CN113100897B - Intelligent external fixing clamp for monitoring spinal rehabilitation state and monitoring method - Google Patents

Intelligent external fixing clamp for monitoring spinal rehabilitation state and monitoring method Download PDF

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CN113100897B
CN113100897B CN202110426097.2A CN202110426097A CN113100897B CN 113100897 B CN113100897 B CN 113100897B CN 202110426097 A CN202110426097 A CN 202110426097A CN 113100897 B CN113100897 B CN 113100897B
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accelerometer
module
fixing clamp
stud
patient
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CN113100897A (en
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周吴
冉龙骐
于慧君
魏敦文
曾志
吴一川
彭倍
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University of Electronic Science and Technology of China
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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
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002—Longitudinal elements, e.g. rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1116—Determining posture transitions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1121—Determining geometric values, e.g. centre of rotation or angular range of movement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1126—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb using a particular sensing technique
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6878—Bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6879—Means for maintaining contact with the body
    • A61B5/6882—Anchoring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient ; user input means
    • A61B5/746—Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient ; user input means
    • A61B5/7465—Arrangements for interactive communication between patient and care services, e.g. by using a telephone network

Abstract

An intelligent external fixing clamp for monitoring a vertebral rehabilitation state and a monitoring method mainly comprise a support rod 1, pedicle screws 2 and 3, external fixing clamps 4 and 5, triaxial accelerometer modules 6 and 7 and accelerometer fixing modules 8 and 9. When a patient performs an operation, the pedicle screws 2 and 3 are implanted into the patient, then the fixing clamps are installed, the pedicle screws 2 and 3 are respectively fixed with the external fixing furniture 4 and 5 through the studs 10 and 11, and the external fixing clamps 4 and 5 are respectively fixed with the supporting rod 1 through the studs 12 and 13. After the fixing clamp is installed, the monitoring device is installed, and the accelerometer fixing modules 8 and 9 are fixed with the pedicle screws 2 and 3 through the locking nuts 14 and 15 respectively.

Description

Intelligent external fixing clamp for monitoring spinal rehabilitation state and monitoring method
Technical Field
The present invention relates generally to an intelligent external fixation clamp for monitoring spinal rehabilitation status and a monitoring method, and more particularly to a process that can be fixed to the spine of a patient for the antero-lateral surgical correction of conditions such as scoliosis, also known as scoliosis.
Background
Thoracolumbar spine diseases such as spine fractures, spine tumors, kyphosis and scoliosis may occur for a number of different reasons. For example, scoliosis may occur as a result of poliomyelitis, a paralytic disease of neuromuscular etiology or spinal injury. However, the most common cause of scoliosis is genetically determined growth abnormalities of the spine, the most common feature of which is the resulting curve development when children transition from late childhood to adolescence. This condition is known as idiopathic scoliosis.
Since the mid-twentieth fifties, the standard scoliosis surgical treatment has been "instrumented spinal fusion" which typically involves implanting a metal product, such as a hook or screw, into the spine at each end of the curve, then attaching a retaining rod to the metal product, then correcting the spine with surgical instruments (by twisting or jacking up the spine), then connecting the rod to the hook or screw and fixing in place to maintain the spine in a lengthened, straightened, and corrected position, surgery may be performed using an anterolateral approach, with correction of the vertebrae or the posterior of the corrected vertebrae being performed from the anterior or lateral side of the patient.
To prevent subsequent loosening of the implant and loss of corrective deformity, spinal fusion of the instrumented portion of the spine is virtually always performed simultaneously with the instrumentation. This means that bone fragments are placed along the part of the spinal column not covered by the implant. These bone fragments or implants induce the vertebrae that are part of the curvature to grow together over a period of weeks to months to years. This fusion maintains the correction of the spinal deformity achieved through the use of the instruments. For many years, the primary surgical approach to spinal instrumentation has tended to incompletely correct the curvature and has typically been to instrument and fuse long segments of the spine, most commonly 7-14 segments. This procedure is an inevitable trauma to the patient, requiring a long recovery time, sometimes even more than a year, and the patient's recovery status cannot be detected.
Disclosure of Invention
In order to solve the problem that the rehabilitation state of a patient cannot be detected after a spine operation at present, the invention provides an intelligent external fixing clamp for monitoring the rehabilitation state of the spine, which mainly comprises a supporting rod 1, a first pedicle screw 2, a second pedicle screw 3, a first external fixing clamp 4, a second external fixing clamp 5, a first accelerometer module 6, a second accelerometer module 7, a first accelerometer fixing module 8 and a second accelerometer fixing module 9.
When a patient performs an operation, as shown in fig. 1, a first pedicle screw 2 and a second pedicle screw 3 are implanted into the patient, then fixing fixtures are installed, the first pedicle screw 2 and the second pedicle screw 3 are fixed with a first external fixing fixture 4 and a second external fixing fixture 5 through a first stud 10 and a second stud 11, and the first external fixing fixture 4 and the second external fixing fixture 5 are fixed with a support rod 1 through a third stud 12 and a fourth stud 13. After the fixing clamp is installed, the monitoring device begins to be installed, and the first accelerometer fixing module 8 and the second accelerometer fixing module 9 are fixed with the first pedicle screw 2 and the second pedicle screw 3 respectively through the first locking nut 14 and the second locking nut 15. First accelerometer module 6, second accelerometer module 7 is because the module below is spherical, can be at the free rotation of certain extent, adjust first accelerometer module 6, second accelerometer module 7 position, make two accelerometer output numerical value unanimous back around, through fourth double-screw bolt 16, first accelerometer module 6 after the fifth double-screw bolt 17 fixed adjustment respectively, second accelerometer module 7 is because receiving the effect of earth's heart attraction, the earth's heart acceleration that the patient received will be exported to the triaxial accelerometer, the output value of accelerometer passes into in the cell-phone through wireless transmission module, handle data in APP, compare two accelerometer input value, if two accelerometer input value differences are greater than the threshold value of settlement, then judge that present patient's posture is in unhealthy posture, cell-phone APP sends the message and reminds the patient. If the posture of the patient is in a healthy state, the walking steps of the patient are counted according to the output value of the accelerometer through an algorithm, and the exercise amount of the patient is counted.
The external fixing clamp is shown in fig. 2, and the accelerometer fixing module and the accelerometer module are shown in fig. 3.
Drawings
FIG. 1 is a schematic view of the overall structure of an external fixation clamp;
FIG. 2 is a schematic view of an external fixation clamp;
FIG. 3 is a schematic view of an accelerometer fixing module and an accelerometer module;
FIG. 4 is a schematic view of a pedicle screw layered structure;
fig. 5 is a flow chart of posture determination.
Detailed Description
The invention is further illustrated by the following examples.
In order to make the objects and technical advantages of the present invention more apparent, the present invention will be described in detail with reference to the accompanying drawings.
The utility model provides an outer mounting fixture of intelligence of recovered state monitoring of vertebra, this outer mounting fixture of intelligence mainly includes bracing piece 1, first pedicle of vertebral arch screw 2, second pedicle of vertebral arch screw 3, the outer mounting fixture 5 of first outer mounting fixture 4, second, first accelerometer module 6, second accelerometer module 7, first accelerometer fixed module 8, second accelerometer fixed module 9.
When a patient performs an operation, as shown in fig. 1, a first pedicle screw 2 and a second pedicle screw 3 are implanted into the patient, then fixing fixtures are installed, the first pedicle screw 2 and the second pedicle screw 3 are fixed with a first external fixing fixture 4 and a second external fixing fixture 5 through a first stud 10 and a second stud 11, and the first external fixing fixture 4 and the second external fixing fixture 5 are fixed with a support rod 1 through a third stud 12 and a fourth stud 13. After the fixing clamp is installed, the monitoring device is installed, and the first accelerometer fixing module 8 and the second accelerometer fixing module 9 are fixed with the first pedicle screw 2 and the second pedicle screw 3 through the locking nuts 14 and 15 respectively. First accelerometer module 6, second accelerometer module 7 is because the module below is spherical, can be at the free rotation of certain extent, adjust first accelerometer module 6, second accelerometer module 7 position, make two front and back accelerometers output numerical value unanimous back, through the double-screw bolt 16, 17 fixed first accelerometer module 6 after adjusting well respectively, second accelerometer module 7, owing to receive the effect of earth heart attraction, the earth heart acceleration that the patient received will be exported to the triaxial accelerometer, the output value of accelerometer passes through during wireless transmission module spreads into the cell-phone into, handle data in APP, compare two accelerometer input value, if two accelerometer input value differences are greater than the threshold value of settlement, then judge that present patient's posture is in unhealthy posture, cell-phone APP sends the message and reminds the patient. If the posture of the patient is in a healthy state, the walking steps of the patient are counted according to the output value of the accelerometer through an algorithm, and the exercise amount of the patient is counted.
The output of the triaxial accelerometer is A ═ a x a y a z ] T The total acceleration is
Figure BDA0003029596640000031
When the support is fixed, the output values of the two accelerometers at the moment are recorded as [ a ] x1 a y1 a z1 ] T And [ a ] x2 a y2 a z2 ] T And carrying out low-pass filtering processing and moving average filtering processing on the original accelerometer, wherein the low-pass filtering processing is used for eliminating interference generated by some hardware, and the moving average filtering processing is used for processing some pseudo peaks. The low-pass filtering output value at the current moment is
z(n)＝(1-a)z(n-1)+ax(n)
Figure BDA0003029596640000032
In the above formula, a is the filter coefficient, x (n) is the current sampling value, z (n) is the current low-pass filtered value, and y (n) is the sliding filter output value. The data is output as Y after being filtered 1 ＝[y x1 y y1 y z1 ] T And Y 2 ＝[y x2 y y2 y z2 ] T In order to determine the change before and after the posture, a threshold th needs to be set as a basis for determining the relative change of the posture, and the determination flow is shown in fig. 5.
The components of the intelligent external fixation clamp for spinal rehabilitation status monitoring may be made of biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics, and bone materials and/or composites thereof. For example, the components of the intelligent external fixation clamp for spinal rehabilitation status monitoring, individually or collectively, may be made of materials such as stainless steel alloys, pure titanium, titanium alloys, super-elastic titanium alloys, cobalt-chromium alloys, super-elastic metals. Alloys, ceramics and composites thereof, e.g. calcium phosphates, thermoplastics such as polyaryletherketones, including polyether ethersKetones (PEEK), Polyetherketoneketones (PEKK), Polyetherketones (PEK), carbon-PEEK composites, PEEK-BaSO 4 Polymer rubbers, polyethylene terephthalate (PET), textiles, silicones, polyurethanes, siloxane-polyurethane copolymers, polymer rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomer composites, polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy resins. It may also be autograft bone material, allograft, xenograft or transgenic cortical and/or cortical cancellous bone, as well as tissue growth or differentiation factors, partially resorbable materials, e.g., composite metals and calcium-based ceramics, composites of PEEK and resorbable polymers, fully resorbable materials, e.g., calcium-based ceramics, e.g., calcium phosphate, tricalcium phosphate (TCP), Hydroxyapatite (HA) -TCP, calcium sulfate or other resorbable polymers, e.g., polyglycolide, poly tyrosine carbonate, polycarboxylic acids and combinations thereof.
The components of the intelligent external fixation clamp for spinal rehabilitation status monitoring may have a material composition including the materials described above to achieve various desired characteristics, such as strength, stiffness, elasticity, compliance, biomechanical properties, durability and radiolucency or imaging preference. The components of the intelligent external fixation clamp for spinal rehabilitation status monitoring, individually or collectively, may also be made of heterogeneous materials, such as a combination of two or more of the above materials. The components of the intelligent external fixation clamp for spinal rehabilitation status monitoring may be integrally formed, integrally connected, or include fastening elements and/or instruments.
The intelligent external fixation clamps for spinal rehabilitation status monitoring may be open or micro-open, minimally invasive and/or minimally invasive, including percutaneous surgical techniques, to deliver and introduce instrumentation and/or spinal implants, such as growing rods. A surgical site in a patient including, for example, a single or multiple levels of the spine. The spinal implant comprises a telescopic structure, wherein the telescopic structure comprises a motor, a screw rod and a nut which are matched with each other. Multiple set screws and/or over-angle placement to resist pull-out from the vertebral tissue. In some embodiments, the spinal implant may include a spinal construct, one or more bone fasteners, an interbody implant, a spinal rod, a tether, and/or a connector.
The intelligent external fixation clamp for monitoring the spinal rehabilitation state allows dynamic support of the spine. Dynamically supporting the spine controllably reduces the load on the facet joints while increasing the intervertebral spacing and intervertebral foramen spacing, a problem that disc replacement may not address. Certain embodiments of the intelligent external fixation clamp for spinal rehabilitation status monitoring control stability by monitoring changes in the gravitational parameters based on the principle of the native spinal segment. The implant device thus complements the spinal gravity monitoring system and can redistribute loads with spinal segments in spinal torsion, extension, lateral bending and flexion. For example, the support rod 1 may be controlled to extend and retract, and the extension and retraction triggering factors include manual control and/or automatic control based on monitoring data of the first accelerometer module 6 and the second accelerometer module 7.
Preferably, as shown in fig. 4, the pedicle screw comprises a layered structure, which comprises a protective layer 18, a sealing layer, a phase change layer 19, a sealing layer and a central layer 20 from outside to inside; the protective layer may be titanium, titanium alloy, stainless steel, cobalt chromium, or any combination thereof; the sealing layer is typically a thin film material; the phase change layer comprises a phase change material and is switched between a solid state and a liquid/glass state, preferably, the solid state is below 20 ℃ and the liquid/glass state is above 30 ℃, the solid state is kept in the operation stage, enough rigidity support is provided for the spine of a patient, and the liquid/glass state is slowly changed into the liquid/glass state after the operation is finished, so that better comfort is provided for the patient.
Preferably, the surface layer of the pedicle screw and/or the screw rod is coated with a double-layer film, the double-layer film is provided with micropores, and the inside of the double-layer film is filled with various medicaments or therapeutic medicaments for helping the rapid growth of bones.
Although the present invention has been described with reference to the preferred embodiments, it is not intended to limit the present invention, and those skilled in the art can make possible variations and modifications of the present invention without departing from the spirit and scope of the present invention by using the methods and technical contents disclosed above, and therefore, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention shall fall within the protection scope of the present invention.

Claims (4)

1. The utility model provides an outer mounting fixture of intelligence of recovered state monitoring of vertebra which characterized in that: comprises a support rod (1), a first pedicle screw (2), a second pedicle screw (3), a first external fixing clamp (4), a second external fixing clamp (5), a first accelerometer module (6), a second accelerometer module (7), a first accelerometer fixing module (8), a second accelerometer fixing module (9), a first stud (10) and a second stud (11), wherein the first stud (10) fixes the first pedicle screw (2) and the first external fixing clamp (4), the second stud (11) fixes the second pedicle screw (3) and the second external fixing clamp (5), the third stud (12) fixes the first external fixing clamp (4) and the support rod (1), the fourth stud (13) fixes the second external fixing clamp (5) and the support rod (1), and the first accelerometer fixing module (8) and the first pedicle screw (2) are fixed by a first locking nut (14), the second accelerometer fixing module (9) is fixed with the second pedicle screw (3) through the second locking nut (15), the bottoms of the first accelerometer module (6) and the second accelerometer module (7) are spherical, the first accelerometer module (6) and the second accelerometer module (7) output the accelerated speed of the patient, and the output of the accelerometer module is A ═ a x a y a z ] T The output values of the first accelerometer module (6) and the second accelerometer module (7) are recorded as [ a ] x1 a y1 a z1 ] T And [ a ] x2 a y2 a z2 ] T The output values of the first accelerometer module (6) and the second accelerometer module (7) are transmitted into the mobile phone through the transmission module, data are processed in the APP, the input values of the first accelerometer module (6) and the second accelerometer module (7) are compared, and if the difference between the input values of the first accelerometer module (6) and the second accelerometer module (7) is larger than a set threshold value, the posture of the patient is judged to be unhealthy.
2. The intelligent external fixation clamp for monitoring the rehabilitation status of vertebral column of claim 1, wherein: the first stud (10) and the third stud (12) are positioned on the same horizontal plane, the directions are mutually vertical, and the first stud (10) sequentially passes through the first external fixing clamp (4) and the support rod (1); the third stud (12) sequentially penetrates through the second outer fixing clamp (5) and the support rod (1); the first outer fixing clamp (4) and the second outer fixing clamp (5) are respectively positioned at two ends of the supporting rod (1).
3. The intelligent external fixation clamp for monitoring the spinal rehabilitation status according to any one of claims 1-2, wherein: the first locking nut (14) is located on the upper end face of the first outer fixing clamp (4), the second locking nut (15) is located on the upper end face of the second outer fixing clamp (5), the first accelerometer fixing module (8) is located on the upper end face of the first locking nut (14), and the second accelerometer fixing module (9) is located on the upper end face of the second locking nut (15).
4. The intelligent external fixation clamp for monitoring the spinal rehabilitation state according to claim 1, characterized in that: the output values of the first accelerometer module (6) and the second accelerometer module (7) are transmitted into the mobile phone through the wireless transmission module, and the mobile phone APP sends a message to remind a patient; if the posture of the patient is in a healthy state, the walking steps of the patient are counted according to the output value of the accelerometer through an algorithm, and the exercise amount of the patient is counted.
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