Inflatable penile prosthesis

Abstract

This invention relates to an inflatable penile prosthesis, comprising: a fluid reservoir configured to contain fluid; an inflatable member; and a pump assembly configured to transfer fluid from the fluid reservoir to the inflatable member during an inflation cycle. The pump assembly includes: a first pump configured to inject fluid into the inflatable member at a first flow rate; and a second pump configured to inject fluid into the inflatable member at a second flow rate less than the first flow rate.

Description

[0001] This application is a divisional application of the application filed on May 13, 2019, with application number 201980029084.2 (international application number PCT / US2019 / 031999) and entitled "Multi-pump system for inflatable penile prosthesis".

[0002] Cross-references to related applications

[0003] This application is a continuation of and claims priority to U.S. non-provisional patent application No. 16 / 409,134, filed May 10, 2019, entitled “MULTIPLE PUMP SYSTEM FOR INFLATABLE PENILE PROSTHESIS,” which claims priority to U.S. provisional patent application No. 62 / 671,583, filed May 15, 2018, entitled “MULTIPLE PUMP SYSTEM FOR INFLATABLE PENILE PROSTHESIS,” the disclosure of which is incorporated herein by reference in its entirety.

[0004] This application also claims priority to U.S. Provisional Patent Application No. 62 / 671,583, filed May 15, 2018, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0005] This disclosure relates generally to body implants, and more specifically to body implants such as penile prostheses including multi-pump systems. Background Technology

[0006] One treatment for erectile dysfunction in men is the implantation of a penile prosthesis that enables mechanical erection. Some existing penile prostheses include a component or inflatable cylinder that can be expanded or contracted using a pump mechanism. The pump mechanism draws fluid from a fluid reservoir and then transfers the fluid to the inflatable component. Depending on some existing designs of inflatable penile prostheses, the amount of time and energy required for a patient to inflate the prosthesis, and the gap between these factors and achieving an erection in a normal human male (e.g., the number of pumps and the time required to provide the desired penile stiffness), may be relatively high. Summary of the Invention

[0007] According to one aspect, an inflatable penile prosthesis includes a fluid reservoir configured to contain fluid, an inflatable member, and a pump assembly configured to transfer fluid from the fluid reservoir to the inflatable member during an inflation cycle. The pump assembly includes: a first pump configured to inject fluid into the inflatable member at a first flow rate; and a second pump configured to inject fluid into the inflatable member at a second flow rate, wherein the second flow rate is less than the first flow rate.

[0008] According to some aspects, an inflatable penile prosthesis may include one or more of the following features (or any combination thereof). A first pump may include a plurality of micropumps, and a second pump may include a plurality of micropumps. The first pump is configured to inject fluid into the inflatable member up to a first maximum output pressure, and the second pump is configured to inject fluid into the inflatable member up to a second maximum output pressure, wherein the second maximum output pressure is higher than the first maximum output pressure. The second pump may be configured to be connected in parallel with the first pump. The pump assembly is configured to move between a parallel configuration in which the second pump is connected in parallel with the first pump and a series configuration in which the second pump is connected in series with the first pump. The inflatable penile prosthesis may include a controller configured to actuate a plurality of valves to move between the parallel and series configurations. The controller may activate the first pump during a first phase of the expansion cycle and may activate the second pump during a second phase of the expansion cycle. The controller may activate the second pump during the second phase of the expansion cycle in response to a pressure level in the inflatable member exceeding a threshold level. A fluid reservoir may include a flexible fluid container disposed within a cavity of the fluid reservoir. The flexible fluid container may contain a fluid at a pressure higher than the fluid contained in the fluid reservoir. At least one of the first or second pumps is configured to transfer fluid in a fluid reservoir during a first phase of the expansion cycle and to transfer fluid contained in a flexible fluid container to an expandable member during a second phase of the expansion cycle. Fluid contained in the flexible fluid container may be transferred to the expandable member after the expansion cycle.

[0009] According to one aspect, an inflatable penile prosthesis includes a fluid reservoir configured to contain fluid, an inflatable member, and a pump assembly configured to transfer fluid from the fluid reservoir to the inflatable member during an inflation cycle. The pump assembly includes: a first pump configured to inject 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 at least activate the second pump during a second phase of the inflation cycle.

[0010] According to some aspects, an inflatable penile prosthesis may include one or more of the following features (or any combination thereof). A first pump may include a plurality of micropumps disposed on a first substrate, and a second pump may include a plurality of micropumps disposed on a second substrate. The number of micropumps disposed on the first substrate may be less than the number of micropumps disposed on the second substrate. The first pump is configured to inject fluid into the inflatable member at a first flow rate up to a first maximum output pressure, and the second pump is configured to inject fluid into the inflatable member at a second flow rate up to a second maximum output pressure, wherein 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. A fluid reservoir may include a flexible fluid container disposed within a cavity of the fluid reservoir, and the flexible fluid container may contain a fluid at a pressure higher than the fluid contained in the fluid reservoir.

[0011] According to one aspect, a method for inflating an inflatable component of a penile prosthesis includes: during a first phase of an inflation cycle, transferring fluid from a fluid reservoir to the inflatable component via a first pump of a pump assembly; detecting a pressure level in the inflatable component via a sensor; activating a second pump of the pump assembly via a controller connected to the sensor in response to the pressure level exceeding a threshold level; and during a second phase of the inflation cycle, transferring fluid from the fluid reservoir to the inflatable component via at least the second pump.

[0012] According to some aspects, the method may include one or more of the following features (or any combination thereof): During a first stage, the second pump may be connected in parallel with the first pump. During a second stage, the second pump may be connected in parallel with the first pump. The first and second pumps may be configured in parallel during the first stage, and the method further includes switching to a series configuration during the second stage. The series configuration is a configuration in which the first pump is connected in series with respect to the second pump. Attached Figure Description

[0013] Figure 1 An inflatable penile prosthesis according to one aspect is shown, which has a pump assembly including a first pump and a second pump.

[0014] Figure 2A An example of a first pump according to one aspect of a pump assembly is shown.

[0015] Figure 2B An example of a second pump based on a pump assembly is shown.

[0016] Figure 3 An inflatable penile prosthesis according to one aspect is shown, which has a pump assembly including a first pump connected in parallel with a second pump.

[0017] Figure 4AAn inflatable penile prosthesis having a multi-pump assembly in a first configuration is shown, according to one aspect.

[0018] Figure 4B An inflatable penile prosthesis with a multi-pump assembly in a second configuration is shown, according to one aspect.

[0019] Figure 4C An inflatable penile prosthesis with a multi-pump assembly in a third configuration is shown, according to one aspect.

[0020] Figure 4D An inflatable penile prosthesis with a multi-pump assembly in a fourth configuration is shown, according to one aspect.

[0021] Figure 4E An inflatable penile prosthesis with a multi-pump assembly in a fifth configuration is shown, according to one aspect.

[0022] Figure 5A An expandable penile prosthesis having a pump assembly and a flexible fluid container in a first configuration is shown, according to one aspect.

[0023] Figure 5B An expandable penile prosthesis with a pump assembly and a flexible fluid container in a second configuration is shown, according to one aspect.

[0024] Figure 5C An expandable penile prosthesis with a pump assembly and a flexible fluid container in a third configuration is shown, according to one aspect.

[0025] Figure 6 An inflatable penile prosthesis with a multi-pump assembly is shown according to one aspect.

[0026] Figure 7 A flowchart depicting an example operation of a pump assembly according to one aspect is shown. Detailed Implementation

[0027] This document discloses detailed embodiments. However, it should be understood that the disclosed embodiments are merely examples and can be implemented in many forms. Therefore, the specific structural and functional details disclosed herein should not be construed as limiting, but merely as the basis for the claims and as a representative basis for teaching those skilled in the art to adopt the embodiments differently with virtually any suitable detailed structure. Furthermore, the terminology and phrases used herein are not intended to be restrictive, but rather to provide an understandable description of this disclosure.

[0028] As used herein, the term "a" or "an" is defined as one or more. As used herein, the term "another" is defined as at least a second or more. As used herein, the terms "comprising" and / or "having" are defined as including (i.e., open transitions). As used herein, the terms "linked" or "movably linked" are defined as a connection, however not necessarily direct and mechanical.

[0029] In general, the embodiments described relate to body implants. Hereinafter, the terms patient or user may be used to refer to a person who benefits from the medical device or method disclosed in this disclosure. For example, a patient can be a person to whom a medical device is implanted or a person to whom an implantation is performed using the method disclosed in this disclosure for operating the medical device. For example, in some embodiments, a patient can be a human or any other mammal.

[0030] Figure 1 An inflatable penile prosthesis 100 with a multi-pump system is shown according to one aspect, the multi-pump system improving the inflation operation of the inflatable component of the prosthesis. The inflatable penile prosthesis 100 may include a fluid reservoir 102, an inflatable component 104, and a pump assembly 106 configured to transfer fluid between the fluid reservoir 102 and the inflatable component 104. The inflatable component 104 may be implanted into the corpora cavernosa of a user's penis, the fluid reservoir 102 may be implanted into the user's abdomen or pelvis (e.g., the fluid reservoir 102 may be implanted in the lower portion of the user's abdomen or the upper portion of the user's pelvis), and the pump assembly 106 may be implanted in the user's scrotum.

[0031] Pump assembly 106 includes multiple pumps that pump fluid into the expandable member 104 during the expansion cycle in a manner that increases efficiency and / or reduces the amount of time required for the expandable member 104 to fully expand. In some examples, the multiple pumps operate at different times during the expansion cycle. In some examples, the multiple pumps operate simultaneously during at least a portion of the expansion cycle. In some examples, the multiple pumps are not individually controlled by the user, but are mechanically and / or programmatically controlled by controller 112, and from the user's perspective, the multiple pumps of pump assembly 106 may appear as a single pump. In some examples, the user is able to program the maximum output pressure and / or pressure distribution during intercourse. For example, the stiffness of the penile implant can be controlled to prevent premature ejaculation.

[0032] The expandable member 104 is capable of expanding when fluid is injected into its cavity. For example, when fluid is injected into the expandable member 104, its length and / or width, and its stiffness, may increase. In some examples, the expandable member 104 may include a pair of expandable cylinders or at least two cylinders, such as a first cylinder member and a second cylinder member. The volumetric capacity of the expandable member 104 may depend on the size of the expandable cylinders. In some examples, the volume of fluid in each cylinder may vary from approximately 10 ml in a smaller cylinder to approximately 50 ml in a larger cylinder. 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.

[0033] The fluid reservoir 102 may include a container with an internal chamber configured to hold or contain fluid for inflating the expandable member 104. The volumetric capacity of the fluid reservoir 102 may vary depending on the size of the expandable penile prosthesis 100. In some examples, the volumetric capacity of the fluid reservoir 102 may be from 3 to 150 cubic centimeters. In some examples, the fluid reservoir 102 is made of the same material as the expandable member 104. In other examples, the fluid reservoir 102 is made of a different material than the expandable member 104. In some examples, the fluid reservoir 102 contains a larger volume of fluid than the expandable member 104.

[0034] The expandable penile prosthesis 100 may include a first catheter connector 103 and a second catheter connector 105. Each of the first catheter connector 103 and the second catheter connector 105 may define a lumen configured to transfer fluid to and from a pump assembly 106. The first catheter connector 103 may be coupled to the pump assembly 106 and the fluid reservoir 102, allowing fluid to be transferred between the pump assembly 106 and the fluid reservoir 102 via the first catheter connector 103. For example, the first catheter connector 103 may define a first lumen configured to transfer fluid between the pump assembly 106 and the fluid reservoir 102. The first catheter connector 103 may include one or more tubular components for transferring fluid between the pump assembly 106 and the fluid reservoir 102.

[0035] The second conduit connector 105 can be coupled to the pump assembly 106 and the expandable member 104, allowing fluid to be transferred between the pump assembly 106 and the expandable member 104 via the second conduit connector 105. For example, the second conduit connector 105 can define a second lumen configured to transfer fluid between the pump assembly 106 and the expandable member 104. The second conduit connector 105 may include one or more tubular components for transferring fluid between the pump assembly 106 and the expandable member 104. In some examples, the first conduit connector 103 and the second conduit connector 105 may include a silicone rubber material. In some examples, the pump assembly 106 may be directly connected to the fluid reservoir 102.

[0036] Pump assembly 106 includes a first pump 108, a second pump 110, a controller 112, a sensor 115, and a power supply 114. Pump assembly 106 may include other features such as a valve body, a pump ball, one or more valves, and / or an expansion mode selector configured to select between an expansion mode and a contraction mode. In some examples, pump assembly 106 includes more than two pumps, such as three or more pumps, which may be arranged in parallel and / or series configurations relative to each pump (and may switch between parallel and series configurations during different phases of the expansion cycle).

[0037] The first pump 108 is configured to transfer fluid from the fluid reservoir 102 to the expandable member 104 at a first flow rate up to a first maximum output pressure. The second pump 110 is configured to transfer fluid from the fluid reservoir 102 to the expandable member 104 at 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 108 is a high-capacity pump (e.g., high flow rate) but has a relatively low output pressure. In some examples, the second pump 110 is a low-capacity pump (e.g., low flow rate) but has a relatively high output pressure.

[0038] The first pump 108 may include one or more devices configured to facilitate the transfer of fluid from the fluid reservoir 102 to the expandable member 104. In some examples, reference is made to... Figure 2AThe first pump 108 includes a micropump 220 disposed on a first substrate 222, the micropump being arranged to provide a first flow rate and a first maximum output pressure. In some examples, the micropump 220 is a piezoelectrically driven micropump. In some examples, the micropump 220 includes a first dimension ranging from 4 mm to 15 mm, a second dimension ranging from 4 mm to 15 mm, and / or a third dimension ranging from 0.4 mm to 2 mm. In some examples, the micropump 220 includes a silicon-based material. In some examples, the micropump 220 includes a metal-based material (e.g., steel). In some examples, the first substrate 222 includes a wafer. Although... Figure 2A Four micropumps 220 are shown, but the embodiments include any number of micropumps 220 disposed on the first substrate 222, including one or more micropumps. In some examples, the first pump 108 includes more than ten micropumps 220 disposed on the first substrate 222. In some examples, the first pump 108 includes more than twenty micropumps 220 disposed on the first substrate 222. In some examples, the first pump 108 includes more than four micropumps 220 disposed on the first substrate 222. In some examples, the micropumps 220 disposed on the first substrate 222 are non-mechanical (e.g., without moving parts).

[0039] The second pump 110 may include one or more devices configured to facilitate the transfer of fluid from the fluid reservoir 102 to the expandable member 104. In some examples, reference... Figure 2B The second pump 110 includes a micropump 220 disposed on a second substrate 225, the micropump being arranged to provide a second flow rate and a second maximum output pressure. In some examples, the first substrate 222 and the second substrate 225 are the same substrate (e.g., the micropump 220 for the first pump 108 and the micropump 220 for the second pump 210 are disposed on the same substrate). In some examples, the first substrate 222 and the second substrate 225 are different substrates.

[0040] In some examples, the second substrate 225 includes a wafer. Although Figure 2BTwo micropumps 220 disposed on a second substrate 225 are shown, but the embodiments include any number of micropumps 220, including one or more micropumps on the second substrate 225. In some examples, the second pump 110 includes more micropumps 220 than the first pump 108. In some examples, the second pump 110 includes fewer micropumps 220 than the first pump 108. In some examples, the second pump 110 includes two or more micropumps 220 disposed on the second substrate 225. In some examples, the second pump 110 includes more than ten micropumps 220 disposed on the second substrate 225. In some examples, the second pump 110 includes more than twenty micropumps 220 disposed on the second substrate 225. In some examples, the micropumps 220 disposed on the second substrate 225 are non-mechanical (e.g., without moving parts).

[0041] In some examples, the first pump 108 and the second pump 110 are arranged in a parallel configuration during the expansion cycle. In some examples, the first pump 108 and the second pump 110 are arranged in a parallel configuration throughout the entire expansion cycle. In some examples, the first pump 108 and the second pump 110 are arranged in a parallel configuration only for a portion of the expansion cycle. In the parallel configuration, each of the first pump 108 and the second pump 110 is configured to receive fluid from the fluid reservoir 102 and inject fluid into the expandable member 104 during the expansion cycle. In some examples, the first pump 108 is configured to fill the expandable member 104 to a first maximum output pressure (e.g., higher flow rate, lower output pressure) at a first flow rate during a first phase of the expansion cycle until the pressure level in the expandable member 104 reaches a threshold level. In some examples, the threshold level is related to the total volume of the expandable member 104. In some examples, the threshold level is related to the total pressure in the expandable member 104. When a threshold level is reached, pump assembly 106 may activate (or switch to) a second pump 110, and the second pump 110 injects the remaining amount of fluid at a second flow rate to a second maximum output pressure (e.g., lower flow rate, higher output pressure). In some examples, controller 112 may deactivate the first pump 108 during the second phase (e.g., after the start of the second phase but before the end of the second phase).

[0042] Sensor 115 is configured to monitor the pressure level in the expandable member 104. In some examples, sensor 115 is calibrated before the start of expansion and contraction cycles. Sensor 115 is communicatively coupled to controller 112 such that controller 112 can receive signals from sensor 115. In some examples, sensor 115 is included within pump assembly 106. In some examples, sensor 115 is configured to sense the amount of fluid transferred to expandable member 104 and send one or more signals to controller 112 indicating that the amount of fluid has been transferred.

[0043] In some examples, sensor 115 is included within the expandable member 104. In some examples, sensor 115 is integrated into the wall of the column of the expandable member 104. In some examples, when sensor 115 is integrated into the wall of the column, sensor 115 can monitor the condition of the column material, and sensor 115 can detect changes in the column material to a point where the column may need to be replaced. In this case, controller 112 can periodically send information via a network to an external device (e.g., located in a hospital or doctor's office) for potential examinations.

[0044] In some examples, sensor 115 is configured to sense the pressure level in expandable member 104 and send one or more signals to controller 112 indicating the pressure level in expandable member 104. In some examples, sensor 115 is configured to monitor flow rate (e.g., flow rate in both directions). Controller 112 can control the start-up (and deactivation) of first pump 108 and second pump 110 based on signals received from sensor 115, such that the pump assembly 106 includes multiple pumps operating at different times without the operator's knowledge. In some examples, controller 112 can send start-up or deactivation signals to first pump 108 and second pump 110 to control the start-up and deactivation of first pump 108 and second pump 110.

[0045] During the first phase of the expansion cycle, controller 112 may activate first pump 108 and deactivate second pump 110, such that fluid is injected into expandable member 104 using first pump 108. Controller 112 may monitor the pressure level in expandable member 104 and / or the amount of fluid transferred by pump assembly 106 (or contained in expandable member 104) (e.g., based on signals received from sensor 115), and when the level meets or exceeds a threshold level, controller 112 may deactivate first pump 108 and activate second pump 110, such that second pump 110 fills the remaining amount in expandable member 104. In some examples, the threshold level is an amount ranging from 85% to 95% of the total volume of expandable member 104. In some examples, the threshold level is essentially 90% of the total volume of expandable member 104. In some examples, controller 112 can monitor the pressure in expandable member 104, and when the pressure meets or exceeds a threshold level, controller 112 can deactivate the first pump 108 and activate the second pump 110, allowing the second pump 110 to fill the remaining amount in expandable member 104. In some examples, the threshold level is between 80% and 90% of the maximum operating pressure level of fully expanded expandable member 104.

[0046] Power source 114 is configured to provide power to controller 112. In some examples, controller 112 includes at least one processor (e.g., coupled to a substrate) and a non-transitory computer-readable medium storing executable code configured to perform the operation of controller 112 discussed herein when executed by at least one processor. In some examples, power source 114 includes a battery. In some examples, controller 112 may include one or more moving parts for controlling the opening and closing of a valve associated with pump assembly 106.

[0047] In some examples, controller 112 is configured to control one or more valves to switch the first pump 108 and the second pump 110 between parallel and series configurations during different phases of the expansion cycle. The valves may be located in fluid passages within the valve body or valve group of pump assembly 106. In some examples, during the first phase of the expansion cycle, the first pump 108 and the second pump 110 are arranged in a parallel configuration. In some examples, controller 112 is configured to actuate one or more valves (e.g., place the valves in an open position where fluid can flow through or a closed position where fluid is blocked) to arrange the first pump 108 and the second pump 110 in a parallel configuration. In some examples, during the first phase of the expansion cycle, both the first pump 108 and the second pump 110 are activated to transfer fluid from fluid reservoir 102 to expandable member 104. In some examples, only the first pump 108 is activated to transfer fluid to expandable member 104.

[0048] In some examples, a first pump 108 is activated to fill the expandable member 104 at a first flow rate to a first maximum output pressure until the expandable member 104 exceeds a threshold level (e.g., the amount or pressure level of fluid detected by controller 112, or the strain of the expandable member exceeds a threshold level). When controller 112 detects that the threshold level has been exceeded, controller 112 is configured to actuate one or more valves to arrange the first pump 108 and the second pump 110 in a series configuration. The first pump 108 and the second pump 110 (in series with each other) are then configured to fill the expandable member 104 with the remaining amount during a second phase of the expansion cycle. In some examples, in the series configuration, the first pump 108 is positioned before the second pump 110 such that the second pump 110 receives the output of the first pump 108, and the output of the second pump 110 is transferred to the expandable member 104. In other examples, in a series configuration, the second pump 110 is positioned before the first pump 108 such that the first pump 108 receives the output of the second pump 110, and the output of the second pump 110 is passed to the expandable member 104.

[0049] In some examples, the fluid reservoir 102 includes a flexible fluid container 113. For example, the flexible fluid container 113 may be a structure separate from the fluid reservoir 102 but disposed within the cavity of the fluid reservoir 102. In some examples, the flexible fluid container 113 includes an expandable bladder disposed within the cavity of the fluid reservoir 102. In some examples, during an initial period (e.g., before the start of an expansion cycle), the pump assembly 106 may move fluid from the fluid reservoir 102 into the flexible fluid container 113, causing the flexible fluid container 113 to expand and increase the pressure inside the flexible fluid container 113. In some examples, the controller 112 is configured to activate one or more valves to direct fluid flow from the fluid reservoir 102 to the flexible fluid container 113, and to pump fluid into the flexible fluid container 113 using a first pump 108 and / or a second pump 110. In some examples, the controller 112 may activate the second pump 110 to transfer fluid from the fluid reservoir 102 to the flexible fluid container 113. Transferring fluid into the flexible fluid container 113 allows energy to be temporarily stored in the walls of the flexible fluid container 113. This energy can later be used to expand the expandable component under high pressure. Energy is stored through the elastic expansion of the walls of the flexible fluid container 113.

[0050] In some examples, during the first phase of the expansion cycle, a first pump 108 (and / or a second pump 110) is activated to transfer fluid from the fluid reservoir 102 to the expandable member 104 until a threshold level is reached. Then, during the second phase of the expansion cycle, a controller 112 can actuate a valve to define a fluid passage within the pump assembly 106 between the flexible fluid container 113 and the expandable member 104, such that the remaining fluid is transferred from the flexible fluid container 113 to the expandable member 104 at a relatively high output pressure. For example, when defining (or opening) the fluid passage between the flexible fluid container 113 and the expandable member 104, fluid automatically flows from the high-pressure flexible fluid container 113 to the low-pressure expandable member 104. After the fluid has been transferred from the flexible container to the expandable member 104, the controller 112 can close the fluid connection between them by closing a valve.

[0051] In some examples, the flexible fluid container 113 is used to transfer fluid to the expandable member 104 at a higher output pressure at a specific point or stage of use (e.g., a point in time after the expansion cycle). For example, the controller 112 may include a sensor configured to sense a point in time during or before ejaculation of the user of the expandable penile prosthesis 100, and upon sensing this point, the controller 112 may actuate one or more valves to establish a fluid passage from the flexible fluid container 113 to the expandable member 104 (this causes fluid to transfer from the flexible fluid container 113 to the expandable member 104), such that the pressure in the expandable member 104 increases during ejaculation. In some examples, the sensor may detect the user's blood pressure, heart rate, or respiratory rate.

[0052] Figure 3 An inflatable penile prosthesis 300 according to one aspect is shown, including a pump assembly 306 having a first pump 308 and a second pump 310 in a parallel configuration. The pump assembly 306 is configured to transfer fluid from a fluid reservoir 302 to a pair of inflatable cylinders 304 during an expansion cycle. The first pump 308 and the second pump 310 are arranged in parallel. The fluid reservoir 302 may include reference... Figure 1 The fluid reservoir 102 may contain any of the features described. The expandable cylinder 304 may include, as referenced Figure 1 The expandable member 104 may include any of the features described herein. The pump assembly 306 may include features referenced to... Figure 1 , Figure 2A and Figure 2B Any of the features discussed.

[0053] Pump assembly 306 may define fluid passages for arranging a first pump 308 and a second pump 310 in parallel with respect to each other. The input fluid of the first pump 308 is connected to a fluid reservoir 302, and the output fluid of the first pump 308 is connected to an expandable column 304. The output fluid of the second pump 310 is connected to the fluid reservoir 302, and the output fluid of the first pump 308 is connected to the expandable column 304.

[0054] In some examples, a first pump 308 is configured to inject fluid into the expandable column 304 during a first phase of the expansion cycle, and a second pump 310 is configured to inject fluid into the expandable column 304 during a second phase of the expansion cycle, wherein the second phase follows the first phase. In other examples, the first pump 308 and the second pump 310 are configured to inject fluid into the expandable column 304 simultaneously during the expansion cycle. In some examples, the first pump 308 is configured to fill the expandable column 304 to a first maximum output pressure (e.g., a higher flow rate, a lower output pressure) at a first flow rate during the first phase until the expandable column 304 reaches a threshold level. When the threshold level is reached, the pump assembly 306 can activate the second pump 310 and inject the remaining amount at a lower flow rate but a higher output pressure.

[0055] In some examples, pump assembly 306 includes a controller (e.g., Figure 1 The controller 112) and sensors (e.g., Figure 1 (Sensor 115). The controller is configured to monitor pressure levels and / or the amount of fluid delivered to the expandable column 304 (e.g., based on signals received from the sensor) and control the activation and deactivation of the first pump 308 and the second pump 310 such that the pump assembly 306 includes multiple pumps without the operator's knowledge. At the start of an expansion cycle, in some examples, the controller may activate the first pump 308 and deactivate the second pump 310, such that the first pump 308 is used to inject fluid into the expandable column 304 during a first phase. In response to a fluid or pressure level meeting or exceeding a threshold level, the controller may deactivate the first pump 308 and activate the second pump 310, such that the second pump 310 can fill the remaining amount in the expandable column 304. In some examples, the threshold level is an amount ranging from 85% to 95% of the total volume of the expandable column 304. In some examples, the threshold level is essentially 90% of the total volume of the expandable column 304. In some examples, the threshold level is 80% to 90% of the maximum operating pressure level of the fully expanded expandable member 104.

[0056] Figures 4A to 4EAn inflatable penile prosthesis 400 according to one aspect is shown, which includes a pump assembly 406 having a first pump 408 and a second pump 410, the first pump 408 and the second pump 410 being configured to switch between a parallel configuration and a series configuration. The pump assembly 406 is configured to transfer fluid from a fluid reservoir 402 to a pair of inflatable cylinders 404 during an expansion cycle. The fluid reservoir 402 may include reference... Figure 1 The fluid reservoir 102 may contain any of the features described herein. The expandable cylinder 404 may include features referenced in the description. Figure 1 The expandable member 104 may include any of the features described herein. Pump assembly 406 may include features referenced to... Figure 1 , Figure 2A and Figure 2B Any of the features of the pump assembly discussed (e.g., 106, 306).

[0057] Pump assembly 406 includes multiple valves, such as valves 430, 432, and 434, disposed within a fluid passage of a valve group or valve body of pump assembly 406. Each of valves 430, 432, and 434 may include means for controlling fluid flow through the fluid passage, the means being disposed within the fluid passage. Each of valves 430, 432, and 434 includes an open position that permits fluid flow through the passage and a closed position that prohibits fluid flow through the passage. Although Figures 4A-4E These valves are illustrated as switches, but the open position of a valve indicates that fluid can pass through the valve, while the closed position indicates that fluid can be prevented from passing through the valve. Furthermore, pump assembly 406 includes a controller (e.g., Figure 1 The controller 112 is configured to control the actuation (e.g., opening and closing) of valves 430, 432, and 434. Each of valves 430, 432, and 434 includes a first port and a second port. In the closed position, fluid does not flow between the first port and the second port. In the open position, fluid is allowed to flow between the first port and the second port.

[0058] The input of the first pump 408 is fluidly connected to the fluid reservoir 402, and the input of the second pump 410 is selectively connected to the fluid reservoir 402 (via valve 430). The output of the first pump 408 is selectively connected to the expandable column 404 (via valve 434), and the output of the first pump 408 is selectively connected to the input of the second pump 410 (via valve 432). The output of the second pump 410 is fluidly connected to the expandable column 404.

[0059] like Figure 4AAs shown, during the first phase of the expansion cycle, the first pump 408 and the second pump 410 are arranged in a parallel configuration. In the parallel configuration, valve 430 is in the open position, valve 432 is in the closed position, and valve 434 is in the open position. In the parallel configuration, the first pump 408 is arranged in parallel with respect to the second pump 410. In some examples, the first pump 408 is configured to inject fluid from the fluid reservoir 402 into the expandable column 404 during the first phase of the expansion cycle. In some examples, the first pump 408 and the second pump 410 are configured to inject fluid from the fluid reservoir 402 into the expandable column 404 during the first phase of the expansion cycle.

[0060] like Figure 4B As shown, during the second phase of the expansion cycle, the first pump 408 and the second pump 410 are arranged in series. In some examples, the controller is configured to control valves 430, 432, and 434 to arrange the first pump 408 and the second pump 410 in series. In some examples, in the series configuration, valve 430 is in the closed position, valve 432 is in the open position, and valve 434 is in the closed position. In some examples, during the second phase, the first pump 408 is connected to and receives fluid from the fluid reservoir 402, and the output of the second pump 410 is connected to the input of the second pump 410. The first pump 408 and the second pump 410 are configured to pump fluid from the fluid reservoir 402 to the expandable column 404 in series.

[0061] like Figure 4C As shown, during the third phase of the expansion cycle (e.g., the holding phase), valves 430, 432, and 434 are in the closed position, thereby disconnecting the fluid reservoir 402 from the expandable column 404. Figure 4D As shown, during the fourth stage (e.g., the release stage), valve 430 is in the open position, valve 432 is in the open position, and valve 434 is in the open position. Figure 4E As shown, during the fifth stage (e.g., normal operation), valve 430 is in the open position, valve 432 is in the closed position, and valve 434 is in the closed position.

[0062] Figures 5A to 5C An inflatable penile prosthesis 500 according to another aspect is shown. The inflatable penile prosthesis 500 includes a pair of inflatable cylinders 504, a flexible fluid container 513 disposed within a fluid reservoir 502, and a pump assembly 506. The pump assembly 506 is configured to transfer fluid from the fluid reservoir 502 to the inflatable cylinders 504 during an expansion cycle. The pump assembly 506 may include a first pump 508, a second pump 510, a valve 532, and a valve 534. The fluid reservoir 502 may include reference... Figure 1The fluid reservoir 102 may contain any of the features described herein. The expandable cylinder 504 may include features referenced in the description. Figure 1 The expandable member 104 may include any of the features described herein. The pump assembly 506 may include features referenced to... Figure 1 , Figure 2A , Figure 2B And any of the features of the pump assembly discussed in Figure 4. For example, pump assembly 506 may include a controller (e.g., controller 112) that controls the start-up or deactivation of the first pump 508 and the second pump 510, and controls the actuation (e.g., opening and closing) of valves 532 and 534.

[0063] In some examples, the flexible fluid container 513 may be pressurized during an initial phase prior to the expansion cycle. The flexible fluid container 513 may include a flexible bladder disposed within the cavity of the fluid reservoir 502. In response to the injection of fluid into the cavity of the flexible fluid container 513, the flexible fluid container 513 may expand, causing an increase in pressure within the flexible fluid container 513. Figure 5A As shown, during the initial phase, valve 534 is in the closed position, while valve 532 is in the open position. During the initial phase, the second pump 510 can transfer fluid from the fluid reservoir 502 to the flexible fluid container 513, which causes the flexible fluid container 513 to expand.

[0064] refer to Figure 5B During the first phase of the expansion cycle, the controller can move valve 534 from the closed position to the open position and valve 532 from the open position to the closed position. During the first phase of the expansion cycle, the first pump 508 and / or the second pump 510 can transfer fluid from the fluid reservoir 502 to the expandable column 504. (Reference) Figure 5C In the second phase of the expansion cycle (e.g., the final and / or high-pressure phase), the controller can switch valve 532 to the open position, while valve 534 remains in the open position. In the second phase, when valve 532 switches to the open position, fluid from the flexible fluid container 513 is transferred to the expandable column 504, causing the flexible fluid container 513 to contract.

[0065] Figure 6An inflatable penile prosthesis 600 with a pump assembly 606 is schematically illustrated according to one aspect. The pump assembly 606 may include any features of the pump assemblies (e.g., 106, 306, 406, 506) described with reference to the preceding figures. The penile prosthesis 600 may include a pair of inflatable pillars 610, and the inflatable pillars 610 are configured for implantation into the penis. For example, one of the inflatable pillars 610 may be disposed on one side of the penis, while the other inflatable pillar 610 may be disposed on the other side of the penis. Each inflatable pillar 610 may include a first end portion 624, a cavity or expansion chamber 622, and a second end portion 628 having a rear end 632.

[0066] A pump assembly 606 can be implanted into a patient's scrotum. A pair of catheter connectors 605 attach the pump assembly 606 to an expandable cylinder 610, allowing the pump assembly 606 to be in fluid communication with the expandable cylinder 610. Furthermore, the pump assembly 606 can be in fluid communication with a fluid reservoir 650 via a catheter connector 603. The fluid reservoir 650 can be implanted into the user's abdomen. An expansion chamber or expansion portion 622 of the expandable cylinder 610 can be disposed within the penis. A first end portion 624 of the expandable cylinder 610 can be at least partially disposed within the coronal portion of the penis. A second end portion 628 can be implanted into the patient's pubic region (PR), with the posterior end 632 proximal to the pubic bone (PB).

[0067] To implant the expandable cylinder 610, the surgeon first prepares the patient. The surgeon typically makes an incision in the penoscrotal region (e.g., where the base of the penis meets the top of the scrotum). The surgeon can then enlarge the patient's corpora cavernosa from the penoscrotal incision to prepare the patient for receiving the expandable cylinder 610. The corpora cavernosa are one of two parallel cylinders of erectile tissue that form the dorsal portion of the body of the penis (e.g., two slender cylinders that significantly extend the length of the penis). The surgeon will also enlarge two areas in the pubic region to prepare the patient for receiving the second terminal portion 628. The surgeon can measure the length of the corpora cavernosa from the enlarged areas in the pubic region and the incision to determine the appropriate size of the expandable cylinder 610 to be implanted.

[0068] After the patient is prepared, the penile prosthesis 600 is implanted into the patient. The end of the first end portion 624 of each inflatable cylinder 610 can be attached to a suture. The other end of the suture can be attached to a needle member (e.g., a Keith needle). The needle member is inserted into the incision and the enlarged corpora cavernosa. The needle member is then pushed through the coronal portion of the penis. The surgeon pulls the suture to pull the inflatable cylinder 610 into the corpora cavernosa. This is done for each of the pair of inflatable cylinders 610. Once the expansion chamber 622 is in place, the surgeon can remove the suture from the end. The surgeon then inserts the second end portion 628. The surgeon inserts the rear end of the inflatable cylinder 610 into the incision and pushes the second end portion 628 toward the pubic bone (PB) until each inflatable cylinder 610 is in place.

[0069] The pump ball 631 of the pump assembly 606 can be squeezed or pressed by the user to facilitate the transfer of fluid from the fluid reservoir 650 to the expandable column 610. For example, in expansion mode, when the user operates the pump ball 631, the pump ball 631 can receive fluid from the fluid reservoir 650 and then output the fluid to the expandable column 610. When the user switches to contraction mode, at least some fluid can be automatically transferred back to the fluid reservoir 650 (due to the pressure difference between the expandable column 610 and the fluid reservoir 650). The user can then squeeze the expandable column 610 to allow fluid to be further transferred to the fluid reservoir 650 via the pump ball 631.

[0070] Figure 7 Flowchart 700 is shown, which depicts an exemplary operation of a method for inflating an inflatable member of a penile prosthesis. The exemplary operation of flowchart 700 can be performed by any pump assembly discussed herein (e.g., 106, 306, 406, 506, 606).

[0071] Operation 702 includes transferring fluid from a fluid reservoir to an expandable member via a first pump of the pump assembly during a first phase of the expansion cycle. Operation 704 includes detecting a pressure level in the expandable member via a sensor. Operation 706 includes activating a second pump of the pump assembly by a controller in response to the pressure level exceeding a threshold level. Operation 708 includes transferring fluid from the fluid reservoir to the expandable member, at least via the second pump, during a second phase of the expansion cycle.

[0072] In some examples, during the first stage, the second pump is configured in parallel with the first pump. In some examples, during the second stage, the second pump is configured in parallel with the first pump. In some examples, the first and second pumps may be configured in a parallel configuration during the first stage, wherein the method further includes switching to a series configuration during the second stage. A series configuration is a configuration in which the first pump is configured in series with respect to the second pump.

[0073] While certain features of the described embodiments have been shown as described herein, those skilled in the art will now be able to make numerous modifications, substitutions, alterations, and equivalents. Therefore, it should be understood that the appended claims are intended to cover all such modifications and alterations falling within the scope of the embodiments.

Claims

1. An expandable penile prosthesis, comprising: A fluid reservoir configured to contain fluid; Expandable components; as well as A pump assembly configured to transfer fluid from the fluid reservoir to the expandable member during an expansion cycle, the pump assembly comprising: A first pump, configured to inject fluid into the expandable member; and A second pump, configured to inject fluid into the expandable member. The sensor is included within the expandable member for monitoring the pressure level within the expandable member, and the pump assembly is configured to move between a parallel configuration and a series configuration, wherein in the parallel configuration, the second pump is connected in parallel with the first pump, and in the series configuration, the second pump is connected in series with the first pump.

2. The expandable penile prosthesis according to claim 1, wherein, The first pump includes a plurality of micropumps, and the second pump includes a plurality of micropumps.

3. The expandable penile prosthesis according to claim 1, wherein, The first pump is configured to inject fluid into the expandable member up to a first maximum output pressure, and the second pump is configured to inject fluid into the expandable member up to a second maximum output pressure, which is higher than the first maximum output pressure.

4. The expandable penile prosthesis according to claim 1, wherein, The second pump is connected in parallel with the first pump.

5. The expandable penile prosthesis according to claim 1, further comprising: A controller configured to actuate multiple valves to move between the parallel configuration and the series configuration.

6. The expandable penile prosthesis according to claim 1, further comprising: A controller configured to activate the first pump during the first phase of the expansion cycle. The controller is configured to activate the second pump during the second phase of the expansion cycle.

7. The expandable penile prosthesis according to claim 6, wherein, The controller is configured to activate the second pump during the second phase of the expansion cycle in response to the pressure level in the expandable member exceeding a threshold level.

8. The expandable penile prosthesis according to claim 1, wherein, The fluid reservoir includes a flexible fluid container disposed within a cavity of the fluid reservoir, the flexible fluid container encapsulating a fluid at a higher pressure than the fluid contained in the fluid reservoir.

9. The expandable penile prosthesis according to claim 8, wherein, At least one of the first pump or the second pump is configured to transfer fluid in the fluid reservoir during a first phase of the expansion cycle, and the fluid contained in the flexible fluid container is transferred to the expandable member during a second phase of the expansion cycle.

10. The expandable penile prosthesis according to claim 8, wherein, After the expansion cycle, the fluid contained in the flexible fluid container is transferred to the expandable member.

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