An auxiliary device for epidural anesthesia needle placement

Abstract

The present invention relates to an auxiliary device for epidural anesthesia needle placement, comprising: a needle placement unit (1), a guiding motion unit (2) for driving the movement of the needle placement unit (1), and a control unit (3) for supporting and controlling the guiding motion unit (2), wherein the needle placement unit (1) is electrically connected to the control unit (3); the needle placement unit (1) includes: a first support (11) for connecting with the guiding motion unit (2), a second support (12) slidably connected to the first support (11), a needle placement assembly (13) slidably connected to the second support (12), and a first drive (14) provided on the first support (11) for driving the movement of the second support (12). The solution of the present invention can perform multi-dimensional real-time monitoring during the puncture process, realizing automatic, precise and safe needle placement and puncture operations.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to an auxiliary device for epidural anesthesia needle placement. Background Art

[0002] Epidural anesthesia has been used clinically for more than 90 years. Through continuous practice and research, it has been gradually improved and has become a commonly used method in current clinical anesthesia. Compared with general anesthesia, epidural anesthesia has a lower incidence of pulmonary embolism, deep vein thrombosis, pneumonia, myocardial infarction, wound infection, and respiratory depression, has less impact on various organs of the whole body, and has better economy. However, at present, epidural anesthesia in clinical practice still adopts blind manual operation. Doctors rely on subjective perception to identify the epidural space, making the positioning of the puncture needle and catheter uncertain, resulting in poor anesthesia controllability and frequent complications, which limits the clinical application of this method.

[0003] In the prior art, the "blind manual operation" technique refers to a technical means by which an anesthesiologist identifies reaching the epidural space by feeling the disappearance of epidural resistance with fingers. Based on subjective judgment, the success rate mainly depends on the clinical experience of the anesthesiologist. In actual clinical practice, due to the lack of a unified evaluation standard for epidural anesthesia effect, the failure rate of clinical epidural anesthesia has been underestimated. The "blind manual operation" may lead to the following situations: incorrect epidural needle placement, the need to change the catheter position twice after positioning, a relatively large dose of local anesthetic, deviation in puncture point positioning, and the patient maintaining an uncomfortable position for a long time. The above situations will all affect the final anesthesia effect and bring uncomfortable experiences to the patient to varying degrees.

[0004] In addition, under the "blind manual operation" technique, even experienced anesthesiologists have a certain failure rate. Especially in elderly patients, spinal stenosis, narrowing of the epidural space, calcification of the ligamentum flavum, etc., often make the puncture and catheter placement operations of epidural anesthesia very difficult.

[0005] In recent decades, except for the improvement of the anesthesia puncture kit, there has been no major improvement and development in the technical operation level related to epidural anesthesia technology. There is still no good solution for the "ideal epidural space positioning technology based on objective indicators" so far, and the defects existing in manual operation have become the main technical bottleneck of epidural anesthesia. Summary of the Invention

[0006] The purpose of the present invention is to provide an auxiliary device for epidural anesthesia needle placement to solve the problem that it is difficult for anesthesiologists to accurately puncture.

[0007] To achieve the above-mentioned invention object, the present invention provides an auxiliary device for epidural anesthesia needle placement, including: a needle placement unit, a guiding motion unit for driving the movement of the needle placement unit, and a control unit for supporting and controlling the guiding motion unit, wherein the needle placement unit is electrically connected to the control unit;

[0008] The needle placement unit includes: a first support for connecting with the guiding motion unit, a second support slidably connected to the first support, a needle placement assembly slidably connected to the second support, and a first drive provided on the first support for driving the movement of the second support.

[0009] According to one aspect of the present invention, the moving direction of the needle placement assembly on the second support is parallel to the moving direction of the second support on the first support.

[0010] According to one aspect of the present invention, the first drive drives the second support to linearly reciprocate on the first support;

[0011] The needle placement assembly linearly reciprocates on the second support.

[0012] According to one aspect of the present invention, the needle placement assembly is provided with a pressure sensor;

[0013] Along the moving direction of the needle placement assembly, a first limit for abutting against the pressure sensor and a second limit for restricting the moving position of the needle placement assembly are oppositely provided on the second support.

[0014] According to one aspect of the present invention, the needle placement assembly further includes: a third support slidably connected to the second support, a fourth support detachably connected to the third support, and a puncture needle mounted on the fourth support.

[0015] According to one aspect of the present invention, the interval between the first limit and the second limit is L1, and the distance between the end of the pressure sensor abutting against the first limit and the end of the third support abutting against the second limit is L2, then L1≥L2 is satisfied.

[0016] According to one aspect of the present invention, a sound detection module is provided on one side of the fourth support close to the puncture needle.

[0017] According to one aspect of the present invention, the third support and the fourth support are snap-connected;

[0018] The puncture needle and the fourth support are snap-connected.

[0019] According to one aspect of the present invention, the puncture needle includes a puncture part and a stylet part;

[0020] The puncture part is a hollow cylinder, and the stylet part is detachably coaxially arranged with the puncture part in the hollow part of the puncture part;

[0021] One end of the stylet part is provided with a first structural member, and one end of the puncture part adjacent to the first structural member is adjacent to the sound detection module.

[0022] According to one aspect of the present invention, an electric conductor for electrically connecting the control unit and the puncture part to each other is provided on the fourth support;

[0023] An insulating layer is provided on the outer surface of the puncture part.

[0024] According to one aspect of the present invention, the insulating layer is a Teflon coating.

[0025] According to one aspect of the present invention, the first drive includes: a power source, and a lead screw nut pair integrally provided with the main shaft of the power source.

[0026] According to one solution of the present invention, the present invention can fully simulate the manual puncture technique, and based on clinical experiences such as the "loss of resistance method", the "negative pressure method", and the human nerve electrophysiological response, and combined with intraoperative imaging positioning technology, multi-sensing technology, electrophysiological monitoring technology, and micro-mechanical control technology, perform multi-dimensional real-time monitoring on the puncture process, and realize automatic, precise, and safe needle placement puncture operation.

[0027] According to one solution of the present invention, multi-sensor technology is adopted to scientifically and reliably detect both the puncture process and the determination after the puncture is completed, greatly reducing the possibility of misjudgment. In addition, electromyophysiological monitoring is added during the puncture process, eliminating the occurrence of cases of serious consequences such as total spinal anesthesia caused by puncture failure.

[0028] According to one solution of the present invention, the puncture depth can be precisely controlled without relying on the clinical experience of anesthesiologists. In the solution of the present invention, pressure monitoring, electromyophysiological monitoring, electrical signal monitoring, and step control technology can be used to perform real-time monitoring and control on the puncture process. When the puncture needle pierces the yellow ligament and reaches the epidural cavity, the needle placement mechanism will not overshoot, and the puncture depth can be precisely controlled.

[0029] According to one solution of the present invention, by connecting a conductor to the puncture needle to detect the conductivity of the current tissue in real time with an electrical signal detection sensor, and simulating and emulating the current punctured tissue based on the conductivity database, the real-time puncture position of the puncture needle can be simulated and emulated. At the same time, based on the travel path and distance, pressure data, and step pulse data of the needle placement unit, the current puncture position of the puncture needle is calculated in real time, and then the simulation data is fused to accurately calculate the real position of the puncture needle after it penetrates the skin, and it is displayed on the system UI interface, realizing the visualization of the accurate puncture process. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 Schematic diagram showing the structure of an auxiliary device according to an embodiment of the present invention;

[0031] Figure 2 Schematic diagram showing the structure of a needle placement unit according to an embodiment of the present invention;

[0032] Figure 3 Schematic exploded view showing the needle placement unit according to an embodiment of the present invention;

[0033] Figure 4 Schematic diagram showing the connection structure of a first support and a second support according to an embodiment of the present invention;

[0034] Figure 5 Schematic diagram showing the connection structure of a third support and a second support according to an embodiment of the present invention;

[0035] Figure 6 Schematic cross-sectional view showing the connection structure of a third support and a second support according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0036] 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 use in the embodiments. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0037] When describing the embodiments of the present invention, the orientation or positional relationships expressed by the terms "longitudinal", "transverse", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer" are based on the orientation or positional relationships shown in the relevant drawings. This is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, the above terms should not be construed as limiting the present invention.

[0038] The present invention will be described in detail below in conjunction with the accompanying drawings and specific embodiments. The embodiments cannot be enumerated one by one here, but the embodiments of the present invention are not limited to the following embodiments.

[0039] Combined with Figure 1 、 Figure 2 and Figure 3 As shown, according to an embodiment of the present invention, an auxiliary device for epidural anesthesia needle placement includes: a needle placement unit 1, a guiding motion unit 2 for driving the movement of the needle placement unit 1, and a control unit 3 for supporting and controlling the guiding motion unit 2. The needle placement unit 1 is electrically connected to the control unit 3. In this embodiment, the needle placement unit 1 includes: a first support 11 for connecting with the guiding motion unit 2, a second support 12 slidably connected to the first support 11, a needle placement assembly 13 slidably connected to the second support 12, and a first drive 14 provided on the first support 11 for driving the second support 12 to move. In this embodiment, the control unit 3 can control the guiding motion unit 2 to drive the needle placement unit 1 to perform a puncture operation, realizing the automation of the puncture process.

[0040] Combined with Figure 2 and Figure 3 As shown, according to an embodiment of the present invention, the moving direction of the needle placement assembly 13 on the second support 12 is parallel to the moving direction of the second support 12 on the first support 11.

[0041] Combined with Figure 2 and Figure 3 As shown, according to an embodiment of the present invention, the first drive 14 drives the second support 12 to linearly reciprocate on the first support 11. The needle placement assembly 13 linearly reciprocates on the second support 12, and the needle placement assembly 13 and the second support 12 are not driven by a power element. In this embodiment, the first drive 14 includes: a power source 141 and a lead screw nut pair 142. The first drive 14 can adopt a linear drive device composed of a stepping motor connected to a lead screw nut pair, which is integrated between the main shaft of the stepping motor and the lead screw nut pair. Of course, the first drive 14 can also directly adopt an integral drive device such as an electric cylinder to achieve. Through the above settings, the main shaft of the stepping motor is the ball screw, so that in the process of the motor driving the screw to rotate, traditional components such as couplings are reduced in the middle, effectively reducing the volume and rotational inertia of the first drive, and improving the response speed of the first drive 14.

[0042] Combined with Figure 2 、 Figure 3 、 Figure 4 、 Figure 5 and Figure 6As shown, according to an embodiment of the present invention, the needle placement assembly 13 is provided with a pressure sensor 131. In this embodiment, along the moving direction of the needle placement assembly 13, a first limit 121 that can abut against the pressure sensor 131 and a second limit 122 for restricting the moving position of the needle placement assembly 13 are oppositely arranged on the second support 12. In this embodiment, when the first drive 14 drives the second support 12 to move forward, if the needle placement assembly 13 encounters resistance from the front, then under the action of the resistance, the needle placement assembly 13 moves backward until the pressure sensor 131 abuts against the first limit 121. At this time, when the first drive 14 continues to drive the second support 12 to move forward, the pressure sensor 131 converts the received resistance into an electrical signal and outputs it to the control unit 3. Furthermore, the change in the resistance received by the needle placement assembly 13 during the puncture process can be obtained through the conversion of the control unit 3. When the first drive 14 drives the second support 12 to move backward, if the needle placement assembly 13 encounters frictional resistance in the direction opposite to the moving direction, the needle placement assembly 13 moves in the direction close to the second limit 122, and then until it abuts against the second limit 122. When the first drive 14 continues to drive the second support 12 to move backward, under the abutting action of the second limit 122, it is convenient to overcome the resistance received by the needle placement assembly 13 and make it continue to move backward with the first drive 14.

[0043] Combined with Figure 2 and Figure 3 As shown, according to an embodiment of the present invention, the needle placement assembly 13 further includes: a third support 132 for slidably connecting with the second support 12, a fourth support 133 for detachably connecting with the third support 132, and a puncture needle 134 installed on the fourth support 133. In this embodiment, the third support 132 is snap-connected to the fourth support 133; the puncture needle 134 is snap-connected to the fourth support 133. Through the above settings, the quick disassembly, assembly, and replacement of the third support 132, the fourth support 133, and the puncture needle 134 can be conveniently achieved, improving the efficiency of disassembly, assembly, and replacement. At the same time, by using the snap-connection method, its positioning accuracy is relatively high, which is beneficial to ensuring the puncture accuracy of the present invention.

[0044] Combined with Figure 2 and Figure 3 As shown, according to an embodiment of the present invention, the third support 132 is slidably connected to the second support 12 through a sliding guide rail. The fourth support 133 includes a connecting plate 1331 and a support plate 1332 that are perpendicularly arranged. In this embodiment, the connecting plate 1331 is snap-connected to the third support 132, and the puncture needle 134 is snap-connected to the support plate 1332. In this embodiment, the support plate 1332 is located on one side of the connecting plate 1331, and thus the puncture needle 134 and the support plate 1332 are located on the same side of the connecting plate 1331.

[0045] Combined withFigure 2 and Figure 3 As shown in Figure 2 and Figure 3 , according to an embodiment of the present invention, a sound detection module 1231 is provided on the fourth support 133. In this embodiment, the sound detection module 1231, the puncture needle 134, and the support plate 1332 are on the same side of the connection plate 1331. Among them, the sound detection module 1231 is directly mounted on the surface of the connection plate 1331, and the sound detection module 1231 and the puncture needle 134 are spaced apart from each other in the thickness direction of the connection plate 1331.

[0046] Combined with Figure 2 and Figure 3 As shown in Figure 2 and Figure 3 , according to an embodiment of the present invention, the puncture needle 134 includes a puncture part 1341 and a stylet part 1342. In this embodiment, the puncture part 1341 is a hollow cylinder, and the stylet part 1342 is detachably coaxially arranged with the puncture part 1341 in the hollow part of the puncture part 1341. The stylet part 1342 is a solid columnar body. By inserting the stylet part 1342 into the puncture part 1341, the hollow part of the puncture part 1341 can be blocked, so as to ensure that the puncture part 1341 of the puncture needle 134 is not connected to the external environment during the puncture process. When it is necessary to remove the stylet part 1342, only need to hold one end of the stylet part 1342 and pull it out of the puncture part 1341.

[0047] Combined with Figure 2 and Figure 3 As shown in Figure 2 and Figure 3 , in this embodiment, a first structural member 1342a is provided at one end of the stylet part 1342, and the end of the puncture part 1341 adjacent to the first structural member 1342a is adjacent to the sound detection module 1231. In this embodiment, by providing the first structural member 1342a on the stylet part 1342, it is convenient to pull out the stylet part 1342 inserted into the puncture part 1341. In addition, through the abutment of the first structural member 1342a against the puncture part 1341, the sealing effect of the stylet part 1342 on the hollow part of the puncture part 1341 can be effectively improved, ensuring the use performance of the present invention.

[0048] Combined with Figure 2 and Figure 3As shown, according to an embodiment of the present invention, an electrical conductor for electrically connecting the control unit 3 and the puncture part 1341 is provided on the fourth support 133; an insulating layer is provided on the outer surface of the puncture part 1341. In this embodiment, the insulating layer is a Teflon coating. In this embodiment, the puncture part 1341 is made of a metal material. Therefore, providing an insulating layer on its outer surface can effectively achieve the effect that the needle tip of the puncture part 1341 is conductive and other parts are insulated. At the same time, using a Teflon coating has effects such as lubrication, making the puncture effect of the present invention better. In this embodiment, by providing an electrical conductor on the fourth support 133 for electrically connecting the control unit 3 and the puncture part 1341, electrophysiological monitoring of the puncture position is realized. Specifically, when the puncture part 1341 touches the nerve root, the electrical signal at the needle tip will stimulate the nerve, so that the control unit 3 can make a corresponding response and control the puncture part 1341 to stop moving, ensuring the safety, accuracy and stability of the puncture process.

[0049] According to an embodiment of the present invention, the interval between the first limit 121 and the second limit 122 is L1, and the distance between the end of the pressure sensor 131 adjacent to the first limit 121 and the end of the third support 132 adjacent to the second limit 122 is L2, then L1≥L2 is satisfied. In this embodiment, the interval between the first limit 121 and the second limit 122 is L1, and the distance between the end of the pressure sensor 131 adjacent to the first limit 121 and the end of the third support 132 adjacent to the second limit 122 is L2, and the difference between L1 and L2 is less than or equal to 0.05 mm, L1 - L2≤0.05 mm. In this embodiment, when the processing accuracy between the structures is high, the smaller the difference between L1 and L2, the better, which can ensure the accuracy and precision of the puncture process of the present invention.

[0050] According to an embodiment of the present invention, the guiding motion unit 2 is a laser guiding system, which has the function of surgical planning. In this embodiment, the needle placement unit 1 performs a puncture operation along a pre-planned path under the action of the guiding motion unit 2.

[0051] According to the present invention, by providing a sound detection module on the fourth support, when the puncture needle of the present invention enters an object and the needle core part is withdrawn, due to the negative pressure generated between the external environment and the hollow part of the puncture part, the sound detection module can effectively and quickly detect the moment when the needle core part is pulled out from the puncture part, and according to the detected sound, the present invention can more quickly and accurately detect the quality of the puncture effect, facilitating the effective and multi-faceted evaluation of the puncture result by the device of the present invention.

[0052] According to the present invention, by energizing the puncture needle and providing an insulating layer on the outer surface of the puncture needle, the needle tip of the puncture needle can be made conductive, and thus the corresponding puncture position can be obtained according to the electrical signal at the needle tip. For example, when the needle placement unit of the present invention is used for puncture operation, if the puncture needle touches the nerve root, the electrical signal will stimulate the nerve, and then the control unit will collect the corresponding electrical signal, emit a sound signal, and trigger the protection mechanism to stop the movement of the mechanism. Therefore, the puncture accuracy of the present invention is further effectively improved according to the solution of the present invention.

[0053] The above content is only an example of the specific solution of the present invention. For the equipment and structures not described in detail therein, it should be understood that the existing general equipment and general methods in the art are adopted for implementation.

[0054] The above description is only one solution of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention can have various changes and modifications. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. An auxiliary device for epidural anesthesia needle placement, characterized in that, it includes: a needle placement unit (1), a guiding motion unit (2) for driving the movement of the needle placement unit (1), and a control unit (3) for supporting and controlling the guiding motion unit (2), and the needle placement unit (1) is electrically connected to the control unit (3); the needle placement unit (1) includes: a first support (11) for connecting with the guiding motion unit (2), a second support (12) slidably connected to the first support (11), a needle placement assembly (13) slidably connected to the second support (12), and a first drive (14) provided on the first support (11) for driving the movement of the second support (12); the first drive (14) includes: a power source (141), and a lead screw nut pair (142) integrally provided with the main shaft of the power source (141); a pressure sensor (131) is provided on the needle placement assembly (13); along the moving direction of the needle placement assembly (13), a first limit (121) that can abut against the pressure sensor (131) and a second limit (122) for restricting the moving position of the needle placement assembly (13) are oppositely provided on the second support (12); the needle placement assembly (13) further includes: a third support (132) slidably connected to the second support (12), a fourth support (133) detachably connected to the third support (132), and a puncture needle (134) mounted on the fourth support (133); a sound detection module (1231) is provided on one side of the fourth support (133) close to the puncture needle (134).

2. The auxiliary device according to claim 1, characterized in that, the moving direction of the needle placement assembly (13) on the second support (12) is parallel to the moving direction of the second support (12) on the first support (11).

3. The auxiliary device according to claim 2, characterized in that, the first drive (14) drives the second support (12) to linearly reciprocate on the first support (11); the needle placement assembly (13) linearly reciprocates on the second support (12).

4. The auxiliary device according to claim 1, characterized in that, the interval between the first limit (121) and the second limit (122) is L1, and the distance between the end of the pressure sensor (131) abutting against the first limit (121) and the end of the third support (132) abutting against the second limit (122) is L2, then L1≥L2 is satisfied.

5. The auxiliary device according to claim 1 or 4, characterized in that, the third support (132) is snap-connected to the fourth support (133); the puncture needle (134) is snap-connected to the fourth support (133).

6. The auxiliary device according to claim 5, characterized in that, The puncture needle (134) includes a puncture portion (1341) and a stylet portion (1342); The puncture portion (1341) is a hollow cylinder, and the stylet portion (1342) is detachably coaxially disposed with the puncture portion (1341) in the hollow portion of the puncture portion (1341); One end of the stylet portion (1342) is provided with a first structural member (1242a), and one end of the puncture portion (1341) adjacent to the first structural member (1242a) is adjacent to the sound detection module (1231).

7. The auxiliary device according to claim 6, wherein, an electric conductor for electrically connecting the control unit (3) and the puncture portion (1341) is provided on the fourth support (133); an insulating layer is provided on the outer surface of the puncture portion (1341).

8. The auxiliary device according to claim 7, wherein, the insulating layer is a Teflon coating.

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