Patent Application
20130204249
The present invention relates to a medical instrument, specifically to an internal asymmetrically 8-shaped steel plate for temporary hemiepiphysiodesis used in the treatment of teenage knee joint angular deformity and application thereof.
Limb periarticular angular deformity is a common disease of abnormal lower limbs development, generally including coronal plane angular deformity and sagittal plane angular deformity, the two can exist at the same time. The coronal plane angular deformity mainly includes idiopathic genu varum and genu valgum, Blount disease and other epiphyseal diseases, genu varum and genu valgum caused by wound or tumor. The sagittal plane angular deformity generally shows as knee-joint fixed in flexed position, often secondary to brain paralysis, spina bifida and other neuromuscular system diseases. The clinical manifestations of knee joint angular deformity are abnormal gait, knee-joint pain and dysfunction, severe cases can cause hip-joint and ankle anomaly. Most diseases can be self-healing in childhood, however, pathological lower limbs angular deformity can cause more serious dysfunction if not treated in time, the treatments of pathological lower limbs angular deformity and nonmalignant genu varum and genu valgum are fundamentally different. The angle of thighbone and shinbone of the lower limbs in children has been changed from neonates, children to youngsters. The thighbone and shinbone at an angle of 15 degrees is considered as normal in neonatal period. The lower limbs gradually become straight around 18 months, and thereafter appear slight genu valgum because of posture and activity factors. From then on, under the body's own correction, slight genu valgum is a normal phenomenon when the body reaches maturity, FAT is generally in the range of 4 degrees to 6 degrees. The fundamental difference of physiological and pathological is that the correction procedure of the former is progressive and asymptomatic. The children's lower limbs deformity can be caused by wound, infection, gene, tumor, metabolism, outside force factors and so on. The genu varum and genu valgum with unknown etiology is named idiopathic.
In recent decades, the therapeutic methods for these diseases continue to evolve. The initial therapeutic method is that the patient is treated with cuneiform osteotomy orthopedics of thighbone or shinbone when the children's growth and development basically finish. This method is mainly applied for the epiphyseal plate closure or the correction of adult patient's knee joint angular deformity at present. In 1949, Blount has proposed that the correction of the imbalance development on two sides of epiphyseal plate could be carried out using epiphyseal nail to limit the growth of one side of epiphyseal plate, which created the first on treatment of the knee joint angular deformity by half-epiphyseal block method. Since then the epiphyseal nail is widely applied in treatment of kinds of knee-joint angular deformities, but because of a series of frequent complications such as epiphyseal nail shifting and breakage, the corrective effect is dissatisfactory and thus result in being limited in clinical application. In 1998, Metaizeau et al. proposed that the epiphyseal screw could solve the problem of epiphyseal nail easy to shifting and breakage, but this method the screw directly pass though the epiphyseal plate could cause irreversible damage to epiphyseal plate, its application is restricted to youngsters whose age is close to the maturation of bone age, so its application is in a narrow range. The 8-shaped steel plate for temporary hemiepiphysiodesis is also used in domestic correlative surgery, but the present 8-shaped steel plate is straight plate which could oppress epiphysis and bring about injury after implanted in the body.
China Application of publication No. CN 201316311 Y and publication date Sep. 30, 2009 discloses a U-shaped fastening nail for orthopedic surgery. This utility model discloses a U-shaped fastening nail for orthopedic surgery. It consists of two acuminate titanium alloy nail legs and a piece of curve titanium alloy connector, with an inverted U-shaped as a whole; it is applied in the fixation of epiphyseal plate, bone joint deformity and wound surgery. However, the assembling asymmetrically 8-shaped steel plate has not been reported at present.
The purpose of this invention is aimed at overcoming the drawbacks of the prior art and to provide an internal asymmetrically 8-shaped steel plate for temporary hemiepiphysiodesis.
Another purpose of this invention is to provide the use of the internal asymmetrically 8-shaped steel plate for temporary hemiepiphysiodesis.
To achieve the above first purpose, this invention takes the following technical solutions:
An internal asymmetrically 8-shaped steel plate for temporary hemiepiphysiodesis includes two single orifice plates, each said unilateral orifice plate is provided with a hinged opening, the two single orifice plates are connected by passing a pivot through the hinged openings, said two single orifice plates can be assembled into the asymmetrically 8-shaped steel plate.
Said pivot is fixed by a screw and a nut.
Said pivot is fixed by a screw and a clamp spring.
The distant between the centre of the orifice in said unilateral orifice plate and the pivot axis is 6-10 mm.
The distant between the centre of the orifice in said unilateral orifice plate and the pivot axis is 6 mm, 8 mm or 10 mm.
The two distances between the centre of the unilateral orifice and the pivot axis of said one asymmetrically 8-shaped steel plate are different. The two distances between the centre of the unilateral orifice and the pivot axis of said asymmetrically 8-shaped steel plate are 6 mm and 8 mm, or 8 mm and 10 mm, or 6 mm and 10 mm.
There is a gap under each hinged opening of said each unilateral orifice plate, the two gaps could form a non-pressure angle after connecting said two single orifice plates.
To achieve the above second purpose, this invention takes the following technical solutions:
The asymmetrically 8-shaped steel plate is applied as a medical instrument in the disease of knee-joint angular deformity.
The advantages of this invention are:
1. The asymmetrically 8-shaped steel plate is supplied with various specifications and can be provided with various combinations according to the asymmetrically deformity condition on the two sides of patient's physeal line.
2. The unilateral orifice plates of the asymmetrically 8-shaped steel plate are connected together in an articulated way so that the set screw can not bring about an outward cutting force on account of the arc structure of bones, and maintain the steel plate implanted position and the epiphyseal blocking effect.
3. There is a large enough gap under the junction of the two single orifice plates, namely a non-pressure angle, the implanted asymmetrically 8-shaped steel plate couldn't touch the epiphysis and cause epiphyseal oppression to decrease the injuries.
4. As proved by animal experimental researches, the asymmetrically 8-shaped steel plate has an effective control function on the growth and shape of immature epiphysis, and it is a safe and effective medical instrument for half-epiphyseal block surgery.
The embodiments of the invention are further described in detail by combining with figures.
The relevant signs and components of the figures are listed as follows:
The 8-Shaped Steel Plate Fixed by a Screw and a Nut
As shown in
The 8-Shaped Steel Plate Fixed Through a Screw and a Clamp Spring
As shown in
It should be noted that there are a first unilateral orifice plate gap (112) under the first hinged opening (111) of the first unilateral orifice plate (11) and a second unilateral orifice plate gap (122) under the second hinged opening (121) of the second unilateral orifice plate (12). The first unilateral orifice plate gap (112) and the second unilateral orifice plate gap (122) could form an arc-shaped gap after the 8-shaped steel plate (1) is fully assembled, named non-pressure angle (17). As shown in
The 8-Shaped Steel Plate Provided with Different Size Combination
Both the first unilateral orifice plate (11) and the second unilateral orifice plate (12) of the 8-shaped steel plate (1) comprise three kinds of specifications; the distant between the centre of the orifice in said unilateral orifice plate and the pivot axis is 6 mm, 8 mm or 10 mm. These orifice plates can be assembled into six kinds of different 8-shaped steel plates. According to the actual sizes of the two sides of patient's epiphysis, doctors can select different pair-combination from six kinds of combinations.
(1) The symmetrical 8-shaped steel plate, the two distances between the centre of the unilateral orifice and the pivot axis are 6 mm and 6 mm As shown in
(2) The symmetrical 8-shaped steel plate provided, the two distances between the centre of the unilateral orifice and the pivot axis are 8 mm and 8 mm.
The first unilateral orifice plate (11) of 8 mm and the second unilateral orifice plate (12) of 8 mm are selected and connected according to the installation method in example 1, the two single orifice plates can be assembled into the symmetrical 8-shaped steel plate with 8 mm-8 mm combination.
(3) The symmetrical 8-shaped steel plate, the two distances between the centre of the unilateral orifice and the pivot axis are 10 mm and 10 mm. The first unilateral orifice plate (11) of 10 mm and the second unilateral orifice plate (12) of 10 mm are selected and connected according to the installation method in example 1, the two single orifice plates can be assembled into the symmetrical 8-shaped steel plate with 10 mm-10 mm combination.
(4) The asymmetrically 8-shaped steel plate, the two distances between the centre of the unilateral orifice and the pivot axis are 6 mm and 8 mm. As shown in
(5) The asymmetrically 8-shaped steel plate, the two distances between the centre of the unilateral orifice and the pivot axis are 6 mm and 10 mm. The first unilateral orifice plate (11) of 6 mm and the second unilateral orifice plate (12) of 10 mm are selected and connected according to the installation method in example 1, the two single orifice plates can be assembled into the asymmetrically 8-shaped steel plate with 6 mm-10 mm combination.
(6) The asymmetrically 8-shaped steel plate, the two distances between the centre of the unilateral orifice and the pivot axis are 8 mm and 10 mm. The first unilateral orifice plate (11) of 8 mm and the second unilateral orifice plate (12) of 10 mm are selected and connected according to the installation method in example 1, the two single orifice plates can be assembled into the asymmetrically 8-shaped steel plate with 8 mm-10 mm combination.
The Surgical Tools of the 8-Shaped Steel Plate
The surgical tools of the internal 8-shaped steel plate for temporary hemiepiphysiodesis are designed in accordance with the sizes of the 8-shaped steel plate (1) and the 8-shaped template (2), which can ensure the accurate and fast implantation of the 8-shaped steel plate (1) and decrease the injuries for patient's epiphysis.
Said surgical tools include: an 8-shaped template (
(1) 8-Shaped Template (2)
As shown in
(2) Template Clamp (3)
As shown in
(3) Angle Adjustable Double Aperture Guide Apparatus (4)
As shown in
In order to avoid damaging the epiphyseal organization and drill accurately, the design use the angle adjusting device (41) to adjust the angle of the center lines of the locating pin (44) and the drill hole. The angle adjusting device (41) is provided with angle index that is easy to adjust to the appropriate angle. As shown in
As shown in
As shown in
The Animal Research of the 8-Shaped Steel Plate for Hemiepiphysiodesis
Thirty (sixty knees) New Zealand white rabbits of forty-six weeks are randomly divided into two groups on average. For the first group, the 8-shaped steel plate is implanted from extraperiosteal into the two ends of the epiphysis which is located at the proximal shinbone of one knee, and the sham operation of another knee is carried out as control group. Three weeks later, the rabbits are put to death to get the local pathological organization after taking photos under X-ray. The second group is randomly divided into two subgroups with seven rabbits (A-subgroup) and eight rabbits (B-subgroup). The 8-shaped steel plate is implanted into the two ends of the epiphysis which is located at the proximal shinbone (A-subgroup from periosteal outside, B-subgroup from periosteal inside). Three weeks later, all of 8-shaped steel plates are taken out after taking photos under X-ray; six weeks later, all of the rabbits are put to death to get the local pathological organization after again taking photos under X-ray. All of the rabbits are not required braking after operation.
All of the rabbits have not show the local adverse reaction after operation, and the activities of the knee-joints have no obvious change.
The first group: the angles of the articular surface diaphysis (ALDA) of the proximal shinbone of the New Zealand white rabbits are 84-88 degrees under X-ray before operation, an average of 86 degrees, after implanting the 8-shaped steel plates, the values of ALDA are reduced to 56-61 degrees, an average of 58 degrees (P<0.05) in three weeks later. The pathological results show that, after implanting the 8-shaped steel plates, the cell proliferation of the growth plate still exist in three weeks later.
The A-subgroup of the second group: the angles of the articular surface diaphysis (ALDA) of the proximal shinbone of the New Zealand white rabbits are 85-87 degrees under X-ray before operation, an average of 85 degrees, after implanting the 8-shaped steel plates, the values of ALDA are reduced to 53-60 degrees, an average of 56 degrees (P<0.05) in three weeks later. The pathological results show that the cell proliferations of the growth plate still exist. The values of ALDA are improved to 65-72 degrees, an average of 68 degrees (P<0.05) in six weeks later. The pathological results show that the cell proliferations of the growth plate still exist.
The B-subgroup of the second group: the angles of the articular surface diaphysis (ALDA) of the proximal shinbone of the New Zealand white rabbits are 84-89 degrees under X-ray before operation, an average of 83 degrees, after implanting the 8-shaped steel plates, the values of ALDA are reduced to 42-49 degrees, an average of 45 degrees (P<0.05) in three weeks later. The pathological results show that the cell proliferations of the growth plate are obviously less than other organization and a small amount of bone bridge form. The values of ALDA are improved to 48-54 degrees, an average of 51 degrees (P<0.05) in six weeks later. The pathological results show that the bone bridge still form and the cell proliferations of the growth plate exist.
The periosteum does not need to be stripped when implanting the 8-shaped steel plate; the operation is simple and not required braking post operation. The 8-shaped steel plate has an effective control function on the growth and shape of the immature epiphysis; it is a safe and effective operation method for half-epiphyseal block.
| Number | Date | Country | Kind |
|---|---|---|---|
| 201010507530.7 | Oct 2010 | CN | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/CN2010/078660 | 11/12/2010 | WO | 00 | 4/12/2013 |
