CN114376667A - Linear bone file with nerve monitoring function - Google Patents

Linear bone file with nerve monitoring function Download PDF

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Publication number
CN114376667A
CN114376667A CN202210049678.3A CN202210049678A CN114376667A CN 114376667 A CN114376667 A CN 114376667A CN 202210049678 A CN202210049678 A CN 202210049678A CN 114376667 A CN114376667 A CN 114376667A
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CN
China
Prior art keywords
file
nerve
bone file
linear
rasping
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Pending
Application number
CN202210049678.3A
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Chinese (zh)
Inventor
不公告发明人
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Shanghai Jinlicheng Medical Technology Co ltd
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Shanghai Jinlicheng Medical Technology Co ltd
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Application filed by Shanghai Jinlicheng Medical Technology Co ltd filed Critical Shanghai Jinlicheng Medical Technology Co ltd
Priority to CN202210049678.3A priority Critical patent/CN114376667A/en
Publication of CN114376667A publication Critical patent/CN114376667A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1659Surgical rasps, files, planes, or scrapers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1662Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1671Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the spine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1757Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the spine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/05Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0538Measuring electrical impedance or conductance of a portion of the body invasively, e.g. using a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316Modalities, i.e. specific diagnostic methods
    • A61B5/388Nerve conduction study, e.g. detecting action potential of peripheral nerves

Abstract

The invention discloses a linear bone file with a nerve monitoring function, which is in a flat belt shape and is provided with a working part and a traction part, wherein the working part comprises a filing area and a frame, the frame is fixed with the outer edge of the filing area, the filing area is a chain-shaped strip formed by longitudinally arranging or flexibly connecting two or more filing sheets longitudinally and transversely, the working surface of each filing sheet is provided with filing grains, the back surface is smooth, the traction part is arranged at two ends of the working part and is fixedly connected with the frame, and the surface of the working part and/or the traction part is provided with at least one nerve monitoring element. The invention optimizes the traditional way of cutting off the vertebral plate by using a high-speed abrasive drill, adopts the wire saw to file the vertebral plate, is easy to operate, has higher safety, can monitor the nerve electrophysiological signals at the operation part in the operation, performs nerve function positioning and function evaluation, assists in guiding the operation and avoids damaging nerves.

Description

Linear bone file with nerve monitoring function
Technical 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 the spinal cord or nerve roots are pressed due to abnormal stenosis of the spinal foramen or intervertebral foramen. Spinal stenosis is most commonly seen as lumbar spinal stenosis, followed by cervical spinal stenosis. Symptoms caused by spinal stenosis include pain, paresthesia, muscle weakness, difficulty walking in the lower extremities, progressive progression of symptoms, and in severe cases urinary incontinence, difficulty defecation, and sexual dysfunction. Spinal stenosis is caused by a number of factors, including degenerative disc disease (degenerative disc disease), spinal cord tumors, trauma, rheumatoid arthritis, and hereditary diseases. The most common degenerative lumbar spinal stenosis occurs, the incidence rate of people of 50-65 years old reaches 8%, and the incidence rate of people of more than 65 years old reaches 20%.
Traditional open laminectomy decompression has the advantage of definite efficacy, but has a large impact on spinal stability and often requires internal fixation and fusion. It has the disadvantages of large surgical trauma, more complications and the like.
With the development of medical technology and the change of life style, people put forward the requirements of faster, more minimally invasive, more accurate and more effective treatment to diseases. Currently, minimal trauma has become an important direction for spinal surgery. In recent years, minimally invasive endoscopic spinal canal Decompression (Microendoscopic surgery and Decompression) is rapidly developed and becomes the first treatment scheme for treating spinal stenosis by modern surgery. Compared with the traditional open surgery method, the minimally invasive endoscopic spinal canal decompression surgery shows numerous advantages: less blood loss, short procedure time, short hospital stay, low anesthetic requirements, reduced surgical infection rate and CSF leakage rate, and reduced rework time.
In the prior art, in the process of a vertebral canal decompression operation, an operation approach enters from the vertebral plate, and the vertebral plate structure is cut by using surgical instruments such as a high-speed abrasive drill, vertebral plate rongeur and the like under an endoscope, so that the aim of forming and decompressing the vertebral canal is fulfilled. However, these conventional cutting tools have high requirements on operators during use, are not easy to control and easily injure the spinal cord, and have certain difficulty in flushing and cleaning due to large bone fragments and soft tissue impurity particles which are cut and ground by using electric drills, vertebral plate rongeurs and the like.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides a linear bone file with a nerve monitoring function, which can monitor the nerve electrophysiological signals at the operation part in the operation, perform nerve function positioning and function evaluation, assist in guiding operation and avoid injuring nerves. The invention optimizes the traditional way of cutting off the vertebral plate by using the high-speed abrasive drill, adopts the wire saw to file the vertebral plate, is easy to operate and has higher safety.
The specific technical scheme of the invention is as follows:
the utility model provides a linear bone file, is flat banding, has work portion and tractive portion, and work portion includes rasping district and frame, and the frame is fixed with rasping district outer fringe, rasping district is the pitch chain form banding that two or more file piece longitudinal arrangement (along the rasp extending direction) or vertical and horizontal flexonics formed, and the working face of every file piece has the rasping line, and the back is smooth, and the work portion both ends are located to tractive portion, links firmly with the frame, work portion and/or tractive portion surface are equipped with at least one nerve monitoring element.
The nerve monitoring element is selected from one or more of electrodes, sensors, outer packaging films with sensing performance, patches or coatings with sensing performance and conduction paths made of media for conducting nerve signals, wherein the media comprise one or more of but are not limited to metal, light, sound, graphene, new media materials and the like.
The lead wire connected with the nerve monitoring element can be embedded in the linear bone file and is connected with electrophysiological signals (such as impedance) or nerve electrophysiological signal receiving and processing equipment (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 efferent and/or afferent signals, differentiating bone tissue, neural tissue or other soft tissue by detection of impedance signals; or the nerve electrophysiological signals generated by the nerve due to direct or indirect stimulation are detected, and the precise position of the nerve is positioned. When the signal is detected on the working surface of the bone file, 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.
In the linear bone file according to the present invention, the pulling portion has a fixing hole or a fixing member to be fixed to the end effector of the surgical robot.
When the linear bone file is matched with a surgical robot for use, a lead wire which is connected with a nerve function monitoring system circuit is arranged in an end effector of the surgical robot, and an interface which is connected with the circuit of the nerve monitoring element or a connection mode in different forms is arranged on the end effector. Preferably, the interface for electrical connection is provided at a fixed contact of the end effector and the linear rasp.
When two or more than two filing pieces are longitudinally arranged, the filing pieces are fixed with the frame, and the filing pieces can be connected or crosslinked without connection. When a plurality of file sheets are longitudinally and transversely cross-linked, the file sheets on the outer edge of the file area are fixed with the frame, the internal file sheets are flexibly connected, the file sheets can rotate relative to the joint to form an angle, and the file sheets can adopt common flexible connection modes, such as hinging, universal connection and the like.
The working surface of each filing sheet has filing lines and the back surface is smooth. The design can ensure that the bone file has better flexibility, closely fits the surface of a bone (such as a vertebral plate), and improves the efficiency and the effect of filing.
Preferably, the file pieces are connected with each other to form a hollow mesh strip, or the file pieces are connected with each other or fixed with the frame to form a grid strip. The design can not only increase the flexibility of the bone file, but also facilitate the flushing of bone chips and soft tissue foreign particles generated in the filing process.
Preferably, the rasping lines are different from thick to thin rasping lines. This design allows for more precise rasping of the lamina, avoiding rough surfaces damaging nerves or other soft tissue.
Preferably, the portion of the linear bone file not in the rasped area has a flexible insulating protective layer.
In a preferred embodiment, the drawing part is a hollow hose, and the rasping area is provided with a through hole passage therein, which is coaxial with the hollow hose. The design can lead the guide wire to pass through the inner part of the bone file when the bone file is matched with the guide wire for use.
The invention also discloses an orthopedic operation device which comprises a guide tube, a guide wire and the linear bone file.
Preferably, the leading ends of the guide tube and guide wire, and the surface of the linear bone file are provided with at least one nerve monitoring element.
The use of the surgical robot of the present invention will be described with reference to a guiding tube, a guide wire and a linear bone file, taking a spinal decompression operation as an example. The method comprises the following specific steps:
(1) penetrating the head end of the guide tube into the intervertebral foramen, and loosening the gap between the ligamentum flavum and the conical plate by using the hardness of the guide tube;
(2) fixing the guide wire with a linear bone file (for example, the guide wire is fixed with the bone file after penetrating into a hollow hose of a traction part of the bone file and a pore canal of a filing area), one end of the guide wire penetrates along a guide tube, and the bone file passes through a ligamentum flavum, a transarticular process and an intervertebral foramen along with the guide wire and is bent to pass through a conical plate;
(3) after the linear bone file reaches the operation position, the connection with the guide wire is released, the guide device is firstly withdrawn, and the guide wire is then withdrawn from the conical plate gap. The nerve monitoring elements on the guide tube, the guide wire and the linear bone file are used for monitoring in real time in the process of executing the operation;
(4) the traction 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 the nerve function monitor or the surgical robot with the nerve function monitoring system. When utilizing the bone file to grind the bone, the nerve monitoring element real-time supervision bone file touches the impedance and/or the neural electrophysiological signal of tissue, and during the no signal, the bone file work, intervertebral foramen enlarges, reaches the decompression purpose, in case detect the signal, the bone file stop work immediately avoids neural damage.
The invention has the advantages that:
1. the greatest risk of the surgical procedure is the accidental injury to the nervous system during operation, which results in permanent functional loss of the patient, such as paralysis and loss of lower limb walking motor function. The bone file adopts the sheet-shaped file veins to be attached to the bone tissue for friction, the bone tissue is ground little by little, the thickness of the removed bone tissue can be controlled in millimeter grade, the space requirement of operation of a surgical tool is completely avoided, and the aim of decompression surgery is achieved on the premise of not damaging the spinal cord and the spinal nerve root. This design has avoided prior art to use high-speed abrasive drilling, vertebral plate rongeur to cut the vertebral plate and has had the risk of damaging nerve, adopts bone file vertebral plate, easy operation, and the working face only contacts with the vertebral plate, has higher security.
2. The bone file adopts a multi-section chain-shaped and hollow mesh/grid-shaped design, and can be designed to have better flexibility, closely adhere to the surface of a vertebral plate and improve the efficiency and the effect of filing. The hollow mesh/grid design can also facilitate flushing bone chips and soft tissue foreign particles generated in the filing process.
3. The bone file 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 a high-speed grinding drill and a vertebral plate rongeur, and avoids the damage to nerves or other soft tissues caused by rough surfaces.
4. The bone file is provided with a nerve monitoring element, can monitor the impedance and/or the nerve electrophysiological signals of the operation part in real time, and can execute the preset track operation to continuously and normally move when detecting the impedance signals and/or the non-nerve electrophysiological signals of non-nerve tissues; when the impedance signal of the nerve tissue and/or the neuroelectrophysiological signal are detected, the signals are transmitted to an impedance monitor or a nerve function monitoring system or a central processing system of the surgical robot, and the operator or the surgical robot stops working immediately. And the position and the rasping direction of the bone rasp 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 simple structure, can be matched with a guide for use, and is suitable for manual operation or operation of a robot 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 schematic view illustrating a mesh structure of a linear bone rasping area according to the present invention.
FIG. 3 is a view illustrating a lattice-like structure of a linear bone rasping area according to the present invention.
Fig. 4 is a schematic structural diagram of the orthopedic surgical device according to the present invention.
Detailed Description
The following examples illustrate specific steps of the present invention, but are not intended to limit the invention.
Terms used in the present invention generally have meanings commonly understood by those of ordinary skill in the art, unless otherwise specified.
The present invention is described in further detail below with reference to specific examples and with reference to the data. It will 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 procedures and methods 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 flat banding, has traction portion 1 and working portion 2, and the working portion includes frame 3 and rasping district 4, and frame 3 is fixed with 4 outer fringe in rasping district, rasping district 4 is the pitch chain form strip that two or more than two rasp 5 longitudinal arrangements or vertical and horizontal flexible connection (as shown in fig. 2) formed, and the working face of every rasp has the rasping line, and the back is smooth, and traction portion 1 locates 2 both ends in working portion, links firmly with frame 3. At least one nerve monitoring element 6 is provided on the surface of the working portion and/or traction portion.
The nerve monitoring element is selected from electrodes, sensors, outer packaging films with sensing performance, patches or coatings with sensing performance and conduction paths made of a medium for conducting nerve signals, and 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 member (not shown in the drawings) to be fixed to the end effector of the surgical robot.
Preferably, the file pieces are connected with each other to form a hollow mesh strip, or the file pieces are connected with each other or fixed with the frame to form a grid strip.
Preferably, the rasping lines are different from thick to thin rasping lines.
Preferably, the portion of the rasp that is not the rasped area has a flexible protective insulating layer.
Preferably, the drawing part is a hollow hose, and the rasping area is internally provided with a through hole 10 (shown in fig. 3) coaxial with the hollow hose.
Example 2
As shown in FIG. 4, this embodiment provides an orthopedic surgical device comprising a guide tube 7, a guide wire 8 and a linear file 9 according to the present invention, based on embodiment 1.
Preferably the tip of the guide tube 7 and guide wire 8, the surface of the linear bone file 9 is provided with at least one nerve monitoring element.
The use of the surgical robot of the present invention will be described with reference to a guiding tube, a guide wire and a linear bone file, taking a spinal decompression operation as an example. The method comprises the following specific steps:
(1) the head end of the guide tube 7 is used for penetrating into the intervertebral foramen, and the gap between the ligamentum flavum and the conical plate is loosened by the hardness of the guide tube;
(2) fixing a hollow hose which penetrates through a pore passage 10 and a traction part in the filing area of the linear bone file 8 with the linear bone file 9, wherein one end of the guide wire 8 penetrates along the interior of the guide pipe 7, and the linear bone file 9 passes through a ligamentum flavum, a transarticular process and an intervertebral foramen along with the guide wire 8 and then bends to pass 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 7 is withdrawn first, and the guide wire 8 is withdrawn from the taper plate gap. The nerve monitoring elements on the guide tube, the guide wire and the linear bone file have nerve monitoring function in the process of executing the operation.
(4) The traction 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 the nerve function monitor or the surgical robot with the nerve function monitoring system. When utilizing the bone file to grind the bone, the nerve monitoring element real-time supervision bone file touches the impedance or the neural electrophysiological signal of tissue, and during the no signal, the bone file work, intervertebral foramen enlarges, reaches the decompression purpose, in case detect the signal, the bone file stop work immediately avoids neural damage.
In addition to the above embodiments, the present invention may have other embodiments. All technical solutions formed by adopting equivalent substitutions or equivalent transformations fall within the protection scope of the claims of the present invention.

Claims (9)

1. The utility model provides a filiform bone file with nerve monitoring function, its characterized in that filiform bone file is flat banding, has work portion and tractive portion, and work portion includes rasping district and frame, and the frame is fixed with rasping district outer fringe, the rasping district is the pitch chain form strip that two or more than two file piece longitudinal arrangement or vertical and horizontal flexible coupling formed, and the working face of every file piece has the rasping line, and the back is smooth, and the tractive portion is located the work portion both ends, links firmly with the frame, work portion and/or tractive portion surface are equipped with at least one nerve monitoring element.
2. The linear bone file of claim 1, wherein the nerve monitoring element is selected from one or more of an electrode, a sensor, an outer coating for sensory properties, a patch or coating for sensory properties, a conductive pathway made of a medium for conducting nerve signals.
3. The linear bone file according to claim 1, wherein the traction portion has a fixing hole or a fixing member to which an end effector of a surgical robot is fixed.
4. The linear bone file according to claim 1, wherein the rasp pieces are connected to each other to form a hollowed-out mesh strip, or the rasp pieces are connected to each other or fixed to the frame to form a rasp-like strip.
5. The linear bone file as set forth in claim 1, wherein the rasp patterns are different from coarse to fine.
6. The linear bone file of claim 1, wherein the portion of the file that is not in the rasped area has a flexible protective insulating layer.
7. The linear bone file of claim 1, wherein the pulling portion is a hollow flexible tube, and the rasping zone is internally provided with a through-going passage coaxial with the hollow flexible tube.
8. An orthopedic surgical device comprising a guide tube, a guide wire, and the linear bone file having a nerve monitoring function according to any one of claims 1 to 8.
9. An orthopaedic surgical device according to claim 8, wherein the leading ends of the guide tube and guide wire, the surface of the linear rasp, are provided with at least one nerve monitoring element.
CN202210049678.3A 2022-01-17 2022-01-17 Linear bone file with nerve monitoring function Pending CN114376667A (en)

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Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030225412A1 (en) * 2001-10-19 2003-12-04 Tateru Shiraishi Surgical ribbon file
JP2004065380A (en) * 2002-08-02 2004-03-04 Manii Kk Surgical file
US20060122458A1 (en) * 2004-10-15 2006-06-08 Baxano, Inc. Devices and methods for tissue access
US20070123888A1 (en) * 2004-10-15 2007-05-31 Baxano, Inc. Flexible tissue rasp
US20080312660A1 (en) * 2007-06-15 2008-12-18 Baxano, Inc. Devices and methods for measuring the space around a nerve root
US20090149865A1 (en) * 2007-12-07 2009-06-11 Schmitz Gregory P Tissue modification devices
US20100274250A1 (en) * 2008-07-01 2010-10-28 Wallace Michael P Tissue modification devices and methods
US20110160772A1 (en) * 2009-12-28 2011-06-30 Arcenio Gregory B Systems and methods for performing spinal fusion
CN106236188A (en) * 2016-08-31 2016-12-21 蒋毅 Mill bone object and prosthetic device
CN217014142U (en) * 2022-01-17 2022-07-22 上海锦立城医疗科技有限公司 Linear bone file and bone surgery device
CN217548207U (en) * 2022-01-17 2022-10-11 上海锦立城医疗科技有限公司 Orthopedic surgery robot with nerve monitoring function

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030225412A1 (en) * 2001-10-19 2003-12-04 Tateru Shiraishi Surgical ribbon file
JP2004065380A (en) * 2002-08-02 2004-03-04 Manii Kk Surgical file
US20060122458A1 (en) * 2004-10-15 2006-06-08 Baxano, Inc. Devices and methods for tissue access
US20070123888A1 (en) * 2004-10-15 2007-05-31 Baxano, Inc. Flexible tissue rasp
US20080312660A1 (en) * 2007-06-15 2008-12-18 Baxano, Inc. Devices and methods for measuring the space around a nerve root
US20090149865A1 (en) * 2007-12-07 2009-06-11 Schmitz Gregory P Tissue modification devices
US20100274250A1 (en) * 2008-07-01 2010-10-28 Wallace Michael P Tissue modification devices and methods
US20110160772A1 (en) * 2009-12-28 2011-06-30 Arcenio Gregory B Systems and methods for performing spinal fusion
CN106236188A (en) * 2016-08-31 2016-12-21 蒋毅 Mill bone object and prosthetic device
CN217014142U (en) * 2022-01-17 2022-07-22 上海锦立城医疗科技有限公司 Linear bone file and bone surgery device
CN217548207U (en) * 2022-01-17 2022-10-11 上海锦立城医疗科技有限公司 Orthopedic surgery robot with nerve monitoring function

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