CN102441232A - An implantable bladder function repair system - Google Patents
An implantable bladder function repair system Download PDFInfo
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- CN102441232A CN102441232A CN2011102810495A CN201110281049A CN102441232A CN 102441232 A CN102441232 A CN 102441232A CN 2011102810495 A CN2011102810495 A CN 2011102810495A CN 201110281049 A CN201110281049 A CN 201110281049A CN 102441232 A CN102441232 A CN 102441232A
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Abstract
The invention relates to an implantable bladder function repair system. The system comprises: the nerve stimulation device comprises electrodes, a nerve signal amplifier, a nerve signal processing circuit and a nerve electrical stimulator; wherein, the electrode is attached to the sacral nerve root sleeve; the electrode is connected with the nerve signal amplifier and is used for sending the nerve signal received from the posterior sacral nerve root in the sacral nerve root sleeve to the nerve signal amplifier for amplification; the nerve signal amplifier is connected with the nerve signal processing circuit and used for sending the amplified nerve electrical signal to the nerve signal processing circuit for processing; the nerve signal processing circuit determines whether the human body needs to urinate according to the amplified nerve electric signal, and if so, sends a urination signal to the connected nerve electric stimulator; the nerve electrical stimulator sends a stimulation electrical signal to the connected electrode according to the urination signal; the electrodes stimulate the sacral nerve root sleeve by using the stimulating electric signals, so that the sacral nerve anterior root in the sacral nerve root sleeve controls the bladder to urinate. The invention can help patients to urinate as required.
Description
Technical Field
The invention relates to the technical field of implantable medical electronic systems, in particular to an implantable bladder function repair system.
Background
Spinal cord injury is a wound seriously harming human health, and complications caused by the injury, such as neurogenic bladder, paraplegia, infection, bedsore and the like, seriously reduce the life quality of patients and improve the medical expenditure of the patients. In spinal cord injury, neurogenic bladder can cause long-term urinary infection, renal failure and other complications, and has become a great threat to the life and health of spinal cord injury patients.
FIG. 1 is a schematic diagram of the nervous system associated with bladder urination. As shown in fig. 1, a vertebral column 103 in the human body extends from the anterior sacral nerve root 102 and the posterior sacral nerve root 101, which meet at the edge of the cauda equina 104 to form a single sacral nerve root sleeve 1012, the end of which is connected to the bladder 105. Anatomical studies have shown that the posterior sacral nerve root 101 and the anterior sacral nerve root 102 converge to form a single posterior sacral nerve root sleeve 1012 on the outside of the cauda equina 104, but the posterior sacral nerve root sleeve 1012 is separable, i.e., it can be dissected into separate posterior sacral nerve root and anterior sacral nerve root by anatomical means, and the posterior sacral nerve root at the separation is connected to the posterior sacral nerve root 101 in the cauda equina 104, and the anterior sacral nerve root at the separation is also connected to the anterior sacral nerve root 102 in the cauda equina 104, so it can be considered that the posterior sacral nerve root 101 and the anterior sacral nerve root 102 converge to a single sacral nerve root 1012 on the outside of the cauda equina 104, but they are still working independently.
The posterior sacral nerve root (including the portion within cauda equina 104 and the portion outside cauda equina 104) is used to send electrical nerve signals to the vertebra 103 that reflect the degree of filling of the bladder 105, while the anterior sacral nerve root (including the portion within cauda equina 104 and the portion outside cauda equina 104) is used to send stimulation signals to the muscles inside the bladder 105 (the urethral sphincter and the bladder detrusor) that stimulate the bladder 105 to void.
In patients with neurogenic bladder, the nerve path between the bladder 105 and the vertebral column 103 (i.e. the posterior sacral nerve root 101, the anterior sacral nerve root 102 and the sacral nerve root sleeve 1012 formed by the confluence of the two in fig. 1) is not smooth, so that the nerve electrical signal or stimulation signal cannot be transmitted between the muscles of the vertebral column 103 and the bladder 105, and the patients cannot urinate autonomously, thereby causing long-term urinary infection, renal failure and other complications.
The existing bladder function repair system helps a patient to urinate by regularly stimulating the sacral nerve root sleeve 1012 of the patient, so that the patient can only urinate at a certain time every day, and the urination mechanism cannot ensure that the patient can urinate in time when the patient needs to urinate, or can not ensure that the patient can urinate at the certain urination time every day (the patient may drink less water without urine).
Disclosure of Invention
The invention aims to provide an implantable bladder function repair system which can help patients urinate as required.
The technical scheme for solving the technical problems is as follows: an implantable bladder function repair system, the system comprising: the nerve stimulation device comprises electrodes, a nerve signal amplifier, a nerve signal processing circuit and a nerve electrical stimulator; wherein,
the electrodes are attached to the sacral nerve root-sleeve;
the electrode is connected with the nerve signal amplifier and is used for sending nerve electric signals received from a posterior sacral nerve root in the sacral nerve root sleeve to the nerve signal amplifier for amplification;
the nerve signal amplifier is connected with the nerve signal processing circuit and used for sending the amplified nerve electrical signal to the nerve signal processing circuit for processing;
the nerve signal processing circuit determines whether the human body needs to urinate according to the amplified nerve electric signal, and if so, sends a urination signal to the connected nerve electric stimulator;
the nerve electrical stimulator sends a stimulation electrical signal to the connected electrode according to the urination signal; the electrode stimulates the sacral nerve root sleeve by the stimulating electric signal, so that the sacral nerve anterior root in the sacral nerve root sleeve controls the bladder to urinate.
The invention has the beneficial effects that: in the invention, the electrode can receive the nerve electrical signal sent by the posterior sacral nerve root in the sacral nerve root sleeve in real time or periodically and send the nerve electrical signal to the nerve signal amplifier for amplification, the nerve signal processing circuit can determine the filling degree of the bladder according to the amplified nerve electrical signal so as to determine whether the human body needs urination, and when the human body needs urination, the nerve signal processing circuit can send a urination signal to the nerve electrical stimulator in real time and send a stimulation electrical signal to the electrode by the nerve electrical stimulator so as to stimulate the sacral nerve root sleeve and control the bladder urination by the anterior sacral nerve root in the sacral nerve root sleeve. Therefore, the invention can stimulate the bladder to urinate immediately when a patient has more urine accumulated in the bladder (namely needs to urinate), thereby helping the patient to urinate as required, preventing the urine from accumulating in the bladder and reducing or eliminating the occurrence of complications such as urinary infection, renal failure and the like.
On the basis of the technical scheme, the invention can be further improved as follows:
further, the device also comprises a transceiver and a coupling coil;
the transceiver is respectively connected with the coupling coil and the neural signal processing circuit;
the nerve signal processing circuit is used for sending the recorded amplified nerve electric signal, the urination signal sent to the nerve electric stimulator and the corresponding recording time to the transceiver;
the transceiver transmits the amplified nerve electrical signal, the urination signal and the corresponding recording time to an external circuit through the coupling coil.
Further, the device also comprises a battery and a power management circuit;
the battery is connected with the power management circuit;
the power supply management circuit is used for stabilizing the voltage of the direct current sent by the battery and then respectively providing the voltage to the nerve signal amplifier, the nerve signal processing circuit, the transceiver and the nerve electric stimulator which are connected with the power supply management circuit.
Further, the battery is a rechargeable battery;
the system also comprises an alternating current-direct current converter which is respectively connected with the coupling coil and the battery and is used for converting alternating current obtained by the coupling coil from the external circuit in a coupling mode into direct current to be supplied to the battery.
Furthermore, the nerve signal amplifier, the nerve signal processing circuit, the nerve electrical stimulator, the transceiver, the AC/DC converter and the power management circuit are integrated in a chip;
the chip is positioned on a printed circuit board;
the coupling coil and the battery are located on the printed circuit board.
Furthermore, the printed circuit board is provided with a fixing hole;
the system also includes a medical screw passing through the fixation hole and secured to cortical bone surrounding the sacral nerve root sleeve.
Further, the coupling coil is also used for receiving a control signal sent by the external circuit in a coupling mode and sending the control signal to the transceiver;
the transceiver is further configured to forward the control signal to the neural signal processing circuitry;
the neural signal processing circuit is also used for adjusting the frequency and/or amplitude of the stimulation electric signal sent by the neural electric stimulator by changing the urination signal according to the control signal.
Further, the electrode includes: the device comprises a transceiving electrode point, a reference electrode point, a substrate and a lead; wherein,
the number of the conducting wires is equal to the sum of the numbers of the transmitting and receiving electrode points and the reference electrode points;
the transmitting-receiving electrode points are attached to the sacral nerve root sleeve, are respectively connected with the nerve signal amplifier and the nerve electric stimulator through the lead, and are used for transmitting a nerve electric signal received from a posterior sacral nerve root in the sacral nerve root sleeve to the nerve signal amplifier and stimulating the sacral nerve root sleeve by using the stimulation electric signal transmitted by the nerve electric stimulator;
the reference electrode point is respectively connected with the nerve signal amplifier and the nerve electric stimulator through the lead and is used for providing a reference potential for the nerve signal amplifier and the nerve electric stimulator;
the substrate is planar; the transmitting electrode point and the receiving electrode point and the reference electrode point are both attached to the surface of the substrate, and the lead is positioned inside the substrate.
Further, the transmitting and receiving electrode point, the reference electrode point and the lead are all made of gold;
the surfaces of the transmitting and receiving electrode point and the reference electrode point are coated with iridium.
Further, a part of the outside of the substrate except the transceiver electrode point and the reference electrode point is wrapped by a wrapping material made of C-type parylene.
Further, the edge of the substrate is provided with more than two sewing holes.
Furthermore, the number of the transmitting and receiving electrode points is one, the number of the reference electrode points is four, and the number of the leads is five;
the transceiver electrode point is positioned at the end part of the substrate surface;
the reference electrode points dispersedly surround the transceiving electrode points, and the distances between the reference electrode points and the transceiving electrode points are all between 1mm and 2 mm.
Further, the neural signal processing circuit determines whether the human body needs to urinate according to whether the frequency of the amplified neural electric signal exceeds a predetermined frequency threshold.
Further, the stimulation electrical signals include low frequency electrical signals and high frequency electrical signals;
the nerve electrical stimulator firstly sends the low-frequency electrical signal to the electrode according to the urination signal and then sends the high-frequency electrical signal to the electrode;
the electrode stimulates the sacral nerve root sleeve by using the low-frequency electric signal, so that the sacral nerve anterior root in the sacral nerve root sleeve controls the contraction of the urethral sphincter and enables the sacral nerve anterior root to be fatigued;
the electrode stimulates the sacral nerve root sleeve by using the high-frequency electric signal, so that the sacral nerve anterior root controls the contraction of the bladder detrusor muscle, and the urination is performed.
Drawings
FIG. 1 is a schematic diagram of the nervous system associated with bladder urination;
FIG. 2 is a block diagram of an implantable bladder function repair system in accordance with the present invention;
FIG. 3 is a block diagram of an embodiment of an implantable bladder function repair system in accordance with the present invention;
fig. 4 is a schematic view of the position of the embodiment of fig. 3 implanted in a human body.
Detailed Description
The principles and features of this invention are described below in conjunction with the following drawings, which are set forth by way of illustration only and are not intended to limit the scope of the invention.
Fig. 2 is a structural diagram of an implantable bladder function repair system according to the present invention. As shown in fig. 2, the system includes: an electrode 201, a nerve signal amplifier 202, a nerve signal processing circuit 203 and a nerve electrical stimulator 204; wherein,
the electrode 201 is attached to the sacral nerve root sleeve 1012 such that the electrode 201 can receive the electrical nerve signals transmitted by the posterior sacral nerve root in the sacral nerve root sleeve 1012 (to the vertebra 103 in fig. 1), and the electrical stimulation signals can be used to stimulate the sacral nerve root sleeve 1012 to enable the anterior sacral nerve root therein to control bladder urination.
The electrode 201 is connected to the nerve signal amplifier 202 such that the electrode 201 can send the nerve electrical signal received from the posterior sacral nerve root in the sacral nerve root cuff 1012 to the nerve signal amplifier 202 for amplification.
The neural signal amplifier 202 is connected to the neural signal processing circuit 203, and the neural signal amplifier 202 can send the neural electric signal amplified by the neural signal amplifier to the neural signal processing circuit 203 for processing.
The neural signal processing circuit 203 may determine whether the human body needs to urinate according to the amplified neural electric signal, and if so, transmit a urination signal to the connected neural electric stimulator 204, otherwise, not transmit the urination signal to the neural electric stimulator 204. Here, the neural signal processing circuit 203 determines whether the human body needs to urinate according to whether the frequency of the amplified neural electric signal exceeds a predetermined frequency threshold, determines that the human body needs to urinate if the frequency of the amplified neural electric signal exceeds the predetermined frequency threshold, and determines that the human body does not need to urinate if the frequency of the amplified neural electric signal is small without exceeding the predetermined frequency threshold. The predetermined frequency threshold is a predetermined frequency value, which can be adjusted according to the needs of different human bodies.
The nerve electrical stimulator 204 sends a stimulation electrical signal to the connected electrode 201 according to the urination signal, so that the electrode 201 can stimulate the sacral nerve root sleeve 1012 by using the stimulation electrical signal to enable the sacral nerve anterior root to control the bladder to urinate, thereby realizing the urination of the human body according to the requirement.
Therefore, in the invention, the electrode can receive the nerve electrical signal sent by the posterior sacral nerve root in the sacral nerve root sleeve in real time or periodically and send the nerve electrical signal to the nerve signal amplifier for amplification, the nerve signal processing circuit can determine the filling degree of the bladder according to the amplified nerve electrical signal so as to determine whether the human body needs urination, and when the human body needs urination, the nerve signal processing circuit can send a urination signal to the nerve electrical stimulator in real time and send a stimulation electrical signal to the electrode by the nerve electrical stimulator so as to stimulate the sacral nerve root sleeve and control the bladder urination by the anterior sacral nerve root in the sacral nerve root sleeve. Therefore, the invention can stimulate the bladder to urinate immediately when a patient has more urine accumulated in the bladder (namely needs to urinate), thereby helping the patient to urinate as required, preventing the urine from accumulating in the bladder and reducing or eliminating the occurrence of complications such as urinary infection, renal failure and the like.
According to the research of human physiology, the stimulation electrical signal sent by the neural electrical stimulator 204 to the electrode 201, that is, the stimulation electrical signal of the electrode 201 to stimulate the sacral nerve root-cuff 1012, may include a low-frequency electrical signal and a high-frequency electrical signal, the neural electrical stimulator 204 sends the low-frequency electrical signal to the electrode 201 first and then sends the high-frequency electrical signal to the electrode 201 according to the urination signal, and the duration time of the two signals may be adjusted as required, for example, the urination signal sent by the neural signal processing circuit 203 includes the duration time information of the low-frequency electrical signal and the high-frequency electrical signal, so that the neural electrical stimulator 204 may send the low-frequency electrical signal and the high-frequency electrical signal of the corresponding duration time length to the electrode 201 successively according to the duration time information in the urination signal, thereby controlling the.
The electrode 201 stimulates the sacral nerve root sleeve 1012 by using low-frequency electric signals, so that the sacral nerve anterior root can control the contraction of the urethral sphincter and cause the urethral sphincter to be fatigued; the electrode 201 stimulates the sacral nerve root sleeve 1012 by high-frequency electric signals, so that the sacral nerve anterior root in the sacral nerve root sleeve can control the bladder detrusor muscle to contract, thereby carrying out urination.
As shown in fig. 2, the system further includes a transceiver 205 and a coupling coil 206, where the transceiver 205 can be implemented by a signal transceiver or a signal receiver and a signal transmitter, respectively, and the coupling coil 206 is a device for communicating with the external circuit 207 by using a coupling method and can be implemented by a coil.
The transceiver 205 is connected with the coupling coil 206 and the neural signal processing circuit 203 respectively;
the neural signal processing circuit 203 is configured to transmit the recorded amplified neural electrical signal, the urination signal transmitted to the neural electrical stimulator 204, and the corresponding recording time (i.e., the recording time of the neural electrical signal and the transmission time of the urination signal) to the transceiver 205, so that the transceiver 205 can transmit the amplified neural electrical signal, the urination signal, and the corresponding recording time to the external circuit 207 through the coupling coil 206, and the amplified neural electrical signal, the urination signal, and the corresponding recording time are analyzed and processed by the external circuit 207.
As shown in fig. 2, the system further includes a battery 209 and a power management circuit 210;
the battery 209 is connected to the power management circuit 210, the power management circuit 210 can stabilize the direct current sent by the battery 209, and then the power management circuit 210 provides the stabilized direct current to the neural signal amplifier 202, the neural signal processing circuit 203, the transceiver 205 and the neural electrical stimulator 204 connected thereto, respectively, where the power supply line is a line indicated by a dotted line in fig. 2.
The power management circuit 210 herein can not only stabilize the dc power and supply power to the neural signal amplifier 202, the neural signal processing circuit 203, the transceiver 205, and the neural electrical stimulator 204, but also detect the remaining power of the battery 209, and determine whether the remaining power can maintain the system to operate for a predetermined time, if the determination result is that it is not possible, the power management circuit 210 will send a power emergency signal to the neural signal processing circuit 203, and after the neural signal processing circuit 203 receives the signal, the power management circuit can send a power shortage signal to the transceiver 205 immediately or after waiting for a period of time, so as to ask for help to the external circuit 207 through the coupling coil 206. Of course, after determining that the remaining power is not sufficient to maintain the system operation for a predetermined time, the power management circuit 210 may directly transmit a power emergency signal to the transceiver 205, and ask for help from the transceiver to the external circuit 207 through the coupling coil 206.
The handling of the shortage of the battery 209 may be to charge it, so that the battery 209 needs to be implemented by a rechargeable battery.
As shown in fig. 2, the system further includes an ac/dc converter 208, which is respectively connected to the coupling coil 206 and the battery 209, and is configured to convert the ac power obtained by the coupling from the external circuit 207 into dc power for being supplied to the battery 209 for storage.
The amplitude, frequency and the like of a stimulation signal applied to the sacral nerve root sleeve 1012 by the existing bladder function repair system are predetermined and cannot be changed by a human, so that in practical clinical application, patients often have serious complications such as lower limb convulsion, pain, cerebrospinal fluid leakage, infection and the like due to overlarge amplitude and frequency of the stimulation signal, or can not urinate normally due to undersize amplitude or frequency of the stimulation signal. The present invention can solve this problem by using information transfer between the coupling coil 206 and the external circuit 207.
In the present invention, the coupling coil 206 may be configured to receive the control signal transmitted by the external circuit 207 through a coupling manner and transmit the control signal to the transceiver 205, such that the transceiver 205 is further configured to forward the control signal to the neural signal processing circuit 203, and the neural signal processing circuit 203 is further configured to adjust the frequency and/or amplitude of the stimulation electrical signal transmitted by the neural electrical stimulator 204 by changing the urination signal according to the control signal. Thus, parameters such as frequency and amplitude of the stimulating electric signal of the sacral nerve root sleeve 1012 stimulated by the electrode 201 can be adjusted through the external circuit 207, so that the sacral nerve root sleeve can be adapted to the requirements of a human body, and the problems of serious complications such as lower limb convulsion, pain, cerebrospinal fluid leakage, infection and the like and incapability of normal urination due to the fact that the amplitude or the frequency of the stimulating signal is too small are prevented.
The present invention is an implantable medical electronics system that is positioned near the bladder of the human body and fits the sacral nerve root sleeve 1012, so that its volume and power consumption should be as small as possible to prevent damage to surrounding tissue organs, and used for as long as possible without replacement. Therefore, the neural signal amplifier 202, the neural signal processing circuit 203, the neural electrical stimulator 204, the transceiver 205, the ac/dc converter 208 and the power management circuit 210 in the present invention can be integrated into a chip, and the chip can be disposed on a printed circuit board, and the coupling coil 206 and the battery 209 are also disposed on the printed circuit board, so as to reduce the volume of the system as much as possible, reduce the power consumption thereof and meet the requirements of the implanted medical electronic system.
Fig. 3 is a block diagram of an embodiment of the system. As shown in fig. 3, the chip is denoted by 302, the printed circuit board is denoted by 301, the coupling coil 304 and the battery 303 are respectively connected to corresponding circuits on the chip 302 through corresponding wires, specifically, the coupling coil 304 is respectively connected to the transceiver and the ac/dc converter in the chip 302, and the battery 303 is respectively connected to the ac/dc converter and the power management circuit in the chip 302.
In this embodiment, the printed circuit board 301 is provided with fixing holes 305, so that the system can fix the printed circuit board 301 and the chip 302, the battery 303 and the coupling coil 304 thereon around the sacral nerve root sleeve inside the human body by using medical screws, thereby realizing the relative rest of the system and the human body and preventing the printed circuit board 301 and various circuits from damaging the human body. Specifically, a medical screw can be passed through the fixation hole 305 and secured to cortical bone surrounding the sacral nerve root sleeve 1012.
As shown in fig. 3, the electrode in the present invention includes: a transmit-receive electrode point 307, a reference electrode point 308, a substrate 306, and a conductive line 311. Wherein the number of the conductive wires 311 is equal to the sum of the numbers of the transceiver electrode points 307 and the reference electrode points 308, as shown in the embodiment of fig. 3, the electrode includes one transceiver electrode point 307 and four reference electrode points 308, so that the number of the conductive wires 311 is five.
The transmitting-receiving electrode point 307 is attached to the sacral nerve root sleeve, is connected with the nerve signal amplifier and the nerve electrical stimulator (in the chip 302) through the connected wires, and is used for transmitting the nerve electrical signal received from the posterior sacral nerve root in the sacral nerve root sleeve to the nerve signal amplifier and stimulating the sacral nerve root sleeve by using the stimulation electrical signal transmitted by the nerve electrical stimulator.
The reference electrode point 308 is connected to the neural signal amplifier (in the chip 302) and the neural electrical stimulator through respective connected leads, respectively, for providing a reference potential to the neural signal amplifier and the neural electrical stimulator. In the embodiment of fig. 3, four reference electrode points 308 are used, and the reference potential here is thus the average of the potentials at all reference electrode points 308.
The substrate 306 is planar, the transceiver electrode point 307 and the reference electrode point 308 are both attached to the surface of the substrate 306, and the conducting wire 311 is located inside the substrate 306.
As shown in fig. 3, the transceiver electrode point 307 and the reference electrode point 308 are both located at one end 309 of the substrate 306 (the other end of the substrate 306 is connected to the printed circuit board 302), and the end 309 is triangular, so as to reduce the contact area between the substrate 306 and the human body, and achieve the purpose of preventing the system from damaging the human body.
The transmitting/receiving electrode point 307, the reference electrode point 308, and the conductive line 311 are made of gold. The lead 311 is located inside the substrate 306 and protected by the substrate 306, and the transceiver electrode point 307 and the reference electrode point 308 are attached to the surface of the substrate 306, so that when the stimulation electrical signal is received and sent to the sacral nerve root sleeve, the transceiver electrode point 307 and the reference electrode point 308 are also separated from the substrate 306 under the action of the stimulation electrical signal, iridium can be coated on the surfaces of the transceiver electrode point 307 and the reference electrode point 308, and the iridium is used as a modifying material on the surfaces of the transceiver electrode point 307 and the reference electrode point 308, so that the transceiver electrode point 307 and the reference electrode point 308 can be prevented from being separated from the surface of the substrate 306.
The substrate 306 may be made of a flexible polyimide polymer material with good flexibility and biocompatibility, and a portion of the outside of the substrate 306 except the transceiver electrode point 307 and the reference electrode point 308 is wrapped with a wrapping material made of C-type parylene, so as to avoid damage to the human body by the electrode as much as possible.
The substrate 306 in fig. 3 is in the shape of a strip, which has a certain length and width, and if the substrate is randomly shaken in a human body, the substrate inevitably scrapes nearby device tissues, so that the substrate 306 needs to be fixed. More than two stitching holes may be provided at the edge of the substrate 306, as shown in fig. 3, the stitching holes being numbered 310, and the four stitching holes near the transceiver electrode point 307 and the reference electrode point 308 (on both sides of the substrate 306) are numbered 3101, 3102, 3103, and 3104, respectively. Fixation of the base 306 may be achieved by attaching the base 306 to cortical bone surrounding the sacral nerve root sleeve using a medical suture passing through some or all of the suture holes 310, preferably suture holes 3101, 3102, 3103 and 3104 in fig. 3.
In fig. 3, there are one transceiver electrode point 307, four reference electrode points 308, and five wires 311;
the transceiver electrode point 307 is located at an end 309 of the surface of the substrate 306;
the reference electrode points 308 are dispersedly surrounding the transceiving electrode points 307, and the distances between the reference electrode points 308 and the transceiving electrode points 307 are all between 1mm and 2mm, so that the reference electrode points 308 and the transceiving electrode points 307 are plum blossom-shaped.
Of course, the number of the reference electrode points 308 and the transceiver electrode points 307 may be other numbers, for example, the transceiver electrode points 307 may be more than one, the reference electrode points 308 may be one, or other numbers, and the potential provided by the reference electrode points and the transceiver electrode points may be zero potential of the whole system.
Fig. 4 is a schematic view of the position of the embodiment of fig. 3 implanted in a human body. As shown in fig. 4, the base 306 is made of a soft material, so that the base can be bent in the human body, and the end 309 can be inserted below the sacral nerve root sleeve 1012 in fig. 4, so as to fit the transmitting/receiving electrode point 307 and the sacral nerve root sleeve 1012. Fixation of the printed circuit board 301 can be accomplished by a medical screw passing through the fixation hole 305 in the printed circuit board 301 and securing with cortical bone around the sacral nerve root sleeve 1012. Fixation of the base 306 may also be accomplished with a medical suture passing through the suture hole 310 in fig. 3 (preferably 3101 and 3104 in fig. 3) and suturing with cortical bone around the sacral radicular cuff 1012.
The figure shows only the case that one implanted bladder function repair system is implanted in a human body, and the sacral nerve root sleeve 1012 has the symmetry in the anatomical sense according to the information provided by the anatomy, so that an even number (for example, two) of implanted bladder function repair systems provided by the invention can be implanted in the human body, and the systems are symmetrically distributed on both sides of the sacral nerve root sleeve 1012, thereby simultaneously realizing the control of muscles on both sides of the bladder and realizing the urine excretion of the human body according to the requirement.
It can be seen that the present invention has the following advantages:
(1) in the invention, the electrode can receive the nerve electrical signal sent by the posterior sacral nerve root in the sacral nerve root sleeve in real time or periodically and send the nerve electrical signal to the nerve signal amplifier for amplification, the nerve signal processing circuit can determine the filling degree of the bladder according to the amplified nerve electrical signal so as to determine whether the human body needs urination, and when the human body needs urination, the nerve signal processing circuit can send a urination signal to the nerve electrical stimulator in real time and send a stimulation electrical signal to the electrode by the nerve electrical stimulator so as to stimulate the sacral nerve root sleeve and control the bladder urination by the anterior sacral nerve root in the sacral nerve root sleeve. Therefore, the invention can stimulate the bladder to urinate immediately when a patient has more urine accumulated in the bladder (namely needs to urinate), thereby helping the patient to urinate as required, preventing the urine from accumulating in the bladder and reducing or eliminating the occurrence of complications such as urinary infection, renal failure and the like.
(2) In the invention, the coupling of the coupling coil and an external circuit is utilized to adjust the parameters of frequency, amplitude and the like of the stimulating electric signals of the electrode stimulating sacral nerve root sleeve, so that the sacral nerve root sleeve can adapt to the requirements of a human body, and the problems of severe complications such as lower limb convulsion, pain, cerebrospinal fluid leakage, infection and the like and incapability of normal urination due to the undersize amplitude or frequency of the stimulating signals are prevented.
(3) The nerve signal amplifier, the nerve signal processing circuit, the nerve electrical stimulator, the transceiver, the AC-DC converter and the power management circuit are integrated in a chip, the chip can be arranged on a printed circuit board, and the coupling coil and the battery are also arranged on the printed circuit board, so that the volume of the system can be reduced, the power consumption of the system can be reduced, and the requirements of an implanted medical electronic system can be met.
(4) In the invention, the printed circuit board is provided with the fixing hole, the substrate is provided with the suture hole, the printed circuit board and the substrate can be fixed relative to the human body, the end part of the substrate is arranged to be triangular, the contact area with the human tissue and organ can be reduced, the contact area between the system provided by the invention and the human body can be reduced, and the human body can be prevented from being damaged.
(5) The invention can simulate the normal bladder urination function, and because the coupling coil can communicate with an external circuit, the invention has the automatic early warning capability, and can realize the control urination of the spinal cord injury patient in free, controllable and near physiological state; meanwhile, the invention is helpful for discussing the mechanism and the mode of sacral nerve electrical signal transmission and the feasibility and the mechanism of the bladder function repair chip, and provides a new basis for the electrical stimulation treatment theory of the neurogenic bladder.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.
Claims (14)
1. An implantable bladder function repair system, the system comprising: the nerve stimulation device comprises electrodes, a nerve signal amplifier, a nerve signal processing circuit and a nerve electrical stimulator; wherein,
the electrodes are attached to the sacral nerve root-sleeve;
the electrode is connected with the nerve signal amplifier and is used for sending nerve electric signals received from a posterior sacral nerve root in the sacral nerve root sleeve to the nerve signal amplifier for amplification;
the nerve signal amplifier is connected with the nerve signal processing circuit and used for sending the amplified nerve electrical signal to the nerve signal processing circuit for processing;
the nerve signal processing circuit determines whether the human body needs to urinate according to the amplified nerve electric signal, and if so, sends a urination signal to the connected nerve electric stimulator;
the nerve electrical stimulator sends a stimulation electrical signal to the connected electrode according to the urination signal; the electrode stimulates the sacral nerve root sleeve by the stimulating electric signal, so that the sacral nerve anterior root in the sacral nerve root sleeve controls the bladder to urinate.
2. The system of claim 1, further comprising a transceiver and a coupling coil;
the transceiver is respectively connected with the coupling coil and the neural signal processing circuit;
the nerve signal processing circuit is used for sending the recorded amplified nerve electric signal, the urination signal sent to the nerve electric stimulator and the corresponding recording time to the transceiver;
the transceiver transmits the amplified nerve electrical signal, the urination signal and the corresponding recording time to an external circuit through the coupling coil.
3. The system of claim 2, further comprising a battery and power management circuitry;
the battery is connected with the power management circuit;
the power supply management circuit is used for stabilizing the voltage of the direct current sent by the battery and then respectively providing the voltage to the nerve signal amplifier, the nerve signal processing circuit, the transceiver and the nerve electric stimulator which are connected with the power supply management circuit.
4. The system of claim 3, wherein the battery is a rechargeable battery;
the system also comprises an alternating current-direct current converter which is respectively connected with the coupling coil and the battery and is used for converting alternating current obtained by the coupling coil from the external circuit in a coupling mode into direct current to be supplied to the battery.
5. The system of claim 4, wherein the neural signal amplifier, the neural signal processing circuit, the neural electrical stimulator, the transceiver, the AC/DC converter, and the power management circuit are integrated into a chip;
the chip is positioned on a printed circuit board;
the coupling coil and the battery are located on the printed circuit board.
6. The system of claim 5, wherein the printed circuit board has a fixing hole;
the system also includes a medical screw passing through the fixation hole and secured to cortical bone surrounding the sacral nerve root sleeve.
7. The system of claim 2, wherein the coupling coil is further configured to receive a control signal transmitted by the external circuit via a coupling manner and transmit the control signal to the transceiver;
the transceiver is further configured to forward the control signal to the neural signal processing circuitry;
the neural signal processing circuit is also used for adjusting the frequency and/or amplitude of the stimulation electric signal sent by the neural electric stimulator by changing the urination signal according to the control signal.
8. The system of claim 1, wherein the electrode comprises: the device comprises a transceiving electrode point, a reference electrode point, a substrate and a lead; wherein,
the number of the conducting wires is equal to the sum of the numbers of the transmitting and receiving electrode points and the reference electrode points;
the transmitting-receiving electrode points are attached to the sacral nerve root sleeve, are respectively connected with the nerve signal amplifier and the nerve electric stimulator through the lead, and are used for transmitting a nerve electric signal received from a posterior sacral nerve root in the sacral nerve root sleeve to the nerve signal amplifier and stimulating the sacral nerve root sleeve by using the stimulation electric signal transmitted by the nerve electric stimulator;
the reference electrode point is respectively connected with the nerve signal amplifier and the nerve electric stimulator through the lead and is used for providing a reference potential for the nerve signal amplifier and the nerve electric stimulator;
the substrate is planar; the transmitting electrode point and the receiving electrode point and the reference electrode point are both attached to the surface of the substrate, and the lead is positioned inside the substrate.
9. The system of claim 8, wherein the transceiver electrode point, the reference electrode point, and the wire are all made of gold;
the surfaces of the transmitting and receiving electrode point and the reference electrode point are coated with iridium.
10. The system of claim 8, wherein a portion of the exterior of the substrate excluding the transceiver electrode point and the reference electrode point is wrapped with a wrapping material made of parylene-C.
11. The system of claim 8, wherein the edge of the substrate is provided with more than two suture holes.
12. The system of claim 8, wherein the number of said transmit/receive electrode points is one, the number of said reference electrode points is four, and the number of said wires is five;
the transceiver electrode point is positioned at the end part of the substrate surface;
the reference electrode points dispersedly surround the transceiving electrode points, and the distances between the reference electrode points and the transceiving electrode points are all between 1mm and 2 mm.
13. The system of claim 1, wherein the neural signal processing circuitry determines whether the person requires urination based on whether the frequency of the amplified neural electrical signal exceeds a predetermined frequency threshold.
14. The system of claim 1, wherein the stimulation electrical signals comprise low frequency electrical signals and high frequency electrical signals;
the nerve electrical stimulator firstly sends the low-frequency electrical signal to the electrode according to the urination signal and then sends the high-frequency electrical signal to the electrode;
the electrode stimulates the sacral nerve root sleeve by using the low-frequency electric signal, so that the sacral nerve anterior root in the sacral nerve root sleeve controls the contraction of the urethral sphincter and enables the sacral nerve anterior root to be fatigued;
the electrode stimulates the sacral nerve root sleeve by using the high-frequency electric signal, so that the sacral nerve anterior root controls the contraction of the bladder detrusor muscle, and the urination is performed.
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| CN2011102810495A CN102441232A (en) | 2011-09-21 | 2011-09-21 | An implantable bladder function repair system |
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| CN107743408A (en) * | 2015-08-05 | 2018-02-27 | 波士顿科学医学有限公司 | Control bladder function is paced using high frequency |
| CN109420252A (en) * | 2017-08-22 | 2019-03-05 | 精能医学股份有限公司 | Electrical stimulation apparatus, method of generating electrical signal, and computer-readable storage medium |
| CN110327548A (en) * | 2019-08-08 | 2019-10-15 | 吉林大学 | A kind of Sacral nerve electrical stimulation system |
| CN111008610A (en) * | 2019-12-16 | 2020-04-14 | 哈尔滨工业大学 | A kind of information-related brain potential evoked experimental method |
| CN111298291A (en) * | 2020-03-20 | 2020-06-19 | 北京航空航天大学 | Autonomous urination auxiliary device and method |
| CN111683599A (en) * | 2017-12-21 | 2020-09-18 | 因卡伯实验室有限责任公司 | Device and method for sensing bladder fullness |
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| CN109420252A (en) * | 2017-08-22 | 2019-03-05 | 精能医学股份有限公司 | Electrical stimulation apparatus, method of generating electrical signal, and computer-readable storage medium |
| CN111683599A (en) * | 2017-12-21 | 2020-09-18 | 因卡伯实验室有限责任公司 | Device and method for sensing bladder fullness |
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| CN110327548A (en) * | 2019-08-08 | 2019-10-15 | 吉林大学 | A kind of Sacral nerve electrical stimulation system |
| CN111008610A (en) * | 2019-12-16 | 2020-04-14 | 哈尔滨工业大学 | A kind of information-related brain potential evoked experimental method |
| CN111008610B (en) * | 2019-12-16 | 2024-03-22 | 哈尔滨工业大学 | Information-related brain potential evoked experiment method |
| CN111298291A (en) * | 2020-03-20 | 2020-06-19 | 北京航空航天大学 | Autonomous urination auxiliary device and method |
| CN111298291B (en) * | 2020-03-20 | 2021-10-08 | 北京航空航天大学 | A kind of automatic urination aid device and method |
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Application publication date: 20120509 |