A system, equipment, and application for designing osteotomy angles in osteotomy and reconstructive surgery.

Abstract

This invention discloses a system, device, and application for designing osteotomy angles in osteotomy correction surgery for kyphosis. The system includes an input module, a data processing module, and an output module. It calculates the osteotomy angle based on spinal data obtained from full-length lateral images of the spine. The spinal data includes data measured from the images and calculated data. Combining clinical experience, after providing the proximal osteotomy angle, the osteotomy angle at the distal osteotomy apex can be directly calculated. The design system of this invention is simple to operate and easy to understand, and is of great significance for the treatment of patients with kyphosis.

Description

Technical Field

[0001] This invention relates to the field of spinal correction technology, specifically to a system, equipment, and application for designing osteotomy angles in osteotomy correction surgery. Background Technology

[0002] Kyphosis is a spinal deformity in which parts of the spine shift forward or backward, resulting in curvature or a "hunchback." Kyphosis causes sagittal imbalance, which plays a crucial role in maintaining the body's overall alignment and motor function. In a balanced state, the body achieves maximum energy efficiency. Patients with kyphosis typically have a forward-leaning trunk, limited vision, and severely impact their quality of life. They can only attempt to return their trunk to a normal position by posterior pelvic rotation and hip extension / knee flexion, but this often results in further imbalance. Therefore, scientific osteotomy and correction for kyphosis patients is of great significance.

[0003] Osteotomy correction should follow the following: (1) Balance: overall balance, spinal-pelvic balance, balance between different parts, and satisfactory visual results. (2) The design of each part should meet the constraints, that is, the corrected part should restore the proper shape of each part, such as normal lumbar lordosis, thoracic kyphosis, etc. (3) Reasonable selection of osteotomy location, osteotomy angle, etc.

[0004] Spinal and pelvic parameters are crucial for evaluating the effectiveness of surgical treatment and designing surgical plans. Among them, the sagittal vertical axis (SVA) refers to the distance from the C7 plumb line to the posterosuperior angle of the sacrum. Patent CN112402075A uses SVA as a standard for specifying surgical plans and evaluating the recovery of sagittal balance. However, many studies have shown that the C7 plumb line is not the center of gravity of the trunk, which also suggests the unscientific nature of using SVA to formulate surgical plans (Lafage V, Schwab F, Patel A, Hawkinson N, Farcy JP. Pelvic tilt and truncal inclination: two key radiographic parameters in the setting of adults with spinal deformity. Spine (Phila Pa 1976). 2009 Aug 1; 34(17): E599-606.).

[0005] Furthermore, the procedures described in discussions of spinal osteotomy are complex and relatively obscure for novice doctors, requiring repeated measurement of relevant parameters each time, which is time-consuming and laborious. Therefore, this application aims to design a simple and rapid method and principle for kyphosis osteotomy correction, especially the calculation of the osteotomy angle, and to provide an ideal operating interface. Summary of the Invention

[0006] In a first aspect, the present invention provides a design system for the osteotomy angle in osteotomy correction surgery for kyphosis, the design system comprising:

[0007] A) Input module: The input data includes spinal data, which includes the distance between the center of the femoral head and the osteotomy apex, and the distance between the center of the femoral head and the C2 dentate process tip;

[0008] B) Data processing module: Calculates the osteotomy angle based on the input data;

[0009] C) Output module: Outputs the calculated osteotomy angle.

[0010] The spinal data also includes the pelvic incident angle PI and the pelvic tilt angle PT.

[0011] The PI mentioned is an inherent parameter of the human body, and it will not change regardless of the degree of deformity.

[0012] Preferably, the pelvic tilt angle PT includes the measured mPT and the ideal iPT.

[0013] Preferably, iPT = 0.44 × PI - 11.4.

[0014] The osteotomy apex is one or two or more, for example, 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 or more. Preferably, the osteotomy apex is two.

[0015] Preferably, the osteotomy apex is located on the spine, and is named sequentially from proximal to distal along the spine with the femoral head as the origin, namely the first osteotomy apex, the second osteotomy apex, ..., the nth osteotomy apex; or the proximal osteotomy apex and the distal osteotomy apex. Correspondingly, the osteotomy angle is named sequentially from proximal to distal along the spine with the femoral head as the origin, namely the first osteotomy angle, the second osteotomy angle, ..., the nth osteotomy angle; or the proximal osteotomy angle and the distal osteotomy angle.

[0016] The data processing module includes calculating the distal osteotomy angle using spinal data and the proximal osteotomy angle.

[0017] The proximal osteotomy angle is obtained based on clinical experience and is any value within the range of 30°-60°. Preferably, the proximal osteotomy angle is any value within the range of 35°-50°, such as 30°, 35°, 40°, 41°, 42°, 43°, 44°, 45°, 46°, 47°, 48°, 49°, 50°, 52°, 54°, 56°, 58°, and 60°.

[0018] In one specific embodiment of the present invention, the proximal osteotomy angle is 45°.

[0019] The proximal osteotomy apex is determined based on clinical experience, and the location of the proximal osteotomy apex includes the second, third, or fourth lumbar vertebrae. Preferably, the location of the proximal osteotomy apex is the second or third lumbar vertebra.

[0020] The distal osteotomy apex is determined based on clinical experience, and its location includes any position within the T2-L1 range, such as the second, third, fourth, fifth, sixth, seventh, eighth, ninth, tenth, eleventh, twelfth, or first lumbar vertebra.

[0021] In one specific embodiment of the present invention, the proximal osteotomy apex is the third lumbar vertebra, and the distal osteotomy apex is the first lumbar vertebra.

[0022] In one specific embodiment of the present invention, the spinal data includes the distance (OM) between the femoral head center O and the proximal osteotomy vertex M, the distance (MN) between the proximal osteotomy vertex M and the distal osteotomy vertex N, the distance (NP) between the distal osteotomy vertex N and the C2 odontoid process tip P, the distance (ON) between the femoral head center O and the distal osteotomy vertex N, the distance (OP) between the femoral head center O and the C2 odontoid process tip P, the pelvic incidence angle (PI), and the pelvic tilt angle (PT).

[0023] The spinal data is obtained from full-length lateral images of the spine of patients with kyphosis; preferably, the full-length lateral images of the spine are obtained from a PACS system.

[0024] More preferably, the full-length lateral spinal image is derived from images generated by a PACS system including an MRI scanner, CT scanner, ultrasound diagnostic instrument, X-ray machine, infrared instrument, or microscope. Even more preferably, the full-length lateral spinal image is an image generated by an X-ray machine in the PACS system.

[0025] The spinal data also includes ∠POP2 measured from the image, where O is the center of the femoral head, P is the position of the C2 dentate process tip before osteotomy, and P2 is the position of the C2 dentate process tip after osteotomy. Preferably, the angle between the line connecting the position P2 of the C2 dentate process tip after osteotomy and the femoral head and the vertical line is -5° to 2°.

[0026] The spinal data includes data measured from full-length lateral images of the spine and data calculated from them.

[0027] The measured data includes the length data of OM, MN, NP, ON, and OP, and the angle data of ∠POP2, PI, and mPT. The calculated data includes the angle data of iPT.

[0028] Patients requiring osteotomy and corrective surgery include those with ankylosing spondylitis, spinal tuberculosis, kyphosis caused by trauma, congenital kyphosis, premyelitis, rickets, fluorosis, primary osteoporosis, or secondary osteochondrosis.

[0029] The osteotomy design system described in this application is based on the standards of overall balance, pelvic balance, balance of each segment of the spine, and normal visual field. Furthermore, experimental results have confirmed that it indeed meets these standards.

[0030] The overall balance is represented by OD-HA (the angle between the line connecting the C2 dentate process tip and the femoral head and the vertical line), which is normally -5 to 2°.

[0031] The parameters for pelvic balance include PI and PT.

[0032] The parameters for balancing the various segments of the spine include lumbar lordosis (LL), thoracolumbar kyphosis (TLK), thoracic kyphosis (TK), and spino-cranial angle (SCA).

[0033] The LL angle is the Cobb angle between the superior endplate of the first lumbar vertebra (L1) and the superior endplate of the first sacrum (S1), and the LL angle is 0.54 × PI + 27.6°.

[0034] The TLK is the Cobb angle between the superior endplate of the tenth thoracic vertebra (T10) and the inferior endplate of the second lumbar vertebra (L2), and the normal range of the TLK is 0±15°.

[0035] The TK angle is the Cobb angle between the superior endplate of the fourth thoracic vertebra (T4) and the superior endplate of the twelfth thoracic vertebra (T12), and the normal range of TK is 10° to 40°.

[0036] The SCA is the line connecting the superior endplate of the seventh cervical vertebra (C7) and the midpoint of the sella turcica. The normal range of the SCA is 83°±9°.

[0037] The aforementioned spinal segment balance parameters also include L4-S1 and T1-T12;

[0038] The L4-S1 mentioned above refers to the Cobb angle between the superior endplate of the fourth lumbar vertebra (L4) and the superior endplate of the first sacral vertebra (S1), and the L4-S1 = 0.66 × L1;

[0039] The T1-T12 refers to the Cobb angle between the superior endplate of the first thoracic vertebra (T1) and the inferior endplate of the twelfth thoracic vertebra (T12), and the T1-T12 = 0.75 × LL.

[0040] The normal visual field is represented by the jaw-brow angle (CBVA), and its normal range is any value in the range of -20° to 20°, preferably any value in the range of -20° to 5°, and more preferably any value in the range of -20° to 0° or any value in the range of -15° to 5°.

[0041] In a second aspect, the present invention provides a computer device comprising the design system described above.

[0042] The computer device includes a memory for storing spinal data and calculated osteotomy angles.

[0043] The computer device includes at least one processor, which can execute the system designed above.

[0044] In a third aspect, the present invention provides an application of the above-described design system or computer equipment in the preparation of osteotomy orthopedic positioning molds or guide plates.

[0045] In a fourth aspect, the present invention provides a method for preparing an osteotomy orthopedic positioning mold or guide plate, the method comprising determining the osteotomy angle through the above-described design system, and then preparing the osteotomy orthopedic positioning mold or guide plate.

[0046] In a fifth aspect of the present invention, a treatment method or surgical method for osteotomy correction of kyphosis is provided, the treatment method or surgical method comprising acquiring a full-length lateral image of the spine, then measuring the spinal data, inputting the data into the design system of the first aspect to calculate the osteotomy angle, and then performing surgical osteotomy correction.

[0047] The kyphosis includes ankylosing spondylitis, spinal tuberculosis, kyphosis caused by trauma, congenital kyphosis, premyelitis, rickets, fluorosis, primary osteoporosis, or secondary osteochondrosis.

[0048] The above only summarizes some aspects of the present invention and is not, and should not be considered as limiting the present invention in any way.

[0049] All patents and publications mentioned in this application are incorporated herein by reference in their entirety. Those skilled in the art will recognize that certain modifications can be made to this invention without departing from its spirit or scope. The following embodiments further illustrate the invention in detail and should not be considered as limiting the scope of the invention or the specific methods described herein. Attached Figure Description

[0050] Figure 1 These are normal values ​​for different parts of the spine. A is the overall balance diagram, where OD-HA represents the angle between the line connecting the C2 odontoid process and the femoral head and the vertical line, and S1 is the first sacrum. B is the pelvic balance diagram, where S1 is the first sacrum, PI is Pelvic incidence (pelvic angle of incidence), and PT is Pelvic tilt (pelvic tilt angle). C and D are the balance diagrams for different spinal segments, where LL is lumbar lordosis (thoracic lordosis), L4-S1 is the Cobb angle between the superior endplate of L4 and the superior endplate of S1, TLK is thoracolumbarkyphosis (thoracolumbar kyphosis), T1-T12 is the Cobb angle between the superior endplate of T1 and the inferior endplate of T12, TK is thoracickyphosis (thoracic kyphosis), and L2 is the second lumbar vertebra. E is a visual field problem diagram, where CBVA is the Chin-brow vertical angle, and SCA is the spino-cranial angle. Angle, the spine-skull angle, C2 is the second cervical vertebra, C7 is the seventh cervical vertebra, and C2-C7 is the Cobb angle between the inferior endplates of C2 and C7.

[0051] Figure 2 The pelvis is rotated from a posterior rotation state to a neutral position, where mPT is the measured PT value, iPT is the ideal PT, θ2 is the rotation angle, Pelvis is the pelvis, tP is the position of the C2 odontoid process tip in the posterior rotation (initial) state, and iP is the position of the C2 odontoid process tip in the neutral position (after the orthodontic procedure is completed).

[0052] Figure 3 To perform a virtual osteotomy on the patient, A is to place the pelvis of the kyphotic patient from a posterior rotation position to a neutral position; B is to perform a wedge osteotomy at the first osteotomy apex (M) with an osteotomy angle of α; C is to perform a wedge osteotomy at the second osteotomy apex (N) with an osteotomy angle of β; D is to integrate the virtual osteotomy process model into a geometric diagram, where ∠POP2 is the angle θ of the overall trunk rotation.

[0053] Figure 4 This is a flowchart of osteotomy and orthopedic surgery.

[0054] Figure 5This is an interface diagram of the osteotomy correction system. Rotation on X-ray (θ1) represents the size of ∠POP2 measured on the X-ray film. O is the center of the femoral head, P is the position of the C2 odontoid process tip before osteotomy, and P2 is the ideal position reached by the C2 odontoid process tip after double-segment osteotomy. The ideal position standard for the C2 odontoid process tip is: the angle between the line connecting the C2 odontoid process tip position P2 and the femoral head and the vertical line is -5° to 2°. MeasuredPT is the actual measured angle between the line connecting the midpoint of the superior endplate of sacral S1 and the femoral head and the vertical line. Osteotomy angle1 (α) is the first osteotomy angle α. angle2(β) is the second osteotomy angle β, OM(a) is the distance between the femoral head center O and the first osteotomy vertex M, MN(b) is the distance between the first osteotomy vertex M and the second osteotomy vertex N, NP(c) is the distance between the second osteotomy vertex N and the C2 dentate tip P, ON(d) is the distance between the femoral head center O and the second osteotomy vertex N, and OP(l1) is the distance between the femoral head center O and the C2 dentate tip P.

[0055] Figure 6 A spinal image of the patient before osteotomy and correction surgery.

[0056] Figure 7 A spinal image of the patient after osteotomy and reshaping surgery. Detailed Implementation

[0057] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. The present invention will be described below with reference to the accompanying drawings and specific embodiments.

[0058] Example 1: Methods and Principles for Constructing a Design System

[0059] The first step is to achieve the ideal state of constraint conditions for each part, that is, the normal values ​​of each part of the spine.

[0060] like Figure 1 As shown: Overall balance ( Figure 1 Figure A in the figure: The angle between the line connecting the C2 dentate process tip and the femoral head and the vertical line is represented by OD-HA, which is normally -5 to 2°.

[0061] Pelvic balance ( Figure 1 (Figure B in the diagram): PI is an inherent parameter of the human body, and it will not change regardless of the degree of deformity; PT = 0.44 × PI - 11.4;

[0062] Segmental balance of the spine Figure 1 (CD diagram in the diagram): LL = 0.54 × PI + 27.6°, L4-S1 = 0.66 × L1-S1, TLK = 0 ± 15°, T1-T12 = 0.75 × L1-S1, TK: 10°~40°, SCA: 83°±9°.

[0063] Field of vision problem ( Figure 1 (E diagram in the figure): Represented by the brow ridge angle (CBVA), which is normally -15° to 5°.

[0064] The second step is to rotate the patient's pelvis from a posterior rotation position to a neutral position.

[0065] like Figure 2 As shown: In patients with kyphosis, the pelvis is often in a posteriorly rotated position. To restore normal function, the pelvis needs to be positioned to a pre-defined neutral position (according to the formula PT = 0.44 × PI - 11.4°), i.e., the pelvis needs to be rotated anteriorly by an angle of θ2. According to the mathematical formula θ2 = mPT - iPT (PT is the pelvic tilt angle)... Figure 2 (As shown in Figure A). When the pelvis rotates, according to the mathematical model, the head and torso will also rotate clockwise, with the same rotation angle θ2. Figure 2 (As shown in Figure B).

[0066] That is, through the above operation, the pelvis is first placed in a balanced position, and the trunk and pelvis are rotated as a whole around the femoral head by θ2 relative to the original position.

[0067] The third step is to perform a virtual osteotomy on the patient.

[0068] Assume the osteotomy involves two segments with degrees α and β. For example... Figure 3 Figure A shows a patient with kyphosis. First, the patient's pelvis was moved from a posteriorly rotated position to a neutral position. Then, a wedge osteotomy (angle α) was performed on the lower segment, achieving rotation above the osteotomy. Figure 3 (See Figure B in the diagram), and then a wedge osteotomy (angle β) is performed on the upper segment. After closure, the initial odontoid process tip of the cervical vertebra C2 falls exactly at point P2. Figure 3 (Figure C in the diagram) makes the angle between OP2 and the vertical line (OD-HA above) between -5° and 2°. The above process model is then integrated into... Figure 3 In diagram D, we can see that ∠POP2 is the angle θ of the overall trunk rotation. However, it's important to note that ∠POP2 measured on a standard X-ray is not the true θ but θ1, because the pelvis is still in a posterior rotation position on a standard X-ray and needs to be rotated to a neutral position. Therefore, θ = θ1 + θ2 exists.

[0069] The fourth step is to establish the relationship between α and β based on trigonometric functions and mathematical equations.

[0070] The relationship between α and β can be established by measuring five line segment lengths and three angles on an X-ray. The line segment lengths are OM(a), MN(b), NP(c), ON(d), and OP(l1), and the angles are the actual θ1, PI, and PT on the X-ray.

[0071] in,

[0072] OM(a) is the distance between the center O of the femoral head and the proximal osteotomy vertex M;

[0073] MN(b) is the distance between the proximal osteotomy vertex M and the distal osteotomy vertex N;

[0074] NP(c) is the distance between the distal osteotomy apex N and the C2 dentate tip P;

[0075] ON(d) is the distance between the center O of the femoral head and the vertex N of the distal osteotomy.

[0076] OP(l1) is the distance between the center O of the femoral head and the apex P of the C2 dentate process;

[0077] θ1 is the size of ∠POP2 measured on a standard X-ray (i.e., on a standard PACS system), where O is the center of the femoral head, P is the position of the C2 dentate tip before osteotomy, and P2 is the ideal position reached by the C2 dentate tip after double-segment osteotomy. The standard for the ideal position reached by the C2 dentate tip is: the angle between the line connecting the position P2 of the C2 dentate tip after osteotomy and the femoral head and the vertical line is -5° to 2°.

[0078] PI is the pelvic incidence angle, which is the angle formed by two lines. One line is the line connecting the midpoint of the superior endplate of the S1 sacrum to the femoral head, and the other line is the line passing through the midpoint of the superior endplate of the S1 sacrum and perpendicular to the S1 endplate.

[0079] PT stands for pelvic tilt. PT is the angle formed by two lines, one of which is the line connecting the midpoint of the upper endplate of the S1 sacrum to the femoral head, and the other is a vertical line.

[0080] The specific derivation process is as follows:

[0081] β=360-∠MN1P2-∠MNP=360-(∠P2N1X+180-∠N1MY)-∠MNP

[0082] =180-∠P2N1X+∠N1MY-∠MNP

[0083]

[0084]

[0085]

[0086]

[0087]

[0088] final,

[0089] β=180-∠MNP(1)-∠N1MY(2)-∠P2N1X(3)

[0090] This establishes the relationship between α and β, where for each given α, there will be a fixed β.

[0091] Example 2: System Design

[0092] according to Figure 4 The flowchart shown constructs a kyphosis osteotomy correction design system. The determination of α and β needs to be based on the above constraints.

[0093] The system design includes an input module, a data processing module, and an output module. The input module includes the lengths of five line segments and three angles of the patient's spine. The line segment lengths are OM(a), MN(b), NP(c), ON(d), and OP(l1), and the angles are the actual θ1, PI, and PT on the X-ray. The data processing module uses the calculation principle of "step four" in Example 1 to calculate and process the five line segment lengths and three angles from the input module. The output module visualizes the osteotomy angles calculated by the data processing module.

[0094] Overall, users won't see such a complex calculation process; it's hidden within the background language. Users only need to measure the lengths of the five line segments and the three angles mentioned above. The user interface is very clear. Figure 5 Moreover, it can be measured repeatedly, saving time and effort.

[0095] Example 3: Applying the above-designed system to osteotomy and correction of a patient.

[0096] Figure 6 For a patient with kyphosis (ankylosing spondylitis), preoperatively, L3 and L1 osteotomies are planned, with osteotomy apexes at M and N, respectively.

[0097] Three angles: PI = 60.2°, measured PT = 63.1°, POP2(θ1) = 18.8°;

[0098] Five lines: OM = 168mm, MN = 48.7mm, NP = 44.1mm, ON = 20.9mm, OP = 54.3mm.

[0099] Enter the above operation interface ( Figure 5 Based on clinical experience, given an osteotomy angle of α of 45°, β was automatically calculated to be 42.8°. The osteotomy was performed intraoperatively according to the calculated plan. Postoperatively... Figure 7 As shown.

Claims

1. A system for designing osteotomy angles in osteotomy correction surgery for kyphosis, characterized in that, The design system includes: A) Input Module: The input data includes spinal data, which includes the distance OM between the femoral head center O and the proximal osteotomy vertex M, the distance MN between the proximal osteotomy vertex M and the distal osteotomy vertex N, the distance NP between the distal osteotomy vertex N and the pre-osteotomy C2 dentate process tip P, the distance ON between the femoral head center O and the distal osteotomy vertex N, the distance OP between the femoral head center O and the pre-osteotomy C2 dentate process tip P, the pelvic incidence angle PI, the pelvic tilt angle PT, and ∠POP2. The pelvic tilt angle PT includes the measured mPT and the ideal iPT, iPT=0.44×PI-11.

4. The angle between the line connecting the position of the C2 dentate process tip P2 after osteotomy and the femoral head and the vertical line is -5°~2°, where O is the femoral head center, P is the position of the C2 dentate process tip before osteotomy, and P2 is the position of the C2 dentate process tip after osteotomy. B) Data processing module: Calculates the distal osteotomy angle based on the input spinal data and proximal osteotomy angle; C) Output module: Outputs the calculated distal osteotomy angle.

2. The design system according to claim 1, characterized in that, The osteotomy apex is located on the spine, with the femoral head as the origin, and is named the proximal osteotomy apex and distal osteotomy apex sequentially from near to far along the spine.

3. The design system according to claim 1, characterized in that, The spinal data was obtained from full-length lateral images of the spine of patients with kyphosis.

4. The design system according to claim 3, characterized in that, The full-length lateral images of the spine were obtained from the PACS system.

5. The design system according to claim 3, characterized in that, The full-length lateral spinal images are derived from images generated by PACS systems, including MRI scanners, CT scanners, ultrasound diagnostic instruments, X-ray machines, infrared instruments, or microscopes.

6. The design system according to claim 1, characterized in that, Patients requiring osteotomy and corrective surgery include those with ankylosing spondylitis, spinal tuberculosis, kyphosis caused by trauma, congenital kyphosis, premyelitis, rickets, fluorosis, primary osteoporosis, or secondary osteochondrosis.

7. A computer device, characterized in that, The computer device comprises the design system as described in any one of claims 1-6.

8. The application of the design system according to any one of claims 1-6 and the computer device according to claim 7 in the preparation of osteotomy orthopedic positioning molds or guide plates.

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