KR100778542B1 - Laminal Spacer in Use for Laminoplasty of Cervical Spine - Google Patents

Abstract

The present invention is composed of bioactive ceramics having the property of combining the middle part with the elastic material and the other part of the joint directly with the bone, so that the middle part can be modified to fit various angles and dimensions while the bone contact part The present invention relates to a laminator spacer for posterior arch surgery.

Laminar spacer 10 for cervical vertebral surgery according to the present invention is disposed in the middle portion and the elastic deformation portion 12 made of a material having excellent elasticity, and the bone (bone) at both ends of the elastic deformation portion 12 And first and second coupling parts 14 and 16, which are made of bioactive ceramics having a property of being directly bonded to each other, and which are combined with the inverted posterior convex surfaces 230a and 230b of the cervical vertebrae. It has a trapezoidal shape.

Posterior arch surgery, cage, spacer, contact area, elastic deformation, bioactivity

Description

Laminal Spacer in Use for Laminoplasty of Cervical Spine}

1A and 1B are explanatory views for explaining a perspective view of a typical vertebra and a central line segmental cervical posterior archplasty, respectively,

Figure 2 is a perspective view showing a laminate spacer for cervical posterior arch surgery according to the present invention,

3A and 3B are perspective views showing a deformation state when a compressive force and a tensile force are applied with an inclination angle with respect to the longitudinal direction of the laminator spacer shown in FIG. 2, respectively;

Figures 4a and 4b is a perspective view showing a deformation state when a compressive force and a tensile force is applied in the longitudinal direction of the laminator spacer shown in Figure 2, respectively,

FIG. 5 is a graph showing a relationship between stress and strain for hydroxyapatite (HA) used as a silicone elastomer and an osteoconductive coupling part used as an elastic deformation part,

Figure 6 is an explanatory diagram for explaining the centerline segmental cervical posterior arch formation using the laminator spacer according to the present invention.

* Explanation of Signs of Major Parts of Drawings *

10: laminator spacer 10a: upper surface

10b, 10c: side 12: elastic deformation portion

14,16 coupling part 18: through hole

20: groove 200: vertebra

210: vertebrae 220: vertebral arch

230a, 230b: Opened incisor surface 240: Plate

250: spinous process 250a, 250b: split spinous process

260: cutting groove 270: cutting line

280: spinal tube 290: longitudinal joint

300: horizontal joint

The present invention relates to a laminate spacer for cervical posterior arch surgery, and in particular, the middle part constitutes a joint made of a material having excellent elasticity, and the other part is composed of bioactive ceramics including hydroxyapatite having the property of directly bonding with bone. The present invention relates to a laminate spacer for cervical posterior arch surgery that can be modified to fit various angles and dimensions, and can be completely joined at the bone contact portion.

Cervical (neck) stenosis, posterior ligamentosclerosis, and spondylotic myelopathy, which are common in elderly men in their 50s and 60s, are associated with paralysis of the arms and legs when the cervical spinal cord is compressed. to be. It is often found in Asians. For the treatment, anterior decompression and fusion are performed, or posterior decompression for Laminoplasty.

However, because the lesion usually progresses through the multi-level, anterior decompression is inadequate for long segmental therapy due to degenerative changes in the adjacent segment or the formation of a joint, leading to the appearance of open door laminoplasty. This method is known to be relatively safe and low incidence of postoperative instability. Posterior arch surgery has been introduced in Japan over the past two decades, and has been recognized as a surgical technique that can relatively safely and effectively depress cervical spinal cord compression.

Cervical posterior arch surgery can be divided into unilateral hinge type, bilateral hinge type, and Z-plastic type according to the method of opening or fixing the posterior arch. The method can be completed by suturing with sutures after opening, but over time the open area may contract and recompress the spinal cord, thus allowing autologous, allogeneic, xenograft grafts or metal cages such as titanium between the open posterior arches. (Cage), complemented by inserting a bioactive ceramic cage or spacer such as hydroxyapatite to ensure fixation.

In addition, the open door laminoplasty has recently been transformed into midline splitting laminoplasty, in which both sides of the lamina are hinged and the spinous processes are in two halves. Divided. Both halves are then rotated outwards so that a strut graft, or laminator spacer, is positioned between the halves to secure the opening.

However, autologous bone graft requires bones from other parts of the patient (usually iliac bone), so complications such as bleeding, pain, and secondary infection in the donor are more likely to occur. It is delayed in the actual clinical practice because of the delayed operation time and much effort. Therefore, as an alternative to autologous bone graft, there are allogeneic bone and xenograft graft, but allogeneic bone graft is a bone graft of another person, and thus donor disease (AIDS, hepatitis, tuberculosis, etc.) can be spread to the transplanter as it is. .

Xenograft transplantation is a method of transplanting bones of non-human animals, and mainly extracts, processes and manufactures calf bones. Recently, due to concerns about mad cow disease and immune reactions in Europe and the United States, it is rarely used in Korea. have.

The method of using a titanium cage is to use a titanium material with high strength and high biocompatibility, and to insert it to stably maintain the space of the extended blame. However, such a titanium cage has a disadvantage in that it is not directly bonded at the cut surface and the incision.

Bioactive ceramics containing hydroxyapatite are artificially synthesized using high-purity purified raw materials, so there is no risk of disease transmission or immune response and mass production is possible. In particular, the bioactive ceramic is spotlighted as a safe bone substitute material because the body is recognized as a component of our body when implanted into the body because it has a property of chemically binding to surrounding tissues without a biological foreign body reaction or an inflammatory reaction. Bioactive ceramics containing hydroxyapatite are processed into various dimensions and shapes to select products suitable for patients.

There are many types of cages or devices for such archoplasty, and Korean Patent Laid-Open Publication No. 2004-0028562 discloses a cage-like member having a general hollow long body having open ends. U.S. Patent Application Publication No. US2004 / 0030388 A1 and Korean Patent Application Publication No. 2005-0016485 include first and second ends and longitudinal axes extending therebetween, wherein the first and second positions of the separated spindle A spacer portion that can be positioned between; And a first weight stabilizing flange adjacent the first end and positioned along at least two of the front, rear, outer, and inner surfaces of the first position of the separated spindle. It describes a plate system for cervical posterior archplasty, characterized in that it comprises a plate engaging portion.

US Patent Publication No. US2003 / 0045935 A1 describes a cage including a concavity and convexity so as to include a space for filling a bone forming material and to prevent slipping at both ends. In addition, U.S. Patent No. 6,572,617 describes a plate having two branches and a groove that is grooved in the plate so as to hold the interval of the centrally inverted bladder and to fix the plate together with the suture. .

U. S. Patent No. 6,080, 157 describes a spacer that can be inserted between an incised bow and an anchor that can hold the spacer as it is. U.S. Patent No. 5,980,572 describes an artificial spinal cord of high biocompatibility, which can open an incision open to expand the spinal cord.

U. S. Patent No. 6,358, 254 describes a device consisting of two stents and two washers, two screws and a cable to separate and fix the inverted spine for spinal canal expansion. When using the device, a pedicle is made in the spine and a screw is then inserted into each cut through the washer and stent to inflate the cut bone. The cable is then attached to each washer and tied around the posterior position of the spine to stabilize the expanded spinal canal and allow the spinal column to recover the expanded spinal canal.

However, all of the cages or devices for archoplasty are hard to deform because the materials themselves exhibit hard characteristics such as metals such as titanium, engineered plastics such as polyetheretherketone (Peek), or hydroxyapatite ceramics. However, according to the size of the skeleton should be provided with a product having a variety of dimensions and angles, and the surface of the product in contact with the incisor of the incisor of the incidence is exactly secured, but it is rare in the actual clinical practice. Therefore, when the degree of fixation of the cage or the device is reduced, there is a problem that the systolic is expanded by the contraction of the expanded spinal canal again, and the inventory burden is a big problem because the manufacturer must have products of various dimensions and angles.

 In order to solve this problem, the cage or device for archoplasty should be easily deformed, but a material having a property of being easily deformed while being directly coupled to bone has not been proposed.

The currently known archoptic cage or device is composed of a non-deformable material.To ensure the stable space of various sizes that occur after the patient's cervical spine is formed, it is necessary to use a cage or device for various angles and dimensions. After the preparation, the patient should be given a trial, etc., to select the product with the closest angle and dimension. However, the probability of complete contact with the bones is very low.

Therefore, the present invention has been devised to overcome the problems of the prior art, the purpose of which is to arrange the elastic deformation portion made of a material having excellent elasticity to act as a joint in the middle portion, and directly to the bone (bone) at both ends of the elastic deformation portion By arranging a pair of osteoconductive joints made of bioactive ceramics having a bonding property, the posterior posterior surface and the posterior posterior surface that are incision can be deformed to correspond to various angles and dimensions when the cervical spine is formed. The present invention provides a laminate spacer for cervical posterior arch surgery that has a contact area and can be completely joined.

Another object of the present invention has an elastic deformation portion in the middle portion of the spacer can be modified to correspond to various angles and dimensions and the posterior arch surface incision during the posterior arch molding of the cervical spine to reduce the time required for the arch molding In addition, to provide a laminate spacer for cervical posterior arch surgery that can reduce the inventory burden of having a product of various dimensions and angles corresponding to the posterior incision surface.

In order to achieve the above object, the present invention is disposed in the middle portion and the elastic deformation portion made of a material having excellent elasticity, respectively connected to both ends of the elastic deformation portion and the first and the inverted posterior surface of the cervical spine is coupled It provides a laminator spacer for the posterior mold surgery of the cervical spine, characterized in that it comprises a second coupling portion.

Preferably, the laminator spacer has a trapezoidal shape or a rectangular parallelepiped shape as a whole, and is formed to correspond to a shape formed between the inverted posterior arch surface of the cervical vertebral body.

In addition, the laminator spacer preferably includes at least one through hole through which the suture passes along the longitudinal direction. In this case, the laminator spacer may include at least one trench-type groove through which the suture passes along the longitudinal direction.

The first and second coupling parts are made of bioactive ceramics having properties capable of directly binding to bone. Bioactive ceramics having a property of directly binding to bones include hydroxyapatite, beta or alpha tricalcium phosphate, calcium phosphate-based ceramics including calcium pyrophosphate, or bioactive glass or crystallization including calcium, silica and phosphorus. It is preferable that it consists of glass.

However, the first and second bonding portions include polyether sulfones, polycarbonates, bioabsorbable polymers, polyaryletherketones, polyetheretherketones, and polymers including carbon fiber reinforced polymers, or titanium, titanium alloys. It may also be made of any one of a metal material, including chromium alloy, cobalt-chromium alloy and stainless steel.

The elastic deformation part is made of, for example, a silicone elastomer or a natural rubber having excellent elastic force that can be deformed by a small external force.

When the lamination spacer of the present invention obtained as described above is used, the intermediate portion is deformed irrespective of the angle of the posterior arch surface, so that the posterior surface and the end surface of the spacer are in direct contact with each other.

As a result, the time required for the posterior arch molding procedure can be reduced, and the contact area with the posterior posterior surface can be widened, resulting in a stable procedure, and the inventory burden for having products of various dimensions and angles corresponding to the posterior posterior incision surface. Can be reduced.

Hereinafter, with reference to the accompanying drawings showing a preferred embodiment of the present invention described above in more detail.

1A and 1B are perspective views illustrating a structure of a typical vertebra and an explanatory view for explaining a centerline segmental cervical posterior archplasty, FIG. 2 is a perspective view showing a laminator spacer for cervical posterior archplasty according to the present invention, FIG. 6 Is an explanatory diagram for explaining the centerline split cervical posterior arch formation using the laminator spacer according to the present invention.

First, with reference to Figures 1a and 1b will be described briefly the centerline cervical posterior archoplasty.

1A is a perspective view showing the structure of a typical vertebra 200. The typical vertebrae 200 include an anterior portion called the spinal body 210 and a posterior portion called the vertebral arch 220, which surrounds the vertebral canal 280. The vertebral arch 220 includes a spinous process 250, which is also articular facet 290 and transverse facet 300 by a laminae 240. Connected to the fields.

There are several posterior surgical methods for creating a wider space in the spinal canal 280. One method of relieving pressure in the spinal cord is midline splitting laminoplasty. In the centerline splitting surgery, as shown in FIG. 1B, hinge coupling is performed according to formation of small incision grooves 260 on both sides of the spindle 240, and the spinous protrusion 250 has a shape of a laminator spacer to be inserted. By cutting along the cutting line 270 in consideration of the divided into two divided spinous processes (250a, 250b).

After the divided spinous processes 250a and 250b are divided and rotated outward, the laminator spacer 10 of the present invention is cut out of the divided spinous processes 250a and 250b as shown in FIG. 6. 230b) to secure the opening. As a result, the laminator spacer 10 maintains a stable interval of the extended vertebra and removes the spinal cord compression of the cervical spine.

Laminar spacer 10 for cervical vertebral surgery according to the present invention is disposed in the middle portion as shown in Figure 2 and the elastic deformation portion 12 made of a material having excellent elasticity, and the elastic deformation portion 12 First and second coupling parts 14 and 16 made of bioactive ceramics having properties capable of directly bonding to bones (bones) at both ends of the body and being coupled to the inverted posterior arch surfaces 230a and 230b of the cervical spine. It includes, and as a whole has a trapezoidal shape.

The laminator spacer 10 has at least one through-hole 18 in the lengthwise direction so that the laminator spacer 10 is easily fixed by using a suture (not shown) when engagement is made with the inverted posterior arch surfaces 230a and 230b of the cervical spine. Is formed, and the trench-type groove 20 is formed in the upper surface 10a.

The elastic deformation part 12 is made of a material such as silicone elastomer or natural rubber having excellent elastic force that can be deformed by a small external force, and has a rectangular plate shape.

In addition, each of the first and second coupling parts 14 and 16 has a right-sided trapezoidal shape in which inner surfaces thereof are connected to both ends of the elastic deformation part 12, respectively. The left / right symmetric trapezoidal hexahedron having a predetermined inclination angle is formed in 10b and 10c). The inclination angle α set between the side surfaces 10b and 10c of the first and second coupling parts 14 and 16 and the reference plane is set to, for example, 66 ° in the steady state.

The first and second coupling parts 14 and 16 are hydroxyapatite (HA, Ca 10 (PO ₄ ) ₆ (OH) ₂ ), beta or alpha tricalcium phosphate, calcium having a property of directly binding to bone. Calcium phosphate ceramics, such as pyrophosphate, or bioactive glass and crystallized glass containing calcium, silica, and phosphorus.

Regardless of the shape and size of the divided spinous processes 250 that are opened when the procedure is performed as shown in FIG. 6 by using the laminator spacer 10 for the posterior arch surgery, the angles of the arch surfaces 230a and 230b are correlated. Without the elastic deformation portion 12 located in the middle is deformed and the cut back surface (230a, 230b) and the laminator spacer 10 both sides (10b, 10c) are in direct contact.

FIG. 5 is a graph illustrating a stress and strain relationship with respect to the silicone elastomer used as the elastic deformation part and the hydroxyapatite (HA) used as the bonding part.

In the lamination spacer 10 of the present invention, as shown in FIG. 5, the silicone elastomer used as the elastic deformation part 12 is deformed to reach 60% of the length even under a stress of 2 MPa or less. It can be seen that the hydroxyapatite ceramics (HA ceramics) used as the bonding portion do not deform at all even when stress is applied.

Meanwhile, FIGS. 3A and 3B are perspective views illustrating a deformation state when a compressive force and a tensile force are applied with an inclination angle with respect to the longitudinal direction of the laminator spacer shown in FIG. 2, respectively. FIGS. 4A and 4B are respectively shown in FIG. 2. It is a perspective view showing a deformation state when a compressive force and a tensile force are applied in the longitudinal direction of the laminator spacer shown.

As shown in FIG. 3A, the laminate spacer 10 according to the present invention has an inclination angle with respect to the longitudinal direction and is compressed upward and is tensioned downward. The inclination angle α formed by the second coupling parts 14 and 16 is changed from 66 ° in a normal state to 72 ° in which 60% deformation occurs, and as shown in FIG. 3B, the inclination angle α is tensioned upward and downward in the longitudinal direction. When compression is applied, the laminate spacer 10 deforms the elastic deformation part 12 so that the inclination angle α of the first and second coupling parts 14 and 16 is 60% at 66 ° in a normal state. It will change to 60 °.

Accordingly, in the laminator spacer 10 according to the present invention, both side surfaces 10b and 10c of the first and second coupling parts 14 and 16 and the reference plane, that is, the inverted posterior arch surfaces 230a and 230b of the cervical vertebral body, respectively. The inclination angle α set in the interval can be adjusted in the range ± 6 °.

In addition, the laminator spacer 10 according to the present invention, when the compressive and tensile force is applied in the longitudinal direction of the laminator spacers, respectively, as shown in Figs. 4a and 4b, the length of 17mm is 60% of the length deformation, that is 15.2 Length shrinkage and expansion can be made in the range from 18.8 mm.

Accordingly, in the laminator spacer 10 according to the present invention, the gap between the side surfaces 10b and 10c of the first and second coupling parts 14 and 16 and the dissected posterior arch surface 230a and 230b of the cervical vertebral body. Length adjustment can be made in the 1.8 mm range.

As a result, in the laminator spacer 10 according to the present invention, deformation may be made in a range of 3.6 mm in the longitudinal direction and 12 ° in the vertical direction, and thus, between the inverted posterior arch surfaces 230a and 230b of the cervical spine, as shown in FIG. 6. When inserted and implanted, deformation can be made to fit various angles and dimensions formed between the incisored posterior arch surfaces 230a and 230b so that a complete contact is made at the bone contact portion.

After the lamination spacer 10 is inserted between the incised posterior arch surfaces 230a and 230b, fixing of the divided spinous protrusions 250a and 250b may include at least one through hole 18 and a trench groove 20. By using the suture can be easily fixed.

In addition, the method of fixing the laminator spacer 10 between the divided spinous processes (250a, 250b) it will be understood that those skilled in the art can use a variety of techniques as needed in addition to the above method.

In this case, in the present invention, for example, the first and second coupling parts 14 and 16 contacting the bones of the incisored posterior arch surfaces 230a and 230b, which have a property of directly binding to bone, include hydroxyapatite. By using bioactive ceramics, they can be permanently bound and internalized.

Meanwhile, in the laminate spacer of the present invention, polymers, ceramics, synthetic materials, and the like may be used instead of bioactive ceramics as the first and second coupling parts 14 and 16 contacting the bones of the inverted posterior arch surfaces 230a and 230b. It may be formed of the same material as the mixture. Examples of suitable polymers include polyether sulfones, polycarbonates, bioabsorbable polymers, polyaryletherketones, polyetheretherketones (Peeks) and carbon fiber reinforced polymers. In addition, the first and second coupling parts 14 and 16 may be formed of a metal material such as titanium, titanium alloy, chromium alloy, cobalt-chromium alloy, and stainless steel (particularly, stainless steel 316L).

As described above, when using a material which cannot be directly bonded to bone as the first and second coupling parts 14 and 16, only the first and second coupling parts 14 and 16 permanently bind to the bone and internalize the body. Except that it can not be, since the middle portion of the laminator spacer is composed of a joint material with excellent elasticity, a stable contact can be made with a wide contact surface at the time of joining the cut back posterior surface (230a, 230b).

When the lamination spacer of the present invention obtained as described above is used, the intermediate portion is deformed irrespective of the angle of the posterior arch surface, so that the posterior surface and the end surface of the spacer are in direct contact with each other.

As a result, in the present invention, it is possible to reduce the time required for the molding of the posterior arch, and the contact area with the posterior arch is widened, thereby making it possible to perform a stable procedure, and to provide products of various dimensions and angles corresponding to the posterior arch incision. Reduce inventory burden.

In the above-described embodiment, the laminator spacers for the formation of the posterior arch of the cervical vertebra are predetermined on both side surfaces 10b and 10c of the first and second coupling portions 14 and 16 so as to be inserted into the inverted triangular spaces between the inverted posterior arch surfaces. The left and right symmetrical trapezoidal shape having an inclination angle of, but the overall shape of the spacer may be changed according to the shape of the space formed between the incised posterior arch surface is determined according to the postoperative arch surgery.

That is, the first and second coupling parts 14 and 16 do not need to have a symmetrical structure so as to form a left / right symmetric trapezoidal shape as a whole. For example, when the shape of the space formed between the incised posterior arch surface is fractured and the patient has a cuboid shape, the laminator spacer may be manufactured into a cuboid shape.

In addition, the present invention can be modified to include a flange portion extending from the upper side to provide a wider contact area for stable engagement between the laminator spacer and the divided spinous process with the incisored posterior surface.

Moreover, in the above embodiment, the present invention has been exemplified to be applied to the posterior arch forming of the cervical vertebral body, but it is also possible to apply to a similar thoracic or lumbar spine by those skilled in the art.

As described above, in the present invention, the middle portion of the lamina spacer laminator is composed of bioactive ceramics including hydroxyapatite having a joint structure made of a material having excellent elasticity and the other portion of the lamination spacer having direct bonding property with bone. It can be modified to fit a variety of angles and dimensions, while complete engagement can be achieved at the bone contacts.

In the above, the present invention has been illustrated and described with reference to specific preferred embodiments, but the present invention is not limited to the above-described embodiments and is not limited to the spirit of the present invention. Various changes and modifications can be made by those who have

Claims (8)

An elastic deformation portion disposed in the middle portion and made of an elastic body, A first and a second coupling part made of bioactive ceramics, which are connected to both ends of the elastic deformation part and have a property of being directly coupled to bone so as to be coupled to the inverted posterior arch surface of the cervical spine. Laminator spacer for the cervical vertebrae. The laminator spacer for cervical vertebral surgery according to claim 1, wherein the laminator spacer has a hexagonal shape having a trapezoidal cross section. The laminator spacer of claim 1 or 2, wherein the laminator spacer includes at least one through hole through which suture passes along the longitudinal direction. 4. The laminator spacer of claim 3, wherein the laminator spacer comprises at least one trench-shaped groove through which suture passes along the longitudinal direction. delete The method of claim 1, wherein the bioactive ceramics are made of hydroxyapatite, beta or alpha tricalcium phosphate, calcium phosphate-based ceramics containing calcium pyrophosphate, or bioactive glass or crystallized glass containing calcium, silica and phosphorus. Laminar spacer for cervical vertebral surgery. An elastic deformation portion disposed in the middle portion and made of an elastic body, Polymers comprising polyether sulfones, polycarbonates, bioabsorbable polymers, polyaryletherketones, polyetheretherketones (Peek) and carbon fiber reinforced polymers, respectively, or titanium, titanium alloys, chromium alloys, cobalt-chromium alloys and Laminar spacer for cervical vertebral surgery, characterized in that it comprises a first and second coupling portion made of any one of a metallic material including stainless steel. The laminator spacer for cervical vertebral surgery according to claim 1 or 7, wherein the elastic deformation portion is made of silicone elastomer or natural rubber.

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