Urethra blocker, urinary incontinence automatic control system and in-vivo machine thereof
阅读说明:本技术 尿道阻断器、尿失禁自动控制系统及其体内机 (Urethra blocker, urinary incontinence automatic control system and in-vivo machine thereof ) 是由 吴双宸 于 2019-11-22 设计创作,主要内容包括:一种尿道阻断器、用于控制尿失禁的体内机和尿失禁自动控制系统。尿道阻断器包括C形囊以及位于C形囊外侧的支撑环,所述C形囊与液体连接管相连通,用于通过液体连接管填充以及排出液体以阻断和放松尿道,所述支撑环被构造成在支撑环内的压力高于一阈值时产生弹性变形而张开。(A urethral blocking device, an intrabody device for controlling urinary incontinence and an automatic urinary incontinence control system. The urethral occluder includes a C-shaped balloon communicating with the liquid connection tube for filling and discharging liquid through the liquid connection tube to occlude and relax the urethra, and a support ring located outside the C-shaped balloon and configured to elastically deform to expand when a pressure inside the support ring is above a threshold value.)
1. A urethral occluder, comprising a C-shaped balloon in communication with a liquid connecting tube for filling and draining liquid through the liquid connecting tube for occluding and relaxing a urethra, and a support ring outside the C-shaped balloon, the support ring being configured to elastically deform to expand when the pressure inside the support ring is above a threshold value.
2. The automated urinary incontinence control system of claim 1 wherein said support ring is configured to maintain a constant shape or return to an original shape prior to elastic deformation when the pressure within the support ring is less than or equal to said threshold value.
3. The urethral occluder of claim 1, wherein the support ring is configured to maintain a constant spring force during elastic deformation.
4. The urethral occluder of any one of claims 1 to 3, wherein the support ring is made of a material having a superelastic effect or a combination of at least two spring blades, wherein the material is preferably a nickel titanium alloy.
5. The urethral occluder of any one of claims 1 to 4, wherein the support ring comprises a first section, a second section, a third section and a fourth section connected in series, wherein the second section and the third section constitute a C-shaped body portion of the support ring, the first section is curved from one end of the second section in a direction opposite to the direction of curvature of the second section, and the fourth section is curved from one end of the third section in a direction opposite to the direction of curvature of the third section, wherein the first section and the fourth section first approach each other until they contact each other and then move away from each other from said one end of the second section and said one end of the third section, respectively.
6. The urethral occluder of any of claims 1-5, wherein a pressure sensor is provided between the C-shaped balloon and the support ring.
7. The urethral occluder of any of claims 1-6, wherein the C-shaped balloon and the support ring are molded as one piece using die casting.
8. The urethral occluder of any of claim 6, wherein the C-shaped balloon, the support ring and the pressure sensor are molded as one piece using die casting.
9. An intrabody apparatus for controlling urinary incontinence, said apparatus being fully implanted in the body, characterized in that it comprises a urethral blocker according to any one of claims 1 to 8.
10. An automated urinary incontinence control system comprising an extra-corporeal unit located outside the body and an intra-corporeal unit implanted completely inside the body, wherein the intra-corporeal unit comprises a urethral occluder according to any one of claims 1 to 8.
Technical Field
The present disclosure relates to a urethral occluder. The present disclosure also relates to an in-vivo machine for controlling urinary incontinence including the urethral blocking device and an automatic urinary incontinence control system including the in-vivo machine.
Background
Urinary incontinence is common among the elderly, and some treatment methods are available, but a large number of patients still have no effective treatment means and can only rely on continuous catheterization or the palliative measures of a urine pad, a diaper and the like, so that the life quality of the patients is seriously reduced, and meanwhile, the family of the patients is also greatly troubled. There is therefore a clinical need to develop new urinary incontinence treatment devices.
An artificial urethral sphincter device has been developed clinically, which has the advantage of restoring control of urination while urinating through the normal urethra without affecting the anatomical structure of the sphincter and nearby tissues and the patient can achieve a better quality of life. However, existing artificial urinary sphincter devices also suffer from several drawbacks. For example, existing artificial urinary sphincter devices have low reliability, e.g., they may under certain circumstances over-stress the urethral tissue, thereby causing damage to the urethral tissue.
Disclosure of Invention
In view of at least one of the drawbacks of the prior art artificial urinary sphincter devices, it is an object of the present disclosure to provide a urethral blocking device including a C-shaped balloon in communication with a fluid connection tube for filling and draining fluid through the fluid connection tube to block and relax the urethra, and a support ring outside the C-shaped balloon, the support ring being configured to elastically deform to expand when the pressure within the support ring is above a threshold value.
In one configuration, the support ring is configured to maintain a shape or return to an original shape prior to elastic deformation when a pressure within the support ring is less than or equal to the threshold value.
In one configuration, the support ring is configured such that the elastic force remains constant during the elastic deformation.
In one configuration, the support ring is made of a material having a superelastic effect or a combination of at least two spring strips, wherein the material is preferably a nickel titanium alloy.
In one configuration, the support ring comprises a first section, a second section, a third section and a fourth section connected in series, wherein the second section and the third section constitute a C-shaped body portion of the support ring, the first section is bent from one end of the second section in a direction opposite to a bending direction of the second section, and the fourth section is bent from one end of the third section in a direction opposite to a bending direction of the third section, wherein the first section and the fourth section are first brought close to each other until they contact each other and then are further away from each other from the one end of the second section and the one end of the third section, respectively.
In one configuration, a pressure sensor is disposed between the C-shaped bladder and the support ring.
In one configuration, the C-shaped bladder and the support ring are molded as one piece using die casting.
In one configuration, the C-shaped bladder, the support ring, and the pressure sensor are molded as one piece using die casting.
In a second aspect of the present disclosure, an intrabody machine for controlling urinary incontinence is provided, the intrabody machine being fully implanted in a body, the intrabody machine comprising a urethral occluder according to the first aspect of the present disclosure.
In a third aspect of the present disclosure, there is provided an automatic urinary incontinence control system comprising an extra-corporeal machine located outside the body and an intra-corporeal machine implanted entirely within the body, the intra-corporeal machine including a urethral block device according to the third aspect of the present disclosure.
Drawings
These and other features, aspects, and advantages of the present disclosure will become better understood when the following detailed description is read with reference to the accompanying drawings in which like characters represent like parts throughout the drawings, wherein:
FIG. 1 is a schematic block diagram of an automated urinary incontinence control system according to the present disclosure;
FIG. 2 is a block circuit diagram of one embodiment of an external wireless transmission module of an external machine and an internal wireless transmission module of an internal machine of the urinary incontinence automatic control system according to the present disclosure;
FIG. 3 is a schematic illustration of an in-vivo machine of an automated urinary incontinence control system according to the present disclosure;
fig. 4 is a schematic view of the internal structure of the control box of the in-body unit of the automatic urinary incontinence control system according to the present disclosure;
FIG. 5 is a schematic view of an in-vivo reservoir of an automated urinary incontinence control system according to the present disclosure;
FIG. 6 is a schematic view of a urethral occluder according to the present disclosure in a first state;
FIG. 7 is a schematic view of a urethral occluder in a second state according to the present disclosure;
FIG. 8 is a schematic view of a third state of a urethral occluder according to the present disclosure;
FIG. 9 is a schematic view of a fluid circuit connection of the body-machine of the automatic urinary incontinence control system according to the present disclosure;
FIG. 10 is a schematic illustration of a first flow condition of the fluid circuit connection shown in FIG. 9;
FIG. 11 is a schematic view of a second flow condition of the fluid circuit connection shown in FIG. 9;
FIG. 12 is a schematic view of a third flow state of the fluid path connection shown in FIG. 9;
FIG. 13 is a schematic view of a fourth flow condition of the fluid circuit connection shown in FIG. 9; and
fig. 14 is a schematic view of a fifth flow state of the fluid path connection shown in fig. 9.
Detailed Description
The present disclosure will now be described with reference to the accompanying drawings, which illustrate several embodiments of the disclosure. It should be understood, however, that the present disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, the embodiments described below are intended to provide a more complete disclosure of the present disclosure, and to fully convey the scope of the disclosure to those skilled in the art. It is also to be understood that the embodiments disclosed herein can be combined in various ways to provide further additional embodiments.
It is to be understood that the terminology used in the description is for the purpose of describing particular embodiments only, and is not intended to be limiting of the disclosure. All terms (including technical and scientific terms) used in the specification have the meaning commonly understood by one of ordinary skill in the art unless otherwise defined. Well-known functions or constructions may not be described in detail for brevity and/or clarity.
The terms "comprising," "including," and "containing" when used in this specification specify the presence of stated features, but do not preclude the presence or addition of one or more other features. The term "and/or" as used in this specification includes any and all combinations of one or more of the associated listed items.
The use of the terms "connected," "coupled," or the like in the description is intended to mean either a direct connection and/or an indirect connection.
The systems described herein may utilize one or more microcontrollers to receive information and transform the received information to generate an output. The microcontroller may comprise any type of computing device, computing circuit, or any type of microcontroller or processing circuit capable of executing a series of instructions stored in memory. The microcontroller may include multiple microcontrollers and/or multicore Central Processing Units (CPUs) and may include any type of microcontroller. The microcontroller may also include a memory to store data and/or algorithms to execute a series of instructions.
Fig. 1 shows a schematic block diagram of an automatic urinary incontinence control system according to the present disclosure. The automatic urinary incontinence control system is used for treating urinary incontinence caused by sphincter relaxation. The urinary incontinence automatic control system includes an extracorporeal machine 100 and an extracorporeal machine 200. The internal body 200 may be fully implanted inside the body, which may be used to perform the primary function of the artificial urinary sphincter. The outdoor unit 100 can be located outside the body, can be used for supplying power to the indoor unit and communicating with the indoor unit, and can also complete the functions of indoor unit control, information display and prompt alarm.
As shown in fig. 1, the outdoor unit 100 may include an outdoor
The external
Therefore, when the external machine 100 supplies power to the internal machine 200, the driving circuit drives a current with a certain waveform to generate an alternating magnetic field through the external coil, an induced electromotive force is generated on the internal coil Ws1 coupled with the external coil, and stable direct-current voltage can be provided for other components in the internal machine through rectification, filtering, voltage stabilization and other processing of the power supply circuit of the internal machine. When information is transmitted between the external machine 100 and the internal machine 200, the communication information is modulated onto the electromagnetic wave transmitting energy according to a certain rule, so that the energy and the information transmission share one set of electromagnetic transmission coil. The effects of simple structure, high energy transmission efficiency and reliable bidirectional information transmission are achieved.
Fig. 2 shows a block circuit diagram of one embodiment of the extracorporeal
In the extracorporeal
In the in-vivo
For the power supply from the external unit 100 to the internal unit 200, a suitable operating frequency is selected, for example, an operating frequency of 100kHz to 4MHz is adopted, so as to reduce the combined loss of the transmission coil and the switching element as much as possible. Both the in-vivo and the ex-vivo coils are impedance matched by connecting appropriate reactive elements (capacitors or inductors) in series and/or in parallel to improve the efficiency of energy transfer.
For wireless information transmission between the external machine 100 and the internal machine 200, in order to meet the requirements of reliable information transmission, electromagnetic compatibility and energy transmission efficiency, an information transmission baud rate far lower than the energy transmission working frequency is selected. When the extracorporeal unit 100 transmits information to the extracorporeal unit 200, the drive circuit appropriately turns on/off the drive of the extracorporeal coil Wp1, and the extracorporeal unit 200 decodes the information according to a predetermined coding rule by detecting the presence/absence of the output voltage of the intracorporeal coil Ws 1. For the internal machine 200 to transmit information to the external machine 100, the equivalent impedance of the external coil Wp1 is changed by adopting a mode of timely short-circuiting the internal coil Ws1 by an alternating current switch or an alternating current switch plus a matching capacitor, so that the current of the external coil Wp1 is changed. The transmitted information can be decoded according to a preset coding rule through a current sensing circuit and a comparator.
The outdoor unit 100 may further include a display and manipulation module 140, an alarm module 150, a bluetooth module 160, and/or a WIFI module. The power module 130 is connected to the display and manipulation module 140, the alarm module 150, the bluetooth module 160, and/or the WIFI module 170, thereby supplying power thereto.
A display and manipulation module 140 is connected to the extracorporeal microcontroller 120. The display and control module 140 is used to display operating information of the incontinence automatic control system and to input operating commands and parameters. For example, the display and control module 140 may display the remaining capacity of the battery in real time, and prompt replacement and charging when the capacity reaches a lower limit. The display and manipulation module 140 may include a touch screen. The display and manipulation module 140 may also be comprised of a separate display screen and input device such as a keyboard.
An alarm module 150 is connected to the extracorporeal microcontroller 120. The alarm module 150 is used for sending an alarm signal of system abnormality to a user. The alarm signal may be an acoustic signal and/or a light signal.
The bluetooth module 160 and/or the WIFI module 170 are connected with the extracorporeal microcontroller 120. Bluetooth module 160 and/or WIFI module 170 are configured to be able to communicate with a cloud server or a mobile terminal such as a cell phone, upload system operating conditions, prompt a patient or caregiver through the mobile terminal for urination operation, and be able to monitor system operating conditions through APP software on the mobile terminal.
In use, when a patient inputs a urination command, the external
The
In one configuration, at least two
The construction of the intrabody machine and the urethral occluder therein will be described in detail below with reference to fig. 3 to 14, taking the example of hydraulically driving the pinching urethra.
As shown in fig. 3 and 4, in addition to the above-described structure, the in-vivo machine 200 includes a pump 240 (e.g., a micro-pump), a solenoid valve 250 (e.g., a micro-solenoid valve), a
Fig. 5 shows a schematic structure of the
Fig. 6-8 illustrate one embodiment of
In one configuration, the
The
By using the
In one configuration, the shape of the
In one configuration, a
When the pressure measurement exceeds the maximum pressure set point, the intrabody microcontroller 220 controls the pump and solenoid valve to release the corresponding
When the pressure measurement in
In addition, the system also adopts a plurality of safety protection measures in addition, and ensures that all the urethral blocking devices can be completely released when the system fails or the power supply fails, so that the urethra can be kept in a free state, the system can not cause the upper urinary tract lesion caused by the long-time blocking of the urethra when the system fails, and the safety and the reliability of the system are improved.
In one configuration, the in-vivo microcontroller 220 is configured to detect the supply voltage of the in-vivo device in real time (e.g., every 100 ms). For example, the in-vivo microcontroller 220 may determine whether the power supply voltage of the in-vivo device is normal by detecting a potential signal in the in-vitro information reading circuit of the in-vivo device. The in vivo microcontroller 220 is configured to control the pump and solenoid valve to immediately stop charging the urethral blocker when an abnormality in the power supply voltage of the in vivo machine is detected, and then continue to detect the power supply voltage of the in vivo machine in real time; if the supply voltage is still abnormal after a set time (e.g., 30s), the in-vivo microcontroller 220 controls the pump and solenoid valve to release all urethral blockers to release the urethra; if the supply voltage returns to normal after a set period of time (e.g., 30s), the in-vivo microcontroller 220 resumes normal control of the pump and solenoid valves.
To further enhance the safety of the system, in one configuration, the in-vivo machine further comprises a protection circuit independent of the in-vivo microcontroller, which is triggered to control the pump and solenoid valve to release all urethral blockers to release the urethra if the signal received by the in-vivo machine 200 from the in-vitro machine 100 is at a low potential (e.g., the level of the "down message read" signal in fig. 2 is "low") and lasts for more than a set time (e.g., more than the normal message transmission low level duration). Thus, the protection circuit can be triggered by the duration of the 'down information read' signal to release the urethral block device without depending on a microcontroller, thereby enhancing the fault-tolerant redundancy of the system.
In order to ensure that the control operation of the internal microcontroller is normally performed when the supply voltage of the internal machine is abnormal, the power supply circuit of the internal machine 200 has an energy storage element for storing electrical energy. In order to ensure that each solenoid valve has enough energy for the release operation of the solenoid valve, each solenoid valve is provided with an energy storage capacitor which stores energy when the solenoid valve works normally. The energy stored in the energy storage capacitor of each solenoid valve is only used for the releasing operation of each solenoid valve.
As previously described, the internal machine 200 may be provided with at least two
As shown in fig. 9, the in vivo machine 200 includes a
Figures 10 and 11 schematically show a principle view of a first
Fig. 12 and 13 schematically show a schematic view of second
Figure 14 schematically illustrates the flow condition with the urethral occluder fully released. When the urine is required to be discharged, the master
In this way, it is ensured that the two urethral occluders alternately and automatically compress the urethra at regular intervals (e.g., 20 minutes), preventing tissue necrosis caused by poor blood flow of the tissue due to prolonged clamping of the urethra.
Industrial applicability
The present disclosure can be applied to automatic control of urinary incontinence, and thus has industrial applicability.
While only certain embodiments of the disclosure have been illustrated and described herein, many modifications and changes will occur to those skilled in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the disclosure.