Spinal fixing system and apparatus
By using image-based assessment and regional fixation of the spinal fixation system, and employing absorbable and non-absorbable pedicle screws and fixation rods, the impact of permanent fixation on mobility and the problem of secondary surgical trauma have been solved, achieving a balance between spinal stability and growth and development.
Patent Information
- Application Number
- PCT/CN2025/088708
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-04-17
- Filing Date
- 2025-04-14
- Publication Date
- 2025-10-23
AI Technical Summary
In existing spinal fixation surgeries, permanent fixation methods have a greater impact on areas with greater mobility, such as the lumbar spine and cervical spine, resulting in restrictions on patients' daily lives and the need for a second surgery to remove the implant, causing trauma.
A spinal fixation system is provided that, by acquiring images of the spinal region, determines the degree of mobility and severity, and recommends temporary or permanent fixation options. It uses absorbable and non-absorbable pedicle screws and fixation rods to fix the spinal region in areas of high or low mobility, respectively, thus avoiding secondary surgery.
It effectively maintains the corrective effect, preserves spinal mobility and growth and development to the greatest extent, reduces trauma, and is suitable for diseases such as scoliosis in children and adolescents, avoiding the pain of secondary surgery.
Smart Images

Figure CN2025088708_23102025_PF_FP_ABST
Abstract
Description
Spinal fixation system and device TECHNICAL FIELD
[0001] The present application relates to the technical field of medical equipment, in particular to a spinal fixation system and device. BACKGROUND
[0002] Clinically, spinal internal fixation can restore the stability of the spine and maintain the support function of the spine. At present, when performing spinal internal fixation, materials with high support and good fixation (such as stainless steel materials, titanium alloy materials, etc.) are generally used for permanent fixation of the affected part of the spine. However, for parts such as the lumbar spine and the cervical spine, which have a greater impact on the range of motion, the use of the above permanent fixation method will seriously affect the daily life of the patient. In particular, for children and adolescents with scoliosis, early surgery for scoliosis can correct the deforming factors as soon as possible, prevent the progression of spinal deformity, prevent the limitation of heart and lung function, and ensure normal body development. When using the permanent fixation method in the prior art to implant and fix the affected part of the spine, a second surgery is generally required to remove the implant, causing secondary trauma to the patient.
[0003] Therefore, when performing spinal internal fixation, it is necessary to minimize the impact on the growth and development of the spine and the range of motion of the spine while ensuring the smooth implementation of the surgery and the orthopedic effect, preventing the progression of deformity, restoring the balance of the spine, correcting deformity as much as possible, preserving as many active segments of the spine as possible, and preventing nerve damage. It is a problem that needs to be solved at present. If the current situation of requiring a second surgery to cause trauma again can be changed, it is the expectation of clinical orthopedic medical staff and the blessing of patients. SUMMARY
[0004] The present application aims to at least solve one of the technical problems existing in the prior art. To this end, the present application provides a spinal fixation system that can provide recommendations for temporary fixation and / or permanent fixation according to the disease conditions of the patient's spinal part, such as the age of the subject, the range of motion of the spine, the severity of the spinal lesion, etc., provide a reference for the application site of temporary fixation and / or temporary fixation, and give temporary fixation to the surgical segment after surgery. Effective maintenance of orthopedics not only solves the problem of requiring a second surgery to remove the fixation device in the prior art, causing trauma, but also maximizes the preservation of the range of motion of the spine and ensures the normal growth and development of the spine.
[0005] The first aspect of the present application discloses a spinal fixation system, the system comprising:
[0006] An acquisition unit for acquiring a spinal part image containing a target to-be-processed region;
[0007] a processing unit configured to determine a spinal region activity of the target region to be treated according to the spinal region image, and divide the target region to be treated into a high activity region or a low activity region according to the activity;
[0008] a recommendation unit configured to output a spinal fixation scheme, the spinal fixation scheme comprising fixing a temporary fixation part in the high activity region and / or fixing a permanent fixation part in the low activity region;
[0009] the temporary fixation part comprises absorbable pedicle screws and absorbable fixation rods, and the absorbable fixation rods are adapted to the absorbable pedicle screws; the permanent fixation part comprises non-absorbable pedicle screws and non-absorbable fixation rods, and the non-absorbable fixation rods are adapted to the non-absorbable pedicle screws.
[0010] the activity judgment criteria comprise a first judgment criterion, which comprises:
[0011] the high activity region comprises a region between lumbar vertebra 1 and sacrum 1, and a region between cervical vertebra 1 and thoracic vertebra 1; the high activity region preferably comprises a region between lumbar vertebra 3 and sacrum 1, and a region between cervical vertebra 1 and cervical vertebra 7; the low activity region comprises a whole thoracic vertebra region, and a region in the spinal region other than the high activity region.
[0012] the processing unit further comprises a unit configured to determine a severity level of the target region to be treated according to the spinal region image, and divide the target region to be treated into a severe region or a non-severe region according to the severity level; the severity level comprises a judgment of a scoliosis angle and whether a lumbar intervertebral disc is diseased; for the scoliosis angle, the judgment of the severe region or the non-severe region is based on a Cobb angle; for whether the lumbar intervertebral disc is diseased, the judgment of the severe region or the non-severe region is based on whether the lumbar intervertebral disc compresses a nerve root or a cauda equina.
[0013] Optionally, the spinal fixation scheme further comprises fixing the permanent fixation part in the severe region and / or fixing the temporary fixation part in the non-severe region.
[0014] Alternatively, the spinal fixation scheme further comprises fixing the permanent fixation part in the severe region and the low activity region, and / or fixing the temporary fixation part in the non-severe region and the high activity region.
[0015] the activity judgment criteria further comprise a second judgment criterion, which comprises judging an age of the subject to be measured according to the spinal region image.
[0016] When the age of the person to be measured is less than or equal to N, the high activity region includes all the spinal regions except the region judged as the severe region, and the low activity region is the region judged as the severe region; when the age of the person to be measured is greater than or equal to N, the second judgment criterion is consistent with the first judgment criterion.
[0017] After the acquisition unit, further comprising an identification unit for identifying whether to implant the target to-be-processed region;
[0018] The identification of whether to implant the target to-be-processed region comprises: acquiring the scoliosis angle of the target to-be-processed region; comparing the scoliosis angle with the standard scoliosis angle to obtain the result of whether the scoliosis angle meets the standard; if the scoliosis angle does not meet the standard, the target to-be-processed region needs to be implanted, and the processing unit is implemented; if the scoliosis angle meets the standard, the target to-be-processed region does not need to be implanted, and the processing unit does not need to be implemented.
[0019] And / or, acquiring whether the lumbar intervertebral disc of the target to-be-processed region is diseased; if the lumbar intervertebral disc is diseased, the target to-be-processed region needs to be implanted, and the processing unit is implemented; if the lumbar intervertebral disc is not diseased, the target to-be-processed region does not need to be implanted, and the processing unit does not need to be implemented.
[0020] When the temporary fixing part and the permanent fixing part are combined and fixed in the target to-be-processed region, the temporary fixing part and the permanent fixing part are connected through a connecting piece; optionally, the connecting piece is sleeved on the outer wall of the absorbable fixing rod or the non-absorbable fixing rod, so that the absorbable fixing rod or the non-absorbable fixing rod is movable along the radial direction of the central axis of the absorbable fixing rod or the non-absorbable fixing rod; the connecting piece includes but is not limited to the following structures: a double-headed nail, a double-U connector, and a connecting rod.
[0021] The double-headed nail comprises: a first connecting part for fixedly connecting the temporary fixing part or the permanent fixing part, and a second connecting part for fixedly connecting the permanent fixing part or the temporary fixing part, the first connecting part and the second connecting part being integrally formed;
[0022] Optionally, the first connecting part comprises a first base and a first fixing block and a second fixing block arranged on the upper end of the first base, the first fixing block and the second fixing block being integrally arranged on the upper end of the first base; the first fixing block and the second fixing block form an opening matched with the absorbable fixing rod or the non-absorbable fixing rod; a screw plug is arranged in the opening; the absorbable fixing rod or the non-absorbable fixing rod in the opening is fixed by the screw plug;
[0023] Optionally, the second connecting part comprises a second base and a second fixing block and a third fixing block arranged on the upper end of the second base, the second fixing block and the third fixing block are integrally arranged on the upper end of the second base; an opening adapted to the non-absorbable fixation rod or the absorbable fixation rod is formed between the second fixing block and the third fixing block; a screw plug is arranged in the opening; the non-absorbable fixation rod or the absorbable fixation rod in the opening is fixed by the screw plug; optionally, a through hole is arranged below the opening between the second fixing block and the third fixing block, and the through hole is used for connecting and fixing the non-absorbable pedicle screw.
[0024] The double-U connector is used to fix and connect the temporary fixing part and / or the permanent fixing part, the double-U connector comprises a third base and a sixth fixing block, a fourth fixing block and a fifth fixing block arranged on the upper end of the third base, the sixth fixing block, the fourth fixing block and the fifth fixing block are integrally arranged on the upper end of the third base; an opening adapted to the non-absorbable fixation rod or the absorbable fixation rod is formed between the sixth fixing block and the fourth fixing block; an opening adapted to the non-absorbable fixation rod or the absorbable fixation rod is formed between the fourth fixing block and the fifth fixing block; a screw plug is arranged in the opening; the non-absorbable fixation rod or the absorbable fixation rod in the opening is fixed by the screw plug.
[0025] The connecting rod and / or the absorbable fixation rod and / or the non-absorbable fixation rod are arranged in a cylindrical structure. The length of the connecting rod is determined according to the target region to be treated. The length of the absorbable fixation rod is determined according to the target region to be treated; the length of the non-absorbable fixation rod is determined according to the target region to be treated.
[0026] The second aspect of the present application discloses a spinal fixation device, the device comprising: one or more processors, and a memory for storing one or more computer programs, when the one or more computer programs are executed by the one or more processors, the following functions are implemented:
[0027] Obtaining an image of a spinal part containing a target region to be treated;
[0028] Determining the activity of the spinal part of the target region to be treated according to the image of the spinal part, dividing the target region to be treated into a high activity region or a low activity region according to the activity; and / or, determining the severity level of the target region to be treated according to the image of the spinal part, dividing the target region to be treated into a severe region or a non-severe region according to the severity level;
[0029] outputting a spinal fixation scheme, the spinal fixation scheme being fixing a temporary fixation part in the high activity region and / or the non-severe region, and / or fixing a permanent fixation part in the low activity region and / or the severe region;
[0030] The device further comprises a spinal fixation instrument, the spinal fixation instrument comprising a temporary fixation part and / or a permanent fixation part, the temporary fixation part comprising absorbable pedicle screws and absorbable fixation rods, the absorbable fixation rods being adapted with the absorbable pedicle screws; the permanent fixation part comprising non-absorbable pedicle screws and non-absorbable fixation rods, the non-absorbable pedicle screws and non-absorbable fixation rods being adapted.
[0031] Any one of the following applications:
[0032] The above-mentioned system in the application of disease development diagnosis; optionally, the disease includes lumbar disc herniation, child and adolescent scoliosis, etc.
[0033] Optionally, the simple nucleus pulposus removal operation in the lumbar disc herniation is adopted.
[0034] Optionally, the adolescent idiopathic scoliosis (AIS) operation, child congenital row scoliosis (CS) operation, etc. in the child and adolescent scoliosis are adopted.
[0035] The beneficial effects of the present application are:
[0036] 1. The present application innovatively discloses a spinal fixation system, introduces the concept of joint or non-joint use of temporary fixation parts and / or permanent fixation parts, and is suitable for patients with spinal diseases; when the temporary fixation part is used in the spinal part, the double thread structure and other settings can effectively make up for the shortcomings of the insufficient strength of absorbable materials such as magnesium-aluminum alloy. In addition, the joint use of the temporary fixation part and the permanent fixation part disclosed in the present application, some of the schemes can be achieved in the current technology, and some of the schemes are expected to be realized in the future technology.
[0037] 2, The scheme of the temporary fixation part and / or the permanent fixation part disclosed in the application is realized based on objective judgment criteria, and can provide temporary internal fixation for the operation segment after orthopedic surgery to maintain orthopedic stability; when the temporary fixation part is absorbed in the body, the fixed segment of the spine regains the activity and growth potential, and the effect of removing the internal fixation can be achieved without secondary surgery; for children and adolescents with scoliosis, the fusion segment can be minimized during the osteotomy orthopedic surgery of the scoliosis, and the influence on the growth and development of the spine and the activity of the spine is minimized. In the actual application stage, the objective judgment criteria include the activity judgment of each vertebral body in the cervical spine, thoracic spine, lumbar spine and sacrum, the judgment of the severity of scoliosis in the spinal region, and the judgment of the age requiring spinal growth and development. Through the above judgments, the scheme of the temporary fixation part and / or the permanent fixation part combined or not combined can be well implemented.
[0038] 3, The absorbable internal fixation unit disclosed in the application can be used alone after simple nucleus pulposus removal to provide temporary internal fixation for the operation segment, provide intervertebral disc stability, and prevent the nucleus pulposus from coming out again; after the absorbable pedicle screw is absorbed in the body, the fixed segment of the lumbar spine regains the activity, and the effect of removing the internal fixation can be achieved without secondary surgery, avoiding the physical and mental pain caused by secondary trauma to the patient; while avoiding the nucleus pulposus from coming out again after simple nucleus pulposus removal and the recurrence of lumbar intervertebral disc herniation, the lumbar fusion internal fixation surgery is also avoided, and the activity of the lumbar spine is maximized. BRIEF DESCRIPTION OF DRAWINGS
[0039] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed in the embodiment description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor.
[0040] Fig. 1 is a flowchart of the spinal fixation system of the present application;
[0041] Fig. 2 is a schematic diagram of the combination of the temporary fixation part and the permanent fixation part provided in at least one embodiment of the present application (the temporary fixation part and the permanent fixation part are connected by a double-end nail or a double-U connector);
[0042] Fig. 3 is a schematic diagram of the absorbable pedicle screw or the non-absorbable pedicle screw in the present application;
[0043] Fig. 4 is a schematic diagram of the double-end nail with a washer inside the double-end nail in the present application;
[0044] Fig. 5 is a schematic diagram of the double-end nail without a washer inside the double-end nail in the present application;
[0045] Fig. 6 is a schematic diagram of the gasket in the present application;
[0046] Fig. 7 is a schematic diagram of the double U connector in the present application;
[0047] Fig. 8 is a schematic diagram of the combination of the temporary fixing part and the permanent fixing part (the temporary fixing part and the permanent fixing part are connected by the connecting rod) provided by at least one embodiment of the present application;
[0048] Fig. 9 is a schematic diagram of the permanent fixing part with the temporary fixing part connected at both ends (the temporary fixing part and the permanent fixing part are connected by the connecting rod) provided by at least one embodiment of the present application;
[0049] Fig. 10 is a schematic diagram of the bone hook in the present application;
[0050] Fig. 11 is a schematic diagram of the permanent fixing part with the temporary fixing part connected at both ends (the permanent fixing part is connected with the temporary fixing part by the double U connector at one end, and the permanent fixing part is connected with the temporary fixing part by the connecting rod at the other end) provided by at least one embodiment of the present application;
[0051] Fig. 12 is a schematic diagram of the temporary fixing part (the absorbable fixing rod and the absorbable pedicle screw) provided by at least one embodiment of the present application;
[0052] Fig. 13 is a schematic diagram of the temporary fixing part (the absorbable fixing rod and the bone hook) provided by at least one embodiment of the present application;
[0053] In the figures, 11 is an absorbable pedicle screw; 12 is an absorbable fixing rod; 21 is a non-absorbable pedicle screw; 22 is a non-absorbable fixing rod; 31 is a nail head; 32 is a nail rod; 33 is a nail seat; 34 is a bayonet; 35 is a screw plug; 4 is a double-end nail; 41 is a first base; 42 is a first fixing block; 43 is a second fixing block; 44 is a second base; 45 is a third fixing block; 46 is a through hole; 47 is a gasket; 5 is a double U connector; 51 is a third base; 52 is a sixth fixing block; 53 is a fourth fixing block; 54 is a fifth fixing block; 6 is a connecting rod; 7 is a bone hook; 71 is a hook seat; 72 is a hook body. DETAILED DESCRIPTION
[0054] In order to make the person skilled in the art better understand the present application, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application.
[0055] In some of the flowcharts described in the specification and claims of the present application and in the above description of the drawings, a plurality of operations are included which occur in a particular order, but it should be clearly understood that the operations can be performed in the order in which they appear herein or in parallel, and the serial numbers of the operations, such as 101, 102, etc., are merely used to distinguish different operations, and the serial numbers themselves do not represent any execution order. In addition, the flowcharts can include more or fewer operations, and the operations can be performed in sequence or in parallel. It should be noted that the descriptions of "first", "second", etc. herein are used to distinguish different messages, devices, modules, etc., and do not represent the order of precedence, nor do "first" and "second" represent different types.
[0056] The technical solutions in the embodiments of the present application will be described clearly and completely below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, not all. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor are within the scope of protection of the present application.
[0057] For example, FIG. 1 is a flowchart of a spinal fixation system of the present application. The present embodiment provides a spinal fixation system, which comprises:
[0058] An acquisition unit is configured to acquire a spinal region image containing a target region to be processed.
[0059] A processing unit is configured to determine a spinal region activity of the target region to be processed according to the spinal region image, and divide the target region to be processed into a high-activity region or a low-activity region according to the activity. The target region to be processed is a scoliosis or kyphosis region or a lumbar region in a spinal region of a subject. The spinal region image can be a coronal spinal image or a sagittal spinal image. The activity of the spinal region is a preliminary examination of the activity of the spinal region, which is used for prevention and timely treatment of spinal disorders. The cervical spine segment and the lumbar spine segment have the largest range of motion. The thoracic spine segment has a smaller range of motion. The sacral vertebrae are fused into bone blocks and have almost no activity. The coccyx vertebrae are fused and fixed and have no activity.
[0060] A recommendation unit is configured to output a spinal fixation scheme, which is to fix a temporary fixation part in the high-activity region and / or fix a permanent fixation part in the low-activity region.
[0061] The temporary fixation part comprises absorbable pedicle screws 11 and absorbable fixation rods 12 which are adapted to the absorbable pedicle screws 11; the permanent fixation part comprises non-absorbable pedicle screws 21 and non-absorbable fixation rods 22 which are adapted to the non-absorbable pedicle screws 21.
[0062] The criteria for judging the activity degree comprise a first criterion, which comprises:
[0063] The high activity degree region comprises the region between the lumbar vertebrae 1 and the sacrum 1 (the region of all lumbar vertebrae and the sacrum 1, L1-S1), the region between the cervical vertebrae 1 and the thoracic vertebrae 1 (the region of all cervical vertebrae and the thoracic vertebrae 1, C1-T1); the high activity degree region preferably comprises the region between the lumbar vertebrae 3 and the sacrum 1 (in particular, clinically common L3-L4, L4-L5, L5-S1), the region between the cervical vertebrae 1 and the cervical vertebrae 7 (C1-C7); the low activity degree region comprises the region of all thoracic vertebrae, and the region of the spinal column region except the high activity degree region. The cervical vertebrae is abbreviated as C, the thoracic vertebrae is abbreviated as T, the lumbar vertebrae is abbreviated as L, and the sacrum is abbreviated as S.
[0064] The processing unit further comprises: a unit for determining the severity level of the target region to be processed according to the spine site image, and dividing the target region to be processed into a severe region or a non-severe region according to the severity level; the severity level comprises the judgment of the scoliosis angle and whether the lumbar intervertebral disc is diseased; for the scoliosis angle, the judgment of the severe region or the non-severe region is based on the Cobb angle; for whether the lumbar intervertebral disc is diseased, the judgment of the severe region or the non-severe region is based on whether the lumbar intervertebral disc compresses the nerve root and the cauda equina; or whether obvious clinical symptoms such as low back pain occur; the disease of the lumbar intervertebral disc is a clinical syndrome that the partial or whole rupture of the annulus fibrosus of the lumbar intervertebral disc, the nucleus pulposus tissue protrudes backward from the rupture, and stimulates or compresses the nerve root and the cauda equina. Among them, when there are usually multiple arcs on the spine, the Cobb angle of each arc is measured and marked; after the X-ray film is taken, the doctor draws a line to measure the Cobb angle, and the Cobb angle within 10° is normal, and the Cobb angle greater than 10° is scoliosis. The severity of scoliosis is usually evaluated by measuring the angle of lateral bending, and the most commonly used method for angle measurement is the Cobb angle measurement method. The X-ray film used for measurement is the standard full-length frontal position of the spine. First step: determine the end vertebra of lateral bending. The upper and lower end vertebrae refer to the vertebrae with the maximum inclination on the concave side of the lateral bending. The intervertebral space on the convex side of the lateral bending is wider, and the first vertebra on the concave side whose intervertebral space starts to widen is considered not to belong to the curve, so its adjacent vertebra is considered to be the end vertebra of the curve. Second step: draw a horizontal line on the upper edge of the vertebral body of the upper end vertebra, and draw a horizontal line on the lower edge of the vertebral body of the lower end vertebra. Make a vertical line on each of the two horizontal lines. Third step: the intersection angle of the two vertical lines is the Cobb angle. Note: for larger lateral bending, the direct intersection angle of the two horizontal lines is also equal to the Cobb angle. The angle of lateral bending is measured by this angle. If the Cobb angle is less than 25 degrees, no surgical treatment is needed, and posture correction action training can be performed under the guidance of a rehabilitation therapist, and dynamic observation is performed every 4-6 months; if 25 degrees < Cobb angle < 50 degrees, brace treatment is recommended; if the Cobb angle is greater than 50 degrees, surgical treatment is recommended. Furthermore, in the spine region, the top cone region of severe scoliosis, the vertebrae with heavy vertebra rotation, and the vertebrae in the osteotomy region are severe regions, the vertebrae region close to the severe region is a transition region, the transition region is defined as a non-severe region, and the region far from the severe region is a normal region without special circumstances. No surgical instrument is implanted for fixation; if L2-L5 belongs to the severe region, L6-L7 belongs to the normal region, then the vertebra region between L5 and L6 is the transition region, i.e. the non-severe region.
[0065] Optionally, the spinal fixation scheme further comprises: fixing the permanent fixation part in the severe region, and / or fixing the temporary fixation part in the non-severe region; or, the spinal fixation scheme further comprises: fixing the permanent fixation part in the severe region and the low-activity region, and / or fixing the temporary fixation part in the non-severe region and the high-activity region.
[0066] The activity degree judgment criterion further comprises a second judgment criterion, comprising: judging the age of the to-be-measured person according to the spinal part image;
[0067] When the age of the person to be measured is less than or equal to N, the high-activity region includes all the spinal regions except the region judged to be the severe region, and the low-activity region is the region judged to be the severe region; when the age of the person to be measured is greater than or equal to N, the second judging criterion is consistent with the first judging criterion. The specific value of N is determined according to any one of the following ways: 1. virtual age: calculated according to the calendar year experienced after birth, that is, 1 year old as soon as born, and then increase 1 year for every new year; generally calculated according to the lunar new year, or calculated according to the Gregorian calendar; 2. age in years: also known as real age, refers to the number of years experienced or birthdays from birth to the time of calculation; 3. exact age: refers to the number of days experienced from the date of birth to the date of calculation. It is more accurate than the age in years to reflect the actual survival time of people. According to the determination method of N, N is not limited to a natural integer, but preferably 10; for children under 10 years old, the growth potential of the spine needs to be considered, and in the important growth region of the spine, the more fixed, the more limited the growth, so it is necessary to minimize the fixation of the spinal vertebrae, and the fewer the number of fixed vertebrae, the better the fixed scheme. Specifically, when the vertebra M is the severe region, the P vertebrae above and / or below the vertebra M are the non-severe region; for example: L6 is judged to be the severe region / high-activity region (i.e. the most severe vertebra of scoliosis or inclination), then L5 and L7 at the upper and lower ends of L6 are the non-severe region (low-activity region). For the scoliosis deformity of children under 10 years old (early-onset scoliosis), the treatment of spinal surgery has always been a difficult problem, because the children at this stage are in the peak period of growth and development, and the scoliosis will undoubtedly have a serious negative impact on the development of the child's skeleton and important organs such as heart and lung. In recent years, relevant research has also shown that the first peak period of longitudinal growth and development of the spine is from birth to 5 years old (with a stable growth rate of about 2 cm per year). During this period, if the child's spinal deformity continues to progress, it will eventually compress the thoracic organs, reduce the thoracic volume, and thus compress the lung parenchyma and reduce the lung volume. If the child cannot be treated in time or is treated improperly, it will have a serious physical deformity and limited heart and lung development in the child, affecting the child's quality of life, and even causing heart and lung failure and even death. However, the traditional orthopedic fusion technique will inevitably lead to the loss of the growth function of the spine in the peak period of growth and development, thereby causing the shortening of the trunk and the limited development of the heart and lung function. Therefore, it is necessary to adopt internal fixation implant to correct the spinal deformity and stabilize the spine while avoiding spinal fusion to maintain the normal growth of the spine, which is a method that the spinal surgeons have been looking for.
[0068] After the acquisition unit, further comprising an identification unit for identifying whether to implant the target region to be processed;
[0069] The identification of whether to implant the target region to be processed includes: obtaining a scoliosis angle of the target region to be processed; comparing the scoliosis angle with a standard scoliosis angle to obtain a result of whether the scoliosis angle meets the standard; if the scoliosis angle does not meet the standard, implanting the target region to be processed is needed, and the processing unit is implemented; if the scoliosis angle meets the standard, implanting the target region to be processed is not needed, and the processing unit is not needed to be implemented.
[0070] And / or, obtaining whether the intervertebral disc of the target region to be processed is diseased; if the intervertebral disc is diseased, implanting the target region to be processed is needed, and the processing unit is implemented; if the intervertebral disc is not diseased, implanting the target region to be processed is not needed, and the processing unit is not needed to be implemented.
[0071] Fig. 2 is a schematic view of a combination of a temporary fixation part and a permanent fixation part (the temporary fixation part and the permanent fixation part are connected by a double-end nail 4 or a double-U connector 5) provided by the present embodiment, Fig. 3 is a schematic view of an absorbable pedicle screw 11 or a non-absorbable pedicle screw 21 provided by the present embodiment, Fig. 4 is a schematic view of a double-end nail 4 provided by the present embodiment and a gasket 47 arranged in the double-end nail 4, Fig. 5 is a schematic view of a double-end nail 4 provided by the present embodiment and a gasket 47 not arranged in the double-end nail 4, Fig. 6 is a schematic view of a gasket 47 provided by the present embodiment, and Fig. 7 is a schematic view of a double-U connector 5 provided by the present embodiment;
[0072] In one embodiment, a spinal fixation device, the device comprising: one or more processors, and a memory storing one or more computer programs that, when executed by the one or more processors, implement:
[0073] obtaining an image of a spinal site containing a target region to be processed;
[0074] determining a spinal site activity of the target region to be processed according to the image of the spinal site, and dividing the target region to be processed into a high activity region or a low activity region according to the activity; and / or determining a severity grade of the target region to be processed according to the image of the spinal site, and dividing the target region to be processed into a severe region or a non-severe region according to the scoliosis angle;
[0075] outputting a spinal fixation scheme, the spinal fixation scheme being to fix a temporary fixation part in the high activity region and / or the non-severe region, and / or to fix a permanent fixation part in the low activity region and / or the severe region;
[0076] The device further comprises a spinal fixation instrument, the spinal fixation instrument comprises a temporary fixation part and / or a permanent fixation part, the temporary fixation part comprises absorbable pedicle screws 11 and absorbable fixation rods 12 which are adapted to the absorbable pedicle screws 11, the permanent fixation part comprises non-absorbable pedicle screws 21 and non-absorbable fixation rods 22 which are adapted to the non-absorbable pedicle screws 21.
[0077] In one embodiment, when the temporary fixation part and the permanent fixation part are combined and fixed in the target region to be treated, the temporary fixation part and the permanent fixation part are connected through a connecting piece; the connecting piece is sleeved on the outer wall of the absorbable fixation rod 12 or the non-absorbable fixation rod 22, so that the absorbable fixation rod 12 or the non-absorbable fixation rod 22 is movable along the radial direction of the central axis of the absorbable fixation rod 12 or the non-absorbable fixation rod 22; the connecting piece comprises but is not limited to the following structures: a double-headed nail 4, a double-U connector 5, and a connecting rod 6.
[0078] As shown in FIG. 2, the temporary fixation part and the permanent fixation part are connected through a double-headed nail 4 or a double-U connector 5, which is completely achievable in terms of technology. In this embodiment, the temporary fixation part is made of absorbable material, which includes but is not limited to the following materials: magnesium-aluminum alloy material, polylactic acid and its copolymer, polycaprolactone and its copolymer, poly-p-dioxanone and its copolymer, and polyglycolic acid and its copolymer. The number of absorbable pedicle screws 11 provided by a single absorbable fixation rod 12 is 1, but the number of absorbable pedicle screws 11 is not limited and can be freely set according to clinical needs. The number of non-absorbable pedicle screws 21 provided by a single non-absorbable fixation rod 22 is 3, but the number of non-absorbable pedicle screws 21 is not limited and can be freely set according to clinical needs.
[0079] As shown in FIG. 3, the absorbable pedicle screw 11 or the non-absorbable pedicle screw 21 comprises a nail head 31 and a nail rod 32 which are integrally connected, the nail head 31 is provided with two pieces of mutually symmetrical nail seats 33 at the end away from the nail rod 32, and the two pieces of nail seats 33 form a bayonet 34 which is adapted to the absorbable fixation rod 12 or the non-absorbable fixation rod 22;
[0080] Optionally, a screw plug 35 which is adapted to the inner wall of the bayonet 34 is further arranged inside the bayonet 34; the absorbable fixation rod 12 or the non-absorbable fixation rod 22 located inside the bayonet 34 is fixed through the screw plug 35;
[0081] Optionally, an internal thread is arranged on the inner wall of the nail seat 33, and the internal thread is adapted to the thread on the outer side of the screw plug 35;
[0082] In one embodiment, the outer wall of the nail rod 32 is provided with a threaded section, which enhances the holding force of the absorbable pedicle screw 11 or non-absorbable pedicle screw 21. The pitch of the threaded section is equal, which enhances the holding force of the pedicle screw.
[0083] As shown in FIG. 4 and FIG. 5, the double-end nail 4 comprises a first connecting part for fixedly connecting the temporary fixing part or the permanent fixing part, and a second connecting part for fixedly connecting the permanent fixing part or the temporary fixing part, the first connecting part and the second connecting part are integrally formed;
[0084] Optionally, the first connecting part comprises a first base 41 and a first fixing block 42 and a second fixing block 43 arranged on the upper end of the first base 41, the first fixing block 42 and the second fixing block 43 are integrally arranged on the upper end of the first base 41; an opening adapted to the absorbable fixing rod 12 or the non-absorbable fixing rod 22 is formed between the first fixing block 42 and the second fixing block 43; a screw plug 35 matched with the inner wall of the opening is arranged inside the opening; the absorbable fixing rod 12 or the non-absorbable fixing rod 22 located inside the opening is fixed by the screw plug 35; the inner wall of the first fixing block 42 and the inner wall of the first side of the second fixing block 43 are symmetrical to each other, and the inner wall of the opening is provided with a thread matched with the screw plug 35; the thread can also adopt a double thread structure. As shown in FIG. 2, the first connecting part is used to fix the absorbable fixing rod 12.
[0085] Optionally, the second connecting part comprises a second base 44 and a second fixing block 43 and a third fixing block 45 arranged on the upper end of the second base 44, the second fixing block 43 and the third fixing block 45 are integrally arranged on the upper end of the second base 44; an opening adapted to the non-absorbable fixing rod 22 or the absorbable fixing rod 12 is formed between the second fixing block 43 and the third fixing block 45; a screw plug 35 matched with the inner wall of the opening is arranged inside the opening; the non-absorbable fixing rod 22 or the absorbable fixing rod 12 located inside the opening is fixed by the screw plug 35; the inner wall of the second side of the second fixing block 43 and the inner wall of the third fixing block 45 are symmetrical to each other, and the inner wall of the opening is provided with a thread matched with the screw plug 35; the first base 41 and the second base 44 are integrally arranged. As shown in FIG. 2, the second connecting part is used to fix the non-absorbable fixing rod 22. Optionally, a through hole 46 is arranged below the opening between the second fixing block 43 and the third fixing block 45, and the through hole 46 is used to connect and fix the non-absorbable pedicle screw 21. A gasket 47 matched with the inner wall of the double-end nail 4 is arranged in the double-end nail 4.
[0086] As shown in FIG. 7, the double-U connector 5 is used to fix the temporary fixation part and / or the permanent fixation part, the double-U connector 5 comprises a third base 51 and a sixth fixing block 52, a fourth fixing block 53 and a fifth fixing block 54 arranged on the upper end of the third base 51; the sixth fixing block 52, the fourth fixing block 53 and the fifth fixing block 54 are integrally arranged on the upper end of the third base 51; the sixth fixing block 52 and the fourth fixing block 53 form an opening adapted to the absorbable fixation rod 12 or the non-absorbable fixation rod 22; the fourth fixing block 53 and the fifth fixing block 54 form an opening adapted to the non-absorbable fixation rod 22 or the absorbable fixation rod 12; a screw plug 35 is arranged in the opening; the absorbable fixation rod 12 or the non-absorbable fixation rod 22 in the opening is fixed by the screw plug 35; the inner wall of the opening is provided with a screw thread adapted to the screw plug 35; the inner wall of the sixth fixing block 52 and the first side of the inner wall of the fourth fixing block 53 are symmetrical to each other, and the second side of the inner wall of the fourth fixing block 53 and the inner wall of the fifth fixing block 54 are symmetrical to each other.
[0087] The connecting rod 6 and / or the absorbable fixation rod 12 and / or the non-absorbable fixation rod 22 are arranged in a cylindrical structure. The length of the connecting rod 6 is determined according to the target area to be treated. The length of the absorbable fixation rod 12 is determined according to the target area to be treated; the length of the non-absorbable fixation rod 22 is determined according to the target area to be treated.
[0088] FIG. 8 is a schematic view of the combination of the temporary fixation part and the permanent fixation part provided by the embodiment (the temporary fixation part and the permanent fixation part are connected by the connecting rod 6),
[0089] In one embodiment, the connecting rod 6 is part of the internal fixation rod, and the connecting rod 6 is also made of absorbable material. As shown in FIG. 8, a single fixation rod can be divided into an absorbable part and a non-absorbable part. After the absorbable part of the fixation rod is absorbed in the body, only the permanent internal fixation part is left, so as to restore the spinal mobility and growth and development ability of the temporary fixation segment. However, this scheme cannot be achieved with the current technology. The number of absorbable pedicle screws 11 arranged by a single absorbable fixation rod 12 is 1, but the number of absorbable pedicle screws 11 arranged is not limited, and can be freely arranged according to clinical needs. The number of non-absorbable pedicle screws 21 arranged by a single non-absorbable fixation rod 22 is 3, but the number of non-absorbable pedicle screws 21 arranged is not limited, and can be freely arranged according to clinical needs.
[0090] FIG. 9 is a schematic view of the permanent fixation part connected with the temporary fixation part at both ends (the temporary fixation part and the permanent fixation part are connected by the connecting rod 6), and FIG. 10 is a schematic view of the bone hook 7 provided by the embodiment,
[0091] As shown in Fig. 10, in one embodiment, the temporary fixation part further comprises a bone hook 7 connected with the absorbable fixation rod 12; the permanent fixation part can also be connected with the bone hook 7, which adopts a conventional laminar hook shape or a double-lock universal laminar hook shape; the bone hook 7 comprises an integrally formed hook base 71 and a hook body 72, a through slot for placing the absorbable fixation rod 12 or the non-absorbable fixation rod 22 is arranged at the end of the hook base 71 away from the hook body 72, and the hook body 72 is connected with the spinal part; the bone hook 7 further comprises a screw plug 35 matched with the slot wall of the through slot; the absorbable fixation rod 12 inside the through slot is fixed by the screw plug 35. Optionally, the through slot is arranged as a U-shaped slot, and the U-shaped slot wall is provided with internal threads.
[0092] In one embodiment, as shown in Fig. 9, the absorbable fixation rod 12 is connected at both ends of the non-absorbable fixation rod 22, the absorbable fixation rod 12 with the non-absorbable pedicle screw 21 at the first end of the non-absorbable fixation rod 22 is sleeved by the connecting rod 6, the absorbable fixation rod 12 with the non-absorbable pedicle screw 21 at the second end of the non-absorbable fixation rod 22 is sleeved by the connecting rod 6, and the hook bodies 72 of the bone hooks 7 are in the same direction. The number of the non-absorbable pedicle screws 21 arranged on a single non-absorbable fixation rod 22 is 2, but the number of the non-absorbable pedicle screws 21 arranged is not limited and can be freely arranged according to clinical needs. The number of the absorbable pedicle screws 11 arranged on a single absorbable fixation rod 12 is 1, but the number of the absorbable pedicle screws 11 arranged is not limited and can be freely arranged according to clinical needs. The mixed internal fixation rod of absorbable and non-absorbable materials is in the shape of a straight rod, the middle material adopts titanium alloy or cobalt-chromium-molybdenum alloy, and the rod ends adopt magnesium alloy material. The upper and lower vertebral bodies are elongated and fixed in the cervical spine stage.
[0093] Fig. 11 is a schematic view of the permanent fixation part connected with the temporary fixation part at both ends (the permanent fixation part is connected with the temporary fixation part at one end through the double-U connector 5, and the permanent fixation part is connected with the temporary fixation part at the other end through the connecting rod 6),
[0094] In one embodiment, as shown in Fig. 11, the absorbable fixation rod 12 is connected at both ends of the non-absorbable fixation rod 22, the absorbable fixation rod 12 with the bone hook 7 at the first end of the non-absorbable fixation rod 22 is sleeved by the double-U connector 5, and the hook bodies 72 of the bone hooks 7 connected at the first end of the non-absorbable fixation rod 22 are in opposite directions; the absorbable fixation rod 12 with the bone hook 7 at the second end of the non-absorbable fixation rod 22 is sleeved by the connecting rod 6, and the hook bodies 72 of the bone hooks 7 connected at the second end of the non-absorbable fixation rod 22 are in opposite directions. The bone hooks 7 at both ends are used for distraction and compression.
[0095] Fig. 12 is a schematic diagram of the temporary fixation part (absorbable fixation rod 12 and absorbable pedicle screw 11) provided by the present embodiment, and Fig. 13 is a schematic diagram of the temporary fixation part (absorbable fixation rod 12 and bone hook 7) provided by the present embodiment;
[0096] In one embodiment, when the spinal internal fixation device is the temporary fixation part, the temporary fixation part is fixed at the spinal part; the length range of the absorbable fixation rod 12 is determined according to the target region to be treated. In one embodiment, as shown in Fig. 12, the temporary fixation part includes the absorbable fixation rod 12 and the absorbable pedicle screw 11, both of which are made of absorbable material; and the number of the absorbable pedicle screws 11 arranged by a single absorbable fixation rod 12 is set to two, but the number of the absorbable pedicle screws 11 is not limited and can be freely set according to clinical needs.
[0097] In one embodiment, when the spinal internal fixation device is the permanent fixation part, the permanent fixation part is fixed at the spinal part, and the length range of the non-absorbable fixation rod 22 is determined according to the target region to be treated; the material selected by the permanent fixation part includes but is not limited to the following materials: conventional titanium alloy or cobalt-chromium-molybdenum alloy. In one embodiment, as shown in Fig. 13, the temporary fixation part includes the absorbable fixation rod 12 and the bone hook 7, both of which are made of absorbable material. And the number of the bone hooks 7 arranged by a single absorbable fixation rod 12 is set to two, and when the number is set to two, the directions of the hook bodies 72 are oppositely arranged; but the number of the absorbable pedicle screws 11 is not limited and can be freely set according to clinical needs.
[0098] Any one of the following applications:
[0099] Application of the above system in diagnosis of disease development; optionally, the disease includes lumbar disc herniation, scoliosis in children and adolescents, etc.
[0100] Optionally, the simple nucleus pulposus removal surgery used in the lumbar disc herniation;
[0101] Optionally, the AIS surgery for adolescent idiopathic scoliosis (AIS), the CS surgery for congenital scoliosis in children (CS), etc. used in the scoliosis in children and adolescents.
[0102] The use method is as follows:
[0103] During the surgery, according to the image of the spinal part of the patient, the appropriate temporary fixation part and / or permanent fixation part are selected for individual or joint use, and are placed at the appropriate spinal segment.
[0104] 1. When the temporary fixation part is applied in the simple nucleus pulposus removal surgery, the absorbable pedicle screw 11 and the absorbable fixation rod 12 are implanted after the simple nucleus pulposus removal surgery to form a temporary fixation between the upper and lower vertebral bodies of the simple nucleus pulposus removal. The absorbable internal fixation is made of magnesium-aluminum alloy, which can be completely degraded in the body for about 6 months. At that time, the fibrous ring of the surgical segment has formed a scar, and the nucleus pulposus will not come out again, and the lumbar vertebrae recover normal activity. The unit can be made of absorbable magnesium-aluminum alloy or other in-vivo absorbable materials with certain strength. The screw is designed in the form of a universal pedicle screw, and the thread can be double-rib structure to make up for the insufficient strength of magnesium-aluminum alloy and avoid internal fixation failure. The fixation rod is also made of absorbable material and is connected to the absorbable pedicle screw 11 through the absorbable tail screw. The simple nucleus pulposus removal surgery is one of the surgical methods for treating simple lumbar disc herniation. The specific operation is as follows: the paraspinal muscles are stripped through the posterior spinal route, the spinal lamina space is performed, the lamina window is opened, and the spinal cord and nerve root are exposed; the nerve root is pulled, the protruding intervertebral disc is explored, the intervertebral disc annulus fibrosus is sharply incised, and the protruding intervertebral disc nucleus pulposus is removed by using nucleus pulposus forceps and other tools; then the incision is closed layer by layer. The advantage of simple nucleus pulposus removal surgery is that the surgical incision is small, no internal fixation is needed, fusion surgery is avoided, and the lumbar activity is maximally preserved. However, due to the destruction of the annulus fibrosus structure, the relative movement between the vertebral bodies will make the nucleus pulposus in the annulus fibrosus more likely to fall out into the spinal canal after the surgery, resulting in recurrence. Generally, for patients after simple nucleus pulposus removal surgery, doctors recommend bed rest for more than 2 weeks to avoid the nucleus pulposus from falling out again due to intense activity of the spine; after the annulus fibrosus breaks and forms a scar, the waist is actively moved. At present, elastic internal fixation rods are used clinically as a spinal fixation system after simple nucleus pulposus removal surgery, but the elastic range of elastic fixation is limited, which still limits the activity of the lumbar vertebrae. If the temporary fixation part is applied in this surgery according to the scheme in this embodiment, the nucleus pulposus can be effectively prevented from falling out again after simple nucleus pulposus removal surgery, and the recurrence of lumbar disc herniation can be avoided, while avoiding lumbar fusion internal fixation surgery and maximizing the preservation of lumbar activity.
[0105] 2. When the temporary fixation part and the permanent fixation part are used together, before the scoliosis correction, the expected internal fixation screw placement scheme needs to be designed: titanium alloy or cobalt-chromium-molybdenum alloy screws / lamina hooks are used for strong permanent internal fixation in the top vertebra area of severe scoliosis or the vertebra with heavy vertebral rotation or the vertebra in the osteotomy area; magnesium alloy absorbable pedicle screws 11 / lamina hooks are used for temporary fixation in the end vertebra of scoliosis or the vertebra with greater influence on spinal activity (such as the lumbar spine). The permanent internal fixation system and the temporary internal fixation system can be connected by absorbable connectors and absorbable internal fixation rods, or can be connected by absorbable and non-absorbable mixed internal fixation rods.
[0106] For example, the combination of temporary fixation and permanent fixation is applied in the surgery of adolescent idiopathic scoliosis (AIS). For AIS patients with lumbar scoliosis, if the distal fusion vertebrae are fused to L4 or L5, the lumbar activity will be significantly reduced. However, for patients with severe inclination of L4 or L5, if L4 or L5 is not fused and fixed, the scoliosis cannot be fully corrected. Therefore, the absorbable temporary fixation system is used to correct and fix L4 or L5 intraoperatively, and after the absorbable internal fixation is absorbed by the body (6 months are needed), the scoliosis correction is maintained for about 6 months, and at this time the L4 or L5 vertebral activity is restored. Therefore, the absorbable internal fixation system can achieve intraoperative correction and fixation, and also preserve the lumbar activity without damage.
[0107] The combination of temporary fixation and permanent fixation is applied in the surgery of congenital scoliosis (CS). For patients with single hemivertebra congenital scoliosis, the posterior one-stage hemivertebra resection short segment (one segment above and one segment below the osteotomy) fixation and fusion surgery is the gold standard for treatment. However, this surgery is only effective for cases with small scoliosis degree and no long compensatory curve, and simple short segment fixation can close the gap between the osteotomies.
[0108] For the patients with large scoliosis angle and long arc, simple hemivertebra resection and short segment fixation may not completely correct the deformity, and sometimes more than 3 segments need to be fixed and fused to enhance the screw holding force and achieve better correction. However, for children, fixing and fusing longer segments means losing the growth potential of the fixed and fused segments and failing to achieve normal growth. Posterior spinal fixation and fusion without fusion of the anterior vertebral body may lead to crankshaft phenomenon, causing coronal plane imbalance and aggravating scoliosis. For such patients, we can use absorbable internal fixation system for temporary internal fixation at the distal end of the osteotomy gap, and permanent internal fixation for the osteotomy segment. After the osteotomy gap is fused and the correction effect is maintained for about 6 months, the temporary internal fixation is absorbed by the body, releasing the tethering effect of the internal fixation on the spine, correcting the deformity while preserving the normal growth and development of the spine, and avoiding coronal plane imbalance such as crankshaft phenomenon. If the scheme in the embodiment is used for temporary fixation in children and adolescents with scoliosis, it can minimize the fusion segments and minimize the impact on the growth and development of the spine and the range of motion of the spine, which is a problem that needs to be solved in clinical practice. Since children and adolescents are still in the process of spinal growth and development, early spinal fusion surgery or too many fusion segments will limit the growth and development of the spine or limit the range of motion of the spine to some extent. Incorrect surgery timing or incorrect spinal fusion segments may even lead to increased spinal deformity and loss of range of motion, affecting daily life. Currently, the solution to the problem of scoliosis in children and adolescents in clinical practice is to perform one-stage correction surgery and implant internal fixation, and then perform two-stage surgery to remove the internal fixation after the bone is fused. For patients, this requires two surgeries and causes more trauma.
[0109] Spinal fixation is widely used in clinical practice. When a patient has a spinal fracture or needs spinal decompression, the posterior accessory structure cone plate is removed, and a nail rod system is used to fix the unstable vertebrae for surgery. The surgical approach includes posterior approach, anterior approach, and lateral anterior approach.
[0110] The following points need to be explained:
[0111] (1) The drawings of the embodiments of the present disclosure only involve the structures involved in the embodiments of the present disclosure, and other structures can be referred to the usual design.
[0112] (2) In the case of no conflict, the embodiments of the present disclosure and the features in the embodiments can be combined to obtain new embodiments.
[0113] The above is only a specific implementation of the present disclosure, but the protection scope of the present disclosure is not limited thereto, and the protection scope of the present disclosure should be subject to the protection scope of the claims.
[0114] The above description of the embodiments is only for understanding the present application. It should be noted that those skilled in the art can make several improvements to the present application without departing from the principles of the present application, and these improvements shall also fall within the protection scope of the claims of the present application.
Claims
1. A spinal fixation system comprising: The system comprises: an acquisition unit configured to acquire a spine site image containing a target region to be treated; a processing unit configured to determine a spine site activity of the target region to be treated according to the spine site image, and divide the target region to be treated into a high activity region or a low activity region according to the activity; a recommendation unit configured to output a spine fixation scheme, the spine fixation scheme being to fix a temporary fixation part in the high activity region and / or to fix a permanent fixation part in the low activity region; the temporary fixation part comprises absorbable pedicle screws and absorbable fixation rods, and the absorbable fixation rods are adapted to the absorbable pedicle screws; the permanent fixation part comprises non-absorbable pedicle screws and non-absorbable fixation rods, and the non-absorbable pedicle screws and non-absorbable fixation rods are adapted to each other.
2. The spinal fixation system of claim 1, wherein, The judgment criteria of the activity further comprise a first judgment criterion, which comprises: the high activity region comprises a region between lumbar vertebra 1 and sacrum 1, and a region between cervical vertebra 1 and thoracic vertebra 1; the high activity region preferably comprises a region between lumbar vertebra 3 and sacrum 1, and a region between cervical vertebra 1 and cervical vertebra 7; the low activity region comprises a whole thoracic vertebra region, and a region in the spine region except the high activity region.
3. The spinal fixation system of claim 1 wherein, The processing unit further comprises a unit configured to determine a severity level of the target region to be treated according to the spine site image, and divide the target region to be treated into a severe region or a non-severe region according to the severity level; the severity level comprises a judgment of a scoliosis angle and whether a lumbar intervertebral disc is diseased; for the scoliosis angle, the judgment of the severe region or the non-severe region is based on a Cobb angle; for whether the lumbar intervertebral disc is diseased, the judgment of the severe region or the non-severe region is based on whether the lumbar intervertebral disc compresses a nerve root or a cauda equina; Optionally, the spine fixation scheme further comprises: fixing the permanent fixation part in the severe region, and / or fixing the temporary fixation part in the non-severe region; Alternatively, the spine fixation scheme further comprises: fixing the permanent fixation part in the severe region and the low activity region, and / or fixing the temporary fixation part in the non-severe region and the high activity region.
4. The spinal fixation system of claim 3, wherein, The judgment criteria of the activity further comprise a second judgment criterion, which comprises: a unit configured to judge an age of a subject to be measured according to the spine site image; when the age of the subject to be measured is less than or equal to N, the high activity region comprises all spine regions except the severe region, and the low activity region is the severe region; when the age of the subject to be measured is greater than or equal to N, the second judgment criterion is consistent with the first judgment criterion.
5. The spinal fixation system according to any of claims 1-4, wherein, After the acquisition unit, a recognition unit is further included, which is configured to recognize whether to perform implantation on the target region to be treated; The identification of whether the target region to be processed is implanted, comprising: obtaining the scoliosis angle of the target region to be processed; comparing the scoliosis angle with the standard scoliosis angle to obtain the result of whether the scoliosis angle meets the standard; if the scoliosis angle does not meet the standard, the target region to be processed needs to be implanted, and the processing unit is implemented; if the scoliosis angle meets the standard, the target region to be processed does not need to be implanted, and the processing unit does not need to be implemented; and / or Obtaining whether the lumbar intervertebral disc of the target region to be processed is diseased; if the lumbar intervertebral disc is diseased, the target region to be processed needs to be implanted, and the processing unit is implemented; if the lumbar intervertebral disc is not diseased, the target region to be processed does not need to be implanted, and the processing unit does not need to be implemented.
6. The spinal fixation system of any of claims 1-4, wherein, When the temporary fixing part and the permanent fixing part are combined and fixed in the target region to be processed, the temporary fixing part and the permanent fixing part are connected through a connecting piece; optionally, the connecting piece is sleeved on the outer wall of the absorbable fixing rod or the non-absorbable fixing rod, so that the absorbable fixing rod or the non-absorbable fixing rod is movable along the radial direction of the central axis of the absorbable fixing rod or the non-absorbable fixing rod; the connecting piece includes but is not limited to the following structures: a double-headed nail, a double-U connector, and a connecting rod.
7. The spinal fixation system of claim 6, wherein, The double-headed nail includes a first connecting part for fixedly connecting the temporary fixing part or the permanent fixing part, and a second connecting part for fixedly connecting the permanent fixing part or the temporary fixing part, and the first connecting part and the second connecting part are integrally formed; Optionally, the first connecting part includes a first base and a first fixing block and a second fixing block arranged on the upper end of the first base, and the first fixing block and the second fixing block are integrally arranged on the upper end of the first base; an opening adapted to the absorbable fixing rod or the non-absorbable fixing rod is formed between the first fixing block and the second fixing block; a screw plug is arranged in the opening; and the absorbable fixing rod or the non-absorbable fixing rod located in the opening is fixed through the screw plug. Optionally, the second connecting part includes a second base and a second fixing block and a third fixing block arranged on the upper end of the second base, and the second fixing block and the third fixing block are integrally arranged on the upper end of the second base; an opening adapted to the non-absorbable fixing rod or the absorbable fixing rod is formed between the second fixing block and the third fixing block; a screw plug is arranged in the opening; and the non-absorbable fixing rod or the absorbable fixing rod located in the opening is fixed through the screw plug; optionally, a through hole is arranged below the opening between the second fixing block and the third fixing block, and the through hole is used for connecting and fixing the non-absorbable pedicle screw.
8. The spinal fixation system of claim 6, wherein, The double U connector is used for fixedly connecting the temporary fixing part and / or the permanent fixing part, the double U connector comprises a third base and a sixth fixing block, a fourth fixing block and a fifth fixing block arranged on the upper end of the third base; the sixth fixing block, the fourth fixing block and the fifth fixing block are integrally arranged on the upper end of the third base; the sixth fixing block and the fourth fixing block form an opening matched with the absorbable fixing rod or the non-absorbable fixing rod; the fourth fixing block and the fifth fixing block form an opening matched with the non-absorbable fixing rod or the absorbable fixing rod; a screw plug matched with the inner wall of the opening is arranged in the opening; the absorbable fixing rod or the non-absorbable fixing rod in the opening is fixed by the screw plug.
9. The spinal fixation system of claim 6 wherein, The connecting rod and / or the absorbable fixing rod and / or the non-absorbable fixing rod are arranged in a cylindrical structure.
10. A spinal fixation device, the device comprising: One or more processors, and a memory for storing one or more computer programs that, when executed by the one or more processors, implement: Obtaining a spine site image containing a target to-be-processed region; Determining the spine site activity of the target to-be-processed region according to the spine site image, and dividing the target to-be-processed region into a high activity region or a low activity region according to the activity; And / or, determining the scoliosis angle of the target to-be-processed region according to the spine site image, and dividing the target to-be-processed region into a severe region or a non-severe region according to the scoliosis angle; Outputting a spine fixation scheme, the spine fixation scheme being to fix a temporary fixing part in the high activity region and / or the non-severe region, and / or to fix a permanent fixing part in the low activity region and / or the severe region; The device further comprises a spine fixation instrument, the spine fixation instrument comprising a temporary fixing part and / or a permanent fixing part, the temporary fixing part comprising an absorbable pedicle screw and an absorbable fixing rod, the absorbable fixing rod being matched with the absorbable pedicle screw; the permanent fixing part comprising a non-absorbable pedicle screw and a non-absorbable fixing rod, the non-absorbable pedicle screw and the non-absorbable fixing rod being matched.
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