Atrophy detection for tissue occluded by an implantable expansion device - Patent Application 20070233633

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. Nonprovisional Patent Application No. 18 / 182,630, entitled "Atrophy Detection for Tissue Occluded by an Implantable Expansion 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 Expansion 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 by reference in its entirety herein.

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

[0004] An implantable expandable device 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 of time. 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 effect 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, the expandable member 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 operatively coupled to the expandable member and configured to detect fluid pressure within the expandable member, and the controller 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 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 an intracorporeal implant includes a pump, the pump being operatively coupled to an expandable member and configured to pump fluid into the expandable member to transition the expandable member from a contracted configuration to an inflated configuration, and detection of contraction of a portion of a patient's body is based on the amount of time it takes the pump to transition the expandable member from the contracted configuration to the inflated configuration.

[0008] In some aspects, the technology described herein relates to an apparatus where the detection of atrophy 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 expansion 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 detection of contraction of a portion of a 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 an apparatus where 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 an 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 contracted configuration to an inflated configuration, and the detection of contraction of a portion of a patient's body is based on a volume of fluid used to transition the expandable member from the contracted 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 an apparatus wherein the detection of contraction of a portion of the patient's body is further based on a comparison of a volume of fluid used to transition the expandable member from a contracted configuration to an inflated configuration to a baseline volume of fluid used to transition the expandable member from a contracted configuration to an inflated configuration determined when the internal implant is implanted in the patient's body.

[0016] 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 a portion of a patient's body is based on a 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 an apparatus wherein the detection of contraction of a portion of the patient's body is further based on a comparison of 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 internal 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 a device 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 where pressure applied by the expandable member occludes the lumen of the urethra.

[0022] In some aspects, the techniques described herein relate to a method that includes transitioning an expandable member of an internal implant implanted within a patient's body between a contracted configuration and an expanded configuration, where the expandable member is configured to be placed within a portion of the patient's body to apply pressure to the 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 detection of contraction of a portion of a 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 description of the drawings]

[0025] [Figure 1] 1 is a schematic diagram of an implantable expansion device according to an embodiment. [Figure 2A] 1 is a schematic diagram of an implantable expansion device according to an additional aspect. [Figure 2B] 1 is a schematic diagram of an implantable expansion device according to an additional aspect. [Diagram 3] 13 is a graph showing a comparison of pressure data during expansion of an implantable device to simulate tissue atrophy according to an embodiment. [Figure 4] 4 is a graph showing an approach for detecting tissue atrophy using the data of FIG. 3 after curve smoothing according to an embodiment. [Diagram 5] 1 illustrates an example of an electronic pump assembly according to an embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[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 interpreted as limiting, but rather as merely a representative basis for teaching those skilled in the art how to use the implementations in various substantially any appropriately detailed structure. Moreover, 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] In general, the implementations 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.

[0029] The implantable expansion devices (corporeal 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 corporeal implant. For example, high occlusion pressure may lead to an increased risk of such tissue atrophy. Since current embodiments of the corporeal implant devices do not have the capability of early detection and identification of tissue atrophy, the occurrence of such atrophy is manifested through pain, tissue trauma, and / or other outward symptoms such as loss of therapeutic effect. 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 modification of 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 the inflatable member. In such embodiments, such monitoring and adjustment of the 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 the 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 shrinkage of a patient's tissue caused by an occlusion pressure applied by an expandable member of device 100.

[0032] 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.

[0033] The implantable inflation device 100 can be configured to be implanted in a patient's or user's body. For example, in some embodiments, the implantable inflation device 100 is an AUS. In such embodiments, the inflatable member 150 can be implanted to surround the urethra of the patient or user. The fluid reservoir 110 can be implanted in the abdominal or pelvic cavity of the user (e.g., the fluid reservoir 110 can be implanted in a lower portion of the abdominal cavity or an upper portion of the pelvic cavity of the user), and the pump assembly 130 and associated control module 170 can be implanted in a portion of the user's body, such as the user's abdomen. In other embodiments, the implantable inflation device 100 is implanted in a different portion of the patient's body and / or for a different purpose.

[0034] 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 embodiments, the fluid reservoir 110 can be a PRB and the pump assembly 130 can include a valve to regulate the flow of inflation fluid from the fluid reservoir 110 to the expandable 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 include a cylindrical cuff or AUS that can be implanted in a patient's body around the junction between the patient's bladder and ureter, for example, 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 expanded state, it can block the urethra and inhibit urine flow, while deflating the expandable member 150 allows urine flow and allows the patient to void their bladder through the control of the expandable member 150. In an AUS implementation, the cylindrical cuff can include a rigid external backing such 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 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.

[0037] The device 100 also includes a pressure sensor 151 that can be disposed in the fluid passage of the connecting member 190 or can otherwise be operatively coupled to the expandable member 150 or the connecting member 190 to sense the fluid pressure at the expandable member 150. As shown in FIG. 1, in this example, the pressure sensor 151 is operatively coupled to the control module 170, which can be configured to receive pressure data from the pressure sensor 151 for use in performing the techniques described herein. That is, the control module 170 can be configured to receive and monitor the occlusion pressure applied by the expandable member 150, determine the amount of time it takes the pump assembly 130 to inflate the expandable member 150, and / or determine the volume of fluid used to achieve the target occlusion pressure. The 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, the control module 170 can be configured to receive and monitor the occlusion pressure applied by the expandable member 150 during the transition from the inflated configuration to the deflated configuration, determine the amount of time it takes the pump assembly 130 to deflate the expandable member 150, and / or determine the volume of fluid used to achieve the target deflation pressure. The 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 to 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, the control module 170 is also operatively coupled to the pump assembly 130. In some embodiments, the pump assembly 130, the control module 170, and / or the 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, 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 at the 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, such as to inflate the inflatable member 150 to a target occlusion pressure. In some embodiments, the 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] 2A, the implantable inflation device 200a includes a pressure-regulated balloon 210a, a pump assembly 230a, an inflatable AUS 250a, and a pressure sensor 251a, which can be fluidly coupled to one another as shown. In this example, the pressure-regulated balloon 210a acts as a fluid reservoir for the device 200a and provides fluid pressure to inflate the inflatable AUS 250a, for example to occlude the patient's urethra. The pump assembly 230a includes a pump 232a and a valve 234a. When the inflatable AUS 250a is inflated with an inflation fluid, such as saline, the pump 232a can be used to deflate the inflatable AUS 250a so that the patient can void their bladder. After the patient voids their bladder, the patient can then indicate that the 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] 2B, device 200b includes a non-pressurized fluid reservoir 210b, a pump assembly 230b, an inflatable AUS 250b, and a pressure sensor 251b, which may 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 205b, and pump 234b, which is used to inflate inflatable AUS 250b. Similar to device 200a, pressure sensor 251b of inflatable AUS 250b may 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 may function as a feedback mechanism for a control module control that may control both pump 232b and pump 234b to maintain a target occlusion pressure in inflatable AUS 250b or to control the deflation of inflatable AUS 250b.

[0044] FIG. 3 is a graph showing a comparison of pressure data during inflation of an implantable device simulating tissue atrophy in accordance with an embodiment compared to pre-atrophy (baseline). The data shown in FIG. 3 shows fluid pressure (cmH2O) over time within an AUS with an internal diameter of 5 centimeters (cm) when inflated using, for example, a pump or PRB to inject inflation fluid into the AUS. In this example, trace 310 shows a 5 cm urethral obstruction (e.g., occlusion of the lumen by the urethra), which may represent the baseline data urethral diameter. Also in FIG. 3, trace 320 shows data for a 4 cm urethral obstruction, which may represent a 5 cm baseline atrophy. The initial negative pressure shown by both sets of data in FIG. 3 is due to 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, e.g., pumped into the AUS, either through a pump or as a result of the 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 are due to 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 tracings 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 of FIG. 3, the larger the gap between the uninflated inner diameter of the AUS and the urethra (no gap for trace 310, 1 cm diameter difference for trace 320), the longer the amount of time spent in the corresponding plateau region. Thus, configuring the controller to measure the amount of time for P1 and P2 (as shown in FIG. 4) and determine the difference between those times can be used as a way to indicate if any changes such as tissue atrophy are occurring over time and 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 of the AUS, this difference could indicate that atrophy of the obstructing tissue (e.g., the patient's urethra) has occurred.

[0048] In some body 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 is believed to be effective in determining the amount of occlusion based on this volume difference, since the AUS cuff is generally 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 restriction of outward expansion by the rigid backing. Thus, the difference between two such inner diameters, e.g., baseline and after detected atrophy, is believed to correspond to the amount of urethral atrophy, which can be determined by the difference of simple respective volume calculations.

[0049] In the data of FIG. 3, for example, the fluctuations observed in the fluid pressure data during P1 and P2 are due, at least in part, to the pillow formed when the AUS expands, and 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 pressure at the AUS rises until a final or target occlusion pressure is reached. Even though the data of FIG. 3 has noise and environmental artifacts, the data shows that the plateau dwell time of P2 is longer than the plateau dwell time of P1, which may indicate atrophy, for example, a 4 cm atrophied urethral diameter versus a 5 cm baseline urethral diameter. In the embodiments described herein, the control module may be configured to apply curve smoothing to the pressure data captured by the pressure sensor, for example, the data of FIG. 3, and such smoothed or curve fitted pressure data is shown in FIG. 4. The smoothed data may then be used to identify potential occurrences of tissue atrophy.

[0050] As mentioned above, Fig. 4 is a graph showing an approach for detecting tissue atrophy using the data of Fig. 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 Fig. 3, respectively. In Fig. 4, lines 415a and 415b are fitted lines for the gradient of fluid pressure in 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 in 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, is responding over time to the applied therapeutic occlusion pressure and to determine whether atrophy of that tissue is occurring.

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

[0052] Obviously, the amount of time spent in this plateau region depends on how fast 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 rates of each of the AUS, any corresponding contraction determinations can be adjusted for such differences in fill rates, for example, when comparing the respective amounts of time spent in the plateau regions (e.g., P1a and P2a). This adjustment is important when using electronic pumps since no two pumps will pump at exactly the same speed. In addition, 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 the expandable member from an expanded configuration to a contracted configuration as described herein, 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 Figures 3 and 4.

[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 FIG. 2A and FIG. 2B, respectively, and may include any of the details discussed with reference to the inflatable devices or body implants described herein.

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

[0057] 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).

[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 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.

[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 FIG. 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 a 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 automatically control the active valve and / or pump to adjust the pressure in response and / or provide notification regarding 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 expandable 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 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.

Claims

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 expandable member is configured to be disposed 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; 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 atrophy of the portion of the body of the patient based on the received pressure data. Device.

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

3. the internal 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 contracted configuration to an expanded configuration; the detecting the contraction of the portion of the patient's body is based on an amount of time it takes the pump to transition the inflatable member from the deflated configuration to the inflated configuration.

3. Apparatus according to claim 1 or 2.

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

4. The apparatus of claim 3.

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

6. the internal 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.

6. Apparatus according to any one of claims 1 to 5.

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

7. The apparatus of claim 6.

8. The apparatus of claim 7 , wherein the baseline contraction time is determined at the time the internal implant is implanted in the body of the patient.

9. the internal 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 contracted configuration to the expanded configuration; the detecting the contraction of the portion of the patient's body is based on a volume of fluid used to transition the expandable member from the contracted configuration to the expanded configuration; the controller is configured to determine the volume of fluid based on a flow rate of the pump.

3. Apparatus according to claim 1 or 2.

10. and detecting the atrophy 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 internal implant is implanted in the patient's body.

10. The apparatus of claim 9.

11. the internal 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; the detecting the contraction of the portion of the patient's body is based on a volume of fluid used to transition the expandable member from the expanded configuration to the contracted configuration; the controller is configured to determine the volume of fluid based on a flow rate of the pump.

11. Apparatus according to claim 9 or 10.

12. and detecting the atrophy 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 internal implant is implanted in the patient's body.

12. The apparatus of claim 11.

13. 13. The apparatus of any one of claims 1 to 12, wherein the inflatable member is an inflatable cuff.

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

15. 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.

15. Apparatus according to any one of claims 1 to 14.

16. 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 expandable member is configured to be disposed 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; 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 atrophy of the portion of the body of the patient based on the received pressure data. Device.

17. 17. The apparatus of claim 16, wherein the expandable member is configured to apply pressure to the portion of the body of the patient when in the expanded configuration.

18. the internal 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 contracted configuration to an expanded configuration; the detecting the contraction of the portion of the patient's body is based on an amount of time it takes the pump to transition the inflatable member from the deflated configuration to the inflated configuration.

17. The apparatus of claim 16.

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

20. The apparatus of claim 18.

20. 20. The apparatus of claim 19, wherein the baseline expansion time is determined when the internal implant is implanted in the body of the patient.

21. the internal 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.

17. The apparatus of claim 16.

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

22. The apparatus of claim 21.

23. 23. The apparatus of claim 22, wherein the baseline contraction time is determined at the time the internal implant is implanted in the body of the patient.

24. the internal 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 contracted configuration to the expanded configuration; and 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.

17. The apparatus of claim 16.

25. 25. The apparatus of claim 24, wherein the controller is configured to determine the volume of fluid based on a flow rate of the pump.

26. and detecting the atrophy 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 internal implant is implanted in the patient's body.

26. The apparatus of claim 25.

27. the internal 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; and 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 contracted configuration.

17. The apparatus of claim 16.

28. 28. The apparatus of claim 27, wherein the controller is configured to determine the volume of fluid based on a flow rate of the pump.

29. and detecting the atrophy 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 internal implant is implanted in the patient's body.

30. The apparatus of claim 28.

30. 17. The apparatus of claim 16, wherein the inflatable member is an inflatable cuff.

31. 31. The device of claim 30, wherein the inflatable cuff is an artificial urinary sphincter.

32. 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.

17. The apparatus of claim 16.

33. transitioning an expandable member of an internal implant implanted within a patient's body between a contracted configuration and an expanded configuration, the expandable member being configured to be positioned within a portion of the patient's body to apply pressure to the portion of the patient's body; determining pressure data corresponding to a fluid pressure within the expandable member during the transition; detecting atrophy of the portion of the body of the patient based on the pressure data; The method includes:

34. the transition being from the contracted configuration to the expanded configuration; The step of detecting the atrophy of the portion of the body of the patient comprises: an amount of time for the expandable member to transition from the deflated configuration to the expanded configuration; and a volume of fluid used to transition the expandable member from the contracted configuration to the expanded configuration; is based on one of 34. The method of claim 33.

35. the transition being from the inflated configuration to the deflated configuration; The step of detecting the atrophy of the portion of the body of the patient comprises: an amount of time for the expandable member to transition from the expanded configuration to the deflated configuration; and a volume of fluid used to transition the expandable member from the expanded configuration to the contracted configuration; is based on one of 34. The method of claim 33.

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