Expandable device with excessive pressuring preventive means

Abstract

To provide a device including an expandable member, a pump configured to transfer fluid to the expandable member, and a housing joined to the expandable member and the pump in an operable manner.SOLUTION: A housing defines a cavity. The housing includes a base member arranged in the cavity defined by the housing, and a seal member arranged in the cavity defined by the housing. The seal member is configured so as to move to the base member.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. Provisional Patent Application No. 18 / 172,921, entitled "INFLATABLE DEVICE WITH OVER-PRESSURIZATION PREVENTION," filed February 22, 2023, which claims priority to U.S. Provisional Patent Application No. 63 / 268,650, entitled "INFLATABLE DEVICE WITH OVER-PRESSURIZATION PREVENTION," filed February 28, 2022, the disclosures of which are incorporated herein by reference in their entireties.

[0002] This application also claims priority to U.S. Provisional Patent Application No. 63 / 268,650, filed February 28, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0003] The present disclosure relates generally to body implants, and more particularly to body implants that include pump and overpressurization features. [Background technology]

[0004] Inflatable implants often include one or more pumps to regulate fluid flow between different parts of the implantable device. In some cases, inflatable implants are used as artificial urinary sphincters. For example, an inflatable cuff can be implanted to surround the urethra. The cuff can be inflated to apply pressure to the urethra and prevent urine from passing through. The cuff can be deflated to allow the patient to urinate. If the cuff presses too hard against the urethra, problems such as erosion of the cuff through the urethra can occur. Some solutions to this problem include electronic sensors, such as fluid or pressure sensors. However, such solutions have drawbacks. For example, many inflatable implants are made of elastomers, which are subject to deformation and stretching, making them less than ideal for electronic fluid or pressure sensors. Therefore, a mechanical means for controlling the pressure of the inflatable implant is needed. Summary of the Invention

[0005] In a general aspect, the device includes an inflatable member, a pump configured to transfer fluid to the inflatable member, and a housing operably coupled to the inflatable member and the pump. The housing defines a cavity. The housing includes a base member disposed within the cavity defined by the housing, and a seal member disposed within the cavity defined by the housing. The seal member is configured to move relative to the base member.

[0006] In some embodiments, the seal member is configured to form a fluid seal with an interior surface of the housing.

[0007] In some embodiments, the housing includes a biasing member disposed within a cavity defined by the housing, the biasing member being disposed between the base member and the seal member. In some embodiments, the housing includes a spring member disposed within a cavity defined by the housing, the spring member being disposed between the base member and the seal member.

[0008] In some embodiments, the housing includes a protrusion extending from an inner surface of the housing. In some embodiments, the housing includes a protrusion extending from the inner surface of the housing and into a cavity defined by the housing, the protrusion configured to engage the seal member.

[0009] In some embodiments, the housing includes an adjustment member, the adjustment member configured to engage the base member. In some embodiments, the housing includes a threaded member, the threaded member configured to engage the base member.

[0010] In some embodiments, the housing is operably coupled to the pump via a tubular member.In some embodiments, the housing is operably coupled to the inflatable member via a tubular member.

[0011] In some embodiments, the expandable member is configured to be placed near the patient's urethra, hi some embodiments, the expandable member is an inflatable cuff member.

[0012] In some embodiments, the device includes a reservoir, the reservoir operably coupled to the housing and configured to receive the fluid. In some embodiments, the device includes a reservoir, the reservoir operably coupled to the housing via a tubular member and configured to receive the fluid. In some embodiments, the device includes a reservoir, the reservoir operably coupled to the housing and configured to receive the fluid, the housing including a protrusion extending from an inner surface of the housing.

[0013] According to another embodiment, an apparatus includes an inflatable member, a pump configured to transfer fluid to the inflatable member, and a housing operably coupled to the inflatable member and the pump, the housing defining a cavity, the housing including a sealing member disposed within the cavity defined by the housing, the sealing member configured to move from a first position within the cavity of the housing to a second position within the cavity of the housing, and the housing including a biasing member configured to engage the sealing member and bias the sealing member toward the first position.

[0014] In some embodiments, the housing includes a protruding member extending from an inner surface of the housing, the protruding member configured to engage the seal member when the seal member is in the first position. In some embodiments, the housing includes a base member disposed within a cavity defined by the housing. In some embodiments, the housing includes a base member disposed within the cavity defined by the housing, the biasing member being disposed between the base member and the seal member. In some embodiments, the inflatable member is an inflatable cuff and is configured to be positioned near the patient's urethra and apply pressure to the urethra. [Brief explanation of the drawings]

[0015] [Figure 1] FIG. 1 is a block diagram of an apparatus according to one aspect. [Figure 2] 1 is a perspective view of an apparatus according to one embodiment. [Figure 3] 3 is a schematic view of the device of FIG. 2 with the seal member in a first position. [Figure 4] 3 is a schematic view of the device of FIG. 2 with the seal member in a second position. [Figure 5] FIG. 3 is a perspective view of the housing of the device of FIG. 2. [Figure 6] FIG. 3 is a schematic diagram of a pump or pump assembly of the device of FIG. 2. [Figure 7] 1 is a schematic diagram of an apparatus according to one embodiment. [Figure 8]FIG. 1 is a block diagram of an apparatus according to one aspect. DETAILED DESCRIPTION OF THE INVENTION

[0016] Detailed embodiments are disclosed herein. However, it is understood that the disclosed embodiments are merely exemplary and can be embodied in various forms. Therefore, the specific structural and functional details disclosed herein should not be construed as limiting, but merely as a basis for the claims and as a representative basis for teaching those skilled in the art how to variously employ the embodiments in substantially any appropriately detailed structure. Furthermore, the terms and phrases used herein are not intended to be limiting, but rather to provide an understandable description of the present disclosure.

[0017] The terms "a" or "an," as used herein, are defined as one or more than one. The term "another," as used herein, is defined as at least a second or more. The terms "including" and / or "having," as used herein, are defined as comprising (i.e., an open transition). The terms "coupled" or "movably coupled," as used herein, are defined as connected, although not necessarily directly and mechanically.

[0018] In general, embodiments are directed to body implants. Hereinafter, the terms patient or user may be used to refer to a person who will benefit from the medical devices or methods disclosed in this disclosure. For example, a patient may be a person whose body has a medical device or a method disclosed for operating a medical device according to the present disclosure implanted in it.

[0019] FIG. 1 is a block diagram of an exemplary inflatable implant or device 100. Device 100 includes a pump 110, an inflatable member 120, and a housing 130. Housing 130 is operably coupled to pump 110 and inflatable member 120. The pump is configured to facilitate the transfer of fluid to and from the inflatable member. In some embodiments, pump 110 is an electric pump. In other embodiments, pump 110 is a manual pump. The device may also include a fluid control system including fluid components, such as one or more valves, configured to facilitate the transfer of fluid to and from inflatable member 120. In some embodiments, pump or pump assembly 110 is configured to move fluid between a fluid reservoir and inflatable member 120. In some embodiments, the fluid reservoir is disposed within or is part of pump or pump assembly 110.

[0020] The expandable member 120 is configured to be disposed in an inflated configuration and a deflated configuration. Specifically, fluid can be pumped or moved by a pump through the expandable member 120 to place the expandable member 120 in the inflated configuration. The fluid can then be removed or at least partially removed from the expandable member 120 to place the expandable member 120 in the deflated configuration.

[0021] The housing 130 defines a cavity 132 and includes a seal member 134. The seal member 134 is configured to form a fluid chamber 136 within the cavity 132 of the housing 130. The seal member 134 is configured to move within the cavity 132 of the housing 130. Thus, as the seal member 134 moves, a smaller or larger fluid chamber is formed. When the seal member 134 is positioned to form a larger fluid chamber, the pressure within the expandable member 120 is less than when the seal member 134 is positioned to form a smaller fluid chamber. In some embodiments, the seal member 134 can be biased, but if the pressure within the expandable member 120 is too great (or exceeds a desired amount), the seal member 134 can be moved against the bias to increase the size of the fluid chamber and reduce (or stabilize) the pressure within the expandable member 120.

[0022] In use, the expandable implant or device 100 can be implanted within a patient's body. In some cases, the expandable implant or device 100 is an artificial urinary sphincter. In such embodiments, the device 100 can be implanted within the patient's pelvic region. The expandable member 120 can be positioned to apply pressure to the patient's urethra. In other embodiments, the device is a different type of expandable implant and is positioned or configured to be positioned at a different location within the patient's body.

[0023] Figures 2-6 illustrate an apparatus 200 according to one embodiment. Figure 2 is a perspective view of the apparatus 200. Figure 3 is a schematic view of the apparatus 200 with the seal member in a first position. Figure 4 is a schematic view of the apparatus 200 with the seal member in a second position. Figure 5 is a perspective view of the housing of the apparatus 200. Figure 6 is a schematic view of a pump or pump assembly of the apparatus 200.

[0024] Device 200 includes a pump 210, an inflatable member 220, and a housing 230. Housing 230 is operably coupled to pump 210 and inflatable member 220. In the illustrated embodiment, a tubular member 212 (such as kink-resistant tubing) operatively and fluidly couples housing 230 to pump 210. Similarly, a tubular member 214 (such as kink-resistant tubing) operably and fluidly couples housing 230 to inflatable member 220.

[0025] In some embodiments, the pump is configured to facilitate the transfer of fluid to and from the inflatable member 220. In some embodiments, the pump 210 is an electric pump. In other embodiments, the pump 210 is a manual pump. In some embodiments, the device can also include a fluid control system including fluid components, such as one or more valves, configured to facilitate the transfer of fluid to and from the inflatable member 220.

[0026] In some embodiments, as best shown in Figure 6, device 200 includes a pump or pump assembly 210. Electronic pump assembly 210 may be an example of pump or pump assembly 210 of Figure 1 and / or electronic pump assembly 210 may include any of the details described with reference to device 100 of Figure 1.

[0027] The electronic pump assembly 210 is configured to transfer fluid to and from the inflatable member 220. In some embodiments, the electronic pump assembly 210 is configured to transfer fluid between a fluid reservoir (such as fluid reservoir 211 in FIG. 6 ) and the inflatable member. In some embodiments, the fluid reservoir 211 is integrated into the pump assembly 210. In other embodiments, the fluid reservoir 211 is separate from the pump or pump assembly 210. The electronic pump assembly 210 can automatically transfer fluid between the fluid reservoir and the inflatable member without the user having to manually operate the pump (e.g., by squeezing and releasing a pump valve).

[0028] The electronic pump assembly 210 includes a pump 220-1 disposed in a fluid passage 227-1 (e.g., a fill passage) and an active valve 218-1 disposed in a fluid passage 224-1 (e.g., a void passage). The pump 220-1 may be an electromagnetic pump or a piezoelectric pump. The pump 220-1 may include a passive check valve 223-1 and a passive check valve 225-1. The fluid passage 227-1 may be a separate (and parallel) fluid branch from the fluid passage 224-1. The fluid passage 227-1 is a passage that transfers fluid from a fluid reservoir to the inflatable member. The fluid passage 224-1 is a passage that transfers fluid from the inflatable member to the fluid reservoir. The pump 220-1 is disposed in parallel with the active valve 218-1.

[0029] In some examples, electronic pump assembly 210 may include active valve 219-1 in series with pump 220-1 (e.g., pump 220-1 and active valve 219-1 are disposed in fluid passage 227-1). In some examples, electronic pump assembly 210 may include pump 220-2 in series with active valve 218-1 (e.g., pump 220-2 and active valve 218-1 are disposed in fluid passage 224-1). Pump 220-2 may be an electromagnetic pump or a piezoelectric pump. Pump 220-2 may include passive check valves 223-1 and 225-1. In some examples, electronic pump assembly 206 includes active valve 248-1 in fluid communication with fluid reservoir 211. Active valve 248-1 may be in series with either active valve 218-1 (and pump 220-2) or pump 220-1 (and active valve 219-1). In some embodiments, electronic pump assembly 210 includes active valve 252-1 in fluid communication with the inflatable member. Active valve 252-1 may be in series with either active valve 219-1 (and pump 220-1) or pump 220-2 (and active valve 218-1).

[0030] Active valve 248-1, pump 220-1, active valve 218-1, active valve 252-1, active valve 218-1, and pump 220-2 may be electronically controlled by a controller and / or driver. Pump 220-1 and pump 220-2 may be unidirectional or bidirectional. With respect to fluid path 227-1, in some embodiments, pump 220-1 and active valve 219-1 may swap positions (e.g., when active valve 219-1 is in series between active valve 248-1 and pump 220-1). With respect to fluid path 224-1, in some embodiments, active valve 218-1 and pump 220-2 may swap positions (e.g., when pump 220-2 is in series between active valve 218-1 and active valve 248-1).

[0031] In some embodiments, one or more additional active valves and / or one or more additional pumps are disposed in series in fluid passage 227-1. In some embodiments, one or more additional active valves and / or one or more additional pumps are disposed in series in fluid passage 324-1. In some examples, electronic pump assembly 210 can include one or more additional (and parallel) fluid passages, each of which can include one or more active valves and one or more pumps.

[0032] The expandable member 220 is configured to be disposed in an inflated configuration and a deflated configuration. Specifically, fluid can be pumped or moved into the expandable member 220 by the pump 210 to place the expandable member 220 in the inflated configuration. The fluid can then be removed or at least partially removed from the expandable member 220 to place the expandable member 220 in the deflated configuration. In some embodiments, the pump 210 is configured to move fluid from the expandable member 220 to place the expandable member 220 in the deflated configuration.

[0033] In the illustrated embodiment, the expandable member 220 is an inflatable cuff (or forms a circle). Thus, the device 200 can be used as an artificial sphincter, with the expandable member 220 or cuff positioned to surround or otherwise compress the patient's urethra. In other embodiments, the expandable member has a different shape. In some other embodiments, the expandable member has a different shape and can be positioned at a different location within the patient's body. For example, in some embodiments, the expandable member can have a planar or tubular shape when positioned in the expanded configuration.

[0034] As best shown in FIGS. 3 and 4 , the housing 230 defines a cavity 232 and includes a seal member 234. The seal member 234 is configured to form a fluid chamber 236 within the cavity 232 of the housing 230. In the illustrated embodiment, the seal member 234 extends from a first portion 244 of an inner surface 242 of the cavity 232 to a second portion 246 of the inner surface 242 of the cavity 232. The seal member 234 forms a fluid seal with the inner surface 242 of the cavity 232. Thus, a fluid chamber 248 is formed within the cavity 232. The fluid chamber 248 is configured to receive and contain a fluid. A second chamber 249 is also formed within the cavity 232 opposite the fluid chamber 248 (the seal member 234 is disposed between the fluid chamber 248 and the second chamber 249). The fluid is configured to remain within the fluid chamber 248 but outside the second chamber 249.

[0035] The seal member 234 is configured to move within the cavity 232 of the housing 230. Figure 3 shows the seal member 234 in a first position. Figure 4 shows the seal member 234 in a second position. As the seal member 234 moves, a smaller (as shown in Figure 3) or larger (as shown in Figure 4) fluid chamber 248 is formed.

[0036] When seal member 234 is positioned so that a larger fluid chamber 248 is formed (as shown in FIG. 4), the pressure within expandable member 220 is less than when seal member 234 is positioned so that a smaller fluid chamber is formed (as shown in FIG. 3).

[0037] In the illustrated embodiment, the housing 230 includes a stop member 262, a biasing member 264, a base member 266, and an adjustment member 268. The biasing member 264 is disposed between and engaged with the base member 266 and the seal member 234. The biasing member 264 is configured to engage the seal member 234 to bias or urge the seal member 234 toward the first position (such that the smaller fluid chamber 248 is formed), as shown in FIG. 3 . The stop member 262 is a protrusion or other member configured to engage the seal member 234 to help retain the seal member 234 in the first position. In the illustrated embodiment, the stop member 262 extends from the sidewall of the housing 230 and into the cavity 232 defined by the housing 230. In other embodiments, the stop member 262 can be a different shape or located in a different position.

[0038] In the illustrated embodiment, biasing member 264 is a spring or spring member. In other embodiments, biasing member 264 is a different type of biasing member. For example, in some embodiments, the biasing member can be a rod or piston mechanism.

[0039] In some embodiments, the seal member 234 can be configured such that when the pressure within the expandable member 220 becomes too great (or exceeds a desired amount), the seal member 234 moves against the bias to expand the size of the fluid chamber and reduce (or stabilize) the pressure within the expandable member 220. In other words, when the pressure within the expandable member 220 becomes too great (or exceeds a desired amount), the seal member 234 is moved from a first position (as illustrated in FIG. 3 ) to a second position (as illustrated in FIG. 4 ) to expand the size of the fluid chamber to reduce (or stabilize) the pressure within the expandable member 220. The amount of bias on the seal member 234 can be set such that the seal member 234 moves when the expandable member reaches a threshold pressure. For example, the spring constant of the bias member 264 can be selected such that the seal member 234 moves when the expandable member 220 reaches a desired amount of pressure.

[0040] In the illustrated embodiment, base member 266 is configured to move within cavity 232. Movement of base member 266 within the cavity can adjust the amount of force that biasing member 264 applies to seal member 234. Adjustment member 268 is configured to engage base member 266 to move base member 266 within cavity 232 of housing 230. In some embodiments, adjustment member 268 is a threaded member, such as a set screw. In other embodiments, adjustment member 268 is a different type of adjustment mechanism. For example, in some embodiments, adjustment member 268 can be a movable rod or a piston mechanism.

[0041] 5, adjustment member 268 can be set (and thereby move base member 266) as desired from outside housing 230. In the illustrated embodiment, adjustment member 268 includes an indicator 272. Housing 230 includes markings 274 that indicate pressure. Adjustment member 268 can be rotated, for example, by a physician, to set the position of base member 266 and thereby set the pressure of inflatable member 220, which in turn moves seal member 234.

[0042] In use, the expandable implant or device 200 can be implanted within a patient. As discussed above, in some cases, the expandable implant or device 200 is an artificial urinary sphincter. In such embodiments, the device 200 may be implanted within the patient's pelvic region. The expandable member 220 can be positioned to apply pressure to the patient's urethra. In other embodiments, the device is a different type of expandable implant and is positioned or configured to be positioned at a different location within the patient's body.

[0043] 7 is a schematic diagram of an apparatus 300 according to one embodiment. Device 300 includes a pump 310, an inflatable member 320, a housing 330, and a reservoir 390. Housing 330 is operably coupled to pump 310 and inflatable member 320. Housing 330 is also operably coupled to reservoir 390. The pump is configured to facilitate the transfer of fluid to and from inflatable member 320. In some embodiments, pump 310 is an electric pump. In other embodiments, pump 310 is a manual pump. The device can also include a fluid control system including one or more fluid components, such as one or more valves, configured to facilitate the transfer of fluid to and from inflatable member 320.

[0044] The expandable member 320 is configured to be disposed in an inflated configuration and a deflated configuration. Specifically, a fluid can be pumped or moved through the expandable member 320 to place the expandable member 320 in the inflated configuration. The fluid can then be removed or at least partially removed from the expandable member 320 to place the expandable member 320 in the deflated configuration.

[0045] The housing 330 defines a cavity 332 and includes a seal member 334. The seal member 334 is configured to form a fluid chamber 336 within the cavity 332 of the housing 330. The seal member 334 is configured to move within the cavity 332 of the housing 330. Thus, as the seal member 334 moves, a smaller or larger fluid chamber is formed. When the seal member 334 is positioned to form a larger fluid chamber, the pressure within the expandable member 320 is less than when the seal member 334 is positioned to form a smaller fluid chamber. In some embodiments, the seal member 334 can be configured such that if the pressure within the expandable member 320 is too great (or exceeds a desired amount), the seal member 334 moves against a bias to increase the size of the fluid chamber and reduce (or stabilize) the pressure within the expandable member 320. In this embodiment, fluid entering the fluid chamber 336 when the fluid chamber 336 is in the larger state can flow to the reservoir 390. Thus, reservoir 390 is a retainer for fluid that, in other embodiments, might be in fluid chamber 336. This embodiment allows for the storage of large volumes of fluid without having to move seal member 334 a large distance or having a housing large enough to contain such fluid.

[0046] In use, the expandable implant or device 300 can be implanted within a patient. In some cases, the expandable implant or device 300 is an artificial urinary sphincter. In such embodiments, the device 300 can be implanted within the patient's pelvic region. The expandable member 320 can be positioned to apply pressure to the patient's urethra. In other embodiments, the device is a different type of expandable implant and is positioned at a different location within the patient's body or configured to be positioned within the patient's body.

[0047] 8 is a block diagram of an apparatus 400 according to one embodiment. The device 400 includes a pump 410, an inflatable member 420, a housing 430, and a controller 495. The housing 430 is operably coupled to the pump 410 and the inflatable member 420. The pump 410 is configured to facilitate the transfer of fluid to and from the inflatable member. In the illustrated embodiment, the pump 410 is an electric pump.

[0048] The expandable member 420 is configured to be disposed in an inflated configuration and a deflated configuration. Specifically, fluid can be pumped or moved by a pump through the expandable member 420 to place the expandable member 420 in the inflated configuration. The fluid can then be removed or at least partially removed from the expandable member 420 to place the expandable member 420 in the deflated configuration.

[0049] The housing 430 defines a cavity and includes a seal member. The seal member is configured to form a fluid chamber within the cavity of the housing 430. The seal member is configured to move within the cavity of the housing 430. Thus, as the seal member moves, a smaller or larger fluid chamber is formed. When the seal member is positioned to form a larger fluid chamber, the pressure within the expandable member 420 is less than when the seal member is positioned to form a smaller fluid chamber. In some embodiments, the seal member can be configured such that when the pressure within the expandable member 420 is too great (or exceeds a desired amount), the seal member moves against a bias to increase the size of the fluid chamber and reduce (or stabilize) the pressure within the expandable member 420.

[0050] In the illustrated embodiment, controller 495 is configured to be operably coupled to pump 410 and / or housing 430 and configured to control or send signals to operate device 400. In some embodiments, controller 495 sends wireless signals to control the device. For example, controller 495 may be operably coupled to pump 410 and / or housing 430 via Bluetooth, radio frequency, or other wireless methods. In some embodiments, controller 495 may be operably coupled to device 400 while pump 410 and housing 430 are located within the patient's body and controller 495 is located outside the patient's body.

[0051] In some embodiments, the controller 495 is configured to send a signal to actuate the pump 410. For example, the controller 495 can send a signal to direct or otherwise cause the pump 410 to move fluid into or out of the expandable member 420. Further, in some embodiments, the controller 495 can be configured to send a signal to adjust the maximum pressure of the expandable member 420. For example, the controller 495 can be configured to send a signal to move a base member disposed within the housing 430 of the device 400.

[0052] In use, the expandable implant or device 100 can be implanted within a patient's body. In some cases, the expandable implant or device 100 is an artificial urinary sphincter. In such embodiments, the device 100 can be implanted within the patient's pelvic region. The expandable member 120 can be positioned to apply pressure to the patient's urethra. In other embodiments, the device is a different type of expandable implant and is positioned or configured to be positioned at a different location within the patient's body.

[0053] While certain features of the described embodiments have been illustrated as set forth herein, many modifications, substitutions, changes, and equivalents will occur to those skilled in the art. It is therefore to be understood that the appended claims are intended to cover all such modifications and variations that fall within the scope of the embodiments of the present invention. [Explanation of symbols]

[0054] 200 equipment 210 Pump 212, 214 Tubular members 220 Expandable member 230 Housing

Claims

1. 1. An apparatus comprising: an expandable member; a pump configured to transfer fluid to the inflatable member; a housing operably coupled to the inflatable member and the pump, the housing defining a cavity, the housing including a seal member disposed within the cavity defined by the housing, the seal member configured to move from a first position within the cavity of the housing to a second position within the cavity of the housing, the housing including a biasing member configured to engage the seal member and bias the seal member toward the first position, and the housing including an adjustment member configured to move a base member within the cavity of the housing; An apparatus comprising:

2. The apparatus of claim 1 , wherein the seal member is configured to form a fluid seal with an interior surface of the housing.

3. The apparatus of claim 1 , wherein the biasing member is a spring member, the spring member being disposed between the base member and the seal member.

4. The device of claim 1 , wherein the housing includes a protrusion extending from an inner surface of the housing.

5. The device of claim 1 , wherein the housing includes a protrusion extending from an inner surface of the housing into the cavity defined by the housing, the protrusion configured to engage the seal member.

6. The device of claim 1 , wherein the adjustment member includes a threaded member, the threaded member configured to engage the base member.

7. The device of claim 1 , wherein the housing is operably coupled to the pump via a tubular member.

8. The device of claim 1 , wherein the housing is operably coupled to the expandable member via a tubular member.

9. The device of claim 1 , wherein the expandable member is configured to be positioned near the patient's urethra.

10. The device of claim 1 , wherein the inflatable member is an inflatable cuff member.

11. The device of claim 1 , further comprising a reservoir operably coupled to the housing and configured to receive a fluid.

12. The device of claim 1 , further comprising a reservoir operably coupled to the housing via a tubular member and configured to receive a fluid.

13. The device of claim 1 , further comprising a reservoir operably coupled to the housing and configured to receive a fluid, the housing including a protrusion extending from an inner surface of the housing.

14. The device of claim 1 , wherein the housing includes a protrusion extending from an inner surface of the housing, the protrusion configured to engage the seal member when the seal member is in the first position.

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