CN209136772U - A kind of open wedge osteotomy device - Google Patents

Abstract

An open wedge-shaped osteotomy device relates to the technical field of medical devices, in particular to a device for bone surgery. The problem of the existing osteotomy guide plate for open wedge osteotomy is solved, such as difficult positioning, low guiding precision, low stability, interference with surgical operation, excessive size, complex structure and the like. The inner surface of the open wedge-shaped osteotomy device matches the bone surface of the operation area, and is provided with a positioning edge, and the outer surface of the open wedge-shaped osteotomy device is provided with a Kirschner wire guide sleeve, an angle marking hole and two opening position marking holes. The open wedge-shaped osteotomy device of the utility model positions itself accurately, the positioning method does not increase the surgical trauma, and is easy for the operator to operate. It has good accuracy in direction, depth and angle when realizing guidance; it ensures good stability, and will not cause deformation or displacement due to the force during operation, which will affect the positioning accuracy. The utility model has the advantages of simple structure, convenient use, does not block the surgical field, and is small in size and can be placed in a small incision.

Description

An open wedge-shaped osteotomy device

technical field

The utility model relates to the technical field of medical instruments, in particular to a device for bone surgery.

Background technique

Open wedge osteotomy is a surgical method for correcting varus and varus of the joint. The core idea is to form a wedge-shaped opening in the bone through osteotomy and distraction, and change the angle of the bone to correct the deformity. The osteotomy may be single-planar or double-planar, and the bone is not cut off during the osteotomy, but a layer of bone is retained as a rotation axis (also known as a hinge) in the subsequent expansion process. In this process, it is necessary to precisely locate the position of the osteotomy plane, the depth of the osteotomy, and the opening angles of the two rotation directions in order to achieve the ideal curative effect.

Most of the osteotomy guides are designed for special surgery and are not suitable for open wedge osteotomy, and the existing osteotomy guide designs for open wedge osteotomy are not satisfactory, such as:

Defect 1. Difficulty in positioning itself: an osteotomy surgical instrument (CN107753088Λ) only mentions "ensure that there is enough area to attach to the bone surface", in order to use the guide plate surface to fit the bone surface to achieve positioning. However, since it is impossible to completely remove the soft tissue attached to the surface of the bone, it cannot fit accurately, and the bone at the site of open wedge osteotomy is usually smooth, and the difference between different positions is small. It is very difficult to find an accurate matching position, which leads to its use. face great inconvenience. In order to improve the positioning accuracy, the area of the guide plate can only be increased during implementation, which will inevitably increase the surgical trauma. An auxiliary tool for high medial tibial osteotomy (CN107320153Λ) uses positioning claw positioning in addition to the positioning method, but the positioning reference mentioned in the document is not exposed during the operation, and the positioning accuracy across the soft tissue is low, and The positioning claw protrudes far out of the surgical incision, and the incision needs to be pulled, which also increases the surgical trauma and easily causes other problems such as infection. In the method and system (CN104869918B) for planning and executing osteotomy, self-positioning cannot be completed independently, and the support of a complete set of navigation system is required, which is inconvenient to use and has a very high cost.

Defect 2. The guidance accuracy is not high: in an osteotomy surgical instrument (CN107753088A), the guidance is completed through the guide groove, and the depth is determined by observing the scale or mark of the saw blade and the outer surface of the groove wall. If the patient is obese, the surgical incision is deep , there are problems of inconvenient observation and difficulty in precise positioning. An auxiliary tool for high medial tibial osteotomy (CN107320153A) does not mention how to determine the depth, and completely depends on the experience of the operator; and the two-axis rotation cannot be differentiated during distraction, which is likely to cause inaccurate distraction. A navigation device capable of accurately locating a high tibial osteotomy and a preparation method thereof (CN105877807Λ) and a combined osteotomy surgical guide (CN104490451B) also cannot constrain the operative depth and the opening angle during use, and cannot achieve the purpose of accurate guidance.

Defect 3. Low stability: In an osteotomy surgical instrument (CN107753088A), the guide plate is divided into two pieces during the osteotomy operation. At this time, the contact area between the single piece and the bone is reduced, the stability is reduced, and it is easy to be affected during the operation. The force is displaced, which affects the accuracy.

Defect 4. Interfere with the surgical operation: in a surgical instrument for osteotomy (CN107753088A), two arms extend from the guide plate to connect two counter-positioned perforations, and an auxiliary tool for high medial tibial osteotomy (CN107320153A) also has multiple The positioning claw is extended. Therefore, during the operation, it is easy to block the sight of the operator, interfere with the instruments, and reduce the practicability of the tools. In addition, due to the space required to accommodate such appendages on the guide plate, the size of the guide plate is inevitably increased, making it difficult to insert the guide plate into the cutout.

Defect 5. Excessive size: The device (CN101155559B) used to form a wedge-shaped opening in a bone for an open wedge osteotomy is obviously too large and requires a large incision for placement, which significantly reduces its practicability.

Defect 6. Complex structure: The device (CN101155559B) used to form a wedge-shaped opening in the bone for open wedge-shaped osteotomy has an extremely complex structure, and is composed of several special parts, which is easy to operate errors during the operation, and reduces the operation efficiency. increase patient suffering.

Utility model content

In order to solve the problems of the existing osteotomy guide plate used for open wedge osteotomy being difficult to position itself, low in guiding precision, low in stability, interfering with surgical operations, too large in size, complex in structure and the like, the utility model provides an open wedge-shaped osteotomy guide plate. Wedge-shaped osteotomy device.

The inner surface of the open wedge-shaped osteotomy device of the utility model matches the bone surface of the operation area, the open wedge-shaped osteotomy device is provided with a positioning edge (2), and the outer surface of the open wedge-shaped osteotomy device is provided with a Kirschner wire guide sleeve, Angle marking hole (5) and two opening position marking holes (6);

The number of K-wire guide sleeves is ≥ 3, of which at least two K-wire guide sleeves are guide holes (3-1), and the centerlines of the guide holes (3-1) are in the same plane and are both perpendicular to the virtual axis; At least one Kirschner wire guide sleeve is a positioning hole (3-2), and the positioning hole (3-2) is not on the connecting line of the guide hole (3-1);

The two opening position marking holes (6) are respectively located on both sides of the connecting line of the guide hole (3-1), and the connecting line of the two opening position marking holes (6) is perpendicular to the connecting line of the guiding hole (3-1);

The number of angle marking holes (5) is greater than or equal to 3, which are not collinear, and are located on both sides of the connecting line of the guide holes (3-1).

The utility model makes up for the defects of the prior art through the clever combination of various guiding and positioning methods and the multi-functionalization of the traditional functional structure, and realizes the integrated small volume, simple structure, no appendages, high precision and full function. Osteotomy guide. It can complete simple and effective self-positioning and stable tightening, and realize precise control of the osteotomy position, direction, depth and rotation angle in two directions.

The open wedge-shaped osteotomy device of the utility model positions itself accurately, the positioning method does not increase the surgical trauma, and is easy for the operator to operate. It has good precision in direction, depth and angle when realizing guidance. Good stability is ensured when the guidance is realized, and the deformation or displacement will not be caused by the force during the operation, which will affect the positioning accuracy. The utility model has the advantages of simple structure, convenient use, does not block the surgical field, does not interfere with the surgical instruments, does not interfere with the surgical operation, and avoids increasing the burden on the operator. Small in size and able to fit in smaller incisions.

Related terms in distal osteotomy:

Horizontal osteotomy surface: The bone is divided into two parts of the osteotomy surface, and the bone is not completely cut off during the actual osteotomy, and a layer of bone is reserved as a hinge.

Rising osteotomy surface: it only occurs in high tibial osteotomy, and the bone is divided into left and right parts. According to the principle of surgery, the angle between it and the horizontal osteotomy surface is about 110° (as shown in Figure 1). Show).

The virtual axis is the edge line between the bone preserved part and the cut part after the horizontal osteotomy. According to the principle of surgery, the virtual axis should be a straight line, and during the opening, both sides of the osteotomy incision should be opened into a wedge shape with the virtual axis as the axis.

Stretch angle: the angle between the upper and lower sides of the osteotomy incision when it is stretched to achieve the predetermined correction effect. Achieving an appropriate opening angle is the goal of surgery.

Spread distance: The width of the wedge-shaped opening at the specified position when the predetermined spread angle is reached. The opening angle can be calculated by measuring the opening distance, which is related to the measurement position (as shown in Figure 2).

Osteotomy Depth: During osteotomy, the oscillating saw is inserted into the bone in the direction perpendicular to the virtual axis, and the distance that the oscillating saw advances to the virtual axis.

Stretch position: the force application position of the horizontal osteotomy surface. The force application osteotomy surface is evenly stressed at the stretch position, and only takes the virtual axis as the axis to open, and will not produce rotation in other directions.

The position and angle values of the above lines and surfaces are calculated based on the 3D bone model restored by 3D tomography and guided by medical theory in preoperative planning. The open position can be calculated according to the biomechanical principle according to the shape of the hinge.

Description of drawings

Figure 1 is a schematic diagram of the position of the horizontal osteotomy surface and the ascending osteotomy surface in distal osteotomy;

Figure 2 is a schematic diagram of the position of the distraction angle and distraction distance of distal osteotomy;

Fig. 3 is the structural representation of embodiment 1;

Figure 4 is a schematic diagram of the structure of Example 4.

Detailed ways

Embodiment 1: This embodiment will be described with reference to FIGS. 3 to 4. In this embodiment, the inner surface of the open wedge-shaped osteotomy device matches the surface of the bone in the surgical area. The open wedge-shaped osteotomy device is provided with a positioning edge 2, an open The outer surface of the wedge-shaped osteotomy device is provided with a Kirschner wire guide sleeve, an angle marking hole 5 and two opening position marking holes 6;

The number of K-wire guide sleeves is greater than or equal to 3, of which at least 2 are guide holes 3-1, and the centerlines of the guide holes 3-1 are in the same plane and are all perpendicular to the virtual axis; at least 1 of them The Kirschner wire guide sleeve is the positioning hole 3-2, and the positioning hole 3-2 is not on the connecting line of the guide hole 3-1;

The two opening position marking holes 6 are respectively located on both sides of the connecting line of the guide hole 3-1, and the connecting line of the two opening position marking holes 6 is perpendicular to the connecting line of the guide hole 3-1;

The number of the angle marking holes 5 is greater than or equal to 3, and they are not collinear, and are located on both sides of the connecting line of the guide hole 3-1.

The guide hole of the K-wire guide sleeve in this embodiment is circular or prismatic, the length of the K-wire guide sleeve is 10-70 mm, and the wall thickness of the K-wire guide sleeve is not less than 2 mm.

The distance between the two opening position marking holes 6 is 5-35 mm; the line connecting the centers of the two opening position marking holes 6 is called the opening line.

The open wedge osteotomy device in this embodiment is made of nylon, PEEK, PMMΛ, photosensitive resin, stainless steel or titanium alloy, and is manufactured by machining or 3D printing. Use the Kirschner wire to guide the osteotomy, the tip of the Kirschner wire inserted into the bone in the guide hole 3-1 is on the virtual axis, and the front end of the oscillating saw is flush with the tip of the Kirschner wire by observing the operation under X-ray during the osteotomy .

The device of the utility model is suitable for the open wedge-shaped osteotomy of the tibia, femur, humerus, ulna, clavicle and the like.

The device of the utility model has a compact structure: the utility model subtly changes the traditional positioning and angle measurement methods, removes the appendages, greatly reduces the size of the instruments, is easy to put into the operating area, and does not increase the incision due to the use of the instruments. mouth, causing additional trauma to the patient. At the same time, because there is no large-sized protrusion of the same kind of utility model, it does not interfere with the operator's operation. And it is easy to use: it adopts an integral design, strong stability, and no additional special instruments are required for use. The use process is completely in line with the habit of freehand surgery, which reduces the burden of doctors' learning and operation, improves the efficiency of surgery, and reduces the risk of surgery. Especially the positioning is accurate: the positioning of its own position adopts the double positioning method of measurement and fitting, which has high positioning accuracy and easy operation. The positioning of the osteotomy position and depth combines the advantages of the positioning of the guide groove and the guide pin to achieve high precision. By marking the opening position, the measurement accuracy is ensured, the control of the rotation in both directions during the opening is realized, and the measurement method is simple.

Embodiment 2: The difference between this embodiment and Embodiment 1 is: there are n positioning edges 2, n≥1; the positioning edge 2 that is closest to the joint is called the first positioning edge, and the first positioning edge is the same as the first positioning edge. The edges of the articular surface (ie, the tibial plateau) are parallel, and the first positioning edge is 8 to 50 mm away from the edge of the articular surface. Others are the same as the first embodiment.

In this embodiment, the distance between the first positioning edge and the edge of the other side of the open wedge-shaped osteotomy device is 30-50 mm. When used for high tibial osteotomy, the distance between the first positioning edge and the tibial plateau should not be less than 10mm.

Embodiment 3: The difference between this embodiment and Embodiment 1 or 2 is that the outer surface of the open wedge-shaped osteotomy device is further provided with a pointing mark 7 and/or explanatory text. Others are the same as the first or second embodiment.

The pointing mark 7 is an arrow-shaped mark, which points to the palpable bony eminence point in or near the surgical field; and is not parallel to the first positioning edge. The pointing mark 7 is depicted in the form of negative or positive text on the outer surface of the open wedge-shaped osteotomy device with a concave depth or a convex height of 0.5 to 3 mm, and the total length of the arrow is not less than 10 mm. The included angle between the pointing mark 7 and the first positioning edge is 15°˜45°.

When used for high tibial osteotomy, the description text marks the distance from the first positioning edge to the tibial plateau. The description text labels the spacing distance.

Embodiment 4: The difference between this embodiment and Embodiments 1, 2 or 3 is that the open wedge-shaped osteotomy device is further provided with a side guide groove 4 . Others are the same as the first, second or third embodiment.

The lateral guide groove 4 appears in the high tibial osteotomy. The width of the guide groove is 1.1 to 3 mm, the thickness of the two side walls is 2 to 10 mm, the height of the side walls is not less than 10 mm, and the tops of the two side walls are in the same plane.

Embodiment 5: The difference between this embodiment and one of Embodiments 1 to 4 is that the inner surface of the open wedge-shaped osteotomy device can be a smooth surface or a shallow pattern for increasing friction. Others are the same as one of the first to fourth embodiments.

Embodiment 6: The difference between this embodiment and one of Embodiments 1 to 5 is that the Kirschner wire guide sleeve is cylindrical, prismatic, truncated cone or prismatic, and the cross section of the through hole in the Kirschner wire guide sleeve is round or rhombus. Others are the same as one of the first to fifth embodiments.

Example 1:

Open wedge osteotomy device (an example of distal femoral osteotomy, shown in Figure 3): The inner surface of the open wedge osteotomy device conforms to the bone surface of the surgical field, and the open wedge osteotomy device has positioning Edge 2. The outer surface of the open wedge-shaped osteotomy device is provided with a Kirschner wire guide sleeve, an angle marking hole 5, and two opening position marking holes 6;

The number of K-wire guide sleeves is 3, of which 2 K-wire guide sleeves are guide holes 3-1, and the centerlines of the guide holes 3-1 are in the same plane and are perpendicular to the virtual axis; The needle guide sleeve is the positioning hole 3-2, and the positioning hole 3-2 is not on the connecting line of the guide hole 3-1;

The two opening position marking holes 6 are respectively located on both sides of the connecting line of the guide hole 3-1, and the connecting line of the two opening position marking holes 6 is perpendicular to the connecting line of the guide hole 3-1;

The number of the angle marking holes 5 is three, which are not collinear and are located on both sides of the connecting line of the guide holes 3-1.

The thickness of the open wedge-shaped osteotomy device is 2-10mm, and the inner surface is engraved with shallow patterns to increase friction.

The edge of the open wedge-shaped osteotomy device close to the joint is called the first positioning edge, which is parallel to the edge of the articular surface and is 15-45 mm away from the edge of the articular surface; the distance from the first positioning edge to the edge of the distal femur is 30-50 mm.

The inner hole of the Kirschner wire guide sleeve is 0.05-2mm larger than the outer diameter of the K-wire for surgery; the length of the Kirschner wire guide sleeve is 10-70mm, and the wall thickness of the Kirschner wire guide sleeve is not less than 2mm.

The distance between the two stretched position marking holes 6 is 5-35 mm; the line connecting the centers of the two stretched position marking holes 6 is called the stretched line, which is perpendicular to the virtual axis.

Pointing mark 7 points to the highest point of the lateral epicondyle of the femur, and the angle with the femoral mechanical axis is 0 to 30 degrees; the pointing mark 7 is depicted on the outer surface of the open wedge-shaped osteotomy device in the form of female characters or male characters, with a concave depth or a convex height of 0.5 ~3mm, the total length of the arrow is not less than 10mm.

Near the first positioning edge, mark the distance from the first positioning edge to the articular surface of the lateral condyle with explanatory text. In the middle of the two spread position marked holes, mark the spread distance.

The diameter of the Kirschner wire is 0.8 to 3 mm.

Three Kirschner wires were inserted into the guide hole 3-1 of the same length, and both were set to L. L was equal to the sum of the depth of the guide hole and the depth of the Kirschner wire inserted into the bone, and the tip of the Kirschner wire did not penetrate the bone.

The guide hole 3-1 can be designed above or below the horizontal osteotomy surface. If the description text is marked "lower edge osteotomy", the guide hole 3-1 is set above the horizontal osteotomy surface; the description text is marked "upper edge osteotomy", then the guide hole 3-1 is set below the horizontal osteotomy surface.

The distance between the two angle marking holes 5 on the same side of the osteotomy surface is not less than 10mm, and the distance between the other angle marking hole 5 and the opposite side two angle marking holes 5 is not less than 25mm. Corresponding to the three marks, the two marks on the same side of the osteotomy surface are set as M and N, and the mark on the other side is set as P. A text description is respectively marked, indicating the length of the connecting lines MP and NP when the predetermined opening angle is reached.

How to use the open wedge osteotomy device:

1. Before preparing the osteotomy, place the open wedge-shaped osteotomy device into the incision, rotate the open wedge-shaped osteotomy device so that the first positioning edge is parallel to the edge of the articular surface of the lateral condyle, move the open wedge-shaped osteotomy device up and down and measure, Make the distance from the first anchor edge to the edge of the femoral plateau equal to the text dimension distance.

2. Move the open wedge-shaped osteotomy device back and forth so that the pointing mark points to the highest point of the lateral epicondyle of the femur.

3. Fine-tune the position of the open wedge-shaped osteotomy device to make the open wedge-shaped osteotomy device fit to the femur to the best degree.

4. Insert the K-wire into the K-wire guide sleeve and drill into the femur with a hand drill or other instruments.

5. Knock the K-wire in the guide hole 3-1 into the guide hole 3-1 until the end of the K-wire is flush with the upper edge of the guide sleeve.

6. Use an electric knife to burn marks on the bone surface through the distraction position marking hole 6 and the angle marking hole 5; or use a bone drill to drill a mark on the bone surface through the distracting position marking hole 6 and the angle marking hole 5.

7. Pull out the Kirschner wire in the positioning hole 3-2 and remove the open wedge osteotomy device.

8. Use an electric knife to burn (or draw with a bone knife) the connection line between the two opening marks, that is, the opening line.

9. Use the oscillating saw to complete the osteotomy along the guiding Kirschner wire (the Kirschner wire located in the guiding hole); observe under the X-ray, the guiding Kirschner wire is coincident, and the front end of the oscillating saw is flush with the tip of the guiding needle, that is, the predetermined amount is reached. Osteotomy depth.

10. Pull out the guiding Kirschner wire, and insert multiple osteotomy knives into the osteotomy incision to initially open the incision.

11. Pull out the osteotome, insert a distractor at the intersection of the distraction line and the osteotomy incision, and perform distraction.

12. During the opening process, measure the width of the opening at the opening line, which can be measured by the sub-gauge, or can be measured directly by using a spreader with a distance scale.

13. When the width of the opening is close to the stretched distance marked by the text, continue to stretch slowly and measure the lengths of the marked connection lines MP and NP. When the difference between the lengths of MP and NP and the text description is within a predetermined error range, and the stretched distance is the same as the stretched distance marked with the text, the predetermined stretched angle is reached. The predetermined error range should be 1 to 3 mm.

Example 2:

The difference between the open wedge-shaped osteotomy device and Example 1 is that the geometric relationship is calculated during design, so that when M, N, and P reach the predetermined opening angle, the lengths of MP and NP are equal.

How to use the open wedge osteotomy device:

Steps 1 to 12 are the same as in Example 1, except that 13. When the opening width is close to the stretched distance marked by the text, continue to stretch slowly, and measure the lengths of the marked connecting lines MP and NP (isosceles triangles). When the difference between the lengths of MP and NP and the text description is within a predetermined error range, and the stretched distance is the same as the stretched distance marked with the text, the predetermined stretched angle is reached. The predetermined error range should be 1 to 3 mm.

Example 3:

The difference between the open wedge-shaped osteotomy device and Example 1 is that the geometric relationship is calculated during design, so that when M, N, and P reach the predetermined opening angle, the lengths of MP, MN and NP are equal.

How to use the open wedge osteotomy device:

Steps 1 to 12 are the same as in Example 1, except that 13. When the opening width is close to the stretched distance marked by the text, continue to stretch slowly, and measure the lengths of the marked connecting lines MP and NP (for an equilateral triangle). When the difference between the lengths of MP and NP and the text description is within a predetermined error range, and the stretched distance is the same as the stretched distance marked with the text, the predetermined stretched angle is reached. The predetermined error range should be 1 to 3 mm.

Example 4:

Open wedge osteotomy (an example of high tibial osteotomy, shown in Figure 4): The inner surface of the open wedge osteotomy conforms to the surface of the bone in the surgical field, and the open wedge osteotomy is provided with positioning edges 2. The outer surface of the open wedge-shaped osteotomy device is provided with a Kirschner wire guide sleeve, an angle marking hole 5, and two opening position marking holes 6;

The number of K-wire guide sleeves is 3, of which 2 K-wire guide sleeves are guide holes 3-1, and the centerlines of the guide holes 3-1 are in the same plane and are perpendicular to the virtual axis; The needle guide sleeve is the positioning hole 3-2, and the positioning hole 3-2 is not on the connecting line of the guide hole 3-1;

The two opening position marking holes 6 are respectively located on both sides of the connecting line of the guide hole 3-1, and the connecting line of the two opening position marking holes 6 is perpendicular to the connecting line of the guide hole 3-1;

The number of the angle marking holes 5 is three, which are not collinear and are located on both sides of the connecting line of the guide holes 3-1.

The thickness of the open wedge-shaped osteotomy device is 2-10mm, and the inner surface is engraved with shallow patterns to increase friction.

The edge of the open wedge-shaped osteotomy device near the joint is called the first positioning edge, which is parallel to the edge of the articular surface and is 15-45 mm away from the edge of the articular surface; the distance from the first positioning edge to the edge of the proximal femur is 30-50 mm.

There is one side guide groove 4, which is coplanar with the ascending osteotomy surface, and its lower edge is 1-3 mm below the horizontal osteotomy surface.

The inner hole of the Kirschner wire guide sleeve is 0.05-2mm larger than the outer diameter of the K-wire for surgery; the length of the Kirschner wire guide sleeve is 10-70mm, and the wall thickness of the Kirschner wire guide sleeve is not less than 2mm.

The distance between the two stretched position marking holes 6 is 5-35 mm; the line connecting the centers of the two stretched position marking holes 6 is called the stretched line, which is perpendicular to the virtual axis.

Pointing mark 7 points to the highest point of the lateral epicondyle of the femur and is parallel to the mechanical axis of the femur; pointing mark 7 is depicted on the outer surface of the open wedge-shaped osteotomy device in the form of yin or yang, with a concave depth or a convex height of 0.5 to 3 mm, and the total arrowhead. The length is not less than 10mm.

Near the first positioning edge, mark the distance from the first positioning edge to the articular surface of the lateral condyle with explanatory text. In the middle of the two spread position marked holes, mark the spread distance.

The diameter of the Kirschner wire is 0.8 to 3 mm.

Three Kirschner wires were inserted into the guide hole 3-1 of the same length, and both were set to L. L was equal to the sum of the depth of the guide hole and the depth of the Kirschner wire inserted into the bone, and the tip of the Kirschner wire did not penetrate the bone.

The guide hole 3-1 can be designed above or below the horizontal osteotomy surface. If the description text is marked "lower edge osteotomy", the guide hole 3-1 is set above the horizontal osteotomy surface; the description text is marked "upper edge osteotomy", then the guide hole 3-1 is set below the horizontal osteotomy surface.

The distance between the two angle marking holes 5 on the same side of the osteotomy surface is not less than 10mm, and the distance between the other angle marking hole 5 and the opposite side two angle marking holes 5 is not less than 25mm. Corresponding to the three marks, the two marks on the same side of the osteotomy surface are set as M and N, and the mark on the other side is set as P. A text description is respectively marked, indicating the length of the connecting lines MP and NP when the predetermined opening angle is reached.

How to use the open wedge osteotomy device:

1. Before preparing the osteotomy, place the open wedge-shaped osteotomy device into the incision, rotate the open wedge-shaped osteotomy device so that the first positioning edge is parallel to the edge of the tibial plateau, move the open wedge-shaped osteotomy device up and down and measure it so that the first positioning edge is parallel to the tibial plateau edge. The distance from a positioning edge to the edge of the tibial plateau is equal to the text callout distance.

2. Move the open wedge osteotomy device back and forth so that the pointing mark points to the highest point of the tibial tubercle.

3. Fine-tune the position of the open wedge-shaped osteotomy device to make the open wedge-shaped osteotomy device fit to the tibia to the best degree.

4. Insert the K-wire into the K-wire guide sleeve, and drill into the tibia with a hand drill or other instruments.

5. Knock the K-wire in the guide hole 3-1 into the guide hole 3-1 until the end of the K-wire is flush with the upper edge of the guide sleeve.

6. Use an electric knife to burn marks on the bone surface through the distraction position marking hole 6 and the angle marking hole 5; or use a bone drill to drill a mark on the bone surface through the distracting position marking hole 6 and the angle marking hole 5.

7. Use an oscillating saw to cut the bone along the guide groove until it passes through the tibia.

8. Pull out the Kirschner wire in the positioning hole 3-2 and remove the open wedge osteotomy device.

9. Use an electric knife to burn (or draw with a bone knife) the connection line between the two opening marks, that is, the opening line.

10. Observe and adjust the shooting angle under the X-ray until the two guiding K-wires are completely coincident under the X-ray.

11. Use the oscillating saw to complete the osteotomy along the guiding K-wire (the K-wire located in the guide hole); observe the front end of the oscillating saw and the tip of the guiding pin flush with the tip of the guide pin under X-ray, that is, the predetermined osteotomy depth is reached.

12. Pull out the guiding Kirschner wire, and insert multiple osteotomy knives into the osteotomy incision to initially open the incision.

13. Pull out the osteotome, insert a distractor at the intersection of the distraction line and the osteotomy incision, and perform distraction.

14. During the opening process, measure the width of the opening at the opening line, which can be measured by the sub-gauge, or can be measured directly by using a spreader with a distance scale.

15. When the width of the opening is close to the stretched distance marked by the text, continue to stretch slowly and measure the lengths of the marked connection lines MP and NP. When the difference between the lengths of MP and NP and the text description is within a predetermined error range, and the stretched distance is the same as the stretched distance marked with the text, the predetermined stretched angle is reached. The predetermined error range should be 1 to 3 mm.

Example 5

The difference between the open wedge osteotomy device and Example 4 is that the geometric relationship is calculated during the design, so that when M, N, and P reach the predetermined opening angle, the lengths of MP and NP are equal.

How to use the open wedge osteotomy device:

Steps 1 to 14 are the same as in Example 4, except that 15. When the opening width is close to the stretched distance marked by the text, continue to stretch slowly, and measure the lengths of the marked connecting lines MP and NP (isosceles triangles). When the difference between the lengths of MP and NP and the text description is within a predetermined error range, and the stretched distance is the same as the stretched distance marked with the text, the predetermined stretched angle is reached. The predetermined error range should be 1 to 3 mm.

Example 6:

The difference between the open wedge-shaped osteotomy device and Example 4 is that the geometric relationship is calculated in the design, so that when M, N, and P reach the predetermined opening angle, the lengths of MP, MN and NP are equal.

How to use the open wedge osteotomy device:

Steps 1 to 14 are the same as in Example 4, except that 15. When the opening width is close to the stretched distance marked by the text, continue to stretch slowly, and measure the lengths of the marked connecting lines MP and NP (for an equilateral triangle). When the difference between the lengths of MP and NP and the text description is within a predetermined error range, and the stretched distance is the same as the stretched distance marked with the text, the predetermined stretched angle is reached. The predetermined error range should be 1 to 3 mm.

Claims (6)

1. an open wedge-shaped osteotomy device, the inner surface of this open wedge-shaped osteotomy device is consistent with the bone surface of the operating area, it is characterized in that this open wedge-shaped osteotomy device is provided with a positioning edge (2), an open wedge-shaped osteotomy device. The outer surface of the bone device is provided with a Kirschner wire guide sleeve, an angle marking hole (5) and two opening position marking holes (6); The number of K-wire guide sleeves is ≥ 3, of which at least two K-wire guide sleeves are guide holes (3-1), and the centerlines of the guide holes (3-1) are in the same plane and are both perpendicular to the virtual axis; At least one Kirschner wire guide sleeve is a positioning hole (3-2), and the positioning hole (3-2) is not on the connecting line of the guide hole (3-1); The two opening position marking holes (6) are respectively located on both sides of the connecting line of the guide hole (3-1), and the connecting line of the two opening position marking holes (6) is perpendicular to the connecting line of the guiding hole (3-1); The number of angle marking holes (5) is greater than or equal to 3, which are not collinear, and are located on both sides of the connecting line of the guide holes (3-1). 2. An open wedge-shaped osteotomy device according to claim 1, characterized in that the number of positioning edges (2) is n, and n≥1; the one closest to the joint among the positioning edges (2) is called the first positioning The first positioning edge is parallel to the edge of the articular surface, and the first positioning edge is 8 to 50 mm away from the edge of the articular surface. 3. An open wedge-shaped osteotomy device according to claim 1, characterized in that the open wedge-shaped osteotomy device is further provided with a side guide groove (4). 4. An open wedge-shaped osteotomy device according to claim 1 or 2, characterized in that the outer surface of the open wedge-shaped osteotomy device is further provided with a pointing mark (7) and/or explanatory text. 5 . The open wedge-shaped osteotomy device according to claim 1 , wherein the inner surface of the open wedge-shaped osteotomy device can be smooth or engraved with shallow patterns for increasing friction. 6 . 6. An open wedge-shaped osteotomy device according to claim 1, characterized in that the Kirschner wire guide sleeve is cylindrical, prismatic, truncated cone or prismatic, and the cross section of the through hole in the Kirschner wire guide sleeve is round or rhombus.