Patent Description:
One treatment for male erectile dysfunction is the implantation of a penile prosthesis that mechanically erects the penis. Some existing penile prostheses include inflatable cylinders or members that can be inflated or deflated using a pump mechanism. The pump mechanism pulls fluid from a fluid reservoir and then transfers the fluid to the inflatable members. According to some existing designs of inflatable penile prostheses, the amount of time, energy and disparity from the occurrence of a normal human male erection for the patient to inflate a penile prosthesis (e.g., the number of pumps and time required to provide the desired penis rigidity) may be relatively high.

Document <CIT> discloses a hand operable, two-component fluid pump for inflating an inflatable penile prosthesis. The pump comprises a high-volume, low-pressure first pump component and at least one low-volume, high-pressure second pump component. Fluid to be pumped to the prosthesis is housed within the first component, and each of the first and second components is in valved communication with the prosthesis and in valved communication with each other. In a preferred embodiment the second pump component is disposed within the first pump component. The pump preferably can be implanted within the user, with the most preferable implantation site being within the scrotal sack.

Document <CIT> discloses a penile prosthesis system including at least one cylinder that has an elongated inner opening, a cylinder spring positioned within the opening and adjacent to a distal end of the inner opening, an activation plunger positioned within a proximal end of the opening of the cylinder, and a plurality of discrete members within the inner opening between the cylinder spring and the plunger. The system further includes a pump comprising a spring and a tube connected to and extending from the cylinder and the pump, wherein the tube is configured for transferring fluid to the at least one cylinder upon activation of the pump.

According to an aspect, an inflatable penile prosthesis includes a fluid reservoir configured to hold fluid, an inflatable member, and a pump assembly configured to transfer the fluid from the fluid reservoir to the inflatable member during an inflation cycle. The pump assembly includes a first pump configured to inject the fluid into the inflatable member according to a first flow rate, and a second pump configured to inject fluid into the inflatable member according to a second flow rate, where the second flow rate is less than the first flow rate.

According to some aspects, the inflatable penile prosthesis may include one or more of the following features (or any combination thereof). The first pump may include a plurality of micro-pumps, and the second pump may include a plurality of micro-pumps. The first pump is configured to inject the fluid into the inflatable member up to a first maximum output pressure, and the second pump is configured to inject the fluid into the inflatable member up to a second maximum output pressure, where the second maximum output pressure is higher than the first maximum output pressure. The second pump may be disposed in parallel with the first pump. The pump assembly is configured to move between a parallel configuration in which the second pump is disposed in parallel with the first pump and a serial configuration in which the second pump is disposed in serial with the first pump. The inflatable penile prosthesis may include a controller configured to actuate a plurality of valves to move between the parallel configuration and the serial configuration. The controller may activate the first pump during a first phase of the inflation cycle, and may activate the second pump during a second phase of the inflation cycle. The controller may activate the second pump during the second phase of the inflation cycle in response to a pressure level in the inflatable member exceeding a threshold level. The fluid reservoir may include a flexible fluid container disposed within a cavity of the fluid reservoir. The flexible fluid container may enclose fluid at a higher pressure than the fluid contained in the fluid reservoir. At least one of the first pump or the second pump is configured to transfer the fluid in the fluid reservoir during a first phase of the inflation cycle, and the fluid contained in the flexible fluid container is transferred to the inflatable member during a second phase of the inflation cycle. The fluid contained in the flexible fluid container may be transferred to the inflatable member after the inflation cycle.

According to an aspect, an inflatable penile prosthesis includes a fluid reservoir configured to hold fluid, an inflatable member, and a pump assembly configured to transfer the fluid from the fluid reservoir to the inflatable member during an inflation cycle. The pump assembly includes a first pump configured to inject the fluid into the inflatable member, a second pump configured to inject fluid into the inflatable member, and a controller configured to activate the first pump during a first phase of the inflation cycle, and activate at least the second pump during a second phase of the inflation cycle.

According to some aspects, the inflatable penile prosthesis may include one or more of the following features (or any combination thereof). The first pump may include a plurality of micro-pumps disposed on a first substrate, and the second pump may include a plurality of micro-pumps disposed on a second substrate. A number of the plurality of micro-pumps disposed on the first substrate may be less than a number of the plurality of micro-pumps disposed on the second substrate. The first pump is configured to inject the fluid into the inflatable member according to a first flow rate up to a first maximum output pressure, and the second pump is configured to inject the fluid into the inflatable member according to a second flow rate up to a second maximum output pressure, where the first flow rate is higher than the second flow rate, and the second maximum output pressure is higher than the first maximum output pressure. The fluid reservoir may include a flexible fluid container disposed within a cavity of the fluid reservoir, and the flexible fluid container may enclose fluid at a higher pressure than the fluid contained in the fluid reservoir.

According to an aspect, a method of inflating an inflatable member of a penile prosthesis includes transferring, by a first pump of a pump assembly, fluid from a fluid reservoir to the inflatable member during a first phase of an inflation cycle, detecting, by a sensor, a pressure level in the inflatable member, activating, by a controller connected to the sensor, a second pump of the pump assembly in response to the pressure level exceeding a threshold level, and transferring, by at least the second pump, fluid from the fluid reservoir to the inflatable member during a second phase of the inflation cycle.

According to some aspects, the method may include one or more of the following features (or any combination thereof). The second pump may be disposed in parallel with the first pump during the first phase. The second pump may be disposed in parallel with the first pump during the second phase. The first pump and the second pump may be disposed in a parallel configuration during the first phase, and the method further includes switching to a serial configuration during the second phase. The serial configuration is a configuration in which the first pump is serially disposed with respect to the second pump.

Detailed embodiments are disclosed herein. However, it is understood that the disclosed embodiments are merely examples, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the embodiments in virtually any appropriately detailed structure. Further, the terms and phrases used herein are not intended to be limiting, but to provide an understandable description of the present disclosure.

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

In general, the embodiments are directed to bodily implants. The term patient or user may hereafter be used for a person who benefits from the medical device or the methods disclosed in the present disclosure. For example, the patient can be a person whose body is implanted with the medical device or the method disclosed for operating the medical device by the present disclosure. For example, in some embodiments, the patient may be a human, or any other mammal.

<FIG> illustrates an inflatable penile prosthesis <NUM> having a multiple pump system that can improve an inflation operation of the prosthesis's inflatable member according to an aspect. The inflatable penile prosthesis <NUM> may include a fluid reservoir <NUM>, an inflatable member <NUM>, and a pump assembly <NUM> configured to transfer fluid between the fluid reservoir <NUM> and the inflatable member <NUM>. The inflatable member <NUM> may be implanted into the corpus cavernosae of the user, the fluid reservoir <NUM> may be implanted in the abdomen or pelvic cavity of the user (e.g., the fluid reservoir <NUM> may be implanted in the lower portion of the user's abdominal cavity or the upper portion of the user's pelvic cavity), and the pump assembly <NUM> may be implanted in the scrotum of the user.

The pump assembly <NUM> includes multiple pumps that pump fluid into the inflatable member <NUM> during an inflation cycle in a manner that increases the efficiency and/or decreases the amount of time required to fully inflate the inflatable member <NUM>. In some examples, the multiple pumps operate at different time periods during the inflation cycle. In some examples, the multiple pumps operate at a same time during at least a portion of the inflation cycle. In some examples, the multiple pumps are not individually controlled by the user, but are mechanically and/or programmatically controlled by a controller <NUM>, which from the point of view of the user, the multiple pumps of the pump assembly <NUM> may appear as a single pump. In some examples, the user is able to program the maximum output pressure and/or the pressure profile during intercourse. For example, the rigidity of the penile implant may be controlled such that preliminary ejaculation may be avoided.

The inflatable member <NUM> may be capable of expanding upon the injection of fluid into a cavity of the inflatable member <NUM>. For instance, upon injection of the fluid into the inflatable member <NUM>, the inflatable member <NUM> may increase its length and/or width, as well as increase its rigidity. In some examples, the inflatable member <NUM> may include a pair of inflatable cylinders or at least two cylinders, e.g., a first cylinder member and a second cylinder member. The volumetric capacity of the inflatable member <NUM> may depend on the size of the inflatable cylinders. In some examples, the volume of fluid in each cylinder may vary from about <NUM> milliliters in smaller cylinders and to about <NUM> milliliters in larger sizes. In some examples, the first cylinder member may be larger than the second cylinder member. In other examples, the first cylinder member may have the same size as the second cylinder member.

The fluid reservoir <NUM> may include a container having an internal chamber configured to hold or house fluid that is used to inflate the inflatable member <NUM>. The volumetric capacity of the fluid reservoir <NUM> may vary depending on the size of the inflatable penile prosthesis <NUM>. In some examples, the volumetric capacity of the fluid reservoir <NUM> may be <NUM> to <NUM> cubic centimeters. In some examples, the fluid reservoir <NUM> is constructed from the same material as the inflatable member <NUM>. In other examples, the fluid reservoir <NUM> is constructed from a different material than the inflatable member <NUM>. In some examples, the fluid reservoir <NUM> contains a larger volume of fluid than the inflatable member <NUM>.

The inflatable penile prosthesis <NUM> may include a first conduit connector <NUM> and a second conduit connector <NUM>. Each of the first conduit connector <NUM> and the second conduit connector <NUM> may define a lumen configured to transfer the fluid to and from the pump assembly <NUM>. The first conduit connector <NUM> may be coupled to the pump assembly <NUM> and the fluid reservoir <NUM> such that fluid can be transferred between the pump assembly <NUM> and the fluid reservoir <NUM> via the first conduit connector <NUM>. For example, the first conduit connector <NUM> may define a first lumen configured to transfer fluid between the pump assembly <NUM> and the fluid reservoir <NUM>. The first conduit connector <NUM> may include a single or multiple tube members for transferring the fluid between the pump assembly <NUM> and the fluid reservoir <NUM>.

The second conduit connector <NUM> may be coupled to the pump assembly <NUM> and the inflatable member <NUM> such that fluid can be transferred between the pump assembly <NUM> and the inflatable member <NUM> via the second conduit connector <NUM>. For example, the second conduit connector <NUM> may define a second lumen configured to transfer fluid between the pump assembly <NUM> and the inflatable member <NUM>. The second conduit connector <NUM> may include a single or multiple tube members for transferring the fluid between the pump assembly <NUM> and the inflatable member <NUM>. In some examples, the first conduit connector <NUM> and the second conduit connector <NUM> may include a silicone rubber material. In some examples, the pump assembly <NUM> may be directly connected to the fluid reservoir <NUM>.

The pump assembly <NUM> includes a first pump <NUM>, a second pump <NUM>, the controller <NUM>, a sensor <NUM>, and a power source <NUM>. The pump assembly <NUM> may include other features such as a valve body, a pump bulb, one or more valves, and/or an inflation mode selector configured to select between an inflation mode and a deflation mode. In some examples, the pump assembly <NUM> includes more than two pumps such as three pumps or more than three pumps, which can be arranged in a parallel configuration and/or a serial configuration with respect to each (and may transition between the parallel configuration and the serial configuration during different phases of the inflation cycle).

The first pump <NUM> is configured to facilitate the transfer of fluid from the fluid reservoir <NUM> to the inflatable member <NUM> according to a first flow rate up to a first maximum output pressure. The second pump <NUM> is configured to facilitate transfer of fluid from the fluid reservoir <NUM> to the inflatable member <NUM> according to a second flow rate up to a second maximum output pressure. In some examples, the first flow rate is higher than the second flow rate. In some examples, the first maximum output pressure is lower than the second maximum output pressure. In some examples, the first pump <NUM> is a high capacity pump (e.g., high flow rate) but with relatively low output pressure. In some examples, the second pump <NUM> is a low capacity pump (e.g., low flow rate) but with relatively high output pressure.

The first pump <NUM> may include one or more devices configured to facilitate the transfer of fluid from the fluid reservoir <NUM> to the inflatable member <NUM>. In some examples, referring to <FIG>, the first pump <NUM> includes micro-pumps <NUM> disposed on a first substrate <NUM>, which are arranged to provide the first flow rate and the first maximum output pressure. In some examples, the micro-pumps <NUM> are piezoelectrically-driven micro-pumps. In some examples, the micro-pumps <NUM> include a first dimension in a range of <NUM> to <NUM>, a second dimension in a range of <NUM> to <NUM>, and/or a third dimension in a range of <NUM> to <NUM>. In some examples, the micro-pumps <NUM> include a silicon-based material. In some examples, the micro-pumps <NUM> includes a metal (e.g., steel) based material. In some examples, the first substrate <NUM> includes a wafer. Although <FIG> illustrates four micro-pumps <NUM>, the embodiments encompass any number of micro-pumps <NUM> disposed on the first substrate <NUM> including one micro-pump or more than one micro-pump. In some examples, the first pump <NUM> includes more than ten micro-pumps <NUM> arranged on the first substrate <NUM>. In some examples, the first pump <NUM> includes more than twenty micro-pumps <NUM> arranged on the first substrate <NUM>. In some examples, the first pump <NUM> includes more than forty micro-pumps <NUM> arranged on the first substrate <NUM>. In some examples, the micro-pumps <NUM> disposed on the first substrate <NUM> are non-mechanical (e.g., without moving parts).

The second pump <NUM> may include one or more devices configured to facilitate the transfer of fluid from the fluid reservoir <NUM> to the inflatable member <NUM>. In some examples, referring to <FIG>, the second pump <NUM> includes micro-pumps <NUM> disposed on a second substrate <NUM>, which are arranged to provide the second flow rate and the second maximum output pressure. In some examples, the first substrate <NUM> and the second substrate <NUM> are the same substrate (e.g., the micro-pumps <NUM> for the first pump <NUM> and the micro-pumps <NUM> for the second pump <NUM> are disposed on the same substrate). In some examples, the first substrate <NUM> and the second substrate <NUM> are different substrates.

In some examples, the second substrate <NUM> includes a wafer. Although <FIG> illustrates two micro-pumps <NUM> disposed on the second substrate <NUM>, the embodiments encompass any number of micro-pumps <NUM> including one micro-pump or more than one micro-pump on the second substrate <NUM>. In some examples, the second pump <NUM> includes more micro-pumps <NUM> than the first pump <NUM>. In some examples, the second pump <NUM> includes less micro-pumps <NUM> than the first pump <NUM>. In some examples, the second pump <NUM> includes two or more micro-pumps <NUM> arranged on the second substrate <NUM>. In some examples, the second pump <NUM> includes more than ten micro-pumps <NUM> arranged on the second substrate <NUM>. In some examples, the second pump <NUM> includes more than twenty micro-pumps <NUM> arranged on the second substrate <NUM>. In some examples, the micro-pumps <NUM> disposed on the second substrate <NUM> are non-mechanical (e.g., without moving parts).

In some examples, the first pump <NUM> and the second pump <NUM> are arranged in a parallel configuration during an inflation cycle. In some examples, the first pump <NUM> and the second pump <NUM> are arranged in the parallel configuration during the entire inflation cycle. In some examples, the first pump <NUM> and the second pump <NUM> are arranged in the parallel configuration for only a portion of the inflation cycle. In the parallel configuration, each of the first pump <NUM> and the second pump <NUM> are configured to receive fluid from the fluid reservoir <NUM>, and inject the fluid into the inflatable member <NUM> during the inflation cycle. In some examples, the first pump <NUM> is configured to fill the inflatable member <NUM> at the first flow rate up to the first maximum output pressure (e.g., higher flow rate, lower output pressure) during a first phase of the inflation cycle until the pressure level in the inflatable member <NUM> reaches a threshold level. In some examples, the threshold level is in relation to the total volume of the inflatable member <NUM>. In some examples, the threshold level is in relation to the total amount of pressure in the inflatable member <NUM>. Upon reaching the threshold level, the pump assembly <NUM> may activate (or switch to) to the second pump <NUM>, and the second pump <NUM> injects the remaining amount of fluid at the second flow rate up to the second maximum output pressure (e.g., lower flow rate, higher output pressure). In some examples, the controller <NUM> may de-activate the first pump <NUM> during the second phase (e.g., after the second phase starts but before the second phase ends).

The sensor <NUM> is configured to monitor the pressure level in the inflatable member <NUM>. In some examples, the sensor <NUM> is calibrated before the inflation and deflation cycle is commenced. The sensor <NUM> is communicatively coupled to the controller <NUM> such that the controller <NUM> can receive signals from the sensor <NUM>. In some examples, the sensor <NUM> is included within the pump assembly <NUM>. In some examples, the sensor <NUM> is configured to sense the amount of fluid transferred to the inflatable member <NUM>, and send one or more signals to the controller <NUM> that indicate the amount of fluid that has been transferred.

In some examples, the sensor <NUM> is included within the inflatable member <NUM>. In some examples, the sensor <NUM> is integrated in a wall of a cylinder of the inflatable member <NUM>. In some example, when the sensor <NUM> is integrated in the wall of the cylinder, the sensor <NUM> may monitor the condition of the cylinder material, and the sensor <NUM> can monitor the changing of the cylinder material to a point where the cylinder might have to be replaced. In this case, the controller <NUM> may send information, over a network, to an external device (e.g., located at a hospital or doctor's office) on a regular basis for potential checkups.

In some examples, the sensor <NUM> is configured to sense the pressure level in the inflatable member <NUM> and send one or more signals to the controller <NUM> that indicate the pressure level in the inflatable member <NUM>. In some examples, the sensor <NUM> is configured to monitor the flowrate (e.g., the flowrate in both directions). The controller <NUM> may control the activation (and deactivation) of the first pump <NUM> and the second pump <NUM> based on the signals received from the sensor <NUM> such that the operator is unaware of that the pump assembly <NUM> includes multiple pumps operating at different times. In some examples, the controller <NUM> may send activation signals or deactivation signals to the first pump <NUM> and the second pump <NUM> to controls the activation and deactivation of the first pump <NUM> and the second pump <NUM>.

During the first phase of the inflation cycle, the controller <NUM> may activate the first pump <NUM> and deactivate the second pump <NUM> such that the fluid is injected into the inflatable member <NUM> using the first pump <NUM>. The controller <NUM> may monitor the pressure level in the inflatable member <NUM>, and/or the amount of fluid that is transferred by the pump assembly <NUM> (or contained in the inflatable member <NUM>) (e.g., based on the signals received from the sensor <NUM>), and when the level meets or exceeds the threshold level, the controller <NUM> may deactivate the first pump <NUM> and activate the second pump <NUM> such that the second pump <NUM> can fill the remaining amount of the inflatable member <NUM>. In some examples, the threshold level is an amount within the range of <NUM>% to <NUM>% of the total volume of the inflatable member <NUM>. In some examples, the threshold level is substantially <NUM>% of the total volume of the inflatable member <NUM>. In some examples, the controller <NUM> may monitor the pressure in the inflatable member <NUM>, and when the pressure meets or exceeds the threshold level, the controller <NUM> may deactivate the first pump <NUM> and activate the second pump <NUM> such that the second pump <NUM> can fill the remaining amount of the inflatable member <NUM>. In some examples, the threshold level is at <NUM>% to <NUM>% of the maximum operating pressure level of a fully inflated inflatable member <NUM>.

The power source <NUM> is configured to provide a power source for the controller <NUM>. In some examples, the controller <NUM> includes at least one processor (e.g., coupled to a substrate) and a non-transitory computer-readable medium storing executable code, that when executed by the at least one processor, is configured to perform the operations of the controller <NUM> discussed herein. In some examples, the power source <NUM> includes a battery. In some examples, the controller <NUM> may include one or more moving parts in order to control open and close valves associated with the pump assembly <NUM>.

In some examples, the controller <NUM> is configured to control one or more valves to transition the first pump <NUM> and the second pump <NUM> between a parallel configuration and a serial configuration during different phases of the inflation cycle. The valves may be disposed in fluid passageways within a valve body or block of the pump assembly <NUM>. In some examples, during the first phase of the inflation cycle, the first pump <NUM> and the second pump <NUM> are arranged in the parallel configuration. In some examples, the controller <NUM> is configured to actuate one or more valves (e.g., place the valves in either an open position where fluid can flow through a valve or a closed position in which fluid is blocked) to arrange the first pump <NUM> and the second pump <NUM> in the parallel configuration. In some examples, during the first phase of the inflation cycle, both the first pump <NUM> and the second pump <NUM> are activated to transfer fluid from the fluid reservoir <NUM> to the inflatable member <NUM>. In some examples, only the first pump <NUM> is activated to transfer fluid to the inflatable member <NUM>.

In some examples, the first pump <NUM> is activated to fill the inflatable member <NUM> at the first flow rate up to the first maximum output pressure until the inflatable member <NUM> exceeds the threshold level (e.g., an fluid amount detected, or pressure level, or strain of the inflatable member, by the controller <NUM> exceeding the threshold level). Upon the detection of exceeding the threshold level by the controller <NUM>, the controller <NUM> is configured to actuate one or more valves to arrange the first pump <NUM> and the second pump <NUM> in the serial configuration. Then, the first pump <NUM> and the second pump <NUM> (in series with one another) are configured to fill the remaining amount of the inflatable member <NUM> during the second phase of the inflation cycle. In some examples, in the serial configuration, the first pump <NUM> is disposed before the second pump <NUM> such that the second pump <NUM> receives the output of the first pump <NUM> and the output of the second pump <NUM> is transferred to the inflatable member <NUM>. In other examples, in the serial configuration, the second pump <NUM> is disposed before the first pump <NUM> such that the first pump <NUM> receives the output of the second pump <NUM>, and the output of the second pump <NUM> is transferred to the inflatable member <NUM>.

In some examples, the fluid reservoir <NUM> includes a flexible fluid container <NUM>. For example, the flexible fluid container <NUM> may be a structure separate from the fluid reservoir <NUM> but disposed inside the cavity of the fluid reservoir <NUM>. In some examples, the flexible fluid container <NUM> includes an expandable balloon disposed inside the cavity of the fluid reservoir <NUM>. In some examples, during a preliminary period (e.g., before the start of the inflation cycle), the pump assembly <NUM> may displace fluid from the fluid reservoir <NUM> into the flexible fluid container <NUM> causing the flexible fluid container <NUM> to expand and increase the pressure inside the flexible fluid container <NUM>. In some examples, the controller <NUM> is configured to activate one or more valves to direct a fluid flow from the fluid reservoir <NUM> to the flexible fluid container <NUM>, and the fluid is pumped into the flexible fluid container <NUM> using the first pump <NUM> and/or the second pump <NUM>. In some examples, the controller <NUM> may activate the second pump <NUM> to transfer the fluid from the fluid reservoir <NUM> into the flexible fluid container <NUM>. The transfer of the fluid into the flexible fluid container <NUM> may temporarily store energy into the wall of the flexible fluid container <NUM> which can be used later to inflate the inflatable member at high pressure. The energy is stored through the elastic expansion of the wall of the flexible fluid container <NUM>.

In some examples, during a first phase of the inflation cycle, the first pump <NUM> (and/or the second pump <NUM>) is/are activated to transfer the fluid from the fluid reservoir <NUM> to the inflatable member <NUM> until reaching the threshold level. Then, during a second phase of the inflation cycle, the controller <NUM> may actuate the valves to define a fluid passageway within the pump assembly <NUM> between the flexible fluid container <NUM> and the inflatable member <NUM> such that the remaining amount is transferred from the flexible fluid container <NUM> to the inflatable member <NUM> at a relatively high output pressure. For example, upon defining (or opening) the fluid passageway between the flexible fluid container <NUM> and the inflatable member <NUM>, the fluid automatically flows from the high pressure of the flexible fluid container <NUM> to the lower pressure of the inflatable member <NUM>. After transferring fluid from the flexible container to the inflatable member <NUM>, the controller <NUM> may close the fluid connection between them by closing the valve.

In some examples, the flexible fluid container <NUM> is used to transfer fluid to the inflatable member at a higher output pressure at a particular point or phase in the use of the inflatable member <NUM> (e.g., at a point in time after the inflation cycle). For example, the controller <NUM> may include a sensor configured to sense a point in time during or before the ejaculation period of the user of the inflatable penile prosthesis <NUM>, and upon sensing that point, the controller <NUM> may actuate one or more valves to establish the fluid passageway from the flexible fluid container <NUM> to the inflatable member <NUM> (which results in the transfer of fluid from the flexible fluid container <NUM> to the inflatable member <NUM>) such that the pressure in the inflatable member <NUM> increases during the ejaculation period. In some examples, the sensor may detect the blood pressure, the heart rate, or the breathing rate of the user.

<FIG> illustrates an inflatable penile prosthesis <NUM> including a pump assembly <NUM> that has a first pump <NUM> and a second pump <NUM> in a parallel configuration according to an aspect. The pump assembly <NUM> is configured to transfer fluid from a fluid reservoir <NUM> to a pair of inflatable cylinders <NUM> during an inflation cycle. The first pump <NUM> is disposed in parallel with the second pump <NUM>. The fluid reservoir <NUM> may include any of the features described with reference to the fluid reservoir <NUM> of <FIG>. The inflatable cylinders <NUM> may include any of the features described with reference to the inflatable member <NUM> of <FIG>. The pump assembly <NUM> may include any of the features discussed with reference to <FIG>, <FIG>.

The pump assembly <NUM> may define fluid passageways that arrange the first pump <NUM> and the second pump <NUM> in parallel with respect to each other. An input of the first pump <NUM> is fluidly coupled to the fluid reservoir <NUM>, and an output of the first pump <NUM> is fluidly coupled to the inflatable cylinders <NUM>. An output of the second pump <NUM> is fluidly coupled to the fluid reservoir <NUM>, and an output of the first pump <NUM> is fluidly coupled to the inflatable cylinders <NUM>.

In some examples, the first pump <NUM> is configured to inject fluid into the inflatable cylinders <NUM> during a first phase of an inflation cycle, and the second pump <NUM> is configured to inject fluid into the inflatable cylinders <NUM> during a second phase of the inflation cycle, where the second phase is after the first phase. In other examples, the first pump <NUM> and the second pump <NUM> are configured to simultaneously inject fluid into the inflatable cylinders <NUM> during the inflation cycle. In some examples, the first pump <NUM> is configured to fill the inflatable cylinders <NUM> at a first flow rate up to a first maximum output pressure (e.g., higher flow rate, lower output pressure) during the first phase until the inflatable cylinders <NUM> reach the threshold level. Upon reaching the threshold level, the pump assembly <NUM> may activate the second pump <NUM> and inject the remaining amount at the lower flow rate but higher output pressure.

In some examples, the pump assembly <NUM> includes a controller (e.g., the controller <NUM> of <FIG>) and a sensor (e.g., the sensor <NUM> of <FIG>). The controller is configured to monitor the pressure level and/or the amount of fluid transferred to the inflatable cylinders <NUM> (e.g., based on the signals received from the sensor), and control the activation and deactivation of the first pump <NUM> and the second pump <NUM> such that the operator is unaware of that the pump assembly <NUM> includes multiple pumps. At the start of the inflation cycle, in some examples, the controller may activate the first pump <NUM> and deactivate the second pump <NUM> such that the fluid is injected into the inflatable cylinders <NUM> using the first pump <NUM> during the first phase. In response to the fluid or pressure level meeting or exceeding the threshold level, the controller may deactivate the first pump <NUM> and activate the second pump <NUM> so that the second pump <NUM> can fill the remaining amount of the inflatable cylinders <NUM>. In some examples, the threshold level is an amount within the range of <NUM>% to <NUM>% of the total volume of the inflatable cylinders <NUM>. In some examples, the threshold level is substantially <NUM>% of the total volume of the inflatable cylinders <NUM>. In some examples, the threshold level is at <NUM>% to <NUM>% of the maximum operating pressure level of a fully inflated inflatable member <NUM>.

<FIG> illustrate an inflatable penile prosthesis <NUM> including a pump assembly <NUM> that has a first pump <NUM> and a second pump <NUM> configured to transition between a parallel configuration and a serial configuration according to an aspect. The pump assembly <NUM> is configured to transfer fluid from a fluid reservoir <NUM> to a pair of inflatable cylinders <NUM> during an inflation cycle. The fluid reservoir <NUM> may include any of the features described with reference to the fluid reservoir <NUM> of <FIG>. The inflatable cylinders <NUM> may include any of the features described with reference to the inflatable member <NUM> of <FIG>. The pump assembly <NUM> may include any of the features of the pump assembly (e.g., <NUM>, <NUM>) discussed with reference to <FIG>, <FIG>.

The pump assembly <NUM> includes a plurality of valves such as a valve <NUM>, a valve <NUM>, and a valve <NUM>, which are disposed within fluid passageways of the valve block or body of the pump assembly <NUM>. Each of the valve <NUM>, the valve <NUM>, and the valve <NUM> may include a device for controlling the passage of fluid through the fluid passageway in which it is disposed. Each of the valve <NUM>, the valve <NUM>, and the valve <NUM> includes an open position in which fluid is permitted to travel through the passageway, and a closed position in which fluid is not permitted to travel through the passageway. Although <FIG> graphically represent the valves as switches, the open position of the valve indicates that fluid may pass through the valve, and the closed position of the valve indicates that fluid may be prevented from passing through the valve. Also, the pump assembly <NUM> includes a controller (e.g., the controller <NUM> of <FIG>) configured to control the actuation (e.g., the opening and closing) of the valve <NUM>, the valve <NUM>, and the valve <NUM>. Each of the valve <NUM>, the valve <NUM>, and the valve <NUM> includes a first port and a second port. In the closed position, fluid does not transfer between the first port and the second port. In the open position, fluid is permitted to transfer between the first port and the second.

An input of the first pump <NUM> may be fluidly coupled to the fluid reservoir <NUM>, and an input of the second pump <NUM> may be selectively coupled to the fluid reservoir <NUM> (via the valve <NUM>). An output of the first pump <NUM> is selectively coupled to the inflatable cylinders <NUM> (via the valve <NUM>), and the output of the first pump <NUM> is selectively coupled to the input of the second pump <NUM> (via the valve <NUM>). The output of the second pump <NUM> is fluidly coupled to the inflatable cylinders <NUM>.

As shown in <FIG>, during a first phase of an inflation cycle, the first pump <NUM> and the second pump <NUM> are arranged in the parallel configuration. In the parallel configuration, the valve <NUM> is in the open position, the valve <NUM> is in the closed position, and the valve <NUM> is in the open position. In the parallel configuration, the first pump <NUM> is disposed in parallel with respect to the second pump <NUM>. In some examples, the first pump <NUM> is configured to inject fluid from the fluid reservoir <NUM> to the inflatable cylinders <NUM> during the first phase of the inflation cycle. In some examples, the first pump <NUM> and the second pump <NUM> are configured to inject fluid from the fluid reservoir <NUM> to the inflatable cylinders <NUM> during the first phase of the inflation cycle.

As shown in <FIG>, during a second phase of the inflation cycle, the first pump <NUM> and the second pump <NUM> are arranged in the series configuration. In some examples, the controller is configured to control valve <NUM>, the valve <NUM>, and the valve <NUM> to arrange the first pump <NUM> and the second pump <NUM> in the series configuration. In some examples, in the series configuration, the valve <NUM> is in the closed position, the valve <NUM> is in the open position, and the valve <NUM> is in the closed position. In some examples, during the second phase, the first pump <NUM> is connected to and receives the fluid from the fluid reservoir <NUM>, and the output of the second pump <NUM> is connected to the input of the second pump <NUM>. The first pump <NUM> and the second pump <NUM> are configured to serially pump the fluid from the fluid reservoir <NUM> to the inflatable cylinders <NUM>.

As shown in <FIG>, during a third phase (e.g., the hold phase) of the inflation cycle, the valve <NUM> is in the closed position, the valve <NUM> is in the closed position, and the valve <NUM> is in the closed position, thereby disconnecting the fluid reservoir <NUM> from the inflatable cylinders <NUM>. As shown in <FIG>, during a fourth phase (e.g., release phase), the valve <NUM> is in the open position, the valve <NUM> is in the open position, and the valve <NUM> is in the open position. As shown in <FIG>, during a fifth phase (e.g., normal operation), the valve <NUM> is in the open position, the valve <NUM> is in the closed position, and the valve <NUM> is in the closed position.

<FIG> illustrate an inflatable penile prosthesis <NUM> according to another aspect. The inflatable penile prosthesis <NUM> includes a pair of inflatable cylinders <NUM>, a flexible fluid container <NUM> disposed inside of a fluid reservoir <NUM>, and a pump assembly <NUM> configured to transfer fluid from the fluid reservoir <NUM> to the inflatable cylinders <NUM> during an inflation cycle. The pump assembly <NUM> may include a first pump <NUM>, a second pump <NUM>, a valve <NUM>, and a valve <NUM>. The fluid reservoir <NUM> may include any of the features described with reference to the fluid reservoir <NUM> of <FIG>. The inflatable cylinders <NUM> may include any of the features described with reference to the inflatable member <NUM> of <FIG>. The pump assembly <NUM> may include any of the features of the pump assembly discussed with reference to <FIG>, <FIG>, <FIG>, and <FIG>. For example, the pump assembly <NUM> may include a controller (e.g., the controller <NUM>) that controls the activation or deactivation of the first pump <NUM> and the second pump <NUM>, and controls the actuating (e.g., the opening and closing) of the valve <NUM> and the valve <NUM>.

In some examples, the flexible fluid container <NUM> may be pressurized during a preliminary phase before the inflation cycle. The flexible fluid container <NUM> may include a flexible balloon disposed inside of the cavity of the fluid reservoir <NUM>. In response to the injection of fluid within the cavity of the flexible fluid container <NUM>, the flexible fluid container <NUM> may expand causing the pressure to increase inside of the flexible fluid container <NUM>. As shown in <FIG>, during the preliminary phase, the valve <NUM> is in the closed position, and the valve <NUM> is in the open position. During the preliminary phase, the second pump <NUM> may transfer fluid from the fluid reservoir <NUM> to the flexible fluid container <NUM>, which causes the flexible fluid container <NUM> to expand.

Referring to <FIG>, in a first phase of the inflation cycle, the controller may move the valve <NUM> from the closed position to the open position, and move the valve <NUM> from the open position to the closed position. In the first phase of the inflation cycle, the first pump <NUM> and/or the second pump <NUM> may transfer fluid from the fluid reservoir <NUM> to the inflatable cylinders <NUM>. Referring to <FIG>, in a second phase (e.g., the last part and/or the high pressure part) of the inflation cycle, the controller may cause the valve <NUM> to transition to the open position, and the valve <NUM> remains in the open position. In the second phase, when the valve <NUM> transitions to the open position, fluid from the flexible fluid container <NUM> is transferred to the inflatable cylinders <NUM> causing the flexible fluid container <NUM> to contract.

<FIG> schematically illustrates an inflatable penile prosthesis <NUM> having a pump assembly <NUM> according to an aspect. The pump assembly <NUM> may include any of the features of the pump assembly (e.g., <NUM>, <NUM>, <NUM>, <NUM>) described with reference to the previous figures. The penile prosthesis <NUM> may include a pair of inflatable cylinders <NUM>, and the inflatable cylinders <NUM> are configured to be implanted in a penis. For example, one of the inflatable cylinders <NUM> may be disposed on one side of the penis, and the other inflatable cylinder <NUM> may be disposed on the other side of the penis. Each inflatable cylinder <NUM> may include a first end portion <NUM>, a cavity or inflation chamber <NUM>, and a second end portion <NUM> having a rear tip <NUM>.

The pump assembly <NUM> may be implanted into the patient's scrotum. A pair of conduit connectors <NUM> may attach the pump assembly <NUM> to the inflatable cylinders <NUM> such that the pump assembly <NUM> is in fluid communication with the inflatable cylinders <NUM>. Also, the pump assembly <NUM> may be in fluid communication with a fluid reservoir <NUM> via a conduit connector <NUM>. The fluid reservoir <NUM> may be implanted into the user's abdomen. The inflation chamber or portion <NUM> of the inflatable cylinder <NUM> may be disposed within the penis. The first end portion <NUM> of the inflatable cylinder <NUM> may be at least partially disposed within the crown portion of the penis. The second end portion <NUM> may be implanted into the patient's pubic region PR with the rear tip <NUM> proximate the pubic bone PB.

In order to implant the inflatable cylinders <NUM>, the surgeon first prepares the patient. The surgeon often makes an incision in the penoscrotal region, e.g., where the base of the penis meets with the top of the scrotum. From the penoscrotal incision, the surgeon may dilate the patient's corpus cavernosae to prepare the patient to receive the inflatable cylinders <NUM>. The corpus cavernosum is one of two parallel columns of erectile tissue forming the dorsal part of the body of the penis, e.g., two slender columns that extend substantially the length of the penis. The surgeon will also dilate two regions of the pubic area to prepare the patient to receive the second end portion <NUM>. The surgeon may measure the length of the corpora cavernosae from the incision and the dilated region of the pubic area to determine an appropriate size of the inflatable cylinders <NUM> to implant.

After the patient is prepared, the penile prosthesis <NUM> is implanted into the patient. The tip of the first end portion <NUM> of each inflatable cylinder <NUM> may be attached to a suture. The other end of the suture may be attached to a needle member (e.g., Keith needle). The needle member is inserted into the incision and into the dilated corpus cavernosum. The needle member is then forced through the crown of the penis. The surgeon tugs on the suture to pull the inflatable cylinder <NUM> into the corpus cavernosum. This is done for each inflatable cylinder <NUM> of the pair. Once the inflation chamber <NUM> is in place, the surgeon may remove the suture from the tip. The surgeon then inserts the second end portion <NUM>. The surgeon inserts the rear end of the inflatable cylinder <NUM> into the incision and forces the second end portion <NUM> toward the pubic bone PB until each inflatable cylinder <NUM> is in place.

A pump bulb <NUM> of the pump assembly <NUM> may be squeezed or depressed by the user in order to facilitate the transfer of fluid from the fluid reservoir <NUM> to the inflatable cylinders <NUM>. For example, in the inflation mode, while the user is operating the pump bulb <NUM>, the pump bulb <NUM> may receive the fluid from the fluid reservoir <NUM>, and then output the fluid to the inflatable cylinders <NUM>. When the user switches to the deflation mode, at least some of the fluid can automatically be transferred back to the fluid reservoir <NUM> (due to the difference in pressure from the inflatable cylinders <NUM> to the fluid reservoir <NUM>). Then, the user may squeeze the inflatable cylinders <NUM> to facilitate the further transfer of fluid through the pump bulb <NUM> to the fluid reservoir <NUM>.

<FIG> illustrates a flow chart <NUM> depicting example operations of a method of inflating an inflatable member of a penile prosthesis. The example operations of the flow chart <NUM> may be performed by any of the pump assemblies (e.g., <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) discussed herein.

Operation <NUM> includes transferring, by a first pump of a pump assembly, fluid from a fluid reservoir to the inflatable member during a first phase of an inflation cycle. Operation <NUM> includes detecting, by a sensor, a pressure level in the inflatable member. Operation <NUM> includes activating, by the controller, a second pump of the pump assembly in response to the pressure level exceeding a threshold level. Operation <NUM> includes transferring, by at least the second pump, fluid from the fluid reservoir to the inflatable member during a second phase of the inflation cycle.

In some examples, the second pump is disposed in parallel with the first pump during the first phase. In some examples, the second pump is disposed in parallel with the first pump during the second phase. In some examples, the first pump and the second pump are disposed in a parallel configuration during the first phase, where the method further includes to a serial configuration during the second phase. The serial configuration is a configuration in which the first pump is serially disposed with respect to the second pump.

Claim 1:
An inflatable penile prosthesis (<NUM>) comprising:
a fluid reservoir (<NUM>) configured to hold fluid;
an inflatable member (<NUM>); and
a pump assembly (<NUM>) configured to transfer the fluid from the fluid reservoir (<NUM>) to the inflatable member (<NUM>) during an inflation cycle, the pump assembly (<NUM>) including:
a first pump (<NUM>) configured to inject the fluid into the inflatable member (<NUM>) according to a first flow rate; and
a second pump (<NUM>) configured to inject fluid into the inflatable member (<NUM>) according to a second flow rate, the second flow rate being less than the first flow rate,
wherein the pump assembly (<NUM>) is configured to move between a parallel configuration in which the second pump (<NUM>) is disposed in parallel with the first pump (<NUM>) and a serial configuration in which the second pump (<NUM>) is disposed in serial with the first pump (<NUM>).