides a regulated fluid pressure and the control device 26 includes a control valve that, after activation, allows the fluid to move from the fluid reservoir 28 to the sleeve 22. This Expands sleeve 22 to allow urethra 24 to open to ensure urination. In some of these embodiments, the control device 26 includes a pump bulb which, when pressed, moves the fluid from the sleeve 22 to the fluid reservoir 28 to deflate the sleeve 22, where the loading of the elastic tube into the sleeve 22 helps to deflate the sleeve 22. The deflated sleeve 22 closes the urethra 24 to maintain continence. In some embodiments, other suitable pumps are used, such as electromechanical pumps, electronic pumps, and button-style cavity pumps.

In some embodiments, the fluid reservoir 28 does not provide a regulated fluid pressure and the control device 26 includes a pump bulb which, when pressed, moves fluid from the fluid reservoir 28 to the sleeve 22.

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This dilates the sleeve 22 to close the urethra 24. In some of these embodiments, the control device 26 includes a control valve that, after activation, allows the fluid to move from the sleeve 22 to the fluid reservoir 28, where the loading of the elastic tube into the sleeve 22 helps deflate the sleeve 22. This deflates the sleeve 22 to allow the urethra 24 to open to ensure urination. In some embodiments, other suitable pumps are used, such as electromechanical pumps, electronic pumps, and button-style cavity pumps.

In some embodiments, the fluid reservoir 28 does not provide a regulated fluid pressure and the control device 26 includes a pump bulb which, when tightened, moves the fluid from the fluid reservoir 28 to the sleeve 22. This dilates the sleeve 22 to allow the urethra 24 to open to ensure urination. In some of these embodiments, the sleeve 22 automatically deflates over time, such as 2 or 3 minutes or less, through a leakage valve arrangement in the control device 26 and the sleeve 22, where the load of the elastic tube in the sleeve 22 helps deflate the sleeve 22. The deflated sleeve 22 closes the urethra 24 to prevent incontinence. In some embodiments, other suitable pumps are used, such as electromechanical pumps, electronic pumps, and button-style cavity pumps.

The control device 26 can be implanted within the scrotum 32, which provides access to the control device 26 by the user. Also, other locations for the placement of the control device 26 are acceptable, for example, as determined by the gender of the user.

The pipe 30 is provided in a twist-resistant manner and includes some style of connector that allows segments of the pipe 30 to be joined together after the various components, such as the control device 26 and the fluid reservoir 28, are primed with liquid. The pipe 30 is a thin-walled tube that can be joined between the control device 26 and the fluid reservoir 28, and between the control device 26 and the sleeve 22. In one embodiment, the pipe 30 is separated from the device for control 26 and separated from the fluid reservoir 28 and connects these components through a locking mechanism, such as a quick connector or other suitable snap-fit connector.

The sleeve 22 is implanted around the bulbous urethra or around the part of the urethra 24 that descends from the neck 34 of the bladder. The sleeve 22 is sized to allow placement as close to the bladder 36 as possible (desired by some surgeons), or positioned distally of the neck 34 of the bladder as properly determined by the responsible surgeon. As illustrated in fig. 1, the sleeve 22 is implanted around the urethra 24 in a location where the urethra 24 moves from a vertical orientation that communicates with the bladder 36 to a horizontal orientation that extends to the penis 38, which desirably corresponds to the area of the urogenital region associated with an increased level of muscle mass.

Fig. 2A is a diagram illustrating an example of a sleeve 100, which includes a previously formed spiral tube 102 and a connector 104, on the urethra 24. In some example, the sleeve 100 is similar to the sleeve 22 (shown in fig. one).

The previously formed spiral tube 102 has a first end 102a and a second end 102b, and the connector 104 includes a first connector 104a, a second connector 104b, and a third connector 104c. The first end 102a and a first end portion 102b of the previously formed spiral tube 102, which is adjacent to the first end 102a, is applied to the first connector 104a to provide a tight, fluid tight fit. The second end 102b and a second end portion 102d of the previously formed spiral tube 102, which is adjacent to the second end 102b, is applied to the second connector 104b to provide a tight, fluid tight fit. The third connector 104c is suitable for connection to a pipe, such as pipe 30 (shown in Fig. 1).

The preformed spiral tube 102 is sized to fit around the urethra 24. The preformed spiral tube 102 is wound around the urethra 24 multiple times, such as 2 or 3 or more times, to form annular rings or turns around of the urethra 24. The previously formed spiral tube 102 is wound around the urethra 24 for a length L2 of the urethra 24. In this embodiment, the same force can be used with multiple turns than with a single turn to constrict the urethra 24 , but the force is applied over an increased area of the urethra 24, such that the pressure at points along the urethra 24 is decreased. The decreased pressure along the urethra 24 leads to less irritation and less erosion of the urethra 24 under the sleeve 100. In some embodiments, the previously formed spiral tube 102 is wound around the urethra 24 for a length L2 of up to 2 centimeters (cm). In some embodiments, the previously formed spiral tube 102 is wound around the urethra 24 for a length L2 of less than 1 cm.

In some embodiments, the previously formed spiral tube 102 includes eyelets 106 and 108 for fixing and anchoring the spiral tube 102 previously formed to the patient's tissue. The eyelets 106 and 108 may be located at the end portions 102c and 102d, respectively, of the previously formed spiral tube 102. The eyelets 106 and 108 are secured or attached to the patient's tissue to anchor the previously formed spiral tube 102 in place to prevent the turns of the previously shaped spiral tube 102 from dilating and further separating along the length L2 of the urethra 24.

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The preformed spiral tube 102 is preformed or preformed to fit around the urethra 24, such that the preformed spiral tube 102 does not twist or wrinkle when it is wound around the urethra 24. In some embodiments, the spiral tube 102 is preformed or pre-formed to a circular shape to fit around the urethra, such that the previously shaped spiral tube 102 does not twist or wrinkle when it is wound around the urethra 24. In some embodiments , the previously formed spiral tube 102 is preformed or previously formed in an oblong or oval shape to fit around the urethra, such that the previously shaped spiral tube 102 does not twist or wrinkle when it is wound around the urethra 24.

The previously formed spiral tube 102 is made of an elastic material, such that the previously formed spiral tube 102 is dilated when filled with fluid. In some embodiments, the previously formed spiral tube 102 includes a urethane elastomer. In some embodiments, the previously formed spiral tube 102 includes a urethane elastomer having a wall thickness of between 0.25 and 2 millimeters (mm), such as a wall thickness of 0.75 mm. In some embodiments, the previously formed spiral tube 102 includes silicone. In some embodiments, the previously formed spiral tube 102 includes silicone with a wall thickness between 1 and 2 mm.

To place the sleeve 100 around the urethra 24, one of the first and second extremities 102a and 102b of the previously shaped spiral tube 102 can be slid behind the urethra 24 to emerge from the other side of the urethra 24. The Selected limb can then be repeatedly wound around the urethra 24 by sliding the selected limb behind the urethra 24 to rotate or rotate the previously formed spiral tube 102 over the urethra 24. After the spiral shaped tube 102 It has previously been wound around the urethra 24 multiple times, the first end 102a is connected to the first connector 104a, the second end 102b is connected to the second connector 104b, and a pipe, such as the pipe 30 (shown in Fig. 1 ), is connected to the third connector 104c.

In some embodiments, eyelets 106 and 108 are secured to the patient's tissue. This prevents the previously formed spiral tube 102 from sliding up and down on the urethra 24 and ensures the expansion of the previously formed spiral tube 102 on the urethra 24 without further separating or separating the turns of the previously formed spiral tube 102.

Fig. 2B is a cross-sectional diagram of the previously formed spiral tube 102 and of the urethra 24 taken along the line B2-B2 in fig. 2A. The previously formed spiral tube 102 has a circular cross section and, in some embodiments, the previously shaped spiral tube 102 has a circular cross section from the first end 102a to the second end 102b. The previously formed spiral tube 102 has an outer surface 102e which is the outermost part of the previously shaped spiral tube 102 and an inner surface 102f that is intended to contact the urethra 24. The outer surface 102e is opposite the inner surface 102f or is displaced 180 degrees from it. In some embodiments, the previously formed spiral tube 102 has an outside diameter D2 of between 2 and 9 mm.

Figs. 2C and 2D are cross-sectional diagrams, taken along the line C2-C2 in fig. 2A illustrating an example of the sleeve 100, which is deflated to contract the previously formed spiral tube 102 and open the urethra 24 to ensure urination and inflation to dilate the previously shaped spiral tube 102 and close the urethra 24 to prevent incontinence . Fig. 2C is a diagram illustrating the previously formed spiral tube 102 located around the urethra 24, wherein the previously formed spiral tube 102 is deflated and the urethra 24 is open to ensure urination. Fig. 2D is a diagram illustrating the previously formed spiral tube 102 located around the urethra 24, where the previously formed spiral tube 102 is inflated and the urethra 24 is closed to prevent incontinence.

In operation, as described in reference to fig. 1, a control device such as the control device 26 and a fluid reservoir such as the fluid reservoir 28 cooperate to move the fluid from the fluid reservoir to the previously formed spiral tube 102 of the sleeve 100. This dilates the tube 102 spirally shaped and crushes or closes urethra 24 (shown in Fig. 2D). At the appropriate time, the fluid is removed from the previously formed spiral tube 102, which relaxes or contracts the previously formed spiral tube 102 from around the urethra 24 to allow the urethra 24 to open to ensure urination (shown in Fig. 2C). The control device and the fluid reservoir further cooperate to move the fluid from the fluid reservoir to the previously formed spiral tube 102 to dilate the previously shaped spiral tube 102 and close the urethra 24 to prevent incontinence.

Figs. 3A and 3B are diagrams illustrating an example of a sleeve 200 that is similar to sleeve 100, except that sleeve 200 includes a previously formed spiral tube 202 that is deflated to contract the previously formed spiral tube 202 to close the urethra 24 and prevent incontinence, and inflated to dilate the previously formed spiral tube 202 to allow the urethra 24 to open to ensure urination. In some example, sleeve 200 is similar to sleeve 22 (shown in Fig. 1).

The sleeve 200 includes the previously formed spiral tube 202 and a connector 204. The spiral tube 202

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Preformed has a first end 202a and a second end 202b, and the connector 204 includes a first connector 204a, a second connector 204b, and a third connector 204c. The first end 202a and a first end portion 202c of the previously formed spiral tube 202, which is adjacent to the first end 202a, is applied to the first connector 204a to provide a tight, fluid tight fit. The second end 202b and a second end part 202d of the previously formed spiral tube 202, which is adjacent to the second end 202b, is applied to the second connector 204b to provide a tight, fluid tight fit. The third connector 204c is suitable for connection to a pipe, such as pipe 30 (shown in Fig. 1).

The previously formed spiral tube 202 is sized to fit around the urethra 24, and similarly to the previously formed spiral tube 102, the previously formed spiral tube 202 is wound around the urethra 24 multiple times, such as 2 or 3 or more times, to form annular rings or turns around the urethra 24. The previously formed spiral tube 202 is wound around the urethra 24 for a length, similar to the length L2, along the urethra 24, where the same force can be used with multiple turns as with a single turn to constrict the urethra 24, but the force is applied over an increased area of the urethra 24, such that the pressure at points along the urethra 24 is diminished The decreased pressure along the urethra 24 leads to less irritation and less erosion of the urethra 24 under the sleeve 200. In some embodiments, the previously formed spiral tube 202 is wound around the urethra 24 for a length of up to 2 cm. In some embodiments, the previously formed spiral tube 202 is wound around the urethra 24 for a length of less than 1 cm.

The previously formed spiral tube 202 has a circular cross section and, in some embodiments, the previously shaped spiral tube 202 has a circular cross section from the first end 202a to the second end 202b. The previously formed spiral tube 202 has an outer surface 202e which is the outermost part of the previously formed spiral tube 202 and an inner surface 202f that is intended to contact the urethra 24. The outer surface 202e is opposite to the inner surface 202f or displaced 180 degrees from it. In some embodiments, the previously formed spiral tube 202 has an outside diameter, similar to diameter D2, between 2 and 9 mm.

In some embodiments, the previously formed spiral tube 202 includes eyelets, such as buttonhole 208, for fixing and anchoring the spiral tube 202 previously formed to the patient's tissue. The eyelets may be located at the end portions 202c and 202d, respectively, of the previously formed spiral tube 202 and fixed or attached to the patient's tissue to anchor the previously formed spiral tube 202 in place and to prevent the turns of the Preformed spiral tube 202 expands and separates further along the length of the urethra 24.

The previously formed spiral tube 202 is pre-formed or pre-formed to fit around the urethra 24, such that the previously shaped spiral tube 202 does not twist or wrinkle when it is wound around the urethra 24. In some embodiments, the previously formed spiral tube 202 is preformed or previously formed in a circular shape to fit around the urethra, such that the previously shaped spiral tube 202 does not twist or wrinkle when it is wound around the urethra 24. In In some embodiments, the previously formed spiral flow 202 is preformed or preformed in an oblong or oval shape to fit around the urethra, such that the previously shaped spiral tube 202 does not twist or wrinkle when it is wound around the urethra 24.

The previously formed spiral tube 202 is made of an elastic material, such that the previously formed spiral tube 202 is dilated when filled with fluid. In some embodiments, the previously formed spiral tube 202 includes a urethane elastomer. In some embodiments, the previously formed spiral tube 202 includes a urethane elastomer having a wall thickness of between 0.25 and 2 mm, such as a wall thickness of 0.75 mm. In some embodiments, the previously formed spiral tube 102 includes silicone. In some embodiments, the previously formed spiral flow 202 includes silicone having a wall thickness between 1 and 2 mm.

The sleeve 200 may be placed around the urethra 24 in a manner similar to the manner in which the sleeve 100 is placed around the urethra 24. Also, in some embodiments, the eyelets are fixed to the patient's tissue to prevent the tube 202 in a previously formed spiral slide up and down on the urethra 24 and to ensure the expansion of the previously formed spiral tube 202 over the urethra without further separating or separating the turns of the previously formed spiral tube 202.

Fig. 3A is a diagram illustrating the previously formed spiral tube 202 located around the urethra 24, where the previously formed spiral tube 202 is deflated and contracted to crush or close the urethra 24 to prevent incontinence. Fig. 3B is a diagram illustrating the previously formed spiral tube 202 located around the urethra 24, where the previously formed spiral tube 202 is inflated and dilated to allow the urethra 24 to open to ensure urination.

In operation, as described in reference to fig. 1, a control device such as the control device 26 and a fluid reservoir such as the fluid reservoir 28 cooperate to move the fluid from the reservoir of

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fluid to the previously formed spiral tube 202 of the sleeve 200. This dilates the previously formed spiral tube 202 from around the urethra 24 and allows the urethra 24 to open to ensure urination (shown in Fig. 3B). After some time, the fluid is removed from the previously formed spiral tube 202, which contracts the previously formed spiral tube 202 to tighten it around the urethra 24 and close the urethra 24 to prevent incontinence (shown in Fig. 3A ).

Fig. 4 is a diagram illustrating an embodiment of a sleeve 300 that includes a previously shaped spiral tube 302 having a connector 304 that is integrated into the previously shaped spiral tube 302. In some embodiments, sleeve 300 is similar to sleeve 22 (shown in Fig. 1).

The previously shaped spiral tube 302 has a first end 302a and a second end 302b, where the connector 304 is formed in the spiral tube 302 previously formed in the first end 302a and a first end portion 302c of the shaped spiral tube 302 previously, which is adjacent to the first limb 302a. Connector 304 includes a first connector 304a and a second connector 304b. The first connector 304a is suitable for attachment to the second end 302b of the elastic tube 302, such that the second end 302b and a second end part 302d of the elastic tube 302, which is adjacent to the second end 302b, is applied to the first connector 304a to provide a tight fluid tight fit. The second connector 304b is suitable for connection to a pipe, such as the pipe 30 (shown in Fig. 1). In some embodiments, sleeve 300 includes eyelets 306 and 308.

In some embodiments, the sleeve 300 is similar to the sleeve 100 (shown in Figs. 2A-2D) with the exception that instead of having a separate connector 104, the connector 304 is integrated in the previously formed spiral tube 302. In some embodiments, sleeve 300 is similar to sleeve 200 (shown in Figs. 3A and 3B) with the exception that instead of having a separate connector 204, connector 304 is integrated in the previously formed spiral tube 302. Since the embodiments of sleeves 100 and 200 have been previously described in this discussion, the descriptions regarding the sleeve 300 will not be repeated here. Also, in some embodiments, sleeve 100 may have an integrated connector, such as connector 304, instead of connector 104, and in some embodiments, sleeve 200 may have an integrated connector, such as connector 304, instead of connector 204.

Fig. 5 is a diagram illustrating an embodiment of a sleeve 400 that includes a previously formed spiral tube 402 wound around the urethra 24 and having multiple turns side by side on the urethra 24. In examples, the sleeve 400 includes a connector separated (not shown in fig. 5), and in embodiments, sleeve 400 includes an integrated connector (not shown in fig. 5). In some embodiments, sleeve 400 is similar to sleeve 22 (shown in Fig. 1).

The previously shaped spiral tube 402 has a first end 402a, a second end 402b, a first end part 402c that is adjacent to the first end 402a, and a second end part 402d that is adjacent to the second end 402b. In some embodiments, the previously formed spiral tube 402 includes eyelets 406 and 408 for fixing and anchoring the spiral tube 402 previously formed to the patient's tissue. The eyelets 406 and 408 may be located at the end portions 402c and 402d, respectively, of the previously formed spiral tube 402.

The previously shaped spiral tube 402 is sized to fit around the urethra 24. The previously shaped spiral tube 402 is wound around the urethra 24 multiple times, such as 2 or 3 or more times, to form rings or annular turns around of the urethra 24. The rings or turns of the previously shaped spiral tube 402 can be stacked on top of each other, such that the rings or turns are located adjacent to each other and touch or almost touch each other, at least one of the states inflated and deflated. The eyelets 406 and 408 can be secured or adapted to the patient's tissue to anchor the previously formed spiral tube 402 in place and to prevent the turns of the previously formed spiral tube 402 from expanding and separating further along a length , such as the length L2 of the urethra 24. In some embodiments, the previously shaped spiral tube 402 is wound around the urethra 24 for a length of up to 2 cm. In some embodiments, the previously shaped spiral tube 402 is wound around the urethra 24 for a length of less than 1 cm.

In some embodiments, sleeve 400 is similar to sleeve 100 (shown in Figs. 2A-2D). In some embodiments, sleeve 400 is similar to sleeve 200 (shown in Figs. 3A and 3B). In some embodiments, sleeve 400 is similar to sleeve 300 (shown in Fig. 4). Since the embodiments of sleeves 100, 200 and 300 have been previously described in this discussion, the descriptions will not be repeated here in relation to sleeve 400.

Figs. 6A-6C are diagrams illustrating an embodiment of a sleeve 500 that includes twist-resistant tubing or a twist-resistant tube 502 and a connector 504. In embodiments, sleeve 500 has an integrated connector similar to the integrated connector 304 (shown in the Fig. 4), which is integrated in the twist-resistant tube 502, instead of including the separate connector 504. In some embodiments, the sleeve 500 is similar to the sleeve 22 (shown in Fig. 1).

The twist-resistant tube 502 is wound around the urethra 24 and the connector 504 is attached to the twist-resistant tube 502. A control device, such as control device 26, is hydraulically coupled

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to connector 504 and a reservoir, such as reservoir 28, to dilate and contract the twist-resistant tube 502 to close the urethra 24 to ensure continence and open the urethra 24 to ensure urination. In some embodiments, the twist-resistant tube 502 is wound around the urethra 24 at least once. In some embodiments, the twist-resistant tube 502 is wound around the urethra 24 at least twice, such as two and a half times.

Fig. 6A is a diagram illustrating an embodiment of the twist-resistant tube 502. A twist-resistant tube 502 has a first end 502a, a second end 502b, a first end portion 502c that is adjacent to the first end 502a, and a second end portion 502d that is adjacent to the second end 502b.

The twist-resistant tube 502 fits around the urethra 24, such that the twist-resistant tube 502 does not twist or wrinkle when it is wound around the urethra 24. The twist-resistant tube 502 is made of an elastic material , such that the twist-resistant tube 502 dilates when filled with fluid. In some embodiments, the twist-resistant tube 502 is produced as a piece of single wall extruded tubing. In some embodiments, the twist-resistant tube 502 includes a urethane elastomer. In some embodiments, the twist-resistant tube 502 includes a urethane elastomer having a wall thickness of between 0.25 and 2 mm, such as a wall thickness of 0.75 mm. In some embodiments, the twist-resistant tube 502 includes silicone. In some embodiments, the twist-resistant tube 502 includes silicone having a wall thickness between 1 and 2 mm.

In some embodiments, the twist-resistant tube 502 includes eyelets 506 and 508 to fix and anchor the twist-resistant tube 502 to the patient's tissue. The eyelets 506 and 508 may be located in the end portions 502c and 502d, respectively, of the twist-resistant tube 502. The eyelets 506 and 508 are fixed or tied to the patient's tissue to anchor the recognition-resistant tube 502 in place and to prevent the turns of the twist-resistant tube 502 from dilating and separating further along a length L6 of urethra 24 (shown in fig. 6B).

Fig. 6B is a diagram illustrating an embodiment of the twist-resistant tube 502 wound around the urethra 24. The twist-resistant tube 502 is wound around the urethra 24 at least once and, in some embodiments, multiple times, such as 2 , 2 ^, or 3 or more times, to form annular rings or turns around the urethra 24. The twist-resistant tube 502 is wound around the urethra 24 during the length L6 of the urethra 24. In this situation, they can be used the same force with multiple turns as with a single turn to constrict the urethra 24, but the force is applied over an increased area of the urethra 24, such that the pressure at points along the letter 24 is decreased. The decreased pressure along the urethra 24 leads to less irritation and less erosion of the urethra 24 under the sleeve 500. In some embodiments, the twist-resistant tube 502 is wound around the urethra 24 for a length L6 of up to 2 cm. In some embodiments, the twist-resistant tube 502 is wound around the urethra 24, for a length L6 of less than 1 cm.

The twist-resistant tube 502 has a circular cross-section and, in some embodiments, the twist-resistant tube 502 has a circular cross-section from the first end 502a to the second end 502b. The twist-resistant tube 502 has an outer surface 502e that is the outermost part of the twist-resistant tube 502 and an inner surface 502f that is intended to contact the urethra 24. The outer surface 502e is opposite the inner surface 502f or It is displaced 180 degrees from it. In some embodiments, the twist-resistant tube 502 has an outer diameter D6 of between 2 and 9 mm.

To place the twist-resistant tube 502 around the urethra 24, one of the first and second extremities 502a and 502b is slid behind the urethra 24 to emerge from the other side of the urethra 24. The selected end may be a then repeatedly slid behind the urethra 24 to rotate or wind the twist-resistant tube 502 over the urethra 24. After the twist-resistant tube 502 has been wound around the urethra 24 multiple times, the resistant tube 502 at twisting it is connected to connector 504.

In some embodiments, eyelets 506 and 508 are secured to the patient's tissue. This prevents the twisting-resistant tube 502 from sliding up and down on the urethra 24 and ensures the expansion of the twisting-resistant tube 502 on the urethra 24 without further separating or separating the turns of the twisting-resistant tube 502.

Fig. 6C is a diagram illustrating an example of the sleeve 500, including the twist-resistant tube 502 and the connector 504 that is not the subject of the patent claims, on the urethra 24.

Connector 504 includes a first connector 504a, a second connector 504b and a third connector 504c. The first end 502a and the first end portion 502c of the twist-resistant tube 502 are applied to the first connector 504a to provide a tight fluid tight fit. The second end 502b and the second end portion 502d of the twist-resistant tube 502 are applied to the second connector 504b to provide a tight, fluid tight fit. The third connector 504c is suitable for connection to a pipe, such as pipe 30 (shown in Fig. 1). In some embodiments, the sleeve includes eyelets 506 and 508.

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In some embodiments of the sleeve 500, the twist-resistant tube 502 is deflated to contract the twist-resistant tube 502 and open the urethra 24 to ensure urination, and inflated to dilate the twist-resistant tube 502 and close the urethra 24 to prevent incontinence In operation, as described in reference to fig. 1, a control device such as the control device 26 and a fluid reservoir such as the fluid reservoir 28 cooperate to move the fluid from the fluid reservoir to the twist-resistant tube 502 of the sleeve 500. This dilates the tube 502 resistant to twisting and crushing or closing the urethra 24. At some point, the fluid is removed from the twist-resistant tube 502, which relaxes or contracts the twist-resistant tube 502 from around the urethra 24 to allow the urethra 24 to Open to ensure urination. The control device and the fluid reservoir further cooperate to move the fluid from the fluid reservoir to the twist-resistant tube 502 to dilate the twist-resistant tube 502 and close the urethra 24 to prevent incontinence.

In some embodiments of the sleeve 500, the twist-resistant tube 502 is deflated and contracted to crush or close the urethra 24 to prevent incontinence, and inflated and dilated to allow the urethra 24 to open to ensure urination. In operation, as described in reference to fig. 1, a control device such as the control device 26 and a fluid reservoir such as the fluid reservoir 28 cooperate to move the fluid from the fluid reservoir to the twist-resistant tube 502 of the sleeve 500. This dilates the tube 502 resistant to twisting around urethra 24 and allowing urethra 24 to open to ensure urination. After some time, the fluid is removed from the twist-resistant tube 502, which contracts the twist-resistant tube 502 to tighten around the urethra 24 and to close the urethra 24 to prevent incontinence.

Fig. 7 is a schematic view of a scalpel 600 and a dissection tool 602 used to dissect tissue through the perineum 604, which is located between the scrotum 606 and the anus 608, to expose the bulbous urethra 610. An incision 612 is made to through the perineum 604 to dissect the tissue.

Fig. 8 is a schematic view of a sleeve 614, such as one of the sleeves 22, 100, 200, 300, 400, and 500 located around the urethral bulb 616. A urinary catheter 618 has been placed inside the bladder through the urethra to drain urine from the bladder, and the surgeon has dissected tissue away from and around the urethral bulb 616 for proper placement of the cuff 614.

Fig. 9 is a schematic view of the sleeve 614 in place around the patient's urethral bulb 616 and connected to an AUS system 620, similar to the AUS system 20 (shown in Fig. 1).

Various modifications and additions may be made to the exemplary embodiments described above without departing from the scope of the present disclosure. For example, although the embodiments described above refer to particular features, the scope of this disclosure also includes embodiments that have different combinations of features and embodiments that do not include all of the features described above.

Claims (12)

5 10 fifteen twenty 25 30 35 40 1. An artificial urinary sphincter system (20), comprising: a reservoir (28) for containing a fluid; a sleeve (22, 300) that includes a previously formed spiral tube (302) configured to be wound around a urethra and a connector (304); Y a control device (26) adapted to be hydraulically coupled to the tank (28) and the sleeve (22, 300) by a pipe (30) and to regulate the transfer of the fluid between the tank (28) and the sleeve (22, 300) such that the sleeve (22, 300) receives and sends the fluid to dilate and contract the previously formed spiral tube (302) and to close the urethra to ensure continence and open the urethra to ensure urination, characterized in that the connector (304) comprises a first connector (304a) and a second connector (304b) and that the connector (304) is formed in the spiral tube (302) previously formed in a first end (302a) and in a first part (302c) of tube end (302), which is adjacent to the first end (302a), and wherein the first connector (304a) is suitable for attachment to a second end (302b) of the tube (302), such that the second end (302b) and a second part (302d) of the end of the tube ( 302), which is adjacent to the second end (302b), are adapted to be applied to the first connector (304a) to provide a tight, fluid tight fit, and the second connector (304b) is suitable for attachment to the pipe (30). 2. The system according to claim 1, wherein the control device and (26) transfer the fluid from the reservoir (28) to the sleeve (22, 300) to dilate the previously formed spiral tube (302) and close the The urethra and the control device (26) transfer the fluid from the sleeve (22, 300) to the reservoir (28) to contract the previously shaped spiral tube (302) and open the urethra. 3. The system according to claim 1, wherein the control device (26) transfers the fluid from the reservoir (28) to the sleeve (22, 300) to dilate the previously shaped spiral tube (302) and open the urethra and the control device (26) transfers the fluid from the sleeve (22, 300) to the reservoir (28) to contract the previously formed spiral tube (302) and close the urethra. 4. The system according to claim 1, wherein the previously formed spiral tube (302) includes a twist-resistant tube. 5. The system according to claim 1, wherein the previously formed spiral tube (302) includes a single wall twist resistant tube. 6. The system according to claim 1, wherein a high fluid pressure is maintained in the reservoir. 7. The system according to claim 6, wherein the control device (26) includes a pump configured to transfer the fluid from the sleeve (22, 300) to the reservoir (28). The system according to claim 6, wherein the control device (26) includes a valve for transferring the fluid from the reservoir (28) to the sleeve (22, 300). 9. The system according to claim 1, wherein the control device (26) includes a pump for transferring the fluid from the reservoir (28) to the sleeve (22, 300). 10. The system according to claim 1, wherein the control device (26) includes a valve for transferring the fluid from the sleeve (22, 300) to the reservoir (28). 11. The system according to claim 1, wherein the pipe (30) is separated from the control device (26) and separated from the reservoir (28) and is connected to these components through a locking mechanism. The system according to claim 1, wherein the previously formed spiral tube (302) includes eyelets (306, 308) located at end portions (302c, 302d), respectively, of the previously formed spiral tube (302) to fix and anchor the spiral tube (302) previously formed to the tissue of a patient.