Multifunctional nephrostomy tube device

Abstract

The invention discloses a multifunctional nephrostomy tube device, which relates to the technical field of medical instruments and comprises a nephrostomy tube handle, a main tube, a flushing tube and a balloon tube penetrate through the internal space of the nephrostomy tube handle; the main channel electromagnetic valve is fixedly mounted on the main pipe; the flushing channel electromagnetic valve is fixedly mounted on the flushing pipe; the control module is used for judging whether urination of the nephrostomy tube is normal or not according to the pressure, collected by the pressure sensor, in the renal pelvis and / or the urine flow, collected by the flow sensor, in the main channel after the insertion end of the nephrostomy tube device is inserted into the kidney, and judging whether urination of the nephrostomy tube is abnormal or not when it is judged that urination is abnormal. And further determining an abnormal type according to the change rate of the pressure in the renal pelvis and / or the urine flow in the main channel, so as to carry out automatic processing according to the abnormal type.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a multifunctional nephrostomy tube device. Background Technology

[0002] Hydronephrosis caused by upper urinary tract obstruction in adults is a common urinary system disease. As the hydronephrosis worsens and the renal pelvis and calyces dilate, patients will experience renal parenchymal atrophy and varying degrees of renal insufficiency. Therefore, maintaining a low-pressure state within the kidneys and monitoring renal pressure are extremely important. In some patients with severe obstruction who are temporarily unable to undergo surgery, a percutaneous nephrostomy tube is placed to quickly relieve acute obstruction and protect renal function. These patients require continued placement of the nephrostomy tube during and after the procedure to maintain patency of the affected urinary tract. Currently, there is no nephrostomy tube for real-time monitoring of renal pressure before the procedure. Intraoperative perfusion pressure is mostly controlled by adjusting the perfusion pump and combining it with the surgeon's experience. The actual pressure changes within the kidney cannot be monitored and precisely controlled in real time. High pressure can lead to renal damage, renal fluid reflux into the blood, and even sepsis, seriously threatening the patient's life. In addition, renal pelvis pressure is a safe and feasible test after upper urinary tract repair surgery. It can assess the recovery after upper urinary tract reconstruction and determine the timing of nephrostomy tube removal (e.g., pressure ≤22cmH2O is the safe threshold and imaging patency, objectively assessing the recovery of drainage function after ureter repair). Summary of the Invention

[0003] To address the aforementioned technical problems, this invention provides a multifunctional nephrostomy tube device.

[0004] This invention provides a multifunctional nephrostomy tube device, comprising:

[0005] The main body of the nephrostomy tube is provided with a main channel, an irrigation channel and a balloon channel;

[0006] A balloon is fixedly mounted on the outer wall near the insertion end of the nephrostomy tube body and communicates with one end of the balloon channel;

[0007] Multiple interfaces, including a main interface, a flushing interface, and a balloon interface, wherein the main channel, the flushing channel, and the balloon channel branch at the tail end of the nephrostomy tube body, forming in sequence a main tube for connecting the main channel and the main interface, a flushing tube for connecting the flushing channel and the flushing interface, and a balloon tube for connecting the balloon channel and the balloon interface;

[0008] A pressure sensor is embedded in the front end of the main channel near the insertion end of the nephrostomy tube body to collect intrarenal pelvic pressure.

[0009] A flow sensor is embedded in the main channel near the tail end of the nephrostomy tube to collect urine flow in the main channel.

[0010] A solenoid valve is embedded in the front end of the flushing channel near the insertion end of the nephrostomy tube body;

[0011] The multifunctional nephrostomy tube device is characterized in that it further includes:

[0012] The handle of the nephrostomy tube is internally permeated by the main tube, flushing tube, and balloon tube.

[0013] The main channel solenoid valve is fixedly installed on the main pipe;

[0014] A solenoid valve for the flushing channel is fixedly installed on the flushing pipe;

[0015] The control module is used to determine whether urination through the nephrostomy tube is normal after the insertion end of the nephrostomy tube device is inserted into the kidney, based on the pressure in the renal pelvis collected by the pressure sensor and / or the urine flow in the main channel collected by the flow sensor. If urination through the nephrostomy tube is found to be abnormal, the module further determines the type of abnormality based on the rate of change of pressure in the renal pelvis and / or the urine flow in the main channel, so as to automatically process the abnormality.

[0016] Preferably, the multifunctional nephrostomy tube device further includes:

[0017] Drug delivery interface, used to inject drugs or contrast agents through the drug delivery interface;

[0018] The administration tube has one end connected to the administration port and the other end connected to the flushing tube;

[0019] A drug delivery solenoid valve is fixedly installed on the drug delivery tube;

[0020] Accordingly, the control module is also used to, during the period when the nephrostomy tube is judged to be urinating normally, if it receives a drug administration instruction sent by the management client, control the main channel solenoid valve to close, and at the same time control the drug administration solenoid valve and the solenoid valve to open, so as to inject the quantitative drug or quantitative contrast agent in the drug syringe or drug injection pump connected to the drug administration interface into the renal pelvis through the flushing channel. After the quantitative drug or quantitative contrast agent is injected into the renal pelvis, control the drug administration solenoid valve and the solenoid valve to close, and start timing. After the timing reaches the preset time, control the main channel solenoid valve to open, so as to discharge the quantitative drug or quantitative contrast agent through the main channel.

[0021] Preferably, the control module is specifically used to compare the multiple intrarenal pelvic pressures collected in real time by the pressure sensor within each preset time period with a preset normal intrarenal pelvic pressure range, and at the same time compare the total urine flow in the main channel collected by the flow sensor within each preset time period with a preset urine flow threshold. If the multiple intrarenal pelvic pressures within the current preset time period are all within the normal intrarenal pelvic pressure range, and / or the total urine flow in the main channel within the current preset time period is greater than the preset urine flow threshold, then it is determined that the nephrostomy tube is urinating normally within the current preset time period.

[0022] Preferably, the control module is specifically used to determine that the nephrostomy tube is urinating abnormally during the current preset time period if at least one of the multiple intrarenal pelvic pressures within the current preset time period is not within the normal intrarenal pelvic pressure range, and / or the total urine flow in the main channel within the current preset time period is not greater than a preset urine flow threshold.

[0023] Preferably, the control module is specifically configured to, when determining that there is abnormal urination through the nephrostomy tube within a current preset time period, determine the abnormality type as partial blockage of the main channel if the rate of pressure change within the nephrostomy tube is greater than a preset first pressure change rate threshold and the total urine flow is less than a preset first urine flow threshold within the current preset time period; determine the abnormality type as complete blockage of the main channel if the rate of pressure change within the nephrostomy tube is greater than a preset second pressure change rate threshold or the total urine flow is zero within the current preset time period; and determine the abnormality type as nephrostomy tube dislodgement if at least a predetermined number of renal pelvic pressures within the nephrostomy tube are less than a preset low-pressure threshold or the urine flow is zero within the current preset time period.

[0024] Preferably, the multifunctional nephrostomy tube device further includes:

[0025] An alarm module, encapsulated in the handle of the nephrostomy tube, includes audible and / or visual alarm elements;

[0026] The display module, encapsulated in the handle of the nephrostomy tube, can display the current intrarenal pelvis pressure and / or urine flow rate in real time, as well as the intrarenal pelvis pressure curve and total urine flow rate of the nephrostomy tube over several recent preset time periods.

[0027] Preferably, the control module is further configured to control the alarm module to sound an alarm when the abnormality type is determined to be partial blockage of the main channel, and simultaneously control the opening of the flushing channel solenoid valve and the solenoid valve within a preset partial blockage flushing time, so as to inject saline solution from the saline syringe or saline injection pump connected to the flushing interface into the main channel for flushing.

[0028] Preferably, the control module is further configured to, when the abnormality type is determined to be a complete blockage of the main channel, control the alarm module to sound an alarm, and simultaneously, within a preset complete blockage flushing time, control the flushing channel solenoid valve and solenoid valve to repeatedly open and close at a set frequency, so as to inject saline from the saline syringe or saline injection pump connected to the flushing interface into the main channel for repeated flushing. After the preset complete blockage flushing time is reached, the module further determines whether the nephrostomy tube urination is abnormal by measuring the rate of change of renal pelvis pressure and / or the urine flow rate in the main channel within a set detection time. If the nephrostomy tube urination is determined to be normal, the alarm module is deactivated, and the channel solenoid valve and solenoid valve are closed. If the nephrostomy tube urination is determined to be continuously abnormal, the above steps are repeated, and the abnormality type of complete blockage of the main channel is reported to the management client.

[0029] Preferably, the control module is further configured to control the alarm module to sound an alarm and report the abnormality of the nephrostomy tube dislodgement to the management client when the abnormality type is determined to be nephrostomy tube dislodgement.

[0030] Preferably, the multifunctional nephrostomy tube device further includes:

[0031] The balloon channel solenoid valve is fixedly installed on the balloon tube;

[0032] Accordingly, the control module is also configured to control the balloon channel solenoid valve to open when a nephrostomy tube removal command is received from the management client, so as to remove the insertion end of the nephrostomy tube device from the kidney.

[0033] The beneficial effects of this invention are that, after the insertion end of the nephrostomy tube device is inserted into the kidney, the normality of urination through the nephrostomy tube is determined based on the pressure in the renal pelvis collected by the pressure sensor and / or the urine flow rate in the main channel collected by the flow sensor. Furthermore, when abnormal urination is detected, the type of abnormality is further determined based on the rate of change of pressure in the renal pelvis and / or the urine flow rate in the main channel, allowing for automatic processing based on the type of abnormality. By combining urine flow information with renal pelvis pressure, this invention improves the accuracy of judgment, provides a basis for blockage warning, reduces the risk of infection, basically meets the clinical needs for differentiated treatment of different types of abnormalities, improves the efficiency of abnormality treatment, reduces reliance on management personnel, and avoids problems such as renal function damage, renal fluid reflux into the blood, or even sepsis caused by high actual intrarenal pressure. Attached Figure Description

[0034] Figure 1 This is an overall schematic diagram of a multifunctional nephrostomy tube device provided in Embodiment 1 of the present invention;

[0035] Figure 2 This is a cross-sectional view of a multifunctional nephrostomy tube device provided in Embodiment 1 of the present invention;

[0036] Figure 3 This is a schematic diagram of the control structure provided in Embodiment 1 of the present invention;

[0037] Figure 4 This is an overall schematic diagram of a multifunctional nephrostomy tube device provided in Embodiment 2 of the present invention;

[0038] Figure 5 This is a cross-sectional view of a multifunctional nephrostomy tube device provided in Embodiment 2 of the present invention;

[0039] Figure 6 This is a schematic diagram of the control structure provided in Embodiment 2 of the present invention.

[0040] 1. Nephrostomy tube body; 11. Insertion end; 12. Tail end; 13. Main channel; 14. Balloon channel; 15. Flushing channel; 2. Flow sensor; 3. Balloon; 41. Balloon channel solenoid valve; 42. Main channel solenoid valve; 43. Flushing channel solenoid valve; 44. Drug delivery solenoid valve; 51. Balloon interface; 52. Main interface; 53. Flushing interface; 54. Drug delivery interface; 6. Solenoid valve; 7. Pressure sensor; 8. Nephrostomy tube handle. Detailed Implementation

[0041] It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention. In the following description, suffixes such as "module," "part," or "unit" used to denote elements are used only for the purpose of illustrative purposes and have no inherent meaning. Therefore, "module," "part," or "unit" may be used interchangeably.

[0042] Example 1

[0043] like Figures 1-3 As shown, Embodiment 1 of the present invention provides a multifunctional nephrostomy tube device, comprising:

[0044] The nephrostomy tube body 1 has a main channel 13, an irrigation channel 15 and a balloon channel 14 inside; wherein, the nephrostomy tube body 1 is mostly made of medical grade silicone or polyurethane material, which has both flexibility and pressure resistance, reducing the stimulation of tissues by long-term indwelling.

[0045] The balloon 3 is fixedly disposed on the outer wall near the insertion end of the nephrostomy tube body 1 and communicates with one end of the balloon channel; furthermore, the balloon 3 of the nephrostomy tube device is made of an elastic material, such as polyvinyl chloride (PVC) or made of a stretchable or compressible film, and water or gas can be injected into the balloon 3;

[0046] Multiple interfaces, including a main interface 52, a flushing interface 53 and a balloon interface 51, wherein the main channel 13, the flushing channel 15 and the balloon channel 14 branch at the tail end of the nephrostomy tube body 1, forming in sequence a main tube for connecting the main channel and the main interface 52, a flushing tube for connecting the flushing channel and the flushing interface 53 and a balloon tube for connecting the balloon channel and the balloon interface 51.

[0047] A pressure sensor 7 is embedded at the front end of the main channel near the insertion end of the nephrostomy tube body 1 to collect intrarenal pelvic pressure. Furthermore, after the nephrostomy tube is inserted into the kidney, the pressure sensor 7 measures the intrarenal pelvic pressure in real time and transmits the pressure data to the control module, which then wirelessly transmits it to an external terminal. This pressure sensor can be a miniature MEMS sensor, such as a MEMS piezoresistive sensor, with a surface covered by a biocompatible membrane such as PDMS to avoid irritating the urinary tract mucosa.

[0048] The flow sensor 2 is embedded in the main channel near the tail end of the nephrostomy tube body 1 to collect the urine flow rate in the main channel; in this invention, the flow sensor 2 can be a thermal flow sensor.

[0049] Solenoid valve 6 is embedded in the front end of the flushing channel near the insertion end of the nephrostomy tube body 1. It is a normally closed solenoid valve, used to close the connection with the flushing channel when the pressure sensor collects the pressure in the renal pelvis to ensure the accuracy of the collected values, and to ensure that the drug remains in the renal pelvis when the drug is injected into the renal pelvis. When the control module controls it to be energized, this solenoid valve is in the open state, so that the saline or drug in the flushing channel is injected into the renal pelvis or the main channel.

[0050] The multifunctional nephrostomy tube device also includes:

[0051] The nephrostomy tube handle 8 has its internal space penetrated by the main tube, flushing tube, and balloon tube;

[0052] The main channel solenoid valve 42 is fixedly installed on the main pipe; when the control module controls it to be energized, the valve opens, allowing urine in the main channel to flow into the urine bag connected to the main interface; when the control module controls it to be de-energized, the valve closes.

[0053] The flushing channel solenoid valve 43 is fixedly installed on the flushing pipe; when the control module controls it to be energized, the valve opens; when the control module controls it to be de-energized, the valve closes.

[0054] The control module is used to determine whether urination through the nephrostomy tube is normal after the insertion end of the nephrostomy tube device is inserted into the kidney, based on the pressure in the renal pelvis collected by the pressure sensor 7 and / or the urine flow in the main channel collected by the flow sensor 2. If urination through the nephrostomy tube is found to be abnormal, the module further determines the type of abnormality based on the rate of change of pressure in the renal pelvis and / or the urine flow in the main channel, so as to automatically process the abnormality.

[0055] In a specific embodiment of the present invention, the control module is specifically used to compare the multiple intrarenal pelvic pressures collected in real time by the pressure sensor within each preset time period with a preset normal intrarenal pelvic pressure range, and at the same time compare the total urine flow in the main channel collected by the flow sensor within each preset time period with a preset urine flow threshold. If the multiple intrarenal pelvic pressures within the current preset time period are all within the normal intrarenal pelvic pressure range, and / or the total urine flow in the main channel within the current preset time period is greater than the preset urine flow threshold, then it is determined that the nephrostomy tube is urinating normally within the current preset time period.

[0056] In a specific embodiment of the present invention, the control module is specifically used to determine that the nephrostomy tube is urinating abnormally during the current preset time period if at least one of the multiple intrarenal pelvic pressures within the current preset time period is not within the normal intrarenal pelvic pressure range, and / or the total urine flow in the main channel within the current preset time period is not greater than a preset urine flow threshold.

[0057] In a specific embodiment of the present invention, the control module is specifically configured to, when determining that there is abnormal urination in the nephrostomy tube during a current preset time period, determine the abnormality type as partial blockage of the main channel if the rate of pressure change in the nephrostomy tube during the current preset time period is greater than a preset first pressure change rate threshold and the total urine flow is less than a preset first urine flow threshold; if the rate of pressure change in the nephrostomy tube during the current preset time period is greater than a preset second pressure change rate threshold, or the total urine flow is zero, determine the abnormality type as complete blockage of the main channel; if at least a predetermined number of renal pelvic pressures in the nephrostomy tube during the current preset time period are less than a preset low-pressure threshold, or the urine flow is zero during the current preset time period, determine the abnormality type as nephrostomy tube dislodgement.

[0058] In one specific embodiment of the present invention, the multifunctional nephrostomy tube device further includes:

[0059] An alarm module, encapsulated at point 8 of the nephrostomy tube handle, includes audible and / or visual alarm elements, such as LED indicator lights (red / yellow / green) and / or a buzzer, for local alarm functionality. Specifically, different colored LED indicator lights indicate different abnormality types: red indicates complete blockage of the main channel, yellow indicates partial blockage, and green indicates nephrostomy tube dislodgement. The buzzer distinguishes between different abnormality types using varying volume and frequency.

[0060] The display module, encapsulated at the handle of the nephrostomy tube, can display the current intrarenal pelvis pressure and / or urine flow rate in real time, as well as the intrarenal pelvis pressure curve and total urine flow rate of the nephrostomy tube over several recent preset time periods.

[0061] In a specific embodiment of the present invention, the control module is further configured to control the alarm module to sound an alarm when the abnormality type is determined to be partial blockage of the main channel, and at the same time, control the opening of the flushing channel solenoid valve 43 and solenoid valve 6 within a preset partial blockage flushing time, so as to inject the saline solution in the saline syringe or saline injection pump connected to the flushing interface into the main channel for flushing.

[0062] In a specific embodiment of the present invention, the control module is further configured to, when the abnormality type is determined to be a complete blockage of the main channel, control the alarm module to sound an alarm, and simultaneously, within a preset complete blockage flushing time, control the flushing channel solenoid valves 43 and 6 to repeatedly open and close at a set frequency, so as to inject saline from the saline syringe or saline injection pump connected to the flushing interface into the main channel for repeated flushing. After the preset complete blockage flushing time is reached, the nephrostomy tube urination is further judged by the rate of change of renal pelvis pressure and / or the urine flow rate in the main channel within a set detection time. If the nephrostomy tube urination is judged to be normal, the alarm module is deactivated, and the flushing channel solenoid valves 43 and 6 are closed. If the nephrostomy tube urination is judged to be continuously abnormal, the above steps are repeated, and the abnormality type of complete blockage of the main channel is reported to the management client.

[0063] It should be noted that the preset normal renal pelvis pressure range, preset urine flow threshold, preset first pressure change rate threshold, preset first urine flow threshold, preset second pressure change rate threshold, preset quantity, preset low pressure threshold, and current preset time period, etc., in this invention can all be set according to the basic information of different patients, including age, gender, physical condition including various test results, etc., or can be set by medical management personnel.

[0064] In one specific embodiment of the present invention, the control module is further configured to control the alarm module to sound an alarm and report the abnormal type of nephrostomy tube dislodgement to the management client when the abnormal type is determined to be nephrostomy tube dislodgement.

[0065] The multifunctional nephrostomy tube device also includes: a balloon channel solenoid valve 41, which is fixedly installed on the balloon tube;

[0066] Accordingly, the control module is also configured to control the balloon channel solenoid valve 41 to open when a nephrostomy tube removal command is received from the management client, so as to remove the insertion end of the nephrostomy tube device from the kidney.

[0067] Specifically, the control module is also used to control the balloon channel solenoid valve 41 to open so that gas / liquid in the syringe or aspiration pump / liquid pump connected to the balloon interface 51 can be injected into the balloon through the balloon channel. After the balloon expands to fix the nephrostomy tube, the balloon channel solenoid valve 41 is controlled to close. The balloon channel solenoid valve 41 is also controlled to open so that after the gas / liquid is drained by the syringe or aspiration pump / liquid pump, the balloon retracts to remove the nephrostomy tube body 1.

[0068] The control module is also used to control the main channel solenoid valve 42 to close and the flushing channel solenoid valve 43 and solenoid valve to open when a drug injector or drug infusion pump connected to the flushing interface is connected to the drug injector or drug infusion pump connected to the drug injection interface is normal, and to inject the quantitative drug or quantitative contrast agent in the drug injector or drug infusion pump connected to the drug injection interface into the renal pelvis through the flushing channel after the quantitative drug or quantitative contrast agent is injected into the renal pelvis. After the quantitative drug or quantitative contrast agent is injected into the renal pelvis, the control module controls the flushing channel solenoid valve and solenoid valve to close and start timing. After the timing reaches the preset time, the control module controls the main channel solenoid valve 42 to open so that the quantitative drug or quantitative contrast agent is discharged through the main channel.

[0069] Example 2

[0070] like Figures 4-6 As shown, Embodiment 2 of the present invention provides a multifunctional nephrostomy tube device, comprising:

[0071] The nephrostomy tube body 1 has a main channel 13, an irrigation channel 15 and a balloon channel 14 inside; wherein, the nephrostomy tube body 1 is mostly made of medical grade silicone or polyurethane material, which has both flexibility and pressure resistance, reducing the stimulation of tissues by long-term indwelling.

[0072] The balloon 3 is fixedly disposed on the outer wall near the insertion end of the nephrostomy tube body 1 and communicates with one end of the balloon channel; furthermore, the balloon 3 of the nephrostomy tube device is made of an elastic material, such as polyvinyl chloride (PVC) or made of a stretchable or compressible film, and water or gas can be injected into the balloon 3;

[0073] Multiple interfaces are provided, including a main interface 52, a flushing interface 53, a drug delivery interface 54 for injecting drugs or contrast agents, and a balloon interface 51. The main channel 13, the flushing channel 15, and the balloon channel 14 branch at the tail end of the nephrostomy tube body 1, forming a main tube for connecting the main channel and the main interface 52, a flushing tube for connecting the flushing channel and the flushing interface 53, and a balloon tube for connecting the balloon channel and the balloon interface 51. A drug delivery tube is branched on the flushing tube, with one end of the drug delivery tube connected to the flushing tube and the other end connected to the drug delivery interface 54.

[0074] A pressure sensor 7 is embedded at the front end of the main channel near the insertion end of the nephrostomy tube body 1 to collect intrarenal pelvic pressure. Furthermore, after the nephrostomy tube is inserted into the kidney, the pressure sensor 7 measures the intrarenal pelvic pressure in real time and transmits the pressure data to the control module, which then wirelessly transmits it to an external terminal. This pressure sensor can be a miniature MEMS sensor, such as a MEMS piezoresistive sensor, with a surface covered by a biocompatible membrane such as PDMS to avoid irritating the urinary tract mucosa.

[0075] The flow sensor 2 is embedded in the main channel near the tail end of the nephrostomy tube body 1 to collect the urine flow rate in the main channel; in this invention, the flow sensor 2 can be a thermal flow sensor.

[0076] Solenoid valve 6 is embedded in the front end of the flushing channel near the insertion end of the nephrostomy tube body 1. It is a normally closed solenoid valve, used to close the connection with the flushing channel when the pressure sensor collects the pressure in the renal pelvis, so as to ensure the accuracy of the collected values.

[0077] The multifunctional nephrostomy tube device also includes:

[0078] The nephrostomy tube handle 8 has its internal space penetrated by the main tube, flushing tube, and balloon tube;

[0079] The main channel solenoid valve 42 is fixedly installed on the main pipe; when the control module controls it to be energized, the valve opens, allowing urine in the main channel to flow into the urine bag connected to the main interface; when the control module controls it to be de-energized, the valve closes.

[0080] The flushing channel solenoid valve 43 is fixedly installed on the flushing pipe; when the control module controls it to be energized, the valve opens; when the control module controls it to be de-energized, the valve closes.

[0081] The drug delivery solenoid valve 44 is fixedly installed on the drug delivery tube;

[0082] The control module is used to determine whether the nephrostomy tube is draining urine normally after the kidney is inserted into the insertion end of the nephrostomy tube device, based on the pressure in the renal pelvis collected by the pressure sensor 7 and / or the urine flow in the main channel collected by the flow sensor 2. When the nephrostomy tube is found to be draining urine abnormally, the module further determines the type of abnormality based on the rate of change of the pressure in the renal pelvis and / or the urine flow in the main channel, so as to automatically process the abnormality according to the type of abnormality.

[0083] The control module is also used to, during the period when the nephrostomy tube is urinating normally, if it receives a drug administration command sent by the management client, control the main channel solenoid valve 42 to close, and at the same time control the drug administration solenoid valve 44 and the solenoid valve to open, so as to inject the quantitative drug or quantitative contrast agent in the drug syringe or drug injection pump connected to the drug administration interface into the renal pelvis through the flushing channel. After the quantitative drug or quantitative contrast agent is injected into the renal pelvis, control the drug administration solenoid valve 44 and the solenoid valve to close, and start timing. After the timing reaches the preset time, control the main channel solenoid valve 42 to open, so as to discharge the quantitative drug or quantitative contrast agent through the main channel.

[0084] In a specific embodiment of the present invention, the control module is specifically used to compare the multiple intrarenal pelvic pressures collected in real time by the pressure sensor within each preset time period with a preset normal intrarenal pelvic pressure range, and at the same time compare the total urine flow in the main channel collected by the flow sensor within each preset time period with a preset urine flow threshold. If the multiple intrarenal pelvic pressures within the current preset time period are all within the normal intrarenal pelvic pressure range, and / or the total urine flow in the main channel within the current preset time period is greater than the preset urine flow threshold, then it is determined that the nephrostomy tube is urinating normally within the current preset time period.

[0085] In a specific embodiment of the present invention, the control module is specifically used to determine that the nephrostomy tube is urinating abnormally during the current preset time period if at least one of the multiple intrarenal pelvic pressures within the current preset time period is not within the normal intrarenal pelvic pressure range, and / or the total urine flow in the main channel within the current preset time period is not greater than a preset urine flow threshold.

[0086] In a specific embodiment of the present invention, the control module is specifically configured to, when determining that there is abnormal urination in the nephrostomy tube during a current preset time period, determine the abnormality type as partial blockage of the main channel if the rate of pressure change in the nephrostomy tube during the current preset time period is greater than a preset first pressure change rate threshold and the total urine flow is less than a preset first urine flow threshold; if the rate of pressure change in the nephrostomy tube during the current preset time period is greater than a preset second pressure change rate threshold, or the total urine flow is zero, determine the abnormality type as complete blockage of the main channel; if at least a predetermined number of renal pelvic pressures in the nephrostomy tube during the current preset time period are less than a preset low-pressure threshold, or the urine flow is zero during the current preset time period, determine the abnormality type as nephrostomy tube dislodgement.

[0087] In one specific embodiment of the present invention, the multifunctional nephrostomy tube device further includes:

[0088] An alarm module, encapsulated at point 8 of the nephrostomy tube handle, includes audible and / or visual alarm elements, such as LED indicator lights (red / yellow / green) and / or a buzzer, for local alarm functionality. Specifically, different colored LED indicator lights indicate different abnormality types: red indicates complete blockage of the main channel, yellow indicates partial blockage, and green indicates nephrostomy tube dislodgement. The buzzer distinguishes between different abnormality types using varying volume and frequency.

[0089] The display module, encapsulated at the handle of the nephrostomy tube, can display the current intrarenal pelvis pressure and / or urine flow rate in real time, as well as the intrarenal pelvis pressure curve and total urine flow rate of the nephrostomy tube over several recent preset time periods.

[0090] In a specific embodiment of the present invention, the control module is further configured to control the alarm module to sound an alarm when the abnormality type is determined to be partial blockage of the main channel, and at the same time, control the opening of the flushing channel solenoid valve 43 and the solenoid valve within a preset partial blockage flushing time, so as to inject the saline solution in the saline syringe or saline injection pump connected to the flushing interface into the main channel for flushing.

[0091] In a specific embodiment of the present invention, the control module is further configured to, when the abnormality type is determined to be a complete blockage of the main channel, control the alarm module to sound an alarm, and simultaneously, within a preset complete blockage flushing time, control the flushing channel solenoid valve 43 and the solenoid valve to repeatedly open and close at a set frequency, so as to inject saline from the saline syringe or saline injection pump connected to the flushing interface into the main channel for repeated flushing. After the preset complete blockage flushing time is reached, the change rate of renal pelvis pressure and / or urine flow rate in the main channel within a set detection time are used to further determine whether the nephrostomy tube urination is abnormal. If the nephrostomy tube urination is determined to be normal, the alarm module is deactivated, and the channel solenoid valve and the solenoid valve are closed. If the nephrostomy tube urination is determined to be continuously abnormal, the above steps are repeated, and the abnormality type of complete blockage of the main channel is reported to the management client.

[0092] It should be noted that the preset normal renal pelvis pressure range, preset urine flow threshold, preset first pressure change rate threshold, preset first urine flow threshold, preset second pressure change rate threshold, preset quantity, preset low pressure threshold, and current preset time period, etc., in this invention can all be set according to the basic information of different patients, including age, gender, physical condition including various test results, etc., or can be set by medical management personnel.

[0093] Furthermore, the pressure sensor 7 and flow sensor 2 of the present invention can be sensors that transmit signals via signal lines. In this case, the nephrostomy tube body 1 also has a signal transmission channel that is independent of the main channel, the irrigation channel, and the balloon channel. Signal lines connected to the pressure sensor 7 and flow sensor 2 are laid within this signal transmission channel to transmit the intrarenal pelvic pressure collected by the pressure sensor 7 and / or the urine flow rate in the main channel collected by the flow sensor 2 to the control module via the signal lines. Alternatively, the pressure sensor 7 and flow sensor 2 can be wireless sensors. In this case, it is not necessary to set up a signal transmission channel inside the nephrostomy tube body 1, so that the intrarenal pelvic pressure collected by the pressure sensor 7 and / or the urine flow rate in the main channel collected by the flow sensor 2 can be transmitted to the control module via a wireless transmission module.

[0094] In one specific embodiment of the present invention, the control module is further configured to control the alarm module to sound an alarm and report the abnormal type of nephrostomy tube dislodgement to the management client when the abnormal type is determined to be nephrostomy tube dislodgement.

[0095] The multifunctional nephrostomy tube device also includes a balloon channel solenoid valve 41, which is fixedly installed on the balloon tube; correspondingly, the control module is also used to control the balloon channel solenoid valve 41 to open when a nephrostomy tube removal command is received from the management client, so as to remove the insertion end of the nephrostomy tube device from the kidney.

[0096] In summary, this invention provides a multifunctional nephrostomy tube device, comprising: a nephrostomy tube body, a pressure sensor (fiber optic pressure sensor or Bluetooth pressure sensor) at the front end of the main channel near the insertion end of the nephrostomy tube body 1, a transmission device (transmitting fiber optic or Bluetooth radio frequency signals), and a corresponding CNC platform (or control module) with monitoring, regulation, and alarm modules, as well as a smart terminal device (pressure measurement data can be transmitted to mobile phones and computers, chips, batteries, and fixing devices). Specific steps include: the insertion end of the nephrostomy tube device entering the renal pelvis for drainage, irrigation, or surgical operations; the fiber optic pressure sensor (… The pressure is measured by a fiber optic pressure sensor (or Bluetooth pressure sensor); the CNC platform (or control module) adjusts the injection pressure based on the real-time pressure value measured by the fiber optic pressure sensor (or Bluetooth pressure sensor), and sets an alarm threshold for the monitored pressure. When the pressure reaches this alarm threshold, the device triggers the alarm module, thereby maintaining the pressure within the preset safety threshold range (e.g., a pressure difference ≤ 10 cmH2O is the safety threshold); the CNC platform interacts with smart terminal devices (mobile app, computer, chip) via wired / wireless means, and the battery is located externally for easy replacement.

[0097] Furthermore, the nephrostomy tube device with a Bluetooth pressure sensor has a dual-lumen design: the main lumen is used to drain urine or pus, and the secondary lumen is a balloon dilation lumen + device lumen (fixed catheter) with a battery and a buzzer installed inside. The nephrostomy tube device with a fiber optic pressure sensor has a triple-lumen design, in which the device lumen contains a fiber optic cable, a battery, a buzzer and / or an indicator light, and the buzzer is electrically or Bluetooth connected to the pressure sensor.

[0098] Furthermore, the insertion end 11 of the nephrostomy tube device may or may not be equipped with a fixing device to facilitate external fixation to the skin. The fixing device may use a medical-grade adhesive similar to that used in the chassis to form a tight fit with the skin through gentle adhesion, while reducing skin irritation. The fixing device may be integrated with the main body 1 of the nephrostomy tube or designed separately in the form of buckles, adhesives, etc.

[0099] Preferably, the alarm module is an audible and / or visual alarm element.

[0100] Furthermore, it also includes a power module connected to the control module, alarm module and display module. The power module uses a button battery, and the battery is covered with a protective cover for easy battery replacement.

[0101] It should be noted that the solenoid valve 6, the main channel solenoid valve 42, the flushing channel solenoid valve 43, the drug delivery solenoid valve 44, and the balloon channel solenoid valve 41 in this invention can be one-way valves or other types.

[0102] The preferred embodiments of the present invention have been described above with reference to the accompanying drawings, but this does not limit the scope of the invention. Any modifications, equivalent substitutions, and improvements made by those skilled in the art without departing from the scope and spirit of the present invention should be within the scope of the present invention.

Claims

1. A multifunctional nephrostomy tube device, comprising: a nephrostomy tube body, which is provided with a main channel, a flushing channel and a balloon channel; a balloon, which is fixedly arranged on the outer wall near the insertion end of the nephrostomy tube body and is in communication with one end of the balloon channel; a plurality of interfaces, including a main interface, a flushing interface and a balloon interface, wherein the main channel, the flushing channel and the balloon channel branch at the tail end of the nephrostomy tube body to form, in sequence, a main tube for connecting the main channel and the main interface, a flushing tube for connecting the flushing channel and the flushing interface, and a balloon tube for connecting the balloon channel and the balloon interface; a pressure sensor, which is embedded in the front end of the main channel near the insertion end of the nephrostomy tube body, for collecting the pressure in the renal pelvis; a flow sensor, which is embedded in the main channel near the tail end of the nephrostomy tube body, for collecting the urine flow in the main channel; a solenoid valve, which is embedded in the front end of the flushing channel near the insertion end of the nephrostomy tube body; characterized in that the multifunctional nephrostomy tube device further comprises: a nephrostomy tube handle, the internal space of which is penetrated by the main tube, the flushing tube and the balloon tube; a main channel solenoid valve, which is fixedly installed on the main tube; a flushing channel solenoid valve, which is fixedly installed on the flushing tube; a control module, which is used to, after the insertion end of the nephrostomy tube device is inserted into the kidney, judge whether the nephrostomy tube urination is normal according to the pressure in the renal pelvis collected by the pressure sensor and / or the urine flow in the main channel collected by the flow sensor, and further determine the abnormal type according to the change rate of the pressure in the renal pelvis and / or the urine flow in the main channel when the nephrostomy tube urination is judged to be abnormal, so as to automatically handle according to the abnormal type.

2. The multi-functional nephrostomy tube device according to claim 1, wherein, The multifunctional nephrostomy tube device further comprises: a drug administration interface, which is used to inject drugs or contrast agents through the drug administration interface; a drug administration tube, one end of which is in communication with the drug administration interface and the other end of which is in communication with the flushing tube; a drug administration solenoid valve, which is fixedly installed on the drug administration tube; Correspondingly, the control module is further used to, during the period when the nephrostomy tube urination is judged to be normal, control the main channel solenoid valve to be closed and the drug administration solenoid valve and the solenoid valve to be opened simultaneously to inject the quantitative drugs or contrast agents in the drug syringe or drug injection pump connected with the drug administration interface into the renal pelvis through the flushing channel, and control the drug administration solenoid valve and the solenoid valve to be closed and start timing simultaneously after the quantitative drugs or contrast agents are injected into the renal pelvis, and control the main channel solenoid valve to be opened to discharge the quantitative drugs or contrast agents through the main channel after the preset time is reached.

3. The multi-functional nephrostomy tube device according to claim 1, wherein, The control module is specifically used to compare the plurality of pressures in the renal pelvis collected by the pressure sensor in each preset time period with the preset normal renal pelvis pressure range simultaneously, and compare the total urine flow in the main channel collected by the flow sensor in each preset time period with the preset urine flow threshold value, and if the plurality of pressures in the renal pelvis in the current preset time period are all within the normal renal pelvis pressure range and / or the total urine flow in the main channel in the current preset time period is greater than the preset urine flow threshold value, it is judged that the nephrostomy tube urination is normal in the current preset time period.

4. The multi-functional nephrostomy tube device according to claim 3, wherein, The control module is specifically configured to determine that the nephrostomy tube is abnormal in the current preset time period if at least one of the multiple intrapelvic pressures in the current preset time period is not within the normal intrapelvic pressure range and / or the total urine flow in the main channel in the current preset time period is not greater than the preset urine flow threshold.

5. The multifunctional nephrostomy tube device of claim 4, wherein, The control module is specifically configured to determine that the main channel is partially blocked if the pressure change rate in the nephrostomy tube in the current preset time period is greater than the preset first pressure change rate threshold and the total urine flow is less than the preset first urine flow threshold when it is determined that the nephrostomy tube is abnormal in the current preset time period. The control module is specifically configured to determine that the main channel is totally blocked if the pressure change rate in the nephrostomy tube in the current preset time period is greater than the preset second pressure change rate threshold or the total urine flow is zero. The control module is specifically configured to determine that the nephrostomy tube is detached if at least a set number of the intrapelvic pressures in the nephrostomy tube in the current preset time period are less than the preset low pressure threshold or the urine flow in the current preset time period is zero.

6. The multifunctional nephrostomy tube device of claim 5, wherein, The multifunctional nephrostomy tube device further comprises: An alarm module encapsulated at the handle of the nephrostomy tube, comprising a sound and / or light alarm element; A display module encapsulated at the handle of the nephrostomy tube, capable of displaying the current intrapelvic pressure and / or urine flow in real time, and the intrapelvic pressure curve and total urine flow of the nephrostomy tube in the recent multiple preset time periods.

7. The multifunctional nephrostomy tube device of claim 6, wherein, The control module is further specifically configured to control the alarm module to alarm when the abnormal type is determined to be partial blockage of the main channel, and to control the flushing channel electromagnetic valve and the electromagnetic valve to open to flush the physiological saline in the physiological saline syringe or physiological saline injection pump connected to the flushing interface into the main channel via the flushing channel within a preset partial blockage flushing time.

8. The multifunctional nephrostomy tube device of claim 6, wherein, The control module is further specifically configured to control the alarm module to alarm when the abnormal type is determined to be total blockage of the main channel, and to control the flushing channel electromagnetic valve and the electromagnetic valve to repeatedly open and close at a set frequency to repeatedly flush the physiological saline in the physiological saline syringe or physiological saline injection pump connected to the flushing interface into the main channel via the flushing channel within a preset total blockage flushing time, and to further determine whether the nephrostomy tube is abnormal by detecting the pressure change rate of the intrapelvic pressure and / or the urine flow in the main channel within a set detection time after the preset total blockage flushing time is reached, control the alarm module to stop alarming if it is determined that the nephrostomy tube is normal, and repeat the above steps if it is determined that the nephrostomy tube is continuously abnormal, and report the abnormal type of total blockage of the main channel to the management client.

9. The multifunctional nephrostomy tube device of claim 6, wherein, The control module is further specifically configured to control the alarm module to alarm when the abnormal type is determined to be detachment of the nephrostomy tube, and to report the abnormal type of detachment of the nephrostomy tube to the management client.

10. The multifunctional nephrostomy tube device of claim 1, wherein, The multifunctional nephrostomy tube device further comprises: A balloon channel electromagnetic valve fixedly installed on the balloon tube; Correspondingly, the control module is further configured to control the solenoid valve of the balloon channel to open when the kidney fistula removal instruction sent by the management client is received, so as to remove the insertion end of the kidney fistula device from the kidney.

Images