Transurethral non-invasive catheter for monitoring the pulse oximetry saturation of the bladder mucosa

Abstract

The transurethral non-invasive monitoring catheter for bladder mucosa pulse oxygen saturation of the present invention comprises a catheter body, two balloons and a photoelectric conduction system. The catheter body is provided with three channels, namely a urine channel, a gas channel and a water channel. The two balloons include a transparent airbag and a water bag. The photoelectric conduction system includes a photoelectric microcircuit board and an elastic valve. The photoelectric microcircuit board is connected to the elastic valve, and the elastic valve is adjacent to the water bag. The elastic valve changes its spatial position under the control of the volume of the water bag, and further controls the folding and unfolding postures of the photoelectric microcircuit board. The photoelectric microcircuit board is connected to a pulse oxygen saturation monitor through a metal wire embedded in the catheter wall, so as to realize the monitoring of pulse oxygen saturation. The operation of the present invention is simple, the signal reliability is high, and it has broad prospects in the application fields of critical care medicine and emergency medicine monitoring. Especially in the cases where other non-invasive monitoring means cannot or are difficult to be applied, such as in cases of total body burns, various types of shock, hypothermia or heat stroke, satisfactory results can also be achieved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical monitoring devices, and particularly to a transurethral non-invasive catheter for monitoring the pulse oxygen saturation of the bladder mucosa. Background Art

[0002] Oxygen saturation (abbreviated as SpO2) refers to the percentage of the O2-binding capacity in all blood volumes that is bound to O2, which is used to evaluate the respiratory and circulatory functions of the body and is one of the important basic data in clinical medicine.

[0003] Accurate determination of oxygen saturation requires taking blood samples from the aorta and main branch arteries or central veins and even the mixed venous blood of the right atrium for biochemical determination. The operation is difficult and it is difficult to achieve real-time continuous monitoring. Currently, continuous pulse oxygen saturation monitoring in clinical applications is divided into invasive and non-invasive methods. The technical principle is based on the difference in the absorption peaks of oxyhemoglobin and deoxyhemoglobin for infrared spectra at specific wavelengths (λ1 = 660 nm, λ2 = 910 nm). Two-way photoelectric signals are amplified, DC removed, power frequency interference removed, and then extracted, calculated, and integrated by the analysis module of the pulse oximeter to output parameters such as pulse waves and oxygen saturation.

[0004] Invasive continuous pulse oxygen monitoring relies on a special probe and a photoelectric conversion module. When in use, vascular puncture needs to be performed and the probe is placed in a deep artery or vein. Clinical operators need to undergo specialized training. There are three main types of risks or complications: 1) Vascular injury, local hematoma, continuous bleeding caused by vascular rupture, and even life-threatening; 2) Inducing thrombosis, resulting in insufficient or interrupted arterial blood supply, causing venous thrombosis or ectopic embolism, and further leading to dysfunction of important organs such as the brain, lungs, and kidneys or limb ischemia necrosis; 3) Inducing endocarditis, or causing infectious diseases such as bacteremia and septicemia. The scope of application of this monitoring method in clinical practice is decreasing day by day and is currently only used in some special cases.

[0005] Non-invasive continuous pulse oxygen monitoring relies on healthy skin. The probe is fixed on the body surface, such as the fingertips or toes, earlobes, and the faces of infants and young children, and can measure the oxygen saturation of local superficial tissues to indirectly evaluate the overall circulatory oxygen supply and oxygen consumption status. This monitoring method is the most widely used in clinical applications, but there are also obvious limitations: 1) It cannot be implemented in cases of extensive skin burns or frostbite, diffuse skin diseases, etc.; 2) In pathophysiological conditions such as shock and hypothermia, there are serious deviations between the monitoring results and the oxygen saturation of deep organs, and it cannot reflect the true respiratory and circulatory functions of the body.

[0006] Recently, there is a domestic patent adopting a non-invasive trans-airway monitoring scheme for mixed venous oxygen saturation. This scheme relies on tracheal intubation technology, which is beneficial for patients who need artificial respiration support simultaneously, but not suitable for patients without tracheal intubation. More importantly, tracheal intubation technology requires specialized training for physicians, but there are still the following risks of complications: 1) Tracheal intubation operation may induce vomiting, aspiration, asphyxia, arrhythmia, and even cardiac arrest, leading to risks such as glottis injury or cervical spine injury; 2) Due to various reasons, tracheal intubation cannot be inserted, resulting in the inability to implement mixed venous oxygen saturation monitoring; 3) Although tracheal intubation has been inserted, the position is inappropriate, making it difficult to obtain effective monitoring data.

[0007] In summary, there are the following problems in the current oxygen saturation monitoring technology: 1) Although the method of obtaining blood samples by puncturing blood vessels for biochemical detection is accurate, it cannot achieve continuous monitoring; 2) Continuous in-vessel monitoring relies on puncturing blood vessels to insert a specialized optoelectronic conversion probe, which is difficult to operate, costly, and has risks of blood vessel injury, thrombosis, and infection, severely restricting its clinical application; 3) Continuous non-invasive surface monitoring relies on healthy skin and is difficult to reflect the true situation of visceral oxygen saturation. Especially in cases of extensive skin burns or frostbite, diffuse skin diseases, shock, hypothermia, etc., effective monitoring cannot be implemented; 4) Some deep blood vessel pulse oximetry detection technology schemes, such as trans-airway mixed venous oxygen saturation, have high clinical technical requirements and high operation risks, limiting their clinical application. Summary of the Invention

[0008] To solve the above problems, a transurethral non-invasive monitoring catheter for bladder mucosa pulse oxygen saturation is provided.

[0009] The transurethral non-invasive monitoring catheter for bladder mucosa pulse oxygen saturation uses the following technical solution:

[0010] The catheter of the present invention includes a catheter body, two balloons, and an optoelectronic conduction system. The catheter body is provided with three channels, namely a urine channel, a gas channel, and a water channel; the two balloons are a transparent balloon and a water balloon respectively; the opening of the urine channel is arranged at the side hole at the head end of the catheter, and the urine channel interface is arranged at the tail of the catheter; the gas channel communicates with the transparent balloon, the port of the gas channel is arranged at the tail of the catheter, and the port of the gas channel is connected to a two-way pressure valve; the transparent balloon is arranged at the front end of the catheter body, and a water balloon is arranged inside the transparent balloon. The water balloon communicates with the water channel, the port of the water channel is arranged at the tail of the catheter, and the port of the water channel is connected to a two-way pressure valve; the optoelectronic conduction system includes an optoelectronic microcircuit board, a spring flap, and a wire. The optoelectronic microcircuit board is arranged between the transparent balloon and the water balloon at the head of the catheter, one end is connected to the spring flap, the other end of the spring flap is fixed on the catheter wall of the catheter body, and the wire is buried in the catheter wall of the catheter body, and the wire is provided with a port at the very end of the catheter body.

[0011] The spring flap is made of spring steel wire.

[0012] The catheter body is a catheter with a circular cross section.

[0013] The wire is a soft metal wire.

[0014] The photoelectric transmission system has three parallel paths, and three groups of corresponding photoelectric microcircuit boards, conductors and signal ports are respectively arranged.

[0015] The head of the catheter body is spherical.

[0016] The transparent airbag is made of transparent elastic material.

[0017] The optoelectronic micro-circuit board includes two groups of light-emitting components, two groups of photosensitive components and micro-circuits. The two groups of light-emitting components and the two groups of photosensitive components correspond to light wavelengths of 660nm and 910nm respectively, and the micro-circuits are connected to the wires.

[0018] The catheter is sterilized and sealed in a sterile package.

[0019] The transurethral non-invasive monitoring bladder mucosal pulse oximetry catheter of the present invention provides a safe and convenient solution for continuously monitoring the blood oxygen saturation of deep organs, and is a safe, convenient and feasible option, especially when the skin on the surface of the body is not suitable for monitoring. It can also be used as a urinary catheter for catheterization, urine collection, urine measurement, and laboratory analysis.

[0020] The technical effects achieved by the present invention are:

[0021] 1. The photoelectric conduction system is integrated with the medical catheter to conveniently obtain the blood oxygen saturation parameters of deep organs;

[0022] 2. Good compatibility, the optoelectronic micro-circuit board adopts a universal design, and the port can be connected to the mainstream pulse blood pressure monitor on the market;

[0023] 3. Safe to use. Since the urethra and bladder are both physiological cavities of the human body, there are almost no complications with normal use within a few days, and there is no risk of serious complications;

[0024] 4. The operation is simple and can be carried out by medical personnel with doctor or nurse qualifications after a little training;

[0025] The present invention has broad application prospects in the fields of emergency medical rescue at various disaster sites, pre-hospital emergency treatment in urban and rural areas, initial treatment in primary hospitals, emergency rescue in hospitals at all levels, and treatment in intensive care units. It is particularly suitable for on-site first aid and intensive care unit treatment for systemic burns, various shocks, hypothermia or heatstroke. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 It is a structural schematic diagram of the present invention.

[0027] Figure 2 It is a partial enlarged view of the front end of the catheter body of the present invention.

[0028] Figure 3 It is a schematic cross-sectional view of the internal structure of the airbag of the present invention.

[0029] Figure 4 It is a schematic view of the internal structure of the airbag of the present invention.

[0030] Figure 5 It is a cross-sectional view of the middle section of the catheter body.

[0031] In the figure: 1 side hole, 2 transparent airbag, 3 water bag, 4 optoelectronic microcircuit board, 5 catheter body, 6 urine cavity interface, 7 water cavity port, 8 gas cavity port, 9 signal port A, 10 signal port B, 11 signal port C, 12 elastic valve, 13 urine cavity, 14 water cavity, 15 metal wire, 16 gas cavity, 17 light-emitting component, 18 microcircuit, 19 photosensitive component, 20 two-way pressure valve. Detailed implementation mode

[0032] Unless otherwise specified, the components used in the present invention are common components in the medical technology field. The optoelectronic microcircuit structure adopted is the optoelectronic detection head circuit structure on a common reflective oximeter, and the two-way pressure valve is the two-way pressure valve used on a 16-24Fr three-chamber catheter produced by Guangzhou Weili Medical Instrument Co., Ltd.

[0033] The transurethral non-invasive monitoring catheter for bladder mucosa pulse oxygen saturation of the present invention will be described below with reference to the accompanying drawings:

[0034] The transurethral non-invasive monitoring catheter for bladder mucosa pulse oxygen saturation includes 3 groups of optoelectronic conduction paths, transparent airbag 2, water bag 3, catheter body 5, gas cavity port 8, water cavity port 7, urine cavity interface 6 and signal port A 9, signal port B 10, signal port C 11.

[0035] The opening of the urine cavity is the side hole at the head end of the catheter. The gas cavity communicates with the transparent airbag. The transparent airbag is made of transparent elastic material. A water bag is arranged inside the transparent airbag, and the water bag communicates with the water cavity. The urine cavity interface is arranged at the tail of the catheter body. The water cavity port is arranged at the tail of the catheter body. The water cavity port is connected to the two-way pressure valve port. The gas cavity port is arranged at the tail of the catheter body. The gas cavity port is connected to the two-way pressure valve port. The signal port is arranged at the very end of the catheter body. The signal port is connected to the optoelectronic conduction system through a wire, and the wire is buried in the catheter wall of the catheter.

[0036] The photoconductive system includes a photoelectric microcircuit board and an elastic flap. The photoelectric microcircuit board is disposed between the transparent airbag and the water bag at the head of the catheter body. One end of the elastic flap is connected to the photoelectric microcircuit board, and the other end is fixed to the catheter wall of the catheter body. The photoelectric microcircuit board includes two groups of light-emitting components, two groups of photosensitive components and microcircuits. The light-emitting components and the photosensitive components are connected to wires through the microcircuits. The two groups of light-emitting / photosensitive components respectively correspond to light wave wavelengths of 660nm and 910nm.

[0037] The elastic flap is composed of elastic steel wires. The displacement of the middle section under the pressure of the water bag can drive the photoelectric microcircuit board to turn.

[0038] In order to relieve and reduce the pain of inserting the catheter of the present invention, the head of the catheter is designed as a spherical head.

[0039] In order to facilitate the insertion of the catheter of the present invention, soft metal wires are used for the metal wires.

[0040] The setting of the two-way pressure valve can maintain the pressure in the water cavity or gas cavity at 20 cmH2O. When the value exceeds this value, the fluid in the cavity is induced to flow.

[0041] In order to prevent the detection effect from being poor after the photoelectric microcircuit board is deployed during deployment, resulting in the need for re-intubation, three groups of photoelectric microcircuit boards are provided, and the optimal detection signal is selected for detection during detection.

[0042] The catheter of the present invention is inserted according to the following steps:

[0043] 1. Open the packaging bag, check the integrity of the instrument, inject sterile 0.9% sodium chloride solution into a disposable syringe to test the elasticity and airtightness of the water bag; inject air to test the elasticity and airtightness of the airbag; after testing, drain all the air or aqueous solution, and apply sterile paraffin oil to lubricate the catheter head, tube body and transparent airbag.

[0044] 2. The patient lies in a supine or semi-recumbent position, is routinely disinfected, and a drape is laid. The catheter head is inserted into the urethral orifice and slowly inserted into the bladder through the urethra. After urine is seen in the urinary catheter, it is inserted 5 cm deeper into the bladder.

[0045] 3. Inject 5-10 ml of air into the two-way pressure valve connected to the gas cavity port with a disposable syringe, and try to withdraw the urinary catheter. It should not be pulled out.

[0046] 4. Inject 3-10 ml of 0.9% sodium chloride solution into the two-way pressure valve connected to the water cavity port with a disposable syringe. At this time, the photoelectric microcircuit board opens and faces the bladder inner wall mucosa.

[0047] 5. Connect the signal line port to the pulse oximeter, and parameters such as blood oxygen saturation (SO2) and pulse rate (P) can be displayed within about 5-10 seconds.

[0048] 6. Try to connect the other two signal ports and continuously monitor the port with the optimal signal.

[0049] 7. If satisfactory signals are not obtained from all three ports, repeat step 4, adjust the water cavity injection volume within the range of 3 - 10 ml, and repeat steps 5 and 6 until a satisfactory monitoring signal is obtained.

[0050] After the monitoring is completed, if urinary catheterization is not required, the catheter can be removed.

[0051] It should be noted that before leaving the factory, it should be disinfected with ethylene oxide and then packaged in a sterile sealed manner. At the same time, clinical operations should follow the technical operation requirements of "Catheterization". The catheter of the present invention should be cared for according to medical routines, and colored liquids should be avoided during bladder irrigation. If the indwelling time exceeds two weeks, it is recommended to replace the new catheter.

Claims

1. Transurethral non-invasive monitoring catheter for bladder mucosa pulse oxygen saturation, comprising a catheter body, two balloons and an optoelectronic conduction system, characterized in that, The catheter body is provided with three channels, namely a urine channel, a gas channel and a water channel; the two balloons are a transparent balloon and a water balloon respectively; the opening of the urine channel is arranged at the side hole at the head end of the catheter, and the urine channel interface is arranged at the tail of the catheter; the gas channel communicates with the transparent balloon, the port of the gas channel is arranged at the tail of the catheter, and the port of the gas channel is connected to a two-way pressure valve; the transparent balloon is arranged at the front end of the catheter body, a water balloon is arranged inside the transparent balloon, the water balloon communicates with the water channel, the port of the water channel is arranged at the tail of the catheter, and the port of the water channel is connected to a two-way pressure valve; the photoelectric conduction system includes a photoelectric microcircuit board, an elastic flap and a wire. The photoelectric microcircuit board is arranged between the transparent balloon and the water balloon at the head of the catheter, one end is connected to the elastic flap, the other end of the elastic flap is fixed on the catheter wall of the catheter body, and the wire is buried in the catheter wall of the catheter body, and the wire is provided with a port at the outermost end of the catheter body.

2. The transurethral non-invasive bladder mucosa pulse oximetry catheter according to claim 1, wherein The elastic flap is made of elastic steel wire.

3. The transurethral non-invasive monitoring bladder mucosa pulse oximetry catheter according to claim 1, characterized in that, The catheter body is a catheter with a circular cross-section.

4. The transurethral non-invasive catheter for monitoring the pulse oxygen saturation of the bladder mucosa according to claim 1, wherein The wire is a soft metal wire.

5. The transurethral non-invasive bladder mucosa pulse oximetry catheter according to claim 1, characterized in that, The photoelectric conduction system has three parallel paths, and three groups of corresponding photoelectric microcircuit boards, wires and signal ports are respectively arranged.

6. The transurethral non-invasive monitoring catheter for bladder mucosa pulse oxygen saturation according to claim 1, characterized in that, The head of the catheter body is a sphere.

7. The transurethral non-invasive monitoring bladder mucosa pulse oximetry catheter according to claim 1, characterized in that, The transparent balloon is made of a transparent elastic material.

8. The transurethral non-invasive catheter for monitoring the pulse oximetry of the bladder mucosa according to claim 1, characterized in that, The photoelectric microcircuit board includes two groups of light-emitting components, two groups of light-sensitive components and a microcircuit. The two groups of light-emitting components and the two groups of light-sensitive components respectively correspond to light wave wavelengths of 660 nm and 910 nm, and the microcircuit is connected to the wire.

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