WO2012048481A1

WO2012048481A1 - Internally installed 8-shaped plate for epiphysiodesis and application thereof

Info

Publication number: WO2012048481A1
Application number: PCT/CN2010/078658
Authority: WO
Inventors: 赵黎; 李海; 喻洪流
Original assignee: 上海交通大学医学院附属新华医院
Priority date: 2010-10-15
Filing date: 2010-11-12
Publication date: 2012-04-19
Also published as: CN101966097B; CN101966097A

Abstract

An internally installed 8-shaped steel plate (1) for epiphysiodesis includes two unilateral hole plates (11, 12). The unilateral hole plates (11, 12) respectively have hinged holes (111, 121). A pivot shaft passes through the hinged holes (111,121) to connect the two unilateral hole plates (11, 12). The two unilateral hole plates (11, 12) are assembled into a symmetrical 8-shaped steel plate (1). The hinging means of the two unilateral hole plates (11, 12) of the 8-shaped steel plate (1) avoids the outwardly cutting force generated by the fixing screws for the arc structure of a bone, and maintains the implant position of the steel plate (1) and the effect of epiphysiodesis. The connection part of the unilateral hole plates (11, 12) of the 8-shaped steel plate (1) has enough space i.e. an avoiding pressing angle (17). During implanted, the steel plate (1) is avoided from contacting with the epiphysis, so that the epiphysis is not pressed and the damage is reduced.

Description

A built-in 8-shaped steel plate for bone block and its application

Technical field

The present invention relates to a medical device, and more particularly to a built-in 8-shaped steel plate for treating ankle angulation of adolescent knee joints and an application thereof.

Background technique

Ankle horn deformity in adolescents is a relatively common set of lower extremity dysplasia, which usually includes coronal horns and sagittal horns, both of which can exist simultaneously. Coronal horn deformities mainly include idiopathic knee valgus, Blount disease and other osteophyte diseases as well as trauma and tumor-induced knee valgus. The sagittal angle is generally expressed as the knee joint fixed in the flexion position, which is often secondary to cerebral palsy, spina bifida and other neuromuscular diseases. Ankle horn deformity is clinically characterized by gait abnormalities, knee pain and dysfunction. In severe cases, hip and ankle joint abnormalities can be caused. Most of the conditions can heal in childhood. However, the pathological lower extremity angulation deformity can cause more severe dysfunction, and its treatment is fundamentally different from benign knee valgus.

The angle of the femur and tibia of the lower extremity in children has physiological changes from newborns, children to adolescents. The angle of the femur and tibia at the age of 15° is considered normal. After 18 months, the lower extremity gradually straightened, and then the lower extremity gradually became mild knee eversion due to posture and activity factors. From then on, under the body's own correction, to the mild knee outside the development. Turning is normal, FTA is generally in the range of 4 ° -6 °. The fundamental difference between physiology and pathology is that the correction process of the former is gradual and asymptomatic. Lower extremity deformities in children can be caused by factors such as trauma, infection, genes, tumors, metabolism, or external forces. Unexplained knee valgus was named idiopathic.

Therapies for these diseases have evolved in recent decades. The initial treatment was to perform a femoral or tibial wedge osteotomy after the child's growth and development was completed. This method is now mainly used for the correction of the tarsal closure of the knee joint in adult patients. In 1949, Blount proposed the use of osteophytes to limit the growth of one side of the tarsal plate to correct the imbalance of development on both sides, and created a precedent for the treatment of angular ankle deformity of the knee joint. Since this bone nail is widely used in the treatment of various types of knee deformity, but due to a series of frequent complications, such as bone nail displacement, fracture, etc., the correction effect is not ideal, so it has been a certain clinical application. Limitations, in 1998, Metaizeau et al proposed that the application of osteophyte screws can solve the problem that the nails are easily displaced and easily broken. However, this method directly passes through the seesaw and causes irreversible damage to the seesaw. The application is limited to age close. Adolescents with a mature age of skeletal, so its application is not wide. In China, 8-plate steel is also used in this operation. However, the straight-line 8-shaped steel plate is currently used in China. After being implanted into the body, it will compress the osteophytes and may cause damage.

Chinese patent document CN: 201316311Y, published on September 30, 2009, discloses an orthopedic surgery U-shaped fixing nails. The utility model discloses a u-shaped fixing nail for orthopedic surgery. It consists of two titanium alloy pointed nail legs and a titanium alloy curved connecting piece in the middle. The overall shape is inverted u-shaped for the fixation of the epiphyseal plate and the bone and joint deformity, and the trauma surgery. However, regarding the assemblable 8-shaped steel plate, No reports have been reported yet.

Summary of the invention

SUMMARY OF THE INVENTION An object of the present invention is to provide a bone cement block internal 8-shaped steel plate for the deficiencies in the prior art.

Still another object of the present invention is to provide a use of a built-in 8-shaped steel plate for osteophyte blockage.

In order to achieve the above object, the technical solution adopted by the present invention is as follows: a built-in 8-shaped steel plate with an osteophyte block, comprising two single-sided orifice plates, wherein the single-sided orifice plates are respectively provided with hinge holes, which are hinged by a pivot. The holes are connected to two single-sided orifice plates, and the two single-sided orifice plates can be assembled into a symmetrical 8-shaped steel plate.

The pivot is fixed by means of a screw and a nut.

The pivot is fixed by means of a screw and a snap spring.

The distance from the central hole of the single-sided orifice plate to the pivot hole is 6-10

The distance from the central hole of the single-sided orifice plate to the pivot hole is 6mm 8mm or 10mm

The symmetrical 8-shaped steel plate refers to the same distance from the center hole of the two single-sided orifice plates to the pivot hole.

The distance between the center hole of the two unidirectional orifice plates of the symmetrical 8-shaped steel plate and the pivot hole is 6mm-6mm 8mm-8mm or lOmm-lOmmo respectively

The two single-sided orifice plates each have a notch under the hinge hole, and form a pressure-free angle after the connection.

In order to achieve the above second object, the technical solution adopted by the present invention is: the application of a 8-character steel plate as a medical device in the treatment of an angular deformity of the knee joint.

The advantages of the invention are:

1 8-word steel plate is assembled and equipped with various specifications for various combinations.

The single-sided orifice plate of the 2-8-shaped steel plate adopts the hinge connection form, so that the fixing screw does not have an outward cutting force due to the curved structure of the bone, and the effect of the plate implantation position and the osteophyte block is maintained.

3 The 8 word steel plate has a large enough gap at the joint of the single side orifice plate, that is, the pressure free angle, the steel plate is not in contact with the epiphysis when implanted, and does not cause the osteophyte to compress and reduce the damage.

4. Experimental studies have shown that the 8-shaped steel plate can effectively control the growth of immature osteophytes and bone shape, and is a safe and effective medical device for the operation of the semi-bone block.

DRAWINGS

Figure 1 is a schematic view showing the structure of a 8-shaped steel plate fixed by a screw and a nut. Figure 2 is a schematic view showing the structure of a 8-shaped steel plate fixed by a card slot screw and a snap spring.

Figure 3 is a left side view of the 8-shaped steel plate after assembly.

Figure 4 is a schematic view showing the structure of a symmetrical 8-shaped steel plate of 6 mm to 6 mm.

Figure 5 is a schematic view showing the structure of an asymmetrical 8-shaped steel plate of 6 mm - 8 mm.

Figure 6 is a schematic view showing the structure of an 8-word template of a 8-shaped steel plate surgical tool.

Figure 7 is a schematic view showing the structure of a template clamp of a 8-shaped steel plate surgical tool

Figure 8 is a diagram showing the working state of the formwork clamp of the 8-shaped steel plate surgical tool.

Figure 9 is a schematic view showing the structure of an angle-adjustable dual-aperture guide for a 8-shaped steel plate surgical tool. Figure 10 is a schematic view showing the structure of an angle adjusting device for a 8-shaped steel plate surgical tool.

Figure 11 is a partially enlarged schematic view showing a portion A of Figure 9;

Figure 12 is a view showing the state of use after the 8-shaped steel plate is fixed.

detailed description

The invention is further described below in conjunction with the embodiments.

The specific embodiments provided by the present invention are described in detail below with reference to the accompanying drawings.

The reference numerals and components referred to in the drawings are as follows:

1. 8-word steel plate I I. First single-sided orifice plate

12. Second single-sided orifice plate I I I. First hinge hole

121. Second hinge hole 13. Screw

131. Thread 14. Nut

15. Card slot screw 151. Card slot

16. circlip 17. pressure free angle

112. The first single side orifice notch 122. the second one side orifice notch

2. 8-word template 21. First template orifice

22. Second template orifice plate 221. Positioning pinhole

222. Template groove 23. Template pivot

3. Template clamp 31. Clamp head

311. Head protrusion 32. Clamp handle

4. Angle adjustable double aperture guide 41. Angle adjustment device

411. Angle adjustment knob 4111. Positioning needle channel 412. Scale plate 413. Angle indicator pin

414. Rotary shaft 415. Connecting screw

416. Double aperture guide connection block 417. Fastening bolt

42. Guide sleeve 421. Guide channel

43. Connecting device 44. Positioning pin

5. Osteophytes line 51. One side of the epiphysis line

52. The other side of the epiphysis line

Example 1

8-shaped steel plate fixed by screw and nut

Referring to Figure 1, Figure 1 is a schematic view showing the structure of a 8-shaped steel plate fixed by a screw and a nut. The 8-shaped steel plate 1 includes a first single-sided orifice plate 11, a second single-sided orifice plate 12, a screw 13 and a nut 14. The first-side orifice plate 1 and the single-sided orifice plate 2 are respectively designed first. The hinge hole 111 and the second hinge hole 121. The head of the screw 13 has a thread 131, and the nut 14 has a circular shape. Two single-sided orifice plates are connected by the screw 13 and the nut 14 through the first hinge hole 111 and the second hinge hole 121. When assembling, the first hinge hole 111 and the second hinge hole 121 are coaxial, and the screw 13 is inserted into the screw 13, and the nut 14 is screwed on the thread 131, and the 8-shaped steel plate 1 is assembled.

Example 2

8-shaped steel plate fixed by screw and circlip

Referring to Figure 2, Figure 2 is a schematic view showing the structure of a 8-shaped steel plate fixed by a slotted screw and a snap spring. The 8-shaped steel plate 1 includes a first single-sided orifice plate 11, a second single-sided orifice plate 12, a slotted screw 15 and a snap spring 16, and the first single-sided orifice plate 11 and the second single-sided orifice plate The first hinge hole 111 and the second hinge hole 121 are respectively designed on the 12th. The card slot screw 15 has a card slot 151 at the head. Two single-sided orifice plates are joined by the card slot screw 15 and the retaining spring 16 through the first hinge hole 111 and the second hinge hole 121. When assembling, the first hinge hole 111 and the second hinge hole 121 are coaxial, and the card slot screw 15 is inserted into the card slot 151, and the circlip 16 is mounted on the card slot 151.

It should be noted that the first single-sided orifice plate 11 of the 8-shaped steel plate 1 has a notch below the first hinge hole 111, that is, the first single-sided orifice plate notch 112, and the second single-sided orifice plate 12 is at the second hinge hole. There is also a notch under the 121, that is, the second single-sided orifice notch 122. After the assembly of the 8-shaped steel plate 1, the first single-sided orifice notch 112 and the second single-sided orifice notch 122 together form an arc-shaped gap. That is, the pressure-free angle 17, please refer to Fig. 3. Fig. 3 is a left side view of the assembled 8-shaped steel plate 1. The pressure-free angle 17 allows the 8-shaped steel plate 1 to have a sufficiently large gap in the hinge portion, and the steel plate is not in contact with the epiphysis when implanted, so that the osteophytes are not pressed and the damage is reduced. Example 3

8-shaped steel plate combination of different sizes

The first single-sided orifice plate 11 and the second single-sided orifice plate 12 of the 8-shaped steel plate 1 respectively comprise three different sizes, that is, the distance from the central hole to the pivot hole is respectively 6 8 mm and 10, and the orifice plates can be combined in total. 6 different sizes of 8 word steel plate 1. The doctor selects different pairing combinations among the six combinations according to the actual size of the patient's epiphysis.

(1) Symmetrical 8 word steel plate 6mm-6 combination

Referring to Figure 4, Figure 4 is a schematic view showing the structure of a symmetrical 8-shaped steel plate of 6 mm - 6 _mm . When installing, the second single-sided orifice plate 12 of the first single-sided orifice plates 11 and 6 having a size of 6 is selected and assembled according to the installation method of the first embodiment, and a symmetrical 8-shaped steel plate 6 mm-6 combination can be formed.

( 2 ) Symmetrical 8 word steel plate 8mm-8 combination

During installation, the second single-sided orifice plate 12 of the first single-sided orifice plates 11 and 8 of size 8 is selected and assembled according to the installation method of the first embodiment, and a symmetrical 8-shaped steel plate 8 mm-8 _mm combination can be formed.

(3) Symmetrical 8 word steel plate 10mm- 10 combination

During installation, the first single-sided orifice plates 11 of size 10 and the second single-sided orifice plate 12 of 10 are selected and assembled according to the installation method of the first embodiment, and a symmetrical 8-shaped steel plate lOmm-lOmm combination can be formed.

(4) Asymmetric 8-character steel plate 6mm-8 combination

Referring to FIG. 5, FIG. 5 is a schematic structural view of a combination of asymmetrical 8-shaped steel plates of 6 mm-8 _mm . During installation, the second single-sided orifice plate 12 of the first single-sided orifice plates 11 and 8 having a size of 6 is selected and assembled according to the installation method of the first embodiment, and an asymmetric 8-shaped steel plate 6 mm-8 mm combination can be formed.

(5) Asymmetric 8-character steel plate 6mm-10 combination

During installation, the first single-sided orifice plates 11 and 10 of the first one-side orifice plates 11 and 10 are selected and assembled according to the installation method of the first embodiment, and an asymmetric 8-shaped steel plate 6 mm-10 mm combination can be formed.

(6) Asymmetric 8-character steel plate 8mm-10 combination

During installation, the first single-sided orifice plates 11 of size 8 and the second single-sided orifice plate 12 of the size of 8 are used, and assembled according to the installation method of the first embodiment, and an asymmetric 8-shaped steel plate 8 mm-10 mm combination can be formed.

Example 4

8-word steel surgical tool

The surgical tool with a built-in 8-shaped plate for the osteophyte block is designed according to the size of the 8-character steel plate 1 and the 8-word template 2. A special set of installation tools ensures accurate and rapid implantation of the 8-character steel plate 1 and reduces damage to the patient's epiphysis.

The surgical tool comprises: a 8 word template (Fig. 6), a template clamp (Fig. 7) and an angle adjustable double aperture guide (Fig. 9), the angle adjustable double aperture guide is equipped with an angle adjustment Device (Figure 10).

(1) 8 word template 2

Referring to Figure 6, Figure 6 is a schematic view showing the structure of an 8-word template of a 8-shaped steel plate surgical tool. The 8-shaped template 2 and the 8-shaped steel plate 1 have the same size specifications, and can also be disassembled and assembled, including the first template orifice plate 21, the second template orifice plate 22 and the template pivot 23, and the second template orifice plate 22 has two The positioning pinhole 221 has two template grooves 222 on the clamping surface. The assembly method of the 8-word template 2 is the same as that of the 8-shaped steel plate 1. The matching template can be selected according to the specifications of the 8-shaped steel plate 1 required for surgery to be assembled symmetrically or not. Symmetric template. The first template orifice plate 21 and the second template orifice plate 22 of the 8-word template 2 respectively comprise three different sizes, that is, the distance from the center hole to the pivot hole is 6 mm 8 mm and 10 mm, respectively, and the orifice plates can be combined into a total of 6 8 different templates of different specifications, including symmetrical 8 word template 6mm-6mm combination, symmetrical 8 word template 8mm-8 combination, symmetrical 8 word template 10mm-10 combination, asymmetric 8 word template 6mm_8 combination, asymmetric 8 word template 6mm_10mm combination, asymmetrical 8 word template 8mm_ 10mm combination. The doctor selects different combinations of the six combinations according to the actual size of the patient's epiphysis.

( 2 ) Template clamp 3

Referring to Figure 7, Figure 7 is a schematic view showing the structure of a template clamp of a 8-shaped steel plate surgical tool. As shown, the formwork clamp 3 includes a clamp head 31 and a clamp handle 32, and the end of the clamp head 31 has a head protrusion 311. Referring to Figure 8, Figure 8 is a diagram showing the working state of the template clamp of the 8-shaped steel plate surgical tool. As shown in the figure, the template clamp 3 is just parallel to the jaws of the template head 31 when it is bitten, and its distance is the distance between the two faces of the 8-word template 2 being clamped. The two head projections 311 of the caliper head 31 are placed just above the stencil recess 222 on the two gripped faces of the stencil 2.

(3) Angle adjustable double aperture guide 4

Referring to Figure 9, Figure 9 is a schematic view showing the structure of an angle-adjustable dual-aperture guide for a 8-shaped steel plate surgical tool. The angle-adjustable dual aperture guide 4 includes an angle adjustment device 41, two guide sleeves 42, a connecting device 43 and a positioning pin 44. The two guiding sleeves 42 and the connecting device 43 together form an "II"-shaped structure, and the two guiding sleeves 42 are respectively fixed with an angle adjusting device 41, and the inner portion of the guiding sleeve is hollow to form a guiding hole 421, two The guide holes 421 have different apertures for ease of use in different bore diameters.

To avoid damage to the callus tissue and accurate guiding of the borehole, the design utilizes an adjustment of the angle adjustment device 41 such that the centerline of the locating pin 44 is at a determined angle to the centerline of the borehole. Wherein the angle adjusting device 41 has an angular scale, Can be rotated to the appropriate angle. Referring to Figure 10, Figure 10 is a schematic view showing the structure of an angle adjusting device for a 8-shaped steel plate surgical tool. The angle adjusting device 41 is provided with an angle adjusting knob 411, a scale plate 412 and a rotating shaft 414, which are connected by a connecting screw 415. The angle indicating pin 413 is fixed on the angle adjusting knob 411 by screws, and the connected whole passes through the scale plate 412. The upper four screw holes are fixed to the double aperture guide connection block 416 and are fixed to the guide sleeve 42 of the dual aperture guide by a double aperture guide connection block 416. The fastening bolts 417 can secure the angle adjustment device 41 to the exact position on the guide sleeve 42.

Referring to Figure 11, Figure 11 is a partially enlarged schematic view of a portion of Figure 9; Before the operation, first select the 8-plate 1 and 8 template 2 of the appropriate size according to the degree of distortion on both sides of the patient's epiphysis line. When using, insert the positioning pin 44 on the exposed part of the exposed bone after the surgical incision, through 8 words. The positioning pinhole 221 on the template 2 is placed on the 8-shaped template 2, and the angle required for the punching is adjusted on the angle adjusting device 41, and the guiding sleeve of the guiding device is placed along the positioning pin 44 through the positioning pin channel 4111 on the angle adjusting device 41. The cylinder 42 is drilled through the guiding hole 421 on the guiding sleeve 42 by a special drill bit, and another hole is drilled in the same way, the 8-shaped template 2 is taken out, the 8-shaped steel plate 1 is placed, the screw is fastened, the screwdriver is fastened, and the sewing operation is performed. incision.

Referring to Figure 12, Figure 12 is a view showing the operation state after the 8-shaped steel plate is fixed. It should be noted that the size specification of the 8-shaped steel plate 1 is determined by the degree of distortion of the epiphyseal line side 51 of the epiphyseal line 5 and the other side 52 of the epiphyseal line. In use, the pivot center line of the 8-shaped steel plate 1 and the epiphyseal line 5 are used. Basically in one plane, the 8-shaped steel plate 1 can minimize the repeated surgery caused by the fact that the fixed size cannot adapt to the actual bone condition of different patients, and the pain of the patient can be alleviated.

Example 5

Animal study of 8-word steel plate with semi-bone stagnation

(1) Experimental data and methods:

30 (60 knees) Only 46-week-old New Zealand white rabbits were randomly divided into 2 groups, 15 each. The first group placed a 8-shaped plate into the (periosteal) side of the proximal humerus at both ends of the humerus. As a control, 3 weeks later, X-slices were sacrificed and local animals were sacrificed. The second group was randomly divided into 2 subgroups (A subgroup and B subgroup), 7 (A subgroup) and 8 rabbits (B subgroup). Group), the 8 word plate was placed at the proximal end of the humerus (A subgroup for periosteal implantation; B subgroup for subperiosteal implantation), 3 weeks after taking X tablets, 8 characters were taken out, 6 weeks later Animals were sacrificed after taking X-slices and local pathology was taken. All animals did not need to be braked after the operation.

( 2 ) Results

No local adverse reactions were observed in all rabbits, and there was no significant change in knee joint activity. The first group of X-slices showed the proximal humeral articular surface angle (ALDA) of New Zealand white rabbits, 84° -88° before operation, with an average of 86°. The angle of ALDA decreased to 56° -61 after 3 weeks of implantation of the 8-shaped plate. ° , average 58 ° (P < 0.05). The pathological results showed that the proliferation activity of the growth plate was still present 3 weeks after the 8-word plate implantation.

The second group of subgroup A X-slices showed the proximal humeral articular surface angle (ALDA) of New Zealand white rabbits, 85° -87° before operation, with an average of 85°, and the angle was reduced to 53° after 3 weeks of implantation of the 8-shaped steel plate ALDA. -60°, average 56° (P<0.05). Pathological results showed that the proliferation activity of growth plate cells existed; after 6 weeks, the ALDA angle improved to 65 ° -72 °, with an average of 68 ° (P < 0.05). The pathological results showed that the proliferation of growth plate cells existed.

The second group B subgroup X showed the proximal humeral articular surface angle (ALDA) of New Zealand white rabbits, 84° -89° before operation, with an average of 83°, and the angle was reduced to 42° after 3 weeks of implantation of the 8-character ALDA. -49°, mean 45° (P<0.05), pathological results showed that the proliferation activity of growth plate cells was significantly reduced compared with other groups, and a small amount of bone bridge was formed; after 8 weeks, the angle of ALDA was improved to 48° -54°, average 5Γ (P<0.05), pathological results showed that there was still a bone bridge in the growth plate, and cell proliferation activity existed.

(3) Conclusion

It does not require periosteal dissection when using 8-shaped steel plate. It is easy to operate and does not require braking after operation. It can effectively control the growth of immature osteophytes and bone shape. It is a safe and effective operation for semi-bone block. the way.

Claims

Rights request

The utility model relates to a built-in 8-shaped steel plate with an osteophyte block, which comprises two single-sided orifice plates, wherein the single-sided orifice plate is respectively provided with a hinge hole, and the pivot shaft connects the two single-sided holes through the hinge hole. The two single-sided orifice plates can be assembled into a symmetrical 8-shaped steel plate.

2. The eight-shaped steel plate according to claim 1, wherein the pivot is fixed by a screw and a nut.

3. The eight-shaped steel plate according to claim 1, wherein the pivot is fixed by a screw and a snap spring.

The stencil according to any one of claims 1 to 3, wherein the distance from the central hole of the one-sided orifice to the pivot hole is 6-10.

The eight-shaped steel plate according to claim 4, wherein the distance from the central hole of the one-sided orifice to the pivot hole is 6 mm, 8 mm or 10 mm.

The eight-shaped steel plate according to claim 5, wherein the symmetrical 8-shaped steel plate has the same distance from the center hole of the two single-sided orifice plates to the pivot hole.

The eight-shaped steel plate according to claim 6, wherein the distance between the center hole of the two single-sided orifice plates of the symmetric 8-shaped steel plate and the pivot hole is 6 hidden-6 hidden, 8 hidden-8 hidden or 10mm-10mm.

8. The 8-shaped steel plate according to claim 7, wherein the two single-sided orifice plates each have a notch under the hinge hole, and the pressure-free angle is formed after the connection.

9. Use of a figure 8 steel plate according to any one of claims 1-8 as a medical device for treating an angular deformity of the knee joint.