Atrophy detection for tissue occluded by an implantable expansion device

Abstract

The apparatus includes an internal implant configured to be implanted within a patient's body. The internal implant includes an expandable member, a sensor, and a controller. The expandable member is configured to be disposed within a portion of the patient's body and to exert a pressure on the portion of the patient's body. The sensor is operatively coupled to the expandable member and configured to detect a fluid pressure within the expandable member. The controller is configured to receive pressure data from the sensor during a transition between a contracted configuration and an expanded configuration of the expandable member, and to detect a contraction of the portion of the patient's body based on the received pressure data.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of and claims priority to U.S. Non-provisional Patent Application No. 18 / 182,630, entitled "Atrophy Detection for Tissue Occluded by an Implantable Dilation Device," filed March 13, 2023, which claims priority to U.S. Provisional Patent Application No. 63 / 269,433, entitled "Atrophy Detection for Tissue Occluded by an Implantable Dilation Device," filed March 16, 2022, the disclosures of which are incorporated herein by reference in their entirety.

[0002] This application also claims priority to U.S. Provisional Patent Application No. 63 / 269,433, filed March 16, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0003] This disclosure relates generally to body implants, and more particularly to detecting atrophy of tissue within a patient's body occluded by an inflatable implant device. [Background technology]

[0004] Implantable expandable devices placed within a patient's body may include an expandable member configured to occlude the patient's tissue for therapeutic purposes. Such devices, such as artificial urinary sphincter (AUS) devices, may occlude the patient's tissue (e.g., the urethra) for long, continuous periods. This occlusion may sometimes lead to atrophy of the tissue surrounded and / or occluded by the expandable member tissue. In addition to symptoms or complications that may be associated with such tissue atrophy, the therapeutic efficacy of the device may also be reduced or lost entirely, which may require surgical intervention to modify or replace the implantable expandable device. Summary of the Invention [Means for solving the problem]

[0005] In some aspects, the technology described herein relates to an apparatus that includes an internal implant configured to be implanted within a patient's body and including an expandable member, a sensor, and a controller, wherein the expandable member is configured to be positioned within a portion of the patient's body to apply pressure to the portion of the patient's body, the sensor is operatively coupled to the expandable member and configured to detect fluid pressure within the expandable member, and the controller is configured to receive pressure data from the sensor during a transition of the expandable member between a contracted configuration and an inflated configuration, and to detect contraction of the portion of the patient's body based on the received pressure data.

[0006] In some aspects, the technology described herein relates to devices in which an expandable member is configured to apply pressure to a portion of a patient's body when in an expanded configuration.

[0007] In some aspects, the technology described herein relates to an apparatus in which the intracorporeal implant includes a pump, the pump operatively coupled to an expandable member and configured to pump fluid into the expandable member to transition the expandable member from a deflated configuration to an inflated configuration, and the detection of contraction of the portion of the patient's body is based on the amount of time it takes for the pump to transition the expandable member from the deflated configuration to the inflated configuration.

[0008] In some aspects, the technology described herein relates to a device in which the detection of contraction of a portion of a patient's body is further based on comparing the amount of time it takes for the pump to transition the inflatable member from a deflated configuration to an inflated configuration to a baseline inflation time.

[0009] In some aspects, the technology described herein relates to an apparatus in which a baseline inflation time is determined when an intracorporeal implant is implanted in a patient's body.

[0010] In some aspects, the technology described herein relates to an apparatus in which an intracorporeal implant includes a pump, the pump operatively coupled to an expandable member and configured to pump fluid out of the expandable member to transition the expandable member from an inflated configuration to a deflated configuration, and the detection of contraction of the portion of the patient's body is based on the amount of time it takes for the pump to transition the expandable member from the inflated configuration to the deflated configuration.

[0011] In some aspects, the technology described herein relates to a device in which the detection of contraction of a portion of a patient's body is further based on comparing the amount of time it takes for the pump to transition the inflatable member from an inflated configuration to a deflated configuration to a baseline deflation time.

[0012] In some aspects, the technology described herein relates to an apparatus in which a baseline contraction time is determined when an intracorporeal implant is implanted in a patient's body.

[0013] In some aspects, the technology described herein relates to an apparatus in which the intracorporeal implant includes a pump, the pump operatively coupled to an expandable member and configured to pump fluid into the expandable member to transition the expandable member from a deflated configuration to an inflated configuration, and the detection of contraction of the portion of the patient's body is based on the volume of fluid used to transition the expandable member from the deflated configuration to the inflated configuration.

[0014] In some aspects, the technology described herein relates to an apparatus in which a controller is configured to determine a volume of fluid based on a flow rate of a pump.

[0015] In some aspects, the technology described herein relates to a device wherein detecting contraction of a portion of a patient's body is further based on comparing a volume of fluid used to transition the expandable member from a deflated configuration to an inflated configuration to a baseline volume of fluid used to transition the expandable member from a deflated configuration to an inflated configuration determined when the intracorporeal implant is implanted in the patient's body.

[0016] In some aspects, the technology described herein relates to an apparatus in which the intracorporeal implant includes a pump, the pump operatively coupled to the expandable member and configured to pump fluid out of the expandable member to transition the expandable member from an inflated configuration to a deflated configuration, and the detection of contraction of the portion of the patient's body is based on the volume of fluid used to transition the expandable member from the inflated configuration to the deflated configuration.

[0017] In some aspects, the technology described herein relates to an apparatus in which a controller is configured to determine a volume of fluid based on a flow rate of a pump.

[0018] In some aspects, the technology described herein relates to a device wherein detecting contraction of a portion of a patient's body is further based on comparing a volume of fluid used to transition the expandable member from an inflated configuration to a deflated configuration to a baseline volume of fluid used to transition the expandable member from an inflated configuration to a deflated configuration determined when the intracorporeal implant is implanted in the patient's body.

[0019] In some aspects, the technology described herein relates to devices in which the inflatable member is an inflatable cuff.

[0020] In some aspects, the technology described herein relates to devices in which the inflatable cuff is an artificial urinary sphincter.

[0021] In some aspects, the technology described herein relates to a device where the portion of the patient's body is the patient's urethra and pressure applied by an expandable member occludes the lumen of the urethra.

[0022] In some aspects, the techniques described herein relate to methods that include transitioning an expandable member of an intracorporeal implant implanted within a patient's body between a contracted configuration and an expanded configuration, the expandable member being configured to be positioned within and apply pressure to a portion of the patient's body; determining pressure data corresponding to a fluid pressure within the expandable member during the transition; and detecting contraction of the portion of the patient's body based on the pressure data.

[0023] In some aspects, the techniques described herein relate to methods where the transition is from a deflated configuration to an inflated configuration and where the detection of contraction of the portion of the patient's body is based on one of an amount of time for transitioning the expandable member from the deflated configuration to the inflated configuration and a volume of fluid used to transition the expandable member from the deflated configuration to the inflated configuration.

[0024] In some aspects, the techniques described herein relate to methods where the transition is from an inflated configuration to a deflated configuration and where detecting contraction of the portion of the patient's body is based on one of an amount of time to transition the expandable member from the inflated configuration to the deflated configuration and a volume of fluid used to transition the expandable member from the inflated configuration to the deflated configuration. [Brief explanation of the drawings]

[0025] [Figure 1] 1 is a schematic diagram of an implantable expansion device according to an embodiment. [Figure 2A] 10 is a schematic diagram of an implantable expansion device according to an additional aspect. [Figure 2B] 10 is a schematic diagram of an implantable expansion device according to an additional aspect. [Figure 3] 10 is a graph showing a comparison of pressure data during inflation of an implantable device to simulate tissue atrophy according to an embodiment. [Figure 4] 4 is a graph illustrating an approach for detecting tissue atrophy using the data of FIG. 3 after curve smoothing according to an embodiment. [Figure 5] 1 illustrates an example of an electronic pump assembly according to an embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0026] Detailed implementations are disclosed herein. However, it is understood that the disclosed implementations are merely examples that may be embodied in various forms. Therefore, the specific structural and functional details disclosed herein should not be construed as limiting, but rather merely as a basis for the claims and as a representative basis for teaching those skilled in the art how to variously use the implementations 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.

[0027] 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.

[0028] Generally, the implementations relate to implants in the body. The terms patient or user may be used below to refer to an individual 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.

[0029] The implantable expansion devices (internal implants) and related methods described herein, when used for therapeutic purposes, can be used to detect tissue atrophy in a patient that may be caused by such expansion devices. Such tissue atrophy may be the result of occlusion pressure exerted on the tissue by the expandable member of the internal implant. For example, high occlusion pressure may lead to an increased risk of such tissue atrophy. Because current embodiments of the internal implant devices lack the capability for early detection and identification of tissue atrophy, the onset of such atrophy manifests itself through other outward symptoms, such as pain, tissue trauma, and / or loss of therapeutic benefit. In the presence of such outward symptoms, the patient may require surgical intervention to resolve the effects of tissue atrophy, which may then be irreversible.

[0030] The body implants and associated methods described herein can provide early detection of the onset of tissue atrophy, which can facilitate early clinical intervention, such as modifying treatment to prevent further atrophy or potentially reverse detected tissue atrophy. For example, the devices described herein can monitor and adjust the occlusion pressure of an inflatable member. In such embodiments, such monitoring and adjustment of a patient's treatment can also be used to detect and prevent potential urethral atrophy without the need for surgical intervention or for such atrophy to manifest through outward symptoms. In some embodiments, the inflatable member can be an inflatable cuff used as an artificial urinary sphincter (AUS) to occlude a patient's urethra for the treatment of urinary incontinence.

[0031] 1 is a schematic diagram of an implantable expansion device 100 or body implant according to an embodiment. Device 100, like other exemplary devices described herein, is configured to detect potential atrophy of a patient's tissue caused by occlusion pressure applied by an expandable member of device 100.

[0032] Device 100 includes a fluid reservoir 110, a pump assembly 130, and an inflatable member 150. In some embodiments, fluid reservoir 110 can be a pressure-regulated balloon (PRB). As shown in FIG. 1 , fluid reservoir 110 is operatively or fluidly coupled to pump assembly 130 through a connecting member 180. Connecting member 180 can be a tubular member such as kink-resistant tubing (KRT). In other embodiments, fluid reservoir 110 is operatively or fluidly coupled to pump assembly 130 through a different mechanism. Similarly, inflatable member 150 is operatively or fluidly coupled to pump assembly 130 through a connecting member 190. Connecting member 190 can be a tubular member such as kink-resistant tubing (KRT). In other embodiments, inflatable member 150 is operatively or fluidly coupled to pump assembly 130 through a different mechanism.

[0033] 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 an AUS. In such embodiments, inflatable member 150 can be implanted to surround the patient's or user's urethra. Fluid reservoir 110 can be implanted in 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 user's 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. In other embodiments, implantable inflation device 100 is implanted in a different portion of the patient's body and / or for a different purpose.

[0034] Pump assembly 130 can include a pump or more pumps configured to pump fluid from reservoir 110 into inflatable member 150 during an inflation cycle. In some examples, one or more pumps can be mechanically and / or programmatically controlled by control module 170. In some embodiments, fluid reservoir 110 can be a PRB, and pump assembly 130 can include a valve to regulate the flow of inflation fluid from fluid reservoir 110 to inflatable member 150.

[0035] The expandable member 150 can be expandable upon injection of a fluid into the cavity of the expandable member 150. In some embodiments, the expandable member 150 can comprise a cylindrical cuff or AUS that can 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 can inflate and deflate the expandable member 150 (AUS) to control urine flow. That is, when the expandable member 150 is in an inflated state, it can occlude the urethra and inhibit urine flow, while deflating the expandable member 150 allows urine flow and allows the patient to void their bladder through control of the expandable member 150. In an AUS implementation, the cylindrical cuff can include a rigid outer backing so that the cuff only expands inward when inflated.

[0036] The fluid reservoir 110 may include a container having an internal cavity or chamber configured to hold or contain the 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.

[0037] Device 100 also includes a pressure sensor 151, which can be disposed in the fluid passageway of connecting member 190 or otherwise operatively coupled to expandable member 150 or connecting member 190 to sense fluid pressure at expandable member 150. As shown in FIG. 1 , in this example, pressure sensor 151 is operatively coupled to control module 170, which can be configured to receive pressure data from pressure sensor 151 for use in performing the techniques described herein. That is, control module 170 can be configured to receive and monitor the occlusion pressure applied by expandable member 150, determine the amount of time it takes pump assembly 130 to inflate expandable member 150, and / or determine the volume of fluid used to achieve the target occlusion pressure. Control module 170 can also be configured to detect potential tissue atrophy, for example, in the patient's urethra, based on a comparison of the inflation time and / or inflation volume with a baseline value. In some embodiments, the baseline value can be determined when the implant is implanted in the patient's body, can be a value determined by a clinician when modifying a treatment therapy, or the like.

[0038] In some embodiments, control module 170 can be configured to receive and monitor the occlusion pressure applied by expandable member 150 during transition from the inflated configuration to the deflated configuration, determine the amount of time it takes pump assembly 130 to deflate expandable member 150, and / or determine the volume of fluid used to achieve the target deflation pressure. Control module 170 can also be configured to detect potential tissue atrophy, for example, in the patient's urethra, based on a comparison of the deflation time and / or deflation volume with a baseline value. In some embodiments, the baseline value can be determined when the implant is implanted in the patient's body, can be a value determined by a clinician when modifying a treatment therapy, or the like.

[0039] In the illustrated embodiment of FIG. 1 , control module 170 is also operatively coupled to pump assembly 130. In some embodiments, pump assembly 130, control module 170, and / or pressure sensor 151 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, control module 170 is configured to activate and stop one or more pumps of pump assembly 130, such as in response to an external controller 177, which may communicate with control module 170 over a wireless link 178, which may be a bidirectional wireless link. Thus, control module 170 may be configured to activate or stop one or more pumps at the request of a patient or user, for example, in response to a signal from external controller 177, to control the inflation pressure or state (inflated or deflated) of expandable member 150, such as to inflate expandable member 150 to a target occlusion pressure. In some embodiments, external controller 177 may be implemented using a smartphone application.

[0040] 2A and 2B are schematic diagrams of implantable expansion devices according to additional aspects, such as device 200a and device 200b, respectively, which are provided exemplary and for illustrative purposes as embodiments of intracorporeal implants capable of implementing the techniques described herein.

[0041] Referring to FIG. 2A , implantable inflation device 200a includes pressure-regulated balloon 210a, pump assembly 230a, inflatable AUS 250a, and pressure sensor 251a, which can be fluidly coupled to each other as shown. In this example, pressure-regulated balloon 210a acts as a fluid reservoir for device 200a and provides fluid pressure for inflating inflatable AUS 250a, for example, to occlude the patient's urethra. Pump assembly 230a includes pump 232a and valve 234a. When inflatable AUS 250a is inflated with inflation fluid, such as saline, pump 232a can be used to deflate inflatable AUS 250a so that the patient can void their bladder. After the patient voids their bladder, the patient can then indicate that inflatable AUS 250a should be re-inflated, such as using an external controller.

[0042] In device 210a, pressure sensor 251a can be configured to measure the fluid pressure at inflatable AUS 250a to ensure that a target occlusion pressure is applied when inflatable AUS 250a is inflated. For example, pressure sensor 251a can serve as a feedback mechanism for the control module control. The control module can then control both valve 234a and pump 232a to, for example, maintain the target occlusion pressure at inflatable AUS 250a or control deflation of inflatable AUS 250a when requested by the patient.

[0043] Referring to FIG. 2B, device 200b includes a non-pressurizable fluid reservoir 210b, a pump assembly 230b, an inflatable AUS 250b, and a pressure sensor 251b, which can be fluidly coupled to one another as shown. In this example, compared to device 210a of FIG. 2A, pump assembly 230b includes pump 232b, which is used to deflate AUS 250b, and pump 234b, which is used to inflate inflatable AUS 250b. Similar to device 200a, pressure sensor 251b of inflatable AUS 250b can be configured to measure the fluid pressure at inflatable AUS 250b to ensure that a target occlusion pressure is applied. For example, pressure sensor 251b can serve as a feedback mechanism for a control module that can control both pump 232b and pump 234b to maintain a target occlusion pressure within inflatable AUS 250b or to control the deflation of inflatable AUS 250b.

[0044] FIG. 3 is a graph illustrating a comparison of pressure data during inflation of an implantable device simulating tissue atrophy, according to an embodiment, compared to pre-atrophy (baseline). The data shown in FIG. 3 illustrates fluid pressure (cmH2O) over time within a 5-centimeter (cm) internal diameter AUS when inflated using, for example, a pump or PRB to inject inflation fluid into the AUS. In this example, trace 310 illustrates a 5-cm urethral obstruction (e.g., urethral lumen obstruction), which may represent baseline data urethral diameter. Also in FIG. 3, trace 320 illustrates a 4-cm urethral obstruction, which may represent a 5-cm baseline atrophy. The initial negative pressure illustrated by both sets of data in FIG. 3 results from the inflation pump evacuating the AUS such that a vacuum is created in the AUS due to the removal of inflation fluid.

[0045] As also shown by each set of data in FIG. 3 , when inflation begins, the fluid pressure at the AUS rises rapidly to a first plateau (P1 for trace 310 and P2 for trace 320) as inflation fluid is transferred from the corresponding fluid reservoir and pumped into the AUS, e.g., through a pump or as a result of a PRB pressure differential. These plateaus P1 and P2 are at relatively low fluid pressures compared to the target occlusion pressure. That is, the respective fluid pressures during the P1 and P2 plateaus result from the AUS filling with inflation fluid but not yet applying pressure to the respective urethra. Once the AUS is sufficiently filled to begin applying pressure to the respective urethra, the pressure within the AUS begins to rise again until it reaches a second plateau, as shown for both data sets, which corresponds to the final desired occlusion pressure to be applied to the urethra, i.e., the target occlusion pressure.

[0046] For each of the traces in FIG. 3, the respective amount of time spent in the first plateaus P1 and P2 corresponds to the amount of time it takes for the AUS to fill until the point at which the AUS begins to apply pressure to the urethra, e.g., after the initial period of transition from internal negative fluid pressure (vacuum) to positive fluid pressure as the AUS begins to fill with inflation fluid.

[0047] As can be seen by comparing P1 and P2 in the data in FIG. 3, the larger the gap between the uninflated inner diameter of the AUS and the urethra (no gap for trace 310, a 1 cm diameter difference for trace 320), the longer the amount of time spent in the corresponding plateau region. Therefore, configuring the controller to measure the amount of time for each of P1 and P2 (as shown in FIG. 4) and determine the difference between those times can be used as a way to indicate whether any changes, such as tissue atrophy, are occurring over time and with the use of the AUS. For example, if the time spent in the plateau region, e.g., P1, for the AUS at the time of implantation (baseline) is 15 seconds, and the time spent in the plateau region, e.g., P1, for the AUS is consistently 25 seconds three months after implantation, this difference could indicate that atrophy of the obstructing tissue (e.g., the patient's urethra) has occurred.

[0048] In some intracorporeal implant embodiments, referring to the example of FIG. 3 , the amount of atrophy can be determined based on the difference between the baseline volume of fluid used at P1 to achieve the target occlusion pressure and the volume of fluid used at P2 to achieve the target occlusion pressure. Such an approach may be effective for determining the amount of occlusion based on this volumetric difference, since the AUS cuff is typically implemented as a cylinder of known outer diameter and includes a rigid backing so that the volume of fluid used to inflate the AUS can be used to determine its inner diameter. For example, the inflatable portion of the AUS can only inflate inward due to the rigid backing restricting outward expansion. Therefore, the difference between two such inner diameters, e.g., baseline and post-detected atrophy, may correspond to the amount of urethral atrophy, which may be determined by a simple difference in the respective volumes.

[0049] In the data of FIG. 3 , for example, the fluctuations observed in the fluid pressure data during P1 and P2 are at least partially due to the pillow formed when the AUS expands, as well as due to the interaction of the AUS with the surrounding urethral tissue, for example, when the AUS contacts the urethra and then releases and / or shifts until full circumferential coaptation occurs. At this point, the respective fluid pressures at the AUS increase until a final or target occlusion pressure is reached. Despite the noise and environmental artifacts present in the data of FIG. 3 , the data show that the plateau dwell time of P2 is longer than the plateau dwell time of P1, which may indicate atrophy, e.g., a 4 cm atrophied urethral diameter compared to a 5 cm baseline urethral diameter. In embodiments described herein, the control module can be configured to apply curve smoothing to the pressure data captured by the pressure sensor, e.g., the data of FIG. 3 ; such smoothed or curve-fitted pressure data is shown in FIG. 4 . The smoothed data can then be used to identify the potential occurrence of tissue atrophy.

[0050] As mentioned above, Figure 4 is a graph illustrating an approach for detecting tissue atrophy using the data of Figure 3 after curve smoothing according to an embodiment. Traces 400 and 420 are curve fits, i.e., smoothed pressure data, corresponding to traces 310 and 320 of Figure 3, respectively. In Figure 4, lines 415a and 415b are fitted lines for the gradient of fluid pressure within the AUS versus time before and after the initial plateau region P1, respectively, for trace 410. Similarly, lines 425a and 425b are fitted lines for the gradient of fluid pressure within the AUS versus time before and after the initial plateau region P2, respectively, for trace 420. Line 430 is a reference used to approximate or represent plateaus P1 and P2, and also serves as an intersection point for the dashed gradient line. The distance between these two intersections, designated P1a and P2a, can be used to compare how the corresponding tissue, e.g., the patient's urethra, responds over time to the applied therapeutic occlusion pressure and to determine whether atrophy of that tissue is occurring.

[0051] As noted above, times P1a and P2a in FIG. 4 correspond to the time spent in the first plateau region, e.g., the low-pressure state as the AUS fills to the point where it fully contacts the surrounding tissue. A threshold change value can be used to determine whether atrophy is occurring. For example, a 15% increase in time spent in the first plateau region can be used. In this example, an increase in P2a over P1a of less than 15% can be considered atrophy-free, while an increase in P2a over P1a of 15% or more can be considered atrophy-free. In an exemplary embodiment, a control module of the corresponding intracorporeal implant can be configured to notify the patient or physician of a potential atrophy indication. Such notification can occur in a variety of ways, such as by remote communication to the physician over a data network accessible to the controller during device interrogation by the physician. Alternatively, the control module can notify the patient to contact the physician, for example, through an external controller for the intracorporeal implant. Furthermore, even if the atrophy-indicating threshold is not met, trends can be observed and used to predict potential future problems.

[0052] Clearly, the amount of time spent in this plateau region depends on how quickly the AUS is filling. The initial pressure gradient (lines 415a and 425a) shown in FIG. 4 can be used to determine the corresponding fill rate, since very little fluid is required to move from the AUS from a vacuum state to the first plateau. By determining the fill rate of each of the AUS, any corresponding collapse determinations can be adjusted for such differences in fill rate, for example, when comparing the respective amounts of time spent in the plateau region (e.g., P1a and P2a). This adjustment is important when using electronic pumps, since no two pumps will pump at exactly the same rate. Additionally, the efficiency and performance of a given pump may vary over time and use.

[0053] In some embodiments, the determination or detection of recoil may be based on transitioning an expandable member from an expanded configuration to a contracted configuration as described herein, and in such embodiments, it is contemplated that the pressure data used may be pressure data that is substantially the inverse or opposite of the pressure data shown in FIGS.

[0054] 5 illustrates an example of a portion of an electronic pump assembly 530, according to an embodiment. Electronic pump assembly 530, or portions thereof, may be an example of pump assembly 130 of FIG. 1 and / or pump assemblies 230a and 230b of the devices of FIGS. 2A and 2B, respectively, and may include any of the details discussed with reference to the inflatable devices or body implants described herein.

[0055] Electronic pump assembly 530 is configured to transfer fluid between fluid reservoir 510 and inflatable member 550 (e.g., an inflatable AUS cuff). Electronic pump assembly 530 can transfer fluid between fluid reservoir 510 and inflatable member 550 through one or more pumps without a user having to manually actuate the pump (e.g., squeeze and release a pump bulb).

[0056] 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 transports fluid from fluid reservoir 510 to inflatable member 550. Fluid passage 524 is a passage that transports fluid from inflatable member 550 to fluid reservoir 510. Pump 520-1 is disposed in parallel with active valve 518.

[0057] In some examples, electronic pump assembly 530 can include active valve 519 in series with pump 520-1 (e.g., pump 520-1 and active valve 519 are disposed in fluid passage 527). In some examples, electronic pump assembly 530 can include pump 520-2 in series with 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 passive check valve 523 and passive check valve 525. In some examples, electronic pump assembly 530 includes active valve 548 fluidly connected with fluid reservoir 510. Active valve 548 can be in series with either active valve 518 (and pump 520-2) or pump 520-1 (and active valve 519). In some examples, electronic pump assembly 530 includes an active valve 552 fluidly connected to inflatable 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).

[0058] Active valve 548, pump 520-1, active valve 518, active valve 552, active valve 518, and pump 520-2 may be electronically controlled by a controller and / or driver (e.g., control module 170 of FIG. 1 and / or a control module implemented in combination with the devices of FIGS. 2A and 2B). Pump 520-1 and pump 520-2 may be unidirectional or bidirectional. With respect to fluid path 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 path 524, in some examples, active valve 518 and pump 520-2 may be swapped (e.g., pump 520-1 is in series between active valve 518 and active valve 548).

[0059] In some examples, one or more additional active valves and / or one or more additional pumps are disposed in series within fluid passage 527. In some examples, one or more additional active valves and / or one or more additional pumps are disposed in series within fluid passage 524. In some examples, electronic pump assembly 530 can include one or more additional (and parallel) fluid passages, each of which can include one or more active valves and one or more pumps.

[0060] In some examples, such as those described herein, electronic pump assembly 530 can include pressure sensor 531 and pressure sensor 532. Pressure sensor 531 and pressure sensor 532 can be connected to a controller, such as control module 170 of FIG. 1 and / or a control module implemented in combination with the devices of FIGS. 2A and 2B, which can receive measured pressures from pressure sensor 531 and pressure sensor 532, respectively, and use those pressure measurements along with associated fill rate information to detect tissue atrophy in the patient as described herein.

[0061] For example, pressure sensor 531 is configured to measure fluid pressure at inflatable member 550. The controller can receive the measured pressure from pressure sensor 531 and, in response, automatically control the active valve and / or pump to adjust the pressure and / or provide notification regarding the detection of potential tissue atrophy. 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 within 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, the pressure sensor can be located between the active valve 518 and the pump 520-2. In some examples, the pressure sensor may be located between the inflatable member 550 and the active valve 552.

[0062] While certain features of the described implementations have been shown as described herein, many modifications, substitutions, changes, and equivalents will now occur to those skilled in the art. 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.

Claims

1. 1. An apparatus comprising: an intracorporeal implant configured to be implanted within a patient's body, the intracorporeal implant including an expandable member, a sensor, and a controller; the inflatable member is configured to be positioned within the portion of the patient's body to apply pressure to the portion of the patient's body; the sensor is operatively coupled to the expandable member and configured to detect fluid pressure within the expandable member; the controller is configured to receive pressure data from the sensor during a transition of the expandable member between a deflated configuration and an inflated configuration, and to detect contraction of the portion of the body of the patient based on the received pressure data; the intracorporeal implant includes a pump operatively coupled to the expandable member and configured to pump fluid into the expandable member to transition the expandable member from the deflated configuration to an inflated configuration; detecting the contraction of the portion of the patient's body based on an amount of time it takes the pump to transition the inflatable member from the deflated configuration to the inflated configuration; Device.

2. An apparatus, an intracorporeal implant configured to be implanted within a patient's body, the intracorporeal implant including an expandable member, a sensor, and a controller; the inflatable member is configured to be positioned within the portion of the patient's body to apply pressure to the portion of the patient's body; the sensor is operatively coupled to the expandable member and configured to detect fluid pressure within the expandable member; the controller is configured to receive pressure data from the sensor during a transition of the expandable member between a deflated configuration and an inflated configuration, and to detect contraction of the portion of the body of the patient based on the received pressure data; the intracorporeal implant includes a pump operatively coupled to the expandable member and configured to pump fluid out of the expandable member to transition the expandable member from the expanded configuration to the deflated configuration; detecting the contraction of the portion of the patient's body based on an amount of time it takes the pump to transition the inflatable member from the inflated configuration to the deflated configuration; Device.

3. 3. The device of claim 1 or 2, wherein the expandable member is configured to apply pressure to the portion of the body of the patient when in the expanded configuration.

4. detecting the contraction of the portion of the patient's body is further based on comparing the amount of time it takes for the pump to transition the inflatable member from the deflated configuration to the inflated configuration to a baseline inflation time.

10. The apparatus of claim 1.

5. 5. The apparatus of claim 4, wherein the baseline expansion time is determined when the intracorporeal implant is implanted in the body of the patient.

6. detecting the contraction of the portion of the patient's body is further based on comparing the amount of time it takes for the pump to transition the inflatable member from the inflated configuration to the deflated configuration to a baseline deflation time.

3. The apparatus of claim 2.

7. 7. The apparatus of claim 6, wherein the baseline contraction time is determined when the intracorporeal implant is implanted in the body of the patient.

8. the intracorporeal implant includes a pump operatively coupled to the expandable member and configured to pump fluid into the expandable member to transition the expandable member from the deflated configuration to the expanded configuration; detecting the contraction of the portion of the patient's body based on a volume of fluid used to transition the expandable member from the contracted configuration to the expanded configuration; 3. The device according to claim 1 or 2.

9. the controller is configured to determine the volume of fluid based on a flow rate of the pump.

9. The apparatus of claim 8.

10. detecting the contraction of the portion of the patient's body is further based on comparing the volume of fluid used to transition the expandable member from the deflated configuration to the inflated configuration to a baseline volume of fluid used to transition the expandable member from the deflated configuration to the inflated configuration determined when the intracorporeal implant is implanted in the patient's body.

10. The apparatus of claim 9.

11. the intracorporeal implant includes a pump operatively coupled to the expandable member and configured to pump fluid out of the expandable member to transition the expandable member from the expanded configuration to the deflated configuration; detecting the contraction of the portion of the patient's body based on a volume of fluid used to transition the expandable member from the expanded configuration to the deflated configuration; 3. The device according to claim 1 or 2.

12. the controller is configured to determine the volume of fluid based on a flow rate of the pump.

12. The apparatus of claim 11.

13. detecting the contraction of the portion of the patient's body is further based on comparing the volume of fluid used to transition the expandable member from the inflated configuration to the deflated configuration to a baseline volume of fluid used to transition the expandable member from the inflated configuration to the deflated configuration determined when the intracorporeal implant is implanted in the patient's body.

13. The apparatus of claim 12.

14. 3. The device of claim 1 or 2, wherein the inflatable member is an inflatable cuff.

15. 15. The device of claim 14, wherein the inflatable cuff is an artificial urinary sphincter.

16. the portion of the patient's body is the patient's urethra; the pressure applied by the expandable member occludes the lumen of the urethra.

3. The device according to claim 1 or 2.

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