Puncture Device and System with Hematoma Monitoring Function

Abstract

The present invention discloses a puncture device and system with a hematoma monitoring function, which relates to the technical field of biomedical engineering. The device includes: an epidural puncture needle, including a needle body and a needle hub; an epidural catheter for entering the epidural space through the epidural puncture needle; the front end of the epidural catheter is an insertion section, which is longitudinally inserted along the epidural space after entering the epidural space, and an impedance measurement structure is provided corresponding to the insertion section for measuring the impedance value around the insertion section and transmitting it to an impedance analyzer; the impedance analyzer is used to receive the aforementioned impedance value and evaluate whether there is a hematoma in the epidural space according to the change information of the impedance. The present invention can sensitively, timely and accurately identify the occurrence and development risks of epidural hematoma, thereby helping to improve the quality of clinical medical safety and improve the perioperative prognosis of patients.

Description

Technical Field

[0001] The present invention relates to the technical field of biomedical engineering, and particularly relates to a puncture device and system with a hematoma monitoring function. Background Art

[0002] In clinical surgery, anesthesia is a key means for the success of surgery and the reduction of patient pain. Among them, epidural anesthesia (fully known as epidural space block anesthesia) is a technique commonly used for spinal analgesia, which can effectively reduce the use of opioid drugs while achieving satisfactory analgesic effects, and is widely used in limb surgeries below the abdomen (such as painless childbirth). The main component used in this anesthesia method is an anesthesia catheter, which needs to be inserted into the narrow epidural space. Since the catheter itself is usually made of polymer material and is relatively soft and unable to penetrate human tissues, an epidural puncture needle is needed to establish a channel to the epidural space. The operation process is generally as follows: First, the epidural puncture needle is inserted into the epidural space, then the epidural catheter (i.e., the anesthesia catheter) is inserted into the epidural space through the inner cavity of the puncture needle, and then the puncture needle is withdrawn, leaving the epidural catheter in the epidural space. In order to achieve a better anesthesia effect, after the epidural catheter enters the epidural space, it needs to move forward a certain distance along the longitudinal direction of the epidural space towards the head direction of the human body to achieve a better anesthesia effect. See Figure 1 as shown.

[0003] There are also potential hazards in the application of epidural anesthesia. One of the main risks is the occurrence of epidural hematoma (EH). Although this situation is relatively rare (about 6 / 1 million), once it occurs, it may lead to serious consequences: Epidural hematoma will compress the spinal cord, resulting in neurological dysfunction, causing the loss of movement and sensation, and even possibly leading to permanent paralysis. In addition, the formation of epidural hematoma is usually accompanied by symptoms such as acute pain, weakness in the lower limbs, and difficulty in urination, seriously affecting the quality of life of patients.

[0004] The main causes of epidural hematoma (EH) include puncture injury and abnormal coagulation function of patients. Although medical staff will perform strict aseptic operations and technical specifications during epidural puncture, it is still possible to cause hematoma due to improper operation or individual vascular variation of patients, and the risk of hematoma formation around the indwelling epidural catheter is relatively high. At present, the detection of epidural hematoma mainly relies on imaging techniques, including magnetic resonance imaging (MRI), computed tomography (CT), ultrasonic exploration, etc. Among them, MRI technology has high resolution and can clearly show the location and scope of the hematoma, but it has the problems of high cost and long examination time; CT has a fast detection speed and relatively high accuracy, but it has radiation and it is difficult to perform continuous or dynamic detection; ultrasonic exploration has the advantages of non-invasiveness, rapidity and bedside availability, but its detection ability for such deep hematomas is limited. In addition, there are also some detection schemes using neuroelectrophysiological examinations, such as electromyogram (EMG), evoked potential (EP), etc., which mainly judge whether a hematoma has occurred by evaluating the nerve function state, conduction ability, etc. The operation is complex, time-consuming, and it is difficult to achieve early diagnosis and timely treatment. It can be seen that the existing monitoring methods are not sensitive to the early detection of epidural hematoma (EH), especially in the initial stage of symptoms, doctors may not be able to identify it in time.

[0005] On the other hand, with the development of bioimpedance technology, the bioelectrical impedance analysis (BIA) technology has been widely used in basic science and clinical science. For example, the conduction and impedance characteristics of electric current by biological tissues such as skin, muscle, fat, blood, bone, and body cavity can be utilized to clearly evaluate the tissue state. As an example, Chinese patent application CN202411708739.8 provides a puncture surgery tissue recognition system based on bioelectrical impedance, including: a double-electrode impedance needle for real-time acquisition of electrical signal data; a feedback display device integrated with a trained random forest model inside, which is used to process the electrical signal data according to the trained random forest model to obtain a classification result; a multi-frequency bioelectrical impedance analyzer for displaying the real-time acquisition waveform and simultaneously displaying the classification result of the random forest model. Among them, the double-electrode impedance needle includes a needle tube structure and an electrode structure located at the head of the needle tube structure; the needle tube structure includes an outer needle tube, an insulating tube layer, and an inner needle core from outside to inside; the electrode structure includes an excitation electrode layer, an insulating layer, and a measurement electrode layer from inside to outside. The excitation electrode layer is connected with an excitation electrode external cable, and the measurement electrode layer is connected with a measurement electrode external cable; the outer needle tube is connected to the measurement electrode layer, and the inner needle core is connected to the excitation electrode layer. The above technical solution measures the impedance value of biological tissues in the puncture area by setting electrodes on the needle tube of the puncture needle, and then analyzes the clinical state of the organism based on the measurement result, infers the physiological state of the biological tissue, so as to identify the type of biological tissue during the puncture process. Summary of the Invention

[0006] The object of the present invention is to overcome the deficiencies of the prior art and provide a puncture device and system with a hematoma monitoring function. Based on the bioelectrical impedance measurement technology and using the characteristic that the impedance of biological tissues changes when their state changes, after improving the puncture device used in epidural anesthesia surgery, the present invention provides a puncture device that can sensitively, timely, and accurately identify the occurrence and development risks of epidural hematoma, thereby helping to improve the quality of clinical medical safety and the prognosis of patients during the perioperative period.

[0007] To achieve the above object, the present invention provides the following technical solutions:

[0008] A puncture device with a hematoma monitoring function, the device includes:

[0009] An epidural puncture needle, including a needle body and a needle seat;

[0010] An epidural catheter is used to enter the epidural space through the epidural puncture needle; the front end of the epidural catheter is an insertion section, which is longitudinally inserted along the epidural space after entering the epidural space, and an impedance measurement structure is provided corresponding to the insertion section for measuring the impedance value around the insertion section and transmitting it to an impedance analyzer;

[0011] An impedance analyzer is used to receive the aforementioned impedance value and evaluate whether there is a hematoma in the epidural space according to the change information of the impedance.

[0012] Furthermore, the impedance measurement structure at least includes excitation electrodes, a measurement circuit, and a processor, and the excitation electrodes are located at both ends of the insertion section;

[0013] The excitation electrodes are used to apply a current signal to the periphery of the insertion section;

[0014] The measurement circuit is used to measure the voltage signal between the two end excitation electrodes or the voltage signal between the measurement electrodes located between the two end excitation electrodes when the excitation electrodes apply a current signal to the periphery of the insertion section;

[0015] The processor is used to calculate the corresponding impedance according to the aforementioned current signal and voltage signal as the impedance around the insertion section.

[0016] Furthermore, the electrodes are in a ring structure and sleeved outside the insertion section catheter;

[0017] The ring electrodes protrude relative to the outer surface of the insertion section catheter or are flush with the outer surface of the insertion section catheter.

[0018] Furthermore, an inflatable structure is provided inside the ring electrode to form an inflation ring,

[0019] When the inflatable structure is in a non-inflated state, the ring electrodes are received in the catheter wall and are flush with the outer surface of the catheter; when the inflatable structure is in an inflated state, it drives the ring electrodes to protrude outward relative to the catheter, so as to facilitate impedance measurement.

[0020] Furthermore, the inflatable structure includes an inflatable body and an inflation control circuit. A conductive material is provided on the outer surface of the inflatable body to form an electrode, and the inflation control circuit is communicatively connected to the impedance analyzer;

[0021] The impedance analyzer is configured to: when it is judged that the epidural space is evolving in the direction of a hematoma, send an inflation control instruction to the inflation control circuit;

[0022] The inflation control circuit is configured to: after receiving the aforementioned inflation control instruction, control the inflatable body to inflate.

[0023] Further, the inflatable body is an airbag, which has a hollow bladder. The bladder is connected to an external inflation structure so that the bladder can be inflated.

[0024] Further, the insertion section includes an inner tube and an outer tube. The inner tube serves as an anesthesia catheter, and at least a first electrode is provided on the inner tube; the outer tube is nested outside the inner tube and can move relative to the inner tube, and at least a second electrode is provided on the outer tube;

[0025] The outer tube is connected to an external traction controller through a traction structure. By driving the traction structure to act through the traction controller, the relative position between the outer tube and the inner tube is adjusted, so as to adjust the distance between the two electrodes to adjust the monitoring range.

[0026] Further, the insertion section includes an inner tube and an outer tube. The inner tube serves as an anesthesia catheter, and the outer tube is nested outside the inner tube and can move relative to the inner tube;

[0027] The outer tube includes a plurality of tube units, and adjacent tube units are connected by a dynamic measurement section. Electrodes are respectively provided on the tube units; the dynamic measurement section is connected to an external adjustment controller, and by the adjustment controller, the length of the dynamic measurement section in the axial direction of the catheter in the insertion section is changed to adjust the distance between the plurality of tube units, so as to adjust the distance between the electrodes to adjust the monitoring range.

[0028] Further, the dynamic measurement section adopts a flexible airbag tube. Both ends of the airbag tube are fixedly connected to the tube units on both sides respectively, and the airbag tube is communicated with the adjustment controller through a delivery pipeline. The adjustment controller includes a filling device and a suction device;

[0029] The adjustment controller is configured to: receive a dynamic measurement adjustment instruction. When the dynamic measurement adjustment instruction is to increase the monitoring range, control the delivery pipeline to be communicated with the filling device to inflate the airbag tube and increase the length of the dynamic measurement section in the axial direction of the catheter in the insertion section; when the dynamic measurement adjustment instruction is to decrease the monitoring range, control the delivery pipeline to be communicated with the suction device to deflate the airbag tube and decrease the length of the dynamic measurement section in the axial direction of the catheter in the insertion section.

[0030] The present invention also provides a hematoma monitoring and evaluation system. The system includes a puncture device and a user terminal. The puncture device is the puncture device with a hematoma monitoring function as described above;

[0031] The user terminal is configured to: receive the analysis result of the impedance analyzer and display and output it; and collect the operation instruction of the user, and control the impedance measurement structure and / or the impedance analyzer to execute the operation according to the operation instruction.

[0032] Due to the adoption of the above technical solutions, compared with the prior art, the present invention has the following advantages and positive effects by way of example: Based on the bioelectrical impedance measurement technology, taking advantage of the characteristic that the impedance of biological tissue changes when its state changes, after improving the puncture device used in epidural anesthesia surgery, the present invention provides a puncture device capable of sensitively, timely, and accurately identifying the occurrence and development risks of epidural hematoma, thereby contributing to improving the quality of clinical medical safety and the prognosis of patients during the perioperative period.

[0033] Furthermore, by improving the electrode structure of the impedance measurement structure, electrodes capable of adjusting the measurement state and monitoring range are provided, so as to better measure the state of the epidural cavity near the insertion section and evaluate the information on the occurrence and development of epidural hematoma. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 Schematic diagram of the indwelling of an epidural catheter in the epidural cavity.

[0035] Figure 2 Schematic diagram of a spinal section.

[0036] Figure 3 Schematic diagram of the structure of the puncture device with hematoma monitoring function provided by an embodiment of the present invention.

[0037] Figure 4 Schematic diagram of an epidural puncture needle provided by an embodiment of the present invention.

[0038] Figure 5 Schematic diagram of an epidural catheter with an insertion section provided by an embodiment of the present invention.

[0039] Figure 6 Schematic diagram of the state after the catheter insertion section is indwelled provided by an embodiment of the present invention.

[0040] Figure 7 Schematic diagram of the structure of the electrode before inflation provided by an embodiment of the present invention.

[0041] Figure 8 Schematic diagram of the structure of the electrode after inflation provided by an embodiment of the present invention.

[0042] Figure 9 Schematic diagram of the electrode structure adopting an airbag expansion ring provided by an embodiment of the present invention.

[0043] Figure 10 Schematic diagram of the insertion section structure including an inner tube and an outer tube provided by an embodiment of the present invention.

[0044] Figure 11 Schematic diagram of the insertion section structure with a dynamic measurement section provided by an embodiment of the present invention.

[0045] Description of reference numerals:

[0046] Puncture device 10;

[0047] Epidural puncture needle 100, needle body 110, needle head 111, needle seat 120;

[0048] Epidural catheter 200, catheter attachment 201, insertion section 210, inner tube 2101, outer tube 2102, tube unit 21, dynamic measurement section 22, catheter head section 211, electrode 212, conductive layer 2121, balloon cavity 2122, opening 2123, delivery pipeline 2124, guide wire 213;

[0049] Electrical impedance analyzer 300;

[0050] Anesthetic syringe 400. DETAILED DESCRIPTION

[0051] The puncture device and system with hematoma monitoring function disclosed in the present invention are further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the technical features or combinations of technical features described in the following embodiments should not be considered isolated, and they can be combined with each other to achieve better technical effects. In the drawings of the following embodiments, the same reference numerals appearing in each drawing represent the same features or components, which can be applied to different embodiments. Therefore, once an item is defined in one drawing, it does not need to be further discussed in subsequent drawings.

[0052] It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the limiting conditions for the implementation of the invention. Any modification of the structure, change of the proportion relationship or adjustment of the size should fall within the scope of the technical content disclosed by the invention without affecting the effects and purposes that can be achieved by the invention. The scope of the preferred embodiments of the present invention includes other implementations, in which the functions can be performed in a substantially simultaneous manner or in a reverse order according to the functions involved, which should be understood by those skilled in the art of the technical field to which the embodiments of the present invention belong.

[0053] Techniques, methods, and devices known to those of ordinary skill in the relevant art may not be discussed in detail, but where appropriate, the techniques, methods, and devices should be considered a part of the authorization specification. In all examples shown and discussed herein, any specific values should be interpreted as merely exemplary and not as limiting. Therefore, other examples of the exemplary embodiments may have different values.

[0054] In the description of the embodiments of the present application, " / " means "or", and "and / or" is used to describe the association relationship of associated objects, indicating that three relationships can exist. For example, "A and / or B" means: A exists alone, B exists alone, and both A and B exist simultaneously. In the description of the embodiments of the present application, "multiple" means two or more. Embodiment

[0055] Electrical impedance is a resistance that interferes with the flow of electric current and depends on the vector sum of resistance and reactance. In the human body, the difference between the impedance and resistance values is small, and the two can be used interchangeably. As a basic physical parameter of biological tissues, electrical impedance has long received extensive attention from biophysicists and physiologists.

[0056] Bioelectrical impedance measurement is a detection technique that uses the electrical properties of biological tissues and organs and their variation laws to extract biomedical information related to the physiological and pathological conditions of the human body. It usually uses an electrode system placed on the body surface to send a small alternating current measurement current or voltage to the detection object, detects the corresponding impedance and its changes, and then obtains relevant physiological and pathological information according to different application purposes. Currently, in the measurement of biological tissue impedance, the commonly used methods are the two-electrode method and the four-electrode method. Among them, the two-electrode measurement technique introduces a current signal into the measured biological tissue through a pair of electrodes, and then detects the voltage at both ends through the same pair of electrodes; the measurement electrodes of the four-electrode method generally consist of four metal electrodes, which are arranged in a row. The outer pair of metal electrodes are used as excitation electrodes, and the inner pair of metal electrodes are used as measurement electrodes. During measurement, the metal electrodes can be inserted into the measured tissue or attached to the surface of the measured tissue.

[0057] The epidural space, also known as the epidural cavity, is the space between the dura mater spinalis and the periosteum on the inner surface of the spinal canal. It contains the internal vertebral venous plexus, loose connective tissue, and fat, and the spinal nerves pass through it. Since the epidural space does not communicate with the intracranial cavity, this space is slightly negative in pressure. See Figure 2 As shown, the epidural space is a discontinuous space, roughly divided into 4 spaces in the front, back, and both sides by the nerve roots on both sides. Among them, the posterior epidural space is located between the posterior side of the posterior root epidural and the periosteum of the vertebral arch and the ligamentum flavum. The posterior space in the entire cervical segment is very narrow, about 1.5 mm, and the upper cervical segment may be closed; from the thoracic segment downwards, the posterior space gradually widens. The middle thoracic segment is about 2-4 mm wide, and the L2-3 segment can reach 6 mm. There is a relatively developed internal vertebral venous plexus in the posterior space, but it is less near the posterior midline. It is the site for indwelling the epidural catheter (the catheter is usually indwelled 2-5 cm in the epidural cavity, which can be appropriately adjusted according to factors such as the patient's age and weight). When performing epidural catheterization, the catheter has to push aside and penetrate some connective tissue and fat in the epidural space during the advancing process, and there is a relatively high risk of damaging blood vessels and forming a hematoma around the indwelling catheter during this process.

[0058] The present invention is based on bioelectrical impedance measurement technology. Utilizing the characteristic that the impedance of biological tissue changes when its state changes, the presence and characteristics of a hematoma are evaluated by detecting the impedance change in the epidural space - because the hematoma will cause a change in tissue impedance.

[0059] Specifically, the present invention provides a puncture device with a hematoma monitoring function. After the epidural catheter is inserted, a weak current is applied to the epidural tissue through the indwelling catheter and the voltage is measured. The impedance is calculated based on the measured value, and the occurrence information of the hematoma in the epidural space is evaluated according to the change in impedance.

[0060] See Figure 3 As shown, the typical structure of the puncture device with a hematoma monitoring function provided by the present invention is exemplified. The puncture device 10 includes an epidural puncture needle 100 and an epidural catheter 200. An impedance measurement structure is provided corresponding to the epidural catheter 200 for measuring the impedance value around the inserted section of the catheter and transmitting it to the impedance analyzer 300. An anesthetic syringe 400 is also connected to the epidural catheter.

[0061] See Figure 4 As shown, the epidural puncture needle 100 includes a needle body 110 and a needle hub 120.

[0062] The needle body 110 may include a needle tube, and the material of the needle tube is medical stainless steel. One end of the needle tube is a needle tip 111, and the other end is fixed with a needle hub 120 that communicates with the needle tube. The front end of the needle tip 111 is a needle opening, and the needle opening is an oval shape close to a circle. An operation handle and a catheterization adapter may be provided on the needle hub 120, and a flap-type seal valve is hermetically provided at the rear end of the catheterization adapter.

[0063] The rear end of the catheterization adapter of the needle hub 120 is detachably connected to the catheterization accessory 201 of the epidural catheter 200. When catheterization is required, after the catheterization accessory 201 is inserted into the rear end interface of the catheterization adapter, the epidural catheter 200 is inserted through the inner cavity of the needle hub and the inner cavity of the needle tube, so that the epidural catheter 200 enters the epidural space through the epidural puncture needle 100.

[0064] During use, insert the needle tube of the epidural puncture needle into the human tissue at the current position. When the puncture needle passes through the ligamentum flavum and reaches the epidural space between the ligamentum flavum and the dura mater (there is an obvious sense of falling through), at this time, after judging that the tip 111 of the needle tube reaches the epidural space, insert the epidural catheter 200 into the needle tube. After the head end of the epidural catheter 200 enters the epidural space through the inner cavity of the puncture needle, it bends towards the patient's head direction through the needle opening under the guidance of the tip 111 and advances longitudinally in the epidural space. After the catheter placement is completed, withdraw the puncture needle, leave the catheter in the epidural space, and after fixing the catheter, administer local anesthetic drugs through the catheter. The epidural catheter 200 is a flexible tube and can adopt a reinforced epidural catheter (provided with a reinforcing lining). A spring is arranged inside the catheter wall of the reinforced epidural catheter to resist bending, and it is not easy to kink and break, reducing the risks of blockage and catheter breakage.

[0065] See Figure 5 As shown, the front end of the epidural catheter 200 is the placement section 210, which is longitudinally placed in the epidural space after entering the epidural space and is basically parallel to the longitudinal direction of the epidural space. See Figure 6 As shown.

[0066] The front end of the placement section 210 is the catheter head section 211, and openings are arranged on the catheter head section 211 to allow liquid to pass through (such as administering anesthetic drugs). The openings can be arranged at the head end and / or the side wall of the catheter head section 211, and multiple rows can be set, such as 4 rows, and one or more openings can be set in each row.

[0067] An impedance measurement structure is correspondingly arranged for the placement section 210 to measure the impedance value around the placement section and transmit it to the impedance analyzer 300. The impedance analyzer 300 is used to receive the aforementioned impedance value and evaluate whether there is a hematoma in the epidural space according to the change information of the impedance.

[0068] When specifically setting, the impedance measurement structure at least includes excitation electrodes, a measurement circuit, and a processor.

[0069] The excitation electrodes are a pair and can be respectively located at both ends of the catheter placement section 210. See Figure 5 And Figure 6 As shown, a pair of metal electrodes 212 are respectively arranged at both ends of the placement section 210 as excitation electrodes. Among them, the first electrode is close to the catheter head section 211 and is located at the distal end of the placement section 210, and the second electrode is far from the catheter head section 211 (close to the epidural puncture needle) and is located at the proximal end of the placement section 210.

[0070] The excitation electrodes apply a current signal to the periphery of the placement section. The applied current signal can be a constant current or an alternating current with a constant amplitude.

[0071] The measurement circuit is used to measure the voltage signal between the two excitation electrodes at both ends when the current signal is applied to the periphery of the implantation section by the foregoing excitation electrodes (corresponding to the two-electrode method, and the excitation electrodes are also the measurement electrodes). At this time, the measurement circuit directly measures the voltage between the two excitation electrodes, and only two electrodes need to be set at this time.

[0072] Alternatively, the measurement circuit is used to measure the voltage signal between the measurement electrodes located between the excitation electrodes at both ends when the current signal is applied to the periphery of the implantation section by the excitation electrodes. At this time, a section is selected between the two excitation electrodes to measure the corresponding voltage of this section. At this time, at least two measurement electrodes also need to be set on the implantation section, and the tissue length between the two measurement electrodes is the measurement section. Taking the setting of four electrodes as an example, the four metal electrodes can be arranged in a row. The pair of outer metal electrodes serve as excitation electrodes for injecting the measurement current, and the pair of inner metal electrodes serve as measurement electrodes for measuring the voltage drop (corresponding to the four-electrode method, separating current injection and voltage measurement), see Figure 7 as shown.

[0073] The processor is used to calculate the corresponding impedance according to the foregoing current signal and the real-time voltage signal as the impedance value of the periphery of the implantation section at the current time. Specifically, the processor is configured to perform the following calculations: obtain the measured voltage drop V and the injected current I, calculate the resistance R = V / I according to Ohm's law, and use this calculated value as the impedance value of the periphery of the implantation section; and, feedback the calculation result to the impedance analyzer in real time, and the feedback data includes the impedance value and the current time information.

[0074] In this embodiment, the electrodes of the impedance measurement structure are arranged on the implantation section 210 (located in the epidural cavity). The measurement circuit may specifically include an external wiring cable and a voltage measurement component. The voltage measurement component may be arranged at the tail end of the epidural catheter 200. The external wiring cable passes through the catheter wall of the epidural catheter 200 to connect the internal electrode and the external voltage measurement component; the processor is located outside the body and may be integrally arranged with the voltage measurement component and is arranged at the tail end of the epidural catheter 200. The processor is communicatively connected to the impedance analyzer 300 for information interaction.

[0075] In this embodiment, the impedance analyzer 300 can receive the impedance data sent by the foregoing processor in real time and continuously, and then evaluate whether there is a hematoma in the epidural cavity according to the change information of the impedance.

[0076] Specifically, a hematoma risk analysis module may be provided in the impedance analyzer 300. The hematoma risk analysis module is configured to: according to the received data, calculate the change amount Ri of the impedance value within each time interval period Ti at a preset time interval period T, where i represents the number of periods and is an integer greater than or equal to 1, i = 1, 2, 3, ……, Ti represents the i-th time interval period, and Ri represents the change value of the impedance value within the i-th time interval period, with the unit of Ω; compare the change amount Ri with a preset change amplitude threshold Rk. When the change amount Ri is greater than or equal to the change amplitude threshold Rk, it is determined that there is a risk of the epidural cavity evolving towards a hematoma, that is, there is a hematoma risk, and a hematoma risk warning can be issued and a prompt for hematoma depth detection can be given. When the change amount Ri is less than the change amplitude threshold Rk, it can be determined that there is no hematoma risk at present. At this time, the monitoring can continue in the existing manner.

[0077] The change amplitude threshold Rk is mainly related to factors such as the type of biological tissue, the magnitude of the injected current during measurement, and the amplitude of current alternation (if alternating current testing is used). In this embodiment, it can be set by the system default or can be personalized by the user according to needs.

[0078] Preferably, in the impedance analyzer, for different types of biological tissues, corresponding reference resistance values Rb and amplitude threshold reference ratios λ are configured in combination with several common current injection situations. The reference resistance value Rb represents the reference resistance value of this type of biological tissue under normal circumstances (without hematoma). The amplitude threshold reference ratio λ is used to calculate the aforementioned change amplitude threshold Rk. As an example, for a certain type of biological tissue, the corresponding current injection situations are divided into two types (one is a preset constant current injection, and the other is a preset amplitude alternating current injection), and the corresponding reference resistance value Rb and amplitude threshold reference ratio λ are configured for these two situations respectively.

[0079] At this time, the impedance analyzer may include a user interface and an initialization module.

[0080] The user interface is used to collect the information of the type of biological tissue and the type of current injection input by the user in the information collection column. Alternatively, the user interface is used to collect the information of the target type of biological tissue and the type of current injection selected by the user. At this time, an option list is provided for the user to select, and the user can select the specific types of biological tissue and current injection displayed in the option list.

[0081] The initialization module is configured to: obtain the target biological tissue type and current injection type input or selected by the user, obtain the reference resistance value Rb and amplitude threshold reference ratio λ corresponding to the target biological tissue type and current injection type from the foregoing configuration information, and determine the corresponding change amplitude threshold Rk according to the reference resistance value Rb and amplitude threshold reference ratio λ, where the change amplitude threshold Rk is the product of the foregoing reference resistance value Rb and amplitude threshold reference ratio λ.

[0082] As an example but not a limitation, for instance, the biological tissue type selected by the user is the epidural cavity tissue, the current injection type is injecting a constant current I0, and the obtained corresponding amplitude threshold reference ratio λ is 10%, then the change amplitude threshold Rk is the foregoing reference resistance value Rb multiplied by 10%.

[0083] Furthermore, considering that a hematoma is a gradually forming process, and during this process, the impedance change of the epidural cavity tissue shows a certain regularity. Therefore, a corresponding hematoma-impedance change law model is configured for each biological tissue type in the impedance analyzer. The hematoma-impedance change law model records the impedance change law of the biological tissue when the biological tissue develops from no hematoma to a hematoma of a preset size (which can be obtained based on a bioelectrical impedance measurement experiment on the biological tissue).

[0084] At this time, the hematoma risk analysis module is further configured to: obtain the target biological tissue type input or selected by the user, and obtain the hematoma-impedance change law model corresponding to the target biological tissue type; sort the impedance values and the corresponding current time information obtained from the impedance measurement structure in chronological order to form the real-time change law of the impedance value over time, and compare the real-time change law with the impedance change law recorded in the foregoing hematoma-impedance change law model. When the matching degree between the real-time change law and the impedance change law is greater than or equal to a preset threshold, such as 70%, it is determined that there is a risk of hematoma development, a hematoma development warning is issued and a prompt is given to perform a hematoma depth detection; when the matching degree between the real-time change law and the impedance change law is less than the preset threshold, it can be determined that there is no current risk of hematoma development, and at this time, monitoring can continue in the existing manner.

[0085] Preferably, the hematoma development warning information may further include hematoma development stage information. For example, the hematoma development stage may include five stages: micro - type hematoma stage, small - type hematoma stage, medium - type hematoma stage, medium - large - type hematoma stage, and large - type hematoma stage. In the hematoma - impedance change rule model, the impedance reference ranges for the above - mentioned hematoma development stages are configured. After determining the existence of hematoma development risk, the hematoma risk analysis module may further be configured to: obtain the impedance value data at the latest N moments, determine which stage's impedance reference range the impedance value data at the previous N moments is located in, and use the corresponding stage as the current hematoma development stage. N is an integer greater than or equal to 2.

[0086] Further, when N = 2 and the two impedance value data are respectively located in two hematoma development stages, the more severe stage may be selected as the current hematoma development stage; when N is greater than or equal to 3 and the N impedance value data are located in different hematoma development stages, the stage with the most data falling into it may be selected as the current hematoma development stage.

[0087] In this way, the impedance analyzer can receive the impedance data sent by the aforementioned processor in real - time and continuously, and then evaluate whether there is a hematoma in the epidural cavity and the hematoma development information according to the change information of the impedance.

[0088] In a preferred embodiment, the electrode is in a ring structure and is sleeved outside the catheter of the insertion section 210. The ring - shaped electrode may protrude relative to the outer surface of the insertion - section catheter or be flush with the outer surface of the insertion - section catheter. See Figure 7 As shown, at this time, that is, the outer surface diameter of the ring - shaped electrode is equal to the outer surface diameter of the catheter, and the inner side of the ring - shaped electrode can be embedded in the catheter wall of the insertion section 210 but the outer surface is exposed in the epidural cavity to be able to apply a current signal to the cavity.

[0089] In one embodiment, an inflatable structure may be further provided inside the ring - shaped electrode to form an inflation ring.

[0090] The inflatable structure has a non - inflated state and an inflated state. In the non - inflated state, the ring - shaped electrode is received in the catheter wall and is flush with the outer surface of the catheter; in the inflated state, it can drive the ring - shaped electrode to protrude outward relative to the catheter to form a protruding electrode structure. See Figure 8 As shown, so as to facilitate measuring the impedance.

[0091] Specifically, the inflatable structure may include an inflatable body and an inflation control circuit, and the inflation control circuit is communicatively connected to the impedance analyzer and can perform information interaction.

[0092] The impedance analyzer is configured to: when it is determined that the epidural space is evolving in the direction of a hematoma, send an inflation control instruction to the inflation control circuit.

[0093] The inflation control circuit is configured to: after receiving the inflation control instruction sent by the aforementioned impedance analyzer, control the inflation of the inflatable body.

[0094] In a preferred embodiment, the inflatable body is an airbag, which has a hollow bladder. The bladder is connected to an external inflation structure so that the bladder can be inflated. As shown in Figure 9 shown, an opening 2123 is provided on the bladder. The opening 2123 is connected to an external inflation structure (such as an inflator pump) through a delivery tube 2124. A conductive layer 2121 is provided on the outer side of the bladder as an electrode. The conductive layer 2121 is connected to an external voltage measurement component through a wire 213 (and an external cable). At this time, the wire 213 can be led out through the delivery tube 2124. The delivery tube 2124 can be provided on the catheter wall of the epidural catheter 200. After the bladder is inflated, an airbag cavity 2122 is formed, driving the annular electrode to expand and protrude outward.

[0095] Preferably, the conductive layer 2121 is a conductive material coated on the surface of the bladder, or a metal ring formed by a metal spiral, which can expand and contract with the bladder. Alternatively, the conductive layer 2121 is a conductive ring assembled by a plurality of arc-shaped metal sheets, and the arc-shaped metal sheets can be connected by a conductive elastic structure (such as a spring) to adapt to the expansion and contraction of the bladder.

[0096] Considering the need for monitoring range adjustment, the catheter structure of the implanted section is improved in this embodiment.

[0097] As shown in Figure 10 shown, in one embodiment, the implanted section 210 of the epidural catheter 200 may include an inner tube 2101 and an outer tube 2102 nestedly arranged. The inner tube 2101 serves as an anesthesia catheter, and at least a first electrode is provided on the inner tube 2101. The outer tube 2102 is sleeved outside the inner tube and can move relative to the inner tube 2101, and at least a second electrode is provided on the outer tube 2102.

[0098] A traction structure is provided corresponding to the outer tube 2102. The traction structure is connected to an external traction controller, and the traction controller is used to drive the traction structure to act to adjust the relative position of the outer tube 2102 and the inner tube 2101, that is, to control the outer tube 2102 to move relative to the inner tube 2101, so as to adjust the distance between the electrodes 212 and thus adjust the monitoring range.

[0099] As an example of a typical method, the traction structure may adopt a traction wire. The traction wire may be one or more. One end of each traction wire is fixedly connected to the outer tube, and the other end is connected to an external traction controller. The traction controller drives the traction wire to wind so that the outer tube moves relative to the inner tube.

[0100] Continue to refer to Figure 10 As shown, taking the two-electrode method as an example, current is introduced into the measured biological tissue through a pair of excitation electrodes 212, and then the voltage across the two ends of the pair of excitation electrodes 212 is measured. By adjusting the distance between the two excitation electrodes 212, the monitoring range around the implanted section is adjusted.

[0101] When the four-electrode method is adopted, it further includes a pair of measurement electrodes. In order to adjust the distance between the measurement electrodes to adjust the measurement range, a first excitation electrode and a first measurement electrode may be provided on the inner tube 2101. The first excitation electrode is located outside the first measurement electrode. A second excitation electrode and a second measurement electrode are provided on the outer tube 2102. The second excitation electrode is located outside the second measurement electrode. By controlling the outer tube 2102 to move relative to the inner tube 2101, the distance between the two excitation electrodes 212 changes, and at the same time the distance between the two measurement electrodes also changes, thereby adjusting the measurement range.

[0102] Refer to Figure 11 As shown, in another embodiment, the implanted section 210 of the epidural catheter 200 may include an inner tube 2101 and an outer tube 2102 nested with each other. The inner tube 2101 serves as an anesthesia catheter, and the outer tube 2102 is sleeved outside the inner tube and can move relative to the inner tube 2101. The outer tube 2102 includes a plurality of tube units 21, and adjacent tube units 21 are connected by a dynamic measurement section 22. Excitation electrodes 212 are respectively provided on the tube units 21; the dynamic measurement section 22 is connected to an external adjustment controller, and by changing the length of the dynamic measurement section 22 in the axial direction of the implanted section catheter through the adjustment controller, the distance between the plurality of tube units is adjusted, so as to adjust the distance between the electrodes, thereby adjusting the monitoring range.

[0103] In a preferred embodiment, the dynamic measurement section 22 adopts a flexible airbag tube. Both ends of the airbag tube are fixedly connected to the two side tube units 22 respectively, and the airbag tube is communicated with the adjustment controller through a delivery pipeline. The adjustment controller includes a filling device and a suction device.

[0104] The adjustment controller is configured to: receive a dynamic measurement adjustment instruction. When the dynamic measurement adjustment instruction is to increase the monitoring range, control the delivery pipeline to be communicated with the filling device to inflate the airbag tube, increasing the length of the dynamic measurement section in the axial direction of the implanted section catheter; when the dynamic measurement adjustment instruction is to reduce the monitoring range, control the delivery pipeline to be communicated with the suction device to deflate the airbag tube, reducing the length of the dynamic measurement section in the axial direction of the implanted section catheter.

[0105] It should be noted that Figure 11 Figure 11 Taking the two - electrode method as an example, the distance adjustment between the two electrodes is illustrated. When the four - electrode method is adopted, it also includes a pair of measuring electrodes. At this time, preferably, at least 4 tube units 21 can be set, and adjacent tube units 21 are all connected by a dynamic measurement section 22, that is, 3 dynamic measurement sections 22 are set. Electrodes are respectively arranged on each tube unit 21. For example, a first excitation electrode can be arranged on the first tube unit 21, a first measuring electrode can be arranged on the second tube unit 21, a second measuring electrode can be arranged on the third tube unit 21, and a second excitation electrode can be arranged on the fourth tube unit 21. The first excitation electrode is located outside the first measuring electrode, and the second excitation electrode is located outside the second measuring electrode. When the dynamic measurement section 22 between the tube units 21 is inflated or deflated, the length of the dynamic measurement section 22 changes, and the distance between the tube units 21 also changes, prompting the distance between the electrodes to change, thereby adjusting the monitoring range.

[0106] Another embodiment of the present invention also provides a hematoma monitoring and evaluation system.

[0107] The system includes a puncture device and a user terminal.

[0108] The puncture device includes an epidural puncture needle and an epidural catheter. An impedance measurement structure is provided corresponding to the epidural catheter to measure the impedance value around the inserted segment of the catheter and transmit it to an impedance analyzer. An anesthetic syringe is also connected to the epidural catheter.

[0109] The epidural puncture needle includes a needle body and a needle hub.

[0110] The epidural catheter is used to enter the epidural cavity through the epidural puncture needle; the front end of the epidural catheter is the inserted segment, which is longitudinally inserted along the epidural cavity after entering the epidural cavity. An impedance measurement structure is provided corresponding to the inserted segment to measure the impedance value around the inserted segment and transmit it to the impedance analyzer.

[0111] The impedance analyzer is used to receive the aforementioned impedance value and evaluate whether there is a hematoma in the epidural cavity according to the change information of the impedance.

[0112] The user terminal is configured to: receive the analysis result of the impedance analyzer and display and output it; and collect the operation instructions of the user, and control the impedance measurement structure and / or the impedance analyzer to perform corresponding operations according to the operation instructions.

[0113] For other technical features, refer to the description of the previous embodiment, and details will not be repeated here.

[0114] In the foregoing description, the disclosure of the present invention is not intended to limit itself to these aspects. Rather, within the scope of the object of the present disclosure, the various components may be selectively and operatively combined in any number. Additionally, terms such as "including", "comprising", and "having" should be construed as inclusive or open by default, rather than exclusive or closed, unless explicitly defined to the contrary. All technical, scientific, or other terms conform to the meanings understood by those skilled in the art, unless defined to the contrary. Common terms found in a dictionary should not be construed too idealistically or too unrealistically in the context of the relevant technical documents, unless the present disclosure clearly defines them as such. Any changes or modifications made by those of ordinary skill in the art of the present invention based on the above disclosure fall within the scope of protection of the claims.

Claims

1. A puncture device with a hematoma monitoring function, characterized in that Comprising: An epidural puncture needle, including a needle body and a needle hub; An epidural catheter for entering the epidural space through the epidural puncture needle; the front end of the epidural catheter is an insertion section, which is longitudinally inserted along the epidural space after entering the epidural space, and an impedance measurement structure is arranged corresponding to the insertion section for measuring the impedance value around the insertion section and transmitting it to an impedance analyzer; An impedance analyzer for receiving the aforementioned impedance value and evaluating whether there is a hematoma in the epidural space according to the change information of the impedance; The impedance measurement structure at least includes excitation electrodes, a measurement circuit and a processor; the excitation electrodes are located at both ends of the insertion section for applying a current signal to the periphery of the insertion section; the measurement circuit is used for measuring the voltage signal between the two excitation electrodes or the voltage signal between the measurement electrodes located between the two excitation electrodes when the excitation electrodes apply a current signal to the periphery of the insertion section; the processor is used for calculating the corresponding impedance according to the aforementioned current signal and voltage signal as the impedance around the insertion section; The electrode is in a ring structure and sleeved outside the insertion section catheter; an inflatable structure is arranged inside the ring electrode to form an inflation ring. When the inflatable structure is in a non-inflated state, the ring electrode is received in the catheter wall and flush with the outer surface of the catheter; when the inflatable structure is in an inflated state, it drives the ring electrode to protrude outward relative to the catheter, so as to facilitate impedance measurement; The insertion section includes an inner tube and an outer tube. The inner tube is used as an anesthesia catheter, and the outer tube is nested outside the inner tube and can move relative to the inner tube; the outer tube includes a plurality of tube units, and adjacent tube units are connected by a dynamic measurement section. Electrodes are respectively arranged on the tube units; the dynamic measurement section is connected to an external adjustment controller, and the length of the dynamic measurement section in the axial direction of the insertion section catheter is changed through the adjustment controller to adjust the distance between the plurality of tube units, so as to adjust the distance between the electrodes to adjust the monitoring range; The dynamic measurement section adopts a flexible airbag tube. Both ends of the airbag tube are fixedly connected to the tube units on both sides, and the airbag tube is communicated with the adjustment controller through a delivery pipeline. The adjustment controller includes a filling device and a suction device; the adjustment controller is configured to: receive a dynamic measurement adjustment instruction. When the dynamic measurement adjustment instruction is to increase the monitoring range, control the delivery pipeline to be communicated with the filling device to inflate the airbag tube and increase the length of the dynamic measurement section in the axial direction of the insertion section catheter; when the dynamic measurement adjustment instruction is to reduce the monitoring range, control the delivery pipeline to be communicated with the suction device to deflate the airbag tube and reduce the length of the dynamic measurement section in the axial direction of the insertion section catheter.

2. The puncture device according to claim 1, wherein: The inflatable structure includes an inflatable body and an inflation control circuit. A conductive material is arranged on the outer surface of the inflatable body to form an electrode, and the inflation control circuit is communicatively connected with the impedance analyzer; The impedance analyzer is configured to: when it is judged that the epidural space is evolving towards a hematoma, send an inflation control instruction to the inflation control circuit; The inflation control circuit is configured to: after receiving the aforementioned inflation control instruction, control the inflatable body to inflate.

3. The puncture device according to claim 2, wherein: The inflatable body is an airbag, which has a hollow capsule body, and the capsule body is connected to an external inflation structure so that the capsule body can be inflated and expanded.

4. A hematoma monitoring and evaluation system, characterized in that: Including a puncture device and a user terminal, The puncture device is the puncture device with a hematoma monitoring function described in any one of claims 1-3; The user terminal is configured to: receive the analysis result of the impedance analyzer and display and output it; and collect the operation instructions of the user, and control the impedance measurement structure and / or the impedance analyzer to perform corresponding operations according to the operation instructions.

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