Improved reflective artificial sphincter

Abstract

The artificial sphincter (1) comprises an inflatable occlusion device (20) for occluding a body passage, a stretchable fluid reservoir (23), a pump device (7) and the occlusion device (20). Pressurized fluid is selectively diverted from the occlusion device to the reservoir to cause the occlusion device to collapse so that the occluded body passage can be opened. The artificial sphincter (1) further comprises a semi-permeable check valve (30) which always allows fluid to flow towards the stretchable fluid reservoir (23). The semi-permeable check valve (30) only allows limited fluid flow from the stretchable fluid reservoir (23). A pressure sensitive check valve (3) is located between the pressure compensating balloon (24) and the lumen of the said balloon holder (11). The pressure sensitive check valve (3) always allows fluid to flow from the pressure compensating balloon (24) to the lumen (28) so that the fluid contained in the pressure compensating balloon is free to flow towards the inflatable occlusion device (20) and, in use, sudden pressure increases occurring in the patient's abdomen are immediately transmitted to the inflatable occlusion device (20).

Description

Technical Field

[0001] This invention generally relates to a device for treating incontinence, and more specifically to a device for providing an expandable artificial sphincter for controlling the excretory pathway. The invention provides a novel solution for effectively occluding the excretory pathway of a patient even in the event of a sudden increase in pressure in the abdomen of a patient with an implanted artificial sphincter. Background Technology

[0002] Biological urethral sphincters prevent urine flow through mucosal adhesion, compression, and pressure transmission. Artificial urethral sphincters, on the other hand, mimic biological urethral sphincters by providing an effective bladder outlet during urine storage and an open, unobstructed outlet to allow spontaneous urination. Similarly, artificial rectal sphincters can be used to treat fecal incontinence caused by neurological or muscular dysfunction of the anal sphincter.

[0003] A known treatment for some cases of incontinence is to provide the patient with a device that occludes the affected circumferential passage. These devices are typically surgically implanted into the patient and are designed to be operated by the patient to selectively open and close the passage. Inflatable artificial sphincters are well-known devices in the art. Inflatable sphincters typically comprise an inflatable cuff for surrounding the passage to be occluded. Typically, a pump associated with a fluid reservoir is used to transfer fluid into and out of the cuff. When fluid is transferred into the cuff, the cuff inflates and closes the circumscribed passage.

[0004] Artificial urethral sphincter (AUS) as known in the art consists of three main parts: a fluid reservoir, a cuff, and a pump, typically designated as the control mechanism of the AUS. This pump can be placed in the scrotum of a man. It can also be placed under the skin of the lower abdomen, labia, or legs of a woman. Two catheters connect all three main parts to each other. The use of additional components, especially catheters, increases implantation time, surgical complexity, and, most importantly, the risk of infection for the patient after implantation.

[0005] A known problem with existing inflatable artificial sphincters is that the cuff cannot effectively block the excretory passage when there is a sudden increase in pressure in the patient's abdomen. For example, a sudden increase in pressure may occur when a patient laughs, coughs, or bursts into laughter, or during certain physical movements such as bending forward or lifting weights. In such cases, the normal pressure formed in the inflatable cuff may not be able to effectively block the excretory passage, and excretory fluid that has accumulated behind the cuff or in the bladder may inadvertently leak out of the patient's body.

[0006] WO 2018 / 156092 A1 discloses an artificial sphincter comprising an inflatable occlusion device for closing a body passage, a stretchable fluid reservoir, and a pump device. The pump device has a first port in fluid communication with the occlusion device and a second port in fluid communication with the fluid reservoir for selectively transferring isotonic fluid from the occlusion device to the reservoir to cause the occlusion device to contract. The artificial sphincter further includes a pressure-compensating balloon attached to the fluid reservoir and implanted in the patient's abdomen during use. However, the artificial sphincter according to this prior art requires further improvement. The isotonic fluid loaded in the artificial sphincter may become contaminated during surgical implantation or later during its use. Contamination typically results in the formation of solid particulate contents in the isotonic fluid. These contaminated solid particulate contents may clog either the flow retarder or either the first or second check valve. Clogging in the flow retarder can cause the artificial sphincter to lose function and requires surgical removal from the patient. Furthermore, the chokes taught in this paper are very small in size, difficult to manufacture, and ultimately require simplification of the entire system to avoid complexity and high manufacturing costs.

[0007] The purpose of this invention The main objective of this invention is to provide a novel artificial sphincter that eliminates the shortcomings of existing artificial sphincter muscles.

[0008] Specifically, one object of the present invention is to provide a novel control mechanism for an artificial sphincter that can effectively block the patient's excretory passage even when there is a sudden increase in pressure in the patient's abdomen.

[0009] Another object of the present invention is to provide a novel artificial sphincter that is simple and easy to manufacture.

[0010] A final objective of the present invention is to provide a simplified artificial sphincter in which the use of a choke is eliminated near the pressure-compensating balloon. Attached Figure Description

[0011] The accompanying drawings, which are provided as brief descriptions, are intended only to provide a better understanding of the invention and are not intended to limit the scope of protection or to interpret the context of the scope in the absence of description.

[0012] Figure 1 A perspective view of the artificial sphincter according to the present invention is shown. Figure 2 It shows Figure 1 A cross-sectional view of the artificial sphincter in the expanded state of the occlusion device. Figure 3 It shows Figure 1A cross-sectional view of an artificial sphincter in the contracted state of an occlusion device. Figure 4 It shows Figure 2 The cross-sectional diagram of the semi-permeable check valve is given in the image. Figure 5a It shows Figure 2 The diagram provided shows a 2D cross-sectional view of a pressure-sensitive check valve. Figure 5b It shows Figure 2 The diagram provided is a 3D representation of a pressure-sensitive check valve. Figure 6 Several perspective views of the concave sphere and its annular support are shown. Figure 7 Several perspective views of the sphere and its recessed support are shown. Figure 8.1 A half-schematic cross-sectional view of a pump used with an artificial sphincter according to the invention is shown; the pump ball is in a compressed state. Dashed arrows indicate the flow direction of the pressurized fluid unless the arrow is marked "x".

[0013] Figure 8.2 It shows Figure 8.1 The pump implementation described herein is in the state when the pump ball is being released.

[0014] Figure 8.3 It shows Figure 8.1 The pump implementation given herein, during the expansion of the blocking device Figure 8.4 It shows Figure 1 The image shows a close-up of the elastic lip of a semi-rigid check valve, when the pump ball is squeezed.

[0015] Figure 8.5 Showing from Figure 8.4 A close-up image of the detail "Q", showing the pump ball being squeezed.

[0016] Figure 8.6 A 2D diagram of a check valve with an elastic lip is shown during the compression of the pump's spherical components. Detailed Implementation

[0017] The following is a list of reference numerals used in the accompanying drawings; 1. Artificial sphincter 3 Pressure-sensitive check valve 6-pump spherical 7 pumps 8 Second tube 9 First tube 11 balloon retainer 13 First Port 14 Second Port 20 Blocking Device 23 Stretchable fluid reservoir 24-Pressure Compensation Balloon 28 lumen 30 semi-permeable check valve 32 through seats 33 sphere 34 depressions 35 sphere 36 Annular Support 37 pits 39 Notch Support 40 recesses 41 gap 42 sphere 43 depressions 44 springs 45-inch concave sphere 431 Semi-rigid Check Valve 432 Elastic Lip Edge 433 sphere 434 valve seat 435 opening 442 check valve The object of the present invention is achieved by the features of claim 1, which discloses an artificial sphincter (1) containing pressurized fluid in use. The artificial sphincter (1) includes an inflatable occlusion device (20) for occluding a body passage, a stretchable fluid reservoir (23), and a pump device (7) having a first port (13) in fluid communication with the occlusion device (20) via a first tube (9) and a second port (14) in fluid communication with the fluid reservoir (23) via a second tube (8), for selectively transferring pressurized fluid from the occlusion device to the reservoir to cause the occlusion device to contract, thereby opening the blocked body passage. The artificial sphincter (1) further includes a balloon retainer (11) having a lumen (28) and a pressure-compensating balloon (24) that establishes fluid communication between the fluid reservoir (23) and the second tube (8), the pressure-compensating balloon being in fluid communication with the lumen of the balloon retainer (11) and to be implanted into the patient's abdominal cavity in use. The artificial sphincter (1) further includes a semi-permeable check valve (30) located in the lumen (28) of the balloon retainer (11), wherein the semi-permeable check valve (30) always allows fluid from the second tube (8) to flow toward the stretchable fluid reservoir (23), and wherein the semi-permeable check valve (30) only allows restricted fluid to flow from the stretchable fluid reservoir (23) to the second tube (8). The artificial sphincter (1) has a pressure-sensitive check valve (3) located between the pressure-compensating balloon (24) and the lumen of the balloon retainer (11), wherein the pressure-sensitive check valve (3) always allows fluid to flow from the pressure-compensating balloon (24) toward the lumen (28), such that fluid contained in the pressure-compensating balloon can flow freely toward the inflatable occluder (20), and in use, a sudden increase in pressure in the patient's abdomen is immediately transmitted to the inflatable occluder (20). The fluid contained in the pressure-compensating balloon can flow freely toward the inflatable occluder (20), and during use, any sudden increase in pressure that may occur in the patient's abdomen can be immediately transmitted to the inflatable occluder. Advantageously, this prevents urinary leakage during coughing or laughing, which can cause a sudden increase in abdominal pressure.

[0018] The size and shape of the occlusion device (20) of the artificial sphincter (1) according to the present invention are configured to occlude the anal canal or urethra of a human.

[0019] Figure 1A perspective view of the artificial sphincter (1) according to the present invention is shown. The artificial sphincter (1) has a pump (7) located between an occlusion device (20) and a stretchable fluid reservoir (23) for selectively transferring pressurized fluid. The pump (7) has a compressible bulb (6) for activation by a patient who has the artificial sphincter (1) implanted. The stretchable fluid reservoir (23) is in fluid communication with a pressure-compensating balloon (24).

[0020] Figure 2 It shows Figure 1 A cross-sectional view of the artificial sphincter in the inflated state of the occlusion device (20). The occlusion device (20) inflates automatically and gradually after its contraction to allow the patient to urinate. When the bulb is squeezed or otherwise compressed, the pressurized fluid contained in the bulb is transferred to the stretchable fluid reservoir (23). Once the bulb is squeezed, the bulb (433) blocks the path to the occlusion device (20). There is always free flow of pressurized fluid between the pressure-compensating balloon (24) and the occlusion device (20). Figure 8.1 As shown, once the bulb (6) of the pump (7) is squeezed, the pressurized fluid contained in the bulb (6) is transferred to the stretchable fluid reservoir (23). Once the patient releases the bulb (6), the pressurized fluid flows from the pressure-compensating balloon (24) toward the occlusion device (20) and toward the bulb (6). After multiple squeezing and releasing, all the fluid contained in the bulb is transferred to the outside of the bulb. Simultaneously, the fluid contained in the occlusion device (20) is completely transferred to the stretchable fluid reservoir (23). exist Figure 2 In the diagram, the arrows shown around the stretchable fluid reservoir (23) indicate that the stretchable fluid reservoir (23) retracts due to the transfer of pressurized fluid from the stretchable fluid reservoir (23) toward the pressure compensation balloon (24) and thus toward the occlusion device (20). This fluid transfer is caused by the patient's abdominal pressure. The dashed lines around the stretchable fluid reservoir (23) correspond to the state of the stretchable fluid reservoir (23) in the contracted state of the occlusion device (20).

[0021] The balloon retainer (11) establishes fluid communication between the stretchable fluid reservoir (23) and the pressure-compensating balloon (24). The balloon retainer (11) has a lumen (28) to which the stretchable fluid reservoir (23) is attached. The other end of the lumen (28) of the balloon retainer (11) is connected to the pump (7) via a second tube (8).

[0022] The stretchable fluid reservoir (23) is made of an elastic material that can be stretched, such that, in the stretched state, the pressure of the pressurized fluid contained in the reservoir (23) is greater than the patient's abdominal pressure due to the stretching of the elastic material. The automatic and gradual transfer of pressurized fluid from the pressure-compensating balloon (24) to the occlusion device is initiated by the internal pressure of the stretchable fluid reservoir (23).

[0023] A semi-permeable check valve (30) is located in the lumen (28) of the balloon retainer (11). The semi-permeable check valve (30) fully allows fluid from the second tube (8) to flow toward the stretchable fluid reservoir (23). However, the semi-permeable check valve (30) only allows a limited flow rate in the opposite direction, i.e., fluid flows from the stretchable fluid reservoir (23) toward the second tube (8) or the remainder of the lumen (28) of the balloon retainer (11). When pressurized fluid comes from the second tube (8), for example during the contraction of the occluder (20), the fluid pushes the ball (35) toward the stretchable fluid reservoir (23), causing the spring (44) to compress. Once the spring is compressed, all fluid from the second tube (8) passes around the ball (35) and flows into the stretchable fluid reservoir (23).

[0024] A pressure-sensitive check valve (3) is located in the lumen (28) of the balloon retainer (11). The pressure-sensitive check valve (3) establishes fluid communication between the lumen (11) and the pressure-compensating balloon (24). The pressure-sensitive check valve (3) allows all fluid from the pressure-compensating balloon (24) to flow toward the lumen (28), and thus toward the closure device (20) via the second tube (8) and the first tube (9).

[0025] Figure 3 It shows Figure 1 A cross-sectional view of the artificial sphincter in the contracted state of the occlusion device (20). The occlusion device (20) is connected to the first port (13) of the pump (7) via a first pipe (9). The pressurized fluid contained in the occlusion device (20) is partially transferred via the first pipe (9) to the bulb (6) of the pump (7) and partially transferred to the stretchable fluid reservoir (23) during its expanded state. The arrows shown around the stretchable fluid reservoir (23) indicate that the volume of the stretchable fluid reservoir (23) increases due to the additional volume of pressurized fluid transferred from the occlusion device (20), from the bulb (6) of the pump (7), and also from the pressure compensation balloon (24).

[0026] Figure 4 It shows Figure 2 and Figure 3The image shows a cross-sectional view of the semi-permeable check valve (30). The semi-permeable check valve (30) may include a spring (44) and a ball (35) housed in a recessed support (39). The recessed support (39) has a recess (40) for allowing restricted fluid flow from the stretchable fluid reservoir (23) toward the lumen (28) of the balloon retainer (11). While the semi-permeable check valve (30) allows all fluid from the lumen (28) to flow toward the stretchable fluid reservoir (23), the recess (40) allows only a very limited flow rate in the opposite direction.

[0027] Although Figure 4 The semi-permeable check valve (30) given herein comprises a conventional combination of a spring (44) and a ball (35) housed in a support, but it may be composed of other check valve constructions. The recess (40) makes the semi-permeable check valve (30) unique and particularly semi-permeable, allowing limited fluid flow in the opposite direction, i.e., from the stretchable fluid reservoir (23) toward the lumen (28) of the airbag retainer (11).

[0028] Figure 6 An alternative embodiment of the semi-permeable check valve (30) is shown, wherein a recessed ball (45) is housed in an annular support (36). The recessed ball (45) has a plurality of recesses (37) on its outer surface, such that a restricted reverse flow of fluid from the stretchable fluid reservoir (23) can be established through the gap between the recesses and the annular support (36). Although it is not actually necessary to have recesses (40) in the annular support (36), one or more recesses (40) may be formed on the annular support (36) if an increase in the reverse flow rate is required.

[0029] Figure 7 Another alternative embodiment of the semi-permeable check valve (30) is shown, wherein a ball with a smooth surface is accommodated in a notch support (39) having a plurality of recesses (40). In this configuration, reverse flow, i.e., flow from the stretchable fluid reservoir (23) toward the lumen (28), can be established through the plurality of gaps between the recesses (40) of the notch support (39) and the ball (42).

[0030] Figure 5a It shows Figure 2 and Figure 3 The diagram provided is a 2D cross-sectional view of a pressure-sensitive check valve. Figure 5bA 3D schematic perspective view of the same pressure-sensitive check valve (3) is shown. The pressure-sensitive check valve (3) is located between the lumen of the pressure-compensating balloon (24) and the balloon retainer (11). The pressure-sensitive check valve (3) always allows fluid to flow from the pressure-compensating balloon (24) toward the lumen (28), such that the fluid contained in the pressure-compensating balloon (24) can flow freely toward the inflatable occluder (20), and in use, a sudden increase in pressure in the patient's abdomen is immediately transmitted to the inflatable occluder (20) to prevent leakage.

[0031] The pressure-sensitive check valve (3) includes a ball (33) that floats freely within a recess (34). The density of the ball (33) is substantially close to the density of the pressurized fluid contained in the artificial sphincter (1) proposed in this invention. Figure 5b As shown, the recess (34) of the pressure-sensitive check valve (3) has a through seat (32) at its end closer to the lumen (28) of the balloon retainer (11). Figure 5b As shown, the geometry of the through seat (32) ensures that fluid always flows toward the lumen even when the sphere (33) rests against the through seat (32) with a rectangular barrier, thus ensuring fluid passage around the sphere (33). The recess (34) has a smooth circular seat that can be blocked at its other end by the sphere (33) when the fluid pressure in the lumen (28) is greater than the fluid pressure in the pressure compensation balloon (24). The check valve (3) is designated as a "pressure-sensitive check valve (3)" because it only prevents fluid from flowing toward the pressure compensation balloon (24) when the fluid pressure in the pressure compensation balloon (24) is significantly less than the fluid pressure in the lumen (28) of the balloon retainer (11).

[0032] Compared to the semi-permeable check valve (30), the pressure-sensitive check valve (3) located in the lumen (28) of the balloon retainer (11) is closer to the second tube (8).

[0033] Return to Figure 2 The occlusion device (20) is depicted as being in an inflated state, the pressure-compensating balloon (24) as being in its inflated form, and the stretchable fluid reservoir (23) as being in its retracted form. In this state, i.e., the occlusion device is in its inflated state, pressurized fluid can flow freely toward the occlusion device (20) at any time. The pressure-sensitive check valve (3) always allows fluid to flow from the pressure-compensating balloon (24) to the lumen (28) and thus to the occlusion device (20). Because the fluid contained in the pressure-compensating balloon (24) can flow freely toward the inflatable occlusion device (20), a sudden increase in pressure in the patient's abdomen is immediately transmitted to the inflatable occlusion device (20), resulting in better prevention of leakage.

[0034] Figure 3 It shows Figure 1 A cross-sectional view of the artificial sphincter in the contracted state of the occlusion device (20). When Figure 3 When the pressure compensation balloon (24) is in its retracted state, the expansion of the pressure compensation balloon (24) will begin simultaneously with the expansion of the occlusion device (20). When the occlusion device (20) expands, the system reaches an equilibrium state, in which the fluid pressure in the occlusion device (20), the stretchable fluid reservoir (23), and the pressure compensation balloon (24) is stable.

[0035] The state of equilibrium corresponds to the occlusion of the body tubes and the patient having established his or her self-control. (Return) Figure 5a and 5b Once near equilibrium is reached, the sphere (33) floats freely within the cavity (34). This indicates that the pressure-sensitive check valve (3) no longer prevents the pressurized fluid from flowing in both directions. Once near equilibrium, the pressure-compensating balloon (24) inflates and presents as shown in the image. Figure 2 As shown in the figure.

[0036] A balanced state is established by a semi-permeable check valve (30), which allows restricted flow from the stretchable fluid reservoir (23) to the lumen (28) of the balloon retainer (11). Overpressure in the stretchable fluid reservoir (23) is smoothly and slowly reduced by the semi-permeable check valve (30), which establishes restricted reverse flow from the stretchable fluid reservoir (23). Once the fluid pressure in the lumen (28) has stabilized smoothly and slowly, the pressure-sensitive check valve (3) opens to flow toward the pressure-compensating balloon (24) and inflates it. The fluid pressures in the occlusion device (20), the stretchable fluid reservoir (23), and the pressure-compensating balloon (24) stabilize and reach a balanced state with the fully inflated occlusion device (20).

[0037] Figure 8.1 A semi-schematic cross-sectional view of a pump (7) used with an artificial sphincter according to the invention is shown. The pump (7) ball is depicted as being in a state where the pump ball is being squeezed. For all Figures 8.1 to 8.5 The dashed arrows indicate the direction of flow of the pressurized fluid unless marked with an "x". In this embodiment of the pump (7), the pump has a check valve (442) that prevents flow from the pump ball (6) toward the stretchable fluid reservoir (23). The check valve (442) only allows pressurized fluid to flow toward the pump ball (7).

[0038] Figure 8.2 It shows Figure 8.1The pump implementation described herein is in the state when the pump ball is released. When the patient stops squeezing the ball, the ball returns to its original shape and volume. During this state, i.e., when the ball returns to its initial shape, there is a flow of pressurized fluid toward the ball, such as... Figure 8.2 As shown. The semi-rigid check valve (431) prevents flow from the closure device (20) toward the pump ball (6).

[0039] Figure 8.2 The flow path of pressurized fluid in the artificial sphincter (1) during contraction of the occlusion device (20) is shown. The pressurized fluid contained in the occlusion device (20) flows into the bulb (6) of the pump (7) via the first tube (9). During contraction, the pressurized fluid contained in the pressure compensation balloon (24) can also flow toward the bulb (6) of the pump (7) due to abdominal pressure. However, as Figure 8.1 As shown, each time the sphere is compressed, the fluid inside the sphere flows toward the stretchable fluid reservoir (23). Figure 8.1 As described, when the flow toward the occlusion device (20) is blocked by the semi-rigid check valve (431), the action of squeezing and releasing the ball causes the fluid contained in the occlusion device (20) to be discharged. In this state, the occlusion device (20) opens the body tube, and the patient can urinate or defecate freely.

[0040] Figure 8.3 The pump is shown during the inflation of the occlusion device (20). During the automatic inflation of the occlusion device (20), when the bulb (6) is full, the pressurized fluid present in the pressure compensation balloon (24) can no longer flow into the pump bulb. When the bulb (6) is full of pressurized fluid, the pressurized fluid will gradually flow toward the occlusion device (20) and also toward the pressure compensation balloon (24), filling both simultaneously until the occlusion device (20) is fully inflated and the patient self-inflicts the fluid again. When the artificial sphincter (1) is close to equilibrium, the fluid pressure in the stretchable fluid reservoir (23) is equal to the pressure in the compensation balloon (24) and the occlusion device (20).

[0041] Contraction of the blocking device: When the patient needs to urinate, the patient should squeeze and release the pump bulb (6) several times, usually 3 or 4 times is sufficient to transfer all the fluid contained in the occlusion device (20) and the pressure-compensating balloon (24) into the stretchable fluid reservoir (23). Figure 8.1 As shown, when the sphere is compressed, the fluid inside the sphere enters the stretchable fluid reservoir (23). Since the pump has a check valve (431) that prevents flow toward the shut-off device (20), there is no fluid flowing toward the shut-off device (20). However, when the sphere (6) is released, the pressurized fluid in the shut-off device (20) is drawn out and partially enters the sphere. Figure 8.2 As shown, when the bulb is released, the bulb (6) draws in the fluid contained in the pressure-compensating balloon (24). A check valve (442) allows fluid from the pressure-compensating balloon (24) to fill the bulb (6) in the pump (7). With each squeeze and release of the bulb, the volume of fluid contained in both the occlusion device (20) and the pressure-compensating balloon (24) decreases simultaneously, and typically after 3-5 squeezes and releases, there is no pressurized fluid remaining in either the occlusion device (20) or the pressure-compensating balloon (24). The patient is now able to urinate freely.

[0042] Expansion of the blocking device: The occlusion device expands automatically due to the patient's abdominal pressure and the increased pressure generated by the stretching of the walls of the stretchable fluid reservoir (23). Because the fluid previously present in the occlusion device (20) and the pressure-compensating balloon (24) is diverted to the stretchable fluid reservoir (23), the internal pressure of the stretchable fluid reservoir (23) is very high, not only because the reservoir (23) is in its stretched form but also because of the patient's abdominal pressure. The expansion of the occlusion device (20) occurs gradually because the semi-permeable check valve (30) only allows restricted reverse fluid flow toward the lumen (28) of the balloon retainer (11). The semi-permeable check valve (30) has a small recess (40) that impedes reverse flow from the stretchable fluid reservoir (23) toward the lumen (28). However, the restricted reverse fluid flow simultaneously fills both the balloon (6) and the occlusion device (20). Figure 8.3 As shown, once the sphere (6) is filled, the reverse flow from the stretchable fluid reservoir (23) begins to cause the closure device (20) to expand. Although the sphere (6) can be compressed and retracted in size, the sphere (6) cannot expand beyond its initial volume.

[0043] Once the restricted flow from the stretchable fluid reservoir (23) causes the occlusion device (20) to inflate, the artificial sphincter (1) according to the invention reaches a nearly stable form, and finally the reverse flow from the stretchable fluid reservoir (23) flows through and fills the pressure-compensating balloon (24). The patient can now urinate at will, and the artificial sphincter (1) is now sensitive to sudden changes in abdominal pressure that occur during laughter, coughing, etc. The gradual and automatic inflation of the occlusion device (20) is usually completed within about 3 minutes, during which time the patient can urinate freely.

[0044] like Figures 8.1 to 8.6As shown, the semi-rigid check valve (431) includes a resilient lip (432), a ball (433), and a seat (434). The ball (433) is typically housed between the seat (434) and the resilient lip (432). In this position, the semi-rigid check valve (431) prevents pressurized fluid from flowing toward the pump ball (6). The ball (433) remains on the seat (434) unless the pump ball is compressed. Figure 8.4 As shown, once the sphere (6) is compressed, the liquid pressure pushes the sphere (433) and thus the elastic lip (432), causing the sphere to displace and block the flow path toward the closure device (20). In this position, the elastic lip (432) bends toward the opening (435) directly above it. Figure 8.5 As depicted, when the elastic lip (432) bends toward the opening (435), it does not block the opening (435) and allows fluid from around the sphere (433) to pass through and flow toward the stretchable fluid reservoir (23).

[0045] like Figure 8.6 As shown, the name "semi-rigid check valve (431)" derives from the limited bending position of the elastic lip (432). Once the elastic lip (432) bends toward the opening (435), the fluid contained in the ball flows around the ball (433) and through the opening (435) toward the stretchable fluid reservoir (23). Typically, after multiple (usually 3-4) squeezes and releases of the ball by the patient, all the fluid contained in the pump ball (6) is able to be transferred to the stretchable fluid reservoir (23). Figure 8.4 and Figure 8.5 As shown in the close-up image, the sphere (433) prevents fluid from flowing toward the closure device (20) at its misaligned position. The arrow marked with "x" indicates that there is no flow in the direction of the arrow. Figure 8.5 The arrows given by the dashed lines in the middle show the flow path of pressurized fluid around the sphere (433) when the sphere (6) is squeezed and the elastic lip (432) bends.

Claims

1. An artificial sphincter (1) containing a pressurized fluid during use, said artificial sphincter (1) comprising: An expandable occlusion device (20) for occluding body passages. Stretchable fluid reservoir (23), A pump device (7) having a first port (13) in fluid communication with the closure device (20) via a first pipe (9) and a second port (14) in fluid communication with the fluid reservoir (23) via a second pipe (8) for selectively transferring pressurized fluid from the closure device to the reservoir to cause the closure device to contract, thereby opening blocked body passages. A balloon retainer (11) having a lumen (28) establishes fluid communication between the fluid reservoir (23) and the second tube (8). A pressure-compensating balloon (24), which is in fluid communication with the lumen of the balloon retainer (11), and which will be implanted into the patient's abdomen during use, The artificial sphincter (1) is characterized in that it further comprises; A semi-permeable check valve (30) is located in the lumen (28) of the balloon retainer (11), wherein the semi-permeable check valve (30) always allows fluid from the second tube (8) to flow toward the stretchable fluid reservoir (23), and wherein the semi-permeable check valve (30) only allows restricted fluid to flow from the stretchable fluid reservoir (23) toward the second tube (8). A pressure-sensitive check valve (3) is located between the pressure-compensating balloon (24) and the lumen of the balloon retainer (11), wherein the pressure-sensitive check valve (3) always allows fluid to flow from the pressure-compensating balloon (24) toward the lumen (28), such that the fluid contained in the pressure-compensating balloon can flow freely toward the inflatable occluder (20), and in use, a sudden increase in pressure in the patient's abdomen is immediately transmitted to the inflatable occluder (20), and wherein the pressure-sensitive check valve (3) only prevents fluid from flowing toward the pressure-compensating balloon (24) when the fluid pressure in the pressure-compensating balloon (24) is significantly less than the fluid pressure in the lumen (28) of the balloon retainer (11).

2. The artificial sphincter (1) according to claim 1, wherein, The semi-permeable check valve (30) has a notch support (39) with one or more recesses (40) such that a restricted fluid flow is established through the recesses (40) from the stretchable fluid reservoir (23) toward the second pipe (8).

3. The artificial sphincter (1) according to claim 1, wherein, The semi-permeable check valve (30) has an annular support (36) and a recessed ball (45) having a plurality of recesses (37) such that a restricted fluid flow is established through the recesses (37) from the stretchable fluid reservoir (23) toward the second pipe (8).

4. The artificial sphincter (1) according to claim 1, wherein, The pressure-sensitive check valve (3) has a ball (33) located in a recess (34) that allows fluid to flow from the lumen (28) toward the pressure-compensating balloon (24) only during the expansion of the closure device (20).

5. The artificial sphincter (1) according to claim 1, wherein, The pressure-sensitive check valve (3) has a ball (33) and a through seat (32) located between the ball (33) and the lumen (28), and ensures that the ball (33) always allows fluid to flow from the pressure-compensating balloon (24) toward the lumen (28) due to its spherical geometry.

6. The artificial sphincter (1) according to claim 5, wherein, A through seat (32) is disposed between the sphere (33) and the lumen (28) to ensure that the pressurized fluid around the sphere (33) flows freely toward the lumen.

7. The artificial sphincter (1) according to claim 4, wherein, The density of the sphere (33) is substantially equal to the density of the pressurized fluid, allowing the sphere to float freely within the recess (34).

8. The artificial sphincter (1) according to claim 1, wherein, The check valve in the pump assembly (7) is arranged such that the pressurized fluid in the pressure compensation balloon (24) can always flow freely toward the closure device (20).

9. The artificial sphincter (1) according to claim 1, wherein, The reservoir (23) is made of an elastic material that can be stretched, such that, in the stretched state, the pressure of the pressurized fluid contained in the reservoir (23) is greater than the abdominal pressure of the patient due to the stretching of the elastic material.

10. The artificial sphincter (1) according to claim 1, wherein, The pump device (7) has a sphere (6) containing pressurized fluid and, when compressed, the sphere delivers the pressurized fluid to the reservoir (23).

11. The artificial sphincter (1) according to claim 1, wherein, Compared to the semi-permeable check valve (30), the pressure-sensitive check valve (3) in the lumen (28) of the balloon retainer (11) is closer to the second tube (8).

12. The artificial sphincter (1) according to claim 1, wherein, The size and shape of the occlusion device (20) are configured to occlude the anal canal or urethra of a human.

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