System, method and lancet for measuring blood pressure

Abstract

The application provides a system, a method and a puncture needle for measuring blood pressure, the system comprising a puncture needle, an optical fiber sensor, an optical fiber transmission line and an optical-electricity conversion regulator; the puncture needle comprises a puncture needle body and a puncture needle core; the body comprises a sheath and a base; the base is connected to the rear end of the sheath; the rear end of the base is provided with an infusion interface and a blood pressure measurement interface; the needle core is used for guiding the sheath to puncture into a blood vessel, and the sheath is used for guiding blood into the inner cavity of the base; the optical fiber sensor comprises a sensor body, a medical instrument interface and an optical fiber interface; the optical fiber sensor is connected to the blood pressure measurement interface through the medical instrument interface and is indirectly connected to the optical-electricity conversion regulator through the optical fiber interface; when the medical instrument interface and the blood pressure measurement interface are in a connected state, the pressure sensitive end of the sensor body enters the inner cavity of the puncture base; the optical-electricity conversion regulator is used for emitting laser to the optical fiber sensor, and blood pressure information is calculated according to optical information reflected by the optical fiber sensor. The application can more accurately measure blood pressure.

Description

Technical Field

[0001] This application belongs to the field of medical device technology, and in particular relates to a system, method and puncture needle for measuring blood pressure. Background Technology

[0002] Blood pressure is a fundamental vital sign, reflecting information such as heart volume, workload, and function, and is an important indicator of circulatory function. Accurate and rapid blood pressure monitoring is particularly important for the diagnosis and treatment of critically ill patients. Invasive arterial blood pressure monitoring, due to its ability to continuously and in real-time monitor hemodynamic changes, has become the gold standard for arterial blood pressure monitoring and is widely used in the monitoring of critically ill patients.

[0003] Currently used invasive arterial blood pressure monitoring systems rely on Pascal's law and the principle of pressure transmission in liquids. A catheter filled with heparinized saline is inserted into the artery, and a resistive pressure transducer at the catheter's end measures the pressure within the catheter, thus replacing direct measurement of arterial blood pressure. The length, material, and elasticity of the pressure-measuring tube can all affect the measurement results. Studies have shown that for every 80cm increase in tube length, systolic blood pressure increases by 10mmHg. Furthermore, the tube material affects compliance, and differences in compliance reduce the accuracy of the measurement. In addition, piezoelectric sensors in liquid catheters are affected by the pressurization system, hydrostatic pressure at the fluid surface, and the elasticity of the catheter wall. Zeroing the system before measurement is essential, significantly impacting the accuracy and stability of the monitoring results. Moreover, an increasing number of critically ill patients require examinations and surgeries under MRI, CT, or digital subtraction angiography. Existing resistive sensors cannot function accurately or may even be damaged in environments with strong magnetic fields, strong radiation, or high energy.

[0004] It should be noted that the information disclosed in the background section above is only for understanding the background of this application, and therefore may include information that does not constitute prior art known to those skilled in the art. Summary of the Invention

[0005] The purpose of this application is to provide a system, method, and puncture needle for measuring blood pressure, aiming to address the deficiencies or defects pointed out in the background art.

[0006] In a first aspect, this application provides a blood pressure measurement system, which includes a puncture needle, an enamel cavity fiber optic sensor, a fiber optic transmission line, and a photoelectric conversion regulator;

[0007] The puncture needle consists of a hollow puncture needle body and a puncture needle core; the puncture needle body is made of non-metallic material.

[0008] The puncture needle body includes a puncture needle sheath and a puncture needle base;

[0009] The front end of the puncture needle base is connected to the rear end of the puncture needle sheath; the rear end of the puncture needle base is provided with a transfusion interface for connecting a transfusion tube and a blood pressure measurement interface for connecting a capillary optical fiber sensor;

[0010] The front end of the puncture needle core is a short bevel angle structure; the puncture needle core is used for guiding the puncture needle sheath to puncture into a blood vessel, which is an artery or a vein; the puncture needle sheath is used for leading blood in the blood vessel into the inner cavity of the puncture needle base;

[0011] The capillary optical fiber sensor comprises a sensor body, a medical instrument interface matched with the blood pressure measurement interface of the puncture needle, and an optical fiber interface;

[0012] The capillary optical fiber sensor is connected to the blood pressure measurement interface of the puncture needle through the medical instrument interface, and is connected to one end of an optical fiber transmission line through the optical fiber interface; the other end of the optical fiber transmission line is connected to a photoelectric conversion regulator; when the medical instrument interface and the blood pressure measurement interface are in a connected state, the pressure sensitive end of the sensor body enters the inner cavity of the puncture needle base;

[0013] The photoelectric conversion regulator is used for emitting laser to the capillary optical fiber sensor and calculating blood pressure information according to optical information reflected by the capillary optical fiber sensor.

[0014] In some embodiments, the medical instrument port of the capillary optical fiber sensor is a luer outer conical interface.

[0015] In some embodiments, the outer periphery of the sensor body is wrapped with a skin.

[0016] In some embodiments, the skin covering the front end of the sensor body is provided with a screw cap.

[0017] In the second aspect, the application provides a puncture needle, which comprises a puncture needle body and a puncture needle core, both of which are hollow structures; the material of the puncture needle body is a non-metal material; the puncture needle body comprises a puncture needle sheath and a puncture needle base; the front end of the puncture needle base is connected to the rear end of the puncture needle sheath; the rear end of the puncture needle base is provided with a transfusion interface for connecting a transfusion tube and a blood pressure measurement interface for connecting a capillary optical fiber sensor; the front end of the puncture needle core is a short bevel angle structure; the puncture needle core is used for guiding the puncture needle sheath to puncture into a blood vessel, which is an artery or a vein; the puncture needle sheath is used for leading blood in the blood vessel into the inner cavity of the puncture needle base.

[0018] In some embodiments, the blood pressure measurement interface and the transfusion interface are both luer inner conical interfaces.

[0019] In some embodiments, the outer periphery of the blood pressure measurement interface is provided with threads.

[0020] In some embodiments, the rear end of the puncture needle core is provided with a blood storage groove for judging a puncture blood return state.

[0021] In some embodiments, when the puncture needle is in a standby state, the puncture needle core passes through the puncture needle base and the puncture needle sheath through the infusion interface, so that the blood storage groove of the puncture needle core forms a sealed structure with the infusion interface.

[0022] In some embodiments, the puncture needle further comprises a protective cap for sealing the blood pressure measurement interface.

[0023] In a third aspect, the present application provides a blood pressure measurement method, which is implemented based on the blood pressure measurement system provided in any of the above embodiments; the method comprises:

[0024] The puncture needle sheath is guided by the puncture needle core to puncture into the target blood vessel, so that the blood in the target blood vessel flows into the inner cavity of the puncture needle base through the puncture needle sheath and directly contacts the pressure-sensitive end of the sensor body in the sensor body of the Papillary cavity optical fiber sensor; the target blood vessel is an artery or a vein;

[0025] The photoelectric conversion regulator emits laser to the Papillary cavity optical fiber sensor, and calculates blood pressure information according to the optical information reflected by the Papillary cavity optical fiber sensor.

[0026] In some embodiments, after the puncture needle sheath punctures into the target blood vessel, the method further comprises:

[0027] Judging whether the backflow state after puncture is normal based on the blood storage groove of the puncture needle core;

[0028] If the backflow state is normal, the puncture needle core is extracted out of the puncture needle body by pushing the puncture needle base, and at the same time, the puncture needle sheath is left in the target blood vessel.

[0029] In some embodiments, when the target blood vessel is a vein and the infusion interface of the puncture needle is connected with an infusion device, before the photoelectric conversion regulator emits laser to the Papillary cavity optical fiber sensor, the method further comprises:

[0030] Close the infusion regulating valve or the three-way valve to suspend the liquid supplement.

[0031] In some embodiments, when the target blood vessel is an artery and the infusion interface of the puncture needle is connected with a pressurized flushing device, the method further comprises:

[0032] Flush the arterial pipeline through the pressurized flushing device at a fixed time or at an indefinite time.

[0033] In some embodiments, before the photoelectric conversion regulator emits laser to the Papillary cavity optical fiber sensor, the method further comprises: performing zero-point setting according to the body position state of the patient.

[0034] The blood pressure measuring system provided in the application adopts a Pap cavity optical fiber sensor to measure blood pressure. The Pap cavity optical fiber sensor is a sensor for measuring pressure by using the Pap cavity interference principle, has the characteristics of small volume, high precision, fast response, and more importantly, has the characteristic of resisting electromagnetic interference, and thus can perform the blood pressure monitoring task in a special environment, such as performing functional nuclear magnetic examination in brain tumor surgery, performing nuclear magnetic resonance examination on critical patients, and performing heart intervention surgery on heart patients. The working principle is to determine the change of external pressure by measuring the change of the optical path difference in the Pap cavity. The Pap cavity is specifically composed of two parallel reflecting surfaces. One reflecting surface is fixed in position, and the other reflecting surface acts as a pressure sensing diaphragm and can deform under the action of external pressure, thereby changing the length of the Pap cavity. The blood pressure measuring interface of the special puncture needle is placed in the inner cavity of the puncture needle (specifically, the inner cavity of the puncture needle base of the puncture needle). After the puncture needle is punctured into the target blood vessel, the blood in the target blood vessel is guided to the inner cavity of the puncture needle, so that the blood is in direct contact with the Pap cavity optical fiber sensor in the inner cavity of the puncture needle, and then the blood can produce a squeezing effect on the Pap cavity in the Pap cavity optical fiber sensor, so that the length of the Pap cavity changes, and then the photoelectric conversion regulator can calculate the blood pressure according to the optical information reflected by the Pap cavity optical fiber sensor.

[0035] The puncture needle provided in the application is provided with a blood pressure measuring interface. The Pap cavity optical fiber sensor can be integrated with the puncture needle as a whole through the docking with the blood pressure measuring interface, and can enter the inner cavity of the puncture needle to be in direct contact with the blood in the target blood vessel. Compared with the method of replacing the arterial blood pressure by measuring the pressure in the catheter in the related art, the blood pressure measuring precision can be obviously improved. At this time, the blood pressure measuring precision is equivalent to the precision of directly implanting the Pap cavity optical fiber sensor into the target blood vessel to measure the blood pressure. Since the Pap cavity optical fiber sensor does not need to be implanted into the target blood vessel, the blood pressure measuring precision is improved, the placement and recovery operation of the sensor during blood pressure measurement is simplified, and the risk of infection caused by the operation is reduced. BRIEF DESCRIPTION OF DRAWINGS

[0036] Figure 1 is a composition schematic diagram of the blood pressure measuring system provided in the embodiment of the application;

[0037] Figure 2 is a schematic diagram of the puncture needle core inserted into the puncture needle body provided in the embodiment of the application;

[0038] Figure 3 is a connection schematic diagram of various components in the blood pressure measuring system during blood pressure measurement provided in the embodiment of the application;

[0039] Figure 4 is a cross-sectional view of part of the structure of the sensor body of the Pap cavity optical fiber sensor provided in the embodiment of the application;

[0040] Figure 5 is a structural schematic diagram of a Fabry-Perot cavity optical fiber sensor provided by an embodiment of the present application;

[0041] Figure 6 is a flow schematic diagram of a blood pressure measurement method provided by an embodiment of the present application;

[0042] Figure 7 is a schematic diagram of a pressurizing and flushing device connected through an infusion interface during blood pressure measurement provided by an embodiment of the present application.

[0043] The reference signs are as follows:

[0044] Blood pressure measurement system 00; puncture needle 1; Fabry-Perot cavity optical fiber sensor 2; optical fiber transmission line 3; photoelectric conversion regulator 4; puncture needle body 11; puncture needle core 12; puncture needle sheath 111; puncture needle base 112; infusion interface 1121; blood pressure measurement interface 1122; inner cavity of puncture needle base 1123; blood storage groove 121; sensor body 21; optical fiber interface 22; two-stage sleeve 211; high-reflection film 212; Fabry-Perot cavity 213; single-mode optical fiber in sensor body 214; fiber core 2141; cladding 2142; coating layer 2143; protective layer 2144; sensitive diaphragm 215; spiral cap 216 provided on the front end skin of the sensor body. DETAILED DESCRIPTION

[0045] In order to make the purposes, technical solutions and beneficial effects of the present application clearer and more apparent, the present application will be further described in detail below in combination with the drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and do not limit the present application.

[0046] In order to illustrate the technical solutions described in the present application, the following will be described through specific embodiments.

[0047] The first aspect of the present application provides a blood pressure measurement system, in some embodiments, as shown in Figure 1 The blood pressure measurement system 00 includes a puncture needle 1, a Fabry-Perot cavity optical fiber sensor 2, an optical fiber transmission line 3 and a photoelectric conversion regulator 4, which will be introduced respectively as follows:

[0048] (1) Regarding the puncture needle 1, it includes a puncture needle body 11 and a puncture needle core 12.

[0049] Both the puncture needle body 11 and the puncture needle core 12 are hollow structures so as to introduce and accommodate blood in the blood vessel.

[0050] Regarding the puncture needle body 11, as Figure 1As shown, it comprises a puncture needle sheath 111 and a puncture needle base 112. The front end of the puncture needle base 112 is connected to the rear end of the puncture needle sheath 111; the rear end of the puncture needle base 112 is provided with two interfaces, namely, a transfusion interface 1121 for connecting a transfusion tube and a blood pressure measurement interface 1122 for connecting a capillary cavity optical fiber sensor. The rear end of the puncture needle base 112 can be any side of the puncture needle base 112, and the front end can be the side opposite to the rear end.

[0051] Specifically, the puncture needle sheath 111 is a hollow structure for guiding the blood in the blood vessel into the inner cavity of the puncture needle base 112 after puncturing into the blood vessel; in some embodiments, the puncture needle sheath 111 can be a catheter-like structure. The puncture needle base 112 is also a hollow structure with a chamber (i.e., an inner cavity 1123) inside; the puncture needle base 112 is provided with three passages in communication with the inner cavity 1123, and the shape of the passage is not particularly limited in this embodiment. The three passages are respectively for connecting the puncture needle sheath 111, the transfusion interface 1121 for connecting the transfusion tube, and the blood pressure measurement interface 1122 for connecting the capillary cavity optical fiber sensor. Further, the puncture needle sheath 111 and the puncture needle base 112 can be an integrally formed structure. The puncture needle sheath 111 and the puncture needle base 112 can also be two independently manufactured structures that are fixedly connected into one whole.

[0052] Regarding the puncture needle core 12, it is used to guide the puncture needle sheath 111 to puncture into the blood vessel, so that the puncture needle sheath 111 can guide the blood in the blood vessel into the inner cavity 1123 of the puncture needle base 112. The blood vessel can be an artery or a vein.

[0053] The puncture needle core 12 is specifically a hollow structure to guide the blood in the blood vessel; one end (which can be referred to as the front end) of the puncture needle core 12 is used for puncture, and the front end is a short bevel structure to improve the efficiency, accuracy and safety of puncture. The outer diameter of the puncture needle core 12 is smaller than the outer diameter of the puncture needle sheath 111, so that the puncture needle core 12 can be inserted into the puncture needle sheath 111.

[0054] In some embodiments, the rear end of the puncture needle core 12 is provided with a blood storage groove 121. When the puncture needle core 12 punctures into the blood vessel, the blood in the blood vessel will quickly flow back to the blood storage groove 121, so that whether the puncture blood return state is normal can be conveniently judged based on the blood storage groove 121.

[0055] The puncture needle core 12 and the puncture needle body 11 are independently provided structures, but when the puncture needle 1 is in a standby state, as shown in FIG. 1, the puncture needle core 12 is inserted into the puncture needle sheath 111, and the puncture needle sheath 111 is inserted into the puncture needle base 112. Figure 2As shown, the puncture needle core 12 can pass through the puncture needle base 112 and the puncture needle sheath 111 through the infusion interface 1121, so that the blood storage groove 121 of the puncture needle core 12 forms a sealed structure with the infusion interface 1121. Inserting the puncture needle core 12 into the puncture needle body 11 is more convenient for storage of the puncture needle 1. When measuring blood pressure, the puncture needle body 11 with the inserted puncture needle core 12 is used for puncture, the short bevel angle structure of the puncture needle core 12 first punctures into the blood vessel, and then guides the puncture needle sheath 111 sleeved outside the puncture needle core 12 to puncture into the blood vessel. When the puncture depth is appropriate, the puncture needle core 12 is pulled out of the puncture needle body 11 to complete the puncture operation. When pulling out the puncture needle core 12, the puncture needle base 112 needs to be pushed to make the puncture needle sheath 111 still remain in the target blood vessel. At this time, since the puncture needle core 12 has been pulled out of the puncture needle body 11, the blood in the blood vessel will flow along the puncture needle sheath 111 into the inner cavity 1123 of the puncture needle base 112. At this time, please refer to Figure 3 As shown.

[0056] In order to be able to perform blood pressure monitoring tasks in special environments such as functional nuclear magnetic examination in craniocerebral tumor surgery, nuclear magnetic resonance examination for critically ill patients, etc., the material of the puncture needle body 11 is selected to be a non-metal material, such as epoxy resin. Since the puncture needle core 12 will be pulled out before measurement, the material thereof can be a metal material, such as stainless steel or other metal materials with good biocompatibility. In addition, the material of the puncture needle core 12 can also be a non-metal material that meets the requirements of medical level, such as high-performance ceramics, etc.

[0057] In some embodiments, the puncture needle 1 further comprises a protective cap (not shown in the figure). The protective cap can be used to seal the blood pressure measurement interface 1122 when the puncture needle 1 is in a standby state.

[0058] (2) Regarding the Fabry-Perot cavity optical fiber sensor 2, in some embodiments, as shown in the figure, it comprises a sensor body 21, an optical fiber interface 22, and a medical instrument interface matched with the blood pressure measurement interface 1122 of the puncture needle 1.

[0059] The Fabry-Perot cavity optical fiber sensor 2 is connected with the blood pressure measurement interface 1122 of the puncture needle 1 through the medical instrument interface, and is connected with one end of the optical fiber transmission line 3 through the optical fiber interface. The other end of the optical fiber transmission line 3 is connected with the photoelectric conversion regulator 4. When the medical instrument interface and the blood pressure measurement interface 1122 are in a connected state, the pressure sensitive end of the sensor body 21 (i.e. the end of the sensor close to the Fabry-Perot cavity) enters the inner cavity 1123 of the puncture needle base 112. Among them, the sensor body 21 can partially or entirely enter the inner cavity 1123 of the puncture needle base 112.

[0060] In some embodiments, please refer to Figure 4The sensor body 21 comprises a two-stage sleeve 211 and a single-mode optical fiber 214; the single-mode optical fiber 214 comprises a fiber core 2141 and a cladding 2142; the single-mode optical fiber 214 is sealedly nested in the two-stage sleeve 211, and the two-stage sleeve 211 has a micron-level optical cavity formed by laser technology therebetween, and the two faces of the optical cavity are respectively plated with high-reflection films 212 (high-precision reflection films) by laser, one of which is close to the end face of the single-mode optical fiber and connected with the single-mode optical fiber, and the other is away from the end face of the single-mode optical fiber 214 and close to the end face of the two-stage sleeve 211, and the two high-reflection films 212 together with the air in the optical cavity form an optical Fabry-Perot cavity (F-P cavity) 213, one of which is connected with the single-mode optical fiber 214 to emit laser and receive optical parameters and transmit optical information back to the photoelectric conversion regulator 4 for data analysis.

[0061] In some embodiments, the single-mode optical fiber and the high-reflection film 212 in the sensor body 21 can be fixed on the two-stage sleeve 211 by non-toxic high-molecular UV glue.

[0062] In some embodiments, the outer periphery of the sensor body 21 is coated with a skin, such as Figure 5 As shown, the skin comprises a coating layer 2143 and a protective layer 2144, and the further coating of the skin on the outer periphery of the sensor body 21 can increase the tensile, torsional and bending resistance of the sensor and improve its service life.

[0063] In some embodiments, the end face of the two-stage sleeve 211 is connected with a high-precision sensitive diaphragm 215, so as to increase the sensitivity and accuracy of the sensor. Further, the sensitive diaphragm 215 is made of single-crystal silicon or silicon dioxide diaphragm to improve the measurement accuracy. The sensitive diaphragm can be obtained by etching through semiconductor micro-electro-mechanical system technology.

[0064] In some embodiments, the Fabry-Perot cavity optical fiber sensor 2 further comprises a protective cap (not shown in the figure) for protecting the pressure-sensitive end. When the Fabry-Perot cavity optical fiber sensor 2 is in an unused state, the protective cap is installed at the front end of the Fabry-Perot cavity optical fiber sensor 2 to ensure the measurement accuracy of the Fabry-Perot cavity optical fiber sensor 2.

[0065] In some embodiments, the expansion coefficient of the material of the two-stage sleeve 211 is consistent with the expansion coefficient of the material of the single-mode optical fiber, so as to reduce the influence of temperature on the sensor as much as possible.

[0066] In some embodiments, since the Fabry-Perot cavity optical fiber sensor 2 will be directly in contact with the blood of the patient, based on medical safety and strict prevention and control of medical infections, the Fabry-Perot cavity optical fiber sensor 2 is disposable.

[0067] In some embodiments, the blood pressure measurement interface 1122 and the infusion interface 1121 are both luer inner conic interfaces. Correspondingly, the medical instrument port 22 of the capnography optical fiber sensor 2 is a luer outer conic interface, so that the blood pressure measurement interface 1122 can be fixedly connected with the medical instrument port 22.

[0068] In some embodiments, the outer periphery of the sensor body 21 is wrapped with a skin. In this way, the sensor body 21 can be better protected.

[0069] Further, in some embodiments, the outer periphery of the blood pressure measurement interface 1122 is provided with a thread (not shown in the figure), and correspondingly, the skin covering the front end of the sensor body is provided with a screw cap 216. Correspondingly, the thread matches the screw cap of the skin covering the front end of the sensor body. When the capnography optical fiber sensor 2 is docked with the blood pressure measurement interface 1122, the docking reliability can be improved by selecting the screw cap into the thread on the outer periphery of the blood pressure measurement interface 1122.

[0070] (3) Regarding the optical fiber transmission line 3, it is connected with the capnography optical fiber sensor 2 and the photoelectric conversion regulator 4 respectively through the optical fiber interfaces arranged at both ends.

[0071] In the present embodiment, the optical fiber transmission line 3 is used for signal transmission, including transmitting the laser emitted by the photoelectric conversion regulator 4 and the optical signal reflected by the capnography optical fiber sensor 2. The number and length of the optical fiber transmission line 3 can be bridged or customized according to specific clinical scenarios, which are not particularly limited in the present embodiment.

[0072] Considering that the optical fiber length of the capnography optical fiber sensor 2 is relatively limited, the present embodiment adopts the optical fiber transmission line 3 for long-distance bridging, rather than directly connecting the capnography optical fiber sensor 2 with the photoelectric conversion regulator 4, so that the actual needs of different clinical application scenarios and different monitoring distances can be met. At the same time, unlike the capnography optical fiber sensor 2, the optical fiber transmission line 3 can be reused, rather than being a disposable consumable, so that the cost of disposable consumables can be reduced, and the burden on patients and medical units can be reduced.

[0073] In some embodiments, the optical fiber transmission line 3 includes a core, a cladding, a coating layer, a protective layer, and ST-type optical fiber interfaces arranged at both ends.

[0074] The core is wrapped with a skin (composed of the coating layer and the protective layer), so that the corrosion resistance, bending performance, and damage resistance such as tensile and torsional resistance of the optical fiber transmission line 3 can be improved.

[0075] In some embodiments, the material and refractive index of the optical fiber transmission line 3 are consistent with those of the capnography optical fiber sensor 2, so that the attenuation of the optical signal transmission can be reduced, and the difference in optical signal transmission caused by different materials can be reduced, thereby improving the signal accuracy.

[0076] (4) A photoelectric conversion regulator 4 for emitting laser to the Fabry-Perot fiber sensor 2 and calculating blood pressure information according to the optical information reflected by the Fabry-Perot fiber sensor 2.

[0077] The photoelectric conversion regulator 4 includes a laser light source, a coupler, a photoelectric conversion chip, and a high-speed data storage module.

[0078] The laser light source emits incident light of a specific wavelength, which is transmitted to the Fabry-Perot fiber sensor 2 through the fiber transmission line 3 after being integrated by the coupler, and the optical information is transmitted back after being reflected by the Fabry-Perot fiber sensor 2. Among them, under the extrusion action of blood, the cavity length of the Fabry-Perot cavity in the Fabry-Perot fiber sensor 2 changes, thereby changing the reflected optical parameters. After the Fabry-Perot fiber sensor 2 transmits back the optical information, it is transmitted to the photoelectric conversion chip after being integrated by the coupler, and the photoelectric conversion chip converts the optical information into an electrical signal according to the pressure correlation and stores it in the high-speed data storage module.

[0079] Specifically, the light transmitted by the fiber transmission line 3 is vertically incident on the end face of the single-mode optical fiber 214 in the Fabry-Perot fiber sensor 2 through the single-mode optical fiber 214, a part of the light power (about 4%) is reflected by the end face of the single-mode optical fiber 214, and the remaining light power is transmitted to the high-reflection film and is partially reflected by the inner surface of the high-reflection film and coupled back into the single-mode optical fiber 214. The reflected light of the end face of the single-mode optical fiber 214 and the reflected light of the inner surface of the high-reflection film interfere. According to the principle of thin film elastic deformation, the high-reflection film arranged away from the end face of the single-mode optical fiber 214 deforms under the extrusion action of blood pressure, thereby changing the cavity length of the Fabry-Perot cavity, causing the interference spectrum to change. By measuring the interference spectrum and demodulating the interference spectrum, the pressure change acting on the high-reflection film arranged away from the end face of the single-mode optical fiber 214 can be obtained.

[0080] Among them, according to the principle of elastic mechanics, the relationship between pressure change and cavity length change can be represented by the following formula:

[0081]

[0082] Among them, Δp represents the change of the pressure difference between the inside and outside of the high-reflection film; h represents the thickness of the high-reflection film; r represents the effective radius of the high-reflection film; Δd represents the change of the cavity length of the Fabry-Perot cavity; μ represents the Poisson's ratio of the high-reflection film; and E represents the Young's modulus of the high-reflection film.

[0083] In some embodiments, the photoelectric conversion regulator 4 can further include a processor and a display module, the processor can read the data in the high-speed data storage module, and the data can be visually displayed through the display module.

[0084] In some embodiments, the photoelectric conversion regulator can be designed as a plug-in device compatible with mainstream monitors, and then the photoelectric conversion chip converts the optical information into electrical signals according to the pressure correlation, and transmits the electrical signals to the compatible monitor through a preset transmission protocol, and the monitor displays the waveform and the measured blood pressure information (such as blood pressure value, etc.). In this embodiment, the photoelectric conversion regulator in the form of plug-in device can realize the function of quick start application through hot plug.

[0085] Based on the same inventive concept, the present application also provides a blood pressure measurement method, which is realized based on the blood pressure measurement system provided in any of the above embodiments; in some embodiments, the method comprises the steps as shown in Figure 6

[0086] S10: The puncture needle sheath is punctured into the target blood vessel through the puncture needle core, so that the blood in the target blood vessel flows into the inner cavity of the puncture needle base through the puncture needle sheath and directly contacts the pressure-sensitive end of the sensor body in the capillary cavity optical fiber sensor; the target blood vessel is an artery or a vein.

[0087] S20: The photoelectric conversion regulator emits laser to the capillary cavity optical fiber sensor, and calculates the blood pressure information according to the optical information reflected by the capillary cavity optical fiber sensor.

[0088] In some embodiments, after the puncture needle sheath is punctured into the target blood vessel, the method further comprises the following steps: judging whether the backflow state after puncture is normal based on the blood storage groove of the puncture needle core; if the backflow state is normal, the puncture needle core is extracted out of the puncture needle body by pushing the puncture needle base, and at the same time, the puncture needle sheath is left in the target blood vessel.

[0089] In the above embodiment, when the blood pressure measurement is performed, the puncture needle body 11 with the puncture needle core 12 inserted is used for puncture, the short bevel angle structure of the puncture needle core 12 first punctures into the blood vessel, and then the puncture needle sheath 111 sleeved outside the puncture needle core 12 punctures into the blood vessel, and when the puncture depth is appropriate, the puncture needle core 12 is extracted out of the puncture needle body 11 to complete the puncture operation, wherein when the puncture needle core 12 is extracted, the puncture needle base 112 needs to be pushed to make the puncture needle sheath 111 still left in the target blood vessel, at this time, since the puncture needle core 12 has been extracted out of the puncture needle body 11, the blood in the blood vessel will flow along the puncture needle sheath 111 to the inner cavity 1123 of the puncture needle base 112.

[0090] In the above embodiment, when the blood pressure measurement is performed, the blood pressure measurement interface 1122 is a necessary interface, and the infusion interface 1121 can be selected to be used or not used according to the actual situation.

[0091] ​In some embodiments, when the target blood vessel is a vein and the infusion interface of the puncture needle is connected to an infusion device, before the photoelectric conversion regulator emits laser to the copper cavity optical fiber sensor, the method further comprises: closing the infusion regulating valve or the three-way joint to suspend the infusion.

[0092] The puncture needle has an infusion interface, so it can be used not only for blood pressure measurement but also as an infusion pipeline. Considering that clinical measurement of venous blood pressure is usually for the purpose of determining volume and right heart load, there is no need for continuous monitoring of venous pressure in the infusion state, so when the infusion interface is connected to an infusion device, if venous pressure measurement is needed, the infusion should be suspended first, which can improve the accuracy of the venous pressure measurement result.

[0093] In some embodiments, when the target blood vessel is an artery and the infusion interface of the puncture needle is connected to a pressurized flushing device, the method further comprises: flushing the arterial pipeline with the pressurized flushing device at a fixed time or at an unfixed time.

[0094] The system (referring to the blood pressure measurement system) does not need to infuse liquid when monitoring arterial blood pressure. In some embodiments, when measuring arterial blood pressure, a pressurized flushing device can be connected to the infusion interface, and the arterial pipeline can be intermittently flushed by the pressurized flushing device during the measurement process, as shown in Figure 7 The pressurized flushing device is connected to the infusion device and the pressurized bag through a three-way joint, and the arterial pipeline is intermittently flushed by timely connecting the three-way joint, which can prevent the puncture needle from being blocked and help ensure the accuracy of the final blood pressure measurement.

[0095] In some embodiments, before the photoelectric conversion regulator emits laser to the copper cavity optical fiber sensor, the method further comprises: setting the zero point according to the patient's body position.

[0096] In the current technology for invasive measurement of arterial and venous blood pressure, system zero calibration is needed before blood pressure measurement. System zero calibration is usually to eliminate the existing pressure of the liquid-filled catheter system, which is a disadvantage of existing arterial pressure measurement systems. System zero calibration requires rotating the three-way joint to make the pressure pipeline communicate with the atmosphere, which will damage the pipeline airtightness. In addition, medical staff need to strictly perform hand hygiene and aseptic operation, which increases the work pressure of medical staff and increases the risk of pipeline contamination. The present embodiment does not need to perform system zero calibration (zero adjustment), but only needs to set the zero point.

[0097] The present embodiment sets the zero point adjustment in the system, which can be set directly through the system in addition to the conventional adjustment through the puncture point. The method is flexible and diverse. In particular, in the operation that needs to change the body position multiple times, the zero point setting can be completed by system adjustment without the need to open and close the three-way joint multiple times, so it has the advantages of reducing the risk of contamination and reducing human error.

[0098] Regarding the zero point setting, the arterial zero point is the left ventricular level, the patient is in a supine position, both hands are naturally placed on both sides of the body, the radial artery height is about the same as the heart position, so in the supine position, the natural position of both hands can be considered as the zero point position, and the zero point can be set. In special body position, such as head-up position or lateral position, etc., in the case of height difference between the heart and the puncture point, the following two ways can be used for adjustment.

[0099] Method 1: The puncture hand of the patient is extended outward, so that the puncture point is flush with the heart, and the zero point position is set.

[0100] Method 2: The height difference between the puncture point and the heart is measured, and the system is adjusted.

[0101] The relevant relationship is that the blood density of the human body is 1.05-1.06 g / cm3, when the sensor is 1 cm lower than the zero point position, about 1 cm H2O static water pressure, about 0.735 mmHg static water pressure, and vice versa, when the sensor is 1 cm higher than the zero point position, about 1 cm H2O static water pressure. According to this relationship, when the puncture point is N cm lower than the heart position, the zero point is set to N cm below the heart through system setting, so that the system will automatically subtract (0.735 * N) mmHg from the measured blood pressure value to obtain the actual blood pressure value; vice versa, when the puncture point is M cm higher than the heart position, the zero point is set to M cm above the heart through system setting, so that the system will automatically add (0.735 * M) mmHg to the measured blood pressure value to obtain the actual blood pressure value.

[0102] For specific limitations of the blood pressure measurement method, please refer to the above description of the blood pressure measurement system, which will not be repeated here.

[0103] Based on the same inventive concept, the present application also provides a puncture needle, which in some embodiments includes a puncture needle body and a puncture needle core, both of which are hollow structures.

[0104] The material of the puncture needle body is a non-metal material

[0105] The puncture needle body includes a puncture needle sheath and a puncture needle base;

[0106] The front end of the puncture needle base is connected to the rear end of the puncture needle sheath; the rear end of the puncture needle base is provided with an infusion interface for connecting an infusion tube and a blood pressure measurement interface for connecting a capillary cavity optical fiber sensor;

[0107] The front end of the puncture needle core is a short bevel structure; the puncture needle core is used to guide the puncture of the puncture needle sheath into the blood vessel, and the blood vessel is an artery or a vein; the puncture needle sheath is used to introduce the blood in the blood vessel into the inner cavity of the puncture needle base.

[0108] In some embodiments, the blood pressure measurement interface and the infusion interface are both luer internal taper interfaces.

[0109] In some embodiments, the outer periphery of the blood pressure measurement interface is threaded.

[0110] In some embodiments, the rear end of the puncture needle core is provided with a blood storage groove for judging the puncture blood return state.

[0111] In some embodiments, when the puncture needle is in standby state, the puncture needle core passes through the puncture needle base and the puncture needle sheath through the infusion interface, so that the blood storage groove of the puncture needle core forms a sealed structure with the infusion interface.

[0112] In some embodiments, the puncture needle further comprises a protective cap for sealing the blood pressure measurement interface.

[0113] For specific limitations of the puncture needle, please refer to the above description of the blood pressure measurement system, and the description of the puncture needle 1 in the above description of the blood pressure measurement system will not be repeated here.

[0114] It should be understood that the steps in each of the embodiments of the present application are not necessarily executed in the order indicated by the step numbers. Unless otherwise specified herein, the execution of these steps is not strictly limited in sequence, and these steps can be executed in other orders. Moreover, at least a part of the steps in each embodiment can include multiple sub-steps or multiple stages, and these sub-steps or stages are not necessarily executed at the same time, but can be executed at different times. The execution sequence of these sub-steps or stages is not necessarily sequential, but can be executed in rotation or alternation with at least a part of other steps or sub-steps or stages of other steps.

[0115] Those skilled in the art can understand that all or part of the processes in the above-mentioned embodiment methods can be completed by instructing the relevant hardware through a computer program. The program can be stored in a non-volatile computer readable storage medium, and when the program is executed, the processes of the above-mentioned embodiment methods can be included. Any reference to memory, storage, database or other medium used in the embodiments provided in the present application can include non-volatile and / or volatile memory. Non-volatile memory can include read-only memory (ROM), programmable ROM (PROM), electrically programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM) or flash memory. Volatile memory can include random access memory (RAM) or external cache memory. As an illustration but not limitation, RAM is available in various forms, such as static RAM (SRAM), dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), synchronous link (Synchlink), DRAM (SLDRAM), memory bus (Rambus) direct RAM (RDRAM), direct memory bus dynamic RAM (DRDRAM), and memory bus dynamic RAM (RDRAM), etc.

[0116] The technical features of the above embodiments can be combined in any way. In order to make the description simple, not all possible combinations of the technical features in the above embodiments are described, but as long as the combination of the technical features does not exist, it should be considered as the scope of the present application.

[0117] The above embodiments only express several implementation manners of the present application, and the description is more specific and detailed, but it should not be understood as a limitation on the scope of the patent. It should be pointed out that for ordinary skilled in the art, without departing from the concept of the present application, a number of modifications and improvements can be made, which are all within the scope of the present application. Therefore, the scope of protection of the present application should be subject to the appended claims.

Claims

1. A blood pressure measurement system, characterized in that, The system includes a puncture needle, an enamel cavity fiber optic sensor, a fiber optic transmission line, and a photoelectric conversion regulator; The puncture needle comprises a puncture needle body and a puncture needle core, both of which are hollow; the puncture needle body is made of non-metallic material. The puncture needle body includes a puncture needle sheath and a puncture needle base; The front end of the puncture needle base is connected to the rear end of the puncture needle sheath; the rear end of the puncture needle base is provided with an infusion interface for connecting an infusion tube and a blood pressure measurement interface for connecting the effusion cavity fiber optic sensor. The tip of the puncture needle core has a short bevel angle structure; the puncture needle core is used to guide the puncture needle sheath into a blood vessel, which is an artery or a vein; the puncture needle sheath is used to introduce blood from the blood vessel into the inner cavity of the puncture needle base. The enamel cavity fiber optic sensor includes a sensor body, a medical device interface that matches the blood pressure measurement interface of the puncture needle, and a fiber optic interface. The effluent cavity fiber optic sensor is connected to the blood pressure measurement interface of the puncture needle via the medical device interface, and to one end of the fiber optic transmission line via the fiber optic interface. The other end of the fiber optic transmission line is connected to the photoelectric conversion regulator. When the medical device interface and the blood pressure measurement interface are connected, the pressure-sensitive end of the sensor body enters the inner cavity of the puncture needle base, and the sensor body is partially or completely inserted into the inner cavity of the puncture needle base. When blood in the blood vessel flows into the inner cavity of the puncture needle base through the puncture needle sheath, the blood comes into direct contact with the pressure-sensitive end of the sensor body. The photoelectric conversion regulator is used to emit laser light to the epoch-optical fiber sensor and calculate blood pressure information based on the optical information reflected by the epoch-optical fiber sensor.

2. The system as described in claim 1, characterized in that, The medical device port of the enamel cavity fiber optic sensor is a Luer external conical interface.

3. The system as described in claim 1, characterized in that, The sensor body is covered with a skin.

4. The system as described in claim 1, characterized in that, The skin covering the front end of the sensor body is provided with a spiral cap.

5. A puncture needle, characterized in that, The puncture needle comprises a puncture needle body and a puncture needle core, both of which are hollow; the puncture needle body is made of non-metallic material. The puncture needle body includes a puncture needle sheath and a puncture needle base; The front end of the puncture needle base is connected to the rear end of the puncture needle sheath; the rear end of the puncture needle base is provided with an infusion interface for connecting an infusion tube and a blood pressure measurement interface for connecting an EPA-electrode fiber optic sensor. The tip of the puncture needle core has a short bevel angle structure; the puncture needle core is used to guide the puncture needle sheath into a blood vessel, which is an artery or vein; the puncture needle sheath is used to introduce blood from the blood vessel into the inner cavity of the puncture needle base; after the blood from the blood vessel flows into the inner cavity of the puncture needle base through the puncture needle sheath, the blood comes into direct contact with the pressure-sensitive end of the sensor body of the epoch-optic fiber optic sensor; when the medical device interface of the epoch-optic fiber optic sensor and the blood pressure measurement interface are connected, the pressure-sensitive end of the sensor body enters the inner cavity of the puncture needle base, and the sensor body partially or completely enters the inner cavity of the puncture needle base.

6. The puncture needle as described in claim 5, characterized in that, Both the blood pressure measurement interface and the infusion interface are Luer conical interfaces.

7. The puncture needle as described in claim 5, characterized in that, The blood pressure measurement interface has threads on its outer periphery.

8. The puncture needle as described in claim 6, characterized in that, The rear end of the puncture needle core is provided with a blood storage groove for judging the blood return status after puncture.

9. The puncture needle as described in claim 8, characterized in that, When the puncture needle is in standby mode, the puncture needle core passes through the infusion interface, the puncture needle base, and the puncture needle sheath, so that the blood storage groove of the puncture needle core and the infusion interface form a sealed structure.

10. The puncture needle as described in claim 5, characterized in that, The puncture needle also includes a protective cap for sealing the blood pressure measurement interface.

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