Inflatable medical system

Abstract

An inflatable medical system having an implantable, inflatable cuff, a fluid reservoir in fluid communication with the cuff, a fluid transfer device having a powered pump adapted for selective moving fluid between the reservoir and the cuff, at least one pressure sensor in operative communication with fluid in the cuff for providing a pressure signal indicative of fluid pressure in the cuff, a controller for receiving the pressure signal from the pressure sensor and controllably actuating the fluid transfer device, and an external actuator in wireless communication with the controller, the external actuator adapted for wirelessly providing a urination signal to the controller, such that upon receipt of the urination signal, the controller causes fluid to be moved from the cuff to the reservoir.

Description

INFLATABLE MEDICAL SYSTEMCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 511,905, filed on July 5, 2023, entitled "Inflatable Medical System.” The entire disclosure of the foregoing provisional patent application is incorporated by reference herein.BACKGROUND

[0002] Urinary incontinence is a common problem, particularly for older adults. Urinary incontinence often occurs because the urinary sphincter muscle is no longer able to impart sufficient force to close the urethra. One common treatment is the implantation of an artificial urinary sphincter in the form of an inflatable cuff that extends completely or partially around a portion of a patient’s urethra. The sphincter cuff is normally inflated with fluid in order to close off the urethra. The cuff is typically only manually deflatable, with fluid pumping provided by a compressible, fluid-filled pumping bulb implanted subcutaneously. For male patients, the pumping bulb is implanted in the scrotum and must be repeatedly squeezed in order to move fluid from the cuff into a balloon reservoir in order to deflate the sphincter cuff and allow urination. Such systems are inconvenient, difficult to operate, and problematic for a variety of other reasons.

[0003] Similar systems are available for promoting weight loss, treating erectile dysfunction (“ED”), treating fecal incontinence, and other conditions. In the case of fecal incontinence, an inflatable sphincter cuff is positioned around the rectum or colon. For weight loss, an inflatable sphincter cuff is used as a gastric cuff (e.g., positioned around the upper portion of the stomach). For ED, a pair of inflatable penile prostheses are used (instead of an inflatable cuff). The inflatable prostheses are typically cylindrical in shape, and are implanted into the corpus cayemosae of the patient such that, upon inflation of the prostheses, the penis becomes erect.

[0004] While a variety of devices and techniques may exist for providing a fluid inflatable, implantable member such as an urethral sphincter cuff, it is believed that no one prior to the inventors have made or used an invention as described herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0005] While the specification concludes with claims particularly pointing out and distinctly claiming the invention, it is believed that the invention will be better understood from the detailed description of certain embodiments thereof when read in conjunction with the accompanying drawings. Unless the context indicates otherwise, like numerals are used in the drawings to identify similar elements in the drawings. In addition, some of the figures may have been simplified by the omission of certain elements in order to more clearly show other elements. Such omissions are not necessarily indicative of the presence or absence of particular elements in any of the exemplary embodiments, except as may be explicitly stated in the corresponding detailed description.

[0006] FIGURE 1 depicts a schematic illustration of one embodiment of an inflatable medical system of the present disclosure.

[0007] FIGURE 1A is a schematic illustration of the external control device of the system of FIG. 1.

[0008]

[0009] FIGURE 2 is an isometric view of an alternative embodiment of an inflatable medical system of the present disclosure, with the cuff positioned about a urethra and in a deflated state.

[0010] FIGURE 3 is an isometric view of a distal portion of the system of FIG. 2, with the cuff in an inflated state and applying clamping pressure to the urethra for closing off flow from the bladder through the urethra.

[0011] FIGURE 4 is the same view as FIG. 2, with the cuff in an inflated state.

[0012] FIGURE 5 is a top view of the system of FIG. 2 with the top portions of the first and second pump housings removed and the distal portion of the system omitted, with fluid pumped from the reservoir into the cuff.

[0013] FIGURE 6 is an isometric view of the first pump housing of the system of FIG. 2 with the top portion of the first pump housing removed.

[0014] FIGURE 7 is a top view of the first pump housing of the system of FIG. 2 with the top portion of the first pump housing removed.

[0015] FIGURE 8 is an isometric view of the second pump housing of the system of FIG. 2 with the top portion of the second pump housing removed.

[0016] FIGURE 9 is a top view of the second pump housing of the system of FIG. 2 with the top portion of the second pump housing removed.

[0017] FIGURE 10A is a schematic illustration of the cuff inflation fluid path in the system of FIG. 2.

[0018] FIGURE 10B is a schematic illustration of the cuff deflation fluid path in the system of FIG. 2.

[0019] FIGURE 11A is a schematic illustration of an alternative embodiment of an inflatable medical system of the present disclosure, wherein two pumps and their associated valves are located in a single housing.

[0020] FIGURE 11B is an isometric view of the system of FIG. 11 A, with the cuff in a deflated state.

[0021] FIGURE 11C is the same view as FIG. 11B, with the top portion of the pump housing removed.

[0022] FIGURE 1 ID is a top plan view of the system of FIG. 1 IB, with the housing omitted.

[0023] FIGURE 1 IE is a bottom plan view of the system of FIG. 1 IB, with the distal portion of the system omitted.

[0024] FIGURE 1 IF is the same view as FIG. 1 IE, with the manifold seal film omitted.

[0025] FIGURE 11G is an enlarged view of the manifold portion of FIG. 1 IF.

[0026] FIGURE 11H is a cross-sectional view of the manifold of FIG. 11G, taken along the line 11H-11H thereof.

[0027] FIGURE 1 II is omitted.

[0028] FIGURE 11J is a top plan view of the scrotal pump portion of the system of FIG. 11 A.

[0029] FIGURE UK is a cross-sectional view of the scrotal pump of FIG. 11 J, taken along the line 1 IK-1 IK thereof.

[0030] FIGURE 1 1L is a cross-sectional view of the scrotal pump of FIG. 11 J, taken along the line 1 IL-1 IL thereof.

[0031] FIGURE 1 IM is an isometric view of the manifold of the system shown in FIG. 11 A,

[0032] FIGURE 12A is a schematic illustration of an alternative embodiment of a portion of a fluid inflation system wherein a single pump and four valves are used, depicting an inflation mode.

[0033] FIGURE 12B is a schematic illustration of the embodiment of FIG. 12A, depicting a deflation mode.

[0034] FIGURE 12C is a schematic illustration of yet another alternative embodiment of a single pump system wherein the pump is only used for deflation purposes.

[0035] FIGURE 13 is an isometric view of one embodiment of an undeployed inflatable cuff assembly for use with an inflatable medical system of the present disclosure.

[0036] FIGURE 13 A is an exploded view of the cuff assembly of FIG. 13.

[0037] FIGURE 14 is an isometric view of the cuff assembly of FIG. 13, deflated and deployed around a urethra.

[0038] FIGURE 15 is the same view as FIG. 14, with the cuff assembly inflated.

[0039] FIGURE 16 is a front view of the cuff assembly of FIG. 13, deflated and deployed around a urethra.

[0040] FIGURE 17 is a cross-sectional view of the cuff assembly of FIG. 16, taken along the line 17-17 thereof, with the cuff inflated.

[0041] FIGURE 18 is an isometric view of an alternative embodiment of an inflatable cuff assembly for use with an inflatable medical system of the present disclosure, wherein the cuff assembly is deflated and deployed around a urethra.

[0042] FIGURE 19 is an isometric view of the inflatable cuff portion of the cuff assembly of FIG. 18.

[0043] FIGURE 20 is a side view of the cuff assembly of FIG. 18.

[0044] FIGURE 21A is a cross-sectional view of the cuff assembly of FIG. 20, taken along the line 21 A-21A thereof.

[0045] FIGURE 2 IB is a cross-sectional view of the cuff assembly of FIG. 20, taken along the line 21B-21B thereof.

[0046] FIGURE 22A is an isometric view of yet another alternative embodiment of an inflatable cuff assembly for use with an inflatable medical system of the present disclosure, wherein the cuff assembly is deflated and deployed around a urethra.

[0047] FIGURE 22B is an isometric view of the inflatable cuff portion of the cuff assembly of FIG. 22A.

[0048] FIGURE 23 is a side view of the cuff assembly of FIG. 22A.

[0049] FIGURE 24 is a cross-sectional view of the cuff assembly of FIG. 23, taken along the line 24-24 thereof.

[0050] FIGURE 24A is an enlarged view of a portion of FIG. 24.

[0051] FIGURE 25 is the same view as FIG. 24, with the cuff inflated about the urethra.

[0052] FIGURE 26 is a cross-sectional view of the cuff assembly of FIG. 23, taken along the line 26-26 thereof.

[0053] FIGURE 27 is a front view of the cuff assembly of FIG. 22A.

[0054] FIGURE 28 is a cross-sectional view of the cuff assembly of FIG. 27, taken along the line 28-28 thereof.

[0055] FIGURE 29 is an isometric view of another alternative embodiment of an inflatable cuff assembly for use with an inflatable medical system of the present disclosure, wherein the cuff assembly is deployed around a urethra and inflated.

[0056] FIGURE 30 is another isometric view of the cuff assembly of FIG. 29.

[0057] FIGURE 31 is a bottom isometric front view of the cuff assembly of FIG. 29.

[0058] FIGURE 32 is a front view of the cuff assembly of FIG. 29.

[0059] FIGURE 33 is a cross-sectional view of the cuff assembly of FIG. 32, taken along the line 33-33 thereof.

[0060] FIGURE 33 A is an enlarged view of a portion of FIG. 33.

[0061] FIGURE 34 is a front view of yet another alternative embodiment of an inflatable cuff assembly for use with an inflatable medical system of the present disclosure, wherein the cuff assembly is deployed around a urethra and inflated.

[0062] FIGURE 35 is a cross-sectional view of the cuff assembly of FIG. 34, taken along the line 35-35 thereof.

[0063] FIGURE 35A is an enlarged view of a portion of FIG. 35.

[0064] FIGURE 36 is a schematic illustration of a yet another alternative embodiment of an inflatable medical system of the present disclosure, implementing the arrangement of FIG. 12A wherein a single pump and four valves are used.

[0065] FIGURE 36A is a schematic illustration of the external actuator of the system of FIG. 36.

[0066] FIGURE 37A is an upper isometric view of the system of FIG. 36, wherein the cuff is omitted an only a portion of the cuff fluid conduit is shown.

[0067] FIGURE 37B is a bottom isometric view of the system of FIG. 37A, wherein the cuff and cuff fluid conduit are omitted.

[0068] FIGURE 38 is the same view as FIG. 37A, with the housing and reservoir omitted.

[0069] FIGURE 39 is an exploded view of the system of FIG. 37A, with the cuff and cuff fluid conduit omitted.

[0070] FIGURE 40 is an exploded view of the housing of the system of FIG. 37A.

[0071] FIGURE 41 is an exploded view of the manifold, valves and pressure sensor of the system of FIG. 37A.

[0072] FIGURE 42 is an exploded bottom view of the manifold of the system of FIG. 37 A.

[0073] FIGURE 43 is a cross-sectional view of the manifold of FIG. 42, taken along the line 43-43 thereof, with the manifold seal fdm omitted.

[0074] FIGURE 44 is a cross-sectional view of the manifold of FIG. 42, taken along the line 44-44 thereof, with the manifold seal fdm omitted.

[0075] FIGURE 45 is a bottom plan view of the manifold of FIG. 42, with the manifold seal film omitted.

[0076] FIGURE 46 is a cross-sectional view of the manifold of FIG. 45, taken along the line 46-46 thereof.

[0077] FIGURE 47 is a bottom isometric view of the manifold of FIG. 45.

[0078] FIGURE 48 is the same view as FIG. 46, with the addition of the cuff fluid connector, with the connector also shown in the inset of FIG. 48A.

[0079] FIGURE 49 is an exploded, upper isometric view of the reservoir of the system of FIG. 37 A.

[0080] FIGURE 50 is an exploded, bottom isometric view of the reservoir of the system of FIG. 37A, including the first lower housing.

[0081] FIGURE 51 s a cross-sectional view of the assembled reservoir and first lower housing of FIG. 50, taken along the line 51-51 thereof, with the manifold mounted thereto.

[0082] FIGURE 51A is an enlarged view of a portion of FIG. 51, and FIG. 51B is an isometric view of the inlet plug of the reservoir.

[0083] FIGURE 52 is a cross-sectional view of the manifold of FIG. 47, taken along the line 52-52 thereof, with the inset of FIG. 52A depicting an enlarged view of FIG. 52.

[0084] FIGURES 53 and 54 are upper and lower isometric views of a vibration assembly attached to the housing of the system of FIG. 37A.

[0085] FIGURES 55-58 depict exemplary algorithms for controlling the operation of the inflatable medical systems described herein.

[0086] The drawings are intended to illustrate rather than limit the scope of the present invention. Embodiments of the present invention may be carried out in ways not necessarily depicted in the drawings. Thus, the drawings are intended to merely aid in the explanation of theinvention. Thus, the present invention is not limited to the precise arrangements shown in the drawings. <DETAILED DESCRIPTION

[0087] The following detailed description describes examples of embodiments of the invention solely for the purpose of enabling one of ordinary skill in the relevant art to make and use the invention. As such, the detailed description and illustration of these embodiments are purely illustrative in nature and are in no way intended to limit the scope of the invention, or its protection, in any manner. It should also be understood that the drawings are not to scale and in certain instances details have been omitted, which are not necessary for an understanding of the present invention.

[0088] As used herein, unless the context indicates otherwise, the terms "fluid communication" and “fluidically coupled” mean that there is a path or route through which fluid may flow between two components, either directly or through one or more intermediate components. Similarly, unless the context indicates otherwise, the term "conduit" encompasses a conduit within or integrated with a valve. In other words, fluid communication between two components means that fluid can flow from one component to another but does not exclude an intermediate component (e.g., a valve, manifold, connector, etc.) between the two recited components that are in fluid communication.

[0089] As used herein, unless the context indicates otherwise, the term “cable” is intended to encompass signal-conducting devices comprising an assembly of two or more conductors such as wires (single or multiple strand), and other types of physical conduits, traces or lines that conduct electrical signals, whether power signals (e.g., DC or AC power) or control signals (e g., a voltage or current indicative of a sensed condition, or used to activate or deactivate a component such as a valve or pump). As also used herein, unless the context indicates otherwise, the term “electrical communication” means that electrical signals can be transmitted between two components, such as via one or more wires, conduits, traces, lines, terminal blocks, posts, solder joints, integrated circuit traces, and the like, either directly or through one or more intermediate components, or through direct contact of the two components.As also used herein, wireless communication includes any suitable wireless communication protocol, including RF, Bluetooth®, NFC, Wi-Fi, impulse signals (e.g., sound), and other electromagnetic signals..

[0090] Embodiments of the present disclosure provide an inflatable medical system comprising an inflatable implant, a fluid reservoir fluidically coupled to the inflatable implant, and a fluid transfer device adapted for selectively and / or controllably moving fluid between the fluid reservoir and the inflatable implant. In some embodiments, the fluid transfer device comprises a pump adapted for transferring fluid between the reservoir and the inflatable implant. In some embodiments, more than one implant, more than one fluid reservoir, or / and more than one pump (or other fluid transfer device) are provided. In one embodiment, the inflatable implant comprises an inflatable member implantable adjacent an anatomical passageway in a patient such that, when the inflatable member is inflated, pressure is exerted against the anatomical passageway thereby compressing the anatomical passageway. For example, in some embodiments the inflatable medical system is for treating urinary incontinence with the inflatable implant comprising an inflatable cuff implantable about a portion of a patient’s urethra for selectively compressing the urethra in order to prevent urine leakage. However, the inflatable medical systems can also be used for promoting weight loss, treating erectile dysfunction (“ED”), treating fecal incontinence, and other conditions. In the case of fecal incontinence, the inflatable cuff is positioned around the rectum or colon. For weight loss, the inflatable cuff is used as a gastric cuff (e.g., positioned around the upper portion of the stomach). For ED, the inflatable cuff is replaced by one or more inflatable penile prostheses, which can be generally cylindrical in shape and implanted into the corpus cayemosae of a patient such that, upon inflation of the prostheses, the penis becomes erect. Unless otherwise indicated, the inflatable medical systems are described herein for use in treating urinary incontinence, with the inflatable cuff implantable about a portion of a patient’s urethra.

[0091] Embodiments of inflatable medical systems according to the present disclosure also include at least one controller for controllably and selectively inflating and deflating an inflatable implant such as a urethral sphincter cuff. The controller is adapted to selectively activate and deactivate the fluid transfer device in order to inflate / deflate the cuff, such as inresponse to sensed parameters and / or user (patient) input. The sensed parameters can include, for example, one or more of fluid pressure within the cuff, bladder pressure, fluid manifold pressure, fluid reservoir pressure, fluid pump pressure, biometric parameters (e.g., heartrate, blood oxygen, and / or patient temperature), patient activity levels, and / or patient movement. In some embodiments, the controller is also (or alternatively) adapted to inflate / deflate the cuff in response to user (i.e., patient) commands, such as those provided wirelessly by an external control device. In particular, in some embodiments, the user can issue a deflate (urinate) command using an external control device when the user wishes to evacuate their balder (urinate).

[0092] Embodiments of inflatable medical systems according to the present disclosure further include one or more power supplies for supplying power to the fluid transfer device, the controller, and other powered components of the system. The power supply can be provided within at least one implantable housing that also houses (or is in electrical communication with) the controller and a receiver for wirelessly receiving signals from (and, optionally, transmitting signals to) an external control device, such as control signals and / or power signals (e.g., for supplying power to an implanted power supply). The controller is operatively connected to (i.e., in electrical communication with) the power supply, the fluid transfer device, and one or more sensors. In some embodiments, the fluid reservoir and fluid transfer device are provided in a first implantable housing, and the controller, power supply, and receiver are provided in a second implantable housing. In other embodiments, the fluid reservoir, fluid transfer device, controller, power supply, and receiver are provided in a single implantable housing. In still further embodiments, the fluid reservoir can be located outside of a housing in which the fluid transfer device (and, optionally, the controller, power supply, and / or receiver) is located. In other embodiments, a third housing is provided, with the fluid transfer device located in a first housing, the reservoir located in a third housing, and one or more controllers, power supplies, receivers, and sensors located within at least one of the three housings (e.g., within a second housing). It will also be understood that, when two (or more) implantable housings are provided, each may include its own controller(s), sensor(s), and / or power supply.

[0093] FIGURE 1 is a schematic illustration of one embodiment of an inflatable medical system (10) of the present disclosure, depicting a portion of the system implanted in a patient (P). The implantable portion of the system includes at least one fluid reservoir (30) in fluid communication with an inflatable implant (12) via at least one fluid conduit (14). In the particular embodiment shown, the inflatable implant is in the form of a cuff (12) adapted for implantation about a portion of a patient’s urethra and for receiving fluid from the reservoir (30) for inflating the cuff (12). When inflated, the cuff (12) acts to compress the urethra and prevent urine from passing therethrough. Suitable inflation fluids for all of the systems described herein include sterilized water, saline, flowable silicone, and other physiologically acceptable fluids. A fluid transfer device, adapted for selectively causing fluid to move between the reservoir (30) and the cuff (12), is also provided. The fluid transfer device includes a pump (60) for selectively moving fluid between the reservoir (30) and the cuff (12) - i.e., from the reservoir to the cuff for inflation of the cuff (12), and from the cuff to the reservoir for deflation of the cuff. The pump (60) is in fluid communication with the reservoir (30) via one or more fluid conduits (15).

[0094] Pump (60) can comprise any of a variety of types of pumping assemblies, including a one-way or two-way piezoelectric pump. (As used herein, a one-way pump is a pumping assembly that moves fluid in one direction, and a two-way pump is a pumping assembly adapted to move fluid in two directions, i.e., a reversible pump). It will also be understood that one or more flow control devices (e.g., controllable valves) can be provided along one or more of the fluid conduits (e.g., 14, 15) for regulating fluid flow (including the flow direction) and / or maintaining or controlling fluid pressure in the cuff (12). Further, one more manifolds can be included for controllably directing fluid flow, such as to selectively inflate and deflate the cuff (12) - particularly when a one-way pump (60) is employed.

[0095] In the embodiment shown in FIG. 1, inflatable medical system (10) further comprises at least a first housing (16). The reservoir (30) and pump (60) are located within the first housing (16), and the fluid conduit (14) extends between the first housing (16) and the inflatable implant in the form of cuff (12). The first housing (16) is adapted for implantation in a patient at a location spaced away from the cuff (12). By way of example, when the cuff (12) is implanted about a portion of the patient’s urethra for treating urinary incontinence, the firsthousing (16) can be adapted for implantation in the subcutaneous space of the lower quadrants of the abdomen. This allows for the first housing (16) to be positioned in a comfortable location, while also limiting the required length of the fluid conduit (14). Of course the first housing (16) can be implanted in a variety of alternative locations.

[0096] The inflatable medical system (10) of FIG. 1 further includes controller circuitry, a power supply (82), and a receiver (84) for wirelessly receiving external signals (e.g., control signals and / or power signals) from an external control device (90)). The receiver (84) is also configured to wirelessly transmit signals to the external control device (90). The controller circuitry, also referred to herein as a controller (80), is used to control the operation of the system (10), as further explained herein. The controller (80), power supply (82), and receiver (84) can be located in the first housing (16). It will be understood, however, that a controller can be provided in the first housing (16) and one or more additional controllers provided elsewhere (e.g., in one or more additional housings).

[0097] In the embodiment of FIG. 1, the controller (80), power supply (82), and receiver (84) are located in a second housing (78) adapted to be implanted in the patient spaced apart from the first housing (16). By locating these components at a location removed from that of the first housing (16), the size of the first housing can be minimized. Further, in order to facilitate access to the power supply (e.g., for periodic replacement of the power supply and / or wireless recharging), the second housing (78) can be implanted subcutaneously such as in the subcutaneous space of the lower quadrants of the abdomen. This placement will also position the receiver (84) closer to the skin, thereby facilitating the receipt of signals from an external control device (90) and / or an external charging device (e.g., an inductive charging device).

[0098] In the embodiment shown in FIG. 1, the system (10) includes at least one external control device (90) adapted for wirelessly sending signals to and receiving signals from the controller (80). These signals can include, for example, control signals, such as signals for instructing the operation of the controller (e.g., for causing deflation of the cuff (12) to allow the patient to urinate) and / or power signals for wirelessly supplying power to the power supply (e.g., to recharge the power supply (82)). In some embodiments, the signals also include arepresentation of one or more identification codes (e.g., a serial number) unique to the patient and / or the control device (90). The controller (80) uses the indemnification code to verify that any signals received from the external control device are from or for the patient within whom the system is implanted.

[0099] In some embodiments, the systems (10, 210, 310, 410) described herein are configured for inductive charging of the power supply (82). In other embodiments, the system is configured for magnetic resonance charging of the power supply (82). In either instance, charging of the power supply is accomplished wirelessly using power signals transmitted into the second housing (78). In some embodiments, two different external control devices (90) are provided - one for remote control and monitoring of the system, and one for wireless charging of the power supply.

[0100] FIGURE 1A is a schematic illustration of one embodiment of an external control device (90) for use with any of the systems (10, 210, 310, 410) described herein. External control device (90) includes a user interface (90A) having one or more input devices such as a keypad and / or touch screen (or other input device) for accepting patient input, as well as a display screen (90D) (which may be a touch screen) for displaying information to the user. The external control device further includes a power supply (90B) (e.g., a rechargeable battery), a controller (90C) (e g., one or more processors such as a microprocessor along with memory storing software for performing the functions of the control device (90)), and the transmitter (92) for transmitting signals to and optionally receiving signals from the controller (80) of the implanted portion of the system (10). In some instances, a personal computing device such as a smartphone can be used as the external control device (90) for communicating control signals between the personal computing device and the controller (80), with one or more software apps performing the necessary functionality. A speaker may also be provided in the external control device (90) for providing audible signals (e g., alarm signals) to the patient, as well as one or more visible indicators (e.g., one or more lights) for providing visual signals to the patient, and / or haptic indicators (e.g., vibratory signaling).

[0101] All of the systems (10, 210, 310, 410) described herein can further be configured to communicate with an external computing device that provides biometric data to the system (e.g., to the controller (80)). This biometric data (e.g., heartrate, activity level, patient position, etc.) is used to aid in the automated control of the system. Such external computing devices include exercise / fitness monitoring devices such as a FitBit® device, a Garmin® watch, a heartrate monitor, etc. Further, the systems described herein can interface with an external software application (or app) that receives biometric, time and activity data and correlates such data with urination events (e.g., based on user-initiated deflation of the cuff) in order to further enhance system control and the user experience (e.g., to signal to the user of an upcoming need to urinate).

[0102] Audible, visual, and / or tactile signals provided by the external control device (90), as well as (or in the alternative) information displayed on the display screen, for example, can alert the patient when their bladder pressure is increasing such that emptying of the bladder (i.e., deflation of the cuff) will be advised or necessary within a predetermined period of time (e.g., urination is advised within the next 30 minutes). As further described herein, in some embodiments the implanted portion of the system can be adapted to provide haptic signals that emptying of the bladder is advised or necessary, such as pulsing of the pump so that the patient will sense the pump pulsations and / or opening and closing of one or more valves and / or the use of a vibrator included in one of the implanted housings. In some embodiments, the fluid transfer device is adapted to allow the pump to be pulsed on and off without resulting in the transfer of fluid into or out of the cuff (as further explained herein).

[0103] The controller (80, 480) is adapted to control the actuation of the fluid transfer device in response to pressure signals received from one or more pressure sensors, in response to one or more signals from various other sensors or components of the system (e.g., a signal indicating the status of the power supply), in accordance with one or more programmed algorithms, in accordance with one or more patient-specific parameters supplied to the controller (e.g., patient-specific clamping pressures), and / or one or more instructions input by the patient (e.g., received by the controller from the external control device (90)). In some embodiments, the controller (80, 480) is adapted to provide one or more control signals to the external controldevice (90) for notifying the patient of a system condition or status - e.g., to cause the external control device to provide one or more audible, visual, or haptic signals indicating that emptying of the bladder is advised (either immediately or within a predetermined period of time).

[0104] The inflatable medical system (10, 210, 310, 410) further includes one or more sensors for detecting various conditions related to the patient, particularly the patient’s bladder, and / or one or more conditions related to the operation or state of the system itself (e.g., the state of the power supply, such as the charge level of the power supply (82)). In the embodiment shown in FIG. 1, a pressure sensor (40) is provided for indirectly monitoring the patient’s bladder pressure. Pressure sensor (40) is in operative communication with fluid in the cuff for providing a pressure signal indicative of fluid pressure in the cuff. In this instance, the pressure sensor is located in fluid communication with the fluid conduit (14). As urine fills the patient’s bladder, bladder pressure increases. With the cuff (12) expanded with fluid in order to close off the urethra, pressure exerted on the cuff by the bladder will increase causing a corresponding increase in the fluid pressure within the cuff and the fluid conduit (14). The pressure signal from the pressure sensor (40) will thus provide an indication of bladder pressure (i.e., the amount of urine within the bladder). The pressure signal is used by the controller (80) predictively - i.e., to predict when the bladder will become full so as to alert the patient a predetermined amount of time beforehand. The pressure signal is also used by the controller (80) for safety - i.e., if the pressure reaches a predetermined threshold, the controller causes the cuff to be deflated in an attempt to prevent injury to the patient. In some embodiments, the pressure signal is also monitored for sharp increases in pressure, which indicates a foreign object is deforming the cuff (e.g., a catheter being inserted into the patient’s urethra). When such a foreign object is detected, the controller (80) causes the cuff to be deflated. In still further embodiments, the pressure signal is monitored for decreases in pressure, which indicates a fluid leak in the system (e.g., a reservoir leak and / or a fluid conduit leak).

[0105] The controller (80, 480) can take a variety of different forms, and include a variety of components. In some embodiments, the controller (80, 480) includes one or more processors such as a microprocessor (along with memory and I / O devices, either standalone or as part of a microcontroller having the microprocessor or an application specific integratedcircuit(s) (ASIC) having the microprocessor). For example, some embodiments include a controller (80, 480) having a microprocessor programmed to monitor and control the operation of the inflatable medical system (10, 210, 310, 410) based on, for example, sensed conditions, preprogrammed algorithms, and patient input and instructions. An advantage of the use of a microprocessor (e.g., in the form of a microcontroller) is that it can also perform other functions such as screening or filtering sensor signals, processing sensor signals, and controlling indicators (visual, audible and / or tactile) that signal the patient.

[0106] In some embodiments, the controller is programmed (e.g., pre-programmed at the time of implantation and / or programmed subsequently using, for example, the external control device (90)) to monitor and control the system using one or more algorithms. The controller can use these algorithms in conjunction with one or more sensor signals, particularly pressure signals from the cuff(s) or elsewhere, to control system operation and / or for patient safety.

[0107] FIGURES 2-10 depict another embodiment of an inflatable medical system (210) of the present disclosure. (The controller (80), power supply (82), and receiver (84) are not shown.) This embodiment is similar to that described above, including a third housing (278) (similar to second housing (78)), the external control device (90), the cuff (212), and the control schemes and the like described previously herein. In this instance, however, the features located within first and second housings (216, 223) are modified as compared to the previously described embodiment. Specifically, in the embodiment of FIGS. 2-10, the implantable portion of the inflatable medical system (210) includes at least one fluid reservoir (230) in fluid communication with an inflatable implant via fluidic circuitry that includes a pair of pumps and associated valves for pumping fluid into and from the inflatable implant via a first fluid conduit (214). As before, the inflatable implant is in the form of cuff (212) adapted for implantation about a portion of a patient’s urethra and for receiving fluid from the reservoir (230) for inflating the cuff (212). It will be understood that the implantable portion of the inflatable medical system (210) can include a variety of alternative inflatable implants such as penile prostheses for treatment of erectile dysfunction.

[0108] In the embodiment of FIGS. 2-10, the fluid transfer device for selectively moving fluid between the reservoir (230) and the cuff (212) comprises a pair of pumps. An inflation pump (i.e., first pump) (260) selectively moves fluid from the reservoir (230) to the cuff (212) for inflation of the cuff, and a deflation pump (i.e., second pump) (269) selectively moves fluid from the cuff to the reservoir for deflation of the cuff. The two pumps (260, 269) are in fluid communication with the reservoir (230) via a plurality of fluid conduits and each has an associated valve (264, 272) for controllably regulating fluid flow, as further described below.

[0109] FIGURE 2 is an isometric view of inflatable medical system (210), with the cuff (212) of the cuff assembly (211) positioned about a urethra and in a deflated state and the reservoir (230) expanded with fluid. FIGURES 3 and 4 depict the system (210) with the cuff in an inflated state and the reservoir at least partially evacuated of fluid. Fluid is evacuated (pumped) from the cuff (212), releasing the urethra to allow urine to pass from the bladder through the urethra for urination. FIGURE 3 is an isometric view of a distal portion of the device of FIG. 2, with the cuff (212) in an inflated state, applying clamping pressure to the urethra and closing off flow from the bladder through the urethra. The schematic illustrations of FIGS. 10A and 10B also depict the system (210) when the cuff is in a deflated state and an inflated state, respectively. In either state, the system (210) is filled with water, saline, silicone, or other physiologically acceptable fluid.

[0110] As seen schematically in FIGS. 10A and 10B, as well as in FIGS. 2-4, the cuff (212) is in fluid communication with the interior of a first housing (216A) (also referred to as the inflation pump housing) via first fluid conduit (214). Fluid is pumped into the cuff (212) for inflation through first fluid conduit (214), and fluid is pumped out of the cuff for deflation through first fluid conduit (214).

[0111] First housing (216) comprises a generally hollow structure, having a bottom portion (216A) and a top portion (216B). FIGURES 6 and 7 are isometric and top views of the proximal portion of the first housing (216), with the top portion (216B) of the first housing (216) removed. The first housing (216) contains the fluidic components for pumping fluid from the fluid reservoir (230) to the cuff (212). The first housing (216) is fluidically coupled to the secondhousing (223) (also referred to as the deflation pump housing) via a second fluid conduit (236), and to the distal end of the fluid reservoir (230) via a first pump inlet conduit (238). The second housing (223) comprises a generally hollow structure, having a bottom portion (223 A) and a top portion (223B). The second housing (223) contains the fluidic components for pumping fluid from the cuff (212) to the fluid reservoir (230) (for deflating the cuff).

[0112] In the embodiment shown, the first housing (216) is located distal to the second housing (223), with the reservoir (230) located therebetween. The reservoir (230) is also an elongate, tubular structure. The reservoir (230) is fluidically coupled to the first housing at its distal end (i.e., fluid outlet) via the first pump inlet conduit (238), and fluidically coupled to the second housing at its proximal end (i.e., fluid inlet) via a second pump outlet conduit (244). In the embodiment shown, the fluid reservoir (230) is made from a physiologically acceptable, elastomeric material such that, when fluid is pumped from the reservoir into the cuff, the reservoir shrinks in size (as seen in FIG. 4).

[0113] In alternative embodiments, one or more of the components located in the third housing (278), including one or more of the receiver (84), the controller (80), and the power supply (82), are located in the first housing (216) or / and the second housing (223). In still further alternative embodiments, the components located within the first and second housings (216, 223) are located in a single housing, as further described herein, optionally including one or more of the components located in the third housing (278) (including one or more of the receiver (84), the controller (80), and the power supply (82)). In additional alternative embodiments, the fluid reservoir (230) is housed within the first housing (216), within the second housing (223), or within a combined single housing containing the fluidic components for both inflation and deflation of the cuff. Further, the fluid reservoir (230) can have a variety of alternative shapes and configurations, such as a spherical configuration, or any other suitable shape. In addition, instead of having a separate fluid inlet and fluid outlet, such as ones located at opposite ends of an elongate fluid reservoir (230), the fluid reservoir can have a single fluid conduit used for both transferring fluid from the cuff to the reservoir (cuff deflation).

[0114] As best seen in FIGS. 6 and 7, first housing (216) houses a first pump (260) (also referred to as the inflation pump) having a pump inlet (261A) and a pump outlet (261B). The pump outlet (26 IB) is fluidically coupled to a first manifold (262), with the first manifold operatively connected to a first active valve (264). The first active valve (264), also referred to as the inflation valve, can be either a monostable valve or a bistable valve. In the embodiment shown, the pump outlet (26 IB) is fluidically coupled to the inlet (265 A) of the first manifold (262) by a pump outlet conduit (263) in the form of flexible tubing. In alternate embodiments, the first pump is directly mounted to the first manifold (262). The outlet (265B) of the first manifold (262) is fluidically coupled to the first fluid conduit (214) by a fluid transfer conduit (268) located within the first housing (216). Fluid transfer conduit (268), like the other fluid conduits described herein, can be in the form of flexible tubing suitable for medical implantation in a patient.

[0115] It will be understood that first active valve (264), as well as the other active valves mentioned herein, can be momentarily switched between open and closed positions in order to conserve power, or can be held in an open or toggled position to control the direction of fluid flow or / and to limit fluid flow.

[0116] As best seen in FIGS. 8 and 9, second housing (223) houses a second pump (269) having a pump inlet (270A) and a pump outlet (270B). The pump inlet (270A) is fluidically coupled to a second manifold (271), with the second manifold operatively connected to a second active valve (272). Once again, the second active valve (272), also referred to as the deflation valve, can be either a monostable valve or a bistable valve. In the embodiment shown, the pump inlet (270A) is fluidically coupled to the outlet (273B) of the second manifold (271) by a second pump inlet conduit (274) in the form of flexible tubing. In alternate embodiments, the second pump is directly mounted to the second manifold (271). The inlet (273 A) of the second manifold (271) is fluidically coupled to the second fluid conduit (236), which extends from the second housing (223) to the first housing (216). Within the first housing, the distal end of the second fluid conduit (236) is fluidically coupled to the fluid transfer conduit (268). In the embodiment shown, the second fluid conduit (236) is fluidically coupled to the fluid transfer conduit (268) at a junction (275) such that there are no intervening valves or other fluid control devices betweenthe second fluid conduit (236) and the fluid transfer conduit (268). In one specific embodiment, the second fluid conduit (236) and the fluid transfer conduit (268) are directly connected. The pump outlet (270B) of the second pump (269) is fluidically coupled to the proximal end of the reservoir (230) by second pump outlet conduit (244), as mentioned previously.

[0117] Thus, fluid communication between the first and second housings (216, 223) is provided through second fluid conduit (236) and (in stages) through the fluid reservoir (230), via second pump outlet conduit (244) and first pump inlet conduit (238). During cuff deflation, fluid is pumped in the proximal direction - i.e., from the first housing (216) to the second housing (223) - through the second fluid conduit (236) and then into the fluid reservoir through the second pump outlet conduit (244). During cuff inflation, fluid is pumped in the distal direction - i.e., from the reservoir (230) to the first housing (216) - through the first pump inlet conduit (238).

[0118] First and second pumps (260, 269) can comprise any of a variety of types of pumps, particularly one-way piezoelectric pumps as depicted in FIGS. 5-9. It will also be understood that one or more additional flow control devices (e.g., controllable valves) can be provided along one or more of the fluid conduits for further regulating fluid flow and / or maintaining fluid pressure in the cuff (212). Further, one more additional manifolds can be included for controllably directing fluid flow.

[0119] The second housing (223) is connected to the third housing (278) via first cable (256), thus providing electrical communication between components in the second and third housings. The third housing (278) houses a power supply (e.g., a rechargeable battery) and a controller, as described previously. The third housing (278) may also include a receiver for wirelessly receiving control signals and / or power signals from one or more external control devices. In some embodiments, the third housing (278) further houses one or more sensors, such as one or more pressure sensors in operative communication (e.g., fluid communication) with, for example, one or both of the pumps, one or more of the fluid conduits, the fluid reservoir (230), and / or cuff (212). Such fluid communication can be provided by a fluid conduit, which can be integrated with or separate from cable (256). Other electronic sensors may be housedwithin third housing (278) such as electronic sensing components for sensing, for example, the state of the power supply (e.g., charge level or condition of the power supply), current applied to one or both pumps, and / or the state of one or both valves. By way of example, one or more conductors extend from one or more electrical components in the third housing (e.g., a controller (80)) to one or more electrical components (e.g., sensors) or powered components (e.g., the first pump and first valve) in the second housing (223). (The electrical conductors are not depicted.) In alternate embodiments, the third housing (278) can be eliminated by locating all of these components within the first housing (216) or / and the second housing (223).

[0120] Similarly, second housing (223) is connected to the first housing (216) via second cable (258), thus providing electrical communication between components in the first and second housings and / or between the first and third housings. By way of example, one or more conductors extend from one or more electrical components in the third housing (e.g., a controller (80)) to one or more electrical components (e.g., sensors) or powered components (e.g., the first pump and first valve) in the first housing (216). These electrical conductors extend from the third housing (278) through the first cable (256) into the second housing (223), through the interior of the second housing, and from the second housing (223) through the second cable (258) into the first housing (216). In an alternative embodiment, second cable (258) can extend between the first and third housings (216, 278) such that electrical conductors for communicating signals between the first and third housings do not extend through the second housing.

[0121] The activation of the first and second pumps (260, 269) and the operation of the first and second valves (264, 272) (i.e., opening and closing) are in response to driving signals received from control circuitry (e.g., controller (80)) via the cables (256, 258). For example, with the second pump (269) deactivated and the second valve (272) closed, a modulated signals received by the first pump (260) and the first valve (264) from a controller located in the second housing (278) causes the first pump to be activated and the first valve to be opened, causing fluid to be pumped from the fluid reservoir into the cuff (212) for inflation of the cuff. With the first pump (260) deactivated and the first valve (264) closed, other modulated signals received by the second pump (269) and the second valve (272) from the causes the second pump to be activatedand the second valve to be opened, causing fluid to be pumped from the cuff (212) into the fluid reservoir (230) for deflation of the cuff.

[0122] FIGURES 10A and 10B schematically depict the inflation and deflation of cuff (212), respectively. During cuff inflation, the deflation (second) pump (269) is deactivated (not powered) and deflation (second) valve (272) is closed (e.g., by the control circuitry applying a control signal to the deflation valve or the cessation of a control signal that results in the closure of a monostable deflation valve). The control circuitry supplies control signals to the inflation (first) pump (260) causing the pump to be activated and to the inflation (first) valve (268) causing the valve to open. As a result, fluid is pumped from the fluid reservoir (230), out the distal end thereof, through first pump inlet conduit (238) into the inflation pump (first) housing (216) to the first pump inlet (261 A) of the first pump (260), and out the first pump outlet (26 IB) into the first pump outlet conduit (263). The fluid flows through the first manifold (262) and first valve (264) into the fluid transfer conduit (268), and then through the first fluid conduit (214) into the cuff (212), causing the cuff to inflate.

[0123] During cuff deflation, the inflation (first) pump (260) is deactivated (not powered) and inflation (first) valve (264) is closed (e.g., by the control circuitry applying a control signal to the inflation valve or the cessation of a control signal that results in the closure of a monostable inflation valve). The control circuitry supplies control signals to the deflation (second) pump (269) causing the pump to be activated and to the deflation (second) valve (272) causing the valve to open. As a result, fluid is pumped out of the cuff (212), through the first fluid conduit (214) into the inflation pump (first) housing (216) and into the fluid transfer conduit (268) therein. The fluid then flows to the junction (275) in the first housing (216) into the second fluid conduit (236), and then into the deflation pump (second) housing (223). The fluid flows through the second manifold (271) and second valve (272), into the second pump inlet conduit (274), to the second pump inlet (270A) of the second pump (269), and out the second pump outlet (270B) into the second pump outlet conduit (244), and then into the fluid reservoir (230) through the proximal end thereof. This results in the cuff (212) deflating and the fluid reservoir filling with fluid.

[0124] FIGURES 11A-11M depict yet another embodiment of an inflatable medical system (310) of the present disclosure. (The controller (80), power supply (82), and receiver (84) are not shown.) This embodiment is similar to the embodiments of FIG. 1 and FIGS. 2-10 described above, however, a single housing (316) is provided. The receiver (84), controller (80), and power supply (82), all described previously but not shown, are located within housing (316). Alternatively, system (310) can include a second housing having the controller, power supply, and receiver, wherein this second housing is adapted to be implanted in the patient spaced apart from the housing (316). By locating these components remote from the housing (316), the size of the housing (316) can be reduced. Further, in order to facilitate access to the power supply (for periodic replacement of the power supply and / or wireless recharging), the second housing can be implanted subcutaneously such as in the subcutaneous space of the lower quadrants of the abdomen. This placement will also position the receiver closer to the skin, thereby facilitating the receipt of signals from an external control device (90).

[0125] In the embodiment of FIGS. 11A-11M, the implantable portion of the inflatable medical system (310) includes at least one fluid reservoir (330) in fluid communication with an inflatable implant via fluidic circuitry that includes a pair of piezoelectric pumps and associated valves for pumping fluid into and from the inflatable implant via cuff fluid conduit (314). By way of example, the piezo pumps (360, 369) can be MP6 Micropumps available from Bartels Mikrotechnik, and described in U.S. Pub. No. 2011 / 0005605, incorporated by reference herein. As before, the inflatable implant is in the form of cuff (312) adapted for implantation about a portion of a patient’s urethra and for receiving fluid from the reservoir (330) for inflating the cuff (312). It will be understood that the implantable portion of the inflatable medical system (310) can include a variety of alternative inflatable implants such as penile prostheses for treatment of erectile dysfunction.

[0126] In the alternative embodiment depicted schematically in FIG. HA, both the first and second pumps (360, 369) and first and second valves (364, 372) are contained within housing (316) (e.g., a titanium housing (316)). A manifold arrangement (described below) is provided in the housing, and is fluidically connected to both the first and second pumps (360, 369) and first and second valves (364, 372), thereby eliminating fluid conduit tubing within thehousing (316). While the first and second check valves (364, 372) are depicted as one-way valves (check valves), in an alternative embodiment one or both of the first and second valves are active valves, controlled by the controller. During cuff inflation, the deflation (second) pump (369) is deactivated (not powered), and the inflation (first) pump (360) is activated. As a result, fluid is pumped from the fluid reservoir (330), into the cuff (312), causing the cuff to inflate. During cuff deflation, the inflation (first) pump (360) is deactivated (not powered) and the deflation (second) pump (369) is activated. As a result, fluid is pumped out of the cuff (312), into the fluid reservoir (330). This results in the cuff (312) deflating and the fluid reservoir filling with fluid.

[0127] The embodiment of FIGS. 11A-11M further includes a manual pump (385) in fluid communication with the cuff (312) and the reservoir (330). In one embodiment, the manual pump (385) comprises a resilient pumping bulb having first and second one-way (check) valves (386, 387) associated therewith. As explained further herein, the manual pump can be implanted in the patient’s scrotum (or other suitable location) and is used to manually deflate the cuff (312) by pumping fluid from the cuff to the reservoir (330), such as when the system loses power or the deflation pump (369) otherwise cannot be activated. In some embodiments, the manual pump (385) can also be used to cause the deflation pump to be activated for deflating the cuff (312).

[0128] FIGURE 1 IB is an isometric view of the inflatable medical system (310), with the cuff (312) of the cuff assembly (311) in a deflated state and the reservoir (330) expanded with fluid. As seen schematically in FIG. 11A as well as in FIGS. 11B-D, the cuff (312) is in fluid communication with the housing (316) via cuff fluid conduit (314), and the reservoir (330) is in fluid communication with the housing (316) via reservoir fluid conduit (338). The manual pump (385) is in fluid communication with the housing (316) via manual pump inlet conduit (388) and manual pump outlet conduit (389). These conduits (314, 338, 388, 389) can be in the form of flexible tubing suitable for medical implantation in a patient, and connect to the housing within a header (317). The system (310) is filled with water, saline, silicone, or other physiologically acceptable fluid. Fluid is pumped into the cuff (312) for inflation through cuff fluid conduit (314), and fluid is pumped out of the cuff for deflation through cuff fluid conduit (314). In the embodiment shown, the fluid reservoir (330) is made from a physiologically acceptable,elastomeric material such that, when fluid is pumped from the reservoir into the cuff, the reservoir shrinks in size. In some embodiments, the reservoir is adapted such that the fluid pressure therein does not materially increase as fluid is pumped from the cuff into the reservoir. In other embodiments, when fluid is pumped into the reservoir (330), the reservoir expands with the fluid retained therein such the pressure in the reservoir increases.

[0129] In FIGS. 11C-11H, the housing (316) and header (317), as well as the receiver (84), controller (80), and power supply (82), are omitted. As best seen in FIGS. HA and 11C, housing (316) houses the first and second pumps (360, 369) (also referred to as the inflation and deflation pumps, respectively). The first and second pumps (360, 369) are located within recesses (360R, 369R) in the upper surface of the manifold (362) (see FIG. 1 IM). A first pump inlet (361A) and a first pump outlet (361B) are provided in the manifold. The first pump outlet (361B) is fluidically coupled to the first check valve (364), which in turn is fluidically coupled to the cuff fluid conduit (314). The first check valve (364) only permits fluid flow from the first pump outlet (361B) to the cuff (312). A second pump inlet (370A) and a second pump outlet (370B) are also provided in the manifold. The second pump outlet (370B) is fluidically coupled to the second check valve (372), which in turn is fluidically coupled to the reservoir fluid conduit (338). The second check valve (372) only permits fluid flow from the second pump outlet (370B) to the reservoir (320). As further described herein, the first and second check valves (364, 372) are located within a flow control section (376) of the manifold (362).

[0130] The manifold (362) further includes at least one cuff fluid connector (351) adapted for fluid coupling with cuff fluid conduit (314) and manual pump inlet conduit (388), and at least one reservoir fluid connector (352) adapted for fluidic coupling with reservoir fluid conduit (338) and manual pump outlet conduit (389). In the embodiment shown, cuff fluid conduit (314) and manual pump inlet conduit (388) merge into a single conduit at first juncture (353), and the resulting single conduit is coupled to the cuff fluid connector (351). Similarly, reservoir fluid conduit (338) and manual pump outlet conduit (389) merge into a single conduit at second juncture (354), and the resulting single conduit is coupled to the reservoir fluid connector (352). Manifold (362) is configured such that internal fluid passageways (not shown) lead from the connectors (351, 352) to a bottom portion of the manifold having fluidpassageways, as seen in FIG. 11G and further described below. A wireless receiving coil (382) is provided within the header (317), beneath the connectors (351, 352), and is used to inductively charge the power supply (82) (not shown).

[0131] In the embodiment of FIGS. 11A-1 IM, an active valve (334) is also provided. In particular, a bistable active valve (334) is located between the first pump inlet (361A) and the reservoir conduit (338). The inlet (334A) of the bistable valve is fluidically coupled to the reservoir fluid conduit (338), and the outlet (334B) of the bistable valve is fluidically coupled to the first pump inlet (361A). Bistable active valve (334) is operatively coupled to the controller such that signals from the controller cause the bistable valve (334) to open or close, and to stay in that position until a subsequent signal is received from the controller.

[0132] In the closed position, bistable valve (334) prevents fluid passing from the reservoir to the cuff. This can be used, for example, following initial implantation of the system such that the cuff cannot be inflated for a predetermined period of time after implantation (e.g., for 10 days, for 20 days, for 30 days, or for a longer after implantation). This allows for sufficient healing of the region surrounding the location of cuff (312). In the closed position, bistable valve (334) also provides an additional measure to prevent inflation of the cuff, such as when the system is in a locked mode, or for purposes of maintaining fluid pressure within the reservoir. The latter is advantageous in that the fluid pressure within the reservoir can be used to at least partially inflate the cuff when the bistable valve is opened. In the open position, the bistable valve (334) allows fluid to pass from the reservoir to the cuff, either due to the pressure differential between the reservoir and the cuff or dues to the activation of the first pump (360). Thus, in some embodiments, when the cuff (312) is to be inflated, the controller causes the bistable valve (334) to open such that fluid transfers from the reservoir to the cuff prior to the activation of the first pump (360). After a predetermined period of time, once the pressure within the cuff reaches a predetermined level, or once the pressure within the reservoir and cuff have equalized, the controller causes the first pump to be activated in order to inflate the cuff (312) to the desired pressure (or volume).

[0133] In order to indirectly monitor bladder pressure, one or more pressure sensors can be provided for monitoring fluid pressure within the cuff (312). In the embodiment shown, a pressure sensor (340) is located so as to provide a sensor signal representative of the pressure within the cuff. The sensing element of the cuff pressure sensor (340) is in operative contact with the interior of a fluid volume that is in direct fluid communication with the interior of the cuff. In the example shown, cuff pressure sensor (340) is located between the first check valve (364) and the cuff fluid conduit (314). Specifically, pressure sensor (340) is located in fluid communication with cuff inflation conduit (336). Pressure within the cuff inflation conduit (336) corresponds to the fluid pressure in the cuff fluid conduit (314), and thereby in the cuff (312). As fluid pressure increases in the bladder in response to accumulating urine, fluid pressure inside the cuff (312) increases. Thus, fluid pressure within the cuff inflation conduit (336), particularly pressure changes over a period of time, can be used to monitor bladder pressure. It will be understood that cuff pressure sensor (340) can be positioned in a variety of locations in direct fluid communication with the cuff (312), such as along a separate pressure sensor line in fluid communication with the cuff (312).

[0134] Similarly, a reservoir pressure sensor (350) is located so as to provide a sensor signal representative of the pressure within the reservoir (330). The sensing element of the reservoir pressure sensor (350) is in operative contact with the interior of a fluid volume that is in direct fluid communication with the interior of the reservoir. In the example shown, reservoir pressure sensor (350) is located between the inlet (334A) of the bistable valve (334) and the reservoir fluid conduit (338). Specifically, pressure sensor (350) is located in fluid communication with reservoir intake conduit (339). Pressure within the reservoir intake conduit (339) corresponds to the fluid pressure in the reservoir fluid conduit (338), and thereby in the reservoir (320). Thus, fluid pressure within the reservoir intake conduit (339), including pressure changes over a period of time, can be monitored in order to, for example, detect a reservoir leak. It will be understood that reservoir sensor (350) can be positioned in a variety of locations in direct fluid communication with the reservoir (330), such as along a separate pressure sensor line in fluid communication with the reservoir (320).

[0135] Although not depicted, a variety of other sensors, including biometric sensors, can be included in system (310), providing sensor signals to the controller (80) for monitoring and controlling the operation of the system (as further described herein with respect to the embodiment of FIGS. 36-52).

[0136] In the depicted embodiment, a printed circuit board (PCB) (not shown) having circuitry for performing various electronic tasks and communications is provided. The controller (80), power supply (82), receiver (84), receiving coil (382), and pressure sensors (340, 350) are provided in electrical communication with the PCB and each other.

[0137] FIGURE HE depicts a bottom plan view of the of the system (310), with the distal portion of the system omitted. As seen in FIG. HE, a manifold seal film (367) extends over, and is sealed to, the bottom of the manifold (362). The manifold seal film (367) can be glued, heat staked, overmolded, or otherwise sealed to the bottom of the manifold (362) to create a seal with internal manifold channels formed in the bottom surface of the manifold. FIGURE 1 IF is the same view as FIG. 1 IE, with the manifold seal film (367) omitted, and FIG. 11G is an enlarged view of the manifold portion of FIG. 1 IF.

[0138] As best seen in FIG. 11G, a plurality of fluid channels are formed in the bottom surface of the manifold (362) in order to create a plurality of fluid conduits in the manifold. An additional plurality of channels extend upwardly away from the bottom surface of the manifold, intersecting the fluid channels and providing the various inlets, outlets, and ports described herein. Fluid moves freely within these fluid channels such that the manifold serves to direct the fluid flow in the desired manner.

[0139] In particular, and with reference to both FIGS. HA and 11G, fluid from the reservoir (330) enters the manifold (362) through reservoir fluid connector (352). Reservoir fluid connector (352) is in fluid communication with reservoir fluid port (352A), through the thickness of the manifold. Fluid from the reservoir (330), under the force of first piezo pump (360) or due to the pressure differential between the reservoir and the cuff (312), flows through reservoir intake conduit (339) to the inlet (334A) of the bistable valve (334). The bistable valve (334) is normally kept open to allow fluid to pass therethrough. In the event of an emergency, the bistablevalve (334) is closed to cut off fluid from being pumped into the cuff. A cuff pressure sensor port (350A) is also provided along reservoir intake conduit (339) for obtaining sensor signals indicative of the pressure within the reservoir (330).[00140J The fluid flows through the bistable valve (334) and exits through outlet (334B) of the bistable valve. The outlet (334B) of the bistable valve is in fluid communication with the inlet (361A) of the first piezo pump (360), as seen in FIGS. 11A and 11G. The fluid is then pumped by (or flows under pressure differential through) the first piezo pump (360), exiting through pump outlet (361B). First pump outlet (361B) is in fluid communication with the inlet (364 A) of the first check valve (364), as seen in FIGS. 11 A and 11G. The first check valve only allows fluid flow in the direction of the inlet (364A) to the outlet (364B) of the check valve (364). The configuration of the check valves is further described below.

[0141] Fluid outlet (364B) of first check valve (364) is in fluid communication with cuff inflation conduit (336), as seen in FIGS. 11A and 11G. Cuff inflation conduit (336) extends substantially along the majority of the length of the manifold to cuff fluid port (351 A). Cuff fluid port (351 A) is in fluid communication with cuff fluid connector (351), through the thickness of the manifold. Thus, fluid pumped through cuff inflation conduit (336) is expelled through cuff fluid connector (351) to the first juncture (353) and into the cuff (312), thereby inflating the cuff. As seen in FIGS. 11 A and 11G, cuff inflation conduit (336) is also in fluid communication with a cuff pressure sensor port (340A) located at the terminus of a pressure sensing conduit (340B) in direct fluid communication with the cuff inflation conduit (336). Cuff pressure sensor port (340A) is adapted for obtaining sensor signals indicative of the pressure within the cuff (312) via cuff pressure sensor (340).

[0142] A deflation transfer conduit (379) is also in fluid communication with cuff inflation conduit (336) as well as inlet (370A) of second (deflation) pump (369). During deflation, fluid is pumped by the second piezo pump (369), exiting through pump outlet (370B). Second pump outlet (370B) is in fluid communication with the inlet (372A) of the second check valve (372), as seen in FIGS. 11A and 11G. The second check valve only allows fluid flow in the direction of the inlet (372A) to the outlet (372B) of the check valve (372).

[0143] The configuration of the check valves is further described below. It will be understood, however, that each of the check valves may be configured to have a cracking pressure >0 psig. The cracking pressure is the amount of fluid pressure necessary to cause the check valve to open and allow a detectable amount of fluid flow in the flow direction. Until the cracking pressure is met, fluid will not flow through the check valve.

[0144] Fluid outlet (372B) of second check valve (372) is in fluid communication with cuff deflation conduit (337), which extends substantially along the majority of the length of the manifold to reservoir fluid port (352A). Reservoir fluid port (352A) is in fluid communication with reservoir fluid connector (352), through the thickness of the manifold. Thus, fluid pumped through cuff deflation conduit (337) is expelled through reservoir fluid connector (352) to the second juncture (354) and into the reservoir (320), thereby deflating the cuff and inflating the reservoir (330). As seen in FIGS. HA and 11G, cuff deflation conduit (337) is also in fluid communication with reservoir intake conduit (339).

[0145] In order to inflate the cuff, the first pump (360) is activated by the controller and pumps fluid through the first (cuff) check valve (364). The fluid then flows into the cuff (312) via the cuff fluid port (351 A). The second (reservoir) check valve (372) prevents fluid from backflowing through the second (deflation) pump (369) and into the fluid reservoir (330) unless the pressure in the urethra cuff (312) meets or exceeds the predetermined cracking pressure of the reservoir check valve (372). When the pressure within the cuff meets or exceeds the cracking pressure of the reservoir check valve (372), excess cuff pressure will bleed off into the fluid reservoir (330). To evacuate the urethra cuff (312), the second (deflation) pump is activated by the controller and pulls fluid through the cuff fluid port (351 A) into the inlet (370A) of the second pump (369). The fluid is pumped through the second (reservoir) check valve (372) and into the fluid reservoir (330) via the reservoir fluid port (352A). The fluid reservoir (330) is expandable and sized such that evacuating fluid from the urethra cuff (312) to the fluid reservoir (330) does not cause a material pressure increase in the fluid reservoir (330). Instead, the fluid reservoir (330) will expand to accommodate the excess fluid.

[0146] In alternative embodiments, the reservoir (330) is configured such that the pressure within the reservoir increases as it is inflated with fluid. This allows the energy stored in the pressurized fluid within the inflated reservoir to assist in filling the cuff, thereby reducing power consumption. This is particularly useful when the system (310) includes the bistable valve (334), as the bistable valve can be closed during cuff deflation to allow the reservoir to be pressurized without fluid leaking through the first (inflation) pump (360). If the bistable pump (334) is not included or normally remains open during cuff deflation and the pressure within the reservoir is not materially increased during cuff deflation, the first (cuff) check valve (364) prevents fluid from leaking flowing back through the first (inflation) pump (360) as long as the pressure in the reservoir (330) remains below the cracking pressure of the first (cuff) check valve (364).

[0147] FIGURE 11G depicts a detailed cross-sectional view of the flow control section (376) of the manifold (362), wherein the first and second check valves (364, 372) are located. The inlet (364 A) of the first (cuff) check valve (364) is in checked fluid communication with the first (cuff) check valve chamber (392), with cuff check valve ball (393) sealed on the cuff check valve seat (394). The cuff check valve spring (395) keeps the cuff check valve ball (393) sealed against the cuff check valve seat (394). The spring force applied by the cuff check valve spring (395) determines the pressure at which the cuff check valve ball (393) will release from the cuff check valve seat and allow fluid flow from the cuff check valve inlet (364A) to the cuff check valve outlet (364B), while at the same time preventing backflow from the cuff check valve outlet (364B) to the cuff check valve inlet (364A). The cracking pressure of the cuff check valve will determine the pressure that the cuff pump must overcome to pump fluid into the urethra cuff (312).

[0148] The reservoir check valve (372) contains identical features to the cuff check valve. Thus, the inlet (372A) of the reservoir check valve (372) is in checked fluid communication with the reservoir check valve chamber (396), with reservoir check valve ball (397) sealed on the reservoir check valve seat (398). The reservoir check valve spring (399) keeps the reservoir check valve ball (397) sealed against the reservoir check valve seat (398). The spring force applied by the reservoir check valve spring (399) determines the pressure atwhich the cuff reservoir valve ball (397) will release from the reservoir check valve seat and allow fluid flow from the reservoir check valve inlet (372 A) to the reservoir check valve outlet (372B), while at the same time preventing backflow from the reservoir check valve outlet (372B) to the reservoir check valve inlet (372A). The reservoir check valve spring (399) may have less, more, or the same spring rate as the cuff check valve spring (395) (i.e., the cracking pressure of the reservoir check valve (372) can be lower than, greater than, or the same as the cracking pressure of the cuff check valve (364)). The cracking pressure of the reservoir check valve will determine the amount of pressure that can be built up in the urethra cuff (312) before pressure (i.e., fluid) bleeds off into the fluid reservoir (330).

[0149] FIGURES 11J-1 IL show detailed views of the manual pump assembly (385). The manual pump (385) may be implanted within the patient’s scrotum. The scrotal pump inlet conduit (388) is fluidically coupled to the urethra cuff (312) via the first juncture (353), and the scrotal pump outlet conduit (389) is fluidically coupled to the fluid reservoir (330). When the scrotal pump is actuated (i.e., manually squeezed), fluid is pulled from the urethra cuff (312) into the fluid reservoir (330). This may be used, for example, in the event of power loss at the controller, so that the user may still deflate the urethra cuff (312), preventing injury to the patient and / or allowing the patient to evacuate their bladder. The scrotal pump (385) may be made of an elastomeric material such that the user may squeeze the scrotal pump to collapse the interior scrotal pump chamber (324).

[0150] As the scrotal pump chamber (324) is compressed, pressure builds inside the pump chamber causing the second (outlet) check valve (387) to open such that fluid is expelled from the pump chamber (324) into the outlet conduit (389). In the example shown, output check valve ball (325) is released from the scrotal pump outlet check valve seat (326), allowing fluid to flow from the scrotal pump chamber (324) to the scrotal pump outlet conduit (389). Scrotal pump outlet bypass channels (327) ensure fluid can flow around the scrotal pump outlet check valve ball (325). During this pumping procedure, the scrotal pump first (intake) check valve (386) prevents fluid from flowing out into the scrotal pump inlet conduit (388). When the user releases the scrotal pump (385), the elastomeric material expands the scrotal pump chamber (324). The resulting negative pressure pulls the scrotal pump outlet check valve ball (325)against the scrotal pump outlet check valve seat (326) to prevent pulling fluid from the scrotal pump outlet conduit (389). Simultaneously, the negative pressure pulls the scrotal pump intake check valve ball (328) away from the scrotal pump intake check valve seat (329), allowing fluid to flow from the scrotal pump inlet conduit (388) into the scrotal pump chamber (324). Alternatively, the scrotal pump check valves may be similar to the check valves described previously, employing a spring (322) to bias the ball against the valve seat.

[0151] The manual scrotal pump (385) can be used to deflate the cuff (312) by repeatedly squeezing the pump bulb until the cuff has been sufficiently deflated. This causes fluid to be pumped from the cuff (312) into the reservoir, even when the system has lost power or the deflation pump is otherwise inoperable.

[0152] Alternatively, the manual pump (385) can be used to initiate the deflation of the cuff (312) by providing an alternative deflate (urinate) command to the controller. This is particularly advantageous when the external control device (90) is inoperable (e.g., is not charged), cannot be readily located, or the user wishes to urinate discretely without having to use to the external control device. This is particularly advantageous for male users in that it allows for single-handed operation. The user merely actuates the manual pump (385) (e.g., by squeezing their scrotum) while standing at a urinal or toilet, or sitting on a toilet, without the need to access the external control device with one hand. This is particularly beneficial in public restrooms, as the user can squeeze their scrotum much more discretely than attempting to access and manipulate the external control device (90). Upon squeezing the manual pump (385), pressure within the cuff deflation conduit (337) and reservoir intake conduit (339) is temporarily increased and this pressure spike will be detected by the reservoir pressure sensor (350). In some embodiments, the user squeezes the manual pump (385) twice in succession, three times in succession, or more than three times in succession, with a small time lag between each squeeze (e g., 0.5 to 3 seconds between each squeeze. The pressure signal is supplied to the controller, and the controller determines, based on the characteristics of the pressure spikes (e.g., amount of pressure spike, number of pressure spikes (e.g., exactly two or exactly three), and / or the duration of each pressure spike) that the user wishes to urinate. The controller then activates the second pump (369), causing the cuff (312) to deflate so as to allow the user to urinate. After apredetermined period of time, when the cuff pressure sensor senses a pressure below a predetermined threshold, and / or the user squeezes the manual pump in a similar manner as before (e.g., a predetermined number of times, e.g., once, twice, or three times in succession) the controller determines that the user has finished urinating and the first pump (360) is activated in order to re-infl ate the cuff (312).

[0153] In yet another alternate embodiment, a single, one-way piezoelectric pump (460) and four active valves (464, 472, 476, 477) are housed within a single housing (416) in fluid communication with a fluid reservoir (430) and an inflatable cuff (412), as shown schematically in FIGS. 12A and 12B, as well as in FIGS. 36-52. In this embodiment, the pump (460) is be used to inflate and deflate the fluid cuff (412) by opening and closing the valves, as shown in FIGS. 12A and 12B and described further herein.

[0154] FIGURE 12C depicts yet another alternative embodiment similar to that of FIGS. 12A and 12B, wherein the fluid reservoir (430A) is used to passively inflate the cuff (412). In this embodiment, the pump (460) is used to deflate the cuff (412) in the same manner as depicted in FIG. 12B. As fluid is pumped from the cuff (412) into the fluid reservoir (430A), the fluid reservoir is pressurized with fluid. Thereafter, when the cuff is to be controllably inflated, the valves (472, 476) are closed and valves (477, 464) are opened, thereby bypassing the pump (460) (i.e., in FIG. 12C the pump (460) is not operatively fluidically coupled to the fluid reservoir (430A)) and placing the fluid reservoir in fluid communication with the cuff (412). Because the fluid reservoir (430A) is pressurized with fluid, fluid flows from the reservoir into the cuff (412), thereby inflating the cuff. The arrangement of FIG. 12C can be used advantageously to reduce power consumption, as the energy used to deflate the cuff is stored in the inflated reservoir. It should also be noted that the valve (476) and associated fluid conduits can be omitted in the arrangement of FIG. 12C, or the valve (476) and conduits can be retained in order to provide additional pumping for cuff inflation, as needed.

[0155] As described previously, in order to indirectly monitor bladder pressure, one or more pressure sensors can be provided for monitoring fluid pressure within the cuff (12, 212, 312, 412), one or more of the fluid conduits, one or more of the pumps, a manifold, the fluidreservoir, and / or a fluid-filled chamber or duct, such as within a pressure sensor line that is in direct fluid communication with one or more of the foregoing. As fluid pressure increases in the bladder in response to accumulating urine, fluid pressure inside the cuff (212) increases. Thus, fluid pressure within the pressure sensor line, particularly pressure changes over a period of time, can be used to monitor bladder pressure. The pressure sensor(s) and association pressure sensor lines are not shown in the embodiment of FIGS. 2-9.

[0156] In some embodiments, the inflatable medical system includes one or more ports for filling the system with fluid and / or bleeding air from the system. In some instances, liquid filling and air bleeding is performed at the time of implantation of the system (e.g., after the cuff is in place around the patient’s urethra). In other instances, liquid filling occurs prior to implantation (e.g., at the time of manufacture or packaging, or prior to placing the cuff around the patient’s urethra) and air bleeding occurs at the time of implantation (e.g., after the cuff is in place around the patient’s urethra). In still further instances, liquid filling and air bleeding occur prior to implantation (e.g., at the time of manufacture or packaging, or prior to placing the cuff around the patient’s urethra). As further described herein, one or more fill / bleed ports can be provided on the system, in fluid communication with the fluid reservoir, the cuff, and / or optionally one or both pumps (when included as a fluid transfer device). A vibrator, either included in a system housing or in an external vibration assembly, can also be used in order to aid in bleeding air from the fluidic circuitry of the system.

[0157] FIGURES 13-17 depict one embodiment of an inflatable cuff assembly (511) for use in any of the inflatable medical system embodiments (10, 210, 310, 410) described herein. Cuff assembly (511) is similar in construction to the cuff assembly (211) depicted in FIGS. 2-4, and is adapted for implantation around a portion of a patient’s urethra. When the inflatable cuff (512) of cuff assembly (511) is selectively inflated with fluid, the cuff (512) will expand radially inward, compressing and closing (i.e., constricting) the urethra so as to prevent the escape of urine (as shown in FIG. 15).

[0158] FIGURE 13 is an isometric view of cuff assembly (511) in its undeployed, flat state, prior to being implanted around a patient’s urethra. FIGURE 13 A is an exploded view ofthe structure shown in FIG. 13. Cuff assembly (511) includes a cuff (512) comprising an inflatable chamber having a first wall (513) and a second wall (514) opposite the first wall. The cuff (512) can be made from an elastomeric material such that, as fluid is pumped into the chamber, the chamber expands. In the embodiment shown the cuff (512), in the undeployed state, has a generally flat, rectangular shape. The width of the cuff (512) is between about 10 mm and about 30 mm, or between about 14 mm and about 19 mm. The cuff (512) is adapted to be implanted in a patient so as to surround the urethra with first wall (513) facing the urethra such that, when the cuff (512) is inflated, the urethra is compressed and closed. An opening (515) (e.g., an aperture) is provided in the second wall (514) of the cuff for providing fluid communication to the interior volume (516) of the cuff. (It will be understood that, for purposes of illustration, the urethra is depicted schematically in the figures and tissue between the cuff and the urethra has been omitted for clarity.)

[0159] The second wall (514) of the cuff (512) is affixed to the bottom surface (522) of a flexible backing strip (520) (e.g., using an adhesive). The backing strip (520) includes a cutout (524) intersecting a distal edge of the backing strip, and a locking hole (526) that extends through the backing strip (520) proximal to the cutout (524). The locking hole (526) is located such that the cuff (512) does not extend over the locking hole (526), as best seen in FIG. 13. As explained below, the locking hole is used to lock the cuff assembly (511) in its deployed position, with the cuff (512) positioned around the urethra, during implantation. In the embodiment shown, the backing strip (520) is elastic (e.g., silicone) such that the backing strip can be stretched and wrapped around the patient’s urethra and locked in position (as described below). In other embodiments, particularly where one or more snaps, adhesive, and / or other locking or connecting features are used to lock the cuff (512) in position about the patient’s urethra, the cuff can be inelastic or only partially elastic.

[0160] A fluid connector (550) having a fluid connector body (554) and a fluid port (551) extending laterally away from the fluid connector body is also provided. The fluid port (551) is attachable to the distal end of a fluid conduit (14, 214, 314). The fluid connector (550) further includes a projection (552) extending downwardly away from a portion of the bottom surface (555) of the connector body (554), wherein the projection (552) has an arcuate bottom surface(553) (see FIG. 17). As best seen in the cross-sectional view of FIG. 17, the fluid connector body(554) includes a fluid passageway that provides fluid communication between the fluid port (551) and an exit port (557) located in the arcuate bottom surface (553) of the projection (552). The downwardly extending projection (552) of the fluid connector (550) extends through cutout (524) in the backing strip over opening (515) in the second wall (514) of cuff (512) such that exit port (557) is in fluid communication with the opening (515). The arcuate bottom surface (553) of the projection (552) is affixed to the second wall (514) of cuff (512) (e.g., using an adhesive), such that the bottom surface (555) of the fluid connector body (554) is spaced away from the upper surface (521) of the backing strip (520). Accordingly, fluid port (551) is in fluid communication with the interior of the cuff (512) via passageway (556) and opening (515) of the cuff.

[0161] The backing strip (520) is used to wrap the cuff (512) around the patient’s urethra and to lock the cuff assembly (511) in position, with the cuff (512) at least partially encircling the urethra. In particular, during deployment of the cuff assembly, a pull tab (528) at the proximal end of the backing strip is used to pull the backing strip (520) and cuff (512) around the urethra, with the first wall (513) of the cuff facing the urethra. As the backing strip encircles the urethra, the fluid connector are passed through the locking hole (526) until the locking hole (526) is positioned around the downwardly extending projection (552) of the fluid connector (550). As a result, the cuff assembly is locked in its deployed position (see FIGS. 14-17). Thereafter, a fluid conduit (14, 214, 314) of the system (10, 210, 310) is fluidically coupled to the fluid port (551) such that fluid can be transferred from the fluid reservoir(s) (30, 230, 330A, 330B) into the interior volume (516) of the cuff (512) in order to inflate the cuff around the urethra and prevent urine from escaping the bladder through the urethra.

[0162] In some embodiments, the cuff (512) or cuff assembly (511) can include a fill / bleed port (not shown). This fill / bleed port is in addition to, or in place of, a fill / bleed port at the proximal end of the fluid volume (or elsewhere). By way of example, a fill / bleed port can be located on the cuff (512) opposite the tubing connector (e.g., in first wall (513) or in second wall (514) adjacent locking hole (526)) to provide fluid communication with the interior volume (516) of the cuff. The medical practitioner may connect a fluid source (e.g., via a fluid tube) tofill the cuff (512) and evacuate any air from the cuff through the fluid tube. Alternatively (or in addition to the foregoing), a fill / bleed port can be provided on fluid connector (550) Similar fill / bleed ports can be provided on the alternative cuff assemblies of FIGS. 18-35.[00163J In some embodiments, the controller (80) is programmed (e.g., pre-programmed at the time of implantation and / or programmed subsequently using, for example, the external control device (90)) to activate a bleeding mode for ensuring that air is removed from the system. For example, upon receipt of a signal from the medical practitioner that the system has been filled with fluid (e.g., using the external control device (90)) or upon detecting that the system has been filled with a predetermined amount of fluid (e.g., based on fluid pressure within the system, reservoir, or cuff), the controller (80) can send control signals to one or more components for enhancing air removal. In one embodiment, the controller causes one or more piezoelectric pumps and / or valves to vibrate at frequencies conducive to removal of air entrained in the fluid while at least on fill / bleed port is open. Such frequencies, for example, may be in the range of about 300 to about 700 Hz, whereas frequencies of about 50 to about 200 Hz are used when activating piezoelectric pumps for fluid pumping.

[0164] FIGURES 18-21 depict another embodiment of an inflatable cuff assembly (611) for use in any of the inflatable medical systems (10, 210, 310, 410) described herein. Cuff assembly (611) is similar in construction to cuff assembly (511) depicted in FIGS. 13-17, but has a dual chamber inflatable cuff (612). In one embodiment, when the cuff (612) of cuff assembly (611) is selectively inflated with fluid, both chambers of the cuff (612) inflate, thereby compressing and closing-off the urethra so as to prevent the escape of urine. In an alternative embodiment, one of the chambers of the cuff (612) is used for pressure sensing only, and is not actively inflated / deflated for controlling fluid flow.

[0165] Dual chamber cuff (612) may be formed in a variety of ways. For example, in one embodiment, an inflatable bladder having a generally flat, rectangular shape (when deflated) similar to cuff (512) can be bifurcated into two separate interior volumes (i.e., chambers) by affixing the first wall (513) to the second wall (514) within the interior volume (516) of theinflatable bladder, such as along a line extending along the length of the bladder (e.g., by heat welding or using an adhesive).

[0166] In the embodiment shown, cuff (612) comprises separate first and second generally rectangular chambers (612A, 612B), as best seen in FIG. 19. The first and second rectangular chambers (612A, 612B) can be made from an elastomeric material such that, as fluid is pumped into the chambers, the chambers will expand. Each inflatable chamber (612A, 612B) has a first wall (613A, 613B) and second wall (614A, 614B) opposite the first wall. The cuff (612) is adapted to be implanted in a patient so as to surround the urethra with first walls (613A, 613B) facing the urethra such that, when one or both chambers (612A, 612B) of the cuff (612) is inflated, the urethra is compressed and closed. An opening (615A, 615B) (e.g., an aperture) is provided in the second wall (614A, 614B) of each of the chambers for providing fluid communication to the interior of the chamber.

[0167] The chambers (612A, 612B) are affixed to a backing strip (620) that is similar in configuration to flexible backing strip (520) of the previous embodiment. The second wall (614A, 614B) of each chamber is affixed to the bottom surface (622) of the backing strip (620) (e.g., using an adhesive). As before, the backing strip (620) includes a cutout (not shown) intersecting a distal edge of the backing strip, and a locking hole (626) (see FIG. 21A) that extends through the backing strip (620) proximal to the cutout. The chambers (612A, 612B) are attached to the backing strip such that, when wrapped around a patient’s urethra, each chamber will at least partially encircle the urethra, with the chambers (612 A, 612B) axially adjacent to one another.

[0168] A fluid connector (650) having a fluid connector body (654) and a fluid port (651) extending laterally away from the fluid connector body is also provided. The fluid port (651) is attachable to the distal end of a fluid conduit (14, 214, 314), and includes first and second lumens (658A, 658B). First lumen (658A) is adapted to be in fluid communication with first chamber (612A), and second lumen (658B) is adapted to be in fluid communication with second chamber (612B). As in the previous embodiment, the fluid connector (650) further includes a projection (652) extending downwardly away from a portion of the bottom surface of the connector body(654), wherein the projection (652) has an arcuate bottom surface. In some embodiments, the first and second lumens (658 A, 658B) have the same size (e.g., the same diameter). In other embodiments, particularly when the first and second chambers (612A, 612B) are different sizes, the first and second lumens (658A, 658B) have different sizes (e.g., the same diameter). For example, the ratio of the diameter of the first lumen (658 A) to the diameter of the second lumen (658B) can be approximately the same as (or ±50%, ±30%, ±20%, or ±10% of) the ratio of the internal volume of the first chamber (612 A) to the internal volume of the second chamber (612B) (when the chambers are deflated or / and inflated)

[0169] As best seen in the cross-sectional views of FIGS. 21A and 21B, the fluid connector body (654) includes fluid passageways that provide fluid communication between the lumens of the fluid port (651) and exit ports located in the arcuate bottom surface (653) of the projection (652). Specifically, the fluid connector body (654) includes a first fluid passageway (656A) that provides fluid communication between the first lumen (658A) of the fluid port (651) and a first exit port (657A) located in the arcuate bottom surface (653) of the projection (652). The fluid connector body (654) includes a second fluid passageway (656B) that provides fluid communication between the second lumen (658B) of the fluid port (651) and a second exit port (657B) located in the arcuate bottom surface (653) of the projection (652).

[0170] As before, the downwardly extending projection (652) of the fluid connector (650) extends through a cutout (624) in the backing strip over the openings (615A, 615B) in the second walls (614A, 614B) of cuff (612) such that first and second exit ports (657A, 657B) are in fluid communication with the first and second openings (615 A, 615B), respectively. The arcuate bottom surface (653) of the projection (652) is affixed to the second walls (614A, 614B) of the first and second chambers (612A, 612B) (e.g., using an adhesive), such that the bottom surface (655) of the fluid connector body (654) is spaced away from the upper surface (621) of the backing strip (620). Accordingly, the lumens (658A, 658B) of fluid port (651) are in fluid communication with the interior of the chambers (612A, 612B) of cuff (612) via passageways (656A, 656B) and openings (615 A, 615B) of the chambers.

[0171] As with the previously described embodiment, the backing strip (620) is used to wrap the cuff (612) around the patient’s urethra and to lock the cuff assembly (611) in position, with the cuff (612) encircling the urethra, in the same manner described previously. With the cuff assembly locked in its deployed position (see FIGS. 20-21), a dual lumen fluid conduit (i.e., similar to fluid conduit (14, 214, 314) but with two internal lumens) is fluidically coupled to the fluid port (651) such that fluid can be transferred from the fluid reservoir(s) (30, 230, 33OA, 330B) into one or both of the interior volumes (616A, 616B) of the cuff (612) in order to inflate the chamber(s) around the urethra and prevent urine from escaping the bladder through the urethra.

[0172] In some embodiments of cuff assembly (611), the first and second chambers (612A, 612B) are located adjacent to one another, as shown, such that the chambers are in contact with one another (when deflated or when inflated). In other embodiments, the first and second chambers (612A, 612B) are located in a spaced-apart relationship. In some embodiments of cuff assembly (611), the first and second chambers (612A, 612B) are approximately the same size. In other embodiments the first chamber (612A) is larger than the second chamber (612B) such that width W1 of the first chamber (612A) is greater than the width W2 of the second chamber (612B) (see FIG. 21 A). By way of example, the width W1 of the first chamber (612A) is between about 10 mm and about 30 mm, or between about 14 mm and about 19 mm. The width W2 of the second chamber (612B) is between about 10% and about 100% of width Wl, or between about 15% and about 50% of width Wl.

[0173] In some embodiments of system (10, 210, 310) employing cuff assembly (611), the system is configured such that the first and second chambers (612A, 612B) of the cuff assembly are inflated simultaneously. In other embodiments of system (10, 210, 310) employing cuff assembly (611), the system is configured such that the first and second chambers (612A, 612B) of the cuff assembly are inflated sequentially, in whole or in part. For example, first chamber (612A) can be fully inflated to apply clamping pressure to the urethra at a first location, and thereafter second chamber (612B) can be inflated to apply clamping pressure to the urethra at a second location (e.g., when additional clamping pressure is needed). As yet another alternative, first chamber (612A) can be partially inflated first, and thereafter the second chamber(612B) inflated while inflation of the first chamber (612A) is completed. As another alternative embodiment, particularly when second chamber (612B) is used solely for pressure sensing (as described below), the second chamber (612B) is not actively inflated / deflated for controlling fluid flow. Instead, the second chamber (612B) is prefilled with a predetermined amount of fluid (e.g., at the time of implantation or prior thereto) and is used to monitor fluid pressure within the second chamber (612B).

[0174] In the embodiment shown wherein first chamber (612A) is larger (e g., wider) than second chamber (612B), the first chamber (612A) can be used primarily (or exclusively) for applying clamping pressure so as to constrict the urethra and actively pressurized and depressurized to control the amount of constriction on the urethra for preventing and allowing urine flow through the urethra. The second chamber (612B) can be used for pressure sensing (i.e., monitoring pressure on the urethra), and, optionally, for also applying clamping pressure to the urethra in order to prevent urine flow. Thus, first chamber (612A) can be employed as a sphincter cuff, and second chamber (612B) employed as a pressure sensor cuff. The second chamber (612B) is in operative communication (e.g., fluid communication) with a pressure sensor located within the second chamber (612B), within second passageway (656B), within second lumen (658B), or within a pressure sensing second lumen within the fluid conduit (14, 214, 314) (e.g., pressure sensor (40) shown in FIG. 1).

[0175] It will be understood that when a pressure sensor in operative communication (e.g., fluid communication) with second chamber (612B) is provided (e.g., within the second chamber (612B)) and the second chamber is not actively inflated and deflated for applying clamping pressure, the second passageway (656B), second lumen (658B), and a second lumen in the fluid conduit (14, 214, 314) can be omitted. It will be understood that when a pressure sensor in operative communication (e.g., fluid communication) with fluid second chamber (612B) is provided (e.g., within the second passageway (656B)) and the second chamber is not actively inflated and deflated for applying clamping pressure, the second lumen (658B), and a pressure sensing lumen in the fluid conduit (14, 214, 314) can be omitted. It will also be understood that a pressure sensor in operative communication (e.g., fluid communication) with the first chamber(612A) can also be provided in any of the various locations mentioned for the sensor in operative communication with the second chamber (612B).

[0176] The cuff assembly (611) can be adapted for positioning the second chamber (612B) around the urethra at a location further from the patient’s bladder than the first chamber (612A) (“downstream pressure sensing,” or distal to the bladder), or for positioning the second chamber (612B) around the urethra at a location nearer to the patient’s bladder than the first chamber (612A) (“upstream pressure sensing,” or proximal to the bladder). Regardless of where it is located (e.g., within the cuff assembly (611) or the fluid conduit (14, 214, 314)), the pressure sensor (e.g., sensor (40)) in operative communication with the second chamber (612B) is adapted to provide a pressure signal indicative of fluid pressure in the second chamber (612B). The pressure sensor is in electrical communication with the controller (80) for providing one or more pressure sensor signals to the controller.

[0177] By way of example, when the second chamber (612B) is oriented for downstream pressure sensing (i.e., second chamber (612B) located further from bladder than the first chamber (612A), changes in fluid pressure within the second chamber can be used to detect if a Foley catheter or other foreign object is deforming the second chamber. Insertion of a Foley catheter, for example, will exert pressure on the wall of the urethra and the second chamber (612B), thereby causing a fluid pressure increase in the second chamber. When such a foreign object is detected, the controller (80) causes the cuff to be deflated.

[0178] By way of further example, when the second chamber (612B) is oriented for upstream pressure sensing (i.e., second chamber (612B) located closer to the bladder than the first chamber (612A)), changes in fluid pressure within the second chamber can be used to monitor, for example, bladder pressure. With the first chamber (612A), and optionally the second chamber (612B), expanded with fluid in order to close off the urethra, pressure exerted on the second chamber (612B) by the bladder will increase causing a corresponding increase in the fluid pressure within the second chamber (612B). The pressure signal from the pressure sensor in operative communication with the second chamber (612B) will thus provide an indication of bladder pressure (i.e., the amount of urine within the bladder). The pressure signal can be usedby the controller (80) predictively - i.e., to predict when the bladder will become full so as to alert the patient a predetermined amount of time beforehand. The pressure signal from an upstream second chamber (612B) also can be used by the controller (80) for safety - i.e., if the pressure reaches a predetermined threshold, the controller causes the cuff to be deflated in an attempt to prevent injury to the patient. In still further embodiments, regardless of whether upstream or downstream orientation, the pressure signal from the second chamber (612B) also can be monitored for decreases in pressure, indicating a fluid leak in the system (e g., a reservoir leak, a cuff leak and / or a fluid conduit leak).

[0179] FIGURES 22-28 depict another embodiment of an inflatable cuff assembly (711) for use in any of the inflatable medical systems (10, 210, 310, 410) described herein, wherein like numerals are used in FIGS. 22-28 to identify elements similar to those described above in connection with FIGS. 18-21. Cuff assembly (711) is similar in construction to cuff assembly (611), but has a tri-chamber inflatable cuff (712). In one embodiment, when the cuff (712) of cuff assembly (711) is selectively inflated with fluid, all three chambers of the cuff (712) inflate, thereby compressing and closing-off the urethra so as to prevent the escape of urine. In an alternative embodiment, one or two of the chambers of the cuff (712) is used for pressure sensing only, and is not actively inflated / deflated for controlling fluid flow.

[0180] Tri-chamber cuff (712) may be formed in a variety of ways. For example, in one embodiment, an inflatable bladder having a generally flat, rectangular shape (when deflated) similar to cuff (512) can be trifurcated into three separate interior volumes (i.e., chambers) by affixing the first wall (513) to the second wall (514) within the interior volume (516) of the inflatable cuff along two parallel, spaced-apart lines extending along the length of the bladder (e.g., by heat welding or using an adhesive).

[0181] In the embodiment shown, cuff (712) comprises separate first, second, and third generally rectangular chambers (712A, 712B, 712C), as best seen in FIG. 22B. The chambers (712A, 712B, 712C) can be made from an elastomeric material such that, as fluid is pumped into the chambers, the chambers will expand. Each inflatable chamber (712A, 712B, 712C) has a first wall (713A, 713B, 713C) and second wall (714A, 714B, 714C) opposite the first wall. The cuff(712) is adapted to be implanted in a patient so as to surround the urethra with first walls (713A, 713B, 713C) facing the urethra such that, when one or more chambers (712A, 712B, 712C) of the cuff (712) is inflated, the urethra is compressed and closed. An opening (715A, 715B, 715C) (e.g., an aperture) is provided in the second wall (714A, 714B, 714C) of each of the chambers for providing fluid communication to the interior of the chamber.

[0182] The chambers (712A, 712B, 712C) are affixed to a backing strip (720) that is similar in configuration to flexible backing strip (620) of the previous embodiment in the same manner described previously. Thus, the second wall (714A, 714B, 714C) of each chamber is affixed to the bottom surface (722) of the backing strip (720) (e.g., using an adhesive). As before, the backing strip (720) includes a cutout (not shown) intersecting a distal edge of the backing strip, and a locking hole (726) (see FIG. 28) that extends through the backing strip (720) proximal to the cutout. The chambers (712A, 712B, 712C) are attached to the backing strip such that, when wrapped around a patient’s urethra, each chamber will at least partially encircle the urethra, with the chambers axially adjacent to one another.

[0183] A fluid connector (750) having a fluid connector body (754) and a fluid port (751) extending laterally away from the fluid connector body is also provided. The fluid port (751) is attachable to the distal end of a fluid conduit (14, 214, 314), and includes first, second, and third lumens (758A, 758B, 758C) adapted to be in fluid communication with the chambers (712A, 712B, 712C), respectively. As in the previous embodiment, the fluid connector (750) further includes a projection (752) extending downwardly away from a portion of the bottom surface of the connector body (754), wherein the projection extends through a cutout in the backing strip and an arcuate bottom surface (753) of the projection (752) is affixed to the second walls (714A, 714B, 714C) of the chambers (e.g., using an adhesive).

[0184] The remaining portions of cuff assembly (711) can be configured similar to the cuff assembly (611) (including the various sizes of the chambers and fluid lumens mentioned above) but with three chambers and associated fluid passageways and sensors. The tri-lumen fluid port (751) can include lumens that are all the same size (diameter) or lumens of two or more different sizes. The three fluid chambers may similarly all have the same size (dimensionsand / or volume), or have two more different sizes. In the example shown, the sphincter cuff lumen (i.e., first lumen (758A)) is fluidically coupled to the sphincter cuff fluid bladder (i.e., first chamber (712A)), the proximal pressure sensor cuff lumen (i.e., second lumen (758B)) is fluidically coupled to the distal pressure sensor cuff fluid bladder (i.e., second chamber (712B))and the distal pressure sensor cuff lumen (i.e., third lumen (758C)) is fluidically coupled to the distal pressure sensor cuff fluid bladder (i.e., third chamber (712C)). The sphincter cuff fluid bladder may be positioned in the center of the backing strip (720) with the distal and proximal pressure sensor cuff fluid bladders on either side, or in any other desired arrangement. The distal and proximal pressure sensor cuff fluid bladders primary purpose is to provide pressure information on either side of the sphincter cuff fluid bladder. A pressure sensor may be provided in operative communication (e.g., fluid communication) with each bladder, such as being mounted within each of the lumens to provide fluid pressure data for each bladder.

[0185] In the specific example shown, the first chamber (712A) is larger (e.g., wider) than second and third chambers (712B, 712C), with the first chamber (712A) used primarily (or exclusively) for applying clamping pressure so as to constrict the urethra and actively pressurized and depressurized to control the amount of constriction on the urethra for preventing and allowing urine flow through the urethra. The second and third chambers (712B, 712C) can be used for upstream and downstream pressure sensing (i.e., monitoring pressure on the urethra), and, optionally, for also applying clamping pressure to the urethra in order to prevent urine flow. Thus, first chamber (712A) can be employed as a sphincter cuff, and second and third chambers (712B, 712C) employed as pressure sensor cuffs. The second chamber (712B) can be in operative communication (e.g., fluid communication) with a pressure sensor located within the second chamber (712B), within a second passageway (756B) in the fluid connector (750), within second lumen (758B) in the fluid port (751), or within a pressure sensing second lumen within the fluid conduit (14, 214, 314) (e.g., pressure sensor (40) shown in FIG. 1). The third chamber (712C) can be in operative communication (e.g., fluid communication) with a pressure sensor located within the third chamber (712C), within a third passageway (756C) in the fluid connector (750), within third lumen (758C) in the fluid port (751), or within a pressure sensing third lumen within the fluid conduit (14, 214, 314) (e.g., pressure sensor (40) shown in FIG. 1).

[0186] In the particular embodiment shown in FIGS. 22-28, and as best seen in the cross- sectional views of FIGS. 24-26 and 28, the fluid connector body (754) includes fluid passageways that provide fluid communication between the lumens of the fluid port (751) and exit ports located in the arcuate bottom surface (753) of the projection (752). Two or more of these fluid passageways are also in fluid communication with each other, within the fluid connector body, optionally via one or more critical orifices.

[0187] Specifically, the fluid connector body (754) includes a first fluid passageway (756A) that provides fluid communication between the first lumen (758A) of the fluid port (751) and a first exit port (757A) located in a bottom surface of the fluid connector body (e.g., an arcuate bottom surface of a projection similar to projection (652)). The fluid connector body (754) includes a second fluid passageway (756B) that provides fluid communication between the second lumen (758B) of the fluid port (751) and a second exit port (757B), as well as a third fluid passageway (756C) that provides fluid communication between the second lumen (758C) of the fluid port (751) and a second exit port (757C). Similar to cuff assembly (611), the fluid connector body (754) is attached to the second walls of the chambers (714A, 714B, 714C) such that exit ports (757A, 757B, 757C) are in fluid communication with the openings (715A, 715B, 715C), respectively. Accordingly, the lumens (758A, 758B, 758C) of fluid port (751) are in fluid communication with the interior of the chambers (712A, 712B, 712C) of cuff (712) via passageways (756A, 756B, 756C) and openings (715A, 715B, 715C) of the chambers, respectively.

[0188] The fluid connector body (750) further includes one or more fluid channels connecting pairs of the passageways (756A, 756B, 756C), with an optional critical orifice located within one or more of the fluid channels. In the embodiment shown, a first fluid channel (760A) provides fluid communication between the first and second fluid passageways (756A, 756B), and a second fluid channel (760B) provides fluid communication between the first and third fluid passageways (756A, 756C). A first critical orifice (761 A) is provided within the first fluid channel (760A), and a second critical orifice (76 IB) is provided within the second fluid channel (760B). Thus, second and third fluid chambers (712B, 712C) are each fluidically coupled to the first fluid chamber (712A) via the passageways (756A, 756C) and through thecritical orifices (761A, 761B). The critical orifices reduce the size (cross-section) of the fluid channels (760A, 760B) at the critical orifices in order to increase the sensitivity of the second and third chambers (712B, 712C) to pressure changes. By way of example, in some embodiments that the critical orifices have a diameter of between about 0.02 mm and about 1 mm.

[0189] In particular, as best seen in FIG. 25, wherein the cuff assembly has been implanted such that the cuff (712) encircles the urethra, the first chamber (712A) is fully inflated such that the chamber has expanded radially inward to compress and close (i.e., constrict) the urethra. The second and third chambers (712B, 712C) encircle the urethra on either side of the first chamber (712A) (i.e., upstream and downstream). However, in some embodiments the second and third chambers are configured (e.g., by geometry and size) such that the chambers do not constrict the urethra when fluid is pumped into the cuff (712). Instead, the second and third chambers (712B, 712C) expand outwardly when inflated rather than applying clamping pressure against the urethra, and are used for providing pressure information via one or more sensors in operative communication with the second and third chambers. With the first chamber (712A) inflated and constricting the urethra, an abrupt change in pressure within the urethra immediately upstream or downstream of the first chamber will result in a momentary pressure spike within one of the second and third chambers (712B, 712C) until the fluid pressure in the three chambers equalizes. The critical orifices will delay pressure equalization and enhance the ability of the system to detect such abrupt pressure changes.

[0190] As with the previously described embodiments, the backing strip (720) is used to wrap the cuff (712) around the patient’s urethra and to lock the cuff assembly (711) in position, with the cuff (712) encircling the urethra, in the same manner described previously. With the cuff assembly locked in its deployed position (see FIGS. 20-21), a tri-lumen fluid conduit (i.e., similar to fluid conduit (14, 214, 314) but with three internal lumens) is fluidically coupled to the fluid port (751) such that fluid can be transferred from the fluid reservoir(s) (30, 230, 33OA, 330B) into one, two, or three of the interior volumes (716A, 716B, 716C) of the cuff (712) in order to inflate the chamber(s) around the urethra and prevent urine from escaping the bladderthrough the urethra while also providing pressure signals representing fluid pressure within one or more of the chambers (712A, 712B, 712C).

[0191] In some embodiments of cuff assembly (711), the second and third chambers (712B, 712C) are located adjacent to the first chamber (712A), on either side thereof (as shown), such that the chambers are in contact with one another (when deflated or when inflated). In other embodiments, the chambers are located in a spaced-apart relationship. In some embodiments of cuff assembly (711), the three chambers are approximately the same size. In other embodiments, the first chamber (712A) is larger than the second and third chambers (712B, 712C) such that the width of the first chamber (712A) is greater than the width of the second and third chambers. By way of example, the width of the first chamber (712A) is between about 10 mm and about 30 mm, or between about 14 mm and about 19 mm. The width of the second and third chambers (712B, 712C) is between about 10% and about 100% of the width of the first chamber (712A), or between about 15% and about 50% of the width of the first chamber. Likewise, the width of the second and third chambers may the same, or one may be larger than the other.

[0192] In some embodiments of system (10, 210, 310, 410) employing cuff assembly (711), the system is configured such that the three chambers of the cuff assembly are inflated simultaneously. In other embodiments of system (10, 210, 310) employing cuff assembly (711), the system is configured such that the chambers of the cuff assembly are inflated sequentially, in whole or in part. For example, first chamber (712A) can be fully inflated to apply clamping pressure to the urethra at a first location, and thereafter second and third chamber (712B, 712C) can be inflated (either to apply clamping pressure to the urethra at a second and third location (e g., when additional clamping pressure is needed) or to provide for pressure sensing. As yet another alternative, first chamber (712A) can be partially inflated first, and thereafter the second and third chambers (712B, 712C) inflated while inflation of the first chamber (712A) is completed. As another alternative embodiment, when the second and third chambers (712B, 712C) are used solely for pressure sensing (as described above), the second and third chambers are not actively inflated / deflated for controlling fluid flow. Instead, the second and third chambers (712B, 712C) are prefilled with a predetermined amount of fluid and used to monitor fluid pressure within the second and third chambers.

[0193] FIGURES 29-33 depict another embodiment of an inflatable cuff assembly (811) for use in any of the inflatable medical systems (10, 210, 310, 410) described herein, wherein like numerals are used in FIGS. 29-33 to identify elements similar to those described above in connection with FIGS. 18-21 and 22-28. Cuff assembly (811) is similar in construction to cuff assemblies (511, 611, 711), and can have a single, bi-, or tri-chamber cuff (812), as described above. In this embodiment, the configuration of the backing strip (820) has been modified to provide an alternative arrangement for locking the cuff assembly (811) in its deployed position after the cuff (812) is positioned around the patient’s urethra. This embodiment allows the cuff to be wrapped around the urethra and locked in position while a fluid conduit (14, 214, 314) is attached to the cuff assembly (811) (e.g., to fluid port (851)). For example, since the fluid port (851) does not have to be passed through a locking hole in the backing strip (820) during implantation, the fluid conduit (14, 214, 314) can be fluidically coupled to the fluid port (851) prior to implantation. This allows the cuff to be pre-filled with fluid and pre-bled of air during manufacture, instead of being bled of air only after the cuff (812) has been deployed about a patient’s urethra and locked in position (as described previously herein). In addition, unlike the previously described embodiments, the fluid connector (850) does not require a projection (552, 652, 752) extending downwardly away from the fluid connector to allow the use of the backing strip locking hole (526, 626, 726). This allows for the cuff assembly (811) to be significantly reduced in size.

[0194] Cuff assembly (811) once again includes an inflatable cuff (812) having a wall (e.g., the second wall(s) of one or more inflatable fluid chambers described previously) which is affixed to the bottom surface (822) of a flexible backing strip (820) (e.g., using an adhesive). The backing strip (820) includes an opening (824) through which fluid connector (850) extends. Fluid port (851) extends laterally away from the fluid connector (850). The fluid port (851) is attachable to the distal end of a fluid conduit (14, 214, 314). As best seen in the cross-sectional view of FIG. 33, the fluid connector (850) includes a fluid passageway (856) that provides fluid communication between the fluid port (851) and an exit port (857) located in the bottom distal end surface (853) of the fluid connector (850). The bottom distal end surface (853) is affixed to the second wall (814) of cuff (812) (e.g., using an adhesive) over opening (815) in the secondwall (814) such that exit port (857) is in fluid communication with the opening (815). Accordingly, fluid port (851) is in fluid communication with the interior of the cuff (812) via passageway (856) and opening (815) of the cuff.[00195J The backing strip (820) is once again used to wrap the cuff (812) around the patient’s urethra and to lock the cuff assembly (811) in position, with the cuff (812) at least partially encircling the urethra. In particular, during deployment of the cuff assembly, a pull tab (828) (or backing strip tail) located at the proximal end of the backing strip is used to pull the backing strip (820) and cuff (812) around the urethra, with the first wall (813) of the cuff facing the urethra.

[0196] The backing strip (820) includes a series of two or more spaced-apart locking slots (830) in a distal portion of the backing strip. The locking slots (830) generally extend widthwise across a portion of the backing strip, such that a flexible locking loop (831) is provided by the area between each pair of adjacent locking slots (830). The locking slots (830) are configured such that the backing strip tail (828) can be inserted through a pair of adjacent locking slots (830) beneath the locking loop (831) located between the adjacent slots. Thus, the width of the backing strip tail (828) is less than the width of the locking slots (830). The proximal end of the backing strip tail (828) has an enlarged locking tab (833) that extends across the width of the proximal end of the tail (828). The locking tab (833) has a width greater than the width of the backing strip tail (828) and greater than the width of the locking slots (830). The locking tab (833) can have any of a variety of shapes and configurations (e.g., the rod shape shown) and may be made from a stiff material. The locking tab (833) is sized and configured such that it can be passed through one locking slot (830), under an adjacent backing strip loop (831) and back out of an adjacent locking slot (830), as seen in FIGS. 31 and 33. During installation, the locking tab (833) is tilted in order to allow the tab to pass through the locking slots (830). However, once passed through a pair of adjacent slots (830), the locking tab (833) extends generally parallel to the locking slots (830), thereby preventing the backing strip tail (828) and locking tab (833) from pulling out of the locking slots (830) and securing the cuff (812) in place around the urethra. The medical practitioner may pass the locking tab (833) through any of the locking slots (830) in order to adjust the size of the cuff for the patient.Alternatively, in some embodiments only a pair of locking slots (830) are provided such that the cuff (812) is not adjustable by the medical practitioner. As a result, the cuff assembly is locked in its deployed position (see FIGS. 14-17). Although not shown in FIGS. 29-33, the cuff assembly (811) can be deployed around the patient’s urethra and locked in position while the fluid conduit (14, 214, 314) of the system (10, 210, 310) is fluidically coupled to the fluid port (851), with the fluid conduit fluidically coupled to the reservoir(s) and pump. In this manner, the entire system (10, 210, 310) can be supplied to the medical practitioner pre-filled with fluid and pre-bled of air. This simplifies and expedites implantation of the system.

[0197] FIGURES 34-35 depict an alternative locking arrangement for an inflatable cuff assembly (911) similar to that of FIGS. 29-33, for use in any of the inflatable medical systems (10, 210, 310, 410) described herein. Like numerals are used in FIGS. 34-35 to identify elements similar to those described above in connection with FIGS. 18-21, 22-28, and 29-33. Cuff assembly (911) is similar in construction to cuff assemblies (511, 611, 711, 811), and can have a single, bi-, or tri-chamber cuff (912), as described above. In this embodiment, the locking tab (833) has been replaced with a relatively stiff, enlarged locking hook (933) at the proximal end of the backing strip tail (828). Like the locking tab (833), the locking hook (933) extends across the width of the proximal end of the tail (828). The locking hook (833) has a width greater than the width of the backing strip tail (928) and greater than the width of the locking slots (930). The locking hook (933) is sized and configured such that it can be passed through one locking slot (930), under an adjacent backing strip loop (931) and back out of an adjacent locking slot (930), as seen in FIGS. 35 and 35 A, with the looking hook looping around and over a portion of the backing strip loop (931) beneath which the hook (933) is passed.

[0198] FIGURES 36-52 depict yet another embodiment of an inflatable medical system (410), in this instance a specific implementation of the arrangement of FIGS. 12A-12B. The fluidic circuitry of system (410) includes a single, one-way piezoelectric pump (460) and four bistable active valves (464, 472, 476, 477) housed within a single housing (416) in fluid communication with a fluid reservoir (430) and an inflatable cuff (412). The pump (460) is used to inflate and deflate the fluid cuff (412) by opening and closing the valves, as depicted in FIGS. 12A and 12B. One suitable piezoelectric pump (460) is that shown and described in U.S. Pat.Pub. No. 2011 / 000506, published January 13, 2011, which is incorporated by reference herein. Such pumps are available from Bartels Mikrotechnik GmbH, in Dortmund, Germany, as the mp6™ micropump. Of course other one-way pumps, particularly piezoelectric pumps, can be used. The cuff (412) may have any of the configurations described previously herein, such as those shown in FIGS. 13-35.

[0199] The embodiment of FIGS. 36-52 is similar to the embodiments of FIG. 1, 2-10, and 11A-11M described above, with a single housing (416) provided. The receiver (484), controller (480), power supply (482), pump (460), valves (464, 472, 476, 477), and other electronic components are located within housing (416). Alternatively, system (410) can include a second housing having the controller, power supply, and receiver, wherein this second housing is adapted to be implanted in the patient spaced apart from, and in electrical communication with, the first housing (416). As with previous embodiments, the reservoir (430) can be provided separate from the housing (416) and fluidically connected thereto by reservoir fluid conduit (438). Alternatively, as further discussed below, the reservoir (430) can be located within (wholly or partially) housing (416) or can be attached to the housing (416) and fluidically coupled with the valves and pump (460) (e.g., via reservoir fluid conduit (438)). Thus, the fluid reservoir (430) is in fluid communication with an inflatable implant via fluidic circuitry (i.e., a fluid transfer device) that includes pump (460) (e.g., a piezoelectric pump), and associated valves (464, 472, 476, 477) for pumping fluid to and from the inflatable implant via cuff fluid conduit (414). As before, the inflatable implant is in the form of cuff (412) adapted for implantation about a portion of a patient’s urethra and for receiving fluid from the reservoir (430) for inflating the cuff. It will be understood that the implantable portion of the inflatable medical system (410) can include a variety of alternative inflatable implants such as penile prostheses for treatment of erectile dysfunction.

[0200] In the embodiment depicted in FIGS. 36-52, both the pump (460) and the valves (464, 472, 476, 477), are contained within housing (416) (e g., a titanium housing (416)). A manifold arrangement (described below) is provided in the housing, and is fluidically connected to both the pump (460) and the valves (464, 472, 476, 477), thereby eliminating fluid tubing within the housing. The valves (464, 472, 476, 477) are active valves, controlled by thecontroller. During cuff inflation, the first and third active valves (464, 476) are open and the second and fourth valves (472, 477) are closed such that fluid is pumped from the fluid reservoir (430), into the cuff (412), causing the cuff to inflate. During cuff deflation, the first and third active valves (464, 476) are closed and the second and fourth valves (472, 477) are open, such that fluid is pumped out of the cuff (412) into the fluid reservoir (430). This results in the cuff deflating and the fluid reservoir filling with fluid.

[0201] FIGURE 37 is an isometric view of the inflatable medical system (410), with the cuff (412) and most of the cuff fluid conduit (414) omitted for clarity. The cuff (412) is in fluid communication with the housing (416) via cuff fluid conduit (414). The conduit (414) can be in the form of flexible tubing suitable for medical implantation in a patient. Fluid is pumped into the cuff (412) for inflation through cuff fluid conduit (414), and fluid is pumped out of the cuff for deflation through cuff fluid conduit (414). FIGURE 38 is the same view as FIG. 37, with the housing (416) and reservoir (430) omitted. FIGURE 39 is an exploded view of FIG. 37, and FIG. 40 is an exploded view of the housing (416).

[0202] Housing (416) comprises a first upper housing (416A), a first lower housing (416B), a second upper housing (416C), and a second lower housing (416D). First upper housing (416A) and first lower housing (416B) are adapted to be secured to one another (e.g., by welding or adhesive) such that a first chamber is provided therebetween. The manifold (462), pump (460), valves (464, 472, 476, 477), pressure sensor (440), power supply (482), controller (480), and receiver (484) are located within the first chamber. Second upper housing (416C) and second lower housing (416D) are adapted to be secured to one another (e.g., by welding or adhesive) such that a second chamber is provided therebetween. One or more wireless receiving coils (419) is located within the second chamber, and is used for to receive signals for inductively charging the power supply (482) and optionally to receive signals from and transmit signal to an external device (e.g., external control device (90), external actuator (449), or another external computing device such as that of a medical practitioner or medical facility). An end plate (418) (see FIG. 40) is secured at an open edge of the first chamber and is attached to the second upper housing (416C). The end plate (418) serves to provide a sealed interface between the first and second chambers, while also providing a passageway that allows electrical communication between thereceiving coil (419) and the controller (480) and power supply (482), and a passageway for receiving a connector (415) to which the proximal end of the cuff fluid conduit (414) can be secured so that there is fluid communication between the manifold (462) and the inflatable cuff.[00203J As best seen in FIGS. 41-44, the pump (460) is secured within a recess (460R) provided in the upper surface of the manifold (462). The pump (460) is omitted in FIGS. 39, 41, and 51 but is similar to the pumps (360, 369) shown in FIG. 11D. A pump inlet (461A) and a pump outlet (46 IB) are provided in the upper surface of the recess (460R) of the manifold, and are located so as to be in fluid communication with the inlet and outlet of the pump (460) when the pump is secured within the recess (460R). Thus, the manifold (462) simplifies the assembly of the device by ensuring proper alignment of the pump, with the appropriate fluid communication with the manifold and other components mounted thereto. As explained further herein, the pump outlet (46 IB) is fluidically coupled to the first valve (464), which in turn is fluidically coupled to the cuff fluid conduit (414). The pump outlet (46 IB) is also fluidically coupled to the fourth valve (477), which in turn is fluidically coupled to the reservoir fluid conduit (438). The pump inlet (461A) is fluidically coupled to the second valve (472), which in turn is fluidically coupled to the cuff fluid conduit (414). The pump inlet (461A) is also fluidically coupled to the third valve (476), which in turn is fluidically coupled to the reservoir fluid conduit (438). The valves are controlled such that during cuff inflation only the first and third valves (464, 477) are open, and during cuff deflation only the second and fourth vales (472, 477) are open. Bistable active valves (464, 472, 476, 477) are operatively coupled to the controller (480) such that signals from the controller cause the bistable valves to open or close, and to stay in that position until a subsequent signal is received from the controller.

[0204] During normal operation, two of the valves (464, 472, 476, 477) will typically be open and two of the valves will be closed. In some embodiments, the controller is configured to open all four of the valves (or at least second and third valves, or the first and fourth valves) for patient safety, such as when the pump becomes inoperative (e.g., fails or is non-responsive). This will allow at least some of the fluid to drain from the cuff into the reservoir. Similarly, in some embodiments, the controller is configured to close all four of the valves (or at least the first and second valves) for patient safety should the pump become inoperative and the cuff is alreadydeflated. In addition, as further described herein, during the air bleeding process prior to implantation, in some embodiments the controller is configured to open all four valves for facilitating the bleeding of air from the fluidic circuitry, the reservoir, and / or the cuff.

[0205] In other instances, the controller is configured to maintain all four valves in their closed positions to prevent fluid passing from the reservoir to the cuff, particularly for a predetermined period of time after initial implantation. This can be used, for example, following initial implantation of the system such that the cuff cannot be inflated for a predetermined period of time after implantation (e.g., for 10 days, for 20 days, for 30 days, or for a longer period after implantation). This allows for sufficient healing of the region surrounding the location of cuff (412). In their closed positions, first and second valves (464, 472) also provide an additional measure to prevent inflation of the cuff, such as when the system is in a locked mode, or for purposes of maintaining fluid pressure within the cuff.

[0206] The manifold (462) is adapted for not only mounting of the pump, valves, and pressure sensor thereto, but also for providing fluid communication between these components. Fluid passageways between the components are formed in the manifold. As a result, tubing and other separate passageways or connectors are not necessary between the components mounted to the manifold (462). This not only simplifies fabrication and assembly, but also allows for a smaller footprint for housing (416). In one embodiment, manifold (463) is fabricated from molded or micro-machined polymer (e.g., polyphenyl sulfone or PPSU).

[0207] As seen in FIGS. 42-46, a plurality of fluid channels are formed in the bottom surface of the manifold (462) in order to create a plurality of fluid conduits or passageways in the manifold. An additional plurality of channels extend upwardly away from the bottom surface of the manifold and through opposing sidewalls of the manifold, intersecting the fluid channels formed in the bottom surface of the manifold, thereby providing fluid communication between the various inlets, outlets, and ports described herein. Fluid moves freely within these fluid channels such that the manifold serves to direct fluid flow in the intended manner.

[0208] As depicted in FIG. 42, a manifold seal member (467) (e.g., a seal film) extends over, and is sealed to, the bottom surface of the manifold (462). Two or more alignmentprojections (428) are may be provided on the bottom surface of the manifold, and are alignably received in corresponding apertures (429) in the seal film (467) to aid in assembly. The manifold seal film (467) can be glued, heat staked, overmolded, or otherwise sealed to the bottom surface of the manifold (462) to enclose the internal fluid channels formed in the bottom surface of the manifold. The manifold seal film (467) is omitted in FIGS. 43-46.

[0209] The manifold includes a cuff fluid passageway (451) adapted for fluid coupling with cuff fluid conduit (414), and at least one reservoir fluid inlet (452) adapted for fluidic coupling with the reservoir (430) (e.g., via reservoir fluid conduit (438)). As best seen in FIG. 46, cuff fluid passageway (451) comprises an upper cuff fluid passageway (451 A) and a lower cuff fluid passageway (45 IB). The upper and lower cuff fluid passageways are in fluid communication with one another via opening (451C). As seen in FIG. 48, a hollow connector (415) (e.g., a tubing barb connector) is secured within upper cuff fluid passageway (451A), with the distal portion of the connector extending out of the manifold. The proximal end portion of the cuff fluid conduit (414) is secured over the distal portion of the connector (415), thereby providing fluid communication between the cuff fluid passageway (451) and the cuff (412).

[0210] In order to monitor fluid pressure within the cuff (and indirectly monitor bladder pressure, one or more pressure sensors are provided in fluid communication with the interior of the cuff (412). In the embodiment shown, a pressure sensor (440) (e.g., a sensor having a sealed membrane, such as a piezoelectric sensor) is located so as to provide a sensor signal representative of the pressure within the cuff. The sensing element of the cuff pressure sensor (440) is in operative contact with a fluid volume that is in direct fluid communication with the interior of the cuff. In the example shown, cuff pressure sensor (440) is located in fluid communication with cuff fluid passageway (451). In particular, a pressure sensor bore (441) extends through the manifold, intersecting lower fluid passageway (45 IB) (see FIG. 46). The pressure sensor (440) is sealingly mounted to the manifold, with the pressure sensing portion of the sensor located within pressure sensor bore (441). Pressure within the cuff fluid passageway (451) corresponds to the fluid pressure in the cuff fluid conduit (414), and thereby in the cuff (412). As fluid pressure increases in the bladder in response to accumulating urine, fluid pressure inside the cuff (412) increases. Thus, fluid pressure within cuff fluid passageway (451),particularly pressure changes over a period of time, can be used to monitor bladder pressure. It will be understood that cuff pressure sensor (440) can be positioned in a variety of locations in direct fluid communication with the cuff (412), such as along a separate pressure sensor line in fluid communication with the cuff (412). One or more additional pressure sensors can be provided, such as a reservoir pressure sensor located so as to provide a sensor signal representative of the pressure within the reservoir (430), as described previously.

[0211] A variety of other sensors, including biometric sensors, can be included in the system (410). The biometric sensors provide sensor signals to the controller (480) indicative of one or more biometric characteristic of the patient for monitoring and controlling the operation of the system. In the example shown in FIG. 36, a heartrate sensor (455A), blood oxygen sensor (455B), and temperature sensor (456C) are included, and are in electrical communication with controller (480). In one embodiment, these biometric sensors are in the form of optical sensors (e.g., infrared sensors) located within housing (416) adjacent an optically clear viewing window (491) such that the sensor(s) can detect conditions of the user - i.e., heartrate, blood oxygen level, and temperature in the region surrounding the housing - through the viewing window and provide signals to the controller (480). In some embodiments, a single optical sensor can be used to provide signals to the controller indicative of two or more of heartrate, blood oxygen level, and temperature, with the controller adapted to determine two or more of heartrate, blood oxygen level, and temperature from the signal.

[0212] In an alternative embodiment, the heartrate sensor (455A) comprises a microphone for detecting the audible sounds indicative of the patient’s heartbeat (or a microphone is included in the housing in addition to the heartrate sensor (455A)). The signal from the microphone is processed by the controller in order to determine the patient’s heartrate - e.g., using the frequency and amplitude of peaks in the audio signal, while filtering out background noise. In this instance, the housing (416) acts as a transducer, amplifying the sound - particularly when the microphone is affixed to an interior wall of the housing such as microphone (455D) in FIGS. 39 and 40. It will be understood that some embodiments will include only one or two of the heartrate sensor, blood oxygen sensor, and temperature sensor.

[0213] In still further embodiments, signals indicative of the patient’s heartrate (or other biometric indicia), patient activity level (patient activity level data), and / or patient location (patient location data) are provided to the controller (430) by an external computing device such as an exercise or wellness monitoring device (e.g., a FitBit® device, a Garmin® watch, a heartrate monitor, or similar external exercise or wellness monitoring device). The external computing device can include an accelerometer and / or an absolute position sensor in order to obtain signals indicative of patient activity level (e.g., exercising, sitting, or lying down). The external computing device can include a GPS component in order to obtain patient location data. The controller (480) is adapted to wirelessly receive signals directly from the external computing device via the receiver (484) or receiving coil (419). Alternatively, the external control device (90) can be in wireless communication with the external computing device (e.g., an exercise / wellness monitoring device) and then transmit signals indicative of the patient’s heartrate, activity level, and / or location to the controller (480). (As yet another alternative, the external actuator device (449) described below can communicate with the external computing device and transmit signals to the controller (480)).

[0214] In yet another alternative, external control device (90) can be configured to acquire data indicative of the patient’s heartrate, activity level, and / or location and transmit that data to the controller (480). For example, the external control device (90) can include an accelerometer and / or an absolute position sensor for obtaining signals indicative of patient activity level, and / or a GPS module to obtain patient location signals. Such signals are processed by either the controller (90C) of the external control device (90) or the controller (480) (after being received from the external control device (90)), in order to monitor the level of patient activity and / or the patient’s location. The controller determines a relative activity level of the patient based on the data provided by the accelerometer and / or absolute position sensor. When provided, microphone (455D) can also be used to detect external noise (i.e., outside of the patient), thereby providing an additional indicator of the patient’s activity level, with the audio signal from the microphone used in the same manner as activity level data.

[0215] Similarly, signals from the heartrate sensor, blood oxygen sensor, and / or temperature sensor are processed by the controller (430) in order to determine, for example, thatthe patient is engaged in a physical activity (e.g., exercising, running, sexual activity) that is more likely to result in urine leakage as compared to when the patient is in a non-active state (e g., sitting or lying down). The controller (480) is programmed such that when at least one, at least two, or at least three of the biometric parameters exceeds a predetermined threshold, optionally for a predetermined period of time, and / or when the patient activity level data exceeds or varies from a predetermined threshold, optionally for a predetermined period of time, the controller causes the fluid transfer device to increase fluid pressure within the cuff (412) by pumping more fluid into the cuff (also referred to as “active mode”). Typically, only a small increase in pressure is necessary to prevent leakage. In some embodiments, the controller is configured to scale the pressure increase based on the activity level. Biometric and / or activity level data indicative of moderate activity results in only a small pressure increase by the controller, while biometric and / or activity level data indicative of intense activity results in a larger pressure increase by the controller.

[0216] The predetermined thresholds (which can be absolute values or ranges) can be selected by the patient (e.g., using external control device (90)), selected by a medical practitioner, or can be established by the controller (480) based on measured values (e.g., averages or medians) over a period of time. For example, if the patient’s heartrate exceeds their average heartrate by a predetermined amount (e.g., >20%, >35%, >50%, >65%, etc.) for a predetermined period of time (e.g., 1 minute, 2 minutes, 3 minutes, 5 minutes, etc.), the controller (430) will cause the fluid pressure within the cuff to be increased. The amount of the increase can also be based on how much the patient’s heartrate exceeds the predetermined threshold and / or for how long the patient’s heartrate exceeds the predetermined threshold. A decrease in blood oxygen, an increase in the patient’s internal temperature, and / or an increase in activity level can be used in the same manner to increase fluid pressure to prevent leakage.

[0217] In some embodiments, the system is adapted to learn from previous biometric data and / or activity level data coupled with leakage events. A leakage event can be detected by a fluid sensor in communication with the controller (90C or (480)), or input to the controller by the patient (e.g., using the user interface of the external control device (90). The controller (90C or 480) correlates each leakage event with biometric data and / or activity level data at the time of theleakage event. The controller then uses the correlation to establish one or more thresholds for the biometric data and / or activity level data. Subsequently, the controller uses these thresholds to determine when cuff pressure should be increased in order to prevent leakage (i.e., when one or more of the biometric parameters and / or activity level data exceeds the threshold).

[0218] Similarly, in some embodiments, signals from the biometric sensors, particularly the heartrate sensor, and / or activity level data are processed by the controller (430) in order to determine, for example, that the patient is resting, lying down, sleeping, or otherwise in a state that is less likely to result in urine leakage as compared to when the patient is in an active state. The controller (480) is programmed such that when at least one, at least two, or at least three of the biometric parameters varies from a predetermined threshold, optionally for a predetermined period of time, and / or when the patient activity level data varies from a predetermined threshold, optionally for a predetermined period of time, the controller causes the fluid pressure within the cuff (412) to be decreased (by pumping fluid out of the cuff) (“rest mode” or “sleep mode”). By decreasing fluid pressure, pressure on the urethra is reduced, thereby preventing atrophy or other damage to the urethra and surrounding tissue. Once again, the predetermined thresholds (which can be absolute values or ranges) can be selected by the patient (e.g., using external control device (90)), selected by a medical practitioner, or can be established by the controller (480) based on measured values (e.g., averages or medians) over a period of time (optionally including the use of leakage event data, as described above). For example, if the patient’s heartrate is less than their average heartrate for a predetermined period of time (e.g., 1 minute, 2 minutes, 3 minutes, 5 minutes, etc.), the controller (430) will cause the fluid pressure within the cuff to be decreased. The amount of the increase can also be based on how much the patient’s heartrate is below the predetermined threshold and / or for how long the patient’s heartrate is below the predetermined threshold. In some embodiments, the system includes other sensors (e.g., an accelerometer) to detect patient activity or inactivity (e.g., that the patient is lying down or sleeping).

[0219] In some embodiments, a vibration sensor is provided in the housing (416). The vibration sensor is adapted to provide a signal to the controller (430) when vibration indicative of the patient externally tapping on or applying pressure to the skin overlying the housing (416),thereby allowing the user to initiate the deflation of the cuff (412) by providing an alternative deflate (urinate) command to the controller. This is particularly advantageous when the external control device (90) is inoperable (e.g., is not charged), cannot be readily located, or the user wishes to urinate discretely without having to use to the external control device. This is particularly advantageous for male users in that it allows for single-handed operation. Since the housing is implanted beneath the skin in a readily accessible location, the patient’s tapping on or applying pressure to the skin overlying the housing is detected by the vibration sensor. The vibration sensor provides a signal indicative of such tapping or pressure to the controller. The controller is programmed such that, when a predetermined series of taps (e.g., two, three, four, five, etc. taps within a predetermined period of time, e g., one, two, three, etc. seconds) is detected, the controller (480) will cause pressure in the cuff to be released to allow for urination. Since the housing (416) is typically implanted in the subcutaneous space of the lower quadrants of the abdomen, this external patient signaling for the need or desire to urinate allows the patient to discretely signal to the system to deflate the cuff for urination. The patient will not need to use remote control device (90) (e.g., their smartphone) for allowing for urination, thereby allowing for discrete deflation of the cuff. In one embodiment, the vibration sensor comprises a microphone - either microphone (455D) or an additional microphone attached to the housing (inside or outside). Audio signals from the microphone are processed by the controller to determine if the user has indicated a desire to urinate by tapping the predetermined series of taps in the region of the implanted housing. Further, microphone (455D) can be used to detect a large impulse indicative of the sound of the patient falling. When a fall is detected using the audio signal from the microphone, the controller is programmed to increase the cuff pressure to aid in preventing a leakage.

[0220] Alternatively, or in addition to the vibration sensor, the manual pump (385) described previously can be used to initiate the deflation of the cuff (412). As a further alternative, and as seen in FIG. 36, an actuator (457) can be provided in electrical communication with the controller such as via cable (456) (or via a wireless connection). The actuator (457) can be implanted in the patient’s scrotum or other readily accessible location. The actuator can include a manually actuated switch or pressure sensor that is responsive to the userapplying pressure thereto (or by externally tapping on the actuator). The actuator provides a signal to the controller (430) indicating that the user desires to urinate.

[0221]

[0222] In the depicted embodiment, a printed circuit board (PCB) (481) is provided. The controller (480), which includes one or more processors, memory, and circuitry for performing various electronic tasks and communications, is provided on the PCB board (481). Power supply (482), receiver (484), receiving coil (414), and pressure sensor (440) are provided in electrical communication with the PCB and each other. It should be noted that one or more receiving coils (414) may be employed, and that one or more of the receiving coils (414) may serve as the receiver (484). An external charging device (not shown) may be used to recharge the power (482), such as by inductive charging, as is well-known to those skilled in the art. For example, the charging device shown in U.S. Pat. Pub. No. 2023 / 0364436, published Nov. 16, 2023, can be used.

[0223] Returning to the fluidic arrangement of the system (410), fluid from the fluid reservoir enters the manifold (462) through reservoir fluid inlet (452), which is in sealed fluid communication with the reservoir. Reservoir fluid inlet (452) is in fluid communication with reservoir passageway (439) formed in the bottom surface of the manifold. As best seen in FIG. 47, reservoir passageway (439) extends along one side of the manifold and is in fluid communication with valve ports in the sidewall of the manifold; specifically, third valve inlet port (486A) and fourth valve outlet port (487B). The valve inlet and outlet ports in the sidewalls of the manifold are configured to fluidically align and couple with corresponding inlets and outlets on the valves (464, 472, 476, 477) when the valves are mounted to the manifold in the manner depicted in FIG. 38. For example, third valve inlet port (486A) will be fluidically aligned and coupled with inlet (476A) of third valve (476), and fourth valve outlet port (487B) will be fluidically aligned and coupled with outlet (477B) of fourth valve (477).

[0224] On the cuff side of the fluidic arrangement of the manifold, cuff fluid passageway (451) further includes an extension (45 ID) that extends along a side of the manifold opposite the location of the reservoir passageway (439). The extension (45 ID) of the cuff fluid passageway(451) is in fluid communication with valve ports in the sidewall of the manifold; specifically, first valve outlet port (465B) and second valve inlet port (473A). When the first and second valves (464, 472) are mounted to the manifold in the manner depicted in FIG. 38, first valve outlet port (465B) will be fluidically aligned and coupled with outlet (464B) of first valve (464), and second valve inlet port (473A) will be fluidically aligned and coupled with inlet (472A) of second valve (472).

[0225] Regarding the pump side of the fluidic arrangement, the manifold includes a pump inlet passageway (436) in fluid communication with pump inlet (461 A) and a pump outlet passageway (437) in fluid communication with pump outlet (461B). The pump inlet passageway (436) and pump outlet passageway (437) are both generally T-shaped, and are in fluid communication with valve ports in the sidewalls of the manifold. Specifically, pump inlet passageway (436) extends away from pump inlet (461A) generally along the center line of the manifold, and then branches laterally away towards opposite sidewalls. Adjacent and spaced inwardly from each of the sidewalls, the pump inlet passageway (436) includes upwardly extending portions (436C). Along one side of the manifold, one of the upwardly extending portions (436C) is in fluid communication with second valve outlet port (473B). Along the opposite side of the manifold, the other upwardly extending portion (436C) is in fluid communication with third valve outlet port (486B). When the second and third valves (472, 476) are mounted to the manifold in the manner depicted in FIG. 38, second valve outlet port (473B) will be fluidically aligned and coupled with outlet (472B) of second valve (472), and third valve outlet port (486B) will be fluidically aligned and coupled with outlet (476B) of third valve (476).

[0226] Similarly, pump outlet passageway (437) extends away from pump outlet (461B) generally along the center line of the manifold, and then branches laterally away towards opposite sidewalls. Adjacent and spaced inwardly from each of the sidewalls, the pump outlet passageway (437) includes upwardly extending portions (437C). Along one side of the manifold, one of the upwardly extending portions (437C) is in fluid communication with first valve inlet port (465A). Along the opposite side of the manifold, the other upwardly extending portion (437C) is in fluid communication with fourth valve inlet port (487A). When the first and fourth valves (464, 477) are mounted to the manifold in the manner depicted in FIG. 38, first valve inletport (465A) will be fluidically aligned and coupled with inlet (464A) of first valve (464), and fourth valve inlet port (487A) will be fluidically aligned and coupled with inlet (477A) of fourth valve (477). It will be seen from FIGS. 43, 44, and 47 that the upwardly extending portions (437C) of the pump inlet passageway (436) allows the first valve inlet port (465A) and fourth valve inlet port (487A) to pass over extension (45 ID) of the cuff fluid passageway (451) and reservoir passageway (439), respectively.

[0227] Any of the fluid reservoirs described previously can be used with the system (410), and can be fluidically coupled to the reservoir fluid inlet (452) by a suitable conduit such as flexible tubing extending between the reservoir and the inlet (452). Such tubing can be sealingly coupled to the manifold (462) using, for example, a barb connector sealed to the inlet (452). Alternatively, the reservoir can be located in the interior of the housing (416), in fluid communication with the fluid inlet (452) and / or the reservoir passageway (439). In the embodiment shown in FIGS. 37-50, reservoir (430) is attached to the housing (416) in sealed fluid communication with fluid inlet (452). By attaching the reservoir to the housing, the system housing (416) and attached reservoir (430) can be implanted at one location within the patient.

[0228] As seen in FIGS. 37B and 49, reservoir (430) comprises a tank (431) and a cover plate (432) secured to the upper surface of the tank (e.g., by welding or adhesive). The tank is rectangular in shape and flexible such that the tank collapses as it deflates (i.e., as fluid is pumped from the tank to the cuff). The perimeter of the cover plate (432) (which is also flexible) extends beyond the outer perimeter of the tank to facilitate securement of the reservoir (430) to the housing. In particular, as seen in FIGS. 49 and 50, a series of apertures (433) are arrayed about the periphery of the cover plate (432), in the region that extends beyond the outer perimeter of the tank. Corresponding protuberances (446) extend away from the bottom surface of the first lower housing (416B), and are oriented to be alignably received in the apertures (433) of the cover plate. This aids in the proper alignment of the reservoir on the housing (416). The cover plate (432) is attached to the bottom surface of the first lower housing (416B), such as by welding or an adhesive (e g., glue).

[0229] When the system is assembled, the interior of the tank (431) is in fluid communication with the reservoir fluid inlet (452). In particular, the tank includes an extension (442) that extends away from the outer periphery of the tank, and includes an aperture (435) in the upper surface thereof. When the reservoir is assembled, the aperture (435) is aligned with a hole (443) in the cover plate. A hollow inlet plug (445) having an enlarged head and a bore (446) extending through a shaft of the inlet plug is provided. The shaft of the inlet plug extends through the aperture (435) in the tank, and through the hole (443) in the cover plate into the reservoir fluid inlet (452), as best seen in FIGS. 51 and 51 A. The shaft of the inlet plug (445) is received within the interior of a sleeve (447) positioned within the fluid inlet (452) of the manifold. The inlet plug (445) provides fluid communication between the interior of the tank (431) and the reservoir fluid inlet (452), thereby allowing fluid to be withdrawn from and expelled into the tank (431) of the reservoir (430). The head of the inlet plug includes castellations or slots (445A) to prevent the tank from collapsing into or otherwise blocking the fluid channel provided by the hollow interior of the inlet plug.

[0230] As seen in FIG. 36, the system (410) further includes an external actuator (449) that is separate from the external control device (90). External actuator, depicted in FIG. 36A, generally comprises an input device (449A), a power supply (449B) (optionally rechargeable), a controller (449C) (e.g. one or more processors such as a microprocessor along with memory storing software for performing the functions of the actuator), a transmitter (449D) for transmitting signals to, and optionally receiving signals from, controller (480) (and optionally controller (90C)), and optionally one or more indicators (449E) (e.g., a light or haptic feedback device such as a vibrator). The external actuator (449) is configured to provide a discrete way for the patient to provide a urination signal to the controller (480), thereby causing fluid to be moved from the cuff to the reservoir (i.e., to relieve pressure within the cuff and permit urination). The external actuator can be provided in a variety of forms, particular as a piece of jewelry (e.g., a ring, a watch, a watchband, a bracelet, or a necklace), a fob (e.g., attachable to a belt or storable in a pocket), or other discrete wearable or carryable device. In the example shown, external actuator (449) is in the form of a ring configured to be worn by the user on a finger. The external actuator (449) need not include a display screen or keyboard, as it is used to transmit user-inputsignals to the controller (480). Therefore, the external actuator (449) can have the appearance of conventional jewelry or other wearable or carryable item. However, actuator (449) does include one or more discrete input devices (449A) such as one or more buttons (e.g., on the outer surface of the band of the ring shown in FIG. 36. These input devices can be tactile buttons, capacitive sensors (for detecting user touch), or other electrical input devices. The actuator (449) wirelessly communicates with the controller (480), in order to provide user-input signals to the controller. Upon receiving a user input (e.g., the user touching a capacitive sensor on the outer surface of the ring), the controller (449C) of the external actuator (449) transmits a signal to the controller (480) of the implant. The controller (449C) is programmed such that, when a predetermined user input is detected, a urination signal is transmitted to the controller (480). Alternatively, the controller (449C) can be configured to transmit the user input to the controller (480), with the controller (480) analyzing the user input to determine that it represents a urination signal. In either instance, upon detection of the predetermined user input, the controller (480) will cause pressure in the cuff to be released (fluid pumped from the cuff to the reservoir) to allow for urination. In some embodiments, the controller (480) is configured to provide a predetermined delay between receipt of a urination signal from the external actuator and deflating the cuff (e.g., at least one, two, three, four, five, ten, fifteen, or twenty, etc. seconds) so that the patient is at a suitable location and position for urination.

[0231] In some embodiments, the delay between receipt of a urination signal from the external control device (90) is longer than the delay when the urination signal is received from the external actuator. For example, the delay when a urination signal is received from the external control device (90) can be at least 10, 20, 30, 40, or 60 etc. seconds. The reason for this is that when the user issues a urination signal using the external actuator, they are more likely to do so when they are already at a urinal or toilet ready to urinate, whereas when the external control device is used the user may need additional time. In either case, the user can set the length of the delays, such as input using the external control device.

[0232] The predetermined user input can take any of a variety of forms, such as a series of taps (e.g., two, three, four, or five, etc.) on the input device (449A) of the actuator (449) within a certain period of time (e.g., one, two, three, or four, etc. seconds). Any of variety ofother patterns may be employed. The external patient signaling for the need or desire to urinate using the external actuator (449) allows the patient to discretely signal to the system to deflate the cuff for urination. The patient will not need to use remote control device (90) (e.g., their smartphone) for allowing for urination, thereby allowing for discrete deflation of the cuff. The external actuator (449) or controller (480) may be further configured to allow the user to provide one or more additional control signals, such as a request to increase cuff pressure when the user intends to engage in an activity likely to cause leakage (i.e.., to place the system into active mode) or if the user is experiencing leakage. For the example, the system can be configured such that a sustained activation of the input device (449A) over a predetermined period of time (e.g., three, four, or five, etc. seconds) is interpreted as an increase cuff pressure signal. Similarly, the system can be further configured such that yet another predetermined user input will cause cuff pressure to be reduced such as when the user is resting, lying down, or about to sleep (e.g., to place the system into rest mode).

[0233] The system (410) is also configured such that signals from the external actuator (449) are only effective (cause cuff pressure to be released or increased) when the actuator is in close proximity to the receiving coil (419) or receiver (484) - e.g., within one, two, or three etc. feet. Proximity is determine by the strength of the wireless signal from the actuator (449), with battery level compensation. For example, in order to compensate for the level of the power supply (449B), the actuator can also transmit to the controller (480) a signal indicative of the power level in power supply (449B) such that the controller (480) can determine signal strength while compensating for the power level of the actuator (449).

[0234] The actuator (449) can optionally include various other sensors described previously herein, such as one or more biometric sensors, an accelerometer, an absolute position sensor, and / or a GPS module to obtain patient location data. Data from these various sensors can be transmitted to the controller (480) and used in the manner described previously. In some embodiments, the actuator (449) can also provide redundant time and date information to the controller (480) for maintaining the proper time conditions within the implant.

[0235] The various embodiments of systems (10, 210. 310. 410) can be supplied to a surgeon in a pre-filled condition, with fluid filling the cuff, the reservoir and the various fluidic components and passageways. In other embodiments, the system is supplied to the surgeon in an unfilled condition or with only the cuff and associated cuff fluid conduit tubing, in which instances one or more ports for filling the system with fluid are provided. Whether the system is provided prefilled, partially prefilled, or empty, it is typically necessary to bleed air from the system at the time of implantation (e g., immediately prior to positioning the implanted system components in the patient). One or more fill / bleed ports are provided on the system, in fluid communication with the fluid reservoir, the pump(s), other fluidic components, and optionally the cuff. The port(s) can be used to inject fluid into the system and withdraw air after the system has been filed with air. In order to facilitate bleeding air from the fluid after filling, embodiments of the present disclosure employ vibration to coalesce entrained air bubble and facilitate the removal of air remaining in the system.

[0236] In some embodiments, the controller (80, 480) is configured to control an air bleed process at the time of implantation. The medical practitioner can provide a signal to the controller to commence an air bleed process, such as by using external control device (90) or an alternative practitioner control device (not shown). Upon commencement of the air bleed process, the controller (80, 480) causes one or more piezoelectric pumps and / or valves of the system to vibrate (pulse) at frequencies conducive to removal of air entrained in the fluid while at least one fill / bleed port is open (or the port is in operative fluid communication with a syringe or other device for extracting fluid and air. Such vibrational frequencies, for example, may be in the range of about 300 to about 700 Hz, whereas frequencies of about 50 to about 200 Hz are used when activating piezoelectric pumps for fluid pumping.

[0237] In system (410), for example, as best seen in FIGS. 52 and 52A, a fill / bleed port (493) is provided in fluid communication with reservoir fluid inlet (452) of the manifold. The port (493) comprises a passageway extending from the fluid inlet through the sidewall of the manifold to an external aperture (494) in the wall of the manifold. A self-healing septum plug (493) is positioned in the port (493) such that a syringe can be used to fill the reservoir and manifold with fluid, and also to bleed air from the system following fluid filling. As best seen inFIG. 37B, an aperture (496) is provided in the sidewall of the first lower housing (416B), in sealed fluid communication with aperture (494) and fill / bleed port (493), thereby providing access to the fill / bleed port from the exterior of the housing. One or more additional fill / bleed ports may be provided at various locations on the manifold in fluid communication with the fluidic circuitry of the manifold.

[0238] As an alternative to using the pump(s) and / or valves of the system to cause vibration of the fluid, FIGS. 53-54 depict a vibration assembly (100) that is mountable to the housing (416) of system (410). Vibration assembly (100) comprises a housing (101), and a vibrator (102) mounted to the housing (101). Any of a variety of devices can be used as the vibrator (102) such as a motor-driven eccentric weight, a piezo vibrator, or other device for vibrating the housing (101). In the embodiment shown, the bottom of the housing (101) is hollow, and includes a cavity (103) configured to receive the reservoir tank (431) therein such that the reservoir tank is in contact with the interior surface of the cavity (103). In this manner, vibration of the housing (101), caused by vibration of the vibrator (102), is transmitted efficiently to the reservoir tank causing the tank to vibrate. Vibration of the tank (431) results in the vibrations propagating throughout the fluid in the tank and in the manifold and even the cuff fluid conduit. The vibration causes the coalescence of entrained air bubbles throughout the fluid and facilitates the removal of air remaining in the system. The one or more fill / bleed ports are then used to bleed the air from the system.

[0239] The a vibration assembly (100) further includes two or more resilient curved clamping arms configured to clamp over the edges of housing (416) and press the housing (101) against the reservoir tank, thereby facilitating the transmission of vibrations from the vibrator (102) into the tank and housing (416). Various other structures for mounting the vibration assembly (100) to the housing (416) can be provided.

[0240] As seen in FIG. 54A, embodiments of the vibration assembly (100) further include a power supply (106) (optionally rechargeable) for supplying power to the vibrator and controller, a controller (107) (e.g. one or more processors such as a microprocessor along with memory storing software for performing the functions of the vibration assembly), and a receiver(108) for receiving signals from, and optionally transmitting signals to, controller (480) (and optionally controller (90C) or another controller such as that of a medical practitioner control device (not shown)). In some embodiments, the controller (80, 480) is configured to control the air bleed process using vibration assembly (100) at the time of implantation. The medical practitioner can provide a signal to the controller (480) or the controller (107) to commence an air bleed process, such as by using external control device (90) or an alternative practitioner control device (not shown). Upon commencement of the air bleed process, the controller (80, 480, 107) causes the vibrator to vibrate at frequencies conducive to removal of air entrained in the fluid (about 300 to about 700 Hz) while at least one fill / bleed port is open (or the port is in operative fluid communication with a syringe or other device for extracting fluid and air).

[0241] In some embodiments, the system is configured to detect air in the fluidic circuitry, particularly in the diaphragms of piezoelectric pumps and particularly at the time of implantation, using pressure hysteresis. In particular, the controller (480) is configured to activate the pump for a predetermined number of cycles for inflating the cuff while monitoring the pressure (e.g., as detected by pressure sensor (440)). Since air is a compressible fluid, air in the fluidic circuitry will cause a delay in the increase in fluid pressure sensed by the pressure sensor. The controller is adapted to compare the pressure response to a predetermined pressure response of the system, and indicate whether air remains in the system - e.g., by providing a notification to the medical practitioner (e.g., by providing a signal that indicates air still needs to be bled from the system).

[0242] In the various system embodiments described above, the controller (80, 480) is programmed to monitor and control the system using one or more algorithms. The controller uses these algorithms in conjunction with one or more sensor signals, particularly pressure signals from the cuff(s) or elsewhere, to control system operation and / or for patient safety. For example, the predictive use algorithm shown in FIG. 55 can be performed by the controller. Using this algorithm, the controller (80, 480) determines whether a pressure sensor (e.g., 440) indicates that an increase in bladder pressure is causing a pressure rise in the cuff due to fluid build-up in the urethra between the bladder and the location of the cuff (e.g., the sphincter cuff or a pressure sensor cuff, as described previously herein). The controller filters the pressure sensorsignal and determines the number of occurrences of pressure increases per a predetermined time period (e.g., 5, 10, 30, or 60 minutes) in order to identify a consistent pressure increase over an extended time period. In some embodiments, a derivative of pressure change is calculated to aid in determining a fluid accumulation rate unique to urine production for the patient. The controller can also apply filtering to detect a large number of pressure spikes in a short period of time (e.g., < 1, 5, 10 minutes) in order to distinguish a pressure affecting event other than fluid accumulation (e.g., exercise, restlessness, sitting position changing, etc ). Further, in some embodiments the controller learns the patient’s urination habits and logs the patient’s time of urination and time between user activated urination events to augment filtering by the controller. For example, in some embodiments, the controller is configured (programmed) to log the user’s urination events (e.g., by time of day and / or time between events) in order to determine and maintain a record of the user’s urination patterns. These patterns include, for example, the typical times of urination and / or the period of time between urination events (which may also be adjusted by time of day, e.g., a longer period of time at night). Using this urination event data, the controller determines (a) whether the time period since the user’s last urination (i.e., when the user last instructed the controller to deflate the cuff (12) to allow the patient to urinate) exceeds the user’s typical time period (which may vary by time of day) by a user-selected amount or a predetermined amount (e.g., by 5, 10, 20, 30, 45 or 60 minutes), and / or (b) whether the user has not urinated within a user-selected amount of time or a predetermined amount of time (e.g., by 5, 10, 20, 30, 45 or 60 minutes) of a typical urination time (e.g., the user typically urinates at 7 AM each day and it’s 7:30 AM without the user urinating since 4 AM). Upon detecting such an atypical urination status, the controller will cause the system to alert the user (e.g., signaling that urination is recommended).

[0243] The system can alert the user that urination is recommended in a variety of ways. For example, the controller (80, 480) can cause a signal to the sent to the external control device (90), which results in the external control device providing a user-detectable urination signal. The user-detectable urination signal can be an audible signal emitted by a speaker of the external control device, a visible indicator (e.g., one or more lights or other visible indication on the display (90D), and / or haptic indicators (e.g., vibratory signaling). Alternatively, or in additionthereto, the controller signal can be received by the external actuator (449) such as the ring shown in the FIG. 36, causing an indicator on the external actuator to be activated (e.g., a light or haptic feedback device such as a vibration of the external actuator). As yet another alternative, the fluid transfer device of the implant can be used to provide haptic feedback that urination is recommended (or to alert the user that the system needs attention, thereby causing the user to check system status using, for example, the external control device (90). For example, for system (410), the controller can activate the pump while controlling the valves such that fluid is pumped in a circuit without inflating or changing the pressure in the cuff. In one specific example, first and second valves (464, 472) are in the closed position and third and fourth valves (476, 477) are in the open position. With the pump (460) activated, fluid is pumped in a circle. The pump (460) can also be pulsed (turned repeatedly on and off) to increase the haptic feedback provided to the user.

[0244] In still further embodiments, the controller is programmed to detect when a Foley catheter is being inserted into the patient so that the cuff can be deflated to prevent patient injury. One such algorithm is depicted schematically in FIG. 56. Here, the algorithm uses pressure signals to detect an abrupt increase in cuff pressure as a result of foreign object deforming the cuff, particularly downstream of the sphincter cuff. The controller can apply filtering to the pressure sensor signal for detecting a number of pressure spikes in a short period of time (e g., < 1, 5, or 10 minutes) to delineate a catheter insertion event from regular fluid accumulation. A derivative of pressure change can be calculated to aid in determining a fluid accumulation rate unique to significant and rapid deformation of the cuff. Further, in some embodiments the controller learns the patient’s urination habits and logs the time of typical urination, time of day, and time between user activated urination events to augment filtering portions of the algorithm, such as described previously. In addition, upon determining a Foley catheter has been inserted, pressure can be continually monitored relative to pump position or activation. An inconsistency between pressure and reduced actuation can aid in foreign object detection and prevent activation of the cuff while the catheter is inserted. Further, upon determining a Foley catheter has been inserted, the system can provide an audible and / or vibratory signal to alert the medical practitioner(s) of the presence of the system.

[0245] In still further embodiments, the controller is programmed to allow for user adjustable cuff pressure. One such algorithm is depicted schematically in FIG. 57. Here, the algorithm uses pressure signals to ensure that a minimal clamping pressure is used to restrict urinary flow. A pumping parameter such as a pump position for rotary pumps or linear displacement for actuator style transfer pumps can be recorded and correlated with cuff pressure. Linear displacement of a linear actuator can be assumed to be directly proportional to cuff pressure, measured in fractions of a millimeter. The patient, using the external control device (90), can trigger clamp pressure increases if leakage occurs. The algorithm can then compare the patient desired increase in pressure with historical clamping pressures, providing a warning to the patient if the desired clamping pressure or pumping parameter necessary to achieve the pressure increase exceeds a pre-determined pressure increase range. Also, cuff pressure can be monitored and used as a diagnostic tool for detecting deterioration of tissue in the clamping area, bolstered by the frequency of patient requests for pressure increase. The clamping pressure safety threshold also may aid in prevention of over clamping force, and tissue damage resultant from any excessive pressure during occlusion.

[0246] In additional embodiments, the controller is programmed to provide a rest / sleep mode, such as using the algorithm depicted schematically in FIG. 58. In this instance, the algorithm once again uses pressure signals to ensure that minimal clamping pressure is used to restrict urinary flow. A pumping parameter such as a pump position for rotary pumps or linear displacement for actuator style transfer pumps can be recorded and correlated with cuff pressure. Linear displacement of a linear actuator can be assumed to be directly proportional to cuff pressure, measured in fractions of a millimeter. Motion sensing provided by an accelerometer and / or absolute position sensor provided in one of the system housings provides the controller with movement data to monitor patient activity levels and / or position, as described previously. It is assumed that patients require reduced clamping pressure when lying down and during periods of inactivity where the bladder experiences less movement and external pressure. The algorithm provides periods of reduced clamping pressure during inactivity or when the position sensor indicates the patient is in a horizontal resting position, as it is believed that reduced clamping pressure is beneficial for tissue health. Pressure can also be monitored and used as a diagnosticfor detecting deterioration of tissue in the clamping area, supported by historical clamping force data and patient requested feedback for leakage.

[0247] In still further embodiments, the controller is programmed to provide an occlusion and urinary health evaluation algorithm. The patient uses, for example, an external method of measuring flow rate for a typical urinary event (e.g., volume of urine produced over a period of time) or even using an external device to measure the force of the urine stream, and the data is supplied to the controller (e g., using the external control device). The controller then correlates this data with system data. A cuff pressure sensor supplies the controller with pressure data for before, during, and after the urinary event for subsequent evaluation by the controller or externally by a medical practitioner. Bladder pressure and flow can be monitored to provide clinically relevant information (e.g., high pressure or urine force but low flow may indicate suspected obstruction of urine, or low pressure and low flow indicating poor bladder function). Further, in some embodiments the controller is ’’smart” and logs the time of typical urination, time of day, and time between user activated urination events to augment these features, such as described previously.

[0248] While various embodiments of an inflatable medical system have been described in detail above, it will be understood that the components, features and configurations, as well as the methods of manufacturing the systems, devices and methods described herein are not limited to the specific embodiments described herein.

Claims

What is claimed is:

1. An inflatable medical system comprising:(a) an implantable, inflatable cuff;(b) a fluid reservoir in fluid communication with the cuff;(c) a fluid transfer device comprising a powered first pump adapted for selective moving fluid between the reservoir and the cuff;(d) at least one pressure sensor in operative communication with fluid in the cuff for providing a pressure signal indicative of fluid pressure in the cuff;(e) a controller for receiving the pressure signal from the at least one pressure sensor and controllably actuating the fluid transfer device; and(f) an external actuator in wireless communication with the controller, said external actuator adapted for wirelessly providing a urination signal to the controller; wherein, upon receipt of the urination signal, the controller causes fluid to be moved from the cuff to the reservoir.

2. The inflatable medical system of claim 1, further comprising at least one biometric sensor for providing a biometric signal indicative of a biometric characteristic of a user, wherein the biometric signal is used by the controller to control operation of the fluid transfer device.

3. The inflatable medical system of claim 2, wherein said first pump is a piezoelectric pump.

4. The inflatable medical system of claim 3, wherein said fluid transfer device further comprises a plurality of controllable valves.

5. The inflatable medical system of claim 5, further comprising a pressure sensor in operative fluid communication with the cuff and adapted for providing a signal indicative of fluid pressure within the cuff to the controller.

6. The inflatable medical system of claim 6, further comprising a manifold, wherein the first pump, valves, and pressure sensor are mounted to the manifold.

7. The inflatable medical system of any one of claims 2-7, wherein said at least one biometric sensor is located within an implantable housing.

8. The inflatable medical system of claim 7, wherein the fluid transfer device and said at least one biometric sensor are located in said implantable housing.

9. The inflatable medical system of claim 7, wherein said at least one biometric sensor is a heartrate sensor, a blood oxygen sensor, or a temperature sensor.

10. The inflatable medical system of claim 7, wherein said controller is adapted to receive a signal from said at least one biometric sensor, compare said signal to a predetermined value, and, if said signal deviates from the predetermined value by a predetermined amount and / or for a predetermined period of time, causes fluid to be moved from the cuff to the reservoir or from the reservoir to the cuff.

11. The inflatable medical system of claim 7, wherein said at least one biometric sensor is an optical sensor.

12. The inflatable medical system of claim 11, wherein the implantable housing includes a viewing window and said at least one biometric sensor is located in the housing for detecting a biometric condition of the patient through the window.

13. The inflatable medical system of claim 1, wherein said external actuator comprises a discrete wearable or carryable device.

14. The inflatable medical system of claim 13, wherein said external actuator comprises a piece of jewelry or a fob.

15. The inflatable medical system of claim 13, wherein said external actuator comprises a ring, a watch, a watchband, a bracelet, or a necklace.

16. The inflatable medical system of claim 15, wherein said external actuator does not include a display screen.

17. The inflatable medical system of any one of claims 13-16, wherein said external actuator has at least one input device.

18. The inflatable medical system of claim 17, wherein, upon receipt of the urination signal, the controller causes fluid to be moved from the cuff to the reservoir to deflate the cuff and allow urination, and further wherein the controller is configured to provide a predetermined delay between receipt of a urination signal from the external actuator and deflating the cuff.

19. The inflatable medical system of any preceding claim, wherein the cuff comprises a single-chamber cuff, a dual -chamber cuff, or a tri-chamber cuff.

20. An inflatable medical system comprising:(a) an implantable, inflatable cuff;(b) a fluid reservoir in fluid communication with the cuff;(c) a fluid transfer device comprising a powered first pump adapted for selective moving fluid between the reservoir and the cuff;(d) at least one pressure sensor in operative communication with fluid in the cuff for providing a pressure signal indicative of fluid pressure in the cuff; and(e) a controller for receiving the pressure signal from the at least one pressure sensor and controllably actuating the fluid transfer device; wherein said controller is adapted to receive a urination signal from an external control device, and, upon receipt of a urination signal the controller causes fluid to be moved from the cuff to the reservoir to deflate the cuff and allow urination.

21. The inflatable medical system of claim 20, wherein the fluid transfer device, pressure sensor, and controller are located in an implantable housing.

22. The inflatable medical system of claim 21, further comprising at least one biometric sensor for providing a biometric signal indicative of a biometric characteristic of auser, wherein the biometric signal is used by the controller to control operation of the fluid transfer device, said at least one biometric sensor located in said implantable housing.

23. The inflatable medical system of claim 22, wherein said fluid transfer device further comprises a plurality of controllable valves located in said implantable housing.

24. The inflatable medical system of claim 23, further comprising a fluid manifold adapted to alignably receive said pump and said valves and having fluid passageways in the manifold for directing fluid flow within the manifold.

25. The inflatable medical system of any one of claims 20-24, wherein the controller is configured to actuate the fluid transfer device without transferring fluid between the cuff and the reservoir so as to produce a user-detectable haptic signal.

26. The inflatable medical system of claim 25, wherein user-detectable haptic signal comprises a urination recommendation signal.

27. The inflatable medical system of claim 26, wherein said user-detectable haptic signal is produced by pulsedly actuating the fluid transfer device without transferring fluid between the cuff and the reservoir.

28. A vibration assembly for facilitating the removal of air from an inflatable medical system having an implantable, inflatable cuff, a fluid reservoir in fluid communication with the cuff, a fluid transfer device comprising a powered first pump adapted for selective moving fluid between the reservoir and the cuff, with the fluid transfer device located in a housing, the vibration assembly comprising:(a) a vibration assembly housing mountable to the housing of the inflatable medical system; and(b) a vibrator operatively connected to the vibration assembly housing.

29. The vibration assembly of claim 28, wherein the vibration assembly housing includes a cavity configured to receive a portion of the inflatable medical system therein.

30. The vibration assembly of claim 29, wherein the cavity of the vibration assembly housing is configured to receive at least a portion of the fluid reservoir of the inflatable medical system therein.

31. A method of bleeding air from an inflatable medical system by vibrating at least a portion of the inflatable medical system.

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