Patent Description:
At present, intraoperatively monitored signals in relevant techniques include an intravesical pressure, an intrarectal pressure, an external urethra sphincter electromyographic activity, and an external anal sphincter electromyographic activity. However, a conventional monitoring apparatus is designed to only monitor one certain signal during a surgical procedure due to its structural limitation, incapable of monitoring multiple signals simultaneously. Detection of the intravesical pressure, the intrarectal pressure, myoelectric recordings of the external urethra sphincter, and myoelectric recordings of the external anal sphincter relies on multiple sets of invasive monitoring instruments that work separately, resulting in a large trauma as well as a high expense to a patient; in addition, conventional measurement approaches are incapable of simultaneously measuring the intravesical pressure, the intrarectal pressure, myoelectric recordings of the external urethra sphincter, and myoelectric recordings of the external anal sphincter, which leads to deteriorated operative safety and increased postoperative risks. <CIT> discloses systems and methods for providing computer-aided diagnosis of lower urinary tract dysfunction/disorders based on data obtained from the urodynamic test. <CIT> discloses a method and an apparatus for analyzing micturition disturbances. <CIT> discloses a wearable neuromodulation device configured for insertion into a pelvic orifice of the human body for treating urinary incontinence, faecal incontinence, muscle wastage, spasm and/or spasticity. <CIT> discloses a system and a method for client-side compression and extraction of medical imaging data. <NPL> discloses that pelvic floor muscle contraction increases with importance of intra-abdominal pressure generated during stress.

The disclosure intends to at least solve one of the above and other technical problems in conventional technologies. To this end, an object of the disclosure is to provide a neuroelectrophysiological monitoring apparatus, which may simultaneously measure an intravesical pressure, an intrarectal pressure, myoelectric recordings of the external urethra sphincter, and myoelectric recordings of the external anal sphincter, thereby eliminating a need of deploying multiple sets of monitoring instruments; as such, integrity of the neuroelectrophysiological monitoring apparatus is improved, operative safety is enhanced, and postoperative risks are reduced.

The present invention is defined by the independent claim. Advantageous embodiments are described in the dependent claims, the following description and the drawings. A neuroelectrophysiological monitoring apparatus according to the disclosure comprises: a urethra testing device, the urethra testing device being provided with a bladder pressure measuring member and a first myoelectricity measuring member, the bladder pressure measuring member being set in a patient's bladder and adapted to measure the patient's intravesical pressure, the first myoelectricity measuring member being adapted to contact an external urethra sphincter to measure an external urethra sphincter electromyographic activity; a rectum testing device, the rectum testing device being provided with a rectal pressure measuring member and a second myoelectricity measuring member, the rectal pressure measuring member being set in the patient's rectum and adapted to measure the patient's intrarectal pressure, the second myoelectricity measuring member being adapted to contact an external anal sphincter to measure an external anal sphincter electromyographic activity; and a monitoring module, the monitoring module being electrically connected to the bladder pressure measuring member, the first myoelectricity measuring member, the rectal pressure measuring member, and the second myoelectricity measuring member, respectively.

In brief, provided with the urethra testing device configured to measure a patient's intravesical pressure and external urethra sphincter electromyographic activity, the rectum testing device configured to measure the patient's intrarectal pressure and external anal sphincter electromyographic activity, and the monitoring module configured to monitor the intravesical pressure, the intrarectal pressure, the external urethra sphincter electromyographic activity, and the external anal sphincter electromyographic activity, the neuroelectrophysiological monitoring apparatus according to the disclosure is enabled to simultaneously monitor the intravesical pressure, the intrarectal pressure, the external urethra sphincter electromyographic activity, and the external anal sphincter electromyographic activity, eliminating a need of deploying multiple sets of monitoring instruments, thereby improving integrity of the neuroelectrophysiological monitoring apparatus as well as operative safety, with reduced postoperative risks.

According to one embodiment of the disclosure, the bladder pressure measuring member comprises: a first communication tube, the first communication tube being adapted to deliver a medium, one end of the first communication tube being open and set in the patient's bladder, opposite end of the first communication tube extending outside the patient's body; a first pressure transducing device, the first pressure transducing device having a first testing end and a first signal output end, the first testing end communicating with the first communication tube and being adapted to measure a pressure of the medium in the first communication tube, the first signal output end being in communicative connection to the monitoring module, the first pressure transducing device being adapted to convert the pressure of the medium in the first communication tube to an intravesical pressure signal and to transmit the intravesical pressure signal to the monitoring module via the first signal output end.

According to one embodiment of the disclosure, the opposite end of the first communication tube is provided with a medium injecting device, the medium injecting device selectively injecting the medium into the first communication tube.

According to one embodiment of the disclosure, the first myoelectricity measuring member is disposed at an outer periphery of the first communication tube.

According to one embodiment of the disclosure, the first myoelectricity measuring member is formed of a plurality of first electromyography electrodes, the plurality of first electromyography electrodes being arranged at intervals in an extending direction of the first communication tube or in a circumferential direction of the first communication tube.

According to one embodiment of the disclosure, the neuroelectrophysiological monitoring apparatus further comprises: a first communication tube anchoring device, the first communication tube anchoring device being disposed at one end of the first communication tube, the first communication tube anchoring device being selectively deformed to be tensioned in the patient's bladder, an expandable cavity being formed inside the first communication tube anchoring device, the expandable cavity communicating with a syringe connection tube so that the medium is injected into the expandable cavity to control deformation of the communication tube anchoring device.

According to one embodiment of the disclosure, the rectal pressure measuring member comprises: a second communication tube, the second communication tube being adapted to deliver the medium, one end of the second communication tube being set in the patient's rectum, opposite end of the second communication tube extending outside the patient's body; an intrarectal expandable balloon, the intrarectal expandable balloon being disposed at one end of the second communication tube and communicating with the second communication tube, an outer peripheral wall of the intrarectal expandable balloon abutting against an inside lining of the patient's rectum; and a second pressure transducing device, the second pressure transducing device having a second testing end and a second signal output end, the second testing end communicating with the second communication tube and being adapted to measure a pressure of the medium in the second communication tube, the second signal output end being in communicative connection to the monitoring module, the second pressure transducing device being adapted to convert the pressure of the medium to an intrarectal pressure signal and transmit the intrarectal pressure signal to the monitoring module via the second signal output end.

According to one embodiment of the disclosure, the opposite end of the second communication tube is adaptable to be connected to the medium injecting device, the medium injecting device selectively injecting the medium into the second communication tube.

According to one embodiment of the disclosure, the neuroelectrophysiological monitoring apparatus further comprises: a three-way tube, the three-way tube having a first interface, a second interface, and a third interface which selectively communicate with each other, the first interface being connected to the opposite end of the second communication tube, the second interface being connected to the second testing end of the second pressure transducing device, the third interface being connected to the medium injecting device.

According to one embodiment of the disclosure, the second myoelectricity measuring member is disposed at an outer periphery of the second communication tube.

According to one embodiment of the disclosure, the second myoelectricity measuring member is formed of a plurality of second electromyography electrodes, the plurality of second electromyography electrodes being arranged at intervals in an extending direction of the second communication tube or in a circumferential direction of the first communication tube.

According to one embodiment of the disclosure, a plurality of scale markers arranged at intervals in the extending direction of the second communication tube are provided on an outer peripheral wall of the second communication tube.

Additional aspects and advantages of the disclosure will be partially given in the detailed description below, or partially become apparent through the detailed description below, or be understood through implementing the disclosure.

Hereinafter, embodiments of the disclosure will be described in detail. Examples of the embodiments are illustrated in the drawings. Throughout the specification, identical or like reference numerals represent same or similar elements or elements with same or similar functions. The embodiments described with reference to the drawings are exemplary, only intended for explaining the disclosure, which shall not be understood as limitations to the disclosure.

A neuroelectrophysiological monitoring apparatus according to a first aspect of embodiments of the disclosure will be described infra, the neuroelectrophysiological monitoring apparatus being configured to measure a patient's intravesical pressure and external urethra sphincter electromyographic activity.

Hereinafter, a neuroelectrophysiological monitoring apparatus <NUM> according to the disclosure not falling under the scope of protection will be described with reference to <FIG>. The neuroelectrophysiological monitoring apparatus <NUM> comprises a bladder pressure measuring member, a myoelectricity measuring member, and a monitoring module <NUM>. The bladder pressure measuring member is set in a patient's bladder and adapted to measure an intravesical pressure of the patient, the myoelectricity measuring member is disposed adjacent to the bladder pressure measuring member and adapted to contact the external urethra sphincter to measure an external urethra sphincter electromyographic activity, and the monitoring module <NUM> is connected to the bladder pressure measuring member and the myoelectricity measuring member, respectively, to monitor the patient's intravesical pressure and external urethra sphincter electromyographic activity.

At present, intraoperatively monitored signals in relevant techniques include an intravesical pressure and an external urethra sphincter electromyographic activity. However, a conventional monitoring instrument is designed to only monitor one certain signal during a surgical procedure due to its structural limitation, incapable of monitoring multiple signals simultaneously. Detection of the intravesical pressure and electromyography recordings of the external urethra sphincter relies on multiple sets of invasive monitoring instruments that work separately, resulting in a large trauma as well as a high expense to the patient; in addition, conventional measurement approaches are incapable of simultaneously measuring the intravesical pressure and the electromyography recordings of external urethra sphincter, which leads to deteriorated operative safety and increased postoperative risks.

Specifically, the neuroelectrophysiological monitoring apparatus <NUM> comprises a bladder pressure measuring member, a myoelectricity measuring member, and a monitoring module <NUM>. The bladder pressure measuring member is disposed in a patient's bladder and adapted to measure the patient's intravesical pressure; the myoelectricity measuring member is disposed adjacent to the bladder pressure measuring member and adapted to contact the external urethra sphincter to measure an external urethra sphincter electromyographic activity via the contact between the myoelectricity measuring member and the external urethra sphincter; the monitoring module <NUM> is connected to the bladder pressure measuring member and the myoelectricity measuring member, respectively, so that the bladder pressure measuring member and the myoelectricity measuring member may transmit signals to the monitoring module <NUM>, so that the monitoring module <NUM> monitors the intravesical pressure and the external urethra sphincter electromyographic activity of the patient based on the signals received.

In brief, with the pressure measuring member configured to measure a patient's intravesical pressure, the myoelectricity measuring member configured to measure the external urethra sphincter electromyographic activity, and the monitoring module <NUM> configured to monitor the intravesical pressure and the external urethra sphincter electromyographic activity, the neuroelectrophysiological monitoring apparatus <NUM> according to the disclosure is enabled to simultaneously monitor the intravesical pressure and the external urethra sphincter electromyographic activity, eliminating a need to deploy multiple monitoring instruments, which improves operative safety and reduces postoperative risks.

According to one embodiment of the disclosure, the bladder pressure measuring member comprises a communication tube <NUM> and a pressure transducing device, the communication tube <NUM> being adapted to deliver a medium, wherein the medium may be a liquid medicine such as physiological saline. One end of the communication tube <NUM> is open and set in the patient's bladder, and the opposite end of the communication tube <NUM> extends out of the patient's body. The communication tube <NUM> is adapted to deliver the medium, whereby the medium is delivered from the external to the patient's body, or delivered from the inside the patient' s body to the external.

The pressure transducing device has a testing end <NUM> and a signal output end, the testing end <NUM> being in communication with the communication tube <NUM> and configured to measure a pressure of the medium in the communication tube <NUM>, wherein an interconnecting catheter <NUM> is provided between the testing end <NUM> and the communication tube <NUM>, one end of the interconnecting catheter <NUM> being connected to the communication tube <NUM>, the opposite end of the interconnecting catheter <NUM> being connected to the testing end <NUM>, so that the testing end <NUM> communicates with an internal cavity of the communication tube <NUM>. In another embodiment of the disclosure, the interconnecting catheter <NUM> and the communication tube <NUM> may be unitarily formed. An on/off valve may be provided between the interconnecting catheter <NUM> and the communication tube <NUM>, the on/off valve allowing for selective communication between the interconnecting catheter <NUM> and the communication tube <NUM>.

The signal output end is connected to the monitoring module <NUM>; the pressure transducing device may convert the pressure of the medium to an intravesical pressure signal and transmit the intravesical pressure signal to the monitoring module <NUM> via the signal output end, so that the monitoring module <NUM> monitors the intravesical pressure of the patient based on the intravesical pressure signal.

According to one embodiment of the disclosure, the opposite end of the communication tube <NUM> is provided with a medium injecting device <NUM>, wherein the medium injecting device may be configured as a syringe. The medium injecting device <NUM> may selectively inject the medium into the communicating device <NUM> so that the medium may be delivered into the patient's bladder via the communication tube <NUM>. An on/off valve may be provided between the medium injecting device <NUM> and the communication tube <NUM>, the on/off valve allowing for selective communication between the medium injecting device <NUM> and the communication tube <NUM>.

According to one embodiment of the disclosure, the neuroelectrophysiological monitoring apparatus <NUM> further comprises a first regulating valve <NUM>, wherein the first regulating valve <NUM> may be configured as a three-way regulating valve; the first regulating valve <NUM> comprises a first port, a second port, and a third port, the first port, the second port, and the third port being in one-to-one communication with the communication tube <NUM>, the interconnecting catheter <NUM>, and the medium injecting device <NUM>, respectively. Provision of the three-way regulating valve may reduce port multiplexing and plugging operations during monitoring, which facilitates a manipulator to pre-connect the monitoring apparatus, further reducing the manipulation difficulty.

When the first port communicates with the third port while the second port is shut down, the communication tube <NUM> communicates with the medium injecting device <NUM>, in which case the medium injecting device <NUM> may selectively inject the medium into the communication tube <NUM> so that the medium may be delivered into the patient's bladder via the communication tube <NUM>; when the first port communicates with the second port while the third port is shut down, the communication tube <NUM> communicates with the interconnecting catheter <NUM>, in which case the pressure transducing device may convert the pressure of the medium in the interconnecting catheter <NUM> to an intravesical pressure signal and transmit the intravesical pressure signal to the monitoring module <NUM> via the signal output end, so that the monitoring module <NUM> monitors the patient's intravesical pressure based on the intravesical pressure signal.

In another embodiment of the disclosure, the interconnecting catheter <NUM> or the medium injecting device <NUM> may be directly connected to the communication tube <NUM>, thereby eliminating configuration of the first regulating valve <NUM>.

According to one embodiment of the disclosure, the myoelectricity measuring member is disposed at an outer periphery of the communication tube <NUM>. Furthermore, when the communication tube <NUM> enters the patient's bladder, the myoelectricity measuring member may directly contact the external urethra sphincter. Contact with the external urethra sphincter allows for the myoelectricity measuring member to measure the external urethra sphincter electromyographic activity. The myoelectricity measuring member may be integrated at the outer periphery of the communication tube <NUM>, ensuring that the neuroelectrophysiological monitoring apparatus <NUM> measures the intravesical pressure and the external urethra sphincter electromyographic activity simultaneously, thereby realizing simultaneous measurement of two parameters, which improves operative safety and reduces postoperative risks.

According to one embodiment of the disclosure, the myoelectricity measuring member comprises a plurality of electromyography electrodes <NUM>, the plurality of electromyography electrodes <NUM> being arranged at intervals at the outer periphery of the communication tube <NUM>; the plurality of electromyography electrodes <NUM> may obtain the external urethra sphincter electromyographic activity by touching a mucous membrane on a surface of the external urethra sphincter, and by arranging the plurality of electromyography electrodes <NUM> at intervals at the outer periphery of the communication tube <NUM>, measurement accuracy and comprehensiveness may be further improved, thereby enhancing operative safety.

According to one embodiment of the disclosure not falling under the scope of protection, as illustrated in <FIG>, each electromyography electrode <NUM> is configured to have a stripped shape, an extending direction of each electromyography electrode <NUM> is consistent with an extending direction of the communication tube <NUM>, and the plurality of electromyography electrodes <NUM> are arranged at intervals at the outer periphery of the communication tube <NUM>, wherein the plurality of electromyography electrodes <NUM> are arranged at intervals, respective electromyography electrodes <NUM> being insulated from each other, each electromyography electrode <NUM> being configured to measure an electromyography signal of the external urethra sphincter, respectively. Specifically, the number of the strip-shaped electromyography electrodes <NUM> may be <NUM>, <NUM>, <NUM>, <NUM>, or more; the number of the strip-shaped electromyography electrodes <NUM> may also be odd. By arranging the plurality of strip-shaped electrodes at intervals in the extending direction of the communication tube <NUM>, at least the electromyography signals of left and right sides of the external urethra sphincter may be monitored, respectively; in addition, the electromyography signals of the external urethra sphincter corresponding to different positions in the peripheral direction of the communication tube <NUM> may also be monitored, thereby realizing more accurate monitoring of the electromyography activities of different positions of the external urethra sphincter.

According to one embodiment of the disclosure not falling under the scope of protection, as illustrated in <FIG>, each electromyography electrode <NUM> is configured to have a ring shape and disposed surrounding the communication tube <NUM>, the plurality of electromyography electrodes <NUM> being arranged at intervals in the extending direction of the communication tube <NUM>, wherein the plurality of electromyography electrodes <NUM> are arranged at intervals, respective electromyography electrodes <NUM> being insulated from each other, each electromyography electrode <NUM> being configured to measure an electromyography signal of the external urethra sphincter, respectively, enabling measurement of the electromyography signals at multiple positions of the external urethra sphincter, whereby the electromyography electrodes <NUM> measure the electromyography signals of the external urethra sphincters more accurately. By arranging the plurality of ring-shaped electromyography electrodes <NUM> at intervals surrounding the communication tube <NUM>, it is enabled to monitor the electromyography signals of the external urethra sphincter at different depth positions corresponding to the extending direction of the communication tube <NUM>, whereby the electromyographic activities at different positions of the external urethra sphincter may be monitored more accurately.

In a neuroelectrophysiological monitoring apparatus <NUM> applicable to an adult male patient, the distance between the upper end of each electromyography electrode <NUM> and the start of the patient's bladder neck may range from <NUM> to <NUM>, the distance being preferably <NUM>. In a neuroelectrophysiological monitoring apparatus <NUM> applicable to an adult female patient, the distance between the upper end of each electromyography electrode <NUM> and the start of the patient's bladder neck may range from <NUM> to <NUM>, the distance being preferably <NUM>. In a neuroelectrophysiological monitoring apparatus <NUM> applicable to an underage patient, the distance between the upper end of each electromyography electrode <NUM> and the start of the patient's bladder neck is smaller than the distance between the upper end of each electromyography electrode <NUM> and the start of the patient's bladder neck in the neuroelectrophysiological monitoring apparatus <NUM> applicable to an adult male patient or adult female patient.

According to one embodiment of the disclosure, a plurality of scale markers arranged at intervals in the extending direction of the communication tube <NUM> are provided on the outer peripheral wall of the communication tube <NUM>. The scale markers are adapted to adjust the depth of the communication tube <NUM> inserted into the patient's urethra, ensuring that the communication tube <NUM> is always disposed in a safe depth, thereby improving operative safety and reducing postoperative risks.

According to one embodiment of the disclosure, the neuroelectrophysiological monitoring apparatus <NUM> further comprises an electromyography electrode connecting harness <NUM>, the electromyography electrode connecting harness <NUM> being adapted to electrically connect the electromyography electrode <NUM> and the monitoring module <NUM>, wherein the electromyography electrode connecting harness <NUM> is at least partially inserted into the inside or the tube wall of the communication tube <NUM>, one end of the electromyography electrode connecting harness <NUM> being connected to a plurality of electromyography electrodes <NUM>, the opposite end of the electromyography electrode connecting harness <NUM> being connected to the monitoring module <NUM>, the plurality of electromyography electrodes <NUM> being independently and separately connectable to the monitoring module <NUM> via the electromyography electrode connecting harness <NUM>, and the measured electromyography signals being transmitted to the monitoring module <NUM> via the electromyography electrode connecting harness <NUM>.

According to one embodiment of the disclosure, the neuroelectrophysiological monitoring apparatus <NUM> further comprises a communication tube anchoring device <NUM>, the communication tube anchoring device <NUM> being provided at one end of the communication tube <NUM>, wherein the communication tube anchoring device <NUM> may be configured as a rubber element, and the communication tube anchoring device <NUM> is selectively deformed to be tensioned inside the patient's bladder. Specifically, the communication tube anchoring device <NUM> has a contracted state and an expanded state. When the communication tube anchoring device <NUM> is in the contracted state, the communication tube <NUM> may enter or be removed out of the patient's bladder; when the communication tube anchoring device <NUM> is in the expanded state, the communication tube <NUM> is securely disposed in the patient's bladder, uneasy to be detached.

According to one embodiment of the disclosure, an expandable cavity is formed inside the communication tube anchoring device <NUM>, the expandable cavity being selectively expanded or contracted. The expandable cavity communicates with a syringe connecting tube <NUM>, the syringe connecting tube <NUM> being adapted to inject a medium into the expandable cavity to control deformation of the communication tube anchoring device <NUM>, wherein the medium may be a liquid or gas; the syringe connecting tube <NUM> injects the medium into the expandable cavity, causing expansion of the expandable cavity, so that the communication tube anchoring device <NUM> securely contacts the inside lining of the patient's bladder.

According to one embodiment of the disclosure, the syringe connecting tube <NUM> is at least partially received inside the communication tube <NUM> or on the tube wall of the communication tube <NUM>, which reduces footprint of the syringe connecting tube <NUM> and enhances integrity of the syringe connecting tube <NUM>.

According to one embodiment of the disclosure, the neuroelectrophysiological monitoring apparatus <NUM> further comprises a urethra catheter <NUM>, one end of the urethra catheter <NUM> being selectively conducted to the communication tube <NUM>, the opposite end of the urethra catheter <NUM> being provided with a urine collection bag <NUM>, the urine collection bag <NUM> being configured to collect the residual urine or medium in the patient's bladder. Specifically, the neuroelectrophysiological monitoring apparatus <NUM> further comprises an intravesical fluid outlet <NUM>, the intravesical fluid outlet <NUM> allowing for drainage of the residual urine or medium out of the bladder; the residual urine or medium in the bladder flows into the urethra catheter <NUM> via the communication tube <NUM> and is then delivered into the urine collection bag <NUM> via the urethra catheter <NUM> till the operation ends.

According to one embodiment of the disclosure, the neuroelectrophysiological monitoring apparatus <NUM> further comprises a second regulating valve <NUM>, wherein the second regulating valve <NUM> may be configured as a three-way regulating valve. The second regulating valve <NUM> comprises a fourth port, a fifth port, and a sixth port, the fourth port, the fifth port, and the sixth port being disposed in one-to-one correspondence with a front segment of the communication tube <NUM>, a rear segment of the communication tube <NUM>, and the urethra catheter <NUM>, respectively. Provision of the three-way regulating valve may reduce the port multiplexing and plugging operations during monitoring, which facilitates a manipulator to pre-connect the monitoring apparatus, further reducing manipulation difficulty.

When the fourth port and the fifth port communicate while the sixth port is shut down, the front segment of the communication tube <NUM> is conducted to the rear segment of the communication tube <NUM>, in which case the medium injecting device <NUM> may inject a medium into the patient's bladder, facilitating monitoring of the intravesical pressure of the patient. When the fourth port and the sixth port communicate while the fifth port is shut down, the front segment of the communication tube <NUM> is conducted to the urethra catheter <NUM>, in which case the residual urine or medium in the patient's bladder flows into the urethra catheter <NUM> along the communication tube <NUM> and is then delivered into the urine collection bag <NUM> via the urethra catheter <NUM> till the operation ends.

Hereinafter, a neuroelectrophysiological monitoring apparatus according to a second aspect of embodiments of the disclosure will be described, the neuroelectrophysiological monitoring apparatus being configured to measure a patient's intrarectal pressure and external anal sphincter electromyographic activity.

A neuroelectrophysiological monitoring apparatus <NUM> according to embodiments of the disclosure not falling under the scope of protection will be described below with reference to <FIG>, the neuroelectrophysiological monitoring apparatus <NUM> comprising a rectal pressure measuring member, a myoelectricity measuring member, and a monitoring module <NUM>. The rectal pressure measuring member is disposed in the patient's rectum and adapted to measure the patient's intrarectal pressure; the myoelectricity measuring member is disposed adjacent to the rectal pressure measuring member and adapted to contact with a mucous membrane on a surface of the external anal sphincter to measure an external anal sphincter electromyographic activity; and the monitoring module <NUM> is connected to the rectal pressure measuring member and the myoelectricity measuring member, respectively, so as to monitor the patient's intrarectal pressure and external anal sphincter electromyographic activity.

At present, intraoperatively monitored signals in relevant techniques include an intrarectal pressure and an external anal sphincter electromyographic activity. However, a conventional monitoring instrument is designed to only monitor one certain signal during a surgical procedure due to its structural limitation, incapable of monitoring multiple signals simultaneously. Detection of the intrarectal pressure and the external anal sphincter myoelectric recordings relies on multiple sets of invasive monitoring instruments that work separately, resulting in a large trauma as well as a high expense to the patient; in addition, conventional measurement approaches are incapable of simultaneously monitoring the intrarectal pressure and external anal sphincter myoelectric recordings, which leads to deteriorated operative safety and increased postoperative risks.

Specifically, the neuroelectrophysiological monitoring apparatus <NUM> comprises a rectal pressure measuring member, a myoelectricity measuring member, and a monitoring module <NUM>. The rectal pressure measuring member is set in a patient's rectum and adaptable to measure the patient's intrarectal pressure; the myoelectricity measuring member is disposed adjacent to the rectal pressure measuring member and adapted to contact a mucous membrane on a surface of the external anal sphincter; contact between the myoelectricity measuring member and the mucous membrane on the surface of the external anal sphincter allows for measuring the external anal sphincter electromyographic activity; the monitoring module <NUM> is connected to the rectal pressure measuring member and the myoelectricity measuring member, respectively; the rectal pressure measuring member and the myoelectricity measuring member may transmit signals to the monitoring module <NUM>, so that the monitoring module <NUM> monitors the patient's intrarectal pressure and external anal sphincter electromyographic activity based on the signals received.

In brief, with the pressure measuring member configured to measure a patient's intrarectal pressure, the myoelectricity measuring member configured to measure an external anal sphincter electromyographic activity, and the monitoring module <NUM> configured to monitor the intrarectal pressure and the external anal sphincter electromyographic activity, the neuroelectrophysiological monitoring apparatus <NUM> according to the disclosure is enabled to simultaneously measure the intrarectal pressure and the external anal sphincter electromyographic activity, eliminating a need to deploy multiple monitoring instruments, which improves operative safety and reduces postoperative risks,.

According to one embodiment, the rectal pressure measuring member comprises a communication tube <NUM>, an intrarectal expandable balloon <NUM>, and a pressure transducing device. A medium may be stored in the communication tube <NUM>, wherein the medium may be a liquid medicine such as physiological saline. One end of the communication tube <NUM> is provided with an intrarectal expandable balloon <NUM>, and the opposite end of the communication tube <NUM> extends out of the patient's body. The communication tube <NUM> is adapted to deliver the medium from the external to the patient's body, or deliver the medium from the inside the patient's body to the external.

The intrarectal expandable balloon <NUM> is disposed at one end of the communication tube <NUM>, and the intrarectal expandable balloon <NUM> may communicate with the communication tube <NUM>, wherein the intrarectal expandable balloon <NUM> may be configured as a rubber element. The intrarectal expandable balloon <NUM> is selectively deformable to be tensioned in the patient's rectum. Specifically, the intrarectal expandable balloon <NUM> has a contracted state and an expanded state. When the intrarectal expandable balloon <NUM> is in the contracted state, the communication tube <NUM> may enter or be removed out of the patient's rectum; when the intrarectal expandable balloon <NUM> is in the expanded state, the outer peripheral wall of the intrarectal expandable balloon <NUM> abuts against the inside lining of the patient's rectum, whereby the communication tube <NUM> is securely anchored in the patient's rectum; when the inside lining of the rectum is contracted, the intrarectal expandable balloon <NUM> is deformed as the pressure changes, thereby transducing the intrarectal pressure signal.

The pressure transducing device has a testing end <NUM> and a signal output end, the testing end <NUM> being in communication with the communication tube <NUM> and configured to measure a pressure of the medium in the communication tube <NUM>, wherein an interconnecting catheter <NUM> is provided between the testing end <NUM> and the communication tube <NUM>, one end of the interconnecting catheter <NUM> being connected to the communication tube <NUM>, the opposite end of the interconnecting catheter <NUM> being connected to the testing end <NUM>, so that the testing end <NUM> communicates with the communication tube <NUM>. In another embodiment of the disclosure, the interconnecting catheter <NUM> and the communication tube <NUM> may be unitarily formed. An on/off valve may be provided between the interconnecting catheter <NUM> and the communication tube <NUM>, the on/off valve allowing for selective communication between the interconnecting catheter <NUM> and the communication tube <NUM>.

The signal output end is connected to the monitoring module <NUM>; the pressure transducing device may convert the pressure of the medium to an intrarectal pressure signal and transmit the intrarectal pressure signal to the monitoring module <NUM> via the signal output end, so that the monitoring module <NUM> monitors the intrarectal pressure of the patient based on the intrarectal pressure signal.

According to one embodiment of the disclosure, the opposite end of the communication tube <NUM> is provided with a medium injecting device <NUM>, wherein the medium injecting device <NUM> may be configured as a syringe. The medium injecting device <NUM> may selectively inject the medium into the communicating device <NUM> so that the medium may be delivered into the intrarectal expandable balloon <NUM> via the communication tube <NUM>, causing the intrarectal expandable balloon <NUM> to be expanded. An on/off valve may be provided between the medium injecting device <NUM> and the communication tube <NUM>, the on/off valve allowing for selective communication between the medium injecting device <NUM> and the communication tube <NUM>.

According to one embodiment of the disclosure, the neuroelectrophysiological monitoring apparatus <NUM> further comprises a three-way tube, wherein the three-way tube may be configured as a third regulating valve <NUM>, the third regulating valve <NUM> having a first interface, a second interface, and a third interface which selectively communicate with each other, wherein the first interface is connected to the opposite end of the communication tube <NUM>, and the second interface is connected to the testing end <NUM> of the pressure transducing device; here, it is to be noted that connection of the second interface to the interconnecting catheter <NUM> realizes further connection of the second interface to the testing end <NUM> of the pressure transducing device, the third interface being connected to the medium injecting device <NUM>. Provision of the three-way regulating valve may reduce port multiplexing and plugging operations during monitoring, which facilitates a manipulator to pre-connect the monitoring apparatus, further reducing manipulation difficulty.

Specifically, when the first interface communicates with the third interface while the second interface is shut down, the communication tube <NUM> communicates with the medium injecting device <NUM>, in which case the medium injecting device <NUM> may selectively inject the medium into the communication tube <NUM> so that the medium may be delivered into the patient's intrarectal expandable balloon <NUM> via the communication tube <NUM>; when the first interface communicates with the second interface while the third interface is shut down, the communication tube <NUM> communicates with the interconnecting catheter <NUM>, in which case the pressure transducing device may convert the pressure of the medium in the interconnecting catheter <NUM> to an intrarectal pressure signal and transmit the intrarectal pressure signal to the monitoring module <NUM> via the signal output end, so that the monitoring module <NUM> monitors the patient's intrarectal pressure based on the intrarectal pressure signal.

According to one embodiment of the disclosure, the myoelectricity measuring member is disposed at the outer periphery of the communication tube <NUM>. Furthermore, when the communication tube <NUM> enters the patient's rectum, the myoelectricity measuring member may directly contact the mucous membrane on the surface of the external anal sphincter. Contact between the myoelectricity measuring member and the mucous membrane on the surface of the external anal sphincter allows for measuring the external anal sphincter electromyographic activity. The myoelectricity measuring member may be integrated at the outer periphery of the communication tube <NUM>, ensuring that the neuroelectrophysiological monitoring apparatus <NUM> measures the intrarectal pressure and the external anal sphincter electromyographic activity simultaneously, thereby realizing simultaneous measurement of two parameters, which improves operative safety and reduces postoperative risks.

According to one embodiment of the disclosure, the myoelectricity measuring member comprises a plurality of electromyography electrodes <NUM>, the plurality of electromyography electrodes <NUM> being arranged at intervals at the outer periphery of the communication tube <NUM>; the plurality of electromyography electrodes <NUM> may be attached to the mucous membrane on the surface of the external anal sphincter to record the external anal sphincter electromyographic activity, and by arranging the plurality of electromyography electrodes <NUM> at intervals at the outer periphery of the communication tube <NUM>, measurement accuracy and comprehensiveness may be further improved, thereby enhancing operative safety.

According to one embodiment of the disclosure, the myoelectricity measuring member comprises a plurality of electromyography electrodes <NUM>, the plurality of electromyography electrodes <NUM> being arranged at intervals at the outer periphery of the communication tube <NUM>; the plurality of electromyography electrodes <NUM> are configured to record the external anal sphincter electromyographic activity by touching the mucous membrane on the surface of the external anal sphincter; by arranging the plurality of electromyography electrodes <NUM> at intervals at the outer periphery of the communication tube <NUM>, measurement accuracy and comprehensiveness may be further improved, thereby enhancing operative safety.

According to one embodiment of the disclosure, each electromyography electrode <NUM> is configured to have a stripped shape, an extending direction of each electromyography electrode <NUM> is consistent with an extending direction of the communication tube <NUM>, the plurality of electromyography electrodes <NUM> being arranged at intervals at the outer periphery of the communication tube <NUM>, wherein the plurality of electromyography electrodes <NUM> are arranged at intervals, respective electromyography electrodes <NUM> being insulated from each other, each electromyography electrode <NUM> being configured to record an electromyography signal of the external anal sphincter, respectively. Specifically, the number of the strip-shaped electromyography electrodes <NUM> may be <NUM>, <NUM>, <NUM>, <NUM>, or more; the number of the strip-shaped electromyography electrodes <NUM> may also be odd. By arranging the plurality of strip-shaped electrodes at intervals in the extending direction of the communication tube <NUM>, at least the electromyography signals of the left and right-sides of the external anal sphincter may be monitored, respectively; in addition, the electromyography signals of the external anal sphincter corresponding to different positions of the outer periphery of the communication tube <NUM> may also be monitored, thereby realizing more accurate monitoring of the electromyographic activities at different positions of the external anal sphincter.

According to one embodiment of the disclosure, each electromyography electrode <NUM> is configured to have a ring shape and disposed surrounding the communication tube <NUM>, the plurality of electromyography electrodes <NUM> being arranged at intervals in the extending direction of the communication tube <NUM>, wherein the plurality of electromyography electrodes <NUM> are arranged at intervals, respective electromyography electrodes <NUM> being insulated from each other, each electromyography electrode <NUM> being configured to measure an electromyography signal of the external anal sphincter, respectively, enabling measurement of the electromyography signals at multiple positions of the external anal sphincter, whereby the electromyography electrodes <NUM> measures the electromyography signals of the external anal sphincters more accurately. By arranging the plurality of ring-shaped electromyography electrodes <NUM> at intervals surrounding the communication tube <NUM>, it is enabled to monitor the electromyography signals of the external anal sphincter corresponding to different depth positions in the extending direction of the communication tube <NUM>, whereby the electromyographic activities at different positions of the external anal sphincter may be monitored more accurately.

According to one embodiment of the disclosure, the neuroelectrophysiological monitoring apparatus <NUM> further comprises an electromyography electrode connecting harness <NUM>, the electromyography electrode connecting harness <NUM> being adapted to electrically connect the electromyography electrode <NUM> and the monitoring module <NUM>, wherein the electromyography electrode connecting harness <NUM> is at least partially disposed inside or on the tube wall of the communication tube <NUM>, one end of the electromyography electrode connecting harness <NUM> being connected to the plurality of electromyography electrodes <NUM>, the opposite end of the electromyography electrode connecting harness <NUM> being connected to the monitoring module <NUM>; the plurality of electromyography electrodes <NUM> may be independently and separately connected to the monitoring module <NUM> via the electromyography electrode connecting harness <NUM>, so that the measured electromyography signals are transmitted to the monitoring module <NUM> via the electromyography electrode connecting harness <NUM>.

According to one embodiment of the disclosure, a plurality of scale markers arranged at intervals in the extending direction of the communication tube <NUM> are provided on an outer peripheral wall of the communication tube <NUM>. The scale markers are adapted to adjust the depth of the communication tube <NUM> inserted into the patient's anus, ensuring that the communication tube <NUM> is always disposed in a safe depth, thereby improving operative safety and reducing postoperative risks.

Hereinafter, a neuroelectrophysiological monitoring apparatus according to a third aspect of embodiments of the disclosure will be described, the neuroelectrophysiological monitoring apparatus being configured to measure a patient's intravesical pressure, intrarectal pressure, external urethra sphincter electromyographic activity, and external anal sphincter electromyographic activity.

Hereinafter, referring to <FIG>, a neuroelectrophysiological monitoring apparatus <NUM> according to embodiments of the disclosure is described, the neuroelectrophysiological monitoring apparatus <NUM> comprising a urethra testing device, a rectum testing device, and a monitoring module <NUM>. The urethra testing device is provided with a bladder pressure measuring member and a first myoelectricity measuring member, the bladder pressure measuring member being set in a patient's bladder and adapted to measure the patient's intravesical pressure, the first myoelectricity measuring member being adapted to contact a mucous membrane on a surface of the external urethra sphincter to measure an external urethra sphincter electromyographic activity; the rectum testing device is provided with a rectal pressure measuring member and a second myoelectricity measuring member, the rectal pressure measuring member being set in the patient's rectum and adapted to measure the patient's intrarectal pressure, the second myoelectricity measuring member being adapted to contact a mucous membrane on a surface of the external anal sphincter to measure an external anal sphincter electromyographic activity; and the monitoring module <NUM> is electrically connected to the bladder pressure measuring member, the first myoelectricity measuring member, the rectal pressure measuring member, and the second myoelectricity measuring member, respectively.

At present, intraoperatively monitored signals in relevant techniques include an intravesical pressure, an intrarectal pressure, an external urethra sphincter electromyographic activity, and an external anal sphincter electromyographic activity. However, a conventional monitoring instrument is designed to only monitor one certain signal during a surgical procedure due to its structural limitation, incapable of monitoring multiple signals simultaneously. Detection of the intravesical pressure, the intrarectal pressure, the external urethra sphincter myoelectric recording, and the external anal sphincter myoelectric recording relies on multiple sets of invasive monitoring instruments that work separately, resulting in a large trauma as well as a high expense to a patient; in addition, conventional measurement approaches are incapable of simultaneously monitoring the intravesical pressure, the intrarectal pressure, the external urethra sphincter myoelectric recording, and the external anal sphincter myoelectric recording, which leads to deteriorated operative safety and increased postoperative risks.

Specifically, the neuroelectrophysiological monitoring apparatus <NUM> comprises a urethra testing device, a rectum testing device, and a monitoring module <NUM>. The urethra testing device is provided with a bladder pressure measuring member and a first myoelectricity measuring member, the bladder pressure measuring member being set in the patient's bladder and adaptable to measure the patient's intravesical pressure, the first myoelectricity measuring member being disposed adjacent to the bladder pressure measuring member and adaptable to contact a mucous membrane on a surface of the external urethra sphincter. Contact between the first myoelectricity measuring member and the external urethra sphincter allows for measuring an external urethra sphincter electromyographic activity.

The rectal pressure measuring member is set in the patient's rectum and adaptable to measure the patient's intrarectal pressure; the second myoelectricity measuring member is set adjacent to the rectal pressure measuring member and adaptable to contact a mucous membrane on a surface of the external anal sphincter; contact between the second myoelectricity measuring member and the mucous membrane on the surface of the external anal sphincter allows for measuring an external anal sphincter electromyographic activity.

The monitoring module <NUM> is electrically connected to the bladder pressure measuring member, the first myoelectricity measuring member, the rectal pressure measuring member, and the second myoelectricity measuring member, respectively, the bladder pressure measuring member, the first myoelectricity measuring member, the rectal pressure measuring member, and the second myoelectricity measuring member being adapted to transmit signals to the monitoring module <NUM> so that the monitoring module <NUM> monitors the patient's intravesical pressure, intrarectal pressure, external urethra sphincter electromyographic activity, and external anal sphincter electromyographic activity based on the signals received.

In this embodiment, the urethra testing device may refer to the neuroelectrophysiological monitoring apparatus <NUM> according to a first aspect of embodiments, and the rectum testing device may refer to the neuroelectrophysiological monitoring apparatus <NUM> according to a second aspect of embodiments.

In brief, with the urethra testing device configured to measure the patient's intravesical pressure and external urethra sphincter electromyographic activity, the rectum testing device configured to measure the patient's intrarectal pressure and external anal sphincter electromyographic activity, and the monitoring module <NUM> configured to monitor the intravesical pressure, the intrarectal pressure, the external urethra sphincter electromyographic activity, and the external anal sphincter electromyographic activity, the neuroelectrophysiological monitoring apparatus <NUM> according to the disclosure is enabled to simultaneously monitor the intravesical pressure, the intrarectal pressure, the external urethra sphincter electromyographic activity, and the external anal sphincter electromyographic activity, eliminating a need to deploy multiple monitoring instruments, which improves integrity of the neuroelectrophysiological monitoring apparatus <NUM>, improves operative safety, and reduces postoperative risks.

According to one embodiment of the disclosure, the neuroelectrophysiological monitoring apparatus <NUM> further comprises a first communication tube <NUM> and a first pressure transducing device. A medium may be stored in the first communication tube <NUM>, wherein the medium may refer to a liquid such as physiological saline. One end of the first communication tube <NUM> is open and set in the patient's bladder, and the opposite end of the first communication tube <NUM> extends out of the patient's body. The first communication tube <NUM> is adapted to deliver the medium, whereby the medium is delivered from the external to the patient's body, or delivered from the inside the patient's body to the external.

The first pressure transducing device has a first testing end <NUM> and a first signal output end, the first testing end <NUM> being in communication with the first communication tube <NUM> and configured to measure a pressure of the medium in the communication tube, wherein a first interconnecting catheter <NUM> is provided between the first testing end <NUM> and the first communication tube <NUM>, one end of the first interconnecting catheter <NUM> being connected to the first communication tube <NUM>, opposite end of the first interconnecting catheter <NUM> being connected to the first testing end <NUM>, so that the first testing end <NUM> communicates with the first communication tube <NUM>; and a diameter of the first interconnecting catheter <NUM> is smaller than that of the communication tube, which ensures that the first interconnecting catheter <NUM> may be fitted with a port of the first testing end <NUM>. In another embodiment of the disclosure, the first interconnecting catheter <NUM> and the first communication tube <NUM> may be unitarily formed. An on/off valve may be provided between the first interconnecting catheter <NUM> and the first communication tube <NUM>, the on/off valve allowing for selective communication between the first interconnecting catheter <NUM> and the first communication tube <NUM>.

The first signal output end is connected to the monitoring module <NUM>; the first pressure transducing device may convert the pressure of the medium to an intravesical pressure signal and transmit the intravesical pressure signal to the monitoring module <NUM> via the signal output end, so that the monitoring module <NUM> monitors the intravesical pressure of the patient based on the intravesical pressure signal.

According to one embodiment of the disclosure, the opposite end of the first communication tube <NUM> is provided with a first medium injecting device <NUM>, wherein the first medium injecting device <NUM> may be configured as a syringe. The first medium injecting device <NUM> may selectively inject a medium into the first communicating device <NUM> so that the medium may be delivered into the patient's bladder via the first communication tube <NUM>. An on/off valve may be provided between the first medium injecting device <NUM> and the first communication tube <NUM>, the on/off valve allowing for selective communication between the first medium injecting device <NUM> and the first communication tube <NUM>.

According to one embodiment of the disclosure, the neuroelectrophysiological monitoring apparatus <NUM> further comprises a fourth regulating valve <NUM>, wherein the fourth regulating valve <NUM> may be configured as a three-way regulating valve, the fourth regulating valve <NUM> comprising a first port, a second port, and a third port, the first port, the second port, and the third port being in one-to-one communication with the first communication tube <NUM>, the first interconnecting catheter <NUM>, and the first medium injecting device <NUM>, respectively. Provision of the three-way regulating valve may reduce port multiplexing and plugging operations during monitoring, which facilitates a manipulator to pre-connect the monitoring apparatus, further reducing manipulation difficulty.

When the first port communicates with the third port while the second port is shut down, the first communication tube <NUM> communicates with the first medium injecting device <NUM>, in which case the first medium injecting device <NUM> may selectively inject a medium into the first communication tube <NUM> so that the medium may be delivered into the patient's bladder via the first communication tube <NUM>; when the first port communicates with the second port while the third port is shut down, the first communication tube <NUM> communicates with the first interconnecting catheter <NUM>, in which case the pressure transducing device may convert the pressure of the medium in the first interconnecting catheter <NUM> to an intravesical pressure signal and transmit the intravesical pressure signal to the monitoring module <NUM> via the signal output end, so that the monitoring module <NUM> monitors the patient's intravesical pressure based on the intravesical pressure signal.

In another embodiment of the disclosure, the first interconnecting catheter <NUM> or the first medium injecting device <NUM> may be directly connected to the first communication tube <NUM>, thereby eliminating configuration of the fourth regulating valve <NUM>.

According to one embodiment of the disclosure, the first myoelectricity measuring member is set at an outer periphery of the first communication tube <NUM>. Furthermore, when the first communication tube <NUM> enters the patient's bladder, the first myoelectricity measuring member may directly contact a mucous membrane on a surface of the external urethra sphincter. Contact between the myoelectricity measuring member and the mucous membrane on the surface of the external urethra sphincter allows for measuring an external urethra sphincter electromyographic activity. The first myoelectricity measuring member may be integrated at the outer periphery of the first communication tube <NUM>, ensuring that the neuroelectrophysiological monitoring apparatus <NUM> measures the intravesical pressure and the external urethra sphincter electromyographic activity simultaneously, thereby realizing simultaneous measurement of two parameters, which improves operative safety and reduces postoperative risks.

According to one embodiment of the disclosure, the first myoelectricity measuring member comprises a plurality of first electromyography electrodes <NUM>, the plurality of first electromyography electrodes <NUM> being arranged at intervals at the outer periphery of the first communication tube <NUM>; the plurality of first electromyography electrodes <NUM> may record the external urethra sphincter electromyographic activity by touching the mucous membrane on the surface of the external urethra sphincter; by arranging the plurality of first electromyography electrodes <NUM> at intervals at the outer periphery of the first communication tube <NUM>, measurement accuracy and comprehensiveness may be further improved, thereby enhancing operative safety.

According to one embodiment of the disclosure, each first electromyography electrode <NUM> is configured to have a stripped shape, an extending direction of each first electromyography electrode <NUM> is consistent with an extending direction of the first communication tube <NUM>, the plurality of first electromyography electrodes <NUM> being arranged at intervals at the outer periphery of the first communication tube <NUM>, wherein a length of individual strip-shaped first electromyography electrodes <NUM> may be set between <NUM> and <NUM>, the length being preferably <NUM>; the plurality of first electromyography electrodes <NUM> are arranged at intervals, respective first electromyography electrodes <NUM> being insulated from each other, each first electromyography electrode <NUM> being configured to measure an electromyography signal of the external urethra sphincter, respectively. Specifically, the number of the strip-shaped first electromyography electrodes <NUM> may be <NUM>, <NUM>, <NUM>, <NUM>, or more; the number of the strip-shaped first electromyography electrodes <NUM> may also be odd. By arranging the plurality of strip-shaped electrodes at intervals in the extending direction of the communication tube <NUM>, at least the electromyography signals of the left and right sides of the external urethra sphincter may be monitored, respectively; in addition, the electromyography signals of the external urethra sphincter corresponding to different positions of the outer periphery of the communication tube <NUM> may also be monitored, thereby monitoring the electromyographic activities at different positions of the external urethra sphincter more accurately.

According to one embodiment of the disclosure, each first electromyography electrode <NUM> is configured to have a ring shape and disposed surrounding the communication tube, the plurality of first electromyography electrodes <NUM> being arranged at intervals in the extending direction of the first communication tube <NUM>, wherein a distribution width of the ring-shaped first electromyography electrodes <NUM> may be set between <NUM> and <NUM>, the distribution width of the ring-shaped first electromyography electrodes <NUM> being preferably <NUM>; the plurality of electromyography electrodes <NUM> are arranged at intervals, respective first electromyography electrodes <NUM> being insulated from each other, each first electromyography electrode <NUM> being configured to measure an electromyography signal of the external urethra sphincter, respectively, enabling measurement of the electromyography signals at multiple positions of the external urethra sphincter, whereby the electromyography electrodes measure the electromyography signals of the external urethra sphincter more accurately. By arranging a plurality of ring-shaped electrodes at intervals surrounding the communication tube <NUM>, it is enabled to monitor the electromyography signals of the external urethra sphincter at corresponding different depth positions in the extending direction of the communication tube <NUM>, whereby the electromyographic activities at different positions of the external urethra sphincter may be monitored more accurately.

In a neuroelectrophysiological monitoring apparatus <NUM> applicable to an adult male patient, the distance between the upper end of each electromyography electrode <NUM> and the start of the patient's bladder neck may range from <NUM> to <NUM>, the distance being preferably <NUM>. In a neuroelectrophysiological monitoring apparatus <NUM> applicable to an adult female patient, the distance between the upper end of each electromyography electrode <NUM> and the start of the patient's bladder neck may range from <NUM> to <NUM>, the distance being being preferably <NUM>. In a neuroelectrophysiological monitoring apparatus <NUM> applicable to an underage patient, the distance between the upper end of each electromyography electrode <NUM> and the start of the patient's bladder neck is smaller than the distance between the upper end of each electromyography electrode <NUM> and the start of the patient's bladder neck in the neuroelectrophysiological monitoring apparatus <NUM> applicable to an adult male patient or adult female patient.

According to one embodiment of the disclosure, the neuroelectrophysiological monitoring apparatus <NUM> further comprises a first electromyography electrode connecting harness <NUM>, the first electromyography electrode connecting harness <NUM> being adapted to electrically connect the first electromyography electrodes <NUM> and the monitoring module <NUM>. Specifically, the first electromyography electrode connecting harness <NUM> is at least partially disposed inside or on the tube wall of the first communication tube <NUM>, one end of the first electromyography electrode connecting harness <NUM> being connected to the plurality of first electromyography electrodes <NUM>, the opposite end of the first electromyography electrode connecting harness <NUM> being connected to the monitoring module <NUM>; the plurality of first electromyography electrodes <NUM> may be separately and independently connected to the monitoring module <NUM> via the first electromyography electrode connecting harness <NUM> so as to transmit the measured first electromyography signals to the monitoring module <NUM> via the first electromyography electrode connecting harness <NUM>.

According to one embodiment of the disclosure, the neuroelectrophysiological monitoring apparatus <NUM> further comprises a first communication tube <NUM> anchoring device, the first communication tube <NUM> anchoring device being disposed at one end of the first communication tube <NUM>, wherein the first communication tube <NUM> anchoring device is configured as a rubber element, and the first communication tube <NUM> anchoring device is selectively deformed to be tensioned in the patient's bladder. Specifically, the first communication tube <NUM> anchoring device has a contracted state and an expanded state. When the first communication tube <NUM> anchoring device is in the contracted state, the first communication tube <NUM> may enter or be removed out of the patient's bladder, so that when the first communication tube <NUM> anchoring device is in the expanded state, the first communication tube <NUM> is anchored in the patient's bladder.

An expandable cavity is formed inside the first communication tube <NUM> anchoring device, the expandable cavity being selectively expanded or contracted. The expandable cavity communicates with a syringe connection tube <NUM>, the syringe connection tube <NUM> being adapted to inject a medium in the expandable cavity to control deformation of the communication tube anchoring device <NUM>, wherein the medium may refer to a liquid or a gas; the syringe connection tube <NUM> allows for expansion of the expandable cavity by injecting the medium into the expandable cavity, so that the communication tube anchoring device <NUM> securely contacts the inside lining of the patient's bladder.

According to one embodiment of the disclosure, the syringe connection tube <NUM> is at least partially received in the communication tube, which reduces footprint of the syringe connection tube <NUM> and improves integrity of the syringe connection tube <NUM>.

According to one embodiment of the disclosure, the neuroelectrophyiological monitoring apparatus <NUM> further comprises a urethra catheter <NUM>, one end of the urethra catheter <NUM> being selectively conducted with the communication tube, opposite end of the urethra catheter <NUM> being provided with a urine collection bag <NUM>, the urine collection bag <NUM> being configured to collect residual urine or medium in the patient's bladder. Specifically, the neuroelectrophysiological monitoring apparatus <NUM> further comprises an intravesical liquid outlet <NUM>, the intravesical liquid outlet <NUM> being adapted to drain the residual urine or medium out of the bladder; the residual urine or medium in the bladder flows into the urethra catheter <NUM> along the communication tube and is then delivered into the urine collection bag <NUM> via the urethra catheter <NUM> till the operation ends.

According to one embodiment of the disclosure, the neuroelectrophysiological monitoring apparatus <NUM> further comprises a fifth regulating valve <NUM>, the fifth regulating valve <NUM> comprising a fourth port, a fifth port, and a sixth port, the fourth port, the fifth port, and the sixth port being set in one-to-one correspondence with a front segment of the first communication tube <NUM>, a rear segment of the first communication tube <NUM>, and the urethra catheter <NUM>. Provision of the three-way regulating valve may reduce port multiplexing and plugging operations during monitoring, which facilitates a manipulator to pre-connect the monitoring apparatus, further reducing manipulation difficulty.

When the fourth port and the fifth port communicate while the sixth port is shut down, the front segment of the first communication tube <NUM> is conducted with the rear segment of the first communication tube <NUM>, in which case the first medium injecting device <NUM> may inject the medium into the patient's bladder to facilitate monitoring of the patient's intravesical pressure. When the fourth port communicates with the sixth port while the fifth port is shut down, the front segment of the first communication tube <NUM> is conducted with the urethra catheter <NUM>, in which case the residual urine or medium in the patient's bladder flows into the urethra catheter <NUM> along the first communication tube <NUM> and is then delivered into the urine collection bag <NUM> via the urethra catheter <NUM> till the operation ends.

In the neuroelectrophysiological monitoring apparatus <NUM> according to the disclosure, the rectal pressure measuring member comprises a second communication tube <NUM>, an intrarectal expandable balloon <NUM>, and a second pressure transducing device. A medium may be stored in the second communication tube <NUM>, wherein the medium may be a liquid such as physiological saline. One end of the second communication tube <NUM> is disposed in the patient's rectum, and the opposite end of the second communication tube <NUM> extends out of the patient's body. The second communication tube <NUM> is adapted to deliver the medium, whereby the medium is delivered from the external into the patient's body, or delivered from inside the patient's body to the outside.

The intrarectal expandable balloon <NUM> is disposed at one end of the second communication tube <NUM>, and the intrarectal expandable balloon <NUM> may communicate with the second communication tube <NUM>, wherein the intrarectal expandable balloon <NUM> may be configured as a rubber element. The intrarectal expandable balloon <NUM> is selectively deformable to be tensioned in the patient's rectum. Specifically, the intrarectal expandable balloon <NUM> has a contracted state and an expanded state. when the intrarectal expandable balloon <NUM> is in the contracted state, the second communication tube <NUM> may enter or be removed out of the patient's rectum; when the intrarectal expandable balloon <NUM> is in the expanded state, the outer peripheral wall of the intrarectal expandable balloon <NUM> abuts against the inside lining of the patient's rectum, whereby the second communication tube <NUM> is anchored in the patient's rectum; when the inside lining of the rectum is contracted, the intrarectal expandable balloon <NUM> is deformed as the pressure changes, whereby the intrarectal pressure signals are conducted.

The second pressure transducing device has a second testing end <NUM> and a second signal output end, the second testing end <NUM> communicating with the second communication tube <NUM>, the second testing end <NUM> being configured to measure a pressure of the medium in the second communication tube <NUM>, wherein a second interconnecting catheter <NUM> is provided between the second testing end <NUM> and the second communication tube <NUM>, one end of the second interconnecting catheter <NUM> being connected to the second communication tube <NUM>, the opposite end of the second interconnecting catheter <NUM> being connected to the second testing end <NUM>, whereby the second testing end <NUM> communicates with the second communication tube <NUM>; a diameter of the second interconnecting catheter <NUM> is smaller than that of the second communication tube <NUM>, ensuring that the second interconnecting catheter <NUM> may fit with the port of the second testing end <NUM>. In another embodiment of the disclosure, the second interconnecting catheter <NUM> and the second communication tube <NUM> may be unitarily configured. An on/off valve may be set between the second interconnecting catheter <NUM> and the second communication tube <NUM>; provision of the on/off valve enables selective communication between the second interconnecting catheter <NUM> and the second communication tube <NUM>.

According to one embodiment of the disclosure, the opposite end of the second communication tube <NUM> is provided with a second medium injecting device <NUM>, wherein the second medium injecting device <NUM> may be configured as a syringe. The second medium injecting device <NUM> selectively injects the medium into the second communication tube <NUM>, so that the medium may flow into the intrarectal expandable balloon <NUM> via the second communicating tube <NUM>. An on/off valve may be provided between the second medium injecting device <NUM> and the second communication tube <NUM>; provision of the on/off valve enables selective communication between the second medium injecting device <NUM> and the second communication tube <NUM>.

According to one embodiment of the disclosure, the neuroelectrophysiological monitoring apparatus <NUM> further comprises a three-way tube, wherein the three-way tube may be configured as a sixth regulating valve <NUM>, the sixth regulating valve <NUM> having a first interface, a second interface, and a third interface which selectively communicate with each other, wherein the first interface is connected to the opposite end of the second communication tube <NUM>, and the second interface is connected to the second testing end <NUM> of the second pressure transducing device. Here, it is noted that connection of the second interface to the second interconnecting catheter <NUM> further realizes connection of the second interface to the second testing end <NUM> of the second pressure transducing device, the third interface being connected to the second medium injecting device <NUM>. Provision of the the three-way regulating valve may reduce port multiplexing and plugging operations during monitoring, which facilitates a manipulator to pre-connect the monitoring apparatus, further reducing the manipulation difficulty.

Specifically, when the first interface communicates with the third interface while the second interface is shut down, the second communication tube <NUM> communicates with the second medium injecting device <NUM>, in which case the second medium injecting device <NUM> may selectively inject the medium into the second communication tube <NUM>, so that the medium may be delivered into the intrarectal expandable balloon <NUM> via the second communication tube <NUM>; when the first interface communicates with the second interface while the third interface is shut down, the second communication tube <NUM> communicates with the second interconnecting catheter <NUM>, in which case the pressure transducing device may convert the pressure of the medium in the second interconnecting catheter <NUM> into an intrarectal pressure signal and transmit the intrarectal pressure signal to the monitoring module <NUM> via the signal output end, so that the monitoring module <NUM> monitors the patient's intrarectal pressure based on the intrarectal pressure signal.

According to one embodiment of the disclosure, the second myoelectricity measuring member is disposed at an outer periphery of the second communication tube <NUM>; furthermore, when the second communication tube <NUM> enters the patient's rectum, the second myoelectricity measuring member may directly contact the mucous membrane on the surface of the external anal sphincter; contact between the myoelectricity measuring member and the mucous membrane on the surface of the external anal sphincter allows for measuring a electromyographic activity of the external anal sphincter; the second myoelectricity measuring member may be integrated at the outer periphery of the second communication tube <NUM>, ensuring that the neuroelectrophysiological monitoring apparatus <NUM> simultaneously monitors the intrarectal pressure and the external anal sphincter electromyographic activity, thereby realizing simultaneous measurement of two parameters, with improved operative safety and reduced postoperative risks.

According to one embodiment of the disclosure, the second myoelectricity measuring member comprises a plurality of second electromyography electrodes <NUM>, the plurality of second electromyography electrodes <NUM> being arranged at intervals at the outer periphery of the second communication tube <NUM>; the plurality of second electromyography electrodes <NUM> may obtain external anal sphincter electromyographic activities by touching the external anal sphincter; by arranging the plurality of second electromyography electrodes <NUM> at intervals at the outer periphery of the second communication tube <NUM>, measurement accuracy and comprehensiveness may be further improved, thereby enhancing operative safety.

According to one embodiment of the disclosure, each second electromyography electrode <NUM> is configured to have a stripped shape, an extending direction of each second electromyography electrode <NUM> being consistent with an extending direction of the second communication tube <NUM>, the plurality of second electromyography electrodes <NUM> being arranged at intervals along the outer periphery of the second communication tube <NUM>, wherein the plurality of second electromyography electrodes <NUM> are arranged at intervals, respective second electromyography electrodes <NUM> being insulated from each other, each second electromyography electrode <NUM> being configured to measure an electromyography signal of the external anal sphincter, respectively. Specifically, the number of the strip-shaped second electromyography electrodes <NUM> may be <NUM>, <NUM>, <NUM>, <NUM>, or more; the number of the strip-shaped second electromyography electrodes <NUM> may also be odd. By arranging the plurality of strip-shaped electrodes at intervals in the extending direction of the communication tube <NUM>, at least the electromyography signals of the left and right sides of the external anal sphincter may be monitored, respectively; and the electromyography signals of the external anal sphincter corresponding to different positions in the circumferential direction of the communication tube <NUM> may also be monitored, thereby realizing more accurate monitoring of the electromyographic activities of different positions of the external anal sphincter.

According to one embodiment of the disclosure, each second electromyography electrode <NUM> is configured to have a ring shape and disposed surrounding the communication tube, the plurality of second electromyography electrodes <NUM> being arranged at intervals in the extending direction of the second communication tube <NUM>, wherein the plurality of second electromyography electrodes <NUM> are arranged at intervals, respective second electromyography electrodes <NUM> being insulated from each other, each second electromyography electrode <NUM> being configured to measure an electromyography signal of the external anal sphincter, respectively, enabling measurement of the electromyography signals at multiple positions of the external anal sphincter, whereby the electromyography electrodes measure the electromyography signals of the external anal sphincter more accurately. By providing the plurality of ring-shaped electrodes at intervals surrounding the communication tube <NUM>, it is enabled to monitor the electromyography signals of the external anal sphincter corresponding to different depth positions in the extending direction of the communication tube <NUM>, so that the electromyographic activities of different positions of the external anal sphincter are measured more accurately.

According to one embodiment of the disclosure, the neuroelectrophysiological monitoring apparatus <NUM> further comprises a second electromyography electrode connecting harness <NUM>, the second electromyography electrode connecting harness <NUM> being adapted to electrically connect the second electromyography electrode <NUM> and the monitoring module <NUM>, wherein the second electromyography electrode connecting harness <NUM> is at least partially disposed inside or on the tube wall of the second communication tube <NUM>, one end of the second electromyography electrode connecting harness <NUM> being connected to the plurality of second electromyography electrodes <NUM>, opposite end of the second electromyography electrode connecting harness <NUM> being connected to the monitoring module <NUM>; the plurality of second electromyography electrodes <NUM> may be connected separately and independently to the monitoring module <NUM> via the second electromyography electrode connecting harness <NUM> so as to transmit the measured second electromyography signals to the monitoring module <NUM> via the second electromyography electrode connecting harness <NUM>.

According to one embodiment of the disclosure, a plurality of scale markers arranged at intervals in the extending direction of the first communication tube <NUM> are provided at the outer peripheral wall of the first communication tube <NUM>, the scale markers being adapted to adjust the depth of the first communication tube <NUM> inserted into the patient's urethra, which ensures that the first communication tube <NUM> is always in a safe depth, thereby improving operative safety and reducing postoperative risks. In addition, a plurality of scale markers arranged at intervals in the extending direction of the second communication tube <NUM> are provided on the outer peripheral wall of the second communication tube <NUM>, the scale markers being adapted to adjust the depth of the second communication tube <NUM> inserted into the patient's anus, which ensures that the second communication tube <NUM> is always in a safe depth, thereby improving operative safety and reducing postoperative risks.

In the neuroelectrophysiological monitoring apparatus <NUM> according to the disclosure, the urethra testing device is configured to measure the intravesical pressure and external urethra sphincter electromyographic activity, and the rectum testing device is configured to measure the intrarectal pressure and the external anal sphincter electromyographic activity. Therefore, the neuroelectrophysiological monitoring apparatus <NUM> may simultaneously measure a patient's intravesical pressure, intrarectal pressure, external urethra sphincter electromyographic activity, and external anal sphincter electromyographic activity simultaneously during a surgical procedure; moreover, the neuroelectrophysiological apparatus <NUM> integrates the urethra testing device and the rectum testing device in the same apparatus, eliminating a need of deploying multiple monitoring instruments during a surgical procedure, which improves integrity of the neuroelectrophysiological monitoring apparatus <NUM>, improves operative safety, and reduces postoperative risks.

In the description of the disclosure, it is noted that the orientational or positional relationships indicated by terms such as "center," "longitudinal," "transverse," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "peripheral" refer to those orientational or positional relationships illustrated in the drawings, which are only intended to facilitate describing the disclosure and simplify the description, rather than indicating or implying that the referred to devices or elements must have such specific orientations, or be configured and operated with such specific orientations; therefore, they should not be construed as limitations to the disclosure.

In the description of the disclosure, the terms "first feature" and "second feature" may include one or more such features.

In the description of the disclosure, the term "plurality" means two or more.

In the description of the disclosure, a first feature being "above" or "below" a second feature may refer to direct contact between the first feature and the second feature, or an indirect contact between the first feature and the second feature via an intermediate feature.

In the description of the disclosure, a first feature being "above," "over," or "on top of" a second feature refers to the first feature being directly perpendicular to or not in direct vertical line with the second feature, or only indicates that a horizontal level of the first feature is higher than that of the second feature.

Claim 1:
A neuroelectrophysiological monitoring apparatus (<NUM>), comprising:
a urethra testing device, the urethra testing device being provided with a bladder pressure measuring member and a first myoelectricity measuring member, the bladder pressure measuring member configured for being set in a patient's bladder and adapted to measure the patient's intravesical pressure, the first myoelectricity measuring member being adapted to contact an external urethra sphincter to measure an external urethra sphincter electromyographic activity;
a rectum testing device, the rectum testing device being provided with a rectal pressure measuring member and a second myoelectricity measuring member, the rectal pressure measuring member configured for being set in the patient's rectum and adapted to measure the patient's intrarectal pressure, the second myoelectricity measuring member being adapted to contact an external anal sphincter to measure an external anal sphincter electromyographic activity; and
a monitoring module (<NUM>), the monitoring module (<NUM>) being electrically connected to the bladder pressure measuring member, the first myoelectricity measuring member, the rectal pressure measuring member, and the second myoelectricity measuring member, respectively so as to monitor an electrophysiological activity of pudendal nerve.