Lumbar anesthesia puncture needle and operation method thereof

Abstract

The invention relates to the technical field of spinal anesthesia puncture, and discloses a spinal anesthesia puncture needle and an operation method thereof.The spinal anesthesia puncture needle comprises a needle base, an inner needle body, a needle core and an expansion wing, a medicine outlet hole is formed in the outer side face of the front end of the inner needle body, and the expansion wing is arranged on the outer side face of the inner needle body and located behind the medicine outlet hole; the expansion wings can be expanded at different angles when being positioned in the epidural space and the subarachnoid space; the outer needle body is coaxially connected to the outer side of the inner needle body in a sliding mode, and a through hole corresponding to the expansion wing in position is formed in the front end of the outer needle body; the positioning mechanism enables the outer needle body to be fixed at different positions so as to control the expansion wings to stretch or retract; the angle detection assembly monitors the angle of the expansion wing in real time; according to the spinal anesthesia puncture needle, through cooperation of the expansion wing and the angle detection assembly, the position of the medicine outlet hole can be accurately judged, the puncture needle is prevented from retreating, and the problems that in-place judgment of the puncture needle is unreliable and the position of the medicine outlet hole is uncertain in the prior art can be effectively solved.

Description

Technical Field

[0001] The present invention relates to the technical field of spinal anesthesia puncture devices, and particularly relates to a spinal anesthesia puncture needle and an operation method thereof. Background Art

[0002] Lumbar puncture is a common medical procedure widely used in clinical scenarios such as spinal anesthesia, diagnostic lumbar puncture, and intrathecal drug administration. When performing lumbar puncture anesthesia, as Figure 1 shown, a doctor needs to insert a puncture needle through the skin, passing through the skin, subcutaneous tissue, supraspinous ligament a, interspinous ligament c, ligamentum flavum d, infraspinous ligament e, epidural space f, dura mater g, and arachnoid mater h, and finally reaching the subarachnoid space i, and then injecting an anesthetic drug for local or regional anesthesia.

[0003] The following problems exist in the existing spinal anesthesia puncture:

[0004] 1. Unreliable judgment of the puncture needle reaching the position:

[0005] When the puncture needle passes through the supraspinous ligament a, interspinous ligament c, and infraspinous ligament e, there will be a certain sense of resistance. At this time, an appropriate pressure needs to be maintained to avoid excessive force. When a significant "falling sensation" is felt, it may enter the epidural space f. Continue to insert the needle carefully. Another "falling sensation" indicates entering the subarachnoid space i. However, due to the too small epidural space (the thickness of the epidural space f) or too fast needle insertion speed, the operator often only feels one "falling sensation". Therefore, it is impossible to determine whether the puncture needle has entered the subarachnoid space i. Although generally, the method of pulling out the needle core to check whether cerebrospinal fluid flows out can be used for judgment, but often multiple operations of pulling out and inserting the needle core are required to determine, which is not only cumbersome in operation but also easy to cause damage to the human body;

[0006] 2. Uncertain position of the drug outlet hole:

[0007] The drug outlet hole of the traditional puncture needle is usually designed on the side of the needle tip. After the needle tip passes through the dura mater g and arachnoid mater h and enters the subarachnoid space, as Figure 2 shown, the drug outlet hole may be partially or completely located in the epidural space f and the situation where the arachnoid mater h stretches and blocks the drug outlet hole, resulting in incorrect drug injection position, thus affecting the anesthetic effect; moreover, even if the position is reached during the puncture process, during the drug injection process, the needle body is prone to retract, resulting in the posterior movement of the drug outlet hole position, thus affecting drug injection and anesthetic effect. Summary of the Invention

[0008] Aiming at the above-mentioned disadvantages of the existing technology, the present invention provides a spinal anesthesia puncture needle and an operation method thereof, which can effectively solve the problems of unreliable judgment of the puncture needle reaching the position and uncertain position of the drug outlet hole in the existing technology.

[0009] To achieve the above object, the present invention is realized by the following technical solutions:

[0010] The present invention provides a spinal puncture needle, comprising:

[0011] A spinal puncture needle, including a needle hub, an inner needle body fixedly connected to the front end of the needle hub, and a stylet slidably connected inside the needle hub and the inner needle body. At least one drug outlet hole is provided on the outer side surface of the inner needle body near the front end. It is characterized in that it further includes:

[0012] At least one dilating wing, arranged on the outer side surface of the inner needle body and behind the drug outlet hole. The natural state of the dilating wing is an expanded state, and when the dilating wing is located in the epidural space and the subarachnoid space, it can expand at a first predetermined angle and a second predetermined angle respectively;

[0013] An outer needle body, coaxially and slidably connected to the outside of the inner needle body. At least one through hole penetrating the wall thickness direction of the outer needle body is provided at the front end of the outer needle body. The through hole corresponds to the position of the dilating wing in the circumferential direction of the outer needle body;

[0014] A positioning mechanism for enabling the outer needle body to be fixed at at least a first fixed position and a second fixed position in the length direction of the inner needle body. When the outer needle body is in the first fixed position, the outer needle body can compress the dilating wing to retract it into a groove on the outer side surface of the inner needle body, and the groove is located behind the drug outlet hole. When the outer needle body is in the second fixed position, the dilating wing can expand freely and extend out of the outer side of the outer needle body through the through hole;

[0015] And an angle detection component for detecting the expansion angle of the dilating wing.

[0016] Further, the inner needle body is composed of a tube body and a needle tip fixedly connected to the front end of the tube body. The drug outlet hole is arranged on the outer wall of the needle tip. The groove is arranged at an interval before and after the rear end of the needle tip, and the outer diameter of the needle tip is equal to the outer diameter of the outer needle body and greater than the outer diameter of the tube body.

[0017] Further, the outer needle body includes a pressing section, a through hole section and a sliding section connected in sequence from front to back, wherein:

[0018] The pressing section can slide back and forth along the front end of the tube body. The length of the pressing section is equal to the length of the groove, and the distance between the front end of the groove and the rear end of the needle tip is equal to or greater than the length of the groove, so that the dilating wing is in a natural expansion state or completely retracted into the groove;

[0019] The through hole is arranged on the through hole section, and it corresponds to the groove on the outer surface of the tube body in the circumferential direction;

[0020] The inner wall of the sliding section is provided with a chute whose length is distributed along the length direction of the tube body, and the chute is in sliding fit with a slide rail provided on the outer surface of the tube body.

[0021] Further, the outer diameter of the slide rail is greater than the inner diameter of the pressing section, and when the outer needle body is in the second fixed position state, the front end of the slide rail is flush with the rear end of the groove, and the rear end of the pressing section is flush with the rear end of the needle tip.

[0022] Further, the rear end of the expansion wing is a movable end, and the front end is fixedly connected to the front end of the inner side wall of the groove, and the depth and shape of the groove are adapted to the size and shape of the expansion wing, so that the expansion wing can be completely accommodated in the groove in the compressed state.

[0023] Further, the positioning mechanism includes an installation hole, a first positioning groove, a second positioning groove and a positioning pin. The installation hole is arranged at the rear end of the side wall of the outer needle body. The first positioning groove and the second positioning groove are arranged at the rear end of the inner needle body and are distributed corresponding to the position of the installation hole in the circumferential direction. The first positioning groove is located behind the second positioning groove, and the distance between the two is equal to the length of the groove. The positioning pin passes through the installation hole and is in interference fit and clamped with the first positioning groove or the second positioning groove.

[0024] Further, the angle detection component includes:

[0025] A strain gauge, fixedly connected to the inner side wall of the expansion wing, for sensing the deformation amount of the expansion wing;

[0026] A signal conditioning unit, for receiving and processing the electrical signal generated by the strain gauge;

[0027] A data processing unit, including a microprocessor, for calculating the expansion angle of the expansion wing;

[0028] And a display module, signal-connected to the signal processing unit, for real-time displaying the expansion angle value of the expansion wing.

[0029] Further, the signal processing unit is also connected to an alarm, for when the expansion angle of the expansion wing reaches the second predetermined angle, the alarm emits a prompt signal.

[0030] A method for operating a spinal anesthesia puncture needle, based on the above spinal anesthesia puncture needle, is characterized by including the following steps:

[0031] S1. Operate the outer needle body to move to the first fixed position and fix it through the positioning mechanism, so that the expansion wing is completely contracted into the groove on the outer side surface of the inner needle body;

[0032] S2. Hold the needle hub and perform a puncture operation with the puncture needle. When the first sense of breakthrough is felt, slide the outer needle body to the second fixed position of the needle body and fix it to release the dilator wings so that they can pass through the through hole at the front end of the outer needle body for free dilation;

[0033] S3. Detect the dilation angle of the dilator wings through the angle detection component. If the detected dilation angle of the dilator wings is equal to the second predetermined angle, the puncture needle stops further forward puncture. If the dilation angle of the dilator wings is equal to the first predetermined angle or less than the second predetermined angle, continue to drive the puncture needle for puncture operation until the operator feels the second sense of breakthrough;

[0034] S4. Withdraw the stylet and perform anesthetic injection operation using a syringe;

[0035] S5. After the anesthetic injection is completed, move the outer needle body to the first fixed position and fix it so that the dilator wings are completely retracted into the groove on the outer side of the needle body, and then move the needle body backward to withdraw the puncture needle.

[0036] Further, in step S4, before withdrawing the stylet, hold the needle hub and drive the inner needle body to move backward. If there is an obvious sense of resistance, at this time, then withdraw the stylet and perform anesthetic injection operation.

[0037] The technical solution provided by the present invention has the following beneficial effects compared with the prior art:

[0038] 1. The dilator wings and the angle detection component are provided. The different pressures received by the dilator wings in the epidural space and the subarachnoid space result in different dilation states, that is, different dilation angles. The angle detection component detects the different dilation angles of the dilator wings and feeds back to judge whether the current puncture needle enters the subarachnoid space, solving the problem of misjudgment caused by the unclear "sense of breakthrough" during traditional spinal anesthesia puncture, greatly improving the accuracy of spinal anesthesia puncture, and avoiding the problem of tissue damage easily caused by observing cerebrospinal fluid by repeatedly inserting and withdrawing the stylet in the traditional method;

[0039] 2. The dilator wings are arranged at the rear position of the drug outlet hole. By detecting the dilation angle of the dilator wings, it is judged whether the drug outlet hole is completely located in the subarachnoid space, avoiding the problem that the drug outlet hole is all or partially located in the epidural space and the problem that the drug outlet hole is blocked by the arachnoid, and improving the spinal anesthesia effect;

[0040] 3. The dilator wings can expand at a predetermined angle inside the subarachnoid space, and their expansion state can prevent the puncture needle from retracting during the operation process, ensuring the stability of the drug outlet hole position;

[0041] 4. The state of the dilator wings is controlled by the cooperation of the outer needle body and the inner needle body. During needle insertion, the dilator wings can be manually controlled to be in a free expansion state, and after injection, the dilator wings can be controlled to retract, avoiding the pulling damage to the surrounding tissues during needle withdrawal;

[0042] 5. The inner needle body is composed of a tube body and a needle tip. The outer diameter of the tube body is smaller than that of the needle tip. When the outer needle body slides forward, the rear end of the needle tip can limit the front end of the outer needle body. And the front end of the slide rail is flush with the rear end of the groove. The outer diameter of the slide rail is larger than the inner diameter of the pressing section. The rear end of the outer needle body can be limited through the slide rail and the pressing section. The above limiting relationship can quickly locate the first fixed position and the second fixed position of the outer needle body, and the operation is convenient;

[0043] 6. When the operator feels the first sense of falling through, the expansion wings can be released. If the expansion wings are in the epidural space, during the continuous needle insertion process, the expansion wings can drive the dura mater and the arachnoid mater to bend medially at the same time until the expansion wings pass through the two and enter the interior of the subarachnoid space, avoiding the problem that the arachnoid mater blocks the medicine outlet hole due to the reverse bending of the dura mater and the arachnoid mater during the needle insertion process of the conventional puncture needle;

[0044] 7. In the operation method of the spinal anesthesia puncture needle, fix the first fixed position of the outer needle body - after the first sense of falling through, move the outer needle body to the second fixed position to release the expansion wings - detect the expansion angle of the expansion wings to judge whether to insert the needle - inject the anesthetic - contract the expansion wings and then withdraw the needle. There are clear judgment criteria for each step in the overall operation process, which can effectively reduce the operation difficulty and improve the success rate of spinal anesthesia;

[0045] 8. Before withdrawing the stylet, the needle holder can be held to drive the inner needle body to move backward. If there is an obvious sense of resistance, it means that the expansion wings are already in the subarachnoid space and expanded at this time. Combining with the expansion angle of the expansion wings, it can further ensure that the expansion wings and the medicine outlet hole are in the subarachnoid space, thereby improving the anesthetic effect. Description of the Drawings

[0046] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0047] Figure 1 It is a schematic diagram of spinal anesthesia puncture in the prior art;

[0048] Figure 2 It is a schematic diagram of the position of the medicine outlet hole during spinal anesthesia puncture in the prior art;

[0049] Figure 3 It is a schematic structural diagram of the present invention;

[0050] Figure 4 Schematic diagram of the structure of the inner needle body;

[0051] Figure 5 For Figure 4Schematic diagram of partial enlargement at position C in

[0052] Figure 6 Schematic diagram of the outer needle body structure;

[0053] Figure 7 For Figure 3 Schematic diagram of partial enlargement at position A in

[0054] Figure 8 For Figure 3 Schematic diagram of partial enlargement at position B in

[0055] Figure 9 Logic schematic diagram of the angle detection component;

[0056] Figure 10 Schematic diagram of the state of the spinal anesthesia puncture needle of the present invention entering the subarachnoid space;

[0057] Figure 11 For Figure 10 Schematic diagram of partial enlargement at position D in

[0058] The labels in the figure respectively represent:

[0059] a, supraspinous ligament; b, spinous process; c, interspinous ligament; d, ligamentum flavum; e, subspinous ligament; f, epidural space; g, dura mater; h, arachnoid mater; i, subarachnoid space; j, spinal nerve; k, cerebrospinal fluid;

[0060] 1, needle hub;

[0061] 2, inner needle body; 21, tube body; 22, needle tip; 23, drug outlet hole; 24, groove; 25, dilation wing; 26, strain gauge; 27, slide rail; 28, first positioning groove; 29, second positioning groove;

[0062] 3, outer needle body; 31, compression section; 32, through-hole section; 33, sliding section; 34, chute; 35, mounting hole;

[0063] 4, stylet; 5, positioning pin; 6, signal conditioning unit; 7, data processing unit; 8, display module; 9, power supply; 10, alarm. Detailed implementation manners

[0064] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the scope of protection of the present invention.

[0065] The present invention will be further described below in conjunction with embodiments.

[0066] It should be noted that, for a clearer description of the present invention, in this embodiment, the end where the inner needle body 2 and the outer needle body 3 first enter the human body is defined as the front end, and the position where the needle seat 1 is located is defined as the rear end.

[0067] Please refer to Figures 3 - 11 , the present invention provides a technical solution: a spinal puncture needle, including a needle seat 1, an inner needle body 2, an outer needle body 3 and a stylet 4. The inner needle body 2 is fixedly connected to the front end of the needle seat 1. The outer needle body 3 is coaxially and slidably connected to the outside of the inner needle body 2. The stylet 4 is slidably connected to the inside of the needle seat 1 and the inner needle body 2. An injection hole 23 and a dilation wing 25 located behind the injection hole 23 are provided on the outer side surface of the front end of the inner needle body 2. And the outer needle body 3 is provided with a first fixed position and a second fixed position in the axial direction of the inner needle body 2 through a positioning mechanism. In the state of the second fixed position, the dilation wing 25 can freely expand outwards. In the state of the first fixed position, the outer needle body 3 can drive the dilation wing 25 to retract. In addition, an angle detection component is further included for detecting the expansion angle of the dilation wing 25.

[0068] Specifically, as shown in Figures 3 - 5 , the inner needle body 2 is composed of a tube body 21 and a needle tip 22 integrally formed at the front end of the tube body 21. Cavities distributed along the length direction are provided inside both the tube body 21 and the needle tip 22, and the internal cavities of the two are communicated. The stylet 4 can be axially and slidably connected to the inside of the tube body 21 and the needle tip 22. The front end of the needle tip 22 is a tip with an inclined section, and an injection hole 23 is provided on the outer side surface. The injection hole 23 is communicated with the internal cavity of the needle tip 22. The outer diameter of the tube body 21 is smaller than the outer diameter of the needle tip 22. A groove 24 is provided on the outer surface of the front end of the tube body 21, that is, the end close to the needle tip 22. The length of the groove 24 is L, and the distance between the front end of the groove 24 and the rear end of the needle tip 22 is also L. A dilation wing 25 is provided inside the groove 24. The dilation wing 25 is an elastic member, and its length is arranged in the front-rear direction. And the front end of the dilation wing 25 is fixed to the side wall of the front end of the groove 24, and the rear end is a free end. The dilation wing 25 can expand outwards in the natural state. The depth and shape of the groove 24 are adapted to the size and shape of the dilation wing 25, so that the dilation wing 25 can be completely accommodated in the groove 24 in the compressed state. In addition, a slide rail 27 is integrally formed on the outer surface of the tube body 21 located at the rear end of the groove 24. The length of the slide rail 27 is distributed along the axial direction of the tube body 21 and the front end extends to the rear end position of the groove 24.

[0069] In this embodiment, the expansion wing 25 is an elastic member made of nickel-titanium shape memory alloy. Under body temperature conditions, it can recover elastic strain and expand outward. The outer surface is treated by electrochemical passivation to form a dense oxide film, which has good biocompatibility. Moreover, the shape memory effect transition temperature is set at 30-32°C, slightly lower than the human body temperature, ensuring that the expansion wing 25 can be quickly activated after entering the human body. Furthermore, the expansion wing 25 can expand outward at a first predetermined expansion angle and a second predetermined expansion angle in the epidural space f and the subarachnoid space i respectively. The first predetermined angle is preferably 15°-25°, and the second predetermined angle is preferably 30°-45°. The reason is that the epidural space f is located between the inner wall of the spinal canal and the dura mater g, and it is a potential cavity filled with loose connective tissue, adipose tissue and venous plexus. The space is relatively limited and there is a degree of fibrosis. When the expansion wing 25 expands outward in the epidural space f, it will be subjected to the rebound extrusion force of the surrounding soft tissue wrapping, thus restricting its expansion angle. While the subarachnoid space i is located between the arachnoid mater h and the pia mater, filled with cerebrospinal fluid, the space is relatively open and there are almost no obstacles. Therefore, the expansion angle of the expansion wing 25 in the subarachnoid space i is larger than that in the epidural space f. By using the difference in the expansion angles of the expansion wing 25 caused by the different pressures in the subdural space f and the subarachnoid space i, the position of the so-called "falling feeling" can be judged, so as to achieve accurate judgment and control of the puncture position.

[0070] The outer needle body 3 is as Figure 3 and Figure 6 shown, with a cavity distributed through from front to back inside. The inner needle body 2 can be coaxially and slidably connected inside the cavity of the outer needle body 3. The outer diameter of the outer needle body 3 is the same as that of the tip 22 and larger than the outer diameter of the tip 22. And the outer needle body 3 is composed of a pressing section 31, a through-hole section 32 and a sliding section 33 connected in sequence from front to back. The pressing section 31 can slide back and forth along the front end of the inner tube body 21, and its length is the same as that of the groove 24, both being L. The length of the through-hole section 32 is equal to that of the groove 24. Through-holes penetrating the wall thickness are provided on the through-hole section 32, and the through-holes are correspondingly distributed in the circumferential direction with the groove 24 for the expansion wing 25 to expand and extend outward. And the inner wall of the sliding section 33 is provided with a chute 34 distributed along the length direction. The front end of the chute 34 extends to the rear end position of the through-hole section 32. The chute 34 cooperates with the slide rail 27 to slide, so as to realize the sliding guidance between the outer needle body 3 and the inner needle body 2. Moreover, an installation hole 35 is provided at the rear end of the sliding section 33. The installation hole 35 penetrates the wall thickness direction of the outer needle body 3 and communicates with the chute 34.

[0071] The positioning mechanism is as Figure 4 、 Figure 6 and Figure 8As shown, it includes a positioning pin 5, a mounting hole 35, a first positioning groove 28, and a second positioning groove 29. The first positioning groove 28 and the second positioning groove 29 are provided at the rear end of the slide rail 27, and the first positioning groove 28 is located behind the second positioning groove 29. The distance between the two is equal to the length of the groove 24. The mounting hole 35 is provided at the rear end of the sliding section 33 of the outer needle body 3 and is distributed through the wall thickness direction of the sliding section 33. After the positioning pin 5 passes through the mounting hole 35, it can be in interference fit and clamped with the first positioning groove 28 to realize the fixation of the outer needle body 3 at the first fixed position on the inner needle body 2, or be in interference fit and clamped with the second positioning groove 29 to realize the fixation of the outer needle body 3 at the second fixed position on the inner needle body 2.

[0072] The connection relationship between the outer needle body 3 and the inner needle body 2 is as Figure 7 and Figure 8 shown. When the outer needle body 3 slides to the second fixed position of the inner needle body 2, as Figure 7 shown, the front end of the pressing section 31 abuts against the rear end face of the needle tip 22. The rear end face of the needle tip 22 can axially limit the front end of the outer needle body 3. At this time, the mounting hole 35 corresponds to the position of the first positioning groove 28. By passing the positioning pin 5 through the mounting hole 35 and clamping it with the first positioning groove 28, the outer needle body 3 and the inner needle body 2 can be axially fixed. In this state, the through hole on the through hole section 32 corresponds to the position of the groove 24, and the expansion wing 25 can pass through the through hole on the through hole section 32 and expand outwards; when the positioning pin 5 is pulled out, the outer needle body 3 slides backward, and the pressing section 31 can compress the expansion wing 25 inward during the backward sliding process until after moving backward by a distance L, the expansion wing 25 completely adheres to the inside of the groove 24, and at this time, the rear end of the pressing section 31 contacts the slide rail 27, which can axially limit the rear end of the outer needle body 3. At the same time, the mounting hole 35 corresponds to the position of the second positioning groove 29, and the outer needle body 3 and the inner needle body 2 can be fixed through the positioning pin 5, thereby realizing the first fixed position of the outer needle body 3. In this state, the expansion wing 25 completely retracts and is fixed by pressing through the pressing section 31 and cannot expand outwards.

[0073] As Figure 4 、 Figure 5 and Figure 7As shown in the figure, the angle detection component includes a strain gauge 26, a signal conditioning unit 6, a data processing unit 7, a display module 8, a power supply 9, and an alarm 10. The strain gauge 26 is fixedly connected to the inner side wall of the expansion wing 25 and is a micro metal foil strain gauge. Four groups of strain gauges 26 are arranged on the inner side wall of each expansion wing 25. Two of the strain gauges 26 are distributed along the length direction of the expansion wing 25 as axial strain gauges, and two of the strain gauges 26 are along the direction perpendicular to the length direction of the expansion wing 25 as transverse strain gauges. The four groups of strain gauges 26 form a standard Wheatstone full bridge circuit. The signal conditioning unit 6 includes an amplifier, a filter, and an analog-to-digital converter. The Wheatstone full bridge circuit is signal-connected to the signal conditioning unit 6 for receiving and converting the electrical signals of the Wheatstone full bridge circuit. This part belongs to the prior art and will not be elaborated here. The data processing unit 7 includes a microprocessor. The signal conditioning unit 6 is connected to the signal input end of the microprocessor, and the display module 8 and the alarm 10 are both connected to the signal output end of the microprocessor. In addition, the signal conditioning unit 6, the data processing unit 7, the power supply 9, and the alarm 10 can all be integrated inside the needle hub 1 (not the injection liquid cavity). The power supply 9 can be used as the excitation source of the Wheatstone full bridge circuit and the power supply for the rest of the components. The excitation source wire passes through the inner needle body 2 and is electrically connected to the Wheatstone full bridge circuit.

[0074] For the accuracy of the detection results, the data table corresponding to the resistance values corresponding to different expansion angles of the expansion wing 25 under different external pressure conditions can be pre-detected and stored in the data processing unit 7 as the determination standard for the calculation of the expansion angle. The strain signal of the strain gauge 26 can be amplified, filtered, and converted into a digital signal by the signal conditioning unit 6, and the deformation amount can be converted into the expansion angle value of the expansion wing 25 by the microprocessor, and the expansion angle value of the expansion wing 25 is displayed by the display module 8. And when the expansion angle of the expansion wing 25 reaches the second predetermined angle (indicating that the puncture needle has reached the subarachnoid space i), the alarm 10 will emit an acoustic and light prompt signal to timely remind the operator to stop further puncture. The alarm signal includes two ways: sound prompt and indicator light flashing, ensuring that the operator's attention can be attracted in different environments. Of course.

[0075] The present invention also provides a method for operating a spinal anesthesia puncture needle. Based on the above spinal anesthesia puncture needle, it includes the following steps:

[0076] S1. Operate the outer needle body 3 to move to the first fixed position and fix it through the positioning mechanism so that the expansion wing 25 is completely contracted into the groove 24 on the outer side surface of the inner needle body 2;

[0077] In the initial state, the outer needle body 3 needs to be in the first fixed position. Otherwise, the outer needle body 3 needs to be operated to slide backward along the inner needle body 2 until the rear end of the pressing section 31 is on the front end face of the slide rail 27 and the outer needle body 3 cannot slide backward any further, indicating that the pressing section 31 completely presses the expansion wing 25 inside the groove 24. At this time, the positioning pin 5 passes through the mounting hole 35 and is engaged with the second positioning groove 29 by clamping.

[0078] S2. Hold the needle holder and perform a puncture operation with the puncture needle. When the first sense of falling through is felt, immediately operate the outer needle body 3 to slide to the second fixed position of the inner needle body 2 and fix it to release the expansion wing 25 so that it can pass through the through hole at the front end of the outer needle body 3 for free expansion;

[0079] By operating the outer needle body 3 to slide forward along the inner needle body 2 until the pressing section 31 abuts against the rear end face of the needle tip 22 and cannot slide forward any further, it indicates that the through hole section 32 has slid to the position of the expansion wing 25 in this state. At this time, the expansion wing 25 can expand outward through the through hole on the through hole section 32. Then, the outer needle body 3 can be fixed by the positioning pin 5 passing through the mounting hole 35 and being engaged with the first positioning groove 28 by clamping.

[0080] It should be noted that when the operator feels the first sense of falling through, it may be caused by the puncture needle passing through the epidural space f, or it may be due to the fact that the epidural space (the thickness of the epidural space f) is too small or the needle insertion speed is too fast, resulting in no obvious feeling when passing through the epidural space f. At this time, the sense of falling through is caused by the puncture needle entering the subarachnoid space i. In either of the above two situations, at this time, the outer needle body 3 needs to be slid to the second fixed position to expand the expansion wing 25, and then the angle detection component in the following steps is used to detect the expansion wing 25 to cooperate in determining the position of the expansion wing 25; moreover, if the sense of falling through is caused by entering the epidural space f, at this time, the expansion wing 25 expands outward at the first predetermined angle in the epidural space f. When continuing to insert the needle forward, when the expansion wing 25 contacts the dura mater g and the arachnoid f, it can drive the dura mater g and the arachnoid f to bend inward simultaneously until the expansion wing 25 passes through the dura mater g and the arachnoid f and enters the subarachnoid space i. Through the driving action of the expansion wing 25, it can effectively avoid the third state as shown in Figure 2 That is, the situation where the separation of the dura mater g and the arachnoid f blocks the medicine outlet hole 23.

[0081] S3. Detect the expansion angle of the expansion wing 25 through the angle detection component. If the detected expansion angle of the expansion wing 25 is equal to the second predetermined angle, the puncture needle stops continuing to puncture forward. If the expansion angle of the expansion wing 25 is equal to the first predetermined angle or less than the second predetermined angle, it indicates that the inner needle body has not been punctured in place at this time, and then continue to drive the puncture needle to perform a puncture operation until the operator feels the second sense of falling through;

[0082] In this embodiment, the first predetermined angle is 15° to 25°, and the second predetermined angle is 30° to 45°. The reason is the difference in the external forces received by the expansion wing 25 in the epidural space f and the subarachnoid space i. By utilizing the above differences, it can be determined whether the expansion wing 25 has reached the subarachnoid space i. If the measured expansion angle of the expansion wing 25 is within the range of the second predetermined angle, it can be determined that the expansion wing 25 is already located in the subarachnoid space i, and based on the relative positional relationship between the expansion wing 25 and the drug outlet hole 23, it can be ensured that the drug outlet hole 23 is completely located in the subarachnoid space i, avoiding problems such as Figure 2 as shown, where part or all of the drug outlet hole 23 is in the epidural space f and the arachnoid h is torn, resulting in poor drug delivery effect of the drug outlet hole 23.

[0083] S4. Withdraw the stylet 4 and use a syringe to perform the operation of injecting anesthetic.

[0084] As Figure 10 and Figure 11 shown, before withdrawing the stylet 4, in order to further ensure whether the expansion wing 25 is in the subarachnoid space i, the needle hub can be held to drive the inner needle body 2 to move backward. If there is an obvious sense of resistance, it indicates that the expansion wing 25 is already located in the subarachnoid space i and is expanded. Combining with the expansion angle of the expansion wing 25, it can be further ensured that the drug outlet hole 23 is completely inside the subarachnoid space i and unobstructed. At this time, then withdraw the stylet 4 and perform the operation of injecting anesthetic on it.

[0085] S5. After the anesthetic injection is completed, move the outer needle body 3 to the first fixed position and fix it, so that the expansion wing 25 completely retracts into the groove 24 on the outer side surface of the inner needle body 2. Finally, move the inner needle body 2 backward to withdraw the puncture needle.

[0086] Operate the outer needle body 3 to slide backward along the surface of the inner needle body 2 until the rear end of the pressing section 31 abuts against the front end of the slide rail 27 and cannot move backward any further. During this process, the pressing section 31 presses the expansion wing 25 inside the groove 24, and then the positioning pin 5 passes through the mounting hole 35 and is engaged with the first positioning groove 28 to fix the outer needle body 3 at the first fixed position. Finally, operate the needle hub 1 to pull out the inner needle body 2 to complete the spinal anesthesia operation.

[0087] The traditional spinal anesthesia puncture method completely relies on the operator's subjective feeling of these two "loss of resistance" to judge the position of the needle tip, which is prone to misjudgment. However, the spinal anesthesia puncture needle of the present invention, through the characteristic that the expansion wing 25 presents different expansion angles at different positions, combined with the real-time monitoring and display of the angle detection component, provides an objective and accurate basis for position judgment for physicians, greatly improving the accuracy and safety of the puncture.

[0088] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: they can still modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements on some of the technical features; and these modifications or replacements will not cause the essence of the corresponding technical solutions to deviate from the protection scope of the technical solutions of the embodiments of the present invention.

Claims

1. A spinal anesthesia puncture needle, comprising a needle seat, an inner needle body fixedly connected to the front end of the needle seat, and a needle core slidably connected inside the needle seat and the inner needle body. At least one drug outlet hole is provided on the outer side surface of the inner needle body near the front end, and it is characterized in that, It further includes: At least one expansion wing, which is arranged on the outer side surface of the inner needle body and behind the medicine outlet hole. The natural state of the expansion wing is an expanded state, and when the expansion wing is located in the epidural cavity and the subarachnoid cavity, it can expand at a first predetermined angle and a second predetermined angle respectively; An outer needle body, which is coaxially and slidably connected to the outside of the inner needle body. At least one through hole penetrating the wall thickness direction of the outer needle body is provided at the front end of the outer needle body, and the position of the through hole corresponds to the position of the expansion wing in the circumferential direction of the outer needle body; A positioning mechanism for enabling the outer needle body to be fixed at at least a first fixed position and a second fixed position in the length direction of the inner needle body. When the outer needle body is in the first fixed position, the outer needle body can compress the expansion wing so that it retracts into the groove on the outer side surface of the inner needle body, and the groove is located behind the medicine outlet hole. When the outer needle body is in the second fixed position, the expansion wing can expand freely and extend out of the outer side of the outer needle body through the through hole; And an angle detection component for detecting the expansion angle of the expansion wing.

2. The spinal anesthesia puncture needle according to claim 1, characterized in that, The inner needle body is composed of a tube body and a needle tip fixedly connected to the front end of the tube body. The medicine outlet hole is arranged on the outer side wall of the needle tip. The groove is arranged at an interval in the front and rear directions with the rear end of the needle tip, and the outer diameter of the needle tip is equal to the outer diameter of the outer needle body and larger than the outer diameter of the tube body.

3. The spinal anesthesia puncture needle according to claim 2, characterized in that, The outer needle body includes a pressing section, a through hole section and a sliding section connected in sequence from front to back, wherein: The pressing section can slide back and forth along the front end of the tube body. The length of the pressing section is equal to the length of the groove, and the distance between the front end of the groove and the rear end of the needle tip is equal to or greater than the length of the groove, so that the expansion wing is in a natural expansion state or completely retracted into the groove; The through hole is arranged on the through hole section, and its position corresponds to the groove on the outer surface of the tube body in the circumferential direction; The inner wall of the sliding section is provided with a chute whose length is distributed along the length direction of the tube body, and the chute is slidably matched with the slide rail arranged on the outer surface of the tube body.

4. The spinal anesthesia puncture needle according to claim 3, characterized in that, The outer diameter of the slide rail is larger than the inner diameter of the pressing section, and in the state of the second fixed position of the outer needle body, the front end of the slide rail is flush with the rear end of the groove, and the rear end of the pressing section is flush with the rear end of the needle tip.

5. The spinal anesthesia puncture needle according to claim 1, wherein, The rear end of the expansion wing is a movable end, and the front end is fixedly connected to the front end of the inner side wall of the groove. The depth and shape of the groove are adapted to the size and shape of the expansion wing, so that the expansion wing can be completely accommodated in the groove in the compressed state.

6. The spinal anesthesia puncture needle according to claim 1, characterized in that, The positioning mechanism includes an installation hole, a first positioning groove, a second positioning groove and a positioning pin. The installation hole is arranged at the rear end of the side wall of the outer needle body. The first positioning groove and the second positioning groove are arranged at the rear end of the inner needle body and are correspondingly distributed in the circumferential direction with the installation hole. The first positioning groove is located behind the second positioning groove, and the distance between them is equal to the length of the groove. The positioning pin passes through the installation hole and is in interference fit and clamped with the first positioning groove or the second positioning groove.

7. The spinal anesthesia puncture needle according to claim 1, wherein The angle detection component includes: A strain gauge fixedly connected to the inner side wall of the expansion wing for sensing the deformation amount of the expansion wing; A signal conditioning unit for receiving and processing the electrical signal generated by the strain gauge; A data processing unit, including a microprocessor, is used for calculating the expansion angle of the expansion wing; And a display module, which is signal-connected to the signal processing unit and is used for displaying the expansion angle value of the expansion wing in real time.

8. The spinal anesthesia puncture needle according to claim 7, characterized in that, The signal processing unit is further connected with an alarm, which is used for sending a prompt signal when the expansion angle of the expansion wing reaches the second predetermined angle.

9. A method for operating a spinal anesthesia puncture needle, based on the spinal anesthesia puncture needle according to any one of claims 1-8, characterized in that, It includes the following steps: S1. Operate the outer needle body to move to the first fixed position and fix it through the positioning mechanism, so that the expansion wing is completely retracted into the groove on the outer side of the inner needle body; S2. Hold the needle holder and use the puncture needle for puncture operation. When the first sense of falling through is felt, operate the outer needle body to slide to the second fixed position of the needle body and fix it to release the expansion wing so that it can pass through the through hole at the front end of the outer needle body for free expansion; S3. Detect the expansion angle of the expansion wing through the angle detection component. If the detected expansion angle of the expansion wing is equal to the second predetermined angle, the puncture needle stops continuing to puncture forward. If the expansion angle of the expansion wing is equal to the first predetermined angle or less than the second predetermined angle, continue to drive the puncture needle for puncture operation until the operator feels the second sense of falling through; S4. Withdraw the needle core and use a syringe to perform anesthetic injection operation; S5. After the anesthetic injection is completed, move the outer needle body to the first fixed position and fix it, so that the expansion wing is completely retracted into the groove on the outer side of the needle body, and move the needle body backward to withdraw the puncture needle.

10. The method for operating a spinal anesthesia puncture needle according to claim 9, wherein, In step S4, before withdrawing the needle core, hold the needle holder and drive the inner needle body to move backward. If there is an obvious sense of resistance, at this time, withdraw the needle core and perform anesthetic injection operation.

Images