CN111166437A - Auxiliary method for epidural anesthesia needle placement - Google Patents
Auxiliary method for epidural anesthesia needle placement Download PDFInfo
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- CN111166437A CN111166437A CN202010096955.7A CN202010096955A CN111166437A CN 111166437 A CN111166437 A CN 111166437A CN 202010096955 A CN202010096955 A CN 202010096955A CN 111166437 A CN111166437 A CN 111166437A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3403—Needle locating or guiding means
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
- A61B90/11—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints
- A61B90/13—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints guided by light, e.g. laser pointers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3403—Needle locating or guiding means
- A61B2017/3405—Needle locating or guiding means using mechanical guide means
- A61B2017/3407—Needle locating or guiding means using mechanical guide means including a base for support on the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
- A61B2034/101—Computer-aided simulation of surgical operations
- A61B2034/105—Modelling of the patient, e.g. for ligaments or bones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
- A61B2034/107—Visualisation of planned trajectories or target regions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
- A61B2034/108—Computer aided selection or customisation of medical implants or cutting guides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B2034/2046—Tracking techniques
- A61B2034/2055—Optical tracking systems
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B2034/2046—Tracking techniques
- A61B2034/2065—Tracking using image or pattern recognition
Abstract
The invention relates to an auxiliary method for epidural anesthesia needle placement, which is applied to a device for epidural anesthesia needle placement, and the device comprises: the needle placing unit is used for driving the guide motion unit of the needle placing unit to move and the control unit is used for supporting and controlling the guide motion unit, and the needle placing unit and the control unit are electrically connected with each other; the auxiliary method comprises the following steps: s1, acquiring a target point position of a target area, and controlling the guide motion unit to guide the needle placement unit to the target point position by a control unit; s2, driving the needle placing unit to advance along the puncture direction, receiving an electric signal fed back by the needle placing unit by the control unit, judging whether a needle stopping signal is triggered or not according to the electric signal, and stopping driving the needle placing unit if the needle stopping signal is triggered; and S3, judging the puncture result of the contraposition needle unit and outputting the judgment result. The invention has diversified monitoring means, scientifically and reliably detects the puncture process and the judgment after the puncture is finished, and greatly reduces the possibility of misjudgment.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to an auxiliary method for epidural anesthesia needle placement.
Background
Epidural anesthesia has been used clinically for more than 90 years, and has been gradually perfected through continuous practice and research, becoming a common method in clinical anesthesia at present. Compared with general anesthesia, the epidural anesthesia has lower morbidity of pulmonary embolism, deep vein thrombosis, pneumonia, myocardial infarction, wound infection and respiratory depression caused by the epidural anesthesia, has small influence on various organs of the whole body and has better economy. However, clinically, epidural anesthesia still adopts bare probe free-hand operation, doctors rely on subjective perception to identify epidural space, so that uncertainty exists in positioning of a puncture needle and a catheter, anesthesia controllability is poor, complications occur frequently, and clinical application of the method is limited.
In the prior art, the technology of 'blind probe manual operation' refers to a technical means that an anesthesiologist recognizes that an epidural space is reached by sensing disappearance of epidural resistance through a finger, and the success rate mainly depends on clinical experience of the anesthesiologist based on subjective judgment. In actual clinics, due to the lack of a unified evaluation standard for epidural anesthesia effect, the clinical epidural anesthesia failure rate is underestimated all the time. "blind probe hand operation" may lead to the following: the epidural needle is incorrect, the position of the catheter needs to be changed for the second time after positioning, the dosage of local anesthetic is larger, the positioning deviation of a puncture point is large, a patient keeps an uncomfortable position for a long time, and the like, so that the final anesthetic effect is influenced to different degrees and the discomfort experience is brought to the patient.
In addition, even experienced anesthesiologists have a certain failure rate under the "blind probleman hand-operated" technique. Especially in the elderly patients, spinal stenosis, epidural space narrowing, ligamentum flavum calcification and the like often make epidural anesthesia puncture and catheterization very difficult.
In recent decades, except for the improvement of the anesthesia puncture package, no great improvement and development exist in terms of the operation level of the epidural anesthesia technology, no good solution exists in the 'ideal epidural space positioning technology based on objective indications', and the defects existing in the manual operation become the main technical bottleneck of the epidural anesthesia.
Disclosure of Invention
The invention aims to provide an auxiliary method for epidural anesthesia needle placement, which solves the problem that an anesthesiologist is difficult to puncture accurately.
In order to achieve the above object, the present invention provides an auxiliary method for an epidural anesthesia needle insertion, which is applied to an epidural anesthesia needle insertion device, the device comprising: the needle placing unit is used for driving the guide motion unit of the needle placing unit to move, and the control unit is used for supporting and controlling the guide motion unit, and the needle placing unit and the control unit are electrically connected with each other;
the auxiliary method comprises the following steps:
s1, acquiring a target point of a target area, wherein the control unit controls the guide motion unit to guide the needle placing unit to the target point;
s2, driving the needle placing unit to advance along the puncture direction, receiving an electric signal fed back by the needle placing unit by the control unit, judging whether a needle stopping signal is triggered or not according to the electric signal, and if so, stopping driving the needle placing unit;
and S3, judging the puncture result of the needle placing unit and outputting a judgment result.
According to an aspect of the invention, in step S2, the electrical signal is at least one of a resistance change signal, a needle insertion displacement signal, an electrophysiological monitoring signal, and a punctured tissue differentiation signal.
According to an aspect of the invention, the needle placing unit comprises: the first support is used for being mutually connected with the guide motion unit, the second support is connected with the first support in a sliding mode, the needle placing assembly is connected with the second support in a sliding mode, and the first drive is arranged on the first support and used for driving the second support to move;
the needle placing assembly is provided with a pressure sensor, and the second support is provided with a first limit position which can be abutted against the pressure sensor;
the pressure sensor is used for outputting the resistance change signal, and the first drive is used for outputting the needle insertion displacement signal.
According to one aspect of the invention, the needle placement assembly further comprises: a third support for sliding connection with the second support, a fourth support for detachable connection with the third support, and a puncture needle mounted on the fourth support;
acquiring the electrophysiological monitoring signal and the punctured tissue differentiation signal based on a puncture position of the puncturing part.
According to one aspect of the invention, the needle includes a piercing portion and a core portion;
the puncture part is a hollow cylinder, and the stylet part is detachably arranged in the hollow part of the puncture part coaxially with the puncture part;
the fourth support is provided with an electric conductor which is used for electrically connecting the control unit and the puncture part with each other;
an insulating layer is arranged on the outer surface of the puncturing part.
According to an aspect of the present invention, in step S2, when the electrical signal is a resistance change signal, if the resistance change signal jumps, the needle stop signal is triggered to stop driving the needle placing unit.
According to an aspect of the present invention, in step S2, when the electrical signal is a needle insertion displacement signal, an actual needle insertion displacement is obtained according to the first driven needle insertion displacement signal, and the actual needle insertion displacement is compared with a pre-planned puncture path distance, and if the actual needle insertion displacement exceeds the pre-planned puncture path distance, the needle stop signal is triggered to stop driving the needle placement unit.
According to an aspect of the present invention, in step S2, when the electrical signal is an electrophysiological monitoring signal, the needle-stopping signal is triggered directly to stop driving the needle-placing unit.
According to an aspect of the present invention, in step S2, when the electrical signal is a punctured tissue differentiation signal, the current tissue conductivity included in the punctured tissue differentiation signal is matched with a pre-established tissue conductivity database, and whether the puncture needle is in place is determined according to a matching result, if yes, the needle stop signal is triggered to stop driving the needle placing unit.
According to one aspect of the invention, in the step of judging whether the puncture needle is in place or not according to the matching result, the puncture process of the puncture needle is visually simulated and displayed according to the matching result.
According to an aspect of the present invention, in the step of evaluating the puncture result of the needle placement unit in step S3, the judgment is performed by using an acoustic sensation detection assistance judgment method and/or a pressure cavity detection assistance judgment method.
According to one aspect of the present invention, a sound detection module for the sound detection assistance determination method is provided on a side of the fourth support close to the puncture needle.
According to an aspect of the present invention, in the step of performing evaluation by the sound sensation detection assistance determination method, the stylet portion is drawn out from the puncture portion, the sound detection module acquires a sound generated when air is drawn into the puncture portion when the stylet portion is detached from the puncture portion, and the sound detection module converts the sound into an electric signal and transmits the electric signal to the control unit for evaluation.
According to one aspect of the invention, in the step of judging by using the pressure cavity detection auxiliary judging method, a syringe pump is communicated with the puncture part, and the syringe pump is rotated forward and backward to judge;
a pressure cavity sensor is arranged in the injection pump.
According to one aspect of the invention, the step of judging by rotating the injection pump positively and negatively comprises the following steps:
the injection pump is positively transmitted, and the pressure cavity sensor is adopted to collect pressure change of a pressure cavity and transmit the pressure change to the control unit for judgment;
the syringe pump was reversed and evaluated for the presence of liquid outflow.
According to one scheme of the invention, the monitoring means of the invention are diversified, and the multi-sensor technology is adopted, so that the puncture process and the judgment after the puncture is finished are scientifically and reliably detected, and the possibility of misjudgment is greatly reduced. In addition, myoelectric physiological monitoring is added in the puncture process, so that the case of serious consequences such as total spinal anesthesia and the like caused by puncture failure is avoided.
According to one scheme of the invention, the invention realizes the visualization of the real-time puncture process. The conductivity of the current tissue is detected in real time through an electric signal detection sensor, the current puncture tissue is simulated according to a conductivity database, namely the real-time puncture position of the puncture needle is simulated, meanwhile, the advancing path and distance of the puncture needle after entering the skin are calculated through the operation planning function of the device, the current puncture position of the puncture needle is calculated in real time through pressure data and stepping pulse data, the simulation data are fused, the real position of the puncture needle after penetrating the skin is accurately calculated, the real position is displayed in a system UI interface, and the visualization of the accurate puncture process is realized.
According to one scheme of the invention, the puncture depth is accurately controlled, and the clinical experience of an anesthesiologist is not depended on. The device of the invention monitors and controls the puncture process in real time through pressure monitoring, myoelectricity physiological monitoring, puncture tissue differentiation monitoring and step control technology, and when the puncture needle punctures ligamentum flavum and reaches the epidural space, the needle placement mechanism can not generate overshoot, and the puncture depth can be accurately controlled.
Drawings
FIG. 1 schematically represents a block diagram of the steps of an assistance method according to an embodiment of the invention;
FIG. 2 schematically shows a block diagram of an arrangement for epidural anesthesia needle placement according to an embodiment of the present invention;
FIG. 3 schematically shows a block diagram of a needle placement unit according to an embodiment of the invention;
FIG. 4 schematically illustrates an exploded view of a needle deployment unit in accordance with an embodiment of the present invention;
FIG. 5 is a schematic view showing a structure of a connection of a third support with a second support according to an embodiment of the present invention;
fig. 6 is a sectional view schematically showing a connection structure of a third support and a second support according to an embodiment of the present invention;
FIG. 7 schematically shows a flow chart of an assistance method according to an embodiment of the invention;
FIG. 8 is a schematic representation of a location map of a target area and target point locations according to one embodiment of the present invention;
FIG. 9 is a graph schematically illustrating resistance changes during lancing according to one embodiment of the present invention;
fig. 10 is a schematic representation of a configuration of a puncture needle for a puncture procedure according to an embodiment of the present invention.
Detailed Description
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the embodiments will be briefly described below. It is obvious that the drawings in the following description are only some embodiments of the invention, and that for a person skilled in the art, other drawings can be derived from them without inventive effort.
In describing embodiments of the present invention, the terms "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like are used in an orientation or positional relationship that is based on the orientation or positional relationship shown in the associated drawings, which is for convenience and simplicity of description only, and does not indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and thus, the above-described terms should not be construed as limiting the present invention.
The present invention is described in detail below with reference to the drawings and the specific embodiments, which are not repeated herein, but the embodiments of the present invention are not limited to the following embodiments.
As shown in fig. 1, according to an embodiment of the present invention, the method for assisting an epidural anesthesia needle insertion of the present invention is applied to an epidural anesthesia needle insertion device, and the method for assisting the epidural anesthesia needle insertion comprises:
s1, acquiring a target point of a target area, and controlling a guide motion unit 2 to guide a needle placing unit 1 to the target point by a control unit 3;
s2, driving the needle placing unit 1 to advance along the puncture direction, receiving an electric signal fed back by the needle placing unit 1 by the control unit 3, judging whether a needle stopping signal is triggered or not according to the electric signal, and if so, stopping driving the needle placing unit 1;
and S3, judging the puncture result of the opposed needle unit 1 and outputting the judgment result.
To further illustrate the present invention, the apparatus of the present invention will be described in detail with reference to the accompanying drawings.
Referring to fig. 2, 3 and 4, according to one embodiment of the present invention, an auxiliary device for an epidural anesthesia needle comprises: the device comprises a needle placing unit 1, a guide motion unit 2 used for driving the needle placing unit 1 to move, and a control unit 3 used for supporting and controlling the guide motion unit 2, wherein the needle placing unit 1 and the control unit 3 are electrically connected with each other. In the present embodiment, the needle placement unit 1 includes: a first support 11 for interconnecting with the guiding movement unit 2, a second support 12 slidably connected with the first support 11, a needle placing assembly 13 slidably connected with the second support 12, and a first drive 14 provided on the first support 11 for driving the second support 12 to move. In the embodiment, the control unit 3 can control the guide motion unit 2 to drive the needle placing unit 1 to execute the puncture operation, so as to realize the automation of the puncture process,
referring to fig. 3 and 4, according to one embodiment of the present invention, the moving direction of the needle positioning assembly 13 on the second support 12 is parallel to the moving direction of the second support 12 on the first support 11.
Referring to fig. 3 and 4, according to an embodiment of the present invention, the first driving unit 14 drives the second support 12 to linearly reciprocate on the first support 11. The needle placing component 13 linearly reciprocates on the second support 12, and the needle placing component 13 and the second support 12 are not driven by power elements. In the present embodiment, the first drive 14 includes: a power source 141 and a lead screw nut pair 142. The first drive 14 can be a linear drive device formed by connecting a stepping motor with a screw nut pair, and a main shaft of the stepping motor and the screw nut pair are integrated. Of course, the first drive 14 may also be implemented directly by an integral drive such as an electric cylinder. Through the arrangement, the main shaft of the stepping motor is the ball screw, so that in the process of driving the screw rod to rotate, traditional parts such as a coupler are reduced in the middle of the motor, the volume and the rotational inertia of the electric first drive are effectively reduced, and the response speed of the first drive 14 is improved.
Referring to fig. 3, 4, 5 and 6, according to one embodiment of the present invention, the needle assembly 13 is provided with a pressure sensor 131. In the present embodiment, a first stopper 121 that can abut against the pressure sensor 131 and a second stopper 122 that restricts the movement position of the needle assembly 13 are provided on the second support 12 so as to face each other in the movement direction of the needle assembly 13. In this embodiment, when the first drive 14 drives the second support 12 to move forward, if the needle assembly 13 receives a resistance force from the front, and then the needle assembly 13 moves backward under the resistance force until the pressure sensor 131 abuts against the first limit 121, at this time, the first drive 14 continues to drive the second support 12 to move forward, the pressure sensor 131 converts the received resistance force into an electrical signal and outputs the electrical signal to the control unit 3, and further, the change of the resistance force received by the needle assembly 13 during the puncturing process can be known through the conversion of the control unit 3. When the first drive 14 drives the second support 12 to move backwards, if the needle assembly 13 receives a frictional resistance opposite to the moving direction, the needle assembly 13 moves in a direction close to the second limit 122 until abutting against the second limit 122, the first drive 14 continues to drive the second support 12 to move backwards, and under the abutting action of the second limit 122, the resistance received by the needle assembly 13 can be conveniently overcome to enable the needle assembly to continue to move backwards along with the first drive 14.
Referring to fig. 3 and 4, according to an embodiment of the present invention, the needle assembly 13 further includes: a third support 132 for slidably coupling with the second support 12, a fourth support 133 for detachably coupling with the third support 132, and a puncture needle 134 mounted on the fourth support 133. In the present embodiment, the third bearing 132 is snap-coupled with the fourth bearing 133; the puncture needle 134 is snap-coupled to the fourth bearing 133. Through the arrangement, the third support 132, the fourth support 133 and the puncture needle 134 can be conveniently and quickly disassembled and replaced, and the disassembling and replacing efficiency is improved. Meanwhile, the positioning precision is higher by adopting a buckling connection mode, so that the puncture accuracy of the invention is further ensured.
Referring to fig. 3 and 4, according to an embodiment of the present invention, the third support 132 is slidably connected to the second support 12 through a sliding guide. The fourth bearing 133 includes a connection plate 1331 and a support plate 1332 that are disposed perpendicular to each other. In the present embodiment, the connection plate 1331 is snap-fitted to the third support 132, and the puncture needle 134 is snap-fitted to the support plate 1332. In this embodiment, the support plate 1332 is located on the side of the attachment plate 1331, and the puncture needle 134 is located on the same side of the attachment plate 1331 as the support plate 1332.
Referring to fig. 3 and 4, according to an embodiment of the present invention, a sound detection module 1231 is disposed on the fourth bearing 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.
Referring to fig. 3 and 4, the needle 134 includes a piercing portion 1341 and a core portion 1342 according to one embodiment of the invention. In the present embodiment, the puncture portion 1341 is a hollow cylindrical body, and the hub portion 1342 is detachably provided in the hollow portion of the puncture portion 1341 coaxially with the puncture portion 1341. The stylet portion 1342 is a solid cylindrical body, and the hollow portion of the puncture portion 1341 can be blocked by inserting the stylet portion 1342 into the puncture portion 1341, thereby ensuring that the puncture portion 1341 is not communicated with the external environment during the puncture process of the puncture needle 134. When the stylet portion 1342 is to be removed, it is only necessary to grip one end of the stylet portion 1342 and pull it out of the piercing portion 1341.
As shown in fig. 3 and 4, in the present embodiment, a first structural member 1342a is provided at one end of the hub portion 1342, and the sound detection module 1231 is adjacent to one end of the puncture portion 1341 adjacent to the first structural member 1342 a. In this embodiment, the first structure 1342a is disposed on the stylet portion 1342, so that the stylet portion 1342 inserted into the puncturing portion 1341 can be conveniently pulled out, and in addition, by abutting the first structure 1342a against the puncturing portion 1341, the sealing effect of the stylet portion 1342 on the hollow portion of the puncturing portion 1341 can be effectively improved, and the usability of the present invention is ensured.
Referring to fig. 3 and 4, according to an embodiment of the present invention, an electrical conductor for electrically connecting the control unit 3 and the piercing part 1341 to each other is provided on the fourth support 133; an insulating layer is provided on the outer surface of the piercing portion 1341. In this embodiment, the insulating layer is a teflon coating. In this embodiment, the piercing part 1341 is made of a metal material, and an insulating layer is further disposed on the outer surface of the piercing part 1341, so that the needle end of the piercing part 1341 is electrically conductive and other parts are insulated. Meanwhile, the Teflon coating has the effects of lubrication and the like, so that the puncture effect of the invention is better. In this embodiment, the fourth support 133 is provided with an electrical conductor for electrically connecting the control unit 3 and the puncturing part 1341, so that electrophysiological monitoring of the puncturing position is achieved, specifically, when the puncturing part 1341 touches a nerve root, an electrical signal at the needle end stimulates the nerve, so that the control unit 3 can make a corresponding response and control the puncturing part 1341 to stop moving, and the safety, accuracy and stability of the puncturing process are ensured.
According to an embodiment of the present invention, the distance between the first stopper 121 and the second stopper 122 is L1, and the distance between the end of the pressure sensor 131 abutting the first stopper 121 and the end of the third support 132 abutting the second stopper 122 is L2, so that L1 ≧ L2 is satisfied. In the present embodiment, the distance between the first limit 121 and the second limit 122 is L1, the distance between the end of the pressure sensor 131 close to the first limit 121 and the end of the third support 132 close to the second limit 122 is L2, the difference between L1 and L2 is less than or equal to 0.05mm, and L1-L2 is less than or equal to 0.05 mm. In the present embodiment, if the processing precision between the structures is high, the smaller the difference between L1 and L2, the better, so that the accuracy and precision of the puncturing process of the present invention can be ensured.
According to one embodiment of the invention, the guiding movement unit 2 is a laser guiding system, which has the function of surgical planning. In the present embodiment, the needle placement unit 1 performs a puncture operation along a previously planned path by the guide movement unit 2.
The method of the present invention will be further explained based on the foregoing detailed description of the apparatus applied to the present invention, with reference to the accompanying drawings.
Referring to fig. 1 and 7, in the step of acquiring the target point of the target region and controlling the guiding motion unit 2 by the control unit 3 to guide the needle unit 1 to the target point in step S1, the device for epidural anesthesia needle placement according to the present invention is calibrated in advance, and mainly calibrated by performing image localization through the guiding motion unit 2. After the device calibration is completed, an X-ray film of a target position to be operated is obtained through a C-arm X-ray machine, an image is positioned in the operation to obtain a target area (see a closed loop area in fig. 8), and a target point position in the target area (see a point position in the closed loop area in fig. 8) is further selected. After the target point location is selected, the control unit 3 drives the guiding and moving unit 2 to move according to the selected target point location, so that the guiding and moving unit 2 aligns the posture of the needle placing unit connected with the guiding and moving unit with the target point location, and further the puncture operation is performed subsequently.
Referring to fig. 1 and 7, according to an embodiment of the present invention, in step S2, after the needle placement unit 1 moves to the target pose, the operator confirms that the needle placement operation is started without error, that is, the motion unit 2 is guided to drive the puncture needle 134 on the needle placement unit 1 to advance along the puncture direction, and the system performs multidimensional monitoring on the needle placement process, such as real-time resistance monitoring, needle insertion displacement monitoring, electrophysiological monitoring, and digital feature recognition of differentiation of puncture tissues, and when any one of the monitoring means triggers a needle stop signal, the needle placement mechanism should immediately stop moving and send a prompt message.
Referring to fig. 1 and 7, in step S2, in the step of receiving the electric signal fed back by the needle unit 1, the electric signal is at least one of a resistance change signal, a needle insertion displacement signal, an electrophysiological monitoring signal, and a punctured tissue differentiation signal. As described above, in the present embodiment, the resistance change signal is acquired by the pressure sensor 131, the needle insertion displacement signal is acquired by the first driver 14, and the electrophysiological monitoring signal and the puncture tissue differentiation signal are acquired by the puncture needle.
In the present embodiment, the resistance change signal is used in the resistance monitoring process. Referring to fig. 9, the resistance monitoring is based on a "resistance disappearing method" which is commonly used in clinic, that is, the resistance of puncture gradually increases when the puncture needle passes through skin, subcutaneous tissue, supraspinous ligament and interspinous ligament in sequence, and reaches the maximum when the ligamentum flavum is reached (it can be understood that air is compressed when the syringe is pushed, and the resistance is felt). When the puncture needle breaks through the ligamentum flavum, the resistance of the needle insertion disappears suddenly (the resistance disappears when the injector is pushed, the air is not compressed, the hollow feeling is achieved, and the back-pumping is free of marrow). The resistance of the puncture needle to insertion should have a jump course. As can be seen from this, the pressure sensor 131 provided in the needle insertion unit 1 of the present invention outputs a pressure change process similar to or the same as the above process, that is, the pressure gradually increases to a pressure jump and decreases. As can be seen from the above process, the pressure sensor 131 can monitor the resistance experienced by the puncture needle 134 during the puncture process in real time, and when the ligamentum flavum is crossed, there is a significant jump in the detected resistance (note that the jump is a relative change, not an absolute value). Further, in step S2, when the electrical signal is a resistance change signal and the resistance change signal makes a transition, a needle stop signal is triggered to stop driving the needle placing unit 1.
In the present embodiment, the needle insertion displacement signal is used for needle insertion displacement monitoring. Specifically, in the process of monitoring the needle insertion displacement, after the puncture needle enters the skin, the pulse number of the stepping motor is recorded through a counter arranged in the device, and then the needle insertion displacement signal of the puncture needle after penetrating the skin is obtained in real time. Furthermore, in step S2, when the electrical signal is a needle insertion displacement signal, as mentioned above, CT data of the preoperative puncture site of the patient can be obtained in advance, and further, a distance of a planned path during the puncture operation can be obtained according to the CT data, so that the planned path distance and an actual movement displacement (obtained from the needle insertion displacement signal) can be compared, and when the actual movement displacement exceeds the planned path distance, the system gives an information prompt and triggers a shutdown signal. In this embodiment, the determination of the penetration of the needle into the skin is triggered by the pressure sensor monitoring a change in pressure.
In this embodiment, the electrophysiological monitoring uses an electrophysiological monitoring signal. In particular, intra-operative neuroelectrophysiological monitoring is used to express the integrity of nervous system function in a dangerous state during surgery using a variety of neuroelectrophysiological techniques. And an indispensable important component for monitoring the functional integrity of nerves, reducing nerve injury and improving the operation quality in clinical operation by adopting electrophysiological monitoring.
In modern medical surgery, various imaging techniques have greatly advanced the development of surgery anatomically. The result of the nerve electrophysiology monitoring in the operation is to know whether the nervous system is damaged or not from the function, objectively evaluate the integrity of the nervous system function of patients in the operations of neurosurgery, orthopaedics, cardiac surgery, ENT and the like, thereby providing reliable information for operating doctors and ensuring that the operation is carried out more smoothly and more safely.
Therefore, the invention adopts the electromyographic nerve monitoring technology in the nerve electrophysiology monitoring technology, and knows whether the puncture needle placed in the human body is too close to the spinal nerves or not through the stimulated electromyogram triggered by the stimulated nerve root filaments. The myoelectric nerve monitoring technology is applied to the invention by adopting a mode of combining the existing complete myoelectric nerve monitoring system with anesthesia puncture and modifying a puncture needle structure. Referring to fig. 10, in this embodiment, the present invention provides an insulating layer (e.g., teflon coating) on the shaft portion of the puncture needle, and the end portion is electrically conductive, while an electrical conductor is provided at the position where the puncture needle is connected to the fourth bearing 133, and is connected to the interface of the sensor through a lead wire. Thus, the puncture needle is locally insulated and connected with the corresponding sensor, and the puncture needle is refitted into the probe for the electromyographic nerve monitor. When the guide motion unit 2 controls the puncture needle to puncture, if the puncture needle touches the nerve root, the electric signal at the end of the puncture needle stimulates the nerve, and then the sensor connected with the puncture needle or receives the corresponding electric signal, the control unit 3 can convert the corresponding electric signal, send out a sound signal, trigger a protection mechanism at the same time, and stop the motion of the needle placing unit 1.
In the present embodiment, the digital feature recognition of the differentiation of the punctured tissue uses a punctured tissue differentiation signal. Specifically, the electrical conductivity under different tissues can be acquired by combining the electrical signals fed back by the electrical stimulation of the muscles in the process of the neuroelectrophysiological monitoring. Through the pre-established different tissue conductivity databases, the current position of the puncture needle can be obtained by matching the acquired conductivity with the databases. Furthermore, the matching result can be visually simulated and output to a display device, so that the whole puncture process can be visualized. In the present embodiment, it is determined whether the puncture needle 124 is in place based on the matching result, and if so, a needle stop signal is triggered to stop driving the needle placement unit 1.
According to one embodiment of the present invention, in the step of evaluating the puncture result of the needle unit 1 in step S3, the judgment is performed by an acoustic sensation detection assistance judgment method and/or a pressure chamber detection assistance judgment method.
In the present embodiment, the auditory sense detection assistance determination method is implemented by the voice detection module 1231. In the embodiment, the basis of the sound detection auxiliary judgment is the epidural space negative pressure principle which is commonly used clinically, when the puncture needle punctures ligamentum flavum and reaches the epidural space, air outside the needle is sucked into the negative pressure cavity at the moment of pulling the needle core, and at the moment, the sound is obviously generated by 'drive', the sound can be clearly heard clinically, and the recurrence rate is basically 100%. Based on the clinical phenomenon, the puncture result is subjected to auxiliary judgment by adopting a sound sensation detection mode. In the present invention, the sensor detection port is packaged, and is adjacent to the connection position of the stylet portion 1342 and the puncture portion 1341 of the puncture needle, and is aligned with the air inlet at the tail end of the puncture needle (i.e. the puncture portion 1341 is opposite to the first member 1342a at the end of the stylet portion 1342), so that the sound can be collected clearly and timely when the stylet portion 1342 is pulled away. When a target signal is generated, the sound detection module 1231 can detect the relative change of the sound wave signal, and then the result of air being pumped back into the negative pressure cavity can be obtained for auxiliary judgment of the puncture result.
In this embodiment, in the step of performing the evaluation by the pressure chamber detection auxiliary judgment method, the judgment is performed by a syringe pump communicating with the puncturing part 1341 and rotating the syringe pump forward or backward. In the present embodiment, the syringe pump is provided with a pressure chamber sensor. Specifically, the basis of the auxiliary judgment of the pressure cavity detection is a clinically common bubble method, namely before the puncture needle breaks through the ligamentum flavum, if the tail end of the puncture needle is connected with an injector, the injector is pushed to feel obvious resistance, and meanwhile, bubbles in the injector are compressed. When the puncture needle breaks through the ligamentum flavum, the resistance disappears if the injector is pushed, the air bubble is not compressed and is pushed along the direction of the normal saline. Based on the clinical phenomenon, the scheme is that the needle core is pulled out, and the injection pump is connected after the sound sensation detection auxiliary judgment result is obtained for auxiliary judgment of pressure cavity detection.
In this embodiment, the syringe pump is a micro syringe pump, and a pressure chamber sensor for detecting the liquid pressure is integrated in the syringe pump. The principle of the auxiliary judgment of the pressure cavity detection is that if the puncture needle does not puncture the ligamentum flavum, the hydraulic pressure value detected by the sensor is rapidly increased by transmitting the injection pump, and the operator feels obvious push needle resistance feeling as if the air bubble is compressed in the air bubble method. If the puncture needle punctures the ligamentum flavum, the hydraulic pressure value detected by the sensor should be kept unchanged basically, and at the moment, the pumping direction of the injection pump is reversed, and no cerebrospinal fluid flows out.
According to the invention, real-time multidimensional monitoring is carried out through the puncture process of the opposed needle unit, such as monitoring the puncture resistance of the puncture needle in real time through a pressure sensor, and the puncture depth is recorded in real time when the puncture needle penetrates into the skin; monitoring whether the puncture needle touches nervous tissue in real time by an electromyographic physiological monitoring technology; the conductivity of the current tissue is detected in real time through an electric signal detection sensor, and the current puncture tissue is simulated according to a conductivity database. The data are detected through multiple sensors, whether the current position is the target position or not is judged, the accuracy of the puncture needle position in the puncture process is guaranteed, and the safety of the operation process is further improved.
According to the invention, after the puncture is finished, namely when the needle placing unit detects that the puncture needle reaches the target position through the multi-sensor monitoring means, the invention also provides at least one judgment means for assisting the judgment of the puncture result, namely, the sound detection module is used for detecting the sound of air reverse pumping at the moment of pumping out the needle core part. In addition, a syringe pump device with pressure cavity detection is also provided for detecting whether the current puncture needle is at the target position. Through the detection means, the accuracy of the puncture position is further accurately determined.
According to the invention, the visualization of the puncture process is realized, the conductivity of the current tissue is detected in real time through the electric signal detection sensor, the current puncture tissue is simulated according to the pre-established tissue conductivity database, namely the real-time puncture position of the puncture needle is simulated, meanwhile, the advancing path and distance of the puncture needle after entering the skin are calculated through the operation planning function of the device, the current puncture position of the puncture needle is calculated in real time through pressure data and step pulse data, then the simulation data are fused, the real position of the puncture needle after penetrating the skin is accurately calculated, and the real position is displayed in a system UI interface, so that the visualization of the accurate puncture process is realized.
According to the invention, the needle placing unit is arranged in a double-layer guide rail mode, and the guide rail is used for bearing bending moment generated by puncture stress, so that the bending moment effect generated in the puncture process is avoided, and the measurement accuracy and the service life of the sensor are ensured.
The foregoing is merely exemplary of particular aspects of the present invention and devices and structures not specifically described herein are understood to be those of ordinary skill in the art and are intended to be implemented in such conventional ways.
The above description is only one embodiment of the present invention, and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (15)
1. An auxiliary method for an epidural anesthesia needle placement, characterized in that, is applied to an epidural anesthesia needle placement device, the device comprises: the device comprises a needle placing unit (1), a guiding movement unit (2) for driving the needle placing unit (1) to move, and a control unit (3) for supporting and controlling the guiding movement unit (2), wherein the needle placing unit (1) and the control unit (3) are electrically connected with each other;
the auxiliary method comprises the following steps:
s1, acquiring a target point position of a target area, wherein the control unit (3) controls the guide motion unit (2) to guide the needle placing unit (1) to the target point position;
s2, driving the needle placing unit (1) to advance along the puncture direction, receiving an electric signal fed back by the needle placing unit (1) by the control unit (3), judging whether a needle stopping signal is triggered or not according to the electric signal, and if so, stopping driving the needle placing unit (1);
and S3, judging the puncture result of the needle placing unit (1) and outputting a judgment result.
2. The assisting method of claim 1, wherein in step S2, the electrical signal is at least one of a resistance variation signal, a needle insertion displacement signal, an electrophysiological monitoring signal, and a punctured tissue differentiation signal.
3. Assistance method according to claim 2, characterized in that said needle placement unit (1) comprises: a first support (11) used for being mutually connected with the guiding movement unit (2), a second support (12) connected with the first support (11) in a sliding way, a needle placing component (13) connected with the second support (12) in a sliding way, and a first drive (14) arranged on the first support (11) and used for driving the second support (12) to move;
the needle placing assembly (13) is provided with a pressure sensor (131), and the second support (12) is provided with a first limit (121) which can be abutted against the pressure sensor (131);
the pressure sensor (131) is used for outputting the resistance change signal, and the first drive (14) is used for outputting the needle insertion displacement signal.
4. Auxiliary method according to claim 3, characterized in that said needle placement assembly (13) further comprises: a third support (122) for sliding connection with the second support (12), a fourth support (123) for detachable connection with the third support (122), and a puncture needle (124) mounted on the fourth support (123);
acquiring the electrophysiological monitoring signal and the punctured tissue differentiation signal based on a puncture location of the puncturing part (1341).
5. The assistance method according to claim 4, characterized in that the puncture needle (124) comprises a puncture portion (1341) and a core portion (1242);
the puncture part (1341) is a hollow cylindrical body, and the stylet part (1242) is detachably arranged in the hollow part of the puncture part (1341) coaxially with the puncture part (1341);
the fourth support (123) is provided with an electric conductor for the mutual electric connection between the control unit (3) and the puncture part (1341);
an insulating layer is disposed on an outer surface of the piercing portion (1341).
6. Auxiliary method according to claim 5, wherein in step S2, when the electrical signal is a resistance change signal, if the resistance change signal jumps, the needle stop signal is triggered to stop driving the needle placing unit (1).
7. Auxiliary method according to claim 5, characterized in that in step S2, when the electrical signal is a needle insertion displacement signal, an actual needle insertion displacement is obtained according to the needle insertion displacement signal of the first driver (14), and compared with a pre-planned puncture path distance, if the actual needle insertion displacement exceeds the pre-planned puncture path distance, the needle stop signal is triggered to stop driving the needle placing unit (1).
8. Auxiliary method according to claim 5, characterized in that in step S2, when the electrical signal is an electrophysiological monitoring signal, the needle-stopping signal is triggered directly to stop driving the needle-placing unit (1).
9. The assisting method of claim 5, wherein in step S2, when the electrical signal is a punctured tissue differentiation signal, the current tissue conductivity included in the punctured tissue differentiation signal is matched with a pre-established tissue conductivity database, and whether the puncture needle (124) is in place is determined according to the matching result, if yes, the needle stopping signal is triggered to stop driving the needle placing unit (1).
10. Auxiliary method according to claim 9, characterized in that in the step of determining whether the puncture needle (124) is in place according to the matching result, the puncture process of the puncture needle (124) is visually simulated and displayed according to the matching result.
11. The assistance method according to any one of claims 5 to 10, wherein in the step of evaluating the result of puncturing by the needle placement unit (1) in step S3, the evaluation is performed by a sound sensation detection assistance determination method and/or a pressure cavity detection assistance determination method.
12. The assisting method according to claim 11, wherein a sound detecting module (1231) for the sound sensation detection assisting determination method is provided on a side of the fourth bearing (123) close to the puncture needle (124).
13. The assisting method according to claim 12, wherein in the step of performing the evaluation by the acoustic sensation detection assisting determination method, the stylet portion (1242) is drawn out from the puncturing portion (1341), the sound detection module (1231) acquires a sound generated when air is sucked into the puncturing portion (1341) when the stylet portion (1242) is detached from the puncturing portion (1341), and the sound detection module (1231) converts the sound into an electric signal and transmits the electric signal to the control unit (3) for the evaluation.
14. The assisting method according to claim 11, wherein in the step of judging by the pressure chamber detection assisting judging method, a syringe pump is used to communicate with the puncturing part (1341), and the syringe pump is rotated in a forward or reverse direction to judge;
a pressure cavity sensor is arranged in the injection pump.
15. The method as recited in claim 14, wherein the step of evaluating by rotating the syringe pump in a forward and reverse direction comprises:
the injection pump is positively transmitted, and the pressure cavity sensor is adopted to collect pressure change of a pressure cavity and transmit the pressure change to the control unit (3) for judgment;
the syringe pump was reversed and evaluated for the presence of liquid outflow.
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| CN202010096955.7A CN111166437B (en) | 2020-02-17 | 2020-02-17 | Auxiliary method for epidural anesthesia needle placement |
| PCT/CN2021/075507 WO2021164577A1 (en) | 2020-02-17 | 2021-02-05 | Auxiliary device and auxiliary method for epidural anesthesia needle placement |
| US17/869,986 US20220354534A1 (en) | 2020-02-17 | 2022-07-21 | Auxilliary device and auxilliary method for epidural anesthesia needle placement |
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| CN202010096955.7A CN111166437B (en) | 2020-02-17 | 2020-02-17 | Auxiliary method for epidural anesthesia needle placement |
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