Temporary male contraceptive devices and related methods

Abstract

Implantable male contraception devices for obtaining temporary sterility are provided, as well as related systems and methods of use. Such devices are adapted, in some embodiments, to restrict the vas deference of a subject during a controlled period in order to prevent sperm from reaching the subject's urethra.

Description

045973.00005TEMPORARY MALE CONTRACEPTIVE DEVICES AND RELATED METHODSCross-Reference to Related Application

[0001] The present application claims the benefit of priority under 35 U. S. C. § 119 to U. S. Patent Application No. 63 / 760,198, filed on Feb. 19, 2025, the disclosure of which is herein incorporated by reference in its entirety.Technical Field

[0002] The present disclosure related to implantable devices and related methods for male contraception, e.g., systems that allow for contraception to be temporarily activated, e.g., in response to manual input from a subject, preset parameters, or the detection of a one or more signals.Background

[0003] To date, options for male contraception are limited. The most common route of male contraception is occlusion of the vas deferens (the sperm transporting duct) by means of a vasectomy procedure (a surgical intervention to cut the vas deferens). A vasectomy is an invasive procedure and typically results in permanent sterility. A patient may be able to have the procedure reversed, however success is not guaranteed and doing so requires a second surgical procedure. More recently, other sealant-based alternatives have become available. One such technique is described in U. S. Patent No. 6,513,528 that relates to a set of silicone plugs for insertion into vas deferens Some implanted sealant compounds may be removed via a subsequent surgery. However, sealant-based implants (and other long-term sterilization options such as a vasectomy procedure) are problematic in that long-term use of these options may045973.00005 result in permanent sterility, e.g., due to the subject developing antibodies directed to their own spermBrief Summary

[0004] Current options for male contraception are inconvenient or problematic; easily reversible options are limited, and long-term use of current options (e.g., vasectomies, implanted sealants) may lead to irreversible side effects, such as sterilization, and / or inflammation-related complications. The present disclosure addresses these and other shortcomings associated with known male contraceptives by providing implantable devices that allow a user to temporarily restrict their vas deferens, providing sterility' on an as-needed basis. Such devices may be placed into a deactivated state when sterility is not desired or a concern, allowing for ejaculation to proceed normally. Such methods are safer and more convenient than existing options, in many respects. For example, the ability to switch between an occluded and open state for sperm and related bodily fluid to pass through the urethra, avoiding prolonged storage (e.g., behind a chemical sealant) that might otherwise result in inflammation or the development of anti-sperm antibodies. Moreover, the ability to easily switch between a sterile and non-sterile state provides greater freedom and options for family planning,

[0005] The various benefits and advantages of the present devices, systems, and methods will become apparent in view of the following written description of exemplary' aspects, as well as the accompanying figures and claims

[0001] In a first general aspect, the disclosure provides an implantable male contraception device, comprising: a tubular housing, comprising one or more side walls, each side wall having an outer surface and an inner surface; a plug, comprising one or more side walls, each side wall having an outer surface, wherein the plug is adapted to fit within the tubular housing and capable of movement along a longitudinal axis of the tubular housing; wherein the one or045973.00005 more side walls of the plug form a flange at a first end of the plug; and one or more sealing members, positioned between the inner surface of the one or more sidewalls of the tubular housing, and the outer surface of the one or more side walls of the plug.

[0006] In some aspects, the one or more sealing members comprises O-ring elements configured to form or improve a seal between the outer surface of the one or mor side walls of the plug and the inner surface of the one or more sidewalls of the tubular housing.

[0007] In some aspects, a) the tubular housing is cylindrical, or substantially cylindrical, in shape; b) the one or more side walls of the plug form a cylindrical structure that terminates in a conical shape at a second end of the plug, wherein the second end of the plug is positioned opposite to the first end along a longitudinal axis of the plug; and / or c) the implantable male contraception device further comprises one or more gas or fluid-filled bladders, attached to or placed in contact with the out surface of the one or more side walls of the housing.

[0008] In a second general aspect, the disclosure provides an implantable male contraception device according to the first general aspect, or otherwise disclosed herein, and one or more magnetic field generators, configured to cause the plug of the implantable male contraception device to move along a direction parallel to a longitudinal axis of the tubular housing of the implantable male contraception device, thereby shifting between a first position wherein the plug seals the tubular housing, and a second position wherein the plug does not seal the tubular housing.

[0009] In a third general aspect, the disclosure provides an implantable male contraception device, comprising: a tubular housing, comprising a first end, and a second end positioned opposite to the first end along a longitudinal axis of the tubular housing, and one or more side walls, each side wall having an outer surface and an inner surface, wherein the one or more side walls form a lumen that allows fluid communication through the tubular housing between the first end and the second end of the tubular housing; wherein the tubular housing further045973.00005 comprises one or more openings in the inner surface of the one or more side walls, which allow fluid communication between the inner surface of the one or more sidewalls and a second end of the tubular housing; a plug, comprising one or more side walls, each side wall having an outer surface and an inner surface, wherein the plug is adapted to fit within the tubular housing and capable of movement along a longitudinal axis of the tubular housing; wherein the one or more side walls of the plug form a flanged opening at a first end of the plug, and a sealed second end opposite to the first end along a longitudinal axis of the plug, thereby forming a lumen within the plug; one or more sealing members, positioned between the inner surface of the one or more sidewalls of the tubular housing, and the outer surface of the one or more side walls of the plug.

[0010] In some aspects, the one or more side walls of the plug comprise at least one opening adapted to allow fluid communication between the lumen of the plug and the second end of the tubular housing, through the one or more openings in the inner surface of the one or more side walls of the tubular housing, when the plug is located at a first position along a longitudinal axis of the tubular housing.

[0011] In some aspects, at least one opening of the plug, and / or the one or more openings in the inner surface of the one or more side walls of the tubular housing, are capable of opening or closing in response to actuation of a valve.

[0012] In some aspects, a) the tubular housing is cylindrical, or substantially cylindrical, in shape; b) the one or more side walls of the plug form a cylindrical structure that terminates in a conical shape at a second end of the plug, wherein the second end of the plug is positioned opposite to the first end along a longitudinal axis of the plug; and / or c) the implantable male contraception device further comprises one or more gas or fluid-filled bladders, attached to or placed in contact with the out surface of the one or more side walls of the housing.045973.00005

[0013] In a third general aspect, the disclosure provides an implantable male contraception device according to the third general aspect, or otherwise disclosed herein, and one or more magnetic field generators, configured to cause the plug of the implantable male contraception device to move along a direction parallel to a longitudinal axis of the tubular housing of the implantable male contraception device, thereby shifting between the first position wherein the plug does not seal the tubular housing, and a second position wherein the plug seals the tubular housing.

[0014] In a fourth general aspect, the disclosure provides an implantable male contraception device, comprising: a tubular housing, comprising a first end, and a second end positioned opposite to the first end along a longitudinal axis of the tubular housing, and one or more side walls, each side wall having an outer surface and an inner surface, wherein the first end comprises a front wall connected to the one or more side walls, and an opening adapted to receive a plug, and the second end comprises a rear wall connected to the one or more side walls; wherein the plug, comprises one or more side walls, each side wall having an outer surface and an inner surface, a real wall connected to the one or more side walls, and a front end comprising a valve capable of allowing or preventing fluid communication with a lumen of the plug formed by the rear wall and the one or more side walls, wherein the plug is adapted to fit within the opening in the front wall of the tubular housing and is capable of movement along a longitudinal axis of the tubular housing, and wherein the plug further comprises one or more openings in the one or more side walls which allow fluid communication between the lumen of the plug and an outer surface of the plug positioned within the tubular housing; and a toroidal anchor element adapted for attachment to an inner surface of a vas deferens of a human subject, wherein the toroidal anchor element is connected to the tubular housing by one or more hydraulic hoses.045973.00005

[0002] In some aspects, the one or more side walls of the tubular housing, and / or the rear wall of the tubular housing, comprise one or more openings adapted to allow fluid communication between the inside of the tubular housing and an outer surface of the second end of the tubular housing.

[0015] In some aspects, the valve of the plug is configured to open or close in response to a magnetic or electronic signal.

[0016] In some aspects, the position of the plug, along the longitudinal axis of the tubular housing, is adjustable in response to a magnetic or electronic signal.

[0003] In a fifth general aspect, the disclosure provides an implantable male contraception device according to the third general aspect, or otherwise disclosed herein, and a controller, configured to wirelessly control the implantable male contraception device by transmitting an electronic or magnetic signal that causes the plug to move along the longitudinal axis of the tubular housing, and / or that causes the valve of the plug to open or close.

[0017] In some aspects, the controller is configured to cause the plug to move along the longitudinal axis of the tubular housing, and / or to cause the valve of the plug to open or close, in response to: (a) user input from the male subject, and / or (b) based on one or more predetermined parameters.

[0018] In some aspects, the one or more predetermined parameters comprise one or more biometric parameters of the male subject.

[0004] In a sixth general aspect, the disclosure provides a method for providing temporary sterility of a male subject, comprising: restricting a vas deferens of a male subject during a controlled period using the implantable male contraception device of claims 1-3, 5-8, or 10-13, or the system of claims 4, 9 or 14-16, thereby preventing sperm from an ampulla vas deferens of the male subject from reaching a urethra of the male subject.045973.00005

[0019] In some aspects, the restriction is caused by user input provided by the male subject via a graphical user interface of a dedicated controller, or software executed on a smart watch or smart phone, configured to control the implantable male contraception device or the system.

[0020] To the accomplishment of the foregoing and related ends, the one or more aspects comprise the features hereinafter fully described and particularly pointed out in the claims. The following description and the annexed drawings set forth in detail certain illustrative features of the one or more aspects. These features are indicative, however, of but a few of the various ways in which the principles of various aspects may be employed, and this description is intended to include all such aspects and their equivalents.Brief Description of the Figures

[0021] FIG. 1 is a diagram illustrating an exemplary implantable male contraception device according to the present disclosure. In this case, the device is depicted from a side view, slightly angled to provide depth (e.g., to illustrate the curvature of the flange 106 of the plug 101).

[0022] FIG. 2 is a diagram illustrating a second exemplary implantable male contraception device according to the present disclosure. In this case, the device is depicted from a side view, slightly angled to provide depth.

[0023] FIG. 3 is a diagram illustrating a third exemplary implantable male contraception device according to the present disclosure. In this case, the device is depicted from a side view, slightly angled to provide depth.

[0024] FIG. 4 is a diagram illustrating a fourth exemplary implantable male contraception device according to the present disclosure. In this case, the device is depicted from a side view, slightly angled to provide depth.

[0025] FIG. 6 is a diagram illustrating another exemplary implantable male contraception device according to the present disclosure, shown as part of a system that further includes a045973.00005 downstream constrictive element (e.g., a hydraulicly inflatable toroidal structure used to constrict the vas deferens) that may be used to prevent or mitigate device slippage.

[0026] FIG. 7 is a diagram illustrating another exemplary implantable male contraception device according to the present disclosure, shown as part of a system that further includes a downstream pumping mechanism that may be used, e.g., to promote upstream repositioning of the device as a corrective measure following downstream slippage.

[0027] FIG. 8 is a is a block diagram of various example system components, capable of being used along the lines as described in example implementations in accordance with aspects of the present disclosure.Detailed Description

[0028] The detailed description set forth below in connection with the appended drawings is intended as a description of various configurations and is not intended to represent the only configurations in which the concepts described herein may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of various concepts. However, it will be apparent to those skilled in the art that these concepts may be practiced without these specific details. In some instances, well known structures and components are shown in block diagram form in order to avoid obscuring such concepts.

[0029] Several aspects of exemplary embodiments according to the present disclosure will now be presented with reference to various systems and methods. These systems and methods will be described in the following detailed description and illustrated in the accompanying drawings by various blocks, components, circuits, processes, algorithms, etc. (collectively referred to as “elements”). These elements may be implemented using electronic hardware, computer software, or any combination thereof. Whether such elements are implemented as hardware or software depends upon the particular application and design constraints imposed on the overall system.045973.00005

[0030] By way of example, an element, or any portion of an element, or any combination of elements may be implemented as a “processing system” or “controller” that includes one or more processors. Examples of processors include microprocessors, microcontrollers, graphics processing units (GPUs), central processing units (CPUs), application processors, digital signal processors (DSPs), reduced instruction set computing (RISC) processors, systems on a chip (SoC), baseband processors, field programmable gate arrays (FPGAs), programmable logic devices (PLDs), application-specific integrated circuits (ASICs), state machines, gated logic, discrete hardware circuits, and other suitable hardware configured to perform the various functionality described throughout this disclosure. One or more processors in the processing system may execute software. Software shall be construed broadly to mean instructions, instruction sets, code, code segments, program code, programs, subprograms, software components, applications, software applications, software packages, routines, subroutines, objects, executables, threads of execution, procedures, functions, etc., whether referred to as software, firmware, middleware, microcode, hardware description language, or otherwise.

[0031] Accordingly, in one or more exemplary embodiments, the functions described may be implemented in hardware, software, or any combination thereof. If implemented in software, the functions may be stored on or encoded as one or more instructions or code on a computer-readable medium. Computer-readable media includes computer storage media. Storage media may be any available media that can be accessed by a computer. By way of example, and not limitation, such computer-readable media can comprise a random- access memory (RAM), a read-only memory (ROM), an electrically erasable programmable ROM (EEPROM), optical disk storage, magnetic disk storage, other magnetic storage devices, combinations of the aforementioned types of computer-readable media, or any other medium that can be used to store computer executable code in the form of instructions or data structures that can be accessed by a computer.045973.00005

[0032] FIG. 1 is a diagram illustrating an exemplary implantable male contraception device according to the present disclosure. In this case, the device is depicted from a side view, slightly angled to provide depth cues. This example illustrates a tubular housing 102 surrounding a plug 101. Various sealing members 104 (e.g., O-rings) are visible between the outer surface of the plug and an inner surface of the tubular housing 102. The outer surface of the tubular housing 102 is shown to be affixed or adjacent to gas or fluid-filled bladder 103 elements, at the top and bottom of the illustrated side view; it is envisioned that in some aspects, gas or fluid-filled bladder 103 elements may surround the entire outer surface of the tubular housing, so as to ensure a tight seal against the inner surface of the vas deferens. The gas or fluid-filled bladder 103 elements may be affixed to the inner surface of the vas deferens, as shown here, by stitching 105, using an adhesive agent, or by any other means known to affix an implant to a body cavity or tissue. The loosely spaced-out stitching shown here is merely for illustrative purposes. In reality, the stitching, adhesive, etc., will form a tight seal between the implant, or a component thereof, and the inner walls of the vas deferens, so as to prevent sperm or other fluid from bypassing the implant.

[0033] In this example, plug 101 is solid and has a cylindrical shape along a majority of its longitudinal axis. This cylindrical shape tapers to a conical shaped end (e.g., on a side that would face a downstream portion of the vas deferens post-implantation) and curves outward to form a flange 106 (e.g., on the side that would face an upstream portion of the vas deferens post-implantation). Without being bound to a theory, it is envisioned that a flanged shape on the upstream side of the plug will improve plug retention.

[0034] The exemplary implantable male contraception device shown in this figure is intended to provide temporary sterility by occluding the vas deferens (e.g., when the plug 101 is in the configuration shown here. When sterility is not required, the plug may be repositioned laterally along the longitudinal axis of the tubular housing 102 (in this case, by shifting leftward045973.00005 along the view shown in FIG. 1). A sufficient lateral shift results in the tubular housing 102 becoming unblocked, allowing sperm and related bodily fluid to pass through the vas deferens towards the urethra. The plug may be repositioned using any of the mechanical, electronic, magnetic, or electromagnetic mechanisms described herein (e.g., in response to a subject entering a command into a dedicated controller, or a smartphone or smart watch application paired with the implanted male contraception device). Such mechanisms shall be described in further detail below.

[0035] FIG. 2 is a diagram illustrating another exemplary implantable male contraception device according to the present disclosure. This configuration is similar to that of the device shown in FIG. 1, however in this case the plug 101 is not solid. Instead, the plug has side walls that extend to form a flanged, open end 202, and which connect to form a conical closed end positioned opposite to the open end, viewed along a longitudinal axis of the plug 101. As shown by this figure, the open end may be located on the side that would face the upstream portion of the vas deferens post-implantation (e.g., here sperm are shown entering from that side and traveling through the hollow lumen of the plug 101). This configuration further differs from the previous example in that the side wall of the plug 101 and of the tubular housing 102 contain a corresponding set of openings 201 that allow for fluid communication between the lumen of the plug 102 and the downstream side of the implant, using a pair of openings 203 provided in the sidewall of the tubular housing 102.

[0036] As illustrated by this figure, fluid communication between the portion of the vas deferens upstream of the implanted male contraception device, and the portion of the vas deferens downstream from the implanted male contraception device, is only possible when the plug 101 is properly aligned with the tubular housing 102. In other words, if the plug 101 is shifted laterally along a longitudinal axis of the tubular housing 102, the openings 201 in the side wall of the tubular housing 102 and in the plug 101, would be offset, resulting in a045973.00005 blockage. Thus, temporary sterility may be achieved by causing the plug 101 to shift position to a point where the corresponding openings are misaligned, and sterility may be reversed by shifting the plug back to the position shown in FIG. 2. It is envisioned that the plug may be repositioned using any of the mechanical, electronic, magnetic, or electromagnetic mechanisms described herein (e.g., in response to a subject entering a command into a dedicated control unit, or an application executed on a smartphone or smart watch paired with the implanted male contraception device).

[0037] FIGs. 3-4 illustrate another exemplary implantable male contraception device according to the present disclosure, in disabled state allowing sperm passage (FIG. 3) and an enabled state that provides contraceptive functionality (FIG. 4). In this example, the device includes a tubular housing 301 designed to be implanted within the vas deferens. The tubular housing 301 is adapted to receive a plug 302 that includes a main valve 303 at its upstream end, which when open, allows fluid communication through one or more internal passages within the plug. Thus, in an open state sperm may travel through the main valve 303 and the internal passages, and exit the plug via an opening (e.g., at or proximal to the downstream end of the plug), and then exit the tubular housing 301 (e.g., using one or more tubular openings as shown in these figures). The main valve 303 may be anchored to the vas deferens as shown in this example. In this case, a toroidal anchor element 304 is implanted upstream of the main valve 303 and further anchors the tubular housing 301 via at least one connective element, such as a hydraulic hose 305 as shown in this embodiment. The toroidal anchor element 304 provides support against downstream movement during hydraulic pressure spikes caused by upstream contractions of the vas deferens. When the device is in a disabled state, sperm and seminal fluid may travel through the toroidal anchor element 304 and the open main valve 303, and exit the tubular housing 301, as described above. When the device is switched to an enabled state, as shown in FIG. 4, the main valve 303 is closed, blocking sperm from traveling downstream.045973.00005 However, in the closed state there is the issue of fluid build-up upstream of the closed main valve 303. To address this issue, it is envisioned that the hydraulic hose 305 may be used to allow transport of sperm-free seminal fluid through (or around) the closed main valve 303. Selective transport may be achieved, e.g., by selecting a tube size for the hydraulic hose 305 that prohibits entry of sperm, or by including a filter element at the upstream end of the tubular housing (e.g., a screen, filter, or other mechanism that would allow fluid passage while blocking entry of sperm). Fluid may pass through the hydraulic hose 305 via passive diffusion or via an active pumping mechanism. As such, the hydraulic hose 305 provides dual functionality in this exemplary embodiment, functioning as both a part of the anchoring system for the tubular housing 301 and as a transport system for fluid. It is envisioned that when the device is in an enabled state (with the main valve 303 closed), sperm-free seminal fluid would build up in the section of the vas deferens between the closed main valve 303 and the tubular housing, as illustrated by element 401 in FIG. 4.

[0038] Fluid pressure spikes inside the lumen at any location occur prior to contraction of the vas deferens at that location. In other words, seminal fluid is forced downstream by sequential contraction of the vas deferens upstream. The seminal fluid pressure spike at a downstream location will register before the vas deferens at that location contracts. Therefore, the devices and systems described herein may be configured to take advantage of upstream contraction in order to manage downstream slippage. The toroidal anchor element 304 used in the embodiment shown in FIGs.3-4 may be configured to leverage this effect by utilizing seals that provide vacuum suction against the wall of the lumen in respond to the pressure spike caused by contraction of the vas deferens, forming a tight seal during the pressure spike. This configuration allows the toroidal anchor element 304 to maintain position in the lumen, securing this element before the pressure spike reaches the downstream tubular housing 301 (to which the anchor element 304 is connected). Thus, tightening (contraction) of the vas045973.00005 deferens at the site of the toroidal anchor element 304 helps mitigate the impact of the pressure spike, both on the toroidal anchor element 304 itself and on the connected tubular housing 301.

[0039] In some aspects, the devices described herein are allowed to move within the lumen of the vas deferens. Permanent attachment of the device in a particular location often results in inflammation. Inflammation may be reduced by configuring the outer wall of an implanted device to be biocompatible, e.g., by adopting a structure that replicates the folds in the luminal wall. However, controlled slippage of the device may be desirable as a solution to this issue. In some aspects, the devices described herein may include hydraulic bladders around the outside of the device in order to promote a tight seal again the lumen. These bladders may be configured to maintain pressure in the dynamic environment of the vas deferens (e.g., by inflating or deflating in response to pressure spikes caused by contractions of the vas deferens).

[0040] In the event of slippage of an implanted device, or any component(s) thereof, such elements may be repositioned using mechanical, electronic, magnetic, or electromagnetic mechanisms. FIG. 5 illustrates the use of an electromagnetic system to reposition a plug 501 upstream or downstream within the vas deferens using electromagnetic fields 502 designed to promote movement along the axis of the vas deferens. Electromagnetic fields (or any other mechanism capable of applying motive force) may be used, e.g., to reposition the plug between a closed and open state, or to ensure that one or more components of the devices described herein remain in their intended location within the vs deferens (e.g., periodic corrective action may be needed to reverse slippage of the device due to hydrostatic pressure caused by upstream contractions of the vas deferens).

[0041] In some embodiments, the implantable male contraception device may be placed within a magnetic field controlled by one or more permanent magnets placed outside the vas deferens, as illustrated by FIG. 5. Magnetic field strength weakens with distance pursuant to the inverse square law. As such, the strength of the magnetic force acting on the device may be045973.00005 tuned to allow or prohibit slippage of the device. In some cases, it may be advantageous to allow slippage (e.g., to alleviate pressure spikes). Alternatively, higher magnetic field strength may counteract the pressure spike caused by upstream contractions, maintaining the position of the device within the vas deferens. The systems described herein may be configured to set and / or modify the magnetic field strength of one or more magnetic elements in order to control or adjust the position of the implantable male contraception device, or any individual element(s) thereof. For example, a system may include a controller configured to receive and process data from one or more pressure sensors, inertial measurement units (e.g., a gyroscope and / or accelerometer), or any other sensors, and to determine the position of the implantable male contraception device. Positioning may be determined with reference to the anatomy of the subject in which the device is implanted, or with reference to one or more components of the system (e.g., the position may be determined with reference to a valve, anchor, or any other element implanted upstream or downstream of the implantable male contraception device). The controller may be configured to set or adjust the magnetic field strength of one or more magnetic elements, directly or indirectly, based on the determined position of any element of the systems, based on the detection of pressure, or any other parameter. Distance and / or pressure thresholds may be set, e.g., a change in magnetic field strength or activation / deactivation of one or more magnetic elements may be triggered in response to a parameter exceeding a predetermined absolute value or rate of change. Activating, deactivation, or modification of the field strength of the one or more magnetic elements may be used in order to cause the implantable male contraception device, or any individual component(s) of the systems described herein, to maintain or shift position within the body of the human subject in which such device or component is implanted.

[0042] In addition to providing motive force, magnetic elements may also provide the secondary benefit of providing a mechanism for controlling valves used by the devices045973.00005 described herein. For example, the present systems and devices may utilize valves that respond to magnetic force. Thus, a controller of the system or device may be used to selectively open or close valves by activating, deactivating or setting a magnetic field strength of one or more magnetic elements. Moreover, the devices and components of the systems described herein may incorporate magnetically controlled valves designed to open or close as the device or component changes position within the system. For example, a device may be implanted upstream of a magnetic, and include valves configured to open (or close) based on proximity to the magnetic, directing fluid either promote movement of the device upstream, or to maintain a seal keeping one or more components of the device in a predetermined position.

[0043] FIG. 6 illustrates another exemplary implantable male contraception device according to the present disclosure, similar to the embodiment shown in FIGs. 3-4, but in this case further demonstrating the use of a ring-shaped constrictive element implanted downstream of the device. This downstream constrictive element may comprise, e.g., a toroidal element or a hydraulic tubing ring, positioned around the outside of the vas deferens, that can be selectively activated to constrict the vas deferens (as shown in FIG. 6), e.g., by inflation or any other hydraulic or mechanical means. The inclusion of a downstream constrictive element further provides a fail-safe against slippage of the device.

[0044] In some aspects, the systems described herein may be include a downstream constrictive element in addition to an implantable male contraception device (implanted upstream). Such systems may further include or more sensors capable of obtaining a signal indicative of the position of the implantable male contraception device and / or the downstream constrictive element. In some embodiments, the system may be configured to inflate the downstream constrictive element hydraulically to prevent slippage of the implantable male contraception device when the implantable male contraception device is detected within proximity to or within a predetermined distance from the downstream constrictive element.045973.00005 Inflation may be achieved using a magnetically controlled valve, or any other element for selectively enabling and disabling fluid passage into or out of the downstream constrictive element.

[0045] In some aspects, the downstream constrictive element may be inflated using the pumping force provided by contractions of the vas deferens. For example, pressure resulting from the contractions may be used to inflate a pressure storage reservoir (e.g., a bladder) positioned in proximity to or around the vas deferens, e.g., via one or more environmentally sensitive pressure pumps positioned outside the vas deferens. When the downstream constrictive element is activating (e.g., in response to the proximity of the implantable male contraceptive device crossing a preset threshold) pressure from the pressure storage reservoir may be used to inflate the downstream constrictive element, providing hydraulic pressure against the outer wall of the vas deferens and temporarily restricting the diameter of the vas deferens at the site of the downstream constrictive element. In some aspects, the mechanism used to power one or more pumps, valves, or other elements used to deploy and / or control the downstream constrictive element may be provided by an implanted battery. In some aspects, the battery may be recharged using the magnetic field changes within the vas deferens environment.

[0046] FIG. 7 illustrates another exemplary implantable male contraception device according to the present disclosure. This example illustrates the use of mechanisms for mitigating pressure spikes caused by vas deferens contractions, and for correcting device slippage. In this example, a tubular housing containing a valve is shown anchored to the inner walls of the vas deferens by two connective elements. Anchoring may be achieved using an adhesive, one or more mechanical elements embedded in the wall of the vas deferens, or by any other means known in the art. In this example, the tubular housing is connected to the two anchor elements using a pair of elastic cables. It is envisioned that any flexible or elastic045973.00005 material may be used as a connective element. Contraction-induced pressure spikes will normally apply a downstream force on the tubular housing (or any other implantable male contraception device described herein). Elastic connective elements may be used to partially mitigate this downstream pressure, as such materials will provide an upstream force upon the implantable male contraception device after the pressure spike subsides, promoting retention of the device. However, as shown by this figure, the systems described herein may further incorporate one or more pumps or the mechanisms to maintain the position of the implantable male contraception device and / or to provide corrective repositioning when needed. Here, a downstream pump us used to apply pressure causing the implantable male contraception device to move upstream. Such pumps may be configured, e.g., to receive and pump sperm-free seminal fluid into the vas deferens downstream of the implantable male contraception device. The sperm-free seminal fluid may be obtained, e.g., via a tube connected upstream of the implantable male contraception device, which incorporates a filter or other element to allow passage of fluid while obstructing sperm).

[0047] It is envisioned that the devices and methods described herein may be used as a temporary male contraceptive device in humans. However, the same or substantially similar embodiments may be used as a contraceptive for animals (e.g., cattle and other livestock, horses, cats, and dogs). The structure of the device(s) may need to be adjusted to accommodate structural differences in the chosen animal (e.g., the vas deferens may have a wider or narrower circumference, or a shorter or longer length). The structures described herein may be scaled as needed to accommodate such differences.

[0048] Aspects of the present disclosure may be implemented using hardware, software, or a combination thereof and may be implemented in one or more computer systems or other processing systems. In an aspect of the present disclosure, features are directed toward one or more computer systems capable of carrying out the functionality described herein. FIG. 8 is a045973.00005 block diagram illustrating an example of a computer system 20 which may be used to implement aspects of the systems and methods described herein. The computer system 20 can be in the form of multiple computing devices, or in the form of a single computing device, for example, a desktop computer, a notebook computer, a laptop computer, a mobile computing device, a smart phone, a tablet computer, a server, a mainframe, an embedded device, and other forms of computing devices.

[0049] As shown, the computer system 20 includes a central processing unit (CPU) 21, a system memory 22, and a system bus 23 connecting the various system components, including the memory associated with the central processing unit 21. The system bus 23 may comprise a bus memory or bus memory controller, a peripheral bus, and a local bus that is able to interact with any other bus architecture. Examples of the buses may include PCI, ISA, PCI-Express, HyperTransport™, InfiniBand™, Serial ATA, I2C, and other suitable interconnects. The central processing unit 21 (also referred to as a processor) can include a single or multiple sets of processors having single or multiple cores. The processor 21 may execute one or more computer-executable code implementing the techniques of the present disclosure. For example, any of commands / steps discussed in this specification, or shown in the accompanying drawings, may be performed by processor 21. The system memory 22 may be any memory for storing data used herein and / or computer programs that are executable by the processor 21. The system memory 22 may include volatile memory such as a random access memory (RAM) 25 and non-volatile memory such as a read only memory (ROM) 24, flash memory, etc., or any combination thereof. The basic input / output system (BIOS) 26 may store the basic procedures for transfer of information between elements of the computer system 20, such as those at the time of loading the operating system with the use of the ROM 24.

[0050] The computer system 20 may include one or more storage devices such as one or more removable storage devices 27, one or more non-removable storage devices 28, or a045973.00005 combination thereof. The one or more removable storage devices 27 and non-removable storage devices 28 are connected to the system bus 23 via a storage interface 32. In an aspect, the storage devices and the corresponding computer-readable storage media are powerindependent modules for the storage of computer instructions, data structures, program modules, and other data of the computer system 20. The system memory 22, removable storage devices 27, and non-removable storage devices 28 may use a variety of computer-readable storage media. Examples of computer-readable storage media include machine memory such as cache, SRAM, DRAM, zero capacitor RAM, twin transistor RAM, eDRAM, EDO RAM, DDR RAM, EEPROM, NRAM, RRAM, SONOS, PRAM; flash memory or other memory technology such as in solid state drives (SSDs) or flash drives; magnetic cassettes, magnetic tape, and magnetic disk storage such as in hard disk drives or floppy disks; optical storage such as in compact disks (CD-ROM) or digital versatile disks (DVDs); and any other medium which may be used to store the desired data and which can be accessed by the computer system 20.

[0051] The system memory 22, removable storage devices 27, and non-removable storage devices 28 of the computer system 20 may be used to store an operating system 35, additional program applications 37, other program modules 38, and program data 39. The computer system 20 may include a peripheral interface 46 for communicating data from input devices 40, such as a keyboard, mouse, stylus, game controller, voice input device, touch input device, or other peripheral devices, such as a printer or scanner via one or more I / O ports, such as a serial port, a parallel port, a universal serial bus (USB), or other peripheral interface. A display device 47 such as one or more monitors, projectors, or integrated display, may also be connected to the system bus 23 across an output interface 48, such as a video adapter. In addition to the display devices 47, the computer system 20 may be equipped with other peripheral output devices (not shown), such as loudspeakers and other audiovisual devices.045973.00005

[0052] The computer system 20 may operate in a network environment, using a network connection to one or more remote computers 49. The remote computer (or computers) 49 may be local computer workstations or servers comprising most or all of the aforementioned elements in describing the nature of a computer system 20. Other devices may also be present in the computer network, such as, but not limited to, routers, network stations, peer devices or other network nodes. The computer system 20 may include one or more network interfaces 51 or network adapters for communicating with the remote computers 49 via one or more networks such as a local-area computer network (LAN) 50, a wide-area computer network (WAN), an intranet, and the Internet. Examples of the network interface 51 may include an Ethernet interface, a Frame Relay interface, SONET interface, and wireless interfaces.

[0053] Aspects of the present disclosure may be a system, a method, and / or a computer program product. The computer program product may include a computer readable storage medium (or media) having computer readable program instructions thereon for causing a processor to carry out aspects of the present disclosure.

[0054] The computer readable storage medium can be a tangible device that can retain and store program code in the form of instructions or data structures that can be accessed by a processor of a computing device, such as the computing system 20. The computer readable storage medium may be an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any suitable combination thereof. By way of example, such computer-readable storage medium can comprise a random access memory (RAM), a read-only memory (ROM), EEPROM, a portable compact disc read-only memory (CD-ROM), a digital versatile disk (DVD), flash memory, a hard disk, a portable computer diskette, a memory stick, a floppy disk, or even a mechanically encoded device such as punch-cards or raised structures in a groove having instructions recorded thereon. As used herein, a computer readable storage medium is not to be construed045973.00005 as being transitory signals per se, such as radio waves or other freely propagating electromagnetic waves, electromagnetic waves propagating through a waveguide or transmission media, or electrical signals transmitted through a wire.

[0055] Computer readable program instructions described herein can be downloaded to respective computing devices from a computer readable storage medium or to an external computer or external storage device via a network, for example, the Internet, a local area network, a wide area network and / or a wireless network. The network may comprise copper transmission cables, optical transmission fibers, wireless transmission, routers, firewalls, switches, gateway computers and / or edge servers. A network interface in each computing device receives computer readable program instructions from the network and forwards the computer readable program instructions for storage in a computer readable storage medium within the respective computing device.

[0056] Computer readable program instructions for carrying out operations of the present disclosure may be assembly instructions, instruction-set-architecture (ISA) instructions, machine instructions, machine dependent instructions, microcode, firmware instructions, statesetting data, or either source code or object code written in any combination of one or more programming languages, including an object-oriented programming language, and conventional procedural programming languages. The computer readable program instructions may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer through any type of network, including a LAN or WAN, or the connection may be made to an external computer (for example, through the Internet). In some embodiments, electronic circuitry including, for example, programmable logic circuitry, field-programmable gate arrays (FPGA), or programmable logic arrays (PLA) may execute the045973.00005 computer readable program instructions by utilizing state information of the computer readable program instructions to personalize the electronic circuitry, in order to perform aspects of the present disclosure.

[0057] In various aspects, the systems and methods described in the present disclosure can be addressed in terms of modules. The term "module" as used herein refers to a real-world device, component, or arrangement of components implemented using hardware, such as by an application specific integrated circuit (ASIC) or FPGA, for example, or as a combination of hardware and software, such as by a microprocessor system and a set of instructions to implement the module’s functionality, which (while being executed) transform the microprocessor system into a special-purpose device. A module may also be implemented as a combination of the two, with certain functions facilitated by hardware alone, and other functions facilitated by a combination of hardware and software. In certain implementations, at least a portion, and in some cases, all, of a module may be executed on the processor of a computer system. Accordingly, each module may be realized in a variety of suitable configurations, and should not be limited to any particular implementation exemplified herein.

[0058] In the interest of clarity, not all of the routine features of the aspects are disclosed herein. It would be appreciated that in the development of any actual implementation of the present disclosure, numerous implementation-specific decisions must be made in order to achieve the developer’s specific goals, and these specific goals will vary for different implementations and different developers. It is understood that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking of engineering for those of ordinary skill in the art, having the benefit of this disclosure.

[0059] Furthermore, it is to be understood that the phraseology or terminology used herein is for the purpose of description and not of restriction, such that the terminology or phraseology of the present specification is to be interpreted by the skilled in the art in light of the teachings045973.00005and guidance presented herein, in combination with the knowledge of those skilled in the relevant art(s). Moreover, it is not intended for any term in the specification or claims to be ascribed an uncommon or special meaning unless explicitly set forth as such.

[0060] The various aspects disclosed herein encompass present and future known equivalents to the known modules referred to herein by way of illustration. Moreover, while aspects and applications have been shown and described, it would be apparent to those skilled in the art having the benefit of this disclosure that many more modifications than mentioned above are possible without departing from the inventive concepts disclosed herein.* * *

[0061] In closing, it is to be understood that although aspects of the present specification are highlighted by referring to specific embodiments, one skilled in the art will readily appreciate that these disclosed embodiments are only illustrative of the principles of the subject matter disclosed herein. Therefore, it should be understood that the disclosed subject matter is in no way limited to a particular compound, composition, article, apparatus, methodology, protocol, and / or reagent, etc., described herein, unless expressly stated as such. In addition, those of ordinary skill in the art will recognize that certain changes, modifications, permutations, alterations, additions, subtractions and sub-combinations thereof can be made in accordance with the teachings herein without departing from the spirit of the present specification. It is therefore intended that the following appended claims and claims hereafter introduced are interpreted to include all such changes, modifications, permutations, alterations, additions, subtractions and sub- combinations as are within their true spirit and scope.

[0062] Certain aspects of the present disclosure are described herein, including the best mode known to the inventors for carrying out the disclosure. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as045973.00005 appropriate, and the inventors intend for the present disclosure to be practiced otherwise than specifically described herein. Accordingly, this disclosure includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described embodiments in all possible variations thereof is encompassed by the disclosure unless otherwise indicated herein or otherwise clearly contradicted by context.

[0063] Groupings of alternative embodiments, elements, or steps of the present disclosure are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other group members disclosed herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.

[0064] Unless otherwise indicated, all numbers expressing a characteristic, item, quantity, parameter, property, term, and so forth used in the present specification and claims are to be understood as being modified in all instances by the term “about.” As used herein, the term “about” means that the characteristic, item, quantity, parameter, property, or term so qualified encompasses a range of plus or minus ten percent above and below the value of the stated characteristic, item, quantity, parameter, property, or term. Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical indication should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.045973.00005

[0065] Use of the terms “may” or “can” in reference to an embodiment or aspect of an embodiment also carries with it the alternative meaning of “may not” or “cannot.” As such, if the present specification discloses that an embodiment or an aspect of an embodiment may be or can be included as part of the inventive subject matter, then the negative limitation or exclusionary proviso is also explicitly meant, meaning that an embodiment or an aspect of an embodiment may not be or cannot be included as part of the inventive subject matter. In a similar manner, use of the term “optionally” in reference to an embodiment or aspect of an embodiment means that such embodiment or aspect of the embodiment may be included as part of the inventive subject matter or may not be included as part of the inventive subject matter. Whether such a negative limitation or exclusionary proviso applies will be based on whether the negative limitation or exclusionary proviso is recited in the claimed subject matter.

[0066] Notwithstanding that the numerical ranges and values setting forth the broad scope of the disclosure are approximations, the numerical ranges and values set forth in the specific examples are reported as precisely as possible. Any numerical range or value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Recitation of numerical ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate numerical value falling within the range. Unless otherwise indicated herein, each individual value of a numerical range is incorporated into the present specification as if it were individually recited herein.

[0067] The terms “a,” “an,” “the” and similar references used in the context of describing aspects of the present disclosure (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Further, ordinal indicators — such as “first,” “second,” “third,” etc. — for identified elements are used to distinguish between the elements, and do not indicate or045973.00005 imply a required or limited number of such elements, and do not indicate a particular position or order of such elements unless otherwise specifically stated. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or “exemplary” language (e.g., “such as”) provided herein is intended merely to better illuminate the present disclosure and does not pose a limitation on the scope of the invention otherwise claimed. No language in the present specification should be construed as indicating any non-claimed element essential to the practice of the invention.

[0068] When used in the claims, whether as filed or added per amendment, the open-ended transitional term “comprising” (and equivalent open-ended transitional phrases thereof like including, containing and having) encompasses all the expressly recited elements, limitations, steps and / or features alone or in combination with unrecited subject matter; the named elements, limitations and / or features are essential, but other unnamed elements, limitations and / or features may be added and still form a construct within the scope of the claim. Specific embodiments disclosed herein may be further limited in the claims using the closed-ended transitional phrases “consisting of’ or “consisting essentially of’ in lieu of or as an amended for “comprising.” When used in the claims, whether as filed or added per amendment, the closed-ended transitional phrase “consisting of’ excludes any element, limitation, step, or feature not expressly recited in the claims. The closed-ended transitional phrase “consisting essentially of’ limits the scope of a claim to the expressly recited elements, limitations, steps and / or features and any other elements, limitations, steps and / or features that do not materially affect the basic and novel characteristic(s) of the claimed subject matter. Thus, the meaning of the open-ended transitional phrase “comprising” is being defined as encompassing all the specifically recited elements, limitations, steps and / or features as well as any optional, additional unspecified ones. The meaning of the closed-ended transitional phrase “consisting045973.00005 of’ is being defined as only including those elements, limitations, steps and / or features specifically recited in the claim whereas the meaning of the closed-ended transitional phrase “consisting essentially of’ is being defined as only including those elements, limitations, steps and / or features specifically recited in the claim and those elements, limitations, steps and / or features that do not materially affect the basic and novel characteristic(s) of the claimed subject matter. Therefore, the open-ended transitional phrase “comprising” (and equivalent open-ended transitional phrases thereof) includes within its meaning, as a limiting case, claimed subject matter specified by the closed-ended transitional phrases “consisting of’ or “consisting essentially of.” As such embodiments described herein or so claimed with the phrase “comprising” are expressly or inherently unambiguously described, enabled and supported herein for the phrases “consisting essentially of’ and “consisting of.”

[0069] All patents, patent publications, and other publications referenced and identified in the present specification are individually and expressly incorporated herein by reference in their entirety for the purpose of describing and disclosing, for example, the compositions and methodologies described in such publications that might be used in connection with the present disclosure. These publications are provided solely for their disclosure prior to the filing date of the present application. Nothing in this regard should be construed as an admission that the inventors are not entitled to antedate such disclosure by virtue of prior disclosure or for any other reason. All statements as to the date or representation as to the contents of these documents is based on the information available to the applicants and does not constitute any admission as to the correctness of the dates or contents of these documents.

[0070] Lastly, the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention, which is defined solely by the claims. Accordingly, the present invention is not limited to that precisely as shown and described.

Claims

045973.00005CLAIMS1. An implantable male contraception device, comprising:a tubular housing, comprising one or more side walls, each side wall having an outer surface and an inner surface;a plug, comprising one or more side walls, each side wall having an outer surface, wherein the plug is adapted to fit within the tubular housing and capable of movement along a longitudinal axis of the tubular housing;wherein the one or more side walls of the plug form a flange at a first end of the plug; andone or more sealing members, positioned between the inner surface of the one or more sidewalls of the tubular housing, and the outer surface of the one or more side walls of the plug.

2. The implantable male contraception device of claim 1,wherein the one or more sealing members comprises O-ring elements configured to form or improve a seal between the outer surface of the one or mor side walls of the plug and the inner surface of the one or more sidewalls of the tubular housing.

3. The implantable male contraception device of claim 1 or claim 2, whereina) the tubular housing is cylindrical, or substantially cylindrical, in shape;b) the one or more side walls of the plug form a cylindrical structure that terminates in a conical shape at a second end of the plug, wherein the second end of the plug is positioned opposite to the first end along a longitudinal axis of the plug; and / orc) the implantable male contraception device further comprises one or more gas or fluid-filled bladders, attached to or placed in contact with the out surface of the one or more side walls of the housing.045973.000054. A system for providing temporary sterility of a male subject, comprising:the implantable male contraception device of any one of claims 1-3, andone or more magnetic field generators, configured to cause the plug of the implantable male contraception device to move along a direction parallel to a longitudinal axis of the tubular housing of the implantable male contraception device, thereby shifting between a first position wherein the plug seals the tubular housing, and a second position wherein the plug does not seal the tubular housing.

5. An implantable male contraception device, comprising:a tubular housing, comprisinga first end, and a second end positioned opposite to the first end along a longitudinal axis of the tubular housing, andone or more side walls, each side wall having an outer surface and an inner surface, wherein the one or more side walls form a lumen that allows fluid communication through the tubular housing between the first end and the second end of the tubular housing;wherein the tubular housing further comprises one or more openings in the inner surface of the one or more side walls, which allow fluid communication between the inner surface of the one or more sidewalls and a second end of the tubular housing;a plug, comprisingone or more side walls, each side wall having an outer surface and an inner surface, wherein the plug is adapted to fit within the tubular housing and capable of movement along a longitudinal axis of the tubular housing;wherein the one or more side walls of the plug form a flanged opening at a first end of the plug, and a sealed second end opposite to the first end along a longitudinal axis of the plug, thereby forming a lumen within the plug;one or more sealing members, positioned between the inner surface of the one or more sidewalls of the tubular housing, and the outer surface of the one or more side walls of the plug.045973.000056. The implantable male contraception device of claim 5, wherein the one or more side walls of the plug comprise at least one opening adapted to allow fluid communication between the lumen of the plug and the second end of the tubular housing, through the one or more openings in the inner surface of the one or more side walls of the tubular housing, when the plug is located at a first position along a longitudinal axis of the tubular housing.

7. The implantable male contraception device of claim 5 or claim 6, wherein theat least one opening of the plug, and / or theone or more openings in the inner surface of the one or more side walls of the tubular housing,are capable of opening or closing in response to actuation of a valve.

8. The implantable male contraception device of any one of claims 5-8, whereina) the tubular housing is cylindrical, or substantially cylindrical, in shape;b) the one or more side walls of the plug form a cylindrical structure that terminates in a conical shape at a second end of the plug, wherein the second end of the plug is positioned opposite to the first end along a longitudinal axis of the plug; and / orc) the implantable male contraception device further comprises one or more gas or fluid-filled bladders, attached to or placed in contact with the out surface of the one or more side walls of the housing.

9. A system for providing temporary sterility of a male subject, comprising:the implantable male contraception device of any one of claims 6-8, andone or more magnetic field generators, configured to cause the plug of the implantable male contraception device to move along a direction parallel to a longitudinal axis of the tubular housing of the implantable male contraception device, thereby shifting between the first position wherein the plug does not seal the tubular housing, and a second position wherein the plug seals the tubular housing.045973.0000510. An implantable male contraception device, comprising:a tubular housing, comprisinga first end, and a second end positioned opposite to the first end along a longitudinal axis of the tubular housing, andone or more side walls, each side wall having an outer surface and an inner surface,wherein the first end comprises a front wall connected to the one or more side walls, and an opening adapted to receive a plug, and the second end comprises a rear wall connected to the one or more side walls;wherein the plug, comprisesone or more side walls, each side wall having an outer surface and an inner surface, a real wall connected to the one or more side walls, and a front end comprising a valve capable of allowing or preventing fluid communication with a lumen of the plug formed by the rear wall and the one or more side walls,wherein the plug is adapted to fit within the opening in the front wall of the tubular housing and is capable of movement along a longitudinal axis of the tubular housing, andwherein the plug further comprises one or more openings in the one or more side walls which allow fluid communication between the lumen of the plug and an outer surface of the plug positioned within the tubular housing; anda toroidal anchor element adapted for attachment to an inner surface of a vas deferens of a human subject, wherein the toroidal anchor element is connected to the tubular housing by one or more hydraulic hoses.

11. The implantable male contraception device of claim 10, whereinthe one or more side walls of the tubular housing, and / orthe rear wall of the tubular housing,045973.00005comprise one or more openings adapted to allow fluid communication between the inside of the tubular housing and an outer surface of the second end of the tubular housing.

12. The implantable male contraception device of claim 10 or claim 11, wherein the valve of the plug is configured to open or close in response to a magnetic or electronic signal.

13. The implantable male contraception device of any one of claims 10-12, wherein the position of the plug, along the longitudinal axis of the tubular housing, is adjustable in response to a magnetic or electronic signal.

14. A system for providing temporary sterility of a male subject, comprising,the implantable male contraception device of any one of claims 10-13, anda controller, configured to wirelessly control the implantable male contraception device by transmitting an electronic or magnetic signal that causes the plug to move along the longitudinal axis of the tubular housing, and / or that causes the valve of the plug to open or close.

15. The system of claim 14, wherein the controller is configured to cause the plug to move along the longitudinal axis of the tubular housing, and / or to cause the valve of the plug to open or close, in response to: (a) user input from the male subject, and / or (b) based on one or more predetermined parameters.

16. The system of claim 15, wherein the one or more predetermined parameters comprise one or more biometric parameters of the male subject.

17. A method for providing temporary sterility of a male subject, comprising:restricting a vas deferens of a male subject during a controlled period using the implantable male contraception device of claims 1-3, 5-8, or 10-13, or the system of claims 4,045973.000059 or 14-16, thereby preventing sperm from an ampulla vas deferens of the male subject from reaching a urethra of the male subject.

18. The method of claim 17, wherein the restriction is caused by user input provided by the male subject via a graphical user interface of an electronic device configured wirelessly communicate with and control one or more settings or functions of the implantable male contraception device or the system.

19. The method of claim 18, wherein the electronic device is a smart watch, a smart phone, or a portable control unit.

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