Neurophysiological monitoring device

Abstract

A kind of nerve electrophysiological monitoring equipment (100), the nerve electrophysiological monitoring equipment (100) includes: urethral detection device, urethral detection device is provided with bladder pressure detection piece and first electromyography detection piece;Rectal detection device, rectal detection device is provided with rectal pressure detection piece and second electromyography detection piece;Monitoring module (13) is electrically connected with bladder pressure detection piece, first electromyography detection piece, rectal pressure detection piece and second electromyography detection piece respectively.According to the nerve electrophysiological monitoring equipment of the present application, the nerve electrophysiological monitoring equipment can detect the intravesical pressure and intrarectal pressure, the electromyographic activity of urethral external sphincter and the electromyographic activity of anal external sphincter simultaneously, without multiple monitoring instruments for detection, thereby improving the integration of nerve electrophysiological monitoring equipment and the safety of operation, reduce postoperative risk.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to Chinese patent application No. 2021108864859, entitled "Neuroelectrophysiological Monitoring Device," filed with the Patent Office of the State Intellectual Property Office of China on August 3, 2021.

[0003] This application claims priority to Chinese patent application No. 2021108865048, entitled "Neuroelectrophysiological Monitoring Device", filed with the Patent Office of the State Intellectual Property Office of China on August 3, 2021.

[0004] This application claims priority to Chinese patent application No. 2021108877454, entitled "Neuroelectrophysiological Monitoring Device", filed with the Patent Office of the State Intellectual Property Office of China on August 3, 2021.

[0005] Its entire contents are incorporated herein by reference. Technical Field

[0006] This invention relates to the field of medical devices, and in particular to a neurophysiological monitoring device. Background Technology

[0007] Currently, the key indicators monitored during surgery in related technologies include pressure in the bladder and rectum, and electromyographic activity of the external urethral sphincter and external anal sphincter. However, due to limitations in the structure of the monitoring devices, existing devices can only monitor one indicator during surgery and cannot monitor multiple indicators simultaneously. Recording pressure in the bladder and rectum, and electromyographic activity of the external urethral sphincter and external anal sphincter, requires multiple invasive monitoring instruments, resulting in significant patient trauma and high costs. Furthermore, this method cannot simultaneously record pressure in the bladder and rectum, and electromyographic activity of the external urethral sphincter and external anal sphincter, reducing surgical safety and increasing postoperative risks. Summary of the Invention

[0008] This invention aims to at least solve one of the technical problems existing in the prior art. Therefore, one object of this invention is to provide a neurophysiological monitoring device that can simultaneously detect intrabladder and rectal pressure, as well as the electromyographic activity of the external urethral sphincter and the external anal sphincter, without requiring multiple monitoring instruments. This improves the integration of the neurophysiological monitoring device and the safety of the surgery, reducing postoperative risks.

[0009] According to the present invention, the neuroelectrophysiological monitoring device comprises: a urethral detection device, wherein the urethral detection device is provided with a bladder pressure detection element and a first electromyography (EMG) detection element; the bladder pressure detection element is disposed in the patient's bladder and is adapted to detect the intrabladder pressure of the patient, and the first EMG detection element is adapted to contact the external urethral sphincter and detect the EMG activity of the external urethral sphincter; a rectal detection device, wherein the rectal detection device is provided with a rectal pressure detection element and a second EMG detection element, wherein the rectal pressure detection element is disposed in the patient's rectum and is adapted to detect the rectal pressure of the patient; the second EMG detection element is adapted to contact the external anal sphincter and detect the EMG activity of the external anal sphincter; and a monitoring module, wherein the monitoring module is electrically connected to the bladder pressure detection element, the first EMG detection element, the rectal pressure detection element, and the second EMG detection element, respectively.

[0010] In short, according to the neurophysiological monitoring device of the present invention, the device includes a urethral detection device, a rectal detection device, and a monitoring module. The urethral detection device is used to detect the patient's intrabladder pressure and the electromyographic activity of the external urethral sphincter. The rectal detection device is used to detect the patient's intrarectal pressure and the electromyographic activity of the external anal sphincter. The monitoring module is used to monitor the intrabladder pressure, intrarectal pressure, and electromyographic activity of the external urethral sphincter and the external anal sphincter. Therefore, the neurophysiological monitoring device can simultaneously detect the intrabladder pressure, intrarectal pressure, and electromyographic activity of the external urethral sphincter and the external anal sphincter without the need for multiple monitoring instruments, thereby improving the integration of the neurophysiological monitoring device and the safety of the surgery, and reducing postoperative risks.

[0011] According to one embodiment of the present invention, the bladder pressure detection device includes: a first connecting tube, the first connecting tube being adapted to deliver a medium and having one end open within the patient's bladder, and the other end of the first connecting tube extending outside the patient's body; a first pressure conversion device, the first pressure conversion device having a first detection end and a first signal output end, the first detection end being connected to the first connecting tube and adapted to detect the pressure of the medium within the first connecting tube, the first signal output end being communicatively connected to the monitoring module, and the first pressure conversion device being adapted to convert the pressure of the medium within the first connecting tube into a bladder pressure signal and transmit it to the monitoring module through the first signal output end.

[0012] According to one embodiment of the present invention, a medium injection device is provided at the other end of the first connecting pipe, the medium injection device selectively injecting a medium into the first connecting pipe.

[0013] According to one embodiment of the present invention, the first electromyography (EMG) detection device is disposed on the outer periphery of the first communicating tube.

[0014] According to one embodiment of the present invention, the first electromyography (EMG) detection device is configured as a plurality of first EMG electrodes, which are arranged at intervals in the extension direction of the first connecting tube or in the circumferential direction of the first connecting tube.

[0015] According to one embodiment of the present invention, the neurophysiological monitoring device further includes: a first connecting tube fixing device, the first connecting tube fixing device being disposed at one end of the first connecting tube, the first connecting tube fixing device being selectively deformable to be tensioned in the patient's bladder, and an expansion cavity being formed inside the first connecting tube fixing device; the expansion cavity being connected to a syringe connecting tube for injecting a medium into the expansion cavity to control the deformation of the connecting tube fixing device.

[0016] According to one embodiment of the present invention, the rectal pressure detection device includes: a second connecting tube, the second connecting tube being adapted to deliver a medium and having one end disposed inside the rectum of a patient, and the other end of the second connecting tube extending outside the patient's body; a rectal dilatation sac, the rectal dilatation sac being disposed at one end of the second connecting tube and communicating with the second connecting tube, the outer peripheral wall of the rectal dilatation sac abutting against the inner wall of the patient's rectum; and a second pressure conversion device, the second pressure conversion device having a second detection end and a second signal output end, the second detection end being communicating with the second connecting tube and adapted to detect the pressure of the medium inside the second connecting tube, the second signal output end being communicatively connected to a monitoring module, and the second pressure conversion device being adapted to convert the pressure of the medium into a rectal pressure signal and transmit it to the monitoring module through the second signal output end.

[0017] According to one embodiment of the present invention, the other end of the second connecting pipe may be connected to a medium injection device, which may selectively inject a medium into the second connecting pipe.

[0018] According to one embodiment of the present invention, the neurophysiological monitoring device further includes: a three-way tube having a first interface, a second interface, and a third interface that are selectively connected to each other; the first interface being connected to the other end of the second connecting tube; the second interface being connected to the second detection end of the second pressure conversion device; and the third interface being connected to the media injection device.

[0019] According to one embodiment of the present invention, the second electromyography (EMG) detection element is disposed on the outer periphery of the second connecting tube.

[0020] According to one embodiment of the present invention, the second electromyography (EMG) detection device is configured as a plurality of second EMG electrodes, which are arranged at intervals in the extension direction of the second connecting tube or in the circumferential direction of the first connecting tube.

[0021] According to one embodiment of the present invention, a plurality of scale markings are provided on the outer peripheral wall of the second connecting pipe at intervals in the extending direction of the second connecting pipe.

[0022] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0023] Figure 1 This is a schematic diagram of the structure of a neurophysiological monitoring device according to a first aspect of an embodiment of the present invention;

[0024] Figure 2 This is a schematic diagram of the structure of a neurophysiological monitoring device according to a second aspect of an embodiment of the present invention;

[0025] Figure 3 This is a schematic diagram of the structure of a neurophysiological monitoring device according to a third aspect of an embodiment of the present invention;

[0026] Figure 4 This is a schematic diagram of the structure of the ring electromyography electrode according to an embodiment of the present invention;

[0027] Figure 5 This is a cross-sectional view of a strip-shaped electromyographic electrode according to an embodiment of the present invention.

[0028] Figure label:

[0029] 100 neurophysiological monitoring devices

[0030] Connecting tube 111, connecting catheter 112, detection end 113, medium injection device 114, electromyographic electrode 121, electromyographic electrode connecting wire harness 122, monitoring module 13, connecting tube fixing device 14, syringe connecting tube 15, urination tube 161, urine collection bag 162, first regulating valve 17, second regulating valve 18, bladder fluid opening 19.

[0031] 200 neurophysiological monitoring devices

[0032] Connecting tube 211, connecting catheter 212, detection end 213, media injection device 214, rectal dilator 215, electromyographic electrode 221, electromyographic electrode connecting wire harness 222, monitoring module 23, third regulating valve 24.

[0033] 300 neurophysiological monitoring devices

[0034] First connecting tube 3111, first connecting catheter 3112, first detection end 3113, first electromyographic electrode 3121, first electromyographic electrode connecting wire harness 3122, connecting tube fixing device 313, syringe connecting tube 314, urination tube 3151, urine collection bag 3152, fourth regulating valve 316, fifth regulating valve 317, bladder fluid opening 318.

[0035] Second connecting tube 3211, second connecting catheter 3212, second detection end 3213, rectal dilation sac 3214, second electromyographic electrode 322, second electromyographic electrode connecting harness 323, sixth regulating valve 324.

[0036] Monitoring module 33, first medium injection device 34, second medium injection device 35

[0037] Circular electromyography electrode 1211, strip electromyography electrode 1212. Detailed Implementation

[0038] Embodiments of the present invention are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.

[0039] The following describes a neurophysiological monitoring device according to a first aspect of this application, which is used to detect intrabladder pressure and electromyographic activity of the external urethral sphincter in a patient.

[0040] The following is for reference. Figure 1 A neurophysiological monitoring device 100 according to an embodiment of the present invention is described. The neurophysiological monitoring device 100 includes a bladder pressure detection device, an electromyography (EMG) detection device, and a monitoring module 13. The bladder pressure detection device is disposed within the patient's bladder and is adapted to detect the intrabladder pressure. The EMG detection device is disposed adjacent to the bladder pressure detection device and is adapted to contact the external urethral sphincter and detect the EMG activity of the external urethral sphincter. The monitoring module 13 is connected to both the bladder pressure detection device and the EMG detection device to monitor the patient's intrabladder pressure and the EMG activity of the external urethral sphincter.

[0041] Currently, the key indicators monitored during surgery in related technologies include intrabladder pressure and external urethral sphincter electromyography (EMG). However, due to limitations in the structure of the monitoring devices, existing devices can only monitor one indicator during surgery, and cannot monitor multiple indicators simultaneously. Measuring intrabladder pressure and recording external urethral sphincter EMG requires multiple invasive monitoring instruments, resulting in significant patient trauma and high costs. Furthermore, this method cannot simultaneously measure bladder pressure and external urethral sphincter EMG, reducing surgical safety and increasing postoperative risks.

[0042] Specifically, the neurophysiological monitoring device 100 includes a bladder pressure detection device, an electromyography (EMG) detection device, and a monitoring module 13. The bladder pressure detection device is placed inside the patient's bladder and can be used to detect the intrabladder pressure. The EMG detection device is placed adjacent to the bladder pressure detection device and can contact the external urethral sphincter. By contacting the external urethral sphincter with the EMG detection device, the electromyographic activity of the external urethral sphincter is detected. The monitoring module 13 is connected to both the bladder pressure detection device and the EMG detection device. The bladder pressure detection device and the EMG detection device can transmit signals to the monitoring module 13. The monitoring module 13 monitors the intrabladder pressure and the electromyographic activity of the external urethral sphincter based on the received signals.

[0043] In short, according to the neurophysiological monitoring device 100 of the present invention, the neurophysiological monitoring device 100 is provided with a pressure detection device, an electromyography (EMG) detection device, and a monitoring module 13. The pressure detection device is used to detect the intrabladder pressure of the patient, the EMG detection device is used to detect the EMG activity of the external urethral sphincter, and the monitoring module 13 is used to monitor the intrabladder pressure and the EMG activity of the external urethral sphincter. Therefore, the neurophysiological monitoring device 100 can simultaneously detect the intrabladder pressure and the EMG activity of the external urethral sphincter without the need for multiple monitoring instruments, thereby improving the safety of the surgery and reducing postoperative risks.

[0044] According to one embodiment of the present invention, a bladder pressure detection device includes a connecting tube 111 and a pressure conversion device. The connecting tube 111 can be used to transmit a medium, wherein the medium can be a drug solution such as physiological saline. One end of the connecting tube 111 is openly disposed inside the patient's bladder, and the other end of the connecting tube 111 extends outside the patient's body. The connecting tube 111 can be used to deliver a medium, thereby delivering the medium from the outside to the patient's body, or delivering the medium inside the patient's body to the outside.

[0045] The pressure conversion device has a detection end 113 and a signal output end. The detection end 113 is connected to the connecting pipe 111 and is used to detect the pressure of the medium inside the connecting pipe 111. A connecting conduit 112 is provided between the detection end 113 and the connecting pipe 111. One end of the connecting conduit 112 is connected to the connecting pipe 111, and the other end of the connecting conduit 112 is connected to the detection end 113, thereby enabling communication between the detection end 113 and the inner cavity of the connecting pipe 111. In another embodiment of the invention, the connecting conduit 112 can be integrally constructed with the connecting pipe 111. An on / off valve can be provided between the connecting conduit 112 and the connecting pipe 111, allowing selective communication between the connecting conduit 112 and the connecting pipe 111.

[0046] The signal output terminal is connected to the monitoring module 13. The pressure conversion device can convert the pressure of the medium into a bladder pressure signal and transmit it to the monitoring module 13 through the signal output terminal. The monitoring module 13 monitors the patient's bladder pressure based on the bladder pressure signal.

[0047] According to one embodiment of the present invention, a medium injection device 114 is provided at the other end of the connecting tube 111, wherein the medium injection device 114 can be configured as a syringe. The medium injection device 114 can selectively inject a medium into the connecting tube 111, and the medium can be delivered to the patient's bladder through the connecting tube 111. An on / off valve can be provided between the medium injection device 114 and the connecting tube 111, and the on / off valve can selectively connect the medium injection device 114 and the connecting tube 111.

[0048] According to one embodiment of the present invention, the neurophysiological monitoring device 100 further includes a first regulating valve 17, wherein the first regulating valve 17 can be configured as a three-way regulating valve, the first regulating valve 17 includes a first port, a second port and a third port, the first port, the second port and the third port being respectively connected to the connecting pipe 111, the connecting catheter 112 and the medium injection device 114. By setting a three-way regulating valve, the reuse and plugging / unplugging of ports during monitoring can be reduced, making it easier for operators to connect the monitoring device in advance, and further reducing the difficulty of operation.

[0049] When the first and third ports are connected and the second port is disconnected, the connecting tube 111 is connected to the media injection device 114. At this time, the media injection device 114 can selectively inject media into the connecting tube 111, and the media can be delivered to the patient's bladder through the connecting tube 111. When the first and second ports are connected and the third port is disconnected, the connecting tube 111 is connected to the connecting catheter 112. At this time, the pressure conversion device can convert the pressure of the media in the connecting catheter 112 into a bladder pressure signal and transmit it to the monitoring module 13 through the signal output terminal. The monitoring module 13 monitors the patient's bladder pressure based on the bladder pressure signal.

[0050] In another embodiment of the present invention, the connecting conduit 112 or the medium injection device 114 can be directly connected to the connecting pipe 111, thereby eliminating the need for the first regulating valve 17 structure.

[0051] According to one embodiment of the present invention, the electromyography (EMG) detection device is disposed on the periphery of the connecting tube 111. Furthermore, when the connecting tube 111 enters the patient's body, the EMG detection device can directly contact the external urethral sphincter. By contacting the EMG detection device with the external urethral sphincter, the EMG activity of the external urethral sphincter can be detected. The EMG detection device can be integrated on the periphery of the connecting tube 111, ensuring that the neurophysiological monitoring device 100 can detect the EMG activity of the external urethral sphincter while detecting the intrabladder pressure, thereby achieving the function of simultaneously detecting two parameters, improving the safety of the surgery, and reducing postoperative risks.

[0052] According to one embodiment of the present invention, the electromyography (EMG) detection device includes a plurality of EMG electrodes 121, which are spaced apart on the periphery of the connecting tube 111. The multiple EMG electrodes 121 can detect the electromyographic activity of the external urethral sphincter by touching the mucosa on the surface of the external urethral sphincter. Furthermore, the multiple EMG electrodes 121 spaced apart on the periphery of the connecting tube 111 can further improve the accuracy and comprehensiveness of the measurement, thereby improving the safety of the surgery.

[0053] According to one embodiment of the present invention, such as Figure 5As shown, each electromyographic electrode 121 is constructed as a strip, and the extension direction of each electromyographic electrode 121 is the same as the extension direction of the connecting tube 111. Multiple electromyographic electrodes 121 are arranged at intervals around the outer periphery of the connecting tube 111. Each electromyographic electrode 121 is insulated from the others, and each electromyographic electrode 121 measures the electromyographic activity signal of the external urethral sphincter. Specifically, the number of strip-shaped electromyographic electrodes 1212 can be 2, 4, 6, 8, or more, and the number can also be an odd number. By arranging multiple strip-shaped electrodes at intervals along the extension direction of the connecting tube 111, the electromyographic activity signals of at least the left and right sides of the external urethral sphincter can be monitored, and the electromyographic activity signals of the external urethral sphincter at different positions along the circumference of the connecting tube 111 can also be monitored, thus enabling more accurate monitoring of the electromyographic activity of the external urethral sphincter at different locations.

[0054] According to one embodiment of the present invention, such as Figure 4 As shown, each electromyographic electrode 121 is constructed in a ring shape and is arranged around the connecting tube 111. Multiple electromyographic electrodes 121 are spaced apart along the extension direction of the connecting tube 111. Each electromyographic electrode 121 is insulated from the others, and each electrode 121 measures the electromyographic activity signal of the external urethral sphincter. This allows for the measurement of electromyographic activity signals at multiple locations of the external urethral sphincter, improving the accuracy of the measurement. By arranging multiple ring-shaped electromyographic electrodes 1211 around the connecting tube 111 at intervals, the electromyographic activity signals of the external urethral sphincter at different depths along the extension direction of the connecting tube 111 can be monitored, enabling more precise monitoring of the electromyographic activity of the external urethral sphincter at different locations.

[0055] In the neurophysiological monitoring device 100 for adult male patients, the distance between the upper end of each electromyographic electrode 121 and the beginning of the bladder neck can be between 2 cm and 5 cm, preferably 3.5 cm. In the neurophysiological monitoring device 100 for adult female patients, the distance between the upper end of each electromyographic electrode 121 and the beginning of the bladder neck can be between 0.5 cm and 3 cm, preferably 1.5 cm. In the neurophysiological monitoring device 100 for minor patients, the distance between the upper end of each electromyographic electrode 121 and the beginning of the bladder neck is smaller than the distance between the upper end of each electromyographic electrode 121 and the beginning of the bladder neck in the neurophysiological monitoring device 100 for adult male or adult female patients.

[0056] According to one embodiment of the present invention, the outer peripheral wall of the connecting tube 111 is provided with a plurality of scale marks spaced apart in the extension direction of the connecting tube 111. The scale marks can be used to adjust the depth of the connecting tube 111 inserted into the patient's urethra, ensuring that the connecting tube 111 is always at a safe depth, improving the safety of the operation and reducing postoperative risks.

[0057] According to one embodiment of the present invention, the neurophysiological monitoring device 100 further includes an electromyographic electrode connection harness 122, which is adapted to electrically connect the electromyographic electrodes 121 to the monitoring module 13. At least a portion of the electromyographic electrode connection harness 122 is embedded inside or on the wall of the connecting tube 111. One end of the electromyographic electrode connection harness 122 is connected to a plurality of electromyographic electrodes 121, and the other end is connected to the monitoring module 13. The plurality of electromyographic electrodes 121 can be connected to the monitoring module 13 separately and independently through the electromyographic electrode connection harness 122, and the measured electromyographic activity signals are transmitted to the monitoring module 13 through the electromyographic electrode connection harness 122.

[0058] According to one embodiment of the present invention, the neurophysiological monitoring device 100 further includes a connecting tube fixing device 14, which is disposed at one end of the connecting tube 111. The connecting tube fixing device 14 can be constructed as a rubber component and can selectively deform to be tensioned within the patient's bladder. Specifically, the connecting tube fixing device 14 has a contracted state and an expanded state. When the connecting tube fixing device 14 is in the contracted state, the connecting tube 111 can enter or exit the patient's bladder; when the connecting tube fixing device 14 is in the expanded state, the connecting tube 111 is fixed within the patient's bladder and will not dislodge.

[0059] According to one embodiment of the present invention, an expansion cavity is formed inside the connecting tube fixing device 14, which can selectively expand or contract. The expansion cavity is connected to a syringe connecting tube 15, which can be used to inject a medium into the expansion cavity to control the deformation of the connecting tube fixing device 14. The medium can be a liquid or a gas. By injecting the medium into the expansion cavity, the syringe connecting tube 15 causes the expansion cavity to expand in volume, thereby allowing the connecting tube fixing device 14 to contact and fix with the inner wall of the patient's bladder.

[0060] According to one embodiment of the present invention, at least a portion of the syringe connecting tube 15 is housed inside or on the wall of the connecting tube 111, thereby reducing the space occupied by the syringe connecting tube 15 and improving the integration of the syringe connecting tube 15.

[0061] According to one embodiment of the present invention, the neurophysiological monitoring device 100 further includes a urination tube 161, one end of which is selectively connected to a connecting tube 111, and the other end of which is provided with a urine collection bag 162. The urine collection bag 162 is used to collect residual urine or media in the patient's bladder. Specifically, the neurophysiological monitoring device 100 also includes a bladder fluid opening 19, which can drain residual urine or media from the bladder. The residual urine or media in the bladder is fed into the urination tube 161 along the connecting tube 111, and then transported to the urine collection bag 162 through the urination tube 161 until the end of the surgery.

[0062] According to one embodiment of the present invention, the neurophysiological monitoring device 100 further includes a second regulating valve 18, wherein the second regulating valve 18 can be configured as a three-way regulating valve, and the second regulating valve 18 includes a fourth port, a fifth port, and a sixth port, which are respectively provided with a one-to-one correspondence between the front section of the connecting tube 111, the rear section of the connecting tube 111, and the urination tube 161. By providing a three-way regulating valve, the reuse and plugging / unplugging of ports during monitoring can be reduced, making it easier for operators to connect the monitoring device in advance, and further reducing the difficulty of operation.

[0063] When the fourth and fifth ports are connected and the sixth port is disconnected, the front and rear sections of the connecting tube 111 are connected. At this time, the media injection device 114 can inject media into the patient's bladder to facilitate monitoring of the bladder pressure. When the fourth and sixth ports are connected and the fifth port is disconnected, the front section of the connecting tube 111 is connected to the urination catheter 161. At this time, residual urine or media in the patient's bladder is fed into the urination catheter 161 along the connecting tube 111, and then transported through the urination catheter 161 to the urine collection bag 162 until the end of the surgery.

[0064] The following describes a neurophysiological monitoring device according to a second aspect of this application, which is used to detect intrarectal pressure and electromyographic activity of the external anal sphincter in a patient.

[0065] The following is for reference. Figure 2 A neurophysiological monitoring device 200 according to an embodiment of the present invention is described. The neurophysiological monitoring device 200 includes a rectal pressure detection device, an electromyography (EMG) detection device, and a monitoring module 23. The rectal pressure detection device is disposed in the patient's rectum and is adapted to detect the rectal pressure. The EMG detection device is disposed adjacent to the rectal pressure detection device and is adapted to contact the mucosa on the surface of the external anal sphincter and detect the EMG activity of the external anal sphincter. The monitoring module 23 is connected to the rectal pressure detection device and the EMG detection device respectively to monitor the patient's rectal pressure and the EMG activity of the external anal sphincter.

[0066] Currently, the key indicators monitored during surgery in related technologies include rectal pressure and external anal sphincter electromyography (EMG). However, due to limitations in the structure of the monitoring devices, existing devices can only monitor one indicator during surgery and cannot monitor multiple indicators simultaneously. Recording rectal pressure and external anal sphincter EMG requires multiple invasive monitoring instruments, resulting in significant patient trauma and high costs. Furthermore, this method cannot simultaneously record rectal pressure and external anal sphincter EMG, reducing surgical safety and increasing postoperative risks.

[0067] Specifically, the neurophysiological monitoring device 200 includes a rectal pressure detector, an electromyography (EMG) detector, and a monitoring module 23. The rectal pressure detector is positioned inside the patient's rectum and is used to detect the rectal pressure. The EMG detector is positioned adjacent to the rectal pressure detector and can contact the mucosa on the surface of the external anal sphincter. By contacting the EMG detector with the mucosa on the surface of the external anal sphincter, the electromyographic activity of the external anal sphincter is detected. The monitoring module 23 is connected to both the rectal pressure detector and the EMG detector. The rectal pressure detector and the EMG detector can transmit signals to the monitoring module 23. The monitoring module 23 monitors the rectal pressure and the electromyographic activity of the external anal sphincter based on the received signals.

[0068] In short, according to the present invention, the neurophysiological monitoring device 200 is provided with a pressure detection device, an electromyography (EMG) detection device, and a monitoring module 23. The pressure detection device is used to detect the rectal pressure of the patient, the EMG detection device is used to detect the EMG activity of the external anal sphincter, and the monitoring module 23 is used to monitor the rectal pressure and the EMG activity of the external anal sphincter. Therefore, the neurophysiological monitoring device 200 can simultaneously detect the rectal pressure and the EMG activity of the external anal sphincter without the need for multiple monitoring instruments, thereby improving the safety of the surgery and reducing postoperative risks.

[0069] According to one embodiment of the present invention, the rectal pressure detection device includes a connecting tube 211, an internal rectal dilatation sac 215, and a pressure conversion device. The connecting tube 211 may contain a medium, which may be a liquid such as physiological saline. One end of the connecting tube 211 is provided with the internal rectal dilatation sac 215, and the other end of the connecting tube 211 extends outside the patient's body. The connecting tube 211 can be used to deliver the medium, thereby delivering the medium from the outside to the patient's body, or delivering the medium from the patient's body to the outside.

[0070] An internal rectal dilatation sac 215 is disposed at one end of the connecting tube 211 and is connected to the connecting tube 211. The internal rectal dilatation sac 215 can be constructed as a rubber component. The internal rectal dilatation sac 215 can selectively deform to be tensioned within the patient's rectum. Specifically, the internal rectal dilatation sac 215 has a contracted state and an inflated state. When the internal rectal dilatation sac 215 is in the contracted state, the connecting tube 211 can enter or exit the patient's rectum. When the internal rectal dilatation sac 215 is in the inflated state, the outer peripheral wall of the internal rectal dilatation sac 215 abuts against the inner wall of the patient's rectum, thereby fixing the connecting tube 211 within the patient's rectum. When the inner wall of the rectum contracts, the internal rectal dilatation sac 215 deforms with pressure changes to transmit pressure signals within the rectum.

[0071] The pressure conversion device has a detection end 213 and a signal output end. The detection end 213 is connected to the connecting pipe 211 and is used to detect the pressure of the medium inside the connecting pipe 211. A connecting conduit 212 is provided between the detection end 213 and the connecting pipe 211. One end of the connecting conduit 212 is connected to the connecting pipe 211, and the other end of the connecting conduit 212 is connected to the detection end 213, thereby connecting the detection end 213 and the connecting pipe 211. In another embodiment of the present invention, the connecting conduit 212 can be integrally constructed with the connecting pipe 211. An on / off valve can be provided between the connecting conduit 212 and the connecting pipe 211, allowing selective connection between the connecting conduit 212 and the connecting pipe 211.

[0072] The signal output terminal is connected to the monitoring module 23. The pressure conversion device can convert the pressure of the medium into a rectal pressure signal and transmit it to the monitoring module 23 through the signal output terminal. The monitoring module 23 monitors the rectal pressure of the patient based on the rectal pressure signal.

[0073] According to one embodiment of the present invention, a medium injection device 214 is provided at the other end of the connecting tube 211, wherein the medium injection device 214 can be configured as a syringe. The medium injection device 214 can selectively inject a medium into the connecting tube 211, and the medium can be transported through the connecting tube 211 to the rectal dilator 215, causing the rectal dilator 215 to dilate. An on / off valve can be provided between the medium injection device 214 and the connecting tube 211, and the on / off valve can selectively connect the medium injection device 214 and the connecting tube 211.

[0074] According to one embodiment of the present invention, the neurophysiological monitoring device 200 further includes a three-way tube, wherein the three-way tube can be configured as a third regulating valve 24, the third regulating valve 24 having a first interface, a second interface, and a third interface that are selectively connected to each other. The first interface is connected to the other end of the connecting tube 211, the second interface is connected to the detection end 213 of the pressure conversion device (note that the second interface is connected to the connecting conduit 212, thereby connecting the second interface to the detection end 213 of the pressure conversion device), and the third interface is connected to the media injection device 214. By setting a three-way regulating valve, the reuse and plugging / unplugging of ports during monitoring can be reduced, making it easier for operators to connect the monitoring device in advance and further reducing the difficulty of operation.

[0075] Specifically, when the first interface is connected to the third interface and the second interface is disconnected, the connecting tube 211 is connected to the media injection device 214. At this time, the media injection device 214 can selectively inject media into the connecting tube 211, and the media can be delivered to the rectal dilation sac 215 through the connecting tube 211. When the first interface is connected to the second interface and the third interface is disconnected, the connecting tube 211 is connected to the connecting catheter 212. At this time, the pressure conversion device can convert the pressure of the media in the connecting catheter 212 into a rectal pressure signal and transmit it to the monitoring module 23 through the signal output terminal. The monitoring module 23 monitors the rectal pressure of the patient based on the rectal pressure signal.

[0076] According to one embodiment of the present invention, the electromyography (EMG) detection device is disposed on the periphery of the connecting tube 211. Further, when the connecting tube 211 enters the patient's rectum, the EMG detection device can directly contact the mucosa on the surface of the external anal sphincter. By contacting the EMG detection device with the mucosa on the surface of the external anal sphincter, the EMG activity of the external anal sphincter can be detected. The EMG detection device can be integrated on the periphery of the connecting tube 211, ensuring that the neurophysiological monitoring device 200 can detect the pressure in the rectum while simultaneously detecting the EMG activity of the external anal sphincter, thereby achieving the function of simultaneously detecting two parameters, improving the safety of the surgery, and reducing postoperative risks.

[0077] According to one embodiment of the present invention, the electromyography (EMG) detection device includes a plurality of EMG electrodes 221, which are spaced apart on the periphery of the connecting tube 211. The plurality of EMG electrodes 221 can adhere to the mucosa on the surface of the external anal sphincter, thereby recording the EMG activity of the external anal sphincter. Furthermore, the spaced arrangement of the plurality of EMG electrodes 221 on the periphery of the connecting tube 211 can further improve the accuracy and comprehensiveness of the measurement, thereby improving the safety of the surgery.

[0078] According to one embodiment of the present invention, the electromyography (EMG) detection device includes a plurality of EMG electrodes 221, which are spaced apart on the periphery of the connecting tube 211. The plurality of EMG electrodes 221 can record the EMG activity of the external anal sphincter by touching the mucosa on the surface of the external anal sphincter. Furthermore, the spaced arrangement of the plurality of EMG electrodes 221 on the periphery of the connecting tube 211 can further improve the accuracy and comprehensiveness of the measurement, thereby improving the safety of the surgery.

[0079] According to one embodiment of the present invention, each electromyographic electrode 221 is constructed as a strip, and the extending direction of each electromyographic electrode 221 is the same as the extending direction of the connecting tube 211. Multiple electromyographic electrodes 221 are arranged at intervals around the outer periphery of the connecting tube 211. Each electromyographic electrode 221 is insulated from the others, and each electromyographic electrode 221 records the electromyographic activity signal of the external anal sphincter. Specifically, the number of strip-shaped electromyographic electrodes 1212 can be 2, 4, 6, 8, or more, and the number can also be an odd number. By arranging multiple strip-shaped electrodes at intervals along the extending direction of the connecting tube 211, the electromyographic activity signals of at least the left and right sides of the external anal sphincter can be monitored, and the electromyographic activity signals of the external anal sphincter at different positions along the circumference of the connecting tube 211 can also be monitored, so as to more accurately monitor the electromyographic activity of the external anal sphincter at different locations.

[0080] According to one embodiment of the present invention, each electromyographic electrode 221 is constructed in a ring shape and arranged around the connecting tube 211. Multiple electromyographic electrodes 221 are arranged at intervals along the extension direction of the connecting tube 211. Each electromyographic electrode 221 is insulated from the others, and each electromyographic electrode 221 measures the electromyographic activity signal of the external anal sphincter, thereby enabling the measurement of electromyographic activity signals at multiple locations of the external anal sphincter and improving the accuracy of the electromyographic electrode 221 in measuring the electromyographic activity signal of the external anal sphincter. By arranging multiple ring-shaped electromyographic electrodes 1211 around the connecting tube 211 at intervals, the electromyographic activity signals of the external anal sphincter at different depths along the extension direction of the connecting tube 211 can be monitored, allowing for more precise monitoring of the electromyographic activity of the external anal sphincter at different locations.

[0081] According to one embodiment of the present invention, the neurophysiological monitoring device 200 further includes an electromyographic electrode connection bundle 222, which is adapted to electrically connect the electromyographic electrodes 221 to the monitoring module 23. At least a portion of the electromyographic electrode connection bundle 222 is disposed inside or on the wall of the connecting tube 211. One end of the electromyographic electrode connection bundle 222 is connected to a plurality of electromyographic electrodes 221, and the other end of the electromyographic electrode connection bundle 222 is connected to the monitoring module 23. The plurality of electromyographic electrodes 221 can be connected to the monitoring module 23 separately and independently through the electromyographic electrode connection bundle 222, and the measured electromyographic activity signals are transmitted to the monitoring module 23 through the electromyographic electrode connection bundle 222.

[0082] According to one embodiment of the present invention, the outer peripheral wall of the connecting tube 211 is provided with a plurality of scale marks spaced apart in the extension direction of the connecting tube 211. The scale marks can be used to adjust the depth of the connecting tube 211 inserted into the patient's anus, ensuring that the connecting tube 211 is always at a safe depth, improving the safety of the operation and reducing postoperative risks.

[0083] The following describes a neurophysiological monitoring device according to a third aspect of this application, which is used to detect intrabladder and rectal pressure, electromyographic activity of the external urethral sphincter, and electromyographic activity of the external anal sphincter in a patient.

[0084] The following is for reference. Figures 3-5 A neurophysiological monitoring device 300 according to an embodiment of the present invention is described. The neurophysiological monitoring device 300 includes a urethral detection device, a rectal detection device, and a monitoring module 33. The urethral detection device is provided with a bladder pressure detection element and a first electromyography (EMG) detection element; the bladder pressure detection element is disposed in the patient's bladder and is adapted to detect the intrabladder pressure of the patient; the first EMG detection element is adapted to contact the mucosa on the surface of the external urethral sphincter and detect the EMG activity of the external urethral sphincter. The rectal detection device is provided with a rectal pressure detection element and a second EMG detection element; the rectal pressure detection element is disposed in the patient's rectum and is adapted to detect the rectal pressure of the patient; the second EMG detection element is adapted to contact the mucosa on the surface of the external anal sphincter and detect the EMG activity of the external anal sphincter. The monitoring module 33 is electrically connected to the bladder pressure detection element, the first EMG detection element, the rectal pressure detection element, and the second EMG detection element, respectively.

[0085] Currently, the key indicators monitored during surgery in related technologies include pressure in the bladder and rectum, and electromyographic activity of the external urethral sphincter and external anal sphincter. However, due to limitations in the structure of the monitoring devices, existing devices can only monitor one indicator during surgery and cannot monitor multiple indicators simultaneously. Recording pressure in the bladder and rectum, and electromyographic activity of the external urethral sphincter and external anal sphincter, requires multiple invasive monitoring instruments, resulting in significant patient trauma and high costs. Furthermore, this method cannot simultaneously record pressure in the bladder and rectum, and electromyographic activity of the external urethral sphincter and external anal sphincter, reducing surgical safety and increasing postoperative risks.

[0086] Specifically, the neurophysiological monitoring device 300 includes a urethral detection device, a rectal detection device, and a monitoring module 33. The urethral detection device is equipped with a bladder pressure detection device and a first electromyography (EMG) detection device. The bladder pressure detection device is placed inside the patient's bladder and can be used to detect the pressure inside the patient's bladder. The first EMG detection device is located adjacent to the bladder pressure detection device and can contact the mucosa on the surface of the external urethral sphincter. By contacting the first EMG detection device with the external urethral sphincter, the electromyographic activity of the external urethral sphincter can be detected.

[0087] A rectal pressure detector is placed inside the patient's rectum and can be used to detect the rectal pressure. A second electromyography (EMG) detector is placed adjacent to the rectal pressure detector and can contact the mucosa on the surface of the external anal sphincter. By contacting the second EMG detector with the mucosa on the surface of the external anal sphincter, the EMG activity of the external anal sphincter can be detected.

[0088] The monitoring module 33 is electrically connected to the bladder pressure detector, the first electromyography (EMG) detector, the rectal pressure detector, and the second EMG detector. The bladder pressure detector, the first EMG detector, the rectal pressure detector, and the second EMG detector can transmit signals to the monitoring module 33. The monitoring module 33 monitors the patient's intrabladder pressure, intrarectal pressure, EMG activity of the external urethral sphincter, and EMG activity of the external anal sphincter based on the received signals.

[0089] The urethral detection device can be the neurophysiological monitoring device 100 of the first aspect embodiment, and the rectal detection device can be the neurophysiological monitoring device 200 of the second aspect embodiment.

[0090] In short, according to the present invention, the neurophysiological monitoring device 300 includes a urethral detection device, a rectal detection device, and a monitoring module 33. The urethral detection device is used to detect the patient's intrabladder pressure and the electromyographic activity of the external urethral sphincter. The rectal detection device is used to detect the patient's intrarectal pressure and the electromyographic activity of the external anal sphincter. The monitoring module 33 is used to monitor the intrabladder pressure, intrarectal pressure, and electromyographic activity of the external urethral sphincter and the external anal sphincter. Therefore, the neurophysiological monitoring device 300 can simultaneously detect the intrabladder pressure, intrarectal pressure, and electromyographic activity of the external urethral sphincter and the external anal sphincter without the need for multiple monitoring instruments, thereby improving the integration of the neurophysiological monitoring device 300 and the safety of the surgery, and reducing postoperative risks.

[0091] According to one embodiment of the present invention, the neurophysiological monitoring device 300 further includes a first connecting tube 3111 and a first pressure conversion device. The first connecting tube 3111 may contain a medium, which may be a liquid such as physiological saline. One end of the first connecting tube 3111 is openly disposed within the patient's bladder, and the other end extends outside the patient's body. The first connecting tube 3111 can be used to transport the medium, thereby transporting the medium from the outside to the patient's body, or transporting the medium from the patient's body to the outside.

[0092] The first pressure conversion device has a first detection end 3113 and a first signal output end. The first detection end 3113 is connected to a first connecting pipe 3111 and is used to detect the pressure of the medium in the connecting pipe. A first connecting conduit 3112 is provided between the first detection end 3113 and the first connecting pipe 3111. One end of the first connecting conduit 3112 is connected to the first connecting pipe 3111, and the other end of the first connecting conduit 3112 is connected to the first detection end 3113, thereby connecting the first detection end 3113 and the first connecting pipe 3111. The diameter of the first connecting conduit 3112 is smaller than that of the connecting pipe, ensuring that the first connecting conduit 3112 can cooperate with the port of the first detection end 3113. In another embodiment of the present invention, the first connecting conduit 3112 can be integrally constructed with the first connecting pipe 3111. An on / off valve can be provided between the first connecting conduit 3112 and the first connecting pipe 3111, allowing selective connection between the first connecting conduit and the first connecting pipe 3111.

[0093] The first signal output terminal is connected to the monitoring module 33. The first pressure conversion device can convert the pressure of the medium into a bladder pressure signal and transmit it to the monitoring module 33 through the signal output terminal. The monitoring module 33 monitors the patient's bladder pressure based on the bladder pressure signal.

[0094] According to one embodiment of the present invention, a first medium injection device 34 is provided at the other end of the first connecting tube 3111, wherein the first medium injection device 34 can be configured as a syringe. The first medium injection device 34 can selectively inject a medium into the first connecting tube 3111, and the medium can be delivered to the patient's bladder through the first connecting tube 3111. An on / off valve can be provided between the first medium injection device 34 and the first connecting tube 3111, and the on / off valve can selectively connect the first medium injection device 34 and the first connecting tube 3111.

[0095] According to one embodiment of the present invention, the neurophysiological monitoring device 300 further includes a fourth regulating valve 316, wherein the fourth regulating valve 316 can be configured as a three-way regulating valve, and the fourth regulating valve 316 includes a first port, a second port, and a third port, the first port, the second port, and the third port being respectively connected to the first connecting pipe 3111, the first connecting catheter 3112, and the first medium injection device 34. By setting a three-way regulating valve, the reuse and plugging / unplugging of ports during monitoring can be reduced, making it easier for operators to connect the monitoring device in advance, and further reducing the difficulty of operation.

[0096] When the first port and the third port are connected and the second port is disconnected, the first connecting tube 3111 is connected to the first medium injection device 34. At this time, the first medium injection device 34 can selectively inject medium into the first connecting tube 3111, and the medium can be delivered to the patient's bladder through the first connecting tube 3111. When the first port and the second port are connected and the third port is disconnected, the first connecting tube 3111 is connected to the first connecting catheter 3112. At this time, the pressure conversion device can convert the pressure of the medium in the first connecting catheter 3112 into a bladder pressure signal and transmit it to the monitoring module 33 through the signal output terminal. The monitoring module 33 monitors the patient's bladder pressure based on the bladder pressure signal.

[0097] In another embodiment of the present invention, the first connecting conduit 3112 or the first medium injection device 34 can be directly connected to the first connecting pipe 3111, thereby eliminating the need for the fourth regulating valve 316 structure.

[0098] According to one embodiment of the present invention, a first electromyography (EMG) detection device is disposed on the periphery of the first connecting tube 3111. Further, when the first connecting tube 3111 enters the patient's bladder, the first EMG detection device can directly contact the mucosa on the surface of the external urethral sphincter. By contacting the EMG detection device with the mucosa on the surface of the external urethral sphincter, the EMG activity of the external urethral sphincter can be detected. The first EMG detection device can be integrated on the periphery of the first connecting tube 3111, ensuring that the neurophysiological monitoring device 300 can detect the EMG activity of the external urethral sphincter while detecting the intrabladder pressure, thereby achieving the effect of simultaneously detecting two parameters, improving the safety of the surgery, and reducing postoperative risks.

[0099] According to one embodiment of the present invention, the first electromyography (EMG) detection device includes a plurality of first EMG electrodes 3121, which are spaced apart on the periphery of the first connecting tube 3111. The plurality of first EMG electrodes 3121 can record the EMG activity of the external urethral sphincter by touching the mucosa on the surface of the external urethral sphincter. The spaced arrangement of the plurality of first EMG electrodes 3121 on the periphery of the first connecting tube 3111 can further improve the accuracy and comprehensiveness of the measurement, thereby improving the safety of the surgery.

[0100] According to one embodiment of the present invention, each first electromyographic electrode 3121 is constructed as a strip, and the extending direction of each first electromyographic electrode 3121 is the same as the extending direction of the first connecting tube 3111. Multiple first electromyographic electrodes 3121 are arranged at intervals around the outer periphery of the first connecting tube 3111. The length of the strip-shaped first electromyographic electrode 3121 can be set to between 2 cm and 3 cm, preferably 2.5 cm. The multiple first electromyographic electrodes 3121 are arranged at intervals, each first electromyographic electrode 3121 is insulated from each other, and each first electromyographic electrode 3121 measures the electromyographic activity signal of the external urethral sphincter. Specifically, the number of strip-shaped first electromyographic electrodes 3121 can be 2, 4, 6, 8, or more, and the number of strip-shaped first electromyographic electrodes 3121 can also be an odd number. By arranging multiple strip electrodes at intervals along the extension direction of the connecting tube 3111, the electromyographic activity signals of the left and right sides of the external urethral sphincter can be monitored separately, and the electromyographic activity signals of the external urethral sphincter at different positions around the connecting tube 3111 can also be monitored, so as to more accurately monitor the electromyographic activity of the external urethral sphincter at different locations.

[0101] According to one embodiment of the present invention, each first electromyographic electrode 3121 is constructed in a ring shape and arranged around the connecting tube. Multiple first electromyographic electrodes 3121 are arranged at intervals along the extension direction of the first connecting tube 3111. The distribution width of the ring-shaped first electromyographic electrodes 3121 can be set between 2 cm and 3 cm, preferably 2.5 cm. The multiple first electromyographic electrodes 3121 are arranged at intervals, each insulated from the others, and each first electromyographic electrode 3121 measures the electromyographic activity signal of the external urethral sphincter, thereby enabling the measurement of electromyographic activity signals at multiple locations of the external urethral sphincter, improving the accuracy of the electromyographic electrode measurement of the external urethral sphincter's electromyographic activity signals. By arranging multiple ring-shaped electrodes around the connecting tube 3111 at intervals, the electromyographic activity signals of the external urethral sphincter at different depths along the extension direction of the connecting tube 3111 can be monitored, allowing for more precise monitoring of the electromyographic activity of the external urethral sphincter at different locations.

[0102] In the neurophysiological monitoring device 300 for adult male patients, the distance between the upper end of each first electromyographic electrode 3121 and the beginning of the bladder neck can be between 2 cm and 5 cm, preferably 3.5 cm. In the neurophysiological monitoring device 300 for adult female patients, the distance between the upper end of each first electromyographic electrode 3121 and the beginning of the bladder neck can be between 0.5 cm and 3 cm, preferably 1.5 cm. In the neurophysiological monitoring device 300 for minor patients, the distance between the upper end of each first electromyographic electrode 3121 and the beginning of the bladder neck is much smaller than the distance between the upper end of each first electromyographic electrode 3121 and the beginning of the bladder neck in the neurophysiological monitoring device 300 for adult male or adult female patients.

[0103] According to one embodiment of the present invention, the neurophysiological monitoring device 300 further includes a first electromyographic electrode connection harness 3122, which is adapted to electrically connect the first electromyographic electrodes 3121 to the monitoring module 33. At least a portion of the first electromyographic electrode connection harness 3122 is disposed inside or on the wall of the first connecting tube 3111. One end of the first electromyographic electrode connection harness 3122 is connected to a plurality of first electromyographic electrodes 3121, and the other end of the first electromyographic electrode connection harness 3122 is connected to the monitoring module 33. The plurality of first electromyographic electrodes 3121 can be connected to the monitoring module 33 separately and independently through the first electromyographic electrode connection harness 3122, and the measured first electromyographic activity signal is transmitted to the monitoring module 33 through the first electromyographic electrode connection harness 3122.

[0104] According to one embodiment of the present invention, the neurophysiological monitoring device 300 further includes a first connecting tube 3111 fixing device, which is disposed at one end of the first connecting tube 3111. The first connecting tube 3111 fixing device can be constructed as a rubber component and can selectively deform to be tensioned within the patient's bladder. Specifically, the first connecting tube 3111 fixing device has a contracted state and an expanded state. When the first connecting tube 3111 fixing device is in the contracted state, the first connecting tube 3111 can enter or exit the patient's bladder; when the first connecting tube 3111 fixing device is in the expanded state, the first connecting tube 3111 is fixed within the patient's bladder.

[0105] The first connecting tube 3111 fixing device has an expansion cavity inside, which can selectively expand or contract. The expansion cavity is connected to the syringe connecting tube 314, which can be used to inject a medium into the expansion cavity to control the deformation of the connecting tube fixing device 313. The medium can be liquid or gas. By injecting the medium into the expansion cavity, the syringe connecting tube 314 causes the expansion cavity to expand in volume, thereby making the connecting tube fixing device 313 contact and fix it to the inner wall of the patient's bladder.

[0106] According to one embodiment of the present invention, at least a portion of the syringe connecting tube 314 is housed within a communicating tube, thereby reducing the space occupied by the syringe connecting tube 314 and improving the integration of the syringe connecting tube 314.

[0107] According to one embodiment of the present invention, the neurophysiological monitoring device 300 further includes a urination tube 3151, one end of which is selectively connected to a connecting tube, and the other end of which is provided with a urine collection bag 3152. The urine collection bag 3152 is used to collect residual urine or media in the patient's bladder. Specifically, the neurophysiological monitoring device 300 also includes a bladder fluid opening 318, which can drain residual urine or media from the bladder. The residual urine or media in the bladder is input into the urination tube 3151 along the connecting tube, and then transported to the urine collection bag 3152 through the urination tube 3151 until the end of the operation.

[0108] According to one embodiment of the present invention, the neurophysiological monitoring device 300 further includes a fifth regulating valve 317, which includes a fourth port, a fifth port, and a sixth port. The fourth port, the fifth port, and the sixth port are respectively configured to correspond one-to-one with the front section of the first connecting tube 3111, the rear section of the first connecting tube 3111, and the urination tube 3151. By setting a three-way regulating valve, the reuse and plugging / unplugging of ports during monitoring can be reduced, making it easier for operators to connect the monitoring device in advance and further reducing the difficulty of operation.

[0109] When the fourth and fifth ports are connected and the sixth port is disconnected, the front and rear sections of the first connecting tube 3111 are connected. At this time, the first media injection device 34 can inject media into the patient's bladder to facilitate monitoring of the bladder pressure. When the fourth and sixth ports are connected and the fifth port is disconnected, the front section of the first connecting tube 3111 is connected to the urination catheter 3151. At this time, residual urine or media in the patient's bladder is fed into the urination catheter 3151 along the first connecting tube 3111, and then transported through the urination catheter 3151 to the urine collection bag 3152 until the end of the surgery.

[0110] According to the neurophysiological monitoring device 300 of the present invention, the rectal pressure detection element includes a second connecting tube 3211, an intrarectal dilatation sac 3214, and a second pressure conversion device. The second connecting tube 3211 may contain a medium, which may be a liquid such as physiological saline. One end of the second connecting tube 3211 is inside the patient's rectum, and the other end extends outside the patient's body. The second connecting tube 3211 can be used to transport the medium, thereby transporting the medium from the outside to the patient's body, or transporting the medium inside the patient's body to the outside.

[0111] An internal rectal dilatation sac 3214 is disposed at one end of the second connecting tube 3211 and is connected to the second connecting tube 3211. The internal rectal dilatation sac 3214 can be constructed as a rubber component. The internal rectal dilatation sac 3214 can selectively deform to be tensioned within the patient's rectum. Specifically, the internal rectal dilatation sac 3214 has a contracted state and an inflated state. When the internal rectal dilatation sac 3214 is in the contracted state, the second connecting tube 3211 can enter or exit the patient's rectum. When the internal rectal dilatation sac 3214 is in the inflated state, the outer peripheral wall of the internal rectal dilatation sac 3214 abuts against the inner wall of the patient's rectum, thereby fixing the second connecting tube 3211 within the patient's rectum. When the inner wall of the rectum contracts, the internal rectal dilatation sac 3214 deforms with pressure changes to transmit pressure signals within the rectum.

[0112] The second pressure conversion device has a second detection end 3213 and a second signal output end. The second detection end 3213 is connected to the second connecting pipe 3211 and is used to detect the pressure of the medium inside the second connecting pipe 3211. A second connecting conduit 3212 is provided between the second detection end 3213 and the second connecting pipe 3211. One end of the second connecting conduit 3212 is connected to the second connecting pipe 3211, and the other end of the second connecting conduit 3212 is connected to the second detection end 3213, thereby connecting the second detection end 3213 and the second connecting pipe 3211. The diameter of the second connecting conduit 3212 is smaller than that of the second connecting pipe 3211, ensuring that the second connecting conduit 3212 can cooperate with the port of the second detection end 3213. In another embodiment of the present invention, the second connecting conduit 3212 can be constructed as an integral part of the second connecting pipe 3211. An on / off valve can be provided between the second connecting conduit 3212 and the second connecting pipe 3211. By providing the on / off valve, the second connecting conduit 3212 and the second connecting pipe 3211 can be selectively connected.

[0113] According to one embodiment of the present invention, a second media injection device 35 is provided at the other end of the second connecting tube 3211, wherein the second media injection device 35 can be configured as a syringe. The second media injection device 35 can selectively inject media into the second connecting tube 3211, and the media can be delivered to the rectal dilator 3214 through the second connecting tube 3211. An on / off valve can be provided between the second media injection device 35 and the second connecting tube 3211, and the on / off valve can selectively connect the second media injection device 35 and the second connecting tube 3211.

[0114] According to one embodiment of the present invention, the neurophysiological monitoring device 300 further includes a three-way tube, wherein the three-way tube can be configured as a sixth regulating valve 324, the sixth regulating valve 324 having a first interface, a second interface, and a third interface that are selectively connected to each other. The first interface is connected to the other end of the second connecting tube 3211, the second interface is connected to the second detection end 3213 of the second pressure conversion device (note that the second interface is connected to the second connecting conduit 3212, thereby connecting the second interface to the second detection end 3213 of the second pressure conversion device), and the third interface is connected to the second media injection device 35. By providing a three-way regulating valve, the reuse and plugging / unplugging of ports during monitoring can be reduced, facilitating pre-connection of the monitoring device by the operator and further reducing operational difficulty.

[0115] Specifically, when the first interface is connected to the third interface and the second interface is disconnected, the second connecting tube 3211 is connected to the second media injection device 35. At this time, the second media injection device 35 can selectively inject media into the second connecting tube 3211, and the media can be delivered to the rectal dilation sac 3214 through the second connecting tube 3211. When the first interface is connected to the second interface and the third interface is disconnected, the second connecting tube 3211 is connected to the second connecting catheter 3212. At this time, the pressure conversion device can convert the pressure of the media in the second connecting catheter 3212 into a rectal pressure signal and transmit it to the monitoring module 33 through the signal output terminal. The monitoring module 33 monitors the rectal pressure of the patient based on the rectal pressure signal.

[0116] According to one embodiment of the present invention, a second electromyography (EMG) detection device is disposed on the periphery of the second connecting tube 3211. Further, when the second connecting tube 3211 enters the patient's rectum, the second EMG detection device can directly contact the mucosa on the surface of the external anal sphincter. By contacting the EMG detection device with the mucosa on the surface of the external anal sphincter, the EMG activity of the external anal sphincter can be detected. The second EMG detection device can be integrated on the periphery of the second connecting tube 3211, ensuring that the neurophysiological monitoring device 300 can detect the EMG activity of the external anal sphincter while detecting the rectal pressure, thereby achieving the effect of simultaneously detecting two parameters, improving the safety of the surgery, and reducing postoperative risks.

[0117] According to one embodiment of the present invention, the second electromyography (EMG) detection device includes a plurality of second EMG electrodes 322, which are spaced apart on the periphery of the second connecting tube 3211. The plurality of second EMG electrodes 322 can detect the EMG activity of the external anal sphincter by touching the external anal sphincter. Furthermore, the spaced arrangement of the plurality of second EMG electrodes 322 on the periphery of the second connecting tube 3211 can further improve the accuracy and comprehensiveness of the measurement, thereby improving the safety of the surgery.

[0118] According to one embodiment of the present invention, each second electromyographic electrode 322 is constructed as a strip, and the extending direction of each second electromyographic electrode 322 is the same as the extending direction of the second connecting tube 3211. Multiple second electromyographic electrodes 322 are arranged at intervals on the outer periphery of the second connecting tube 3211. Each second electromyographic electrode 322 is insulated from the others, and each second electromyographic electrode 322 measures the electromyographic activity signal of the external anal sphincter. Specifically, the number of strip-shaped second electromyographic electrodes 322 can be 2, 4, 6, 8, or more, and the number can also be an odd number. By arranging multiple strip-shaped electrodes at intervals along the extending direction of the connecting tube 3211, the electromyographic activity signals of at least the left and right sides of the external anal sphincter can be monitored, and the electromyographic activity signals of the external anal sphincter at different positions along the circumference of the connecting tube 3211 can also be monitored, so as to more accurately monitor the electromyographic activity of the external anal sphincter at different locations.

[0119] According to one embodiment of the present invention, each second electromyographic electrode 322 is constructed in a ring shape and arranged around the connecting tube. Multiple second electromyographic electrodes 322 are arranged at intervals along the extension direction of the second connecting tube 3211. Each second electromyographic electrode 322 is insulated from the others, and each second electromyographic electrode 322 measures the electromyographic activity signal of the external anal sphincter, thereby enabling the measurement of electromyographic activity signals at multiple locations of the external anal sphincter and improving the accuracy of the electromyographic electrode measurement of the electromyographic activity signal of the external anal sphincter. By arranging multiple ring-shaped electrodes around the connecting tube 3211 at intervals, the electromyographic activity signals of the external anal sphincter at different depths along the extension direction of the connecting tube 3211 can be monitored, allowing for more precise monitoring of the electromyographic activity of the external anal sphincter at different locations.

[0120] According to one embodiment of the present invention, the neurophysiological monitoring device 300 further includes a second electromyographic electrode connection bundle 323, which is adapted to electrically connect the second electromyographic electrodes 322 to the monitoring module 33. At least a portion of the second electromyographic electrode connection bundle 323 is disposed inside or on the wall of the second connecting tube 3211. One end of the second electromyographic electrode connection bundle 323 is connected to a plurality of second electromyographic electrodes 322, and the other end of the second electromyographic electrode connection bundle 323 is connected to the monitoring module 33. The plurality of second electromyographic electrodes 322 can be connected to the monitoring module 33 independently and separately through the second electromyographic electrode connection bundle 323, and the measured second electromyographic activity signal is transmitted to the monitoring module 33 through the second electromyographic electrode connection bundle 323.

[0121] According to one embodiment of the present invention, the outer peripheral wall of the first connecting tube 3111 is provided with a plurality of scale marks spaced apart along the extension direction of the first connecting tube 3111. These scale marks can be used to adjust the depth to which the first connecting tube 3111 is inserted into the patient's urethra, ensuring that the first connecting tube 3111 is always at a safe depth, thereby improving the safety of the surgery and reducing postoperative risks. Furthermore, the outer peripheral wall of the second connecting tube 3211 is provided with a plurality of scale marks spaced apart along the extension direction of the second connecting tube 3211. These scale marks can be used to adjust the depth to which the second connecting tube 3211 is inserted into the patient's anus, ensuring that the second connecting tube 3211 is always at a safe depth, thereby improving the safety of the surgery and reducing postoperative risks.

[0122] According to the neurophysiological monitoring device 300 of the present invention, the urethral detection device of the neurophysiological monitoring device 300 can detect the intrabladder pressure and the electromyographic activity of the external urethral sphincter, and the rectal detection device can detect the intrarectal pressure and the external anal sphincter. Therefore, the neurophysiological monitoring device 300 can simultaneously detect the intrabladder pressure and rectal pressure, the electromyographic activity of the external urethral sphincter and the external anal sphincter during surgery. Furthermore, the neurophysiological monitoring device 300 integrates the urethral detection device and the rectal detection device into a single device, thus eliminating the need for multiple monitoring instruments during surgery, thereby improving the integration of the neurophysiological monitoring device 300, the safety of the surgery, and reducing postoperative risks.

[0123] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0124] In the description of this invention, "first feature" and "second feature" may include one or more of the features.

[0125] In the description of this invention, "a plurality of" means two or more.

[0126] In the description of this invention, the first feature being "above" or "below" the second feature may include the first and second features being in direct contact, or it may include the first and second features not being in direct contact but being in contact through another feature between them.

[0127] In the description of this invention, the terms "above," "over," and "on top" for the first feature and the second feature include the first feature being directly above or diagonally above the second feature, or simply indicating that the first feature is at a higher horizontal level than the second feature.

[0128] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "illustrative embodiment," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0129] Although embodiments of the invention have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.

Claims

1. A neurophysiological monitoring device, characterized in that, include: A urethral detection device, wherein the urethral detection device is equipped with a bladder pressure detection element and a first electromyography detection element; The bladder pressure detection device is disposed in the patient's bladder and is suitable for detecting the bladder pressure of the patient. The first electromyography detection device is suitable for contacting the external urethral sphincter and detecting the electromyographic activity of the external urethral sphincter. A rectal detection device, comprising a rectal pressure detection element and a second electromyography (EMG) detection element, wherein the rectal pressure detection element is disposed in the patient's rectum and is adapted to detect the rectal pressure of the patient; and the second EMG detection element is adapted to contact the external anal sphincter and detect the EMG activity of the external anal sphincter. The monitoring module is electrically connected to the bladder pressure detection device, the first electromyography (EMG) detection device, the rectal pressure detection device, and the second EMG detection device, respectively. The bladder pressure detection device includes: A first connecting tube, adapted to deliver a medium and with one end open, is disposed inside the patient's bladder, and the other end of the first connecting tube extends outside the patient's body; A first pressure conversion device has a first detection end and a first signal output end. The first detection end is connected to the first connecting pipe and is suitable for detecting the pressure of the medium in the first connecting pipe. The first signal output end is communicatively connected to the monitoring module. The first pressure conversion device is suitable for converting the pressure of the medium in the first connecting pipe into an intrabladder pressure signal and transmitting it to the monitoring module through the first signal output end. A first connecting tube fixing device is disposed at one end of the first connecting tube. The first connecting tube fixing device can selectively deform to be tensioned in the patient's bladder. An expansion cavity is formed inside the first connecting tube fixing device. The expansion cavity is connected to a syringe connecting tube for injecting a medium into the expansion cavity to control the deformation of the connecting tube fixing device. At least a portion of the syringe connecting tube is housed inside or on the wall of the first connecting tube.

2. The neurophysiological monitoring device according to claim 1, characterized in that, The other end of the first connecting pipe is provided with a medium injection device, which can selectively inject a medium into the first connecting pipe.

3. The neurophysiological monitoring device according to claim 1, characterized in that, The first electromyography (EMG) detection device is disposed on the outer periphery of the first connecting tube.

4. The neurophysiological monitoring device according to claim 3, characterized in that, The first electromyography (EMG) detection device is constructed as a plurality of first EMG electrodes, which are arranged at intervals in the extension direction of the first connecting tube or in the circumferential direction of the first connecting tube.

5. The neurophysiological monitoring device according to claim 4, characterized in that, Each of the first electromyographic electrodes is constructed in the shape of a strip, and the extension direction of the first electromyographic electrode is the same as the extension direction of the first connecting tube. Multiple first electromyographic electrodes are arranged at intervals on the outer periphery of the first connecting tube.

6. The neurophysiological monitoring device according to claim 4, characterized in that, Each of the first electromyographic electrodes is constructed in a ring shape and is disposed around the first connecting tube, and a plurality of the first electromyographic electrodes are arranged at intervals in the extending direction of the first connecting tube.

7. The neurophysiological monitoring device according to claim 5 or 6, characterized in that, Also includes: An electromyography (EMG) electrode connection harness is provided, at least a portion of which is disposed within the first communicating tube, and one end of the EMG electrode connection harness is connected to a plurality of the first EMG electrodes, and the other end is connected to the monitoring module.

8. The neurophysiological monitoring device according to claim 1, characterized in that, Also includes: A urination tube, one end of which is selectively connected to the first connecting tube and the other end of which is provided with a urine collection bag.

9. The neurophysiological monitoring device according to claim 1, characterized in that, The rectal pressure detection device includes: A second connecting tube, which is adapted to deliver a medium and has one end placed in the patient's rectum, and the other end of the second connecting tube extends to the outside of the patient's body; An intrarectal dilator, wherein the intrarectal dilator is disposed at one end of the second connecting tube and communicates with the second connecting tube, and the outer peripheral wall of the intrarectal dilator is against the inner wall of the patient's rectum; The second pressure conversion device has a second detection end and a second signal output end. The second detection end is connected to the second connecting pipe and is adapted to detect the pressure of the medium in the second connecting pipe. The second signal output end is communicatively connected to the monitoring module. The second pressure conversion device is adapted to convert the pressure of the medium into an intrarectal pressure signal and transmit it to the monitoring module through the second signal output end.

10. The neurophysiological monitoring device according to claim 9, characterized in that, The other end of the second connecting pipe may be connected to a medium injection device, which may selectively inject a medium into the second connecting pipe.

11. The neurophysiological monitoring device according to claim 10, characterized in that, Also includes: A three-way pipe has a first interface, a second interface, and a third interface that are selectively connected to each other, wherein the first interface is connected to the other end of the second connecting pipe; The second interface is connected to the second detection end of the second pressure conversion device; the third interface is connected to the medium injection device.

12. The neurophysiological monitoring device according to claim 10, characterized in that, The second electromyography (EMG) detection device is disposed on the outer periphery of the second connecting tube.

13. The neurophysiological monitoring device according to claim 12, characterized in that, The second electromyography (EMG) detection device is constructed as a plurality of second EMG electrodes, which are arranged at intervals in the extension direction of the second connecting tube or in the circumferential direction of the second connecting tube.

14. The neurophysiological monitoring device according to claim 13, characterized in that, Each of the second electromyographic electrodes is constructed as a strip, and the extension direction of the second electromyographic electrode is the same as the extension direction of the second connecting tube. A plurality of the second electromyographic electrodes are arranged at intervals on the outer periphery of the second connecting tube.

15. The neurophysiological monitoring device according to claim 13, characterized in that, Each of the second electromyographic electrodes is constructed in a ring shape and is disposed around the second connecting tube, and a plurality of the second electromyographic electrodes are arranged at intervals in the extending direction of the second connecting tube.

16. The neurophysiological monitoring device according to any one of claims 13-15, characterized in that, Also includes: The electromyographic electrode connecting wire harness has at least a portion disposed within the second communicating tube, with one end connected to a plurality of second electromyographic electrodes and the other end connected to the monitoring module.

17. The neurophysiological monitoring device according to claim 9, characterized in that, The outer peripheral wall of the second connecting pipe is provided with a plurality of scale markings spaced apart in the extension direction of the second connecting pipe.

18. A method for using the neurophysiological monitoring device according to any one of claims 1-17, characterized in that, include: The urethral detection device was used to detect intrabladder pressure signals and external urethral sphincter electromyographic activity signals. The rectal detection device was used to detect the pressure signal in the rectum and the electromyographic activity signal of the external anal sphincter. The bladder pressure signal, the electromyographic activity signal of the external urethral sphincter, the rectal pressure signal, and the electromyographic activity signal of the external anal sphincter are sent to the monitoring module to monitor the electrophysiological activity of the pudendal nerve.

Images