Soft implantable assistive device for bladder management

Abstract

Disclosed herein is an in-vivo implantable system for bladder management. The system includes an actuator, a urine-level sensor, and a microcontroller connected to the actuator and the urine-level sensor. The actuator includes a two-way smart biomaterial having a changeable / restorable shape due to applying / removing at least one of an electric field, a magnetic field, a light change, a temperature change, ultrasound waves, and combinations thereof. The actuator is utilized to contract / release at least one of the bladder, the urethra, and the ureter(s). The urine-level sensor includes one of a strain sensor, a pressure / force sensor, and an impedance sensor and is used to measure bladder fullness during filling / voiding. The microcontroller is used to perform a method of management of micturition, prevention of bladder leakage, prevention of urine reflux to kidneys of the living body, and combinations thereof utilizing the actuator and the urine-level sensor.

Description

SOFT IMPLANTABLE ASSISTIVE DEVICE FOR BLADDER MANAGEMENT TECHNICAL FIELD

[0001] The present disclosure generally relates to a medical device, and particularly, to a soft,smart, and user-controlled implantable device for bladder management. BACKGROUND

[0002] Bladder dysfunctions affect more than 85% of individuals with spinal cord injuries(SCI) as well as many others with multiple sclerosis (MS), Parkinson’s disease, and diabetes. This leads to several complications, such as loss of bladder sensation, urinary incontinence, urinary retention, difficulty in urination, bladder stones, and kidney damage. Pharmacological agents often result in severe side effects and there is no effective medication for bladder contractility to initiate urination and complete emptying of the bladder.

[0003] Current strategies include physiotherapy, pharmacotherapy, catheterization forconservative management to magnetically actuated intraurethral valve pumps, electrical stimulation, optogenetics and bladder actuating devices that involve implantation of devices to control bladder function. All approaches come with limitations and side-effects. While electrical stimulation (nerves / muscles) has been previously approved for clinical use, it is of note that optogenetics and bladder actuating approaches have yet to be approved for clinical use. Regardless, none of these interventions have shown sufficient efficacy. The common solution, catheterization, is highly prone to urinary tract infection and urethral erosion, and also it is not suitable for self-use by individuals with upper limb impairment. Extensive research has focused on electrical stimulation of various nerves associated with bladder control. However, electrical stimulation can lead to undesired stimulation of neighboring nerves, gradual desensitization, pain, inflammation, and injury. Other studies provided controls of bladder functions via optogenetics; however, a biosafety level 1 virus that can be applied to clinical trials has not been demonstrated in the bladder in animals other than mice due to difficulties in virus transfection, which are still clear technical limitations. Also, optogenetics has been only introduced for bladder overactivity not inducing the micturition.

[0004] Therefore, there is a clear need for a fully implantable, lightweight, and soft assistivedevice to compensate the lack of sensation and actuation of bladder function and also be able to be controlled by the user for on-demand micturition.SUMMARY

[0005] This summary is intended to provide an overview of the subject matter of the presentdisclosure, and is not intended to identify essential elements or key elements of the subject matter, nor is it intended to be used to determine the scope of the claimed implementations. The proper scope of the present disclosure may be ascertained from the claims set forth below in view of the detailed description below and the drawings.

[0006] In one general aspect, the present disclosure describes an in-vivo implantable systemfor bladder management of a living body having urinary system dysfunctions. In an exemplary embodiment, the in-vivo implantable system may include an actuator, a urine-level sensor, and a microcontroller. In an exemplary embodiment, the actuator may be securable to at least one of bladder external wall, urethra, at least one ureter, and combinations thereof of the living body. In an exemplary embodiment, the actuator may include one or more pieces of a two-way smart biomaterial. In an exemplary embodiment, the two-way smart biomaterial may include a changeable shape due to applying at least one of an electric field, a magnetic field, a light change, a temperature change, ultrasound, and combinations thereof thereto. In an exemplary embodiment, the two-way smart biomaterial may further include a restoring shape to an original form due to removing the at least one of the electric field, the magnetic field, the light change, the temperature change, the ultrasound, and combinations thereof. In an exemplary embodiment, the actuator may be utilized to contract and / or release the at least one of the bladder external wall, the urethra, the at least one ureter, and combinations thereof. In an exemplary embodiment, the urine-level sensor may be securable to the bladder external wall. In an exemplary embodiment, the urine-level sensor may include at least one of a strain sensor, a pressure / force sensor, an impedance sensor, and combinations thereof. In an exemplary embodiment, the urine-level sensor may be utilized to measure urine volume in the bladder by measuring changes of at least one of strain of the bladder external wall, electrical impedance of the bladder external wall, pressure / force applied to the bladder external wall, and combinations thereof during filling and / or voiding the bladder. In an exemplary embodiment, the microcontroller may be subcutaneously implantable in abdominal area of the living body. In an exemplary embodiment, the microcontroller may include a base layer, a communication module attached onto the base layer, and a processing unit attached onto the base layer. In an exemplary embodiment, the base layer may include a piece of a soft flexible biocompatiblematerial. In an exemplary embodiment, the communication module may be wirelessly coupled to a user-notifying device. In an exemplary embodiment, the processing unit may be connected to the actuator, the urine-level sensor, and the communication module. In an exemplary embodiment, the processing unit may include a memory having processor-readable instructions stored therein and a processor. In an exemplary embodiment, the processor may be used to access the memory and the communication module. In an exemplary embodiment, the processor may be utilized to execute the processor readable instructions to perform at least one method of management of micturition, prevention of bladder leakage, prevention of urine reflux to kidneys of the living body, and combinations thereof.

[0007] Other exemplary systems, methods, features and advantages of the implementationswill be, or will become, apparent to one of ordinary skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be included within this description and this summary, be within the scope of the implementations, and be protected by the claims herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The drawing figures depict one or more implementations in accord with the presentteachings, by way of example only, not by way of limitation. In the figures, like reference numerals refer to the same or similar elements.

[0009] FIG. 1A schematically shows an exemplary in-vivo implantable system for bladdermanagement of a living body having urinary system dysfunctions, consistent with one or more exemplary embodiments of the present disclosure.

[0010] FIG. 1B schematically shows an exemplary actuator, consistent with one or moreexemplary embodiments of the present disclosure.

[0011] FIG. 2A schematically shows an exemplary in-vivo implantable system implanted formicturition management, consistent with one or more exemplary embodiments of the present disclosure.

[0012] FIG. 2B schematically shows an exemplary in-vivo implantable system implanted formanagement of a leaky bladder, consistent with one or more exemplary embodiments of the present disclosure.

[0013] FIG. 2C schematically shows an exemplary in-vivo implantable system implanted forprevention of urine reflux to kidneys, consistent with one or more exemplary embodiments of the present disclosure.

[0014] FIG. 3A schematically shows an exemplary buckle-type structure of an exemplary atleast one substrate along with an exemplary actuator embedded therein in an exemplary open position, consistent with one or more exemplary embodiments of the present disclosure.

[0015] FIG. 3B schematically shows an exemplary buckle-type structure of an exemplary atleast one substrate along with an exemplary actuator embedded therein in an exemplary closed position, consistent with one or more exemplary embodiments of the present disclosure.

[0016] FIGs. 4A-4B schematically show two exemplary views and of an exemplary cap-typestructure of an exemplary at least one substrate along with an exemplary actuator and an exemplary urine-level sensor embedded therein, consistent with one or more exemplary embodiments of the present disclosure.

[0017] FIG. 5 schematically shows an exemplary mesh-like structure of an exemplaryactuator, consistent with one or more exemplary embodiments of the present disclosure.

[0018] FIG. 6A schematically shows an exemplary strain sensor, consistent with one or moreexemplary embodiments of the present disclosure.

[0019] FIG. 6B schematically shows an exemplary strain sensor embedded inside anexemplary at least one substrate, consistent with one or more exemplary embodiments of the present disclosure.

[0020] FIG.7 schematically shows an exemplary microcontroller, consistent with one or moreexemplary embodiments of the present disclosure.

[0021] FIG. 8 schematically shows an exemplary block diagram of an exemplary batteryrecharging circuit, consistent with one or more exemplary embodiments of the present disclosure.

[0022] FIG. 9 shows an example computer system in which an embodiment of the presentinvention, or portions thereof, may be implemented as computer-readable code, consistent with exemplary embodiments of the present disclosure.

[0023] FIG.10 shows a flowchart of an exemplary method for bladder management, consistentwith one or more exemplary embodiments of the present disclosure.

[0024] FIG.11 shows a map of temperature and an exemplary maximum temperature of wiresof an exemplary fabricated actuator BMX150 before actuation (top image) and 2 seconds afteractuation with duty cycle of 50% (bottom image), consistent with one or more exemplary embodiments of the present disclosure.

[0025] FIG. 12 shows an exemplary diagram of recorded temperatures at different actuationtime intervals at core and surface of an exemplary fabricated actuator BMX150 after actuation with 50% duty cycle (2 seconds on, 2 seconds off), consistent with one or more exemplary embodiments of the present disclosure.

[0026] FIG. 13 shows an exemplary diagram of percentage of bladder voiding along withrecorded maximum temperatures on surface of exemplary fabricated actuators at different applied duty cycles for exemplary fabricated actuator BMX150, consistent with one or more exemplary embodiments of the present disclosure.

[0027] FIG. 14 shows an exemplary mold fabricated based on an exemplary 3D model ofrodents’ bladder, consistent with one or more exemplary embodiments of the present disclosure. DETAILED DESCRIPTION

[0028] In the following detailed description, numerous specific details are set forth by way ofexamples in order to provide a thorough understanding of the relevant teachings. However, it should be apparent that the present teachings may be practiced without such details. In other instances, well known methods, procedures, components, and / or circuitry have been described at a relatively high-level, without detail, in order to avoid unnecessarily obscuring aspects of the present teachings.

[0029] The following detailed description is presented to enable a person skilled in the art tomake and use the methods and devices disclosed in exemplary embodiments of the present disclosure. For purposes of explanation, specific nomenclature is set forth to provide a thorough understanding of the present disclosure. However, it will be apparent to one skilled in the art that these specific details are not required to practice the disclosed exemplary embodiments. Descriptions of specific exemplary embodiments are provided only as representative examples. Various modifications to the exemplary implementations will be readily apparent to one skilled in the art, and the general principles defined herein may be applied to other implementations and applications without departing from the scope of the present disclosure. The present disclosure is not intended to be limited to the implementations shown, but is to be accorded the widest possible scope consistent with the principles and features disclosed herein.

[0030] Herein, a system for urinary system management is disclosed. In an exemplaryembodiment, an exemplary system may be implanted in a living body (i.e., an animal or a human) having a dysfunction in urinary system. In an exemplary embodiment, an exemplary dysfunction may include at least one of an underactive bladder (UAB), a neurogenic bladder, an overactive bladder (OAB), a leaky bladder, urine reflux to kidneys, and combinations thereof. In an exemplary embodiment, an exemplary system may include an actuator. In an exemplary embodiment, an exemplary actuator may include at least one of a bladder actuator, a urethra actuator, a ureter actuator, and combinations thereof. In an exemplary embodiment, an exemplary actuator may be implanted at a location of at least one of onto bladder wall of an exemplary living body, around an exemplary bladder wall of an exemplary living body, around a urethra of an exemplary living body, around a ureter of an exemplary living body, and combinations thereof. In an exemplary embodiment, an exemplary bladder actuator may be utilized to contract an exemplary bladder of an exemplary living body when micturition is needed. In an exemplary embodiment, an exemplary urethra actuator may be utilized to basically keep an exemplary urethra of an exemplary living body contracted and prevent urine leakage from an exemplary urethra. In an exemplary embodiment, an exemplary contraction by an exemplary urethra actuator may be released and an exemplary urethra may be opened for urine to exit right before initiating urination by an exemplary living body. In an exemplary embodiment, an exemplary ureter actuator may be fastened around at least one of ureters of an exemplary living body and right before initiating urination, an exemplary ureter actuator may be contracted to prevent reflux of urine to kidney during micturition. In an exemplary embodiment, an exemplary actuator may include one or more pieces of a two-way smart material. In an exemplary embodiment, an exemplary two-way smart material may include a changeable shape due to applying at least one of an electric field, a magnetic field, a light change, a temperature change, ultrasound waves, and combinations thereof thereto. In an exemplary embodiment, an exemplary two-way smart material may further include a restoring shape to an original form due to removing at least one of an exemplary electric field, an exemplary magnetic field, an exemplary light change, an exemplary temperature change, exemplary ultrasound waves, and combinations thereof

[0031] In an exemplary embodiment, an exemplary system may further include a urine-levelsensor utilized for measuring an amount of bladder fullness of an exemplary living body. In an exemplary embodiment, an exemplary bladder actuator may contract an exemplary bladderwall if an exemplary measured amount of bladder fullness is more than a threshold. In an exemplary embodiment, an exemplary urine-level sensor may include at least one of a strain sensor, a pressure / force sensor, an impedance sensor, and combinations thereof. In an exemplary embodiment, an exemplary urine-level sensor may be utilized to measure urine volume in an exemplary bladder by measuring changes of at least one of strain of an exemplary bladder external wall, electrical impedance of an exemplary bladder external wall, pressure / force applied to an exemplary bladder external wall, and combinations thereof during filling and / or voiding an exemplary bladder.

[0032] In an exemplary embodiment, an exemplary system may further include amicrocontroller coupled to an exemplary actuator and an exemplary urine-level sensor. In an exemplary embodiment, microcontroller may include a processing unit to perform one or more methods utilizing an exemplary actuator. In an exemplary embodiment, an exemplary urine- level sensor may be additionally utilized to perform an exemplary one or more methods. In an exemplary embodiment, a first method of an exemplary one or more methods may include detecting an exemplary amount of an exemplary bladder fullness by measuring urine volume in an exemplary bladder utilizing an exemplary urine-level sensor and inducing micturition by contracting an exemplary bladder via applying at least one of an exemplary electric field, an exemplary magnetic field, an exemplary light change, an exemplary temperature change, exemplary ultrasound waves, and combinations thereof to an exemplary bladder actuator. In an exemplary embodiment, a second method of an exemplary one or more methods may include keeping an exemplary urethra contracted by applying at least one of an exemplary electric field, an exemplary magnetic field, an exemplary light change, an exemplary temperature change, exemplary ultrasound waves, and combinations thereof to an exemplary urethra actuator and opening an exemplary urethra for urine outflow by releasing urethra contraction right before initiating micturition via ceasing applying at least one of an exemplary electric field, an exemplary magnetic field, an exemplary light change, an exemplary temperature change, exemplary ultrasound waves, and combinations thereof to an exemplary urethra actuator. In an exemplary embodiment, a third method of an exemplary one or more methods may include contracting an exemplary ureter via applying at least one of an exemplary electric field, an exemplary magnetic field, an exemplary light change, an exemplary temperature change, exemplary ultrasound waves, and combinations thereof to an exemplary ureter actuator right before initiating micturition.

[0033] In an exemplary embodiment, an exemplary microcontroller may further include acommunication module wirelessly coupled to a user-notifying device. In an exemplary embodiment, an exemplary communication module may be utilized to inform a user (e.g., an exemplary living body, a physician, a caregiver, etc.) by a set of information, including at least one of an exemplary measured urine volume, an alarm of detecting an exemplary percentage of an exemplary bladder fullness being more than an exemplary threshold and combinations thereof. In an exemplary embodiment, an exemplary communication module may be further utilized to receive a command from an exemplary user, where an exemplary command may include initiating micturition by an exemplary system. In an exemplary embodiment, an exemplary one or more methods may further include communicating a set of data with an exemplary user-notifying device in real time based on an exemplary detected percentage of an exemplary bladder fullness utilizing an exemplary communication module. In an exemplary embodiment, an exemplary set of data may include at least one of an exemplary measured urine volume, an alarm of an emergency need for micturition responsive to detecting the percentage of an exemplary bladder fullness being more than an exemplary threshold, an alarm of start of micturition, a command from an exemplary user to start micturition, and combinations thereof.

[0034] FIG. 1A schematically shows an in-vivo implantable system 100 for bladdermanagement of a living body having urinary system dysfunctions, consistent with one or more exemplary embodiments of the present disclosure. In an exemplary embodiment, in-vivoimplantable system 100 may include an actuator 102 and a microcontroller 106. In anexemplary embodiment, in-vivo implantable system 100 may further include a urine-levelsensor 104. In an exemplary embodiment, microcontroller 106 may be coupled to actuator 102and urine-level sensor 104. In an exemplary embodiment, microcontroller 106 may beelectrically connected to actuator 102 via an electrically conductive line 108. Furthermore,microcontroller 106 may be electrically connected to urine-level sensor 104 via an electricallyconductive line 110.

[0035] In an exemplary embodiment, actuator 102 may include a smart material. In anexemplary embodiment, an exemplary smart material may include a material having a changeable shape when is stimulated by an external force. In an exemplary embodiment, an exemplary smart material may include an exemplary material having a changeable shape due to applying at least one of an electric field, a magnetic field, a light change, a temperature change, ultrasound waves, and combinations thereof to an exemplary smart material. In anexemplary embodiment, an exemplary smart material may include a stretchable material, which may be stretched due to stimulation by an external force. In an exemplary embodiment, an exemplary smart material may include a biomaterial being compatible with an exemplary livingbody; allowing for implanting actuator 102 inside an exemplary living body. In an exemplaryembodiment, an exemplary smart material may include a two-way smart material. In an exemplary embodiment, an exemplary two-way smart material may include an exemplary material further having a restoring shape to an original form due to removing an external force. In an exemplary embodiment, an exemplary two-way smart material may include an exemplary restoring shape to an exemplary original form by removing at least one of an exemplary electric field, an exemplary magnetic field, an exemplary light change, an exemplary temperature change, exemplary ultrasound waves, and combinations thereof from an exemplary two-way smart material. In an exemplary embodiment, no external stimuli may be needed to revert shape of an exemplary two-way smart material to its original form. However, in an exemplary embodiment, an exemplary two-way smart material may relax to an original shape by applying an external stimulation. In an exemplary embodiment, an exemplary two-way smart material may relax / revert to an exemplary original shape by applying at least one of an exemplary electric field, an exemplary magnetic field, an exemplary light change, an exemplary temperature change, exemplary ultrasound waves, and combinations thereof.

[0036] In an exemplary embodiment, actuator 102 may include one or more pieces of anexemplary smart material. In an exemplary embodiment, actuator 102 may include exemplaryone or more pieces of a two-way smart biomaterial. In an exemplary embodiment, actuator 102may be made of at least one of a shape memory alloy (SMA), a shape memory polymer (SMP), an electroactive polymer (EAP), a magneto-responsive material, a thermoresponsive polymer, an ultrasound-responsive material, and combinations thereof. In an exemplary embodiment, an exemplary SMA may include a thermally activated material that may be stimulated by applying voltage through Joule heating. In an exemplary embodiment, an exemplary SMP may include a material that may be activated by a change in temperature or light. In an exemplary embodiment, an exemplary EAP may include a material that may be activated by applying an electric field. In an exemplary embodiment, an exemplary EAP may bend or expand by applying an electrical voltage. In an exemplary embodiment, an exemplary magneto- responsive material may be activated by applying an external magnetic field and an exemplary thermoresponsive polymer may be activated by a change in temperature during volume phasetransition. In an exemplary embodiment, an exemplary ultrasound-responsive material may bend or expand due to exposure to ultrasound waves. In an exemplary embodiment, an exemplary two-way smart material may include nitinol. In an exemplary embodiment, nitinol may include a nickel-titanium (Ni-Ti) alloy. In an exemplary embodiment, exemplary one or more pieces of an exemplary smart material may include one or more fibers of nitinol.

[0037] FIG. 1B schematically shows actuator 102, consistent with one or more exemplaryembodiments of the present disclosure. In an exemplary embodiment, actuator 102 may includea wire shape. In an exemplary embodiment, actuator 102 may include one or more wires 120of an exemplary smart material. In an exemplary embodiment, each wire 120 may include anexemplary smart material with a coil shape twisted / wound in form of a plurality of microhelices122. In an exemplary embodiment, each microhelix 122 may include a diameter 124 (i.e., acoil diameter) in a range of about 0.1 mm to about 5 mm. In an exemplary embodiment, eachwire 120 may have a diameter 126 in a range of about 0.05 mm to about 0.5 mm. In anexemplary embodiment, each wire 120 may have a length 126 of at least about 0.5 cm. In anexemplary embodiment, each wire 120 may have a length 126 equal to an external diameter ofat least one of a bladder, a urethra, at least one ureter, and combinations thereof of an exemplaryliving body; allowing for covering actuator 102 one round around at least one of an exemplarybladder, an exemplary urethra, at least one ureter, and combinations thereof of an exemplaryliving body. In an exemplary embodiment, each wire 120 may have a length 126 in a range ofabout 0.5 cm to about 20 cm to cover at most one round at least one of an exemplary bladder, an exemplary urethra, at least one ureter, and combinations thereof of an exemplary livingbody. In an exemplary embodiment, each wire 120 may have a length 126 of more than about20 cm to cover more than one rounds around at least one of an exemplary bladder, an exemplary urethra, at least one ureter, and combinations thereof of an exemplary living body.

[0038] In an exemplary embodiment, at least one of actuator 102, urine-level sensor 104, andcombinations thereof may be directly implanted in an exemplary living body. In anotherexemplary embodiment at least one of actuator 102, urine-level sensor 104, and combinationsthereof may be embedded in a sublayer (e.g., a flexible sheath) and along with an exemplarysublayer may be implanted in an exemplary living body. With more reference to FIG. 1, in-vivo implantable system 100 may further include at least one substrate 101. In an exemplaryembodiment, actuator 102 and urine-level sensor 104 may be separately or integratedlyembedded inside at least one substrate 101. In an exemplary embodiment, at least one substrate101 may include a single piece and both of actuator 102 and urine-level sensor 104 may beembedded therein as exemplary shown in FIG. 1. In an exemplary embodiment, at least onesubstrate 101 may include two pieces and actuator 102 and urine-level sensor 104 may beseparately embedded in respective pieces (not illustrated). In an exemplary embodiment, atleast one substrate 101 may include a plurality of pieces and exemplary one or more pieces ofan exemplary smart material may be separately embedded in exemplary plurality of pieces (notillustrated).

[0039] In an exemplary embodiment, at least one substrate 101 may include a soft flexiblematerial. In an exemplary embodiment, at least one substrate 101 may include a soft flexiblepolymer. In an exemplary embodiment, at least one substrate 101 may include an elastomer. Inan exemplary embodiment, at least one substrate 101 may include a biocompatible material. Inan exemplary embodiment, at least one substrate 101 may include a silicon elastomer.

[0040] In an exemplary embodiment, in-vivo implantable system 100 may be implanted in anexemplary living body. As used herein, “an exemplary living body” may refer to an animal or human. In an exemplary embodiment, “an exemplary living body” may refer to an animal or human having bladder or urinary system dysfunctions. In an exemplary embodiment, “an exemplary living body” may refer to an animal or human having at least one of an underactive bladder (UAB), a neurogenic bladder, an overactive bladder (OAB), a leaky bladder, urine reflux to kidneys, and combinations thereof. In an exemplary embodiment, in-vivo implantablesystem 100 may be utilized for at least one of determining a time of micturition, detectingbladder fullness percentage, detecting a need for micturition, management of micturition, initiating micturition, preventing bladder leakage from urethra of an exemplary living body, preventing urine reflux from bladder of an exemplary living body to kidneys of an exemplary living body through ureter(s) of an exemplary living body, and combinations thereof. In anexemplary embodiment, parts of in-vivo implantable system 100 may be utilized and in-vivoimplanted based on a process to be carried out using in-vivo implantable system 100. In anexemplary embodiment, actuator 102 and microcontroller 106 may be used without a need forimplanting urine-level sensor 104. In an exemplary embodiment, urine-level sensor 104 andmicrocontroller 106 may be used without a need for implanting actuator 102. In an exemplaryembodiment, whole parts of in-vivo implantable system 100 may be necessarily implanted andutilized. Furthermore, one or more parts or whole parts of actuator 102, urine-level sensor 104,and microcontroller 106 may be utilized.

[0041] In an exemplary embodiment, in-vivo implantable system 100 may be implanted insidean exemplary living body to overcome one or more urinary system dysfunctions as illustratedin FIGs. 2A-2C. FIG. 2A schematically shows in-vivo implantable system 100 implanted formicturition management, consistent with one or more exemplary embodiments of the presentdisclosure. In an exemplary embodiment, in-vivo implantable system 100 may be non-invasively and flexibly implanted externally to bladder 202. In an exemplary embodiment,actuator 102 and urine-level sensor 104 may be implanted on a bladder external wall 204 ofbladder 202 of an exemplary living body. In an exemplary embodiment, actuator 102 and urine-level sensor 104 may be implanted onto detrusor muscle (i.e., a first external layer of bladder202) of bladder 202 of an exemplary living body. In an exemplary embodiment, actuator 102and urine-level sensor 104 may be secured to bladder external wall 204 of an exemplary livingbody. In an exemplary embodiment, microcontroller 106 may be implanted under skin of anexemplary living body in the vicinity of bladder 202. In an exemplary embodiment,microcontroller 106 may be subcutaneously implanted in abdominal area of an exemplaryliving body in the vicinity of actuator 102 and urine-level sensor 104. In an exemplaryembodiment, microcontroller 106 may be secured to bladder external wall 204 of an exemplaryliving body. In an exemplary embodiment, actuator 102 may be attached firmly to bladderexternal wall 204 and may be utilized to contract bladder 202 via applying an exemplaryexternal force to actuator 102. In an exemplary embodiment, an exemplary external force toactuator 102 may be applied using microcontroller 106.

[0042] In an exemplary embodiment, microcontroller 106 may be in communication with auser-notifying device 206 via a wired or wireless connection 208. In an exemplaryembodiment, user-notifying device 206 may include at least one of a computing device havingan interface, a processor coupled to an interface, a smartphone, a computer, a vibrator, a sound making device, a light emitting device, and combinations thereof. In an exemplaryembodiment, user-notifying device 206 may include at least one of a wearable device by anexemplary living body, an attachable device to an exemplary living body, a device utilizing by an exemplary living body, a device being in the vicinity of an exemplary living body, a device being far from an exemplary living body.

[0043] In an exemplary embodiment, user-notifying device 206 may include an interface andmay be used to communicate a set of data in real time between a user who may access user-notifying device 206 and microcontroller 106. In an exemplary embodiment, an exemplary usermay include at least one of an exemplary living body, a patient who may have urinary system dysfunctions, a physician, a caregiver, an expert in urinary system dysfunctions, and combinations thereof. In an exemplary embodiment, an exemplary set of data may include atleast one of a measured urine volume using urine-level sensor 104, an alarm of an emergencyneed for micturition if an exemplary percentage of bladder fullness is more than a threshold, an alarm of start of micturition, a command from an exemplary user to start micturition, and combinations thereof. In an exemplary embodiment, communicating an exemplary set of datawith user-notifying device 206 may include at least one of sending an exemplary set of data touser-notifying device 206, producing at least one of vibration, light, sound, and combinationsthereof under / over skin of an exemplary living body, producing at least one of vibration, light,sound, and combinations thereof on user-notifying device 206, and combinations thereof. In anexemplary embodiment, an exemplary set of data may be stored in microcontroller 106 andmay be called on-demand using user-notifying device 206.

[0044] In an exemplary embodiment, an exemplary set of data may include an exact amountof an exemplary percentage of bladder fullness and / or a range of an exemplary percentage of bladder fullness. In an exemplary embodiment, a specific vibration, light, sound, or any otheralarm or announcing sign may be produced and alerted by user-notifying device 206.

[0045] In an exemplary embodiment, percentage of bladder fullness of bladder 202 may bedetected by measuring urine volume in bladder 202 using urine-level sensor 104. In anexemplary embodiment, an exemplary detected percentage of bladder fullness may be accessedby microcontroller 106 and reported to an exemplary user using user-notifying device 206. Inan exemplary embodiment, micturition may be induced by microcontroller 106 due to at leastone of detecting an exemplary percentage of bladder fullness being more than an exemplary threshold, receiving a command from an exemplary user to start micturition, and combinations thereof. In an exemplary embodiment, an exemplary threshold may be determined and presetbased on a status of bladder 202 and / or an exemplary dysfunction of urinary system of anexemplary living body using at least one of microcontroller 106, user-notifying device 206,and combinations thereof. In an exemplary embodiment, an exemplary threshold may includea 90 percent fullness of bladder 202. In an exemplary embodiment, an exemplary thresholdmay include an 80 percent fullness of bladder 202. In an exemplary embodiment, micturitionmay be induced by applying at least one of an exemplary electric field, an exemplary magneticfield, an exemplary light change, an exemplary temperature change, exemplary ultrasoundwaves, and combinations thereof to actuator 102.

[0046] FIG. 2B schematically shows in-vivo implantable system 100 implanted formanagement of a leaky bladder, consistent with one or more exemplary embodiments of thepresent disclosure. In an exemplary embodiment, in-vivo implantable system 100 may beimplanted inside an exemplary living body to prevent urine leakage from bladder 202. In anexemplary embodiment, actuator 102 may be secured around urethra 210 of bladder 202. In anexemplary embodiment, urethra 210 may be kept contracted when micturition is not needed byapplying at least one of an exemplary electric field, an exemplary magnetic field, an exemplary light change, an exemplary temperature change, exemplary ultrasound waves, andcombinations thereof to actuator 102. In an exemplary embodiment, a path of urine throughurethra 210 may remain closed; thereby, urine leakage may not happen. In an exemplaryembodiment, actuator 102 may be coupled to microcontroller 106 via an electrically conductiveline 212. In an exemplary embodiment, a contraction of urethra 210 may be released byremoving at least one of an exemplary electric field, an exemplary magnetic field, an exemplary light change, an exemplary temperature change, exemplary ultrasound waves, andcombinations thereof from actuator 102 right before starting micturition. In an exemplaryembodiment, contraction of urethra 210 may be released when at least one of a command ofmicturition is sent by an exemplary user to microcontroller 106 using user-notifying device206, an exemplary detected percentage of bladder fullness is more than an exemplary threshold,and combinations thereof. In an exemplary embodiment, urine-level sensor 104 may be usedto detect an exemplary percentage of bladder fullness as described herein above in connectionwith FIG. 2A.

[0047] FIG.2C schematically shows in-vivo implantable system 100 implanted for preventionof urine reflux to kidneys, consistent with one or more exemplary embodiments of the presentdisclosure. In an exemplary embodiment, in-vivo implantable system 100 may be implantedinside an exemplary living body to prevent urine reflux to kidneys through at least one ureter 214 while micturition is occurred. In an exemplary embodiment, in-vivo implantable system100 may be implanted inside an exemplary living body to prevent reflux of urine from bladder202 to kidneys through at least one ureter 214 connecting an exemplary kidney (not illustrated)to bladder 202. In an exemplary embodiment, actuator 102 may be secured around at least oneureter 214 to keep ureter 214 contracted during micturition; thereby, no reflux from bladder202 to kidneys may occur. In an exemplary embodiment, actuator 102 may be coupled tomicrocontroller 106 via an electrically conductive line 216. In an exemplary embodiment, atleast one ureter 214 may be contracted by applying at least one of an exemplary electric field,an exemplary magnetic field, an exemplary light change, an exemplary temperature change,exemplary ultrasound waves, and combinations thereof to actuator 102 right before initiatingmicturition. In an exemplary embodiment, contraction of at least one ureter 214 may beconducted when at least one of an exemplary command of micturition is sent by an exemplaryuser to microcontroller 106 using user-notifying device 206, an exemplary detected percentageof bladder fullness is more than an exemplary threshold, and combinations thereof. In anexemplary embodiment, urine-level sensor 104 may be used to detect an exemplary percentageof bladder fullness as described herein above in connection with FIG. 2A.

[0048] In further details with respect to FIG. 1, at least one substrate 101 may be in differentshapes. In an exemplary embodiment, at least one substrate 101 may be in a shape of at leastone of a band, a strip, a cap, a patch, a ring, and combinations thereof. In an exemplaryembodiment, actuator 102 and / or urine-level sensor 104 embedded inside at least one substrate101 may be securable to at least one of bladder 202, urethra 210, at least one ureter 214, andcombinations thereof by at least one of placing at least one substrate 101 along with actuator102 and / or urine-level sensor 104 embedded therein on top of bladder 202, fastening at leastone substrate 101 along with actuator 102 and / or urine-level sensor 104 embedded thereinaround bladder external wall 204, adhering at least one substrate 101 along with actuator 102and / or urine-level sensor 104 embedded therein to bladder external wall 204, suturing at leastone substrate 101 along with actuator 102 and / or urine-level sensor 104 embedded therein tobladder external wall 204, fastening at least one substrate 101 along with actuator 102 and / orurine-level sensor 104 embedded therein around urethra 210 and / or at least one ureter 214,suturing at least one substrate 101 along with actuator 102 and / or urine-level sensor 104embedded therein around urethra 210 and / or at least one ureter 214, and combinations thereofas illustrated in FIGs. 2A-2C and described hereinbelow.

[0049] In an exemplary embodiment, at least one substrate 101 may include one or moreopenings and at least one substrate may be sutured to at least one of bladder external wall 204,urethra 210, at least one ureter 214, and combinations thereof through an exemplary one ormore openings. In an exemplary embodiment, at least one substrate 101 may include a patchadherable to at least one of bladder external wall 204, urethra 210, at least one ureter 214, andcombinations thereof. FIGs. 3A-3B schematically show a buckle-type structure 300 of at leastone substrate 101 along with actuator 102 embedded therein in two open (FIG.3A) and closed(FIG. 3B) positions, consistent with one or more exemplary embodiments of the presentdisclosure. In an exemplary embodiment, at least one substrate 101 may include a band of anexemplary soft flexible material with two ends 302 and 304. In an exemplary embodiment, twoends 302 and 304 may form a buckle used for fastening at least one substrate 101 around atleast one of bladder external wall 204, urethra 210, at least one ureter 214, and combinationsthereof. In an exemplary embodiment, two ends 302 and 304 may join together to fasten atleast one substrate 101 around at least one of bladder external wall 204, urethra 210, at leastone ureter 214, and combinations thereof.

[0050] FIGs. 4A-4B schematically show two views 402 and 404 of a cap-type structure 400of at least one substrate 101 along with actuator 102 and urine-level sensor 104 embeddedtherein, consistent with one or more exemplary embodiments of the present disclosure. In anexemplary embodiment, at least one substrate 101 may include a cap-shaped layer of anexemplary soft flexible material. In an exemplary embodiment, actuator 102 and urine-levelsensor 104 may be embedded inside an exemplary cap-shaped layer of an exemplary softflexible material. In an exemplary embodiment, at least one substrate 101 having cap-typestructure 400 may be implanted over bladder external wall 204. In an exemplary embodiment,at least one substrate 101 may include at least one opening 406 to fasten cap-type structure 400over bladder external wall 204, for example, by suturing at least one substrate 101 throughopening 406 onto bladder external wall 204.

[0051] FIG. 5 schematically shows a mesh-like structure 500 of actuator 102, consistent withone or more exemplary embodiments of the present disclosure. In an exemplary embodiment,actuator 102 may have a mesh-like structure 500, including one or more wires 502 of anexemplary smart material interconnected (woven) together. In an exemplary embodiment,actuator 102 with mesh-like structure 500 may be implantable at a location of at least one ofon top of bladder 202, onto a portion of bladder external wall 204, around bladder external wall204, and combinations thereof. In an exemplary embodiment, actuator 102 with mesh-likestructure 500 may be in shape of a cap; allowing for placing over bladder 202 with or withouta complementary fastening tool. In an exemplary embodiment, actuator 102 with mesh-likestructure 500 may be connected to microcontroller 106 to be used for contracting bladder 202when micturition is needed. In an exemplary embodiment, actuator 102 with mesh-likestructure 500 may be in a ring shape and may be externally implanted around bladder 202. Inan exemplary embodiment, actuator 102 with mesh-like structure 500 may be in one or morepieces attached onto a portion of bladder external wall 204. In an exemplary embodiment,actuator 102 with mesh-like structure 500 may additionally be sutured or adhered to bladderexternal wall 204. In an exemplary embodiment, actuator 102 with mesh-like structure 500may cover parts or whole of bladder external wall 204; allowing for inducing high contractionfor urination. In an exemplary embodiment, actuator 102 with mesh-like structure 500 maycover most area of bladder external wall 204; allowing for inducing high contraction forurination.

[0052] In further details with respect to FIG. 1A, urine-level sensor 104 may be securable tobladder external wall 204. In an exemplary embodiment, urine-level sensor 104 may includeat least one of a strain sensor, a pressure / force sensor, an impedance sensor, and combinationsthereof. In an exemplary embodiment, urine-level sensor 104 may be utilized to measure urinevolume in bladder 202 by measuring changes of at least one of strain of bladder external wall204, electrical impedance of bladder external wall 204, pressure / force applied to bladderexternal wall 204, and combinations thereof during filling and / or voiding bladder 202.

[0053] FIG. 6A schematically shows a strain sensor 600, consistent with one or moreexemplary embodiments of the present disclosure. Furthermore, FIG. 6B schematically showsstrain sensor 600 embedded inside at least one substrate 101, consistent with one or moreexemplary embodiments of the present disclosure. In an exemplary embodiment, strain sensor600 may be capable of detecting deformation and / or stretching of bladder external wall 204during filling and / or voiding. In an exemplary embodiment, a measurable parameter by strainsensor 600 may include a change in resistance or capacitance of strain sensor 600 that may beproportional to bladder volume of bladder 202. In an exemplary embodiment, strain sensor 600may include at least one of an electrical capacitance, an electrical resistance, and combinations thereof being changeable due to a change in bladder volume during filling and / or voidingbladder 202. In an exemplary embodiment, strain sensor 600 may include at least one of apiezoresistive material, a capacitive layer, a stretchable conductive composite, andcombinations thereof. In an exemplary embodiment, strain sensor 600 may include anelectrically conductive material. In an exemplary embodiment, strain sensor 600 may includea biocompatible electrically conductive material. In an exemplary embodiment, strain sensor600 may include at least one of silver nanowires (AgNWs), carbon nanotubes (CNTs), carbonblack nanoparticles (CBNPs), and combinations thereof.

[0054] In an exemplary embodiment, an exemplary pressure / force sensor may be utilized tomeasure pressure and / or mechanical force changes on bladder external wall 204 during fillingand / or voiding bladder 202 as a criterion of an exemplary percentage of an exemplary bladderfullness. In an exemplary embodiment, a pressure / force signal may be measured utilizing an exemplary pressure / force sensor. In an exemplary embodiment, an exemplary measured pressure / force signal may correlate with bladder volume. In an exemplary embodiment, an exemplary pressure / force sensor may include at least one of a capacitive sensing element, a piezoresistive sensing element, an optical sensing element, a micro-electro-mechanical system (MEMS)-based sensor, and combinations thereof.

[0055] In an exemplary embodiment, an exemplary impedance sensor may monitor changes intissue impedance as bladder external wall 204 stretches. In an exemplary embodiment, anexemplary impedance sensor may include electrode pairs embedded in or placed onto bladderexternal wall 204. In an exemplary embodiment, a variation in impedance of bladder externalwall 204 may be measured by an exemplary impedance sensor. In an exemplary embodiment,an exemplary measured variation in impedance of bladder external wall 204 may correlate withtissue deformation of bladder 202 during filling and / or voiding bladder 202. In an exemplaryembodiment, an exemplary impedance sensor may include a pair of electrodes attached tobladder external wall 204.

[0056] FIG. 7 schematically shows microcontroller 106, consistent with one or moreexemplary embodiments of the present disclosure. In an exemplary embodiment,microcontroller 106 may include a base layer 702 and further parts of microcontroller 106 maybe attached, coupled, or adhered to base layer 702. In an exemplary embodiment, base layer 702 may include a printed circuit board (PCB). In an exemplary embodiment, base layer 702 may include a piece of a soft flexible material. In an exemplary embodiment, base layer 702 may include a piece of at least one of a soft flexible biomaterial, a soft flexible biocompatible material, and combinations thereof. In an exemplary embodiment, base layer 702 may include a piece of a soft flexible biocompatible polymer. In an exemplary embodiment, base layer 702 may include a piece of a soft flexible biocompatible thermoplastic polymer. In an exemplary embodiment, base layer 702 may include a piece of at least one of polyimide, a fiberglass- reinforced epoxy-laminated material, Polyurethane, Polyethylene Terephthalate, PolyethyleneNaphthalate, and combinations thereof. In an exemplary embodiment, base layer 702 may include a flat board with a length in a range of 5 mm to 20 mm and a width in a range of 5 mm to 20 mm. In an exemplary embodiment, base layer 702 may include a flat board with a length of 15 mm and a width of 15 mm. In an exemplary embodiment, such small size of base layer702 and consequently, a small size of microcontroller 106 may allow for simple and safeimplantation of microcontroller 106 in an exemplary living body, specifically, under skin of anexemplary living body. In an exemplary embodiment, base layer 702 may have laser cutsmooth edges allowing for preventing damage to a tissue or skin of an exemplary living bodywhen microcontroller 106 is placed in contact thereto.

[0057] Referring to FIG. 7, microcontroller 106 may further include a processing unit 704attached onto base layer 702. In an exemplary embodiment, processing unit 704 may include amicrocontroller (MCU). In an exemplary embodiment, processing unit 704 may be electricallycoupled to actuator 102 and urine-level sensor 104. In an exemplary embodiment,microcontroller 106 may further include a communication module 706 coupled to processingunit 704. In an exemplary embodiment, communication module 706 may be at least one ofattached to base layer 702, embedded inside processing unit 704, and combinations thereof. Inan exemplary embodiment, communication module 706 may be coupled to user-notifyingdevice 206 via at least one of a wireless connection, electrically conductive wires, andcombinations thereof. In an exemplary embodiment, an exemplary wireless connection may include Bluetooth devices or Bluetooth modules, which may be embedded in communicationmodule 706 and processing unit 704.

[0058] In an exemplary embodiment, processing unit 704 may utilize and control at least oneof actuator 102, urine-level sensor 104, communication module 706, and combinations thereofto perform a method for urinary system management. In an exemplary embodiment, an exemplary method may include at least one method of management of micturition, prevention of bladder leakage, prevention of urine reflux to kidneys of the living body, and combinationsthereof. In an exemplary embodiment, processing unit 704 may include a memory and aprocessor. In an exemplary embodiment, memory may have processor-readable instructions stored therein and processor may be capable of accessing an exemplary memory and execute exemplary processor-readable instructions. In an exemplary embodiment, an exemplary processor may perform an exemplary method when exemplary processor-readable instructions are executed by an exemplary processor.

[0059] In an exemplary embodiment, microcontroller 106 may include one or more voltagedrivers 701 coupled to actuator 102 and processing unit 704. In an exemplary embodiment, oneor more voltage drivers 701 may be electrically connected to actuator 102 and processing unit704. In an exemplary embodiment, one or more voltage drivers 701 may be utilized byprocessing unit 704 to apply an exemplary electric field to actuator 102. In an exemplaryembodiment, one or more voltage drivers 701 may be utilized to apply an electrical voltage toactuator 102; thereby, resulting in contracting at least one of bladder external wall 204, urethra210, at least one ureter 214, and combinations thereof. In an exemplary embodiment, one ormore voltage drivers 701 may be utilized to apply a set of electrical voltage cycles to one ormore pieces of an exemplary smart material of actuator 102. In an exemplary embodiment,each electrical voltage cycle of an exemplary set of electrical voltage cycles may include an electrical voltage in a range of about 1 V to about 15 V during a time period in a range of about 5 s to about 50 s with a frequency in a range of about 0.1 Hz to about 0.5 Hz.

[0060] In an exemplary embodiment, microcontroller 106 may further include an analog-to-digital converter (ADC) 703. In an exemplary embodiment, ADC 703 may be coupled to urine-level sensor 104 and processing unit 704. In an exemplary embodiment, ADC 703 may beelectrically connected to urine-level sensor 104 and processing unit 704. In an exemplaryembodiment, ADC 703 may be utilized to convert an exemplary detected percentage of bladderfullness of bladder 202 by urine-level sensor 104 to a digital data readable by processing unit704.

[0061] In an exemplary embodiment, microcontroller 106 may include an ultra-low energyconsuming device with a required power in a range of 360 nW to 160 mW. In an exemplaryembodiment, microcontroller 106 may further include a wirelessly recharging mechanism forpower-needed elements of in-vivo implantable system 100. In an exemplary embodiment withreference to FIG. 7, an exemplary wirelessly recharging mechanism may include arechargeable battery 708 coupled to base layer 702, a wireless battery charging module 710attached onto base layer 702, a wireless power receiver 712, and a wireless power transmitter714. In an exemplary embodiment, rechargeable battery 708 may supply a power consumed byone or more elements of in-vivo implantable system 100, for example, actuator 102, urine-levelsensor 104, microcontroller 106, and exemplary Bluetooth devices or Bluetooth modules.Furthermore, FIG. 8 schematically shows a block diagram 800 of battery recharging circuit,consistent with one or more exemplary embodiments of the present disclosure.

[0062] Referring to FIGs. 7 and 8, rechargeable battery 708 may be attached to base layer 702at battery connection port 716 via connecting line 718. In an exemplary embodiment,connecting line 718 may include a soft stretchable electrically conductive line; allowing forimplanting rechargeable battery 708 either in the vicinity of at least one of bladder 202, urethra210, at least one ureter 214, and combinations thereof or far from. In an exemplaryembodiment, connecting line 718 may be capable of stretching up to 70%. In an exemplaryembodiment, rechargeable battery 708 may be subcutaneously placed under skin of anexemplary living body in the vicinity of at least one of bladder 202, urethra 210, at least oneureter 214, and combinations thereof and base layer 702. In an exemplary embodiment,rechargeable battery 708 may be subcutaneously placed under skin of an exemplary living bodyaway from at least one of bladder 202, urethra 210, at least one ureter 214, and combinationsthereof and base layer 702.

[0063] In an exemplary embodiment, wireless power receiver 712 may include a receiverantenna 720 and a matching circuit 722. In an exemplary embodiment, matching circuit 722may tune wireless power reception frequency range, ensuring maximum power transferbetween wireless power transmitter 714 and wireless power receiver 712 on base layer 702. Inan exemplary embodiment, receiver antenna 720 may be coupled to matching circuit 722 onbase layer 702 via a connection between receiver antenna 720 and base layer 702. In anexemplary embodiment, receiver antenna 720 may be connected to base layer 702 in tetheredfashion. In an exemplary embodiment, receiver antenna 720 may be connected to base layer702 by connecting receiver antenna 720 to an antenna connection 724 embedded on base layer702 via connecting line 726. In an exemplary embodiment, connecting line 726 may includean electrically conductive wire. In an exemplary embodiment, connecting line 726 may includea soft stretchable electrically conductive line; allowing for implanting receiver antenna 720either in the vicinity of at least one of bladder 202, urethra 210, at least one ureter 214, andcombinations thereof or far from. In an exemplary embodiment, connecting line 726 may becapable of stretching up to 70%. In an exemplary embodiment, receiver antenna 720 may besubcutaneously placed under skin of an exemplary living body in the vicinity of at least one ofbladder 202, urethra 210, at least one ureter 214, and combinations thereof and base layer 702.In an exemplary embodiment, receiver antenna 720 may be placed on base layer 702. In anexemplary embodiment, receiver antenna 720 may be subcutaneously placed under skin of anexemplary living body away from at least one of bladder 202, urethra 210, at least one ureter214, and combinations thereof and base layer 702. In an exemplary embodiment,microcontroller 106 may be subcutaneously placed under skin of an exemplary living body viaa surgery and cut area may be sutured.

[0064] In an exemplary embodiment, wireless power transmitter 714 may include a powergeneration unit 728 and a transmitter antenna 730. In an exemplary embodiment, transmitterantenna 730 may be wirelessly coupled to receiver antenna 720. In an exemplary embodiment,transmitter antenna 730 may be coupled to receiver antenna 720 through a magnetic resonantconnection. In an exemplary embodiment, receiver antenna 720 may receive a signal / fieldgenerated by power generation unit 728 and sent by transmitter antenna 730. In an exemplaryembodiment, a wireless communication between transmitter antenna 730 and receiver antenna720 may be used to transfer a power generated by power generation unit 728 to rechargeablebattery 708. In an exemplary embodiment, transmitter antenna 730 and power generation unit728 may be placed outside an exemplary living body. In an exemplary embodiment, transmitterantenna 730 may be placed at a location over skin of an exemplary living body in the vicinityof receiver antenna 720. In an exemplary embodiment, transmitter antenna 730 and receiverantenna 720 may be placed in the vicinity of at least one of bladder 202, urethra 210, at leastone ureter 214, and combinations thereof. In an exemplary embodiment, power generation unit728 may be placed outside of an exemplary living body far from transmitter antenna 730. In anexemplary embodiment, power generation unit 728 may be placed over skin of an exemplaryliving body in the vicinity of transmitter antenna 730 or far from transmitter antenna 730. In anexemplary embodiment, transmitter antenna 730 and receiver antenna 720 may becoupled / connected together through a wireless magnetic resonant connection 732. In anexemplary embodiment, transmitter antenna 730 may be coupled to power generation unit 728via an electrically conductive line 734 (e.g., a wired connection). In an exemplary embodiment,wireless battery charging module 710 may be coupled to wireless power receiver 712 andrechargeable battery 708. In an exemplary embodiment, wireless battery charging module 710may transmit a received power by wireless power receiver 712 to rechargeable battery 708. Inan exemplary embodiment, rechargeable battery 708 may be charged by wireless batterycharging module 710 utilizing a power transmitted from wireless power transmitter 714 towireless power receiver 712 at a low frequency range of 100 kHz to 200 kHz. In an exemplaryembodiment, an exemplary low frequency range of wireless power transmission may allow forundistorted wave and minimum absorption in an exemplary living body, leading to a long-range transmission of wireless power into skin and / or tissue; thereby, resulting in fast andsimple recharge of rechargeable battery 708 with minimum absorption by tissues in anexemplary living body.

[0065] In an exemplary embodiment, a wireless communication between transmitter antenna730 and receiver antenna 720 may further be used for further wireless communications. In anexemplary embodiment, transmitter antenna 730 may be coupled to a near-fieldcommunication (NFC) device, for example, user-notifying device 206. In an exemplaryembodiment, an exemplary NFC device may be utilized for on-demand modulations when needed. An exemplary on-demand modulation may be done through fully passive communication protocols by an exemplary NFC device. In an exemplary embodiment, an exemplary NFC device may be used for powerless programming on-the-fly of operations andfunctions performed by microcontroller 106. In an exemplary embodiment, modulationparameters may be pre-programmed for an autonomous control by microcontroller 106 andalso may be changed on-the-fly after implantation of microcontroller 106 using an exemplaryNFC device via a wireless connection through transmitter antenna 730. In an exemplaryembodiment, acquired data from at least one of bladder 202, urethra 210, at least one ureter214, and combinations thereof by various parts of microcontroller 106 and / or urine-level sensor104 may be wirelessly transmitted to an outside-the-body module and transmitted back upon analysis to a control module for actuation. Also, an exemplary acquired data may be analyzedin microcontroller 106 to control contractions and / or releases of at least one of bladder 202,urethra 210, at least one ureter 214, and combinations thereof by actuator 102.

[0066] In an exemplary embodiment regarding FIG. 7, in-vivo implantable system 100 mayfurther include a heat control mechanism. In an exemplary embodiment, in-vivo implantablesystem 100 may further include a temperature sensor 736. In an exemplary embodiment,temperature sensor 736 may be adhered onto at least one of base layer 702, substrate 101,actuator 102, urine-level sensor 104, and combinations thereof. In an exemplary embodiment,temperature sensor 736 may be coupled to processing unit 704. In an exemplary embodiment,temperature sensor 736 may be utilized by one or more processors of processing unit 704 toautonomous keeping a temperature of at least one of bladder 202, urethra 210, at least oneureter 214, and combinations thereof and nearby tissues at a safe range. In an exemplaryembodiment, at least one of microcontroller 106, actuator 102, urine-level sensor 104, andcombinations thereof and nearby environment may be heated while working; thereby, atemperature of at least one of bladder 202, urethra 210, at least one ureter 214, andcombinations thereof and nearby environment may rise up above a safe temperature of about40 °C for an exemplary living body. In an exemplary embodiment, temperature sensor 736 maybe utilized to measure a temperature of at least one of bladder 202, urethra 210, at least oneureter 214, and combinations thereof and nearby environment at least one of before, during,and after performing an exemplary method for urinary system management. In an exemplary embodiment, an exemplary measured temperature may be compared with a threshold temperature value and one or more processes of a set of processes may be performed byprocessing unit 704 if an exemplary measured temperature is more than an exemplary thresholdtemperature value. In an exemplary embodiment, an exemplary threshold temperature value may be a temperature range of about 38 °C to 40 °C. In an exemplary embodiment, an exemplary threshold temperature value may be a temperature value of about 40 °C. In an exemplary embodiment, one or more parameters of applying at least one of an exemplary electric field, an exemplary magnetic field, an exemplary light change, an exemplarytemperature change, exemplary ultrasound waves, and combinations thereof to actuator 102may be changed to reduce an exemplary temperature of at least one of bladder 202, urethra210, at least one ureter 214, and combinations thereof and nearby tissues below an exemplarythreshold temperature value. For example, a time duration of applying at least one of an exemplary electric field, an exemplary magnetic field, an exemplary light change, an exemplary temperature change, exemplary ultrasound waves, and combinations thereof toactuator 102 may be reduced to maintain an exemplary temperature of at least one of bladder202, urethra 210, at least one ureter 214, and combinations thereof and nearby tissues belowan exemplary threshold temperature value. In an exemplary embodiment, a voltage magnitudeof an exemplary applied electric field to actuator 102 may be reduced to maintain an exemplarytemperature of at least one of bladder 202, urethra 210, at least one ureter 214, andcombinations thereof and nearby tissues below an exemplary threshold temperature value. In an exemplary embodiment, applying at least one of an exemplary electric field, an exemplary magnetic field, an exemplary light change, an exemplary temperature change, exemplaryultrasound waves, and combinations thereof to actuator 102 may be ceased temporarily orpredominantly to reduce an exemplary temperature of at least one of bladder 202, urethra 210,at least one ureter 214, and combinations thereof and nearby tissues below an exemplarythreshold temperature value.

[0067] In an exemplary embodiment, temperature sensor 736 may be utilized to measure atemperature of microcontroller 106. In an exemplary embodiment, an exemplary temperatureof microcontroller 106 may rise up when rechargeable battery 708 is being wirelesslyrecharged. In an exemplary embodiment, an exemplary heat control mechanism may be utilizedto limit an amount of heat generated by microcontroller 106 to avoid damage to at least one ofbladder 202, urethra 210, at least one ureter 214, and combinations thereof and nearby tissues.In an exemplary embodiment, temperature sensor 736 may be utilized to measure a temperatureof microcontroller 106 during recharging rechargeable battery 708. In an exemplaryembodiment, an exemplary measured temperature may be compared with an exemplary threshold temperature value. In an exemplary embodiment, an exemplary threshold temperature value may be a temperature range of about 38 °C to 40 °C. In an exemplary embodiment, an exemplary threshold temperature value may be a temperature value of about40 °C. In an exemplary embodiment, wireless charging of rechargeable battery 708 may bestopped if an exemplary measured temperature of microcontroller 106 is more than anexemplary threshold temperature value; allowing for prevention of incident electromagneticflux heat-up of microcontroller 106.

[0068] FIG.9 shows an example computer system 900 in which an embodiment of the presentinvention, or portions thereof, may be implemented as computer-readable code, consistent with exemplary embodiments of the present disclosure. For example, processes describedhereinabove associated with in-vivo implantable system 100 and / or one or more steps ofmethod 1000 described herein below may be implemented in computer system 900 usinghardware, software, firmware, tangible computer readable media having instructions stored thereon, or a combination thereof and may be implemented in one or more computer systems or other processing systems. Hardware, software, or any combination of such may embody anyof the modules and components in FIGs. 1-8.

[0069] If programmable logic is used, such logic may execute on a commercially availableprocessing platform or a special purpose device. One ordinary skill in the art may appreciate that an embodiment of the disclosed subject matter can be practiced with various computer system configurations, including multi-core multiprocessor systems, minicomputers, mainframe computers, computers linked or clustered with distributed functions, as well as pervasive or miniature computers that may be embedded into virtually any device.

[0070] For instance, a computing device having at least one processor device and a memorymay be used to implement the above-described embodiments. A processor device may be a single processor, a plurality of processors, or combinations thereof. Processor devices may have one or more processor “cores.”

[0071] An embodiment of the invention is described in terms of this example computer system900. After reading this description, it will become apparent to a person skilled in the relevant art how to implement the invention using other computer systems and / or computer architectures. Although operations may be described as a sequential process, some of the operations may in fact be performed in parallel, concurrently, and / or in a distributed environment, and with program code stored locally or remotely for access by single or multi- processor machines. In addition, in some embodiments the order of operations may be rearranged without departing from the spirit of the disclosed subject matter.

[0072] Processor device 904 may be a special purpose or a general-purpose processor device.As will be appreciated by persons skilled in the relevant art, processor device 904 may also bea single processor in a multi-core / multiprocessor system, such system operating alone, or in acluster of computing devices operating in a cluster or server farm. Processor device 904 maybe connected to a communication infrastructure 906, for example, a bus, message queue,network, or multi-core message-passing scheme.

[0073] In an exemplary embodiment, computer system 900 may include a display interface902, for example a video connector, to transfer data to a display unit 930, for example, amonitor. Computer system 900 may also include a main memory 908, for example, randomaccess memory (RAM), and may also include a secondary memory 910. Secondary memory910 may include, for example, a hard disk drive 912, and a removable storage drive 914.Removable storage drive 914 may include a floppy disk drive, a magnetic tape drive, an opticaldisk drive, a flash memory, or the like. Removable storage drive 914 may read from and / orwrite to a removable storage unit 918 in a well-known manner. Removable storage unit 918may include a floppy disk, a magnetic tape, an optical disk, etc., which may be read by andwritten to by removable storage drive 914. As will be appreciated by persons skilled in therelevant art, removable storage unit 918 may include a computer usable storage medium havingstored therein computer software and / or data.

[0074] In alternative implementations, secondary memory 910 may include other similarmeans for allowing computer programs or other instructions to be loaded into computer system900. Such means may include, for example, a removable storage unit 922 and an interface 920.Examples of such means may include a program cartridge and cartridge interface (such as that found in video game devices), a removable memory chip (such as an EPROM, or PROM) andassociated socket, and other removable storage units 922 and interfaces 920 which allowsoftware and data to be transferred from removable storage unit 922 to computer system 900.

[0075] Computer system 900 may also include a communications interface 924.Communications interface 924 allows software and data to be transferred between computersystem 900 and external devices. Communications interface 924 may include a modem, anetwork interface (such as an Ethernet card), a communications port, a PCMCIA slot and card,or the like. Software and data transferred via communications interface 924 may be in the formof signals, which may be electronic, electromagnetic, optical, or other signals capable of beingreceived by communications interface 924. These signals may be provided to communicationsinterface 924 via a communications path 926. Communications path 926 carries signals andmay be implemented using wire or cable, fiber optics, a phone line, a cellular phone link, an RF link or other communications channels.

[0076] In this document, the terms “computer program medium” and “computer usablemedium” are used to generally refer to media such as removable storage unit 918, removablestorage unit 922, and a hard disk installed in hard disk drive 912. Computer program mediumand computer usable medium may also refer to memories, such as main memory 908 andsecondary memory 910, which may be memory semiconductors (e.g. DRAMs, etc.).

[0077] Computer programs (also called computer control logic) are stored in main memory508 and / or secondary memory 910. Computer programs may also be received viacommunications interface 924. Such computer programs, when executed, enable computersystem 900 to implement different embodiments of the present disclosure as discussed herein.In particular, the computer programs, when executed, enable processor device 904 toimplement the processes of the present disclosure, such as the operations described hereinabove in connection with in-vivo implantable system 100 and / or operations in method 1000described herein below illustrated by FIGs. 1-8 discussed above and flowchart of FIG. 10described herein below, respectively. Accordingly, such computer programs representcontrollers of computer system 900. Where an exemplary embodiment of method 1000 isimplemented using software, the software may be stored in a computer program product andloaded into computer system 900 using removable storage drive 914, interface 920, and harddisk drive 912, or communications interface 924.

[0078] Embodiments of the present disclosure also may be directed to computer programproducts including software stored on any computer useable medium. Such software, when executed in one or more data processing device, causes a data processing device to operate as described herein. An embodiment of the present disclosure may employ any computer useable or readable medium. Examples of computer useable mediums include, but are not limited to, primary storage devices (e.g., any type of random access memory), secondary storage devices (e.g., hard drives, floppy disks, CD ROMS, ZIP disks, tapes, magnetic storage devices, and optical storage devices, MEMS, nanotechnological storage device, etc.).

[0079] The embodiments have been described above with the aid of functional building blocksillustrating the implementation of specified functions and relationships thereof. The boundaries of these functional building blocks have been arbitrarily defined herein for the convenience of the description. Alternate boundaries can be defined so long as the specified functions and relationships thereof are appropriately performed.

[0080] In another general aspect, the present disclosure may describe one or more methods forbladder management of an exemplary living body having a urinary system dysfunction. In an exemplary embodiment, exemplary one or more methods may be carried out utilizingexemplary in-vivo implantable system 100 described hereinabove. In an exemplaryembodiment, one or more steps of exemplary one or more methods may be implementedutilizing one or more processors. FIG. 10 shows a flowchart of a method 1000 for bladdermanagement, consistent with one or more exemplary embodiments of the present disclosure.In an exemplary embodiment, different steps of method 1000 may be implemented using in-vivo implantable system 100. Hence, method 1000 may be described herein below inconnection with in-vivo implantable system 100 fully described hereinabove through FIGs. 1-9. In an exemplary embodiment, one or more steps of method 1000 may be conducted as amethod of at least one of management of micturition, prevention of bladder leakage, prevention of urine reflux to kidneys of the living body, and combinations thereof. In an exemplaryembodiment, method 1000 may include fabricating at least one of actuator 102, urine-levelsensor 104, microcontroller 106, and combinations thereof (step 1002), implanting exemplaryfabricated at least one of actuator 102, urine-level sensor 104, microcontroller 106, andcombinations thereof in an exemplary living body (step 1004), detecting a percentage ofbladder fullness (step 1006), communicating an exemplary set of data with user-notifyingdevice 206 in real time based on an exemplary detected percentage of bladder fullness (step1008), and conducting at least one of inducing micturition by contracting bladder 202, keepingurethra 210 contracted, opening urethra 210 for urine outflow by releasing an exemplaryurethra contraction, contracting at least one ureter 214, and combinations thereof (step 1010).

[0081] In further detail with respect to step 1002, step 1002 may include fabricating at leastone of actuator 102, urine-level sensor 104, microcontroller 106, and combinations thereof. Inan exemplary embodiment, step 1002 may include fabricating at least one of actuator 102embedded in at least one substrate 101, urine-level sensor 104 embedded in at least onesubstrate, microcontroller 106, and combinations thereof. In an exemplary embodiment,actuator 102 may be fabricated by placing an exemplary one or more pieces of an exemplarytwo-way smart material inside a first biocompatible sheath as at least one substrate 101 or anexemplary one or more pieces of an exemplary two-way smart material may be directly appliedas actuator 102, for example, in mesh-like structure 500. Furthermore, urine-level sensor 104may be fabricated by embedding a sensing element in an exemplary first biocompatible sheathor a second biocompatible sheath as at least one substrate 101. Moreover, microcontroller 106may be fabricated with a structure as exemplary shown in FIG. 7. In an exemplaryembodiment, fabricated actuator 102 and urine-level sensor 104 may be electrically coupled tofabricated microcontroller 106.

[0082] In further detail with respect to step 1004, step 1004 may include implanting exemplaryfabricated at least one of actuator 102, urine-level sensor 104, microcontroller 106, andcombinations thereof in an exemplary living body. In an exemplary embodiment, at least oneof fabricated actuator 102, urine-level sensor 104, microcontroller 106, and combinationsthereof may be implanted to an exemplary living body as described hereinabove in connectionwith description of in-vivo implantable system 100.

[0083] In further detail with respect to step 1006, step 1006 may include detecting a percentageof bladder fullness. In an exemplary embodiment, urine-level sensor 104 may be utilized tomeasure a urine amount in bladder 202 as described hereinabove in connection with descriptionof in-vivo implantable system 100.

[0084] In further detail with respect to step 1008, step 1008 may include communicating anexemplary set of data with user-notifying device 206 in real time based on an exemplarydetected percentage of bladder fullness. In an exemplary embodiment, an exemplary set of datamay be communicated between microcontroller 106 and user-notifying device 206. In anexemplary embodiment, an exemplary set of data may include an exemplary detectedpercentage of bladder fullness by urine-level sensor 104, a command from user to user-notifying device 206 about a time of starting / stopping inducing micturition, an alarm to userabout an exemplary measured urine amount in bladder 202, and combinations thereof.

[0085] In further detail with respect to step 1010, step 1010 may include conducting at leastone of inducing micturition by contracting bladder 202, keeping urethra 210 contracted,opening urethra 210 for urine outflow by releasing an exemplary urethra contraction,contracting at least one ureter 214, and combinations thereof. In an exemplary embodiment, atleast one of bladder 202, urethra 210, at least one ureter 214, and combinations thereof may becontracted or released based on an exemplary set of data communicated betweenmicrocontroller 106 and user-notifying device 206.

[0086] EXAMPLE 1: Bladder Management system with buckle-type sensor-actuator

[0087] In this example, an actuator as an example of actuator 102 described herein above witha buckle-type structure 300 was designed and fabricated. A two-way shape memory alloy(SMA) with a coil diameter of 0.62 mm and a wire diameter of 0.15 mm was used. Firstly, two- way shape memory alloy fibers (SMAFs) were connected to sheath-stripped regular electrical wires with 0.1 mm diameter using soldering. Then, the SMAFs were stretched to 150% of their initial length, which is the maximum these SMAFs wires may be able to be stretched. Also, a mold was designed and 3D printed to make exemplary actuators. The SMAFs were stretched and held in the mold, and a mix of precursors of a silicon elastomer (as exemplary substrate 101) was added. Each exemplary actuator was degassed in a vacuum chamber and left for 4 hours to be cured. Two small cylinders were 3D printed using a biocompatible resin andattached to silicon elastomer to complete protruded parts of exemplary end 302 of buckledesign of exemplary actuators. An exemplary design may help exemplary fabricated actuator to be soft, flexible, stretchable, and easy to implant and secure around bladder external wall 204.

[0088] Two types of SMAs including micro-fibers (BMF) and microhelices / coils (BMX) weretested. It was obtained that microhelices generate a higher contraction force which is neededfor fully emptying bladder 202. Also, three different BMXs including BMX50 (coil diameter0.2 mm, wire diameter 0.05 mm), BMX100 (coil diameter 0.4 mm, wire diameter 0.1 mm), and BMX150 (coil diameter 0.62 mm, wire diameter 0.15 mm) were tested. Exemplaryactuators with one, two, and three wires in series and parallel arrangements were fabricated. For each actuator, power consumption, minimum voltage, and current needed were calculated.Different thickness of elastomer of substrate 101 including 0.5 mm, 1 mm, and 1.5 mm weretested to achieve an optimum thickness for having optimized thermal insulation, flexibility, and also freedom for wires’ contraction in exemplary fabricated actuators. Actuation behaviors of exemplary fabricated actuator with three parallel BMX150 in the silicon elastomer with 1.5 mm thickness was tested. The actuator was contracted about 40% after applying a voltage in less than 2 seconds, and then recovered to its original form in about 4 seconds after removal of voltage due to a two-way shape memory behavior of used SMAs.

[0089] Two different methods were used to monitor core / wires (maximum) temperature andalso surface temperature of exemplary fabricated actuators during activation. First method isusing a thermal camera. FIG. 11 shows a map of temperature and an exemplary maximumtemperature of wires of an exemplary fabricated actuator BMX150 before actuation (top image1102) and 2 seconds after actuation with duty cycle of 50% (bottom image 1104), consistentwith one or more exemplary embodiments of the present disclosure. Furthermore, a thermocouple was attached to an external surface of exemplary fabricated actuator BMX150 that shows temperature of the surface which may contact with tissues of an exemplary livingbody. FIG. 12 shows a diagram 1200 of recorded temperatures at different actuation timeintervals at core and surface of an exemplary fabricated actuator BMX150 after actuation with 50% duty cycle (2 seconds on, 2 seconds off), consistent with one or more exemplary embodiments of the present disclosure. Based on the results, temperature increase on the implant surface was minimized by having an exemplary insulated layer. Based on the FDA, the maximum temperature increase that can be tolerated by an exemplary living body is about 2-3 °C depending on a relative tissue. Exemplary fabricated actuator BMX150 was connected to an electric / control module to control an applied duty cycle and frequency of actuation.Results shown in diagram 1200 reveals that the temperature of core and surface of exemplaryfabricated actuator BMX150 after actuation with 50% duty cycle (2 seconds on, 2 seconds off). As may be seen, utilized silicon elastomer in structure of exemplary fabricated actuators may work well as an insulation layer, and after about 18 seconds the temperature at the surface of exemplary fabricated actuator BMX150 may remain within the FDA’s tolerable range (38.2 °C).

[0090] Moreover, flexible and stretchable strain sensors as examples of urine-level sensor 104based on silver nanowires and carbon black particles were fabricated and embedded in the same silicon-based elastomer along with exemplary fabricated actuators. Therefore, integration of these two components (sensor and actuator) may be achieved without interference. A mechanism of the sensors is based on changes in capacitance (or resistance) by changing straindue to stretching of the sensors during filling bladder 202. Exemplary fabricated sensors andactuators embedded in the same silicon-based elastomer were connected to a control moduleas an example of microcontroller 106; thereby, a system as an example of in-vivo implantablesystem 100 was obtained. The obtained system was used for bladder management of phantomrats. The obtained system was very easy to implant on rat bladders since it was very compatible with rat bladders’ size and shape without any potential tissue damage. Specifically, softness ofthe obtained system may be noticeable. FIG.13 shows a diagram 1300 of percentage of bladdervoiding along with recorded maximum temperatures on surface of exemplary fabricated actuators at different applied duty cycles for exemplary fabricated actuator BMX150, consistent with one or more exemplary embodiments of the present disclosure. These results may show a percentage of emptying and maximum surface temperature after about 10 seconds of actuation with different duty cycles. As may be seen, the duty cycle should be kept less than about 60% to not exceed a temperature of 39 °C in 10 seconds of actuation. All of these data may demonstrate that temperature increase as well as the percentage of volume emptying percentage may be controlled using the control module.

[0091] EXAMPLE 2: Bladder Management system with cap-type sensor-actuator

[0092] In this example, a device as an example of actuator 102 and urine-level sensor 104embedded in at least one substrate 101 described herein above with a cap-type structure 400was designed and fabricated. A 3D model of rodents’ bladder and a 3D model of a mold 1400(shown in FIG. 14) based on the 3D model of rodents’ bladder was designed. FIG. 14 showsmold 1400 fabricated based on the 3D model of rodents’ bladder, consistent with one or moreexemplary embodiments of the present disclosure. Mold 1400 may include two parts 1402 tofabricate a shell and 1404 forming some holes for securing SMA wires. The device includingan elastomeric, soft, and flexible sensor-actuator-embedded cap-type substrate with a capdesign was fabricated for a rat bladder using such 3D printed mold 1400. A design of thefabricated device may be very easy to implant on rat bladders since it may be very compatible with rat bladders’ size and shape without any potential tissue damage. Specifically, softness ofthe fabricated device may be noticeable. A thickness of shell of the fabricated device may be basically about 1.5 mm, and a number of SMAFs may be one, two, and three in a parallel arrangement. There were two holes in the fabricated device, which may include points that thefabricated device may be sutured to a first layer of bladder 202. Since ureters are in the bottomand back of bladder 202, the fabricated device may not interfere with ureters. The fabricateddevice may be placed on the top of bladder 202 like a cap. This process may be extended todesign a similar device to fit larger bladders such as a human bladder. A control module as anexample of microcontroller 106 was used to control the fabricated device. The was controlmodule had a Bluetooth low-energy module embedded therein which connected to a user'scellphone as an example of user-notifying device 206. The used Bluetooth low energy moduleintermittently sends data to user while consuming less power; thereby, increasing control module’s battery life. The fabricated device may be sutured to first layer of bladder externalwall 204 to secure well during frequent movements of bladder 202.

[0093] Exemplary fabricated devices and systems in Examples 1 and 2 hereinabove wasimplanted and secured on bladder external wall of rat bladders using sutures on anaesthetizedrat animal model. An only about 1.5 cm incision on the rat animal model was needed since the fabricated device / system was soft, miniaturized, and flexible. After suturing the fabricated device / system, the rat bladder was frequently filled with saline, and emptied to test normal behaviors of bladder tissue after the fabricated device / system implantation. A similar device to the fabricated device / system may be adapted for implantation in other larger mammals or humans. Exemplary devices / systems for implantation in larger mammals may include aflexible elastomer with a thickness of at least 2 mm as at least one substrate 101 having a greaternumber and thickness of smart material (e.g., SMAFs) as actuator 102 than the fabricateddevice / system implanted in rats. The SMAFs in an exemplary larger device / system may have a coil diameter (microhelix diameter) of at least 5 mm and a wire diameter of at least 1 mm and may be present in numbers of at least 50 providing coverage of a larger area of an exemplarybuckle-type structure 300 and / or cap-type structure 400 on bladder 202. An exemplary cap-type structure 400 for larger mammals may be at least 10 times larger than the exemplarydescribed design for rodent animal models. Industrial Applicability

[0094] Herein, a system is disclosed for actuating bladder to cause micturition on-demand orvia a closed-loop feature. An exemplary system may include an implantable actuator includingsmart materials embedded in a flexible elastomer sheath. An exemplary system may further include a sensor to determine volume of urine in an exemplary bladder and a microcontroller. Exemplary smart materials behave as “two-way” smart material wherein no external stimuli are needed to revert a shape of an exemplary material to its original form. An exemplary microcontroller may provide either an open-loop, on-demand micturition system, or a closed- loop that causes urination upon sensing a full bladder. An exemplary actuator may mechanically contract an exemplary bladder and / or urethra or ureter(s) if needed. An exemplary sensor may be implanted internally or may be a wearable sensor that may be placed over skin to measure urine level. An exemplary microcontroller may communicate wirelessly with a user (a patient or a clinician) via a user device (e.g., a smart phone or a computer), or may produce sound, light and / or vibration under / over skin.

[0095] An exemplary system may be activated / stopped / controlled by either an externalelectronic component or by directly interfacing with the implanted system and / or a wearable device over skin by for example an audio that may be voice-recognizable or by physically pressing. An exemplary system may be useful for individuals with neurogenic underactive bladder caused by injury or different types of diseases and injuries including but not limited to spinal cord injury, multiple sclerosis, and diabetes as well as in the aging population with compromised urination control. These dysfunctions may include but are not limited to neurogenic overactive or underactive bladder, urinary retention, urinary in continence, and bladder cancer. An exemplary system may be used in conjunction with drugs or in conjunction with a second device to control urethral sphincter in patients in need thereof.

[0096] An exemplary disclosed system may overcome problems associated with urinarysystem dysfunctions of animals and / or humans. Furthermore, an exemplary disclosed system may be lightweight, non-invasive, flexible, soft, and simply in-vivo implantable inside a living body to manage micturition process, preventing bladder leakage, preventing urine reflux to kidneys, and so on. An exemplary system may compensate lack of sensation and actuation of bladder function and also may be able to be controlled by a user for on-demand micturition.

[0097] While the foregoing has described what may be considered to be the best mode and / orother examples, it is understood that various modifications may be made therein and that the subject matter disclosed herein may be implemented in various forms and examples, and that the teachings may be applied in numerous applications, only some of which have beendescribed herein. It is intended by the following claims to claim any and all applications, modifications and variations that fall within the true scope of the present teachings.

[0098] Unless otherwise stated, all measurements, values, ratings, positions, magnitudes, sizes,and other specifications that are set forth in this specification, including in the claims that follow, are approximate, not exact. They are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain.

[0099] The scope of protection is limited solely by the claims that now follow. That scope isintended and should be interpreted to be as broad as is consistent with the ordinary meaning of the language that is used in the claims when interpreted in light of this specification and the prosecution history that follows and to encompass all structural and functional equivalents. Notwithstanding, none of the claims are intended to embrace subject matter that fails to satisfy the requirement of Sections 101, 102, or 103 of the Patent Act, nor should they be interpreted in such a way. Any unintended embracement of such subject matter is hereby disclaimed.

[0100] Except as stated immediately above, nothing that has been stated or illustratedis intended or should be interpreted to cause a dedication of any component, step, feature, object, benefit, advantage, or equivalent to the public, regardless of whether it is or is not recited in the claims.

[0101] It will be understood that the terms and expressions used herein have theordinary meaning as is accorded to such terms and expressions with respect to their corresponding respective areas of inquiry and study except where specific meanings have otherwise been set forth herein. Relational terms such as first and second and the like may be used solely to distinguish one entity or action from another without necessarily requiring or implying any actual such relationship or order between such entities or actions. The terms “comprises,” “comprising,” or any other variation thereof, are intended to cover a non- exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by “a” or “an” does not, without further constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises the element.

[0102] The Abstract of the Disclosure is provided to allow the reader to quicklyascertain the nature of the technical disclosure. It is submitted with the understanding that itwill not be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, it can be seen that various features are grouped together in various implementations. This is for purposes of streamlining the disclosure, and is not to be interpreted as reflecting an intention that the claimed implementations require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed implementation. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separately claimed subject matter.

[0103] While various implementations have been described, the description is intendedto be exemplary, rather than limiting and it will be apparent to those of ordinary skill in the art that many more implementations and implementations are possible that are within the scope of the implementations. Although many possible combinations of features are shown in the accompanying figures and discussed in this detailed description, many other combinations of the disclosed features are possible. Any feature of any implementation may be used in combination with or substituted for any other feature or element in any other implementation unless specifically restricted. Therefore, it will be understood that any of the features shown and / or discussed in the present disclosure may be implemented together in any suitable combination. Accordingly, the implementations are not to be restricted except in light of the attached claims and their equivalents. Also, various modifications and changes may be made within the scope of the attached claims.

Claims

WHAT IS CLAIMED IS:

1. An in-vivo implantable system for bladder management of a living body having urinarysystem dysfunctions, the system comprising: an actuator securable to at least one of bladder external wall, urethra, at least one ureter, and combinations thereof of the living body, the actuator comprising one or more pieces of a two-way smart biomaterial comprising a changeable shape due to applying at least one of an electric field, a magnetic field, a light change, a temperature change, ultrasound, and combinations thereof thereto, the two-way smart biomaterial further comprising a restoring shape to an original form due to removing the at least one of the electric field, the magnetic field, the light change, the temperature change, the ultrasound, and combinations thereof, the actuator configured to contract and / or release the at least one of the bladder external wall, the urethra, the at least one ureter, and combinations thereof; a urine-level sensor securable to the bladder external wall, the urine-level sensor comprising at least one of a strain sensor, a pressure / force sensor, an impedance sensor, and combinations thereof, the urine-level sensor configured to measure urine volume in the bladder by measuring changes of at least one of strain of the bladder external wall, electrical impedance of the bladder external wall, pressure / force applied to the bladder external wall, and combinations thereof during filling and / or voiding the bladder; and a microcontroller subcutaneously implantable in abdominal area of the living body, the microcontroller comprising: a base layer, comprising a piece of a soft flexible biocompatible material; a communication module attached onto the base layer, the communication module being wirelessly coupled to a user-notifying device; and a processing unit attached onto the base layer, the processing unit connected to the actuator, the urine-level sensor, and the communication module, the processing unit comprising: a memory having processor-readable instructions stored therein; and a processor configured to access the memory and the communication module, the processor configured to execute the processor readable instructions, which, when executed by the processor configures the processor to perform at least one method of management of micturition, prevention of bladder leakage, 1prevention of urine reflux to kidneys of the living body, and combinations thereof.

2. The system of claim 1, wherein the method of management of micturition comprises:detecting, utilizing the urine-level sensor, percentage of bladder fullness by measuring the urine volume in the bladder; communicating, utilizing the communication module, a set of data with the user- notifying device in real time based on the detected percentage of bladder fullness, the set of data comprising at least one of the measured urine volume, an alarm of an emergency need for micturition responsive to detecting the percentage of the bladder fullness being more than a threshold, an alarm of start of micturition, a command from a user to start micturition, and combinations thereof; and inducing micturition by contracting, utilizing the actuator, the bladder via applying the at least one of the electric field, the magnetic field, the light change, the temperature change, the ultrasound, and combinations thereof to the one or more pieces of the two-way smart biomaterial responsive to at least one of detecting the percentage of the bladder fullness being more than the threshold, receiving the command from the user to start micturition, and combinations thereof.

3. The system of claim 1, wherein the method of management of prevention of bladderleakage comprises: keeping, utilizing the actuator, the urethra contracted by applying the at least one of the electric field, the magnetic field, the light change, the temperature change, the ultrasound, and combinations thereof to the one or more pieces of the two-way smart biomaterial; and opening urethra for urine outflow by releasing, utilizing the actuator, urethra contraction right before initiating micturition via ceasing applying the at least one of the electric field, the magnetic field, the light change, the temperature change, the ultrasound, and combinations thereof to the one or more pieces of the two-way smart biomaterial.

4. The system of claim 1, wherein the method of prevention of urine reflux to kidneys ofthe living body comprises contracting, utilizing the actuator, the at least one ureter via applying the at least one of the electric field, the magnetic field, the light change, the temperature change, 2the ultrasound, and combinations thereof to the one or more pieces of the two-way smart biomaterial right before initiating the micturition.

5. The system of claim 1, wherein the two-way smart biomaterial comprises at least oneof a shape memory alloy (SMA), a shape memory polymer (SMP), an electroactive polymer (EAP), a magneto-responsive material, a thermoresponsive polymer, an ultrasound-responsive material, and combinations thereof.

6. The system of claim 5, wherein the one or more pieces of the two-way smart biomaterialcomprises one or more fibers of nitinol, the nitinol comprising a nickel-titanium (Ni-Ti) alloy.

7. The system of claim 1, wherein each piece of the one or more pieces of the two-waysmart biomaterial comprises at least one wire of the two-way smart biomaterial with a length in a range of 0.5 cm to 20 cm and a diameter in a range of 0.05 mm to 0.5 mm.

8. The system of claim 1, wherein the one or more pieces of the two-way smart biomaterialcomprises a wire twisted in form of a plurality of microhelices, each respective microhelix comprising a diameter in a range of 0.1 mm to 5 mm.

9. The system of claim 1, wherein the actuator comprises a mesh-like structure, the mesh-like structure comprising one or more wires of the two-way smart biomaterial interconnected together, the mesh-like structure being implantable at a location comprising at least one of on top of the bladder, onto a portion of the bladder external wall, around the bladder external wall, and combinations thereof.

10. The system of claim 1, wherein the system further comprises at least one substratecomprising a soft biocompatible elastomer in a shape of at least one of a band, a strip, a cap, a patch, and combinations thereof, the actuator and the urine-level sensor being separately or integratedly embedded inside the at least one substrate.

311. The system of claim 10, wherein the actuator and the urine-level sensor are in-vivoimplantable by at least one of placing the at least one substrate on top of the bladder, fastening the at least one substrate around the bladder external wall, adhering the at least one substrate to the bladder external wall, suturing the at least one substrate to external wall of the bladder, fastening the at least one substrate around the urethra, fastening the at least one substrate around the at least one ureter, and combinations thereof.

12. The system of claim 11, wherein the at least one substrate comprises one or moreopenings, the at least one substrate being sutured to at least one of the external wall of the bladder, the urethra, the at least one ureter, and combinations thereof through the one or more openings.

13. The system of claim 11, wherein the at least one substrate comprises a buckle joiningtwo ends of the at least one substrate around at least one of the external wall of the bladder, the urethra, the at least one ureter, and combinations thereof.

14. The system of claim 1, wherein the strain sensor comprises at least one of apiezoresistive material, a capacitive layer, a stretchable conductive composite, and combinations thereof, wherein the strain sensor comprises at least one of an electrical capacitance, an electrical resistance, and combinations thereof being changeable due to a change in bladder volume during filling and / or voiding the bladder.

15. The system of claim 14, wherein the strain sensor comprises at least one of silvernanowires (AgNWs), carbon nanotubes (CNTs), carbon black nanoparticles (CBNPs), and combinations thereof.

16. The system of claim 1, wherein the pressure / force sensor comprises at least one of acapacitive sensing element, a piezoresistive sensing element, an optical sensing element, a micro-electro-mechanical system (MEMS)-based sensor, and combinations thereof, the pressure / force sensor configured to measure pressure or mechanical force changes on bladder wall during filling and / or voiding the bladder.

417. The system of claim 1, wherein the impedance sensor comprises a pair of electrodesattached to bladder wall, the impedance sensor configured to measure an electrical impedance of the bladder wall during filling and / or voiding the bladder.

18. The system of claim 1, wherein the base layer comprises a piece of a soft flexiblebiocompatible polymer with a length in a range of 5 mm to 20 mm and a width in a range of 5 mm to 20 mm.

19. The system of claim 1, further comprising one or more voltage drivers attached ontothe base layer, the one or more voltage drivers coupled to the actuator and the processing unit, wherein applying the at least one of the electric field, the magnetic field, the light change, the temperature change, the ultrasound, and combinations thereof to the one or more pieces of the two-way smart biomaterial comprises applying, utilizing the one or more voltage drivers, a set of electrical voltage cycles to the one or more pieces of the two-way smart biomaterial, each respective electrical voltage cycle comprising an electrical voltage in a range of 1 V to 15 V during a time period in a range of 5 s to 50 s with a frequency in a range of 0.1 Hz to 0.5 Hz.

20. The system of claim 1, wherein communicating the set of data with the user-notifyingdevice comprises at least one of sending the set of data to the user-notifying device, producing at least one of vibration, light, sound, and combinations thereof under / over skin of the living body, producing at least one of vibration, light, sound, and combinations thereof on the user- notifying device, and combinations thereof, the user-notifying device comprising at least one of a computing device having an interface, a processor coupled to an interface, a smart phone, a computer, a vibrator, a sound making device, a light emitting device, and combinations thereof, wherein the user-notifying device comprises at least one of a wearable device by the living body, an attachable device to the living body, a device utilizing by the living body, a device being in the vicinity of the living body, a device being far from the living body. 5

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