IMPLANTABLE DEVICE FOR SIZING EXPANDABLE MEMBER - Patent application

Abstract

An implantable device including a fluid reservoir configured to hold a fluid, an expandable member configured to be implanted in a patient's body, and an electronic pump assembly. The electronic pump assembly includes a controller configured to operate at least one of a pump or an active valve to inflate the expandable member, and a pressure sensor configured to monitor a pressure in the expandable member. The controller is configured to detect a value of at least one fluid transfer parameter for a pressure in the expandable member to reach a target pressure during an inflation cycle. The controller is configured to generate size function information of the expandable member for the patient based on the detected value of the at least one fluid transfer parameter.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of and claims priority to U.S. Nonprovisional Patent Application No. 18 / 172,939, entitled "AN IMPLANTABLE DEVICE FOR SIZING AN INFLATABLE MEMBER," filed on February 22, 2023, which claims priority to U.S. Provisional Patent Application No. 63 / 268,647, entitled "AN IMPLANTABLE DEVICE FOR SIZING AN INFLATABLE MEMBER," filed on February 28, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0002] This application also claims priority to U.S. Provisional Patent Application No. 63 / 268,647, filed February 28, 2022, the disclosure of which is incorporated by reference in its entirety herein.

[0003] SUMMARY The present disclosure relates generally to an implantable device having an electronic pump assembly capable of determining sizing information for an expandable member. [Background technology]

[0004] An artificial urinary sphincter device or an inflatable penile prosthesis includes an inflatable member (e.g., a cuff or cylinder). The inflatable member may have a number of different sizes that can be implanted in the patient. For a urinary sphincter device, a tape or cuff sizing tool may be utilized to measure the circumference of the urethra to indicate which cuff size should be used for the procedure. In some cases, the tape is flexible (and the urethral tissue is compressible), which may make sizing and cuff selection relatively difficult. For an inflatable penile prosthesis, a physician may select the size of the cylinder based on visual inspection and the ability to expand the fascia, and a physician may perform the sizing selection in a different manner. An incorrect selection of the size of the inflatable member may lead to poor performance or damage to the patient. Summary of the Invention [Means for solving the problem]

[0005] According to an aspect, an implantable device includes a fluid reservoir configured to hold a fluid, an expandable member configured to be implanted in a patient's body, and an electronic pump assembly. The electronic pump assembly includes a controller configured to operate at least one of a pump or an active valve to inflate the expandable member, and a pressure sensor configured to monitor a pressure in the expandable member. The controller is configured to detect a value of at least one fluid transfer parameter for a pressure in the expandable member to reach a target pressure during an inflation cycle. The controller is configured to generate size function information of the expandable member for the patient based on the detected value of the at least one fluid transfer parameter.

[0006] According to some aspects, the implantable device can include one or more features (or any combination thereof). The size function information indicates whether a size of the expandable member is compatible with the patient. The size function information indicates a sizing option for the expandable member for the patient. The controller is configured to transmit the size function information to an external device. The controller includes a memory device that stores the sizing information, the sizing information defining at least one sizing option, the at least one sizing option being mapped to a value range of the at least one fluid transfer parameter. The controller is configured to determine the size function information based on whether the detected value falls within the value range of the at least one fluid transfer parameter. The at least one fluid transfer parameter includes a time duration for achieving the target pressure. The at least one fluid transfer parameter includes a volume of fluid transferred to the expandable member to achieve the target pressure. The at least one fluid transfer parameter includes a pump flow rate required to achieve the target pressure within a predetermined amount of time.

[0007] According to an aspect, an implantable device includes a fluid reservoir configured to hold a fluid, an expandable member, and an electronic pump assembly. The electronic pump assembly includes a controller configured to operate at least one of a pump or an active valve to expand the expandable member. The controller includes a memory device that stores sizing information. The sizing information defines one or more of a plurality of sizing options. Each sizing option is mapped to a value range of at least one fluid transfer parameter. The electronic pump assembly includes a pressure sensor configured to monitor a pressure of the expandable member. The controller is configured to detect a value of the at least one fluid transfer parameter for a pressure of the expandable member to reach a target pressure during an inflation cycle. The controller is configured to select a sizing option from the plurality of sizing options based on the detected value of the at least one fluid transfer parameter.

[0008] According to some aspects, the implantable device can include one or more features (or any combination thereof). The plurality of sizing options includes a first sizing option and a second sizing option. The first sizing option is mapped to a first range of values. The second sizing option is mapped to a second range of values. The controller is configured to select the first sizing option in response to the detected value falling within the first range of values. The at least one fluid transfer parameter includes a time duration to achieve the target pressure, a volume of fluid transferred to the expandable member to achieve the target pressure, or a pump flow rate required to achieve the target pressure within a predetermined amount of time. The controller is configured to detect a performance problem event based on a value of the at least one fluid transfer parameter for a pressure of the expandable member to reach the target pressure during an inflation cycle. The controller is configured to detect a tissue atrophy event based on a value of the at least one fluid transfer parameter for a pressure of the expandable member to reach the target pressure during an inflation cycle. The implantable device includes a urethral sphincter device. The implantable device includes an inflatable penile prosthesis. The controller is configured to transmit the selected sizing option to an external device for display.

[0009] According to an aspect, a method for determining size capability information for an implantable device includes activating at least one of a pump or an active valve of an electronic pump assembly to transfer fluid from a fluid reservoir to an expandable member implanted in a patient during an inflation cycle, monitoring a pressure of the expandable member within the patient's body with a pressure sensor of the electronic pump assembly, detecting a value of at least one fluid transfer parameter for the pressure of the expandable member to reach a target pressure during an inflation cycle, and generating size capability information for the expandable member for the patient based on the detected value of the at least one fluid transfer parameter. In some examples, the method can include transmitting the size capability information to an external device. The size capability information indicates at least one of whether a size of the expandable member is compatible with the patient or sizing options for the expandable member for the patient. [Brief description of the drawings]

[0010] [Figure 1A] FIG. 1 illustrates an implantable device having an electronic pump assembly according to an embodiment. [Figure 1B] FIG. 1 illustrates a controller for an electronic pump assembly according to an embodiment. [Figure 1C] 11A-11C illustrate examples of sizing information used to determine size function information according to an embodiment. [Diagram 2] FIG. 13 illustrates a pressure profile depicting sizing information for multiple sizing options according to an embodiment. [Diagram 3] 11A-11C show pressure profiles depicting sizing information indicating whether an expandable member according to an embodiment will fit a patient. [Figure 4] FIG. 13 shows a pressure profile depicting sizing information for the expandable member of a penile prosthesis according to an embodiment. [Diagram 5] 11A-11C show pressure profiles depicting tissue atrophy events for an expandable member according to an embodiment. [Figure 6]11 is a flow chart illustrating an example operation of generating size capability information for an expandable member of an implantable device according to an aspect. [Figure 7] FIG. 1 illustrates an example of a urethral control device according to an embodiment. [Figure 8] FIG. 1 illustrates an example of an inflatable penile prosthesis according to an embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] The present disclosure relates to an implantable device that can automatically determine size capability information for an expandable member that is to be implanted in a patient's body. In some examples, the size capability information can indicate whether a size of the expandable member is compatible with the patient. In some examples, the size capability information can indicate sizing options for the expandable member for the patient. The size capability information can be transmitted to an external device for display.

[0012] In some examples, the implantable device is an artificial urinary sphincter device. In some examples, the implantable device is an inflatable penile prosthesis. The implantable device can include an inflatable member, an electronic pump assembly, and a fluid reservoir. The electronic pump assembly can transfer fluid between the fluid reservoir and the inflatable member without a user manually activating a pump bulb (pump valve).

[0013] The electronic pump assembly may include a controller, one or more active valves, one or more pumps, and one or more pressure sensors. The controller may receive pressure readings from the pressure sensor and control the pump and active valve to maintain and / or adjust the pressure of the inflatable member. The controller may send control signals to the pump and active valve to inflate or deflate the inflatable member. In some examples, control of the inflation and deflation states is based on wireless signals received from an external device (and the detected pressure of the inflatable member from the pressure sensor) that is actuated by the patient. For example, the patient may use the external device to inflate or deflate the inflatable member, which in turn will send commands to the controller on the electronic pump assembly.

[0014] The controller can include a sizing module configured to generate size capability information that can indicate whether the size of the expandable member is compatible with the patient and / or indicate sizing options for the expandable member for the patient.

[0015] The inflatable member can be implanted in the patient. In some examples, the implanted inflatable member can have a particular size (e.g., one of the sizing options). In some examples, the implanted inflatable member is a test member having a size large enough to encompass multiple sizing options. In some examples, the electronic pump assembly and fluid reservoir are also implanted in the patient's body. In some examples, the electronic pump assembly and / or fluid reservoir are not implanted in the patient's body to determine the sizing options for the patient.

[0016] To determine the size function information, the controller can actuate at least one of the pump or the active valve to inflate the inflatable member. For example, the controller can receive a wireless signal from an external device to initiate an inflation cycle, whereby the controller sends a control signal to the pump and / or the active valve to transfer fluid to the inflatable member. The controller can detect values ​​of at least one fluid transfer parameter for the pressure of the inflatable member to reach a target pressure during an inflation cycle. In some examples, the at least one fluid transfer parameter is a time duration to achieve the target pressure. In some examples, the at least one fluid transfer parameter is a volume of fluid transferred to the inflatable member to achieve the target pressure. In some examples, the at least one fluid transfer parameter is a pump flow rate required to reach the target pressure in a predetermined length of time. In some examples, the at least one fluid transfer parameter includes multiple parameters, such as time, volume, and / or pump flow rate, in which case the controller detects values ​​for time, volume, and / or pump flow rate and examines the sizing information to see which sizing options map to the time, volume, and / or pump flow rate. For example, the time, pump flow rate, or range of fluid volumes required to reach a target pressure can be used to size the inflatable member.

[0017] The controller can include sizing information that defines one or more sizing options that each map to a range of values ​​for the fluid transfer parameter. For example, the sizing information can indicate a first range of values ​​for reaching the target pressure for a first size option, a second range of values ​​for reaching the target pressure for a second size option, a third range of values ​​for reaching the target pressure for a third size option, and similar ranges of values.

[0018] In some examples, an inflatable member having a first size option can be implanted in a patient. The controller can detect values ​​of fluid transfer parameters (e.g., time, transferred fluid volume, or pump flow rate) for the pressure of the inflatable member to reach a target pressure during an inflation cycle and use the sizing information to determine whether the inflatable member having the first size option is compatible with the patient. If the detected value is outside of a range associated with the first sizing option, the size function information can indicate that the first sizing option is not compatible with the patient. In this case, another inflatable member having a second sizing option can be implanted in the patient to determine whether the second sizing option is compatible with the patient. If the detected value is within a range associated with the second sizing option, the size function information can indicate that the second sizing option is compatible with the patient.

[0019] In some examples, the inflatable member can have a size large enough to encompass multiple different sizing options (e.g., a test inflatable member), and the test inflatable member can be implanted into the patient's body. The controller can detect values ​​of fluid transfer parameters (e.g., time, transferred fluid volume, or pump flow rate) for the pressure of the inflatable member to reach a target pressure during an inflation cycle, and use the sizing information to determine and select a sizing option appropriate for the inflatable member. The test inflatable member can then be removed, and an inflatable member having the selected sizing option can be implanted into the patient's body. These and other features are described in further detail with reference to the figures.

[0020] 1A-1C show an implantable device 100 according to an embodiment. In some examples, the implantable device 100 is an artificial urinary sphincter device. In some examples, the implantable device 100 is an inflatable penile prosthesis. However, the implantable device 100 can include any type of medical device that transfers fluid between components of the implantable device 100.

[0021] The implantable device 100 can automatically determine size capability information 174 of the expandable member 104 implanted in the patient's body. In some examples, the size capability information 174 can indicate whether the size of the expandable member 104 is compatible with the patient. In some examples, the size capability information 174 can indicate sizing options 156 for the expandable member 104 for the patient. The size capability information 174 can be transmitted to the external device 101. In some examples, the external device 101 includes a display 175 that displays the size capability information 174.

[0022] Implantable device 100 includes a fluid reservoir 102 , an expandable member 104 , and an electronic pump assembly 106 configured to transfer fluid between the fluid reservoir 102 and the expandable member 104 .

[0023] The fluid reservoir 102 may include a container having an internal chamber configured to hold or store a fluid used to inflate the expandable member 104. In some examples, the fluid reservoir 102 is pressurized. In some examples, the fluid reservoir 102 is a pressurized balloon. In some examples, the implantable device 100 includes a single pressurized balloon. In some examples, the implantable device 100 includes two or more pressurized balloons. In some examples, when the active valve 118 is in an open position, a pressure differential between the expandable member 104 and the fluid reservoir 102 causes a portion of the fluid to flow from the fluid reservoir 102 to the expandable member 104. In some examples, the pump 120 is activated to transfer the fluid to the expandable member 104.

[0024] The volume capacity of the fluid reservoir 102 may vary depending on the size of the implantable device 100. In some examples, the volume capacity of the fluid reservoir 102 may be between 3 cubic centimeters and 150 cubic centimeters. In some examples, the fluid reservoir 102 is composed of the same material as the expandable member 104. In other examples, the fluid reservoir 102 is composed 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.

[0025] The implantable device 100 may include a first conduit connector 103 and a second conduit connector 105. The first conduit connector 103 and the second conduit connector 105 may each define a lumen configured to transfer fluid to and from the electronic pump assembly 106. The first conduit connector 103 may be coupled to the electronic pump assembly 106 and the fluid reservoir 102 such that fluid may be transferred therethrough between the electronic pump assembly 106 and the fluid reservoir 102. For example, the first conduit connector 103 may define a first lumen configured to transfer fluid between the electronic pump assembly 106 and the fluid reservoir 102. The first conduit connector 103 may include a single or multiple tubing members for transferring fluid between the electronic pump assembly 106 and the fluid reservoir 102.

[0026] The second conduit connector 105 can be coupled to the electronic pump assembly 106 and the expandable member 104 such that fluid can be transferred therethrough between the electronic pump assembly 106 and the expandable member 104. For example, the second conduit connector 105 can define a second lumen configured to transfer fluid between the electronic pump assembly 106 and the expandable member 104. The second conduit connector 105 can include a single or multiple tubing members for transferring fluid between the electronic pump assembly 106 and the expandable member 104. In some examples, the first conduit connector 103 and the second conduit connector 105 can include a silicone rubber material. In some examples, the electronic pump assembly 106 can be directly connected to the fluid reservoir 102.

[0027] The electronic pump assembly 106 can automatically transfer fluid between the fluid reservoir 102 and the expandable member 104 without a user having to manually activate the pump (e.g., squeezing and releasing a pump bulb). The electronic pump assembly 106 can control and regulate the pressure 153 within the expandable member 104.

[0028] The electronic pump assembly 106 may include a controller 114, one or more active valves 118, one or more pumps 120, and a pressure sensor 130 (or multiple pressure sensors). The controller 114 may control the pump 120 and the active valve 118 to move fluid between the expandable member 104 and the fluid reservoir 102 to transition the expandable member 104 between an inflated state and a deflated state. The pressure sensor 130 may monitor the pressure 153 in the expandable member 104. The controller may receive pressure readings from the pressure sensor 130 and control the pump 120 and the active valve 118 to maintain and / or adjust the pressure 153 in the expandable member 104. The controller 114 may send control signals to the pump 120 and the active valve 118 to inflate or deflate the expandable member 104.

[0029] In some examples, the electronic pump assembly 106 can include additional pressure sensors, including those that can be positioned at various locations therein to monitor the pressure of the fluid reservoir 102. The pressure sensor 130 can be communicatively coupled to the controller 114 such that the controller 114 can receive a signal (e.g., a pressure reading) from the pressure sensor 130.

[0030] The electronic pump assembly 106 can include a battery 116 configured to power the controller 114 and other components on the electronic pump assembly 106. In some examples, the battery 116 is a non-rechargeable battery. In some examples, the battery 116 is a rechargeable battery. In some examples, the electronic pump assembly 106 (or a portion thereof) (or the controller 114) is configured to be connected to an external charger to charge the battery 116. In some examples, the electronic pump assembly 106 can define a charging interface configured to connect to the external charger. In some examples, the charging interface includes a Universal Serial Bus (USB) interface configured to accept a USB charger. In some examples, the charging technology can be electromagnetic or piezoelectric.

[0031] The electronic pump assembly 106 can include an antenna 112 configured to wirelessly transmit (and receive) a radio signal 109 to (and from) the external device 101. The external device 101 can be any type of component capable of communicating with the electronic pump assembly 106. The external device 101 can be a computer, a smart phone, a tablet, a pendant, a key fob, etc. A user can control the implantable device 100 using the external device 101. In some examples, a user can use the external device 101 to inflate or deflate the expandable member 104.

[0032] The external device 101 can communicate with the electronic pump assembly 106 over a network. In some examples, the network can include a short-range wireless network, such as Near Field Communication (NFC), Bluetooth, or infrared communication. In some examples, the network can include the Internet (e.g., Wi-Fi) and / or other types of data networks, such as a local area network (LAN), a wide area network (WAN), a cellular network, a satellite network, or other types of data networks.

[0033] The controller 114 can be any type of controller configured to control the operation of the pump 120 and the active valve 118. In some examples, the controller 114 is a microcontroller. In some examples, the controller 114 includes one or more drivers configured to drive the pump 120 and the active valve 118. In some examples, the drivers are separate components from the controller 114. The controller 114 can be communicatively coupled to the active valve 118, the pump 120, and the pressure sensor 130. In some examples, the controller 114 is connected to the active valve 118, the pump 120, and the pressure sensor 130 through wired data lines. The controller 114 can include a processor 113 and a memory device 115.

[0034] The processor 113 may be formed in a substrate configured to execute one or more machine executable instructions or some software, firmware, or a combination thereof. The processor 113 may be semiconductor based, i.e., the processor may include semiconductor materials capable of executing digital logic. The memory device 115 may store information in a format that the processor 113 may read and / or execute. The memory device 115 may store executable instructions that, when executed by the processor 113, cause the processor 113 to perform certain operations discussed herein. The controller 114 may receive data through the pressure sensor 130 and / or the external device 101 and control the active valve 118 and / or the pump 120 by sending control signals thereto.

[0035] The memory device 115 can store control parameters that a user and / or physician can set or modify by using the external device 101. In some examples, the control parameters can include a target pressure 154 used to determine the size function information 174. In some examples, the control parameters can include a target inflation pressure and / or a partial inflation pressure. In some examples, the target inflation pressure is a maximum (or desired) pressure allowable in the expandable member 104. In some examples, the partial inflation pressure is a pressure threshold at which the expandable member 104 is deflated. In some examples, the partial inflation pressure is zero PSI. In some examples, the partial inflation pressure is a value greater than zero PSI but less than the target inflation pressure. A user or physician can update the control parameters using the external device 101, which can be communicated to the controller 114 through the antenna 112 and then updated in the memory device 115.

[0036] The inflatable member 104 can be implanted (e.g., temporarily implanted, permanently implanted) in the patient's body. For example, the inflatable member 104 can be implanted around the urethra when it is an inflatable cuff member. The inflatable cuff member can have an inflated state that constricts the urethra (e.g., to provide a continence function) and a contracted state that does not constrict the urethra (allowing urination). If the size (e.g., diameter) of the inflatable cuff member is too small for the patient, the inflatable cuff member may constrict the urethra even in the contracted state, which may cause the patient to strain during urination, causing urine retention in the bladder, or in some cases leading to urinary retention. If the size of the inflatable cuff member is too large, the inflatable cuff member may move to an unexpected location on the urethra.

[0037] The expandable member 104, when it is an expandable cylinder (or a pair of expandable cylinders), is designed to be implanted within the corpus cavernosum and to produce a rigid erect penis when expanded. The expandable member 104 can expand to a state where tension develops within the walls of the cylinder when expanded, giving the cylinder rigidity (and may not rely on fascia to generate rigidity). If the size (e.g., diameter) of the cylinder within the corpus cavernosum is too large, it may not be possible to achieve the desired expansion before contacting the fascia (thereby failing to reach the desired rigidity of the expandable member). If the size of the cylinder within the corpus cavernosum is too small, it may be possible to develop rigidity but not achieve closeness of the expandable member 104 to the implanted tissue (thereby potentially compromising performance results and compromising the cosmetic appearance of the expandable member).

[0038] 1B, the controller 114 includes a sizing module 140 configured to generate size function information 174 that can indicate whether the size of the expandable member 104 is compatible with the patient and / or the sizing options 156 for the expandable member 104 relative to the patient. For example, the expandable member 104 can be implanted within the patient. In some examples, the size of the implanted expandable member 104 is one of the sizing options 156. In some examples, the expandable member 104 is a test member having a size large enough to encompass multiple sizing options 156.

[0039] To determine the size capability information 174, the expandable member 104 is implanted in the patient's body. In some examples, the electronic pump assembly 106 and the fluid reservoir 102 are also implanted in the patient's body. In some examples, the fluid reservoir 102 may be implanted in the abdominal or pelvic cavity of the user (e.g., the fluid reservoir 102 may be implanted in a lower portion of the user's abdominal cavity or an upper portion of the user's pelvic cavity). In some examples, at least a portion of the electronic pump assembly 106 may be embodied in the patient's body. In some examples, to determine the size capability information 174, the electronic pump assembly 106 and / or the fluid reservoir 102 are not implanted in the patient's body.

[0040] To determine the size function information 174, the controller 114 can actuate at least one of the pump 120 or the active valve 118 to inflate the expandable member 104. For example, the controller 114 can receive a wireless signal 109 from the external device 101 to initiate an inflation cycle, whereby the controller 114 sends a control signal to the pump 120 and / or the active valve 118 to transfer fluid to the expandable member 104.

[0041] The controller 114 can control the pump 120 to pump fluid between the expandable member 104 and the fluid reservoir 102. The controller 114 can control the active valve 118 to transition between an open position (fluid is allowed to flow through the active valve 118) and a closed position (fluid is prevented from flowing through the active valve 118). In some examples, the controller 114 can control the active valve 118 to reach an intermediate position between the open and closed positions where the active valve 118 is partially open.

[0042] For example, in response to a user initiating an inflation cycle with the external device 101 (e.g., selecting a user controller on the external device 101), the external device 101 can transmit a wireless signal 109 to the electronic pump assembly 106 (received through the antenna 112) to initiate the inflation cycle, and the controller 114 can control the pump 120 and / or the active valve 118 to enable transfer of fluid from the fluid reservoir 102 to the expandable member 104 until a target pressure of the expandable member 104 is reached. In some examples, the controller 114 can control the active valve 118 to be in an open position such that a pressure differential between the fluid reservoir 102 and the expandable member 104 allows fluid to be transferred to the expandable member 104. In some examples, the controller 114 can control the pump 120 to operate to pump fluid into the expandable member 104. The controller 114 can receive pressure readings from the pressure sensor 130, and when the pressure in the expandable member 104 reaches (or exceeds) the target pressure, the controller 114 can control the active valve 118 to a closed position, thereby maintaining the pressure within the expandable member 104.

[0043] In some examples, in response to a user activating a deflation cycle with the external device 101 (e.g., selecting a user controller on the external device 101), the external device 101 can transmit a wireless signal 109 to the electronic pump assembly 106 (received through the antenna 112) to initiate a deflation cycle, and the controller 114 can control the active valve 118 and / or the pump 120 to transfer fluid from the inflatable member 104 to the fluid reservoir 102. In some examples, the controller 114 can activate the pump 120 to transfer fluid back to the fluid reservoir 102. In some examples, the controller 114 can transition the active valve 118 to an open position to transfer fluid back to the fluid reservoir 102.

[0044] In some examples, during a deflation cycle, the active valve 118 can be in a closed position and the controller 114 can control the pump 120 to pump fluid from the expandable member 104 to the fluid reservoir 102 until the pressure 153 within the expandable member 104 reaches a lower threshold (e.g., zero pounds per square inch (PSI)). For example, the controller 114 can receive pressure readings from the pressure sensor 130, and in response to detecting that the pressure within the expandable member 104 has reached the lower threshold, the controller 114 can control the pump 120 to shut off (e.g., stop pumping).

[0045] In some examples, the electronic pump assembly 106 includes a single pump 120. The pump 120 can be arranged in parallel with the active valve 118. In some examples, the electronic pump assembly 106 includes multiple pumps 120. In some examples, one or more pumps 120 can be arranged in parallel with one another (e.g., parallel pumps). In some examples, one or more pumps 120 can be arranged in series with one another. In some examples, the electronic pump assembly 106 includes one or more parallel pumps, one or more series pumps, or a combination of parallel and series pumps.

[0046] In some examples, the pump 120 is disposed in a fluid passage 125 that is used to empty the expandable member 104 (e.g., during a deflation cycle). In some examples, the fluid passage 125 is used to fill the expandable member 104 (e.g., during an inflation cycle). In some examples, the fluid passage 125 can be used to both fill and empty the expandable member 104. In some examples, the pump 120 is disposed in a fluid passage 124 that is used to fill the expandable member 104 (e.g., during an inflation cycle). In some examples, the fluid passage 124 is used to empty the expandable member 104. In some examples, the fluid passage 124 is used to fill and empty the expandable member 104. In some examples, the electronic pump assembly 108 includes a single fluid passage having one or more pumps 120 and an active valve 118. In some examples, the electronic pump assembly 108 includes more than two fluid passages, each having a pump 120 or an active valve 118 (or both). The fluid path 125 may include one or more pumps 120 and / or one or more active valves 118. The fluid path 124 may include one or more pumps 120 and / or one or more active valves 118.

[0047] The pump 120 is an electronically controlled pump. The pump 120 can be electronically controlled by the controller 114. For example, the pump 120 can be connected to the controller 114 and can receive a signal to operate the pump 120. The pump 120 can be unidirectional, capable of transferring fluid from the fluid reservoir 102 to the expandable member 104 or from the expandable member 104 to the fluid reservoir 102. In some examples, the pump 120 can be bidirectional, capable of transferring fluid from the fluid reservoir 102 to the expandable member 104 and from the expandable member 104 to the fluid reservoir 102.

[0048] In some examples, the pump 120 is an electromagnetic pump that uses electromagnetism to move fluid from the expandable member 104 to the fluid reservoir 102. With an electromagnetic pump, a magnetic field is set at an angle to the direction in which the fluid is moving and the electric current is applied.

[0049] In some examples, the pump 120 is a piezoelectric pump. In some examples, the piezoelectric pump can be a diaphragm micropump that uses actuation of a diaphragm to drive fluid. In some examples, the piezoelectric pump can include one or more piezoelectric pumps (e.g., piezoelectric elements) that can be implemented with a substrate layer of high-voltage piezoelectric elements (e.g., a single substrate layer) or multiple substrate layers of low-voltage piezoelectric elements (e.g., stacked substrate layers). In some examples, the pump 120 includes multiple micropumps (e.g., piezoelectrically driven micropumps) disposed on one or more substrates (e.g., wafers). In some examples, the micropump includes a silicon-based material. In some examples, the micropump includes a metal (e.g., steel)-based material. In some examples, the pump 120 is non-mechanical (e.g., has no moving parts).

[0050] The active valve 118 can be an electronically controlled valve. The active valve 118 can be electronically controlled by the controller 114. For example, the active valve 118 can be connected to the controller 114 and can receive a signal to transition the active valve 118 between an open position where fluid flows through the active valve 118 and a closed position where fluid is prevented from flowing through the active valve 118. In some examples, the active valve 118 can be actuated to an intermediate position between the open and closed positions where the active valve 118 is partially open. When the active valve 118 is in the partially open position, fluid flows through the valve at a rate lower than the fluid transfer rate of a fully open valve.

[0051] In some examples, the active valve 118 is disposed in a fluid passage 124 that is used to fill (e.g., in an inflation cycle) the expandable member 104. In some examples, the active valve 118 can be transitioned to a closed position to retain (e.g., substantially retain) pressure within the expandable member 104. In some examples, the active valve 118 can be transitioned to an open position to transfer fluid back to the expandable member 104.

[0052] In some examples, the electronic pump assembly 106 includes a single active valve 118. In some examples, the electronic pump assembly 106 includes multiple active valves 118. In some examples, one or more additional active valves 118 can be in series with the pump 120. In some examples, the additional active valves 118 (e.g., the series active valves 118) can be disposed in the fluid path portion 117 connected to the fluid reservoir 102. In some examples, the additional active valves 118 (e.g., the series active valves 118) can be disposed in the fluid path portion 119 connected to the expandable member 104. These additional active valves 118 can reduce leakage when at maximum inflation pressure.

[0053] 1B , the controller 114 can detect a value 150 of a fluid transfer parameter 142 for the pressure 153 of the expandable member 104 to reach a target pressure 154 during an inflation cycle. In some examples, the fluid transfer parameter 142 is a time duration 144 to reach the target pressure 154. In some examples, the fluid transfer parameter is a fluid volume 146 transferred to the expandable member 104 to reach the target pressure 154. In some examples, the fluid transfer parameter 142 is a pump flow rate 147 required to reach the target pressure 154 in a predetermined length of time. For example, the range of time, pump flow rate, or fluid volume required to reach the target pressure 154 can be used to determine the size of the expandable member 104.

[0054] In some examples, the controller 114 can determine a first time at which an inflation cycle is initiated, receive pressure readings from the pressure sensor 130, and determine a second time at which the pressure 153 reaches the target pressure 154. In some examples, the value 150 is the time duration from the first time to the second time. In some examples, the target pressure 154 is a threshold level at which the expandable member 104 contacts tissue. In some examples, the target pressure 154 is a value greater than zero PSI but less than a maximum pressure threshold.

[0055] In some examples, the controller 114 can measure the amount of fluid transferred to the expandable member 104 when an expansion cycle is initiated. In some examples, the pressure sensor 130 can measure the amount of fluid transferred to the expandable member using the pressure readings. After the pressure 153 reaches the target pressure 154, the controller 114 can determine the amount of fluid transferred from a first time when the expansion cycle is initiated to a second time when the pressure 153 reaches the target pressure 154. The value 150 can indicate the volume of fluid transferred from the first time to the second time.

[0056] In some examples, the controller 114 can control the flow rate at which the pump 120 moves fluid therethrough. For example, the controller 114 can operate the pump 120 according to a first pumping flow rate, a second pumping flow rate, a third pumping flow rate, etc. In some examples, the controller 114 can activate the pump 120 at a first time and move fluid to the expandable member 104 according to one of the pumping flow rates until a second time when the pressure 153 reaches the target pressure 154. The value 150 can include the pumping flow rate from the first time to the second time.

[0057] The sizing module 140 may include sizing information 152 that defines one or more sizing options 156 that each map to a value range 158 of the fluid transfer parameter 142. In some examples, the range 158 may be referred to as a window or set of values. A sizing option 156 is a particular size of the expandable member 104. In some examples, the size of the expandable member 104 may be referred to as the diameter of the expandable member 104.

[0058] As shown in FIG. 1C, the sizing information 152 can include a sizing option 156-1 that is mapped to a value range 158-1 of one or more fluid transfer parameters 142. In some examples, each sizing option 156 can be mapped to one fluid transfer parameter 142 or multiple fluid transfer parameters 142 (e.g., both a time range and a volume range). The range 158-1 can include two or more values ​​of the fluid transfer parameter 142 that may be compatible with an expandable member 104 having the sizing option 156-1. The sizing information 152 can include a sizing option 156-2 that is mapped to a value range 158-2 of the fluid transfer parameter 142. The sizing option 156-2 is a different size than the sizing option 156-1. The range 158-2 can include two or more values ​​of the fluid transfer parameter 142 that may be compatible with an expandable member 104 having the sizing option 156-2. The range 158-2 can include values ​​that are different from the values ​​of the range 158-1.

[0059] The sizing information 152 may include a sizing option 156-3 that is mapped to a value range 158-3 of the fluid transfer parameter 142. The sizing option 156-3 is a different size than the sizing option 156-1 or the sizing option 156-2. The range 158-3 may include two or more values ​​of the fluid transfer parameter 142 that may be accommodated for an expandable member 104 having the sizing option 156-3. The range 158-3 may include values ​​that are different from the values ​​in the range 158-1 or the range 158-2. Although three sizing options 156 are shown in FIG. 1C, the sizing information 152 may define ranges 158 for any number of sizing options 156, including one sizing option 156, two sizing options 156, or more than three sizing options 156.

[0060] For example, if the fluid transfer parameter 142 is a time duration 144, the sizing information 152 may indicate a first time window (e.g., range 158-1) for sizing option 156-1 to reach the target pressure 154, a second time window (e.g., range 158-2) for sizing option 156-2, a third time window (e.g., range 158-3) for sizing option 156-3, and similar time windows. Instead of using the time duration 144, the sizing options 156 may map to different ranges of fluid volumes 146 to reach the target pressure 154 or different ranges of pump flow rates 147 to reach the target pressure 154 within a predetermined period of time.

[0061] In some examples, the expandable member 104 having the sizing option 156-1 can be implanted in a patient. The sizing module 140 can detect values ​​150 of the fluid transfer parameters 142 (e.g., time duration 144, fluid volume 146, or pump flow rate 147) for the pressure 153 of the expandable member 104 to reach a target pressure 154 during an inflation cycle and use the sizing information 152 to determine whether the expandable member 104 having the sizing option 156-1 is compatible with the patient.

[0062] If the detected value 150 is outside the range 158-1 associated with sizing option 156-1, then the size capability information 174 may indicate that sizing option 156-1 is not compatible with the patient. Another expandable member 104 having sizing option 156-2 may then be implanted into the patient to determine whether sizing option 156-2 is compatible with the patient. If the detected value 150 is within the range 158-2 associated with sizing option 156-2, then the size capability information 174 may indicate that sizing option 156-2 is compatible with the patient.

[0063] In some examples, the inflatable member 104 can have a size large enough to encompass a number of different sizing options 156 (e.g., a test inflatable member), and the test inflatable member can be implanted into the patient. The controller can detect the values ​​150 of the fluid transfer parameters 142 (e.g., time duration 144, fluid volume 146, or pump flow rate 147) for the pressure 153 of the inflatable member 104 to reach the target pressure 154 during an inflation cycle, and use the sizing information 152 to determine and select the appropriate sizing option 156 for the inflatable member 104. The test inflatable member 104 can then be removed, and the inflatable member 104 with the selected sizing option 156 can be implanted into the patient's body.

[0064] In some examples, the controller 114 includes a device performance detector 170 configured to detect the performance of the implantable device 100 after the expandable member 104 (having an appropriate size) is implanted in the patient's body. The device performance detector 170 can detect a performance problem event based on the value 150 of the fluid transfer parameter 142 for the pressure 153 of the expandable member 104 to reach the target pressure 154 during at least a portion of an inflation cycle. For example, the device performance detector 170 can periodically detect the value 150 while the implantable device 100 is in use and use the sizing information 152 (or other information) to determine whether a performance problem exists in the implantable device 100. For example, if the detected value 150 is outside of a range 158 associated with a sizing option 156 of the expandable member 104, the controller 114 can detect a performance problem event and send a notification to one or more external devices (including the external device 101).

[0065] In some examples, the device performance detector 170 can detect a performance problem event based on pressure readings from the pressure sensor 130. For example, a leak (e.g., a leak event) can be detected based on the pressure readings from the pressure sensor 130. Additionally, pump and active valve performance can be inferred from the pressure readings from the pressure sensor 130. For example, the pressure readings can indicate that the pump 120 and / or the active valve 118 are not working properly. In some examples, the controller 114 can detect a performance problem when the pump takes longer than a threshold amount of time to reach a predetermined pressure. For example, the controller 114 can use the pressure readings from the pressure sensor 130 in conjunction with the time scale or range 158 to detect a performance problem associated with one or more of the pumps 120. In response to detecting a performance problem based on the pressure readings, a notification message can be sent over the network.

[0066] In some examples, the controller 114 includes a tissue atrophy detector 172 configured to detect a tissue atrophy event based on a value 150 of the fluid transfer parameter 142 for the pressure 153 of the expandable member 104 to reach a target pressure 154 during at least a portion of an inflation cycle. In some examples, the tissue atrophy detector 172 can send a notification message over the network to one or more external devices (including the external device 101) when the value 150 is greater than a threshold level, thereby indicating tissue atrophy. In some examples, the controller 114 is configured to detect a tissue damage event (e.g., fascia stretched or ruptured) based on a value 150 of the fluid transfer parameter 142 for the pressure 153 of the expandable member 104 to reach a target pressure 154 during at least a portion of an inflation cycle. In some examples, the controller 114 can send a notification message over the network to one or more external devices (including the external device 101) when the value 150 is greater than a threshold level, thereby indicating tissue damage (e.g., tissue rupture).

[0067] FIG. 2 illustrates a pressure profile 280 depicting sizing information 252 for multiple sizing options, such as sizing option 256-1, sizing option 256-2, sizing option 256-3, and sizing option 256-4. Pressure profile 280 depicts incremental values ​​for pressure on the y-axis and incremental values ​​for a fluid transfer parameter on the x-axis. In pressure profile 280, the fluid transfer parameter is a time duration. However, the fluid transfer parameter can be a fluid volume or a pump flow rate. Sizing option 256-1 is associated with time window 258-1. Sizing option 256-2 is associated with time window 258-2. Sizing option 256-3 is associated with time window 258-3. Sizing option 256-4 is associated with time window 258-4.

[0068] 3 shows a pressure profile 380 depicting sizing information 352 for sizing option 356-1. Pressure profile 380 depicts incremental values ​​for pressure on the y-axis and incremental values ​​for a fluid transfer parameter on the x-axis. In pressure profile 380, the fluid transfer parameter is a time duration. However, the fluid transfer parameter could be a fluid volume or a pump flow rate. Pressure curve 381 depicts an undersized inflatable member and pressure curve 383 depicts an oversized inflatable member. Sizing option 356-1 is associated with a time window 358-1 (e.g., between pressure curve 381 and pressure curve 383).

[0069] FIG. 4 shows a pressure profile 480 depicting sizing information 452 for sizing options for a penile prosthesis. Pressure profile 480 depicts incremental values ​​for pressure on the y-axis and incremental values ​​for a fluid transfer parameter on the x-axis. In pressure profile 480, the fluid transfer parameter is fluid volume. However, the fluid transfer parameter could be time duration or pump flow rate. Pressure curve 481 depicts an oversized inflatable member and pressure curve 483 depicts an appropriately sized inflatable member.

[0070] 5 shows a pressure profile 580 plotting a pressure curve 583 indicative of a tissue atrophy event. In some examples, the tissue atrophy detector 172 of FIGS. 1A-1C can detect a tissue atrophy event using the pressure profile 580. The pressure profile 580 plots incremental values ​​for pressure on the y-axis and incremental values ​​for a fluid transfer parameter on the x-axis. The fluid transfer parameter can be a time duration, a fluid volume, or a pump flow rate. The pressure curve 581 may indicate a properly working (and properly sized) implantable device, while the pressure curve 583 may indicate a potential tissue atrophy event.

[0071] 6 shows a flow chart 600 depicting exemplary operations for sizing an expandable member of an implantable device according to an embodiment. Although flow chart 600 is described with respect to implantable device 100 of FIGS. 1A-1C, the exemplary operations of flow chart 600 may be performed by any of the devices discussed herein.

[0072] Operation 602 includes activating at least one of the pump 120 or active valve 118 of the electronic pump assembly 106 during an inflation cycle to transfer fluid from the fluid reservoir 102 to the expandable member 104. The expandable member 104 is implanted in the patient's body. Operation 604 includes monitoring the pressure 153 of the expandable member 104 within the patient's body with the pressure sensor 130 of the electronic pump assembly 106. Operation 606 includes detecting a value 150 of the fluid transfer parameter 142 for the pressure 153 of the expandable member 104 to reach a target pressure 154 during an inflation cycle. Operation 608 includes generating size capability information 174 of the expandable member 104 for the patient based on the detected value 150 of the fluid transfer parameter 142.

[0073] 7 illustrates a urethral control device 700 having an electronic pump assembly 706 according to an embodiment. The electronic pump assembly 706 may include any of the features of the electronic pump assemblies and implantable devices discussed herein. The urethral control device 700 includes a pump assembly 706, a fluid reservoir 702, and a cuff 704.

[0074] The fluid reservoir 702 may be a pressure regulating inflation balloon or element. The fluid reservoir 702 is in operative fluid communication with the cuff 704 through one or more tubular members 703, 705. The fluid reservoir 702 is made of a polymeric material capable of elastic deformation to reduce the fluid volume therein and push the fluid therefrom into the cuff 704. However, the material of the fluid reservoir 702 may preferably or include a shape memory structure adapted to maintain the fluid reservoir 702 in a generally expanded state while having a relatively constant fluid volume and pressure. In some examples, this constant level of pressure exerted by the fluid reservoir 702 on the cuff 704 will keep the cuff 704 in a desired expanded state when a fluid connection is established between the fluid reservoir 702 and the cuff 704. This is primarily because only a small level of fluid displacement is required to inflate or deflate the cuff 704. In some examples, the fluid reservoir 702 is implanted in the abdominal space.

[0075] A user can control the urethral control device 700 using the external device 701. In some examples, the user can inflate or deflate the cuff 704 using the external device 701. For example, in response to a user initiating an inflation cycle using the external device 701, the external device 701 can send a wireless signal to the electronic pump assembly 706 to initiate an inflation cycle to transfer fluid from the fluid reservoir 702 to the cuff 704 (e.g., by opening an active valve such that pressure in the fluid reservoir 702 moves fluid through the active valve to the cuff 704). In some examples, in response to a user initiating a deflation cycle using the external device 701, the external device 701 can send a wireless signal to the electronic pump assembly 706 to initiate a deflation cycle to pump fluid from the cuff 704 to the fluid reservoir 702.

[0076] FIG. 8 illustrates, in a simplified manner, an inflatable penile prosthesis 800 having an electronic pump assembly 806 according to an embodiment. The electronic pump assembly 806 may include any of the features of the electronic pump assemblies and implantable devices discussed herein. The inflatable penile prosthesis 800 may include an inflatable member 804 (e.g., a pair of inflatable cylinders 810) configured to be implanted within the penis. For example, one of the inflatable cylinders 810 may be disposed on one side of the penis and the other inflatable cylinder 810 may be disposed on the other side of the penis. Each inflatable cylinder 810 may include a first end portion 824, a cavity or expansion chamber 822, and a second end portion 828 having a rear tip 832.

[0077] At least a portion of the electronic pump assembly 806 can be implanted in the patient's body. A pair of conduit connectors 805 can attach the electronic pump assembly 806 to the inflatable cylinder 810 such that the electronic pump assembly 806 is in fluid communication with the inflatable cylinder 810. Similarly, the electronic pump assembly 806 can be in fluid communication with the fluid reservoir 802 through the conduit connector 803. The fluid reservoir 802 can be implanted in the abdomen of the user. The expansion chamber 822 of the inflatable cylinder 810 can be disposed in the penis. The first end portion 824 of the inflatable cylinder 810 can be disposed at least partially in the glans portion of the penis. The second end portion 828 can be implanted in the patient's pubic region PR with the rear tip 832 proximate the pubic bone PB.

[0078] To implant the expandable cylinder 810, the surgeon will first prepare the patient. Often, the surgeon will create an incision, for example, in the penoscrotal region where the base of the penis meets the top of the scrotum. The surgeon can expand the patient's corpus cavernosum from the penoscrotal incision to prepare the patient to receive the expandable cylinder 810. The corpus cavernosum is one of two parallel columns of erectile tissue, e.g., two elongated columns that extend substantially the entire length of the penis, that form the dorsal portion of the body of the penis. The surgeon will also expand two areas of the pubic region to prepare the patient to receive the second end portion 828. The surgeon can measure the length of the corpus cavernosum from the incision and the length of the expanded region of the pubic region to determine the appropriate size of the expandable cylinder 810 to be implanted.

[0079] After the patient is prepared, the inflatable penile prosthesis 800 is implanted in the patient. The tip of the first end portion 824 of each inflatable cylinder 810 can be connected to a suture. The other end of the suture can be connected to a needle (e.g., a Keith needle). The needle is inserted into the incision and into the expanded corpus cavernosum. The needle is then pushed through the glans penis. The surgeon pulls on the suture to retract the inflatable cylinder 810 into the corpus cavernosum. This retraction is performed for each inflatable cylinder 810 of the pair. With the expansion chamber 822 in place, the surgeon can remove the suture from the tip. The surgeon then inserts the second end portion 828. The surgeon inserts the rear end of the inflatable cylinder 810 into the incision and presses the second end portion 828 firmly against the pubic bone PB until each inflatable cylinder 810 is in place.

[0080] A user can control the inflatable penile prosthesis 800 using the external device 801. In some examples, the user can inflate or deflate the inflatable cylinder 810 using the external device 801. For example, in response to a user initiating an inflation cycle using the external device 801, the external device 801 can send a wireless signal to the electronic pump assembly 806 to initiate an inflation cycle and transfer fluid from the fluid reservoir 802 to the inflatable cylinder 810. In some examples, in response to a user initiating a deflation cycle using the external device 801, the external device 801 can send a wireless signal to the electronic pump assembly 806 to initiate a deflation cycle and transfer fluid from the inflatable cylinder 810 to the fluid reservoir 802. In some examples, during a deflation cycle, fluid is transferred back until the pressure in the inflatable cylinder 810 reaches a partial inflation pressure.

[0081] Detailed embodiments have been discussed in this specification. However, it is understood that the disclosed embodiments of the present invention are merely examples that can be embodied in various forms. Therefore, the specific structural and functional details disclosed in this specification should not be interpreted as limiting, but merely as a representative basis for teaching those skilled in the art to further adapt these embodiments to virtually any suitable detailed structure as a basis for the claims. Furthermore, the terms and phrases used in this specification are not limiting, but are intended to provide an understandable description of the disclosure of the present invention.

[0082] The terms "a" or "an," as used herein, are defined as one or more than one. The term "another," as used herein, is defined as at least a second or more. The terms "including" and / or "having," as used herein, are defined as comprising (i.e., an open transition). The terms "coupled" or "movably coupled," as used herein, are defined as a connection, but not necessarily a direct, mechanical connection.

[0083] Generally, the embodiments relate to body implants. In this specification, the terms patient or user can be used for an individual who can benefit from the medical device or method disclosed in the present disclosure. For example, a patient can be an individual whose body is implanted with the medical device or method of operating the same disclosed by the present disclosure.

[0084] While certain features of the described implementations have been illustrated as described herein, many modifications, substitutions, variations, and equivalents will now occur to those of ordinary skill in the art, and it is therefore to be understood that the appended claims are intended to cover all such modifications and variations as fall within the scope of the embodiments. [Explanation of symbols]

[0085] 100 Implantable Devices 104 Expandable member 106 Electronic Pump Assembly 118 Active Valve 120 Pump

Claims

1. a fluid reservoir configured to hold a fluid; an expandable member configured to be implanted in a patient's body; an electronic pump assembly, The electronic pump assembly includes: a controller configured to operate at least one of a pump or an active valve to inflate the inflatable member; and a pressure sensor configured to monitor a pressure in the expandable member; The implantable device, wherein the controller is configured to detect a value of at least one fluid transfer parameter for the pressure in the expandable member to reach a target pressure during an inflation cycle, and the controller is configured to generate size function information of the expandable member for the patient based on the detected value of the at least one fluid transfer parameter.

2. The implantable device of claim 1 , wherein the size capability information indicates whether a size of the expandable member is compatible with the patient.

3. The implantable device of claim 1 or 2, wherein the size capability information indicates sizing options for the expandable member for the patient.

4. The implantable device of any one of claims 1 to 3, wherein the controller is configured to transmit the size capability information to an external device.

5. The implantable device of any one of claims 1 to 4, wherein the controller includes a memory device storing sizing information defining at least one sizing option mapped to a value range of the at least one fluid transfer parameter.

6. The implantable device of claim 5 , wherein the controller is configured to determine the size-function information based on whether the detected value falls within the value range of the at least one fluid transfer parameter.

7. The implantable device of any one of claims 1 to 6, wherein the at least one fluid transfer parameter comprises a time duration for achieving the target pressure.

8. The implantable device of any one of claims 1 to 6, wherein the at least one fluid transfer parameter comprises a volume of the fluid transferred to the expandable member to achieve the target pressure.

9. The implantable device of any one of claims 1 to 6, wherein the at least one fluid transfer parameter comprises a pump flow rate required to achieve the target pressure in a predetermined length of time.

10. The implantable device of any one of claims 1 to 9, wherein the controller is configured to detect a performance problem event based on the value of the at least one fluid transfer parameter for the pressure in the expandable member to reach the target pressure during the expansion cycle.

11. The implantable device of any one of claims 1 to 10, wherein the implantable device comprises a urethral sphincter device.

12. The implantable device of any one of claims 1 to 11, wherein the implantable device comprises an inflatable penile prosthesis.

13. 1. A method for determining size capability information for an implantable device, comprising: activating at least one of a pump or an active valve of an electronic pump assembly to transfer fluid from a fluid reservoir to an expandable member during an inflation cycle, the expandable member being implanted in a patient's body; monitoring the pressure of the inflatable member within the body of the patient with a pressure sensor of the electronic pump assembly; detecting a value of at least one fluid transfer parameter for the pressure in the expandable member to reach a target pressure during the expansion cycle; generating size capability information for the expandable member for the patient based on the sensed value of the at least one fluid transfer parameter; The method includes:

14. The method of claim 13 , further comprising transmitting the size capability information to an external device.

15. The method of claim 13 or 14, wherein the size capability information indicates at least one of whether a size of the expandable member is compatible with the patient or sizing options for the expandable member for the patient.

16. a fluid reservoir configured to hold a fluid; an expandable member configured to be implanted in a patient's body; an electronic pump assembly, The electronic pump assembly includes: a controller configured to operate at least one of a pump or an active valve to inflate the inflatable member; and a pressure sensor configured to monitor a pressure in the expandable member; The implantable device, wherein the controller is configured to detect a value of at least one fluid transfer parameter for the pressure in the expandable member to reach a target pressure during an inflation cycle, and the controller is configured to generate size function information of the expandable member for the patient based on the detected value of the at least one fluid transfer parameter.

17. The implantable device of claim 16 , wherein the size capability information indicates whether a size of the expandable member is compatible with the patient.

18. The implantable device of claim 16 , wherein the size capability information indicates sizing options for the expandable member for the patient.

19. The implantable device of claim 16 , wherein the controller is configured to transmit the size capability information to an external device.

20. The implantable device of claim 16 , wherein the controller includes a memory device that stores sizing information defining at least one sizing option that is mapped to a range of values ​​for the at least one fluid transfer parameter.

21. The implantable device of claim 20 , wherein the controller is configured to determine the size-function information based on whether the detected value falls within the value range of the at least one fluid transfer parameter.

22. The implantable device of claim 16 , wherein the at least one fluid transfer parameter includes a time duration for achieving the target pressure.

23. The implantable device of claim 16 , wherein the at least one fluid transfer parameter includes a volume of the fluid transferred to the expandable member to achieve the target pressure.

24. 17. The implantable device of claim 16, wherein the at least one fluid transfer parameter comprises a pump flow rate required to achieve the target pressure in a predetermined length of time.

25. a fluid reservoir configured to hold a fluid; an expandable member; an electronic pump assembly, The electronic pump assembly includes: a controller configured to operate at least one of a pump or an active valve to inflate the inflatable member, the controller including a memory device storing sizing information defining one or more of a plurality of sizing options, each sizing option being mapped to a range of values ​​for at least one fluid transfer parameter; and a pressure sensor configured to monitor a pressure in the expandable member; The implantable device, wherein the controller is configured to detect a value of the at least one fluid transfer parameter for the pressure in the expandable member to reach a target pressure during an inflation cycle, and the controller is configured to select a sizing option from the plurality of sizing options based on the detected value of the at least one fluid transfer parameter.

26. 26. The implantable device of claim 25, wherein the plurality of sizing options includes a first sizing option and a second sizing option, the first sizing option mapped to a first range of values ​​and the second sizing option mapped to a second range of values, and the controller is configured to select the first sizing option in response to the detected value falling within the first range of values.

27. 26. The implantable device of claim 25, wherein the at least one fluid transfer parameter comprises a time duration to achieve the target pressure, a volume of the fluid transferred to the expandable member to achieve the target pressure, or a pump flow rate required to achieve the target pressure in a predetermined length of time.

28. 26. The implantable device of claim 25, wherein the controller is configured to detect a performance problem event based on the value of the at least one fluid transfer parameter for the pressure in the expandable member to reach the target pressure during the expansion cycle.

29. 26. The implantable device of claim 25, wherein the controller is configured to detect a tissue atrophy event or tissue damage based on the value of the at least one fluid transfer parameter for the pressure in the expandable member to reach the target pressure during the expansion cycle.

30. 26. The implantable device of claim 25, wherein the implantable device comprises a urethral sphincter device.

31. 26. The implantable device of claim 25, wherein the implantable device comprises an inflatable penile prosthesis.

32. 26. The implantable device of claim 25, wherein the controller is configured to transmit the selected sizing option to an external device for display.

33. 1. A method for determining size capability information for an implantable device, comprising: activating at least one of a pump or an active valve of an electronic pump assembly to transfer fluid from a fluid reservoir to an expandable member during an inflation cycle, the expandable member being implanted in a patient's body; monitoring the pressure of the inflatable member within the body of the patient with a pressure sensor of the electronic pump assembly; detecting a value of at least one fluid transfer parameter for the pressure in the expandable member to reach a target pressure during the expansion cycle; generating size capability information for the expandable member for the patient based on the sensed value of the at least one fluid transfer parameter; The method includes:

34. 34. The method of claim 33, further comprising transmitting the size capability information to an external device.

35. 35. The method of claim 33 or 34, wherein the size capability information indicates at least one of whether a size of the expandable member is compatible with the patient or sizing options for the expandable member for the patient.

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