Leak detection for implantable expansion devices - Patents.com

Abstract

The implantable inflation device includes a fluid reservoir defining a cavity, an inflatable member, an inflation fluid, a pump assembly configured to transport the inflation fluid from the fluid reservoir to the inflatable member, and a circuit for measuring electrical resistance. The pump assembly is configured to transport the inflation fluid from the fluid reservoir to the inflatable member. The circuit is configured to measure electrical resistance between the inflation fluid in the implantable inflation device and the body of a patient in which the implantable inflation device is implanted.

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 / 182,628, entitled "LEAK DETECTION FOR IMPLANTABLE EXPANSION DEVICES," filed March 13, 2023, which claims priority to U.S. Provisional Patent Application No. 63 / 269,431, entitled "LEAK DETECTION FOR IMPLANTABLE EXPANSION DEVICES," filed March 16, 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 / 269,431, filed March 16, 2022, the disclosure of which is incorporated by reference in its entirety herein.

[0003] The present disclosure relates generally to internal implants, and more particularly to detecting fluid leaks in internal implants that include an expandable member, a fluid reservoir, and a pump. [Background technology]

[0004] Implantable expansion devices often include one or more pumps that regulate the flow of fluid between different portions of the implantable device to provide inflation and deflation of one or more fluid-fillable implant components of the device. For example, some implantable expansion devices include an inflatable member, a fluid reservoir, and a pump or pump assembly. In such implantable expansion devices, leaks can occur, causing loss of fluid from within the implantable expansion device, which can adversely affect the effectiveness and / or operation of the implantable expansion device. Thus, a need exists for techniques to detect such leaks. Summary of the Invention [Means for solving the problem]

[0005] According to an aspect, an implantable inflation device includes a fluid reservoir defining a cavity, an inflatable member, an inflation fluid, a pump assembly configured to transport the inflation fluid from the fluid reservoir to the inflatable member, and a circuit for measuring electrical resistance. The pump assembly is configured to transport the inflation fluid from the fluid reservoir to the inflatable member. The circuit is configured to measure electrical resistance between the inflation fluid in the implantable inflation device and a body of a patient in which the implantable inflation device is implanted.

[0006] In some embodiments, the circuit includes a first electrical contact disposed on an exterior surface of the implantable expansion device and a second electrical contact disposed in a fluid passageway of the implantable expansion device, hi some embodiments, the electrical resistance measured by the circuit is the electrical resistance between the first electrical contact and the second electrical contact.

[0007] In some embodiments, the fluid reservoir is fluidly coupled to the pump assembly through a first tubular member and the expandable member is fluidly coupled to the pump assembly through a second tubular member, hi some embodiments, the pump assembly is configured to fluidly isolate the fluid reservoir and the first tubular member from the expandable member and the second tubular member.

[0008] In some embodiments, the second electrical contact is a conductive connector used to fluidly couple one of the first tubular member or the second tubular member with the pump assembly. In some embodiments, the first tubular member and the second tubular member include kink-resistant tubing. In some embodiments, the second electrical contact is disposed on an inner wall of at least one of the first tubular member or the fluid reservoir. In some embodiments, the second electrical contact is disposed on an inner wall of at least one of the second tubular member or the inflatable member. In some embodiments, the circuit includes a third electrical contact disposed on an inner wall of at least one of the first tubular member or the fluid reservoir, the circuit further configured to measure an electrical resistance between the first electrical contact and the third electrical contact. In some embodiments, the circuit is configured to selectively measure an electrical resistance between the first electrical contact and the second electrical contact or an electrical resistance between the first electrical contact and the third electrical contact. In some embodiments, the second electrical contact and the third electrical contact are connected in parallel with each other, and the circuit is configured to selectively measure the electrical resistance between the first electrical contact and the second electrical contact and the third electrical contact connected in parallel.

[0009] In some embodiments, the implantable inflation device includes a housing, and the pump assembly and at least a portion of the circuitry are disposed within the housing. In some embodiments, the first electrical contact is disposed external to the housing. In some embodiments, the housing is the first electrical contact, and the housing includes a conductive material.

[0010] In some embodiments, the inflation fluid comprises saline.In some embodiments, the expandable member is one of an expandable penile prosthesis or an artificial urinary sphincter.

[0011] In some embodiments, the portion of the patient's body is proximate an exterior surface of the implantable expansion device.

[0012] In some embodiments, the implantable inflation device includes a control module configured to activate the pump assembly to transfer inflation fluid from the fluid reservoir to the inflatable member and to deactivate the pump assembly to fluidly isolate the fluid reservoir from the inflatable member, hi some embodiments, the control module is configured to be controlled by a device positioned outside the patient's body.

[0013] In some embodiments, the circuitry is configured to measure a resistance between the first electrical contact and the second electrical contact in response to a signal from a device external to the patient's body.

[0014] According to another aspect, a method for detecting leakage of inflation fluid in an implantable expansion device includes measuring electrical resistance between inflation fluid disposed within the implantable expansion device and the body of a patient in which the implantable expansion device is implanted.

[0015] In some implementations, measuring the electrical resistance includes measuring an electrical resistance between a first electrical contact disposed on an exterior surface of the implantable expansion device and a second electrical contact disposed on an interior surface of the implantable expansion device. In some implementations, the second electrical contact is disposed on one of a fluid reservoir of the implantable expansion device, a first tubular member fluidly coupling the fluid reservoir with a pump assembly of the implantable expansion device, an inflatable member of the implantable expansion device, or a second tubular member fluidly coupling the inflatable member with a pump assembly of the implantable expansion device. In some implementations, the pump assembly is configured to fluidly isolate the fluid reservoir and the first tubular member from the inflatable member and the second tubular member. [Brief description of the drawings]

[0016] [Figure 1] 1 is a schematic diagram of an implantable expansion device according to an embodiment. [Diagram 2] FIG. 13 is a schematic diagram of another implantable expansion device according to an embodiment. [Diagram 3]FIG. 13 is a schematic diagram of another implantable expansion device according to an embodiment. [Figure 4A] 1 is a schematic diagram of an implantable expansion device according to various aspects. [Figure 4B] 1 is a schematic diagram of an implantable expansion device according to various aspects. [Figure 4C] 1 is a schematic diagram of an implantable expansion device according to various aspects. [Diagram 5] 1 illustrates an example of an electronic pump assembly according to an embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] Detailed embodiments are disclosed herein. However, it is understood that the disclosed embodiments are merely examples that may be embodied in various forms. Therefore, the specific structural and functional details disclosed herein should not be interpreted as limiting, but rather as merely a representative basis for teaching those skilled in the art how to use the embodiments in various ways in substantially any appropriately detailed structure. Furthermore, the terms and phrases used herein are not intended to be limiting, but rather to provide an understandable description of the present disclosure.

[0018] 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 a third or more. The terms "including" and / or "having," as used herein, are defined as comprising (i.e., an open transition). The terms "coupled" or "movably coupled," as used herein, are defined as connected, but not necessarily directly and mechanically.

[0019] In general, the embodiments relate to implants in the body. The terms patient or user may be used below for individuals who may benefit from the medical devices or methods disclosed in the present disclosure. For example, a patient may be an individual in whose body a medical device is implanted or an individual on whom the disclosed methods are implemented to operate a medical device according to the present disclosure.

[0020] 1 is a schematic diagram of an implantable inflation device 100 according to an embodiment. Device 100, as well as other exemplary devices described herein, are configured to detect leakage of inflation fluid from device 100, such as from the device's fluid circuitry to an environment external to device 100, such as the body of a patient in which the device is implanted.

[0021] The device 100 includes a fluid reservoir 110, a pump assembly 130, and an inflatable member 150. In some embodiments, the fluid reservoir 110 can be a pressure regulated balloon (PRB). As shown in FIG. 1, the fluid reservoir 110 is operatively or fluidly coupled to the pump assembly 130 through a connecting member 180. The connecting member 180 can be a tubular member such as kink resistant tubing (KRT). In other embodiments, the fluid reservoir 110 is operatively or fluidly coupled to the pump assembly 130 through a different mechanism. Similarly, the inflatable member 150 is operatively or fluidly coupled to the pump assembly 130 through a connecting member 190. The connecting member 190 can be a tubular member such as kink resistant tubing (KRT). In other embodiments, the inflatable member 150 is operatively or fluidly coupled to the pump assembly 130 through a different mechanism.

[0022] Implantable inflation device 100 can be configured to be implanted within a patient's or user's body. For example, in some embodiments, implantable inflation device 100 is a penile implant. In such embodiments, expandable member 150 can be implanted within the patient's or user's corpus cavernosum, fluid reservoir 110 can be implanted within the user's abdominal or pelvic cavity (e.g., fluid reservoir 110 can be implanted in a lower portion of the user's abdominal cavity or an upper portion of the pelvic cavity), and pump assembly 130 and associated control module 170 can be implanted within a portion of the user's body, such as the user's abdomen.

[0023] In other embodiments, implantable expansion device 100 is implanted in different parts of the patient's body and / or for different purposes. For example, in some embodiments, implantable expansion device 100 may be an artificial sphincter, such as an artificial urinary sphincter.

[0024] The pump assembly 130 can include a pump or more than one pump configured to pump fluid from the reservoir 110 into the expandable member 150 during an inflation cycle. In some examples, the pump or pumps can be mechanically and / or programmatically controlled by the control module 170. In some examples, the fluid reservoir 110 can be a PRB, and the pump assembly 130 can include a valve that regulates the flow of inflation fluid from the fluid reservoir 110 to the expandable member 150.

[0025] The expandable member 150 can be expandable upon injection of a fluid into a cavity of the expandable member 150. For example, upon injection of a fluid into the expandable member 150, the expandable member 150 can increase its length and / or width as well as increase its stiffness. In some examples, the expandable member 150 can include a pair of expandable cylinders or at least two cylinders, such as a first cylinder member and a second cylinder member, that can be implanted into the corpus cavernosum of the patient's or user's penis. The volume of the expandable member 150 can depend on the size of the expandable cylinders.

[0026] In some embodiments, the expandable member 150 may comprise a cylindrical cuff or artificial urinary sphincter (AUS) that may be implanted in a patient's body around the junction between the patient's bladder and ureter, e.g., the urethra of such a patient, as a treatment for incontinence. For example, a patient may inflate and deflate the expandable member 150 (AUS) to control urine flow. That is, when the expandable member 150 is in an expanded state, it may block the urethra and inhibit urine flow, while deflating the expandable member 150 allows urine flow and allows the patient to empty their bladder through control of the expandable member 150. In an AUS implementation, the cylindrical cuff may comprise a rigid external backing such that the cuff only expands inward when inflated.

[0027] The fluid reservoir 110 may include a container having an internal cavity or chamber configured to hold or contain a fluid used to inflate the expandable member 150. The volume of the fluid reservoir 110 may vary. In some examples, the volume of the fluid reservoir 110 may be between 3 and 150 cubic centimeters. In some examples, the fluid reservoir 110 is composed of the same material as the expandable member 150, e.g., silicone. In other examples, the fluid reservoir 110 is composed of a different material than the expandable member 150. In some examples, the fluid reservoir 110 may be sized to contain a larger volume of fluid than the expandable member 150.

[0028] In the embodiment illustrated in FIG. 1, the control module 170 is operatively coupled to the pump assembly 130. In some embodiments, the pump assembly 130 and the control module 170 may be integrated into a single component or module and may be included in a common housing that may be implanted in the patient's body. In some embodiments, the control module 170 is configured to start and stop one or more pumps of the pump assembly 130, such as in response to an external controller 177, which may communicate with the control module 170 through a wireless link 178, which may be a bidirectional wireless link. Thus, the control module 170 may be configured to start or stop one or more pumps upon request of the patient or user, for example, in response to a signal from the external controller 177, to control the inflation pressure or state (inflated or deflated state) of the inflatable member 150. In some embodiments, the external controller 177 may be implemented using a smartphone application.

[0029] In an exemplary embodiment, device 100 may also include electrical resistance measurement circuitry, such as an ohmmeter circuit (not explicitly shown in FIG. 1 ). Such resistance measurement circuitry may be included in control module 170 or may be implemented separately from and operatively coupled to control module 170. In an exemplary embodiment, a power source, such as a battery, used to operate pump assembly 130 and / or control module 170 may also be used to operate or provide the resistance measurement circuitry.

[0030] 1, device 100 may also include electrical terminals 112, 152, 182, and 192 operatively (e.g., electrically) coupled to the resistance measurement circuit. In the example of FIG. 1, terminal 112 may be disposed on an inner wall of fluid reservoir 110 such that terminal 112 contacts an inflation fluid, such as saline, disposed within fluid reservoir 110. Similarly, terminals 152, 182, and 192 are disposed, in this example, on inner walls of expandable member 150, connecting member 180, and connecting member 190, respectively, such that they contact an inflation fluid disposed in their respective elements of the fluid circuitry of device 100.

[0031] Further in device 100, terminals 172 are disposed on an exterior surface of device 100 (e.g., outside of the fluid circuitry of device 100), such as on a surface of a housing enclosing control module 170 and / or pump assembly 130. That is, when device 100 is implanted in a patient's body, terminals 172 would be in contact with the patient's body (e.g., the patient's bodily fluids). In some embodiments, the housing enclosing pump assembly 130 and / or control module 170 can include a biocompatible material that is also electrically conductive, such as stainless steel. In such an embodiment, the housing can act as terminals 172. In other embodiments, terminals 172 can be disposed on a non-conductive housing and electrically connected to a resistance measurement circuit disposed in the housing.

[0032] In this example, device 100 can be configured to use its resistance measurement circuitry to measure resistance between terminal 172 and each of the other terminals 112, 152, 182, and 192 to detect whether there is leakage of inflation fluid from the device's fluid circuit into the patient's body, assuming that the inflation fluid in a non-leaking device is electrically isolated from the patient's body or that elements of the fluid circuit insulate the inflation fluid from the environment external to device 100. These respective resistances can be measured together, individually, and / or selectively. In some embodiments, external controller 177 can be configured to communicate with control module 170 (or directly with the resistance measurement circuitry) to initiate one or more such resistance measurements and / or to receive results of such resistance measurements, such as for measurements made automatically by device 100 on a scheduled or continuous basis.

[0033] In this example, if there is no leak between the fluid circuit of device 100 and the inside of the patient's body in which it is implanted, then correspondingly there would be no flow path (or corresponding electrical path) between the inflation fluid in the fluid circuit of device 100 and the patient's body. Thus, in this situation, a resistance measurement between terminal 172 and any or all of terminals 112, 152, 182, and 192 would be considered to indicate an open circuit (i.e., no electrical or fluid path) or near infinite resistance, since no current would be considered to flow between any of terminals 111, 152, 182, and 192 in the fluid circuit and terminal 172 external to the patient's body and the fluid circuit.

[0034] However, in this example, if there is a leak between the fluid circuit and the patient's body, a fluid flow path and corresponding electrical pathway would exist from the inflation fluid in the fluid circuit of device 100 to the patient's body, e.g., a portion of the patient's body proximate the exterior surface of the implanted device. For example, if there is a defect (fluid leak) in fluid reservoir 110, expandable member 150, connecting member 180, connecting member 190, and / or any associated fluid couplings, there would be fluid communication between the inflation fluid inside device 100 and the patient's body, as well as terminal 172.

[0035] For example, with respect to a fluid leak at fluid reservoir 110, connecting member 180, and / or any associated fluid couplings, a resistance measurement between terminal 172 and at least any of terminals 112 and 182 would no longer indicate an open circuit, but rather would instead indicate a finite impedance, with the measured impedance being dependent on the severity of the leak and the impedance of the patient's body between the terminals used when making the resistance measurement. Similarly, with respect to a fluid leak at expandable member 150, connecting member 190, and / or any associated fluid couplings, a resistance measurement between terminal 172 and at least any of terminals 152 and 192 would no longer indicate an open circuit, but rather would indicate a finite impedance, with the measured impedance being dependent on the severity of the leak and the impedance of the patient's body between the terminals used when making the resistance measurement.

[0036] Additionally, in some embodiments, pump assembly 130 can fluidly isolate fluid reservoir 110 and connecting member 180 from expandable member 150 and connecting member 190. In such embodiments, resistance measurements such as those described herein can be used to isolate where the leak occurred, for example, the fluid reservoir 110 side of pump assembly 130 or the expandable member 150 side of pump assembly 130. Isolating the location of the leak can be beneficial in determining treatment progress and / or for repair of device 100 to address and correct the leak.

[0037] FIG 2 is a schematic diagram of another implantable inflation device according to an embodiment. The implantable inflation device of FIG 2 includes a housing 200 having disposed therein, in this example, a pump assembly 230, a control module 270, and a resistance measurement circuit 271. The resistance measurement circuit 271 may include an ohmmeter circuit. As shown in FIG 2, the pump assembly 230 and the resistance measurement circuit 271 are operatively coupled to the control module 270, although other operative couplings may be made depending on the particular embodiment.

[0038] 2 also includes a fluid reservoir 210, which in some embodiments may be a pressure regulated balloon (PRB). In this example implementation, the fluid reservoir 210 may be operatively or fluidly coupled to the pump assembly 230 through a connecting member 280, such as a KRT, that is fluidly coupled to the housing 200, and may then be fluidly coupled to the pump assembly 230 within the housing 200. Additionally, in this example, the at least one cylindrical inflatable member 250 may be operatively or fluidly coupled to the pump assembly 230 through a connecting member 290, which may be a KRT fluidly coupled to the housing 200, and may then be fluidly coupled to the pump assembly 230 within the housing 200.

[0039] Similar to device 100, the implantable expansion device of FIG. 2 can be configured to be implanted within the body of a patient or user. For example, in some embodiments, the implantable expansion device is a penile implant including at least one cylindrical expandable member 250. The expandable member 250 of the device of FIG. 2 can be implanted within the corpus cavernosum of a patient or user, the fluid reservoir 210 can be implanted within the abdominal or pelvic cavity of a user (e.g., the fluid reservoir 210 can be implanted within a lower portion of the abdominal cavity or an upper portion of the pelvic cavity of a user), and the housing 200 including the pump assembly 230, the control module 270, and the resistance measurement circuit 271 can be implanted within a portion of the user's body, such as the user's abdomen.

[0040] As shown in FIG. 2, the exemplary device includes electrical terminals 272 and 292 operatively coupled to a resistance measurement circuit 271. In some embodiments, the electrical terminals 272 can be included in the housing 200, e.g., the housing can be electrically conductive and can act as the electrical terminals 272. In other embodiments, the electrical terminals 272 can be disposed on the housing 200, which can be electrically insulating. The electrical terminals 292 can be disposed on an inner wall of the connection member 290, e.g., in contact with an inflation fluid, such as saline, disposed in the fluid circuit of the device. In this example, the device can use the resistance measurement circuit 271 to measure the resistance between the electrical terminals 272 and 292 to determine if an inflation fluid leak exists from at least one cylindrical expandable member 250 and / or the connection member 290, with an open circuit indicating no leakage and a finite impedance indicating a leakage exists. In some embodiments, other electrical terminals can be included to detect the presence of an inflation fluid leak in other portions of the fluid circuit of the exemplary device.

[0041] Figure 3 is a schematic diagram of another implantable inflation device according to an embodiment. The implantable inflation device of Figure 3 includes a housing 300 having disposed therein, in this example, a pump assembly 330 and a control module 370. In the device of Figure 3, the control module 370 includes an integrated resistance measurement circuit 371, which may be an ohmmeter circuit. As shown in Figure 3, the pump assembly 330 and the control module 370 are operatively coupled to one another, although other operative couplings can be made depending on the particular embodiment.

[0042] The device of Figure 3 includes a fluid reservoir 310, which in some embodiments may be a pressure regulated balloon (PRB). In this example, the fluid reservoir 310 is operatively or fluidly coupled to a pump assembly 330 through a connecting member 380 and a conductive fluid coupler, such as a conductive nipple 382. Further in this example, an inflatable member 350, which in this example is an AUS cuff, is operatively or fluidly coupled to the pump assembly 330 through a connecting member 390 and a conductive fluid coupler, such as a conductive nipple 392.

[0043] Similar to device 100, the implantable inflation device of Fig. 3 can be configured to be implanted within a patient's or user's body. For example, in some embodiments, the implantable inflation device is an AUS that includes an inflatable cuff of inflatable member 350. The inflatable member 350 of the device of Fig. 3 can be implanted such that the inflatable member 350 surrounds the patient's urethra, while the fluid reservoir 310 can be implanted in the abdominal or pelvic cavity of a user (e.g., the fluid reservoir 310 can be implanted in a lower portion of the abdominal cavity or an upper portion of the pelvic cavity of a user), and the housing 300 including the pump assembly 330, the control module 370 can be implanted in a portion of the user's body, such as the user's abdomen.

[0044] As shown in FIG. 3, the exemplary device includes an electrical terminal 372 operatively coupled to a resistance measurement circuit 371. Also in this example, conductive nipples 382 and 392 can embody respective electrical terminals also operatively coupled to integrated resistance measurement circuit 371. In some embodiments, electrical terminal 372 can be included in housing 300, e.g., the housing can be conductive and act as electrical terminal 372. In other embodiments, electrical terminal 372 can be disposed on housing 300, which can be electrically insulating. Because conductive nipple 382 is disposed within connecting member 380 and conductive nipple 392 is disposed within connecting member 390, conductive nipples 382 and 392 are in contact with inflation fluid disposed in the fluid circuit of the device.

[0045] In this example, the device can use resistance measurement circuit 371 to measure the resistance between electrical terminal 372 and electrical terminal 382 to determine if there is an inflation fluid leak from fluid reservoir 310 and / or connecting member 380, with an open circuit indicating no leak and a finite impedance indicating a leak. Also in this example, the device can use resistance measurement circuit 371 to measure the resistance between electrical terminal 372 and electrical terminal 392 to determine if there is an inflation fluid leak from inflatable member 350 and / or connecting member 390, with an open circuit indicating no leak and a finite impedance indicating a leak. In some embodiments, other electrical terminals can be included to detect the presence of inflation fluid leaks in other portions of the fluid circuitry of the example device.

[0046] 4A-4C are schematic diagrams of implantable expansion devices according to various embodiments. The devices shown in FIGS. 4A-4C include similar embodiments as those described above with respect to FIGS. 1-3. Thus, for brevity, these embodiments may not be discussed in detail with respect to FIGS. 4A-4C. For example, the device in FIG. 4A includes a fluid reservoir 410a, a connecting member 480a, an expandable member 450a (AUS), and a connecting member 490a. The device in FIG. 4B includes a fluid reservoir 410b, a connecting member 480b, an expandable member 450b (the expandable cylinder of the penile prosthesis), and a connecting member 490b. The device in FIG. 4C includes a fluid reservoir 410c, a connecting member 480c, an expandable member 450c (AUS), and a connecting member 490c.

[0047] 4A-4C includes a respective control module 470a, 470b, and 470c that may include at least a controller and a pump assembly disposed in a housing. Further, in the example of FIGURES 4A-4C, each of the control modules 470a-470c includes a resistance measurement circuit 471 that may be operatively coupled and / or integrated with the corresponding controller of the respective control module.

[0048] 4A, the exemplary device includes electrical terminals 412a disposed on an inner wall of fluid reservoir 410a, electrical terminals 492a disposed on an inner wall of connecting member 490a, and electrical terminals 472a disposed external to the fluid circuitry of the device, for example, on or as part of a housing of control module 470a. As also shown in FIG. 4A, control module 470a includes a switch 476 that can selectively couple resistance measurement circuit 471 to electrical terminals 412a or electrical terminals 492a.

[0049] In this example, switch 476 can be used to selectively test for the presence or absence of leaks in different portions of the fluid circuit of the exemplary device. For example, if switch 476 is used to selectively couple resistance measurement circuit 471 to electrical terminal 412a, resistance measurement circuit 471 can then be used to measure the resistance between electrical terminal 472a and electrical terminal 412a to determine whether there is an inflation fluid leak from fluid reservoir 410a and / or connecting member 480a to the patient's body, as represented by the resistor connected to electrical terminal 472a. Similarly, if switch 476 is used to selectively couple resistance measurement circuit 471 to electrical terminal 492a, resistance measurement circuit 471 can then be used to measure the resistance between electrical terminal 472a and electrical terminal 492a to determine whether there is an inflation fluid leak from inflatable member 450a and / or connecting member 490a to the patient's body, as represented by the resistor connected to electrical terminal 472a. In some implementations, the switch 476 may be controlled by an external controller, such as the external controller 177 shown in FIG.

[0050] 4B, the exemplary device includes electrical terminals 482b disposed on an inner wall of connecting member 480b, electrical terminals 492b disposed on an inner wall of connecting member 490b, and electrical terminals 472b disposed external to the fluid circuitry of the device, for example, on or as part of a housing of control module 470b. As also shown in FIG. 4B, electrical terminals 482b and electrical terminals 492b are coupled in parallel to resistance measurement circuit 471. Thus, in this example, resistance measurement circuit 471 can be used to simultaneously test for the presence or absence of inflation fluid leakage in fluid reservoir 410b, inflatable member 450b, connecting member 480b, and connecting member 490b. In some implementations, such resistance measurements to test for the presence or absence of inflation fluid leakage can be made in response to commands from an external controller, such as external controller 177 shown in FIG. 1.

[0051] 4C, the exemplary device includes electrical terminal 482c disposed on an inner wall of connection member 480c, electrical terminal 492c disposed on an inner wall of connection member 490c, and electrical terminal 472c disposed externally to the fluid circuit of the device, for example, on or as part of a housing of control module 470c. As also shown in FIG. 4C, control module 470c includes switch 477 and switch 478. Switch 477 can be used to selectively enable or disable resistance measurement by resistance measurement circuit 471. For example, when switch 477 is open, resistance measurement between electrical terminal 472c and any of electrical terminals 482c and 492c is disabled (e.g., not possible). However, when switch 477 is closed, resistance measurement between electrical terminal 472c and any of electrical terminals 482c and 492c is enabled (e.g., possible). When switch 477 is closed, switch 478 can be used to selectively couple resistance measurement circuit 471 to electrical terminal 482c or to electrical terminal 492c.

[0052] That is, in this example, when switch 477 is closed, switch 478 can be used to selectively test for the presence or absence of leaks in different portions of the fluid circuit of the exemplary device. For example, if switch 478 is used to selectively couple resistance measurement circuit 471 to electrical terminal 482c when switch 477 is closed, resistance measurement circuit 471 can be used to measure the resistance between electrical terminal 472c and electrical terminal 482c to determine whether there is an inflation fluid leak from fluid reservoir 410c and / or connecting member 480c to the patient's body, as represented by a resistor connected to electrical terminal 472c. Similarly, when switch 476 is used to selectively couple resistance measurement circuit 471 to electrical terminal 492a when switch 477 is closed, resistance measurement circuit 471 can be used to measure the resistance between electrical terminal 472c and electrical terminal 492c to determine whether there is inflation fluid leakage from inflatable member 450c and / or connecting member 490c to the patient's body, as represented by a resistor connected to electrical terminal 472a. In some implementations, switches 477 and 478 can be controlled by an external controller, such as external controller 177 shown in FIG. 1.

[0053] Figure 5 illustrates an example of a portion of an electronic pump assembly 530 according to an embodiment. Electronic pump assembly 530 may be an example of an electronic pump assembly implemented in combination with electronic pump assembly 130 of Figure 1, electronic pump assembly 230 of Figure 2, electronic pump assembly 330 of Figure 3, and / or control modules 470a, 470b, and 470c of Figures 4A-4C, and may include any of the details discussed with reference to the inflatable devices described herein (e.g., inflatable penile prosthesis, artificial urinary sphincter, etc.).

[0054] The electronic pump assembly 530 is configured to transfer fluid between the fluid reservoir 510 and the inflatable member 550, such as the two inflatable cylinders of an inflatable penile prosthesis. For example, the pump assembly can be configured to transfer fluid from the fluid reservoir 510 to the inflatable member 550 and from the inflatable member to the fluid reservoir. The electronic pump assembly 530 can transfer fluid between the fluid reservoir 510 and the inflatable member 550 through one or more pumps without the user having to manually activate the pump (e.g., squeeze and release the pump bulb). In other exemplary embodiments, the pump assembly can transfer fluid unidirectionally, for example, from the fluid reservoir to the inflatable member or from the inflatable member to the fluid reservoir.

[0055] For example, electronic pump assembly 530 includes pump 520-1 disposed in fluid passage 527 (e.g., a fill passage) and active valve 518 disposed in fluid passage 524 (e.g., an empty passage). Pump 520-1 can be an electromagnetic pump or a piezoelectric pump. Pump 520-1 can include passive check valve 523 and passive check valve 525. Fluid passage 527 can be a separate (and parallel) fluid branch to fluid passage 524. Fluid passage 527 is a passage that transfers fluid from fluid reservoir 510 to expandable member 550. Fluid passage 524 is a passage that transfers fluid from expandable member 550 to fluid reservoir 510. Pump 520-1 is disposed in parallel with active valve 518.

[0056] In some examples, the electronic pump assembly 530 can include an active valve 519 in series with a pump 520-1 (e.g., pump 520-1 and active valve 519 are disposed in fluid passage 527). In some examples, the electronic pump assembly 530 can include a pump 520-2 in series with an active valve 518 (e.g., pump 520-2 and active valve 518 are disposed in fluid passage 524). Pump 520-2 can be an electromagnetic pump or a piezoelectric pump. Pump 520-2 can include a passive check valve 523 and a passive check valve 525. In some examples, the electronic pump assembly 530 includes an active valve 548 fluidly connected with the fluid reservoir 510. The active valve 548 can be in series with either the active valve 518 (and pump 520-2) or the pump 520-1 (and active valve 519). In some examples, electronic pump assembly 530 includes an active valve 552 fluidly connected to expandable member 550. Active valve 552 can be in series with either active valve 519 (and pump 520-1) or pump 520-2 (and active valve 518).

[0057] Active valve 548, pump 520-1, active valve 518, active valve 552, active valve 519, and pump 520-2 may be electronically controlled by a controller and / or driver (e.g., control module 170 of FIG. 1, control module 270 of FIGS. 2A and 2B, control module 370 of FIG. 3, and / or control modules 470a, 470b, 470c of FIGS. 4A-4C). Pump 520-1 and pump 520-2 may be unidirectional or bidirectional. With respect to fluid passage 527, in some examples, pump 520-1 and active valve 519 may be swapped (e.g., active valve 519 is in series between active valve 548 and pump 520-1). With respect to fluid passage 524, in some examples, active valve 518 and pump 520-2 may be swapped (eg, pump 520-1 is in series between active valve 518 and active valve 548).

[0058] In some examples, one or more additional active valves and / or one or more additional pumps are disposed in series in fluid passage 527. In some examples, one or more additional active valves and / or one or more additional pumps are disposed in series in fluid passage 524. In some examples, electronic pump assembly 530 can include one or more additional (and parallel) fluid passages, each additional (and parallel) fluid passage can include one or more active valves and one or more pumps.

[0059] In some examples, electronic pump assembly 530 can include pressure sensor 531 and pressure sensor 532. Pressure sensor 531 and pressure sensor 532 are connected to a controller (e.g., control module 170 of FIG. 1, control module 270 of FIGS. 2A and 2B, control module 370 of FIG. 3, and / or control modules 470a, 470b, and 470c of FIGS. 4A-4C), which receives the measured pressures from pressure sensor 531 and pressure sensor 532, respectively.

[0060] Pressure sensor 531 is configured to measure pressure at inflatable member 550. A controller can receive the measured pressure from pressure sensor 531 and automatically control the active valve and / or pump to adjust the pressure in response. In some examples, pressure sensor 532 is configured to measure pressure at fluid reservoir 510. In some examples, pressure sensor 532 can detect intra-abdominal pressure (which may increase during activities such as exercise) and the controller can control the active valve and pump to minimize or prevent accidental inflation. In some examples, electronic pump assembly 530 can include one or more pressure sensors elsewhere in electronic pump assembly 530. For example, a pressure sensor can be located between active valve 548 and pump 520-1. In some examples, a pressure sensor can be located between pump 520-1 and active valve 519. In some examples, a pressure sensor can be located between active valve 548 and active valve 518. In some examples, a pressure sensor can be located between active valve 518 and pump 520-2. In some examples, the pressure sensor may be located between the expandable member 550 and the active valve 552 .

[0061] While certain features of the described embodiments have been shown as described herein, many modifications, substitutions, changes, 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 changes as fall within the scope of the embodiments. [Explanation of symbols]

[0062] 100 Implantable expansion device 110 Fluid Reservoir 130 Pump Assembly 150 Expandable member 180 Connection parts

Claims

1. 1. An implantable expansion device comprising: a fluid reservoir defining a cavity; an expandable member; An expansion fluid; a pump assembly configured to transport the inflation fluid from the fluid reservoir to the inflatable member; a circuit for measuring electrical resistance, the circuit being configured to measure electrical resistance between the inflation fluid in the implantable inflation device and a portion of a patient's body in which the implantable inflation device is implanted; 16. An implantable expansion device comprising:

2. the circuit includes a first electrical contact disposed on an exterior surface of the implantable expansion device and a second electrical contact disposed in a fluid passageway of the implantable expansion device; The implantable expansion device of claim 1 , wherein the electrical resistance measured by the circuit is the electrical resistance between the first electrical contact and the second electrical contact.

3. the fluid reservoir is fluidly coupled to the pump assembly through a first tubular member; the expandable member is fluidly coupled to the pump assembly through a second tubular member; The implantable expansion device of claim 2 , wherein the pump assembly is configured to fluidly isolate the fluid reservoir and the first tubular member from the expandable member and the second tubular member.

4. The implantable inflation device of claim 3 , wherein the second electrical contact is a conductive connector used to fluidly couple one of the first tubular member or the second tubular member with the pump assembly.

5. The implantable expansion device of claim 3 , wherein the second electrical contact is disposed on an interior wall of at least one of the first tubular member or the fluid reservoir.

6. The implantable expansion device of claim 3 , wherein the second electrical contact is disposed on an interior wall of at least one of the second tubular member or the expandable member.

7. the circuit further includes a third electrical contact disposed on an interior wall of at least one of the first tubular member or the fluid reservoir; The implantable expansion device of claim 6 , wherein the circuit is further configured to measure an electrical resistance between the first electrical contact and the third electrical contact.

8. The circuit comprises: the electrical resistance between the first electrical contact and the second electrical contact; or the electrical resistance between the first electrical contact and the third electrical contact; The implantable expansion device of claim 7 , configured to selectively measure:

9. the second electrical contact and the third electrical contact are connected in parallel with each other; 9. The implantable expansion device of claim 7 or 8, wherein the circuit is configured to selectively measure electrical resistance between the first electrical contact and the parallel-connected second and third electrical contacts.

10. Further comprising a housing; The implantable inflation device of any one of claims 1 to 9, wherein the pump assembly and at least a portion of the circuitry are disposed within the housing.

11. The implantable expansion device of claim 10 , wherein the first electrical contact is disposed on an exterior of the housing.

12. The implantable expansion device of claim 10 , wherein the housing is the first electrical contact, the housing comprising a conductive material.

13. The implantable expansion device of any one of claims 1 to 12, wherein a portion of the patient's body is proximate an exterior surface of the implantable expansion device.

14. 14. The implantable expansion device of claim 1, wherein the expandable member is one of an expandable penile prosthesis or an artificial urinary sphincter.

15. The implantable expansion device of any one of claims 1 to 14, wherein the circuit is configured to measure the electrical resistance between the first electrical contact and the second electrical contact in response to a signal from a device external to the patient's body.

16. 1. An implantable expansion device comprising: a fluid reservoir defining a cavity; an expandable member; An expansion fluid; a pump assembly configured to transport the inflation fluid from the fluid reservoir to the inflatable member; a circuit for measuring electrical resistance, the circuit being configured to measure electrical resistance between the inflation fluid in the implantable inflation device and a portion of a patient's body in which the implantable inflation device is implanted; 16. An implantable expansion device comprising:

17. the circuit includes a first electrical contact disposed on an exterior surface of the implantable expansion device and a second electrical contact disposed in a fluid passageway of the implantable expansion device; 17. The implantable expansion device of claim 16, wherein the electrical resistance measured by the circuit is the electrical resistance between the first electrical contact and the second electrical contact.

18. the fluid reservoir is fluidly coupled to the pump assembly through a first tubular member; the expandable member is fluidly coupled to the pump assembly through a second tubular member; 20. The implantable expansion device of claim 17, wherein the pump assembly is configured to fluidly isolate the fluid reservoir and the first tubular member from the expandable member and the second tubular member.

19. 20. The implantable inflation device of claim 18, wherein the second electrical contact is a conductive connector used to fluidly couple one of the first tubular member or the second tubular member with the pump assembly.

20. 20. The implantable expansion device of claim 18, wherein the second electrical contact is disposed on an interior wall of at least one of the first tubular member or the fluid reservoir.

21. 20. The implantable expansion device of claim 18, wherein the second electrical contact is disposed on an interior wall of at least one of the second tubular member or the expandable member.

22. the circuit further includes a third electrical contact disposed on an interior wall of at least one of the first tubular member or the fluid reservoir; 22. The implantable expansion device of claim 21, wherein the circuit is further configured to measure an electrical resistance between the first electrical contact and the third electrical contact.

23. The circuit comprises: the electrical resistance between the first electrical contact and the second electrical contact; or the electrical resistance between the first electrical contact and the third electrical contact; 23. The implantable expansion device of claim 22, configured to selectively measure:

24. the second electrical contact and the third electrical contact are connected in parallel with each other; 23. The implantable expansion device of claim 22, wherein the circuit is configured to selectively measure electrical resistance between the first electrical contact and the parallel connected second and third electrical contacts.

25. Further comprising a housing; The implantable inflation device of claim 17 , wherein the pump assembly and at least a portion of the circuit are disposed within the housing.

26. 26. The implantable expansion device of claim 25, wherein the first electrical contact is disposed on an exterior of the housing.

27. 26. The implantable expansion device of claim 25, wherein the housing is the first electrical contact, the housing comprising a conductive material.

28. The implantable expansion device of claim 16 , wherein the portion of the patient's body is proximate an exterior surface of the implantable expansion device.

29. 17. The implantable expansion device of claim 16, wherein the expandable member is one of an expandable penile prosthesis or an artificial urinary sphincter.

30. The method further includes a control module, the control module comprising: activating the pump assembly to transfer the inflation fluid from the fluid reservoir to the expandable member or from the expandable member to the fluid reservoir; and 17. The implantable inflation device of claim 16 configured to stop the pump assembly to fluidly isolate the fluid reservoir from the expandable member.

31. 31. The implantable expansion device of claim 30, wherein the control module is configured to be controlled by a device positioned outside the patient's body.

32. 17. The implantable expansion device of claim 16, wherein the circuit is configured to measure the electrical resistance between the first electrical contact and the second electrical contact in response to a signal from a device external to the patient's body.

33. 1. A method for detecting leakage of inflation fluid in an implantable inflation device, comprising: measuring electrical resistance between the inflation fluid disposed within the implantable inflation device and a portion of the patient's body in which the implantable inflation device is implanted; The method includes:

34. 34. The method of claim 33, wherein measuring the electrical resistance comprises measuring the electrical resistance between a first electrical contact disposed on an exterior surface of the implantable expansion device and a second electrical contact disposed on an interior surface of the implantable expansion device.

35. The second electrical contact comprises: a fluid reservoir of the implantable expansion device; a first tubular member fluidly coupling the fluid reservoir with a pump assembly of the implantable inflation device; an expandable member of the implantable expansion device; or a second tubular member fluidly coupling the expandable member with the pump assembly of the implantable expansion device; is placed in one of 35. The method of claim 34, wherein the pump assembly is configured to fluidly isolate the fluid reservoir and the first tubular member from the expandable member and the second tubular member.

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