Linear bone file with nerve monitoring functionTechnical Field
The invention belongs to the field of medical instruments, and particularly relates to a linear bone file with a nerve monitoring function.
Background
Spinal stenosis is a condition in which a spinal cord or nerve root is pressed due to abnormal stenosis of a foramen or an intervertebral foramen. Spinal stenosis is most common with lumbar spinal stenosis, followed by cervical spinal stenosis. Symptoms caused by lumbar spinal stenosis include pain in the lower extremities, paresthesia, muscle weakness, difficulty walking, progressive progression of symptoms, and severe effects on urinary incontinence, difficulty defecation and sexual dysfunction. Spinal stenosis is a cause of many diseases including degenerative disc disease (DEGENERATIVE DISC DISEASE), spinal cord tumor, trauma, rheumatoid arthritis, and hereditary disease. Most of the patients have degenerated lumbar spinal stenosis, the incidence rate of the patients is 8% between 50 and 65 years old, and the incidence rate of the patients over 65 years old is 20%.
Traditional open laminectomy decompression has the advantage of definite efficacy, but has a large impact on spinal stability, often requiring internal fixation and fusion. It has the disadvantages of large surgical wound, more complications and the like.
With the development of medical technology and lifestyle changes, faster, less invasive, more accurate and more effective treatment of diseases is required. Minimally invasive surgery has become an important direction in spinal surgery. In recent years, minimally invasive endoscopic spinal canal decompression (Microendoscopic Laminectomy and Decompression) has evolved rapidly, becoming the treatment of choice for modern surgery to treat spinal canal stenosis. Minimally invasive endoscopic spinal canal decompression procedures present numerous advantages over traditional open surgical approaches: the blood loss is small, the operation time is short, the hospitalization time is short, the anesthetic requirement is low, the operation infection rate and the CSF leakage rate are reduced, and the reworking time is reduced.
Under the prior art, in the vertebral canal decompression operation process, an operation access is accessed from the space between vertebral plates, and surgical instruments such as a high-speed abrasive drill, a vertebral plate rongeur and the like are used under an endoscope to cut off the vertebral plate structure, so that the purpose of vertebral canal forming and decompression is achieved. However, these conventional cutting tools are very demanding to the operator, are not well controlled, and are prone to injuring the spinal cord, and the bone fragments and soft tissue impurity particles which are shaved off by using electric drills, laminar rongeurs, etc. are large, and the washing and cleaning have certain difficulty.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides the linear bone file with the nerve monitoring function, which can monitor nerve electrophysiological signals at an operation part in operation, perform nerve function positioning and function assessment, assist in guiding operation and avoid damaging nerves. The invention optimizes the traditional mode of cutting the vertebral plate by using the high-speed abrasive drill, adopts the wire saw for filing the vertebral plate, is easy to operate and has higher safety.
The specific technical scheme of the invention is as follows:
A linear bone file is in a flat strip shape and is provided with a working part and a pulling part, wherein the working part comprises a file grinding area and a frame, the frame is fixed with the outer edge of the file grinding area, the file grinding area is a chain-shaped strip formed by longitudinally arranging two or more file sheets (along the extending direction of the bone file) or longitudinally and transversely flexibly connecting the file sheets, the working surface of each file sheet is provided with file grinding lines, the back surface is smooth, the pulling part is arranged at two ends of the working part and fixedly connected with the frame, and at least one nerve monitoring element is arranged on the surface of the working part and/or the pulling part.
The nerve monitoring element is selected from one or more of an electrode, a sensor, an outer envelope of sensing performance, a patch or coating of sensing performance, and a conducting path made of a medium for conducting nerve signals, wherein the medium comprises one or more of metal, light, sound, graphene, a new medium material and the like.
The lead wire connected with the nerve monitoring element can be buried in the linear bone file, and is connected with an electrophysiological signal (such as impedance) or a nerve electrophysiological signal receiving and processing device (such as an impedance monitor, a nerve function monitor or a surgical robot with an impedance monitoring or nerve function monitoring system) when in use. The nerve monitoring element is capable of transmitting and/or receiving signals, distinguishing bone tissue, nerve tissue or other soft tissue by detecting impedance signals; or detecting nerve electrophysiological signals generated by direct or indirect stimulation of the nerve, and positioning the accurate position of the nerve. When the working surface of the bone file detects a signal, the nerve monitoring element can transmit the detected signal to an electrophysiological signal (such as impedance) or a nerve electrophysiological signal receiving and processing device, and an operator or a surgical robot receives feedback information to stop filing.
The linear bone file of the invention, the pulling part is provided with a fixing hole or a fixing piece which is fixed with an end effector of a surgical robot.
When the linear bone file is matched with the surgical robot for use, a wire connected with a circuit of the nerve function monitoring system is arranged in an end effector of the surgical robot, and an interface connected with a circuit of the nerve monitoring element or different connecting modes are arranged on the end effector. Preferably, the interface for the circuit connection is provided at the fixed contact of the end effector and the linear bone file.
When the linear bone file provided by the invention adopts two or more file pieces to be longitudinally arranged, the file pieces are fixed with the frame, and the file pieces can be crosslinked without connection. When a plurality of file pieces are longitudinally and transversely crosslinked, the file pieces at the outer edge of the file grinding area are fixed with the frame, the file pieces are flexibly connected inside, the file pieces can rotate relative to the connecting part to form an angle, and common flexible connection modes such as hinging, universal connection and the like can be adopted among the file pieces.
The working surface of each file piece is provided with file lines, and the back surface is smooth. The design can enable the bone file to have better flexibility, be closely attached to the surface of bones (such as vertebral lamina), and improve the efficiency and effect of file grinding.
Preferably, the file pieces are connected with each other to form a hollowed-out net-shaped strip, or the file pieces are connected with each other or fixed with the frame to form a grid-shaped strip. The design can not only increase the flexibility of the bone file, but also can conveniently flush bone fragments and soft tissue impurity particles generated in the filing process.
Preferably, the rasping lines are different rasping lines from thick to thin. The design can more finely file the lamina and avoid the rough surface from damaging nerves or other soft tissues.
Preferably, the part of the linear bone file, which is not the rasping area, is provided with a flexible insulating protective layer.
In a preferred scheme, the traction part is a hollow hose, and a through hole coaxial with the hollow hose is formed in the rasping area. The design can enable the guide wire to pass through the bone file when the bone file is matched with the guide wire.
The invention also discloses an orthopedic operation device which comprises a guide tube, a guide wire and the linear bone file.
Preferably, at least one nerve monitoring element is arranged on the surfaces of the head ends of the guide tube and the guide wire and the linear bone file.
Taking vertebral canal decompression operation as an example, the use process of the surgical robot provided by the invention is described by combining a guide tube, a guide wire and a linear bone file. The method comprises the following specific steps:
(1) Penetrating the intervertebral foramina by utilizing the head end of the guide tube, and loosening the gap between the ligamentum flavum and the conical plate by utilizing the hardness of the guide tube;
(2) Fixing the guide wire with a linear bone file (for example, after the guide wire penetrates into a hollow hose of a bone file traction part and a pore canal of a file grinding area, fixing the guide wire with the bone file), penetrating one end of the guide wire along the guide pipe, and bending the bone file along with the guide wire to pass through a yellow ligament, a articular process and a intervertebral foramina and penetrate through a conical plate;
(3) After the linear bone file reaches the operation position, the connection with the guide wire is released, the guide wire is withdrawn in advance, and the guide wire is withdrawn from the cone plate gap. The nerve monitoring elements on the guide tube, the guide wire and the linear bone file are monitored in real time in the process of executing the operation;
(4) The pulling part of the linear bone file is fixed with the end effector of the surgical robot, and the nerve monitoring element is also connected with a nerve function monitor or the surgical robot with a nerve function monitoring system. When the bone file is used for grinding bones, the nerve monitoring element monitors impedance of the bone file to tissues and/or nerve electrophysiological signals in real time, when no signal exists, the bone file works, the intervertebral foramen is enlarged, the aim of reducing pressure is achieved, and once the signal is detected, the bone file immediately stops working, so that nerve injury is avoided.
The invention has the advantages that:
1. The biggest risk of the surgical procedure is the accidental injury of the nervous system during operation, which causes permanent loss of functions of the patient, such as paralysis and loss of walking movement functions of the lower limbs. The bone file is adhered to bone tissue by adopting the flaky file, the bone tissue is rubbed, the bone tissue is ground off at a point, the thickness of the bone tissue is removed, the control can be performed in millimeter level, the space requirement of operation tool operation is completely avoided, and the aim of decompression operation is fulfilled on the premise that spinal cord and spinal nerve root are not damaged. The design avoids the risk of nerve injury caused by the fact that the vertebral plate is cut off by using the high-speed grinding drill and the vertebral plate rongeur in the prior art, adopts the bone file to grind the vertebral plate, is simple to operate, and has higher safety due to the fact that the working face is only contacted with the vertebral plate.
2. The bone file adopts a multi-section chain-shaped and hollowed-out net-shaped/grid-shaped design, can be designed to enable the bone file to have better flexibility, be tightly attached to the surface of a vertebral plate, and improve the efficiency and effect of filing. The hollowed-out net-shaped/grid-shaped design can also conveniently flush bone fragments and soft tissue impurity particles generated in the rasping process.
3. The invention further adopts the design that the working surface of the bone file is provided with different file lines from thick to thin. Compared with the prior art, the design can more finely file the vertebral plate by using the high-speed grinding drill and the vertebral plate rongeur, and avoid the damage of nerves or other soft tissues on the rough surface.
4. The bone file is provided with the nerve monitoring element, can monitor the impedance and/or the nerve electrophysiological signal of an operation part in real time, and can execute the preset orbit operation to continuously and normally move when the impedance signal and/or the nerve electrophysiological signal of the non-nerve tissue are detected; when impedance signals and/or neuro-electrophysiologic signals of nerve tissues are detected, the signals are transmitted to an impedance monitor or a nerve function monitoring system or a surgical robot central processing system, and an operator or a surgical robot immediately stops working. And the position and the rasping direction of the bone file can be adjusted according to the impedance signal and/or the nerve electrophysiological signal, so that the nerve site is avoided, and the operation is safer.
5. The bone file has a simple structure, can be matched with an introducer for use, and is suitable for manual operation or operation of a robotic surgical system.
Drawings
Fig. 1 is a schematic view of a linear bone file with nerve monitoring function according to the present invention.
Fig. 2 is a diagram showing a mesh structure of a linear bone rasp area according to the present invention.
Fig. 3 is a schematic view showing a grating structure of the linear bone rasp area according to the present invention.
Fig. 4 is a schematic structural view of an orthopedic operation device according to the present invention.
Detailed Description
The following examples illustrate the specific steps of the present invention, but are not limited thereto.
The terms used in the present invention generally have meanings commonly understood by those of ordinary skill in the art unless otherwise indicated.
The invention will be described in further detail below in connection with specific examples and with reference to the data. It should be understood that these examples are intended to illustrate the invention and are not intended to limit the scope of the invention in any way.
In the following examples, various processes and methods, which are not described in detail, are conventional methods well known in the art.
Example 1
The embodiment discloses a linear bone file, as shown in fig. 1, the linear bone file is in a flat strip shape, and is provided with a traction part 1 and a working part 2, wherein the working part comprises a frame 3 and a file grinding area 4, the frame 3 is fixed with the outer edge of the file grinding area 4, the file grinding area 4 is a joint chain-shaped strip formed by longitudinally arranging or longitudinally and transversely flexibly connecting more than two file pieces 5 (as shown in fig. 2), the working surface of each file piece is provided with file grinding lines, the back surface is smooth, and the traction part 1 is arranged at two ends of the working part 2 and fixedly connected with the frame 3. At least one nerve monitoring element 6 is provided on the working and/or pulling part surface.
The nerve monitoring element is selected from an electrode, a sensor, an outer envelope with sensing performance, a patch or a coating with sensing performance, and a conducting path made of a medium for conducting nerve signals, wherein the medium is selected from one or more of metal, light, sound, graphene and a new medium material.
Further, the pulling part may also have a fixing hole or a fixing piece (not shown in the drawings) to be fixed with the end effector of the surgical robot.
Preferably, the file pieces are connected with each other to form a hollowed-out net-shaped strip, or the file pieces are connected with each other or fixed with the frame to form a grid-shaped strip.
Preferably, the rasping lines are different rasping lines from thick to thin.
Preferably, the portion of the non-rasped area of the rasp has a flexible insulating protective layer.
Preferably, the pulling part is a hollow hose, and a through hole 10 (shown in fig. 3) coaxial with the hollow hose is arranged in the rasping area.
Example 2
As shown in fig. 4, this embodiment provides an orthopedic operation device including a guide tube 7, a guide wire 8, and a linear bone file 9 according to the present invention on the basis of embodiment 1.
Preferably, at least one nerve monitoring element is arranged on the surfaces of the head ends of the guide tube 7 and the guide wire 8 and the linear bone file 9.
Taking vertebral canal decompression operation as an example, the use process of the surgical robot provided by the invention is described by combining a guide tube, a guide wire and a linear bone file. The method comprises the following specific steps:
(1) Penetrating the intervertebral foramina by using the head end of the guide tube 7, and loosening the gap between the ligamentum flavum and the conical plate by using the hardness of the guide tube;
(2) Fixing a guide wire 8 with a linear bone file 9 through a through hole 10 in a linear bone file filing area and a hollow hose of a traction part, penetrating one end of the guide wire 8 along the guide pipe 7, and bending the linear bone file 9 along the guide wire 8 through a yellow ligament, a articular process and a intervertebral foramen through a conical plate;
(3) After the linear bone file 9 reaches the operation site, the connection with the guide wire 8 is released, the guide wire 7 is withdrawn in advance, and the guide wire 8 is withdrawn from the cone plate gap. The nerve monitoring element on the guide tube, the guide wire and the linear bone file has the nerve monitoring function in the process of executing the operation.
(4) The pulling part of the linear bone file is fixed with the end effector of the surgical robot, and the nerve monitoring element is also connected with a nerve function monitor or the surgical robot with a nerve function monitoring system. When the bone file is used for grinding bones, the nerve monitoring element monitors impedance of the bone file to tissues or nerve electrophysiological signals in real time, when no signals exist, the bone file works, the intervertebral foramen is enlarged, the aim of reducing pressure is achieved, and once the signals are detected, the bone file immediately stops working, so that nerve injury is avoided.
In addition to the embodiments described above, other embodiments of the invention are possible. All technical schemes formed by equivalent substitution or equivalent transformation fall within the protection scope of the invention.