Patent Grant
12171459
The disclosure relates to the technical field of medical instruments, in particular relates to an auxiliary device and auxiliary method for epidural anesthesia needle placement.
Having been applied to clinical practice for more than 90 years, Epidural Anesthesia has been improved step by step in the course of practices and researches, and therefore become a commonly used method in the current clinical anesthesia. Compared with general anesthesia, epidural anesthesia has a lower incidence in pulmonary embolism, deep venous thrombosis, pneumonia, myocardial infarction, wound infection, and respiratory depression, with small influence on body organs and better economy efficiency. However, the current clinical epidural anesthesia is still performed by blind manual operation, where doctors recognize epidural space in dependence on subjective perception, such that there is uncertainty in the positioning of puncture needle and catheter, which renders poor controllability and frequent complications of anesthesia and therefore limits clinical application of the said method.
In the prior art, the technique of “Blind Manual Operation” refers to a technical means in which an anesthetist identifies reaching to the epidural space by feeling disappearance of epidural resistance via his/her fingers. Since this depends on subjective determination, the rate of success is mainly decided by clinical experiences of the anesthetist. In actual clinical practice, due to lack of consistent assessment standards of epidural anesthesia effect, the failure rate of clinical epidural anesthesia is always underestimated. “Blind Manual Operation” may cause the following issues: incorrect epidural anesthesia needle placement, catheter repositioning after positioning, local overdose of anesthetics, positioning deviation of puncture point, long-time uncomfortable posture of the patient, and etc., all of which may affect the final effect of anesthesia to varying degree and bring uncomfortable experiences to the patient.
Furthermore, as for the technique of “Blind Manual Operation”, even the most experienced anesthetist also has a certain rate of failure. Particularly, the operation of epidural anesthesia puncture, catheter placement may become very difficult in the case of elder patients, spinal stenosis, narrowed epidural space, calcification of yellow ligament and etc.
Over the recent decades, in addition to the improvement of anesthesia puncture kit, there is no extraordinary improvement and development in the aspect of technical operation of epidural anesthesia, and so far there is no good solution for an “ideal epidural space positioning technique based on objective indications”, so that the defects existing in manual operation become the main technical obstacle of epidural anesthesia.
The present application aims at providing an auxiliary device and method for epidural anesthesia needle placement to solve the difficulty of anesthetists in accurate puncture.
In order to solve the above problem, the present disclosure provides an auxiliary device for epidural anesthesia needle placement, comprising: a needle placement unit, a motion guide unit for driving the needle placement unit into movement, and a control unit for supporting and controlling the motion guide unit, the needle placement unit being electrically connected to the control unit; the needle placement unit comprises: a first support connected to the motion guide unit, a second support connected to the first motion guide unit, a needle placement assembly slidably connected to the second support, and a first drive arranged on the first support for driving the second support into movement.
According to an aspect of the present disclosure, the movement direction of the needle placement assembly on the second support is parallel to the movement direction of the second support on the first support.
According to an aspect of the present disclosure, the first drive drives the second support to linearly reciprocate on the first support.
The needle placement assembly linearly reciprocates on the second support.
According to an aspect of the present disclosure, the needle placement assembly is provided with a pressure sensor.
In the movement direction of the needle placement assembly, a first stop abutting against the pressure sensor is arranged opposite to the second support and a second stop for limiting a movement position of the needle placement assembly.
According to an aspect of the present application, the needle placement assembly further comprises: 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.
According to an aspect of the present application, the space between the first stop and the second stop is L1, and the distance between an end at which the pressure sensor abuts against the first stop and an end at which the third support abuts against the second stop is L2, L1≥L2.
According to an aspect of the present application, a sound detection module is provided on a side where the fourth support is in proximity to the puncture needle.
According to an aspect of the present disclosure, the third support is in clip-connection to the fourth support.
The puncture needle is in clip-connection to the fourth support.
According to an aspect of the present application, the puncture needle comprises a puncturing portion and a needle core portion.
The puncturing portion is a hollow cylinder. The needle core portion is arranged coaxially with the puncturing portion in a detachable manner in the hollow portion of the puncturing portion.
A first structural member is provided on an end of the needle core portion, and an end of the puncturing portion which is adjacent to the first structure member adjoins the sound detection module.
According to an aspect of the present disclosure, an electric conductor for electrically connecting the control unit and the puncturing portion is provided on the fourth support.
The puncturing portion is provided with an insulation layer on its outer surface.
According to an aspect of the present disclosure, the insulation layer is a Teflon coating.
According to an aspect of the present disclosure, the first drive comprises: a power source, and a lead screw pair provided integrally with a main shaft of the power source.
In order to achieve the above purpose of the disclosure, the present disclosure provides an auxiliary method for epidural anesthesia needle placement, comprising:
According to an aspect of the present disclosure, in step S2, the electric signal is one of a resistance change signal, a needle advance displacement signal, an electrophysiological monitoring signal, and a puncture-tissue differentiation signal.
According to an aspect of the present disclosure, the pressure sensor provided for the needle placement assembly of the needle placement unit is for outputting the resistance change signal, and the first drive of the needle placement unit is for outputting the needle advance displacement signal.
According to an aspect of the present disclosure, the electrophysiological monitoring signal and the puncture tissue differentiation signal are acquired based on a puncture position of the puncturing portion on the puncture needle of the needle placement assembly.
According to an aspect of the present disclosure, in step S2, when the electric signal is the resistance change signal, if a hopping occurs in the resistance change signal, the needle stop signal is triggered to stop driving the needle placement unit.
According to an aspect of the present disclosure, in step S2, when the electric signal is the needle advance displacement signal, an actual displacement of needle advancement is obtained in accordance with the needle advance displacement signal of the first drive, and comparing the actual displacement of needle advancement with a predetermined distance of puncture path, if the actual displacement of needle advancement exceeds the predetermined distance of puncture path, the needle stop signal is triggered to stop driving the needle placement unit.
According to an aspect of the present disclosure, in step S2, when the electric signal is the electrophysiological monitoring signal, the needle stop signal is triggered to stop driving the needle placement unit.
According to an aspect of the present disclosure, in step S2, when the electric signal is the puncture-tissue differentiation signal, a current tissue conductivity contained in the puncture-tissue differentiation signal is matched with a pre-established tissue conductivity data base to determine whether or not the puncture needle is in place, if yes, the needle stop signal is triggered to stop driving the needle placement unit.
According to an aspect, in the step of determining whether or not the puncture needle is in place in accordance with a matching result, the puncture process of the puncture needle is visually stimulated and displayed in accordance with the matching result.
According to an aspect of the present disclosure, in step S3, in the step of evaluating the puncture result of the needle placement unit, evaluation is carried out using an auxiliary determination method of acoustic detection and/or an auxiliary determination method of pressure cavity detection.
According to an aspect of the present disclosure, in the step of evaluating with the auxiliary determination method of acoustic detection, the needle core portion of the puncture needle is pulled out of the puncturing portion. When the sound detection module detects removal of the needle core portion from the puncturing portion, the sound generated as drawing the air into the puncturing portion is converted into an electric signal by the sound detection module and transmitted to the control unit for evaluation.
According to an aspect of the present disclosure, in the step of evaluating with the auxiliary determination method of pressure cavity detection, the evaluation is executed by positively and negatively rotating an injection pump which is in communication with the puncturing portion; a pressure cavity sensor is provided inside the injection pump.
According to an aspect of the present disclosure, the step of positively and negative rotating the injection pump for evaluation comprises: positively rotating the injection pump, acquiring a pressure change of the pressure cavity using the pressure cavity sensor and transmitting it to the control unit for evaluation; negatively rotating the injection pump, performing evaluation in accordance with whether or not there is outflow of fluid.
According to a solution of the present disclosure, the disclosure may sufficiently stimulates the skill of manual puncture, performing a real-time multidimensional monitoring to the puncture process based on “Resistance Disappearance Method”, “Negative Pressure Method”, human neurophysiological reactions, and other clinical experiences, in combination with intraoperative image positioning technique, multi-sensor technique, electrophysiological monitoring technique, and micromechanical control technique, and consequently achieving an autonomous, precise, and safe needle placement operation.
According to a solution of the present disclosure, by means of multi-sensor technique, the puncture process and the determination following the puncture are scientifically, reliably detected, enormously reducing the possibility of misjudgment. Furthermore, electrophysiological monitoring is also added in the puncture process which eliminates occurrence of a case with a serious consequence, such as total spinal anesthesia, caused by puncture failure.
According to a solution of the present disclosure, it is possible to accurately control a deep of puncture independently of the clinical experience of anesthetists. In the solution, pressure monitoring, electrophysiological monitoring, and electric signal monitoring can be achieved, and stepping control technique can be used to perform real-time monitoring and control over the puncture process. When the puncture needle pierces through yellow ligamentum, reaching epidural space, the needle placement mechanism does not have overshoot and may accurately control the deep of puncture.
According to a solution of the present disclosure, the electrical single monitoring is execute by connecting a conductor to the puncture needle, where the sensor measures an electrical conductivity of the current tissue in real time, and simulates the current tissue in accordance with a data base of electrical conductivity, that is, a real-time puncture position of the puncture needle can be simulated, and at the same time a current needle position of the puncture needle can be calculated in real time by means of the advance path and distance, the pressure data, and the stepping pulse data of the needle placement unit, followed by merging the simulation data, a real position of the puncture needle into skin is accurately calculated and displayed in a system UI interface, and a precise visualization of the puncture process is therefore achieved.
According to a solution of the present disclosure, the disclosure has various monitoring means, where multi-sensor technique is used to scientifically, reliably detect both of the puncture process and the determination following the puncture, enormously reducing the possibility of misjudgment.
In order to more clearly illustrates embodiments of the present disclosure or technical solutions in the prior art, figures used in the embodiments are simply introduced as follows. Apparently, the figures in the following description are merely some embodiments of the present disclosure. Person skilled in the art could also obtain other figures in accordance with these figures without contributing innovative effort.
As describing embodiments of the present disclosure, the orientations or position relationships represented by terms “longitudinal”, “transverse”, “upper”, “lower”, “front”, “rear”, “left”, “right”, “vertical”, “horizontal”, “top”, “bottom”, “inner”, “outer” are orientations or position relationships shown based on the related figures, which are merely for the purpose of describing and simplifying the present disclosure, but do not indicate or imply that the said devices or elements must have certain orientations, and are configured and operated in certain orientations, so that the above terms cannot be understood as limits to the present disclosure.
Hereinafter, the present disclosure is described in detail in combination with figures and specific embodiments that cannot be specified here, however, embodiments of the present disclosure are not limited to the following embodiments.
As shown in combination with
As shown in combination with
As shown in combination with
As shown in combination with
As shown in combination with
As shown in combination with
As shown in combination with
As shown in combination with
As shown in combination with
As shown in combination with
According to an embodiment of the present disclosure, if the space between the first stop 121 and the second stop 122 is L1, the distance between the end of pressure sensor 131 which abuts against the first stop 121 and the end of third stop 132 which abuts against the second stop is L2, L1≥L2. In the present embodiment, if the space between the first stop 121 and the second stop 122 is L1, the distance between the end of pressure sensor 131 which abuts against the first stop 121 and the end of third support 132 which abuts against the second stop 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 the present embodiment, in the case of high machining precision between components, a smaller difference between L1 and L2 is better, which may guarantee accuracy and precision of the puncture process.
According to an embodiment of the present disclosure, the motion guide unit 2 is a laser guide system having a function of surgery planning. In the present embodiment, the needle placement unit 1 carries out the puncture operation along a predefined path under the action of motion guide unit 2.
According to the present disclosure, by disposing a sound detection module on the fourth support, when the puncture needle enters in an object, followed by pulling out the core portion, the sound detection module may, due to the negative pressure produced between the external environment and the hollow space in the puncture portion, effectively and quickly detect the moment at which the needle core portion is pulled out of the puncture portion. Depending on the detected sound, the present disclosure may more quickly and accurately detect the quality of puncture, such that the device of the present disclosure may conveniently, effectively and multi-dimensionally evaluate the puncture result.
According to the present disclosure, by way of electrifying the puncture needle and providing an insulation layer on the outer surface of the puncture needle, the needle tip of the puncture needle becomes electrically conductive, and a corresponding puncture position is further obtained depending on the electric signal of the needle tip. In the case that a puncture operation is executed by the needle placement unit of the present disclosure, if the puncture needle touches a nerve root, the electric signal will stimulate the nerve, and the control unit will further acquire a corresponding electric signal, giving a sound signal, and at the same time triggering a protection mechanism and stopping the movement of the mechanism. Hence, the solution of the present disclosure further effectively enhances puncture precision of the present disclosure.
As shown in combination with
As shown in combination with
As shown in combination with
As shown in combination with
In the present embodiment, a resistance change signal is adopted during the resistance monitoring. Referring to
In the present embodiment, a needle displacement signal is used in the needle displacement monitoring. Specifically, during the needle displacement monitoring, when the puncture needle enters skin, the pulse number of the stepping motor is recorded by means of a counter provided in the device so as to obtain the needle displacement signal in real time after piercing the puncture needle into skin. Further, in the step S2, when the electrical signal is a needle displacement signal, as the above stated, by way of acquiring CT data of the preoperative puncture site of the patient in advance, a planned route distance in the puncture operation may be obtained depending on the CT data, such that by comparing the planned route distance with an actual displacement, the system can provide prompt information and triggers a stop signal, when the actual displacement exceeds the planned route distance. In the embodiment, the entrance of puncture needle into the skin is determined depending on the change of pressure detected by the pressure sensor.
In the present embodiment, the electrophysiological monitoring uses an electrophysiological monitoring signal. Specifically, the intraoperative electro-neurophysiological monitoring is for monitoring the integrity of a function of nervous system in dangerous state during the surgery using various electro-neurophysiological techniques. Hence, it is an indispensable component for improvement of surgery quality to apply electrophysiological monitoring in clinical operations to monitor the integrity of nerve function, reducing nerve damage.
In modern surgical operations, various imaging techniques enormously contribute to the development of operative surgery in the aspect of anatomical structure. Result of the intraoperative electro-neurophysiological monitoring is to find out whether or not a nerve system is damaged in function, so as to objectively evaluate the integrity of nerve system function of a patient in neurosurgical, orthopedic, cardiac-surgical, and facial operations and etc., in order to provide reliable information for surgeons which may in turn perform the operation more smoothly and safely.
Hence, the present disclosure adopts myoelectric nerve monitoring technique in electro-neurophysiological monitoring techniques to know whether the puncture needle placed in human body is too close to spinal nerves via a stimulation electromyogram produced by stimulating nerve rootlets. The myoelectric nerve monitoring technique is applied in the present disclosure in such a way that the structure of the puncture needle is modified in the manner of combining the whole of the current myoelectric nerve monitoring system and anesthesia puncture. Referring to
In the present embodiment, the digital characteristic identification of puncture tissue differentiation uses a puncture tissue differentiation signal. Specifically, electrical conductivities under different tissues can be acquired in combination with the above mentioned electric signals fed back from the muscular electrical stimulation during neuro-electrophysiological monitoring. By establishing a data base of electrical conductivities of different issues in advance, the current position of the puncture needle can be further obtained by comparing the acquired electrical conductivity with the data base. Furthermore, a comparison result can be visually simulated and output on the display device, achieving visualization of the entire puncture process. In the present embodiment, whether the puncture needle 134 is in place according to the comparison result, if so, a needle stop signal is triggered to stop driving the needle placement unit 1.
According to an embodiment of the present disclosure, in step S3, a determination is made by using an assistant determination method of acoustic detection and/or an assistant determination method of pressure cavity detection, in the step of determining a puncture result of the needle placement unit 1.
In the present embodiment, the assistant determination method of acoustic detection is performed by means of a sound detection module 1231. In the embodiment, the assistant determination of acoustic detection is based on the principle of negative epidural pressure commonly used in clinic practice. When the puncture needle penetrates yellow ligament and reaches epidural space, the air outside the needle will be drawn into the negative pressure cavity at the moment the needle core is withdrawn. At this moment, there is an obvious “whoosh” which can be clearly heard with a recurrence rate of substantially 100% in clinic practice. Based on such a clinical phenomenon, the present solution adopts acoustic detection to carry out an assistant determination. In the present disclosure, a detection port of the sensor is encapsulated, which is in a position adjacent to the location at which the core portion 1342 and the puncture portion 1341 of the puncture needle are connected and which is aligned to an air inlet on the puncture needle tail (i.e., the puncture portion 1341 is opposite to a first member 1342a of the core portion 1342), in order to clearly and promptly acquire the sound produced in the withdrawal of the core portion 1342. When a target signal is generated, the sound detection module 1231 may detect a relative change of the acoustic signal, i.e., a result of air being sucked back into the negative pressure cavity is obtained, for the assistant determination of the puncture result.
In the present embodiment, an injection pump is in communication with the puncture portion 1341 and is positively and negatively rotated to perform determination, in the step of performing a determination using the assistant determination method of pressure cavity detection. In the present embodiment, the injection pump is provided with a pressure cavity sensor therein. Specifically, the assistant determination of pressure cavity detection is depending on the “Bubble Method” commonly used in the clinic practice, i.e., if an injector is connected to the tail of the puncture needle, as pushing the injector, man may feel an obvious sensation of resistance, before the puncture needle pierces yellow ligament, and bubbles in the injector are compressed at the same time. After the puncture needle pierces yellow ligament, as pushing the injector, man may feel the resistance disappears, with the bubbles are not compressed and advanced in the direction of saline solution. Based on the above clinic phenomenon, in the present solution, the injection pump is connected for assistant determination of pressure cavity detection, only after withdrawing the needle core and obtaining the result of the assistant determination of acoustic detection.
In the present embodiment, the injection pump is a micro injection pump which is integrated with a pressure cavity sensor for detecting a liquid pressure. The principle of assistant determination of pressure cavity detection is that if the puncture needle does not pierce through yellow ligament, the injection pump rotates positively, the sensor will detect a rapid rise of liquid pressure, while the operator may feel an obvious sensation of resistance in needle advance, just like the feeling when bubbles are compressed in the “Bubble Method”. If the puncture needle has pierced through the yellow ligament, the liquid pressure detected by the senor remains substantially unchanged, at which moment the suction direction of the injection pump reverses and no cerebrospinal fluid flows out.
According to the disclosure, by way of performing a real-time, multi-dimensional monitoring to the puncture process of the needle placement unit, for example, monitoring the puncture resistance against the puncture needle in real time by means of the pressure sensor, a puncture depth is recorded once the skin has been pierced through; whether a nerve tissue is touched is monitored in real time by means of the electro-neurophysiological monitoring technique; a conductivity of the current tissue is detected in real time via an electric-signal detection sensor and the current puncture tissue is stimulated according to the conductivity data base. Based on the data detected by multiple sensors, it is determined whether the current position is the target position, ensuring precision of the puncture position during the puncture process, and further enhancing safety during the surgical operation.
According to the disclosure, having finished the puncture, i.e., when it is detected by means of the multiple sensors that the needle placement unit reaches the target position, the present disclosure also provides at least one determination means to assist the determination of puncture result, i.e., uses a sound detection module to detect the back-suction sound of air at the moment when the core portion is withdrawn. Further, an injection pump device with pressure cavity detection is provided for detecting whether the puncture needle is currently in the target position. By the aid of the above detection means, the accuracy of puncture position is further precisely determined.
According to the disclosure, visualization of the puncture process is achieved by detecting the conductivity of the current tissue by means of the electric signal detection sensor and stimulating the current puncture tissue according to the preset tissue conductivity data base, i.e., stimulating the real-time puncture position of the puncture needle and simultaneously calculating an advance path and distance of the puncture needle in the skin in real time by means of a surgery planning function of the apparatus in the present disclosure, calculating the current puncture position in real time via pressure data and stepping pulse data, then, by means of merging with stimulation data, accurately calculating the real position of the puncture needle piercing through the skin, and displaying the real position in the system UI interface so as to achieve precise visualization of the puncture process.
According to the disclosure, the needle placement unit in a form of a double-track arrangement bears, by the aid of the tracks, the bending moment produced by puncture force, preventing thereby the effect of bending moment and ensuring measurement precision and service life of the sensors.
The above content merely concerns examples of the embodiments of the present disclosure. The apparatuses and structures which are not described with details therein shall be understood to be implemented by means of the existing universal apparatuses and methods in the present field.
The above mentioned is only a scheme of the present disclosure and is not intended to limit the present disclosure. For a person skilled in the art, the present disclosure may have various modifications and variations. Any other modifications, equivalent substitutions, adaptations, and etc. made under the spirit and within the concept of the present disclosure shall be encompassed in the protection extent of the present disclosure.
| Number | Date | Country | Kind |
|---|---|---|---|
| 202010096939.8 | Feb 2020 | CN | national |
| 202010096955.7 | Feb 2020 | CN | national |
This application is a bypass continuation application of PCT application no.: PCT/CN2021/075507. This application claims priorities from PCT Application PCT/CN2021/075507, filed Feb. 5, 2021, Chinese Patent Application No. 202010096955.7, entitled “Auxiliary Method for Epidural Anesthesia Needle Placement”; and to Chinese Patent Application No. 202010096939.8, entitled “Auxiliary Device for Epidural Anesthesia Needle Placement”, filed with China Patent Bureau on Feb. 17, 2020, which are incorporated by reference in their entirety into this application.
| Number | Name | Date | Kind |
|---|---|---|---|
| 4414983 | Evans et al. | Nov 1983 | A |
| 5104382 | Brinkerhoff et al. | Apr 1992 | A |
| 8715234 | Bethi | May 2014 | B2 |
| 8920388 | Slocum | Dec 2014 | B2 |
| 9743875 | Maguire | Aug 2017 | B2 |
| 10646660 | Hochman | May 2020 | B1 |
| 20130066191 | Parihar | Mar 2013 | A1 |
| 20190192247 | Woo | Jun 2019 | A1 |
| 20200397399 | Adams | Dec 2020 | A1 |
| 20210378627 | Yarmush | Dec 2021 | A1 |
| Number | Date | Country |
|---|---|---|
| 102083377 | Jun 2011 | CN |
| 105963018 | Sep 2016 | CN |
| 106943180 | Jul 2017 | CN |
| 108567475 | Sep 2018 | CN |
| 108577945 | Sep 2018 | CN |
| 111150462 | May 2020 | CN |
| 111166437 | May 2020 | CN |
| 211674480 | Oct 2020 | CN |
| Number | Date | Country | |
|---|---|---|---|
| 20220354534 A1 | Nov 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/CN2021/075507 | Feb 2021 | WO |
| Child | 17869986 | US |
