WO2012030141A2 - Interspinous process spacer - Google Patents

Interspinous process spacer Download PDF

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Publication number
WO2012030141A2
WO2012030141A2 PCT/KR2011/006408 KR2011006408W WO2012030141A2 WO 2012030141 A2 WO2012030141 A2 WO 2012030141A2 KR 2011006408 W KR2011006408 W KR 2011006408W WO 2012030141 A2 WO2012030141 A2 WO 2012030141A2
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WO
WIPO (PCT)
Prior art keywords
spinous process
main body
spacer
preventing member
departure
Prior art date
Application number
PCT/KR2011/006408
Other languages
French (fr)
Korean (ko)
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WO2012030141A3 (en
Inventor
김경학
김윤혁
김현집
김기정
윤상훈
현승재
Original Assignee
(주)서한케어
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Publication date
Application filed by (주)서한케어 filed Critical (주)서한케어
Publication of WO2012030141A2 publication Critical patent/WO2012030141A2/en
Publication of WO2012030141A3 publication Critical patent/WO2012030141A3/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7062Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
    • A61B17/7065Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7053Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant with parts attached to bones or to each other by flexible wires, straps, sutures or cables
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/38Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs

Definitions

  • the present invention relates to a medical spacer, and more particularly, to a spinous process spacer inserted between the posterior spinous process of the vertebral body and suppressing stenosis between the spinous processes.
  • degenerative lumbar spinal canal stenosis is a phenomenon in which the spinal canal, intervertebral cavity, nerve roots, etc. are narrowed by the degeneration of the lumbar spine.
  • the resulting pressure on the nerves causes pain, numbness and cramps in the lower back, hips, and legs and causes nervous system disorders.
  • intervertebral fusion using an intervertebral insert cage and a posterior pedicle screw as a surgical treatment for the above diseases.
  • This fusion technique often removes or destroys many elements of the spine, such as the lamina and spinous processes, which can lead to structural deformation of the spine and instability of each region.
  • the fusion technique completely restricts the movement of the surgical site, which may cause a problem in that the movement of the adjacent segment is increased to accelerate lumbar degeneration.
  • the spinous process inserting the insertion of a fixing mechanism (a spinal process spacer) between the posterior spinal process of the vertebral body is being performed.
  • the spinous process spacer serves to lift the height of the lumbar segment reduced by the degeneration of the intervertebral disc to the height of the normal lumbar spine. Accordingly, the path through which the nerve bundle passes is no longer narrowed, limiting extension movements and making a slight bend to reduce pain.
  • a spinous process spacer used for spinous process implantation the U-shaped fastener (Interspinous-U) developed by Fixano, France, and St. X STOP, developed by Francis Medical Technologies, has been disclosed.
  • the U-shaped fixation mechanism is so rigid that it completely restricts the temple, which may cause degeneration of other adjacent lumbar segments like fusion.
  • the spinal ligament is removed without removing the spuraspinous ligament and interspinous ligament. ) From the side of the spine.
  • the procedure using the X-STOP one wing is inserted in a separated state and then the separated wing is fastened, so the procedure is inconvenient and the procedure takes a long time.
  • X-STOP is made of a titanium material having strength above bone
  • X-STOP does not absorb the cyclic load of the human body after the procedure, the cyclic load is transferred to the lower node as it is, and the spinous processes are damaged and secondary. May cause a risk of side effects.
  • the present invention has been made in view of the above problems, to facilitate the procedure and to reduce the procedure time, and to increase the decompression effect without interfering with the lumbar segment movement, and to prevent spinous process damage and secondary side effects It is an object of the present invention to provide a spinous process spacer applied to spinous process implantation of a structure that can be made.
  • the present invention in the spinous process spacer inserted between the adjacent spinous process to suppress the stenosis between the spinous process, a spacing part for spacing the spacing between the spinous process at a predetermined interval, and on one side of the spacing part A main body provided with a wing to prevent separation of the separation part, and a predetermined working space formed on the other side of the separation part;
  • the operation space is variably between the first position which is an insertable position and the second position which is a position which prevents the detachment of the main body.
  • the detachment preventing member may include an operation unit to be changed from the first position to the second position by the interference with the spinous process when inserted between the spinous processes.
  • the departure preventing member may include first and second departure preventing members installed in the working space to be rotated in opposite directions when varying from the first position to the second position.
  • the first departure preventing member includes: a first departure preventing part preventing the departure of the main body at the second position; A first interlocking portion interlocked with the second separation preventing member;
  • the first locking part may include a first locking part for locking the first release preventing part at the second position.
  • the second departure preventing member includes: a second departure preventing portion preventing the departure of the main body at the second position; A second interlocking unit interlocked with and interlocked with the first interlocking unit; It may include a second locking portion for locking the second departure preventing portion in the second position.
  • an end portion of at least one of the first release preventing portion and the second release preventing portion is formed to be tapered to facilitate insertion between the spinous processes at the first position.
  • Each of the first interlocking portion and the second interlocking portion may be formed of cog wheels that are meshed with each other.
  • the first locking portion and the second locking portion may be hooked to each other.
  • At least one of the first locking portion and the second locking portion may be hooked, ratcheted or screwed with respect to the main body.
  • the width of the spacer in the transverse spinous process may be tapered to gradually narrow toward the distal end of the spinous process toward the spinal body.
  • the separation portion of the main body is made of a polyether ether ketone (PEEK) material
  • at least one of the wing portion and the separation preventing member of the main body may be made of PEEK material or titanium material.
  • the present invention may further include a bending member formed on the main body and the separation preventing member, the bending member for bending the spinous process through the bending portion at the second position.
  • the bending member may be made of a polyester material.
  • At least one of the spaced apart portion, the wing portion, and the separation preventing member may include a spike portion formed at a portion opposite to the spinous process, thereby increasing the fixing force between the spinous process.
  • a surgical tool insertion hole may be formed in the wing portion of the main body.
  • the wing portion is spaced apart by a predetermined interval in the vertical direction of the wing portion and is formed with first and second insertion holes different in at least one of a shape and a size, so as to misinsert the surgical tool. You can prevent it.
  • the spinous process spacer according to the present invention is applied to a minimal incision that is performed without removing the spinal ligament, thereby minimizing skin incision and removal of biological tissue. Accordingly, there is an advantage that can reduce the surgical recovery time, and alleviate the pain.
  • the present invention has a structure in which the separation prevention member is locked after moving to the separation prevention position by interaction with the spinous process when inserting the spinous process spacer into the dissected spinal ligament, it is easy to perform the procedure and reduce the procedure time There is an advantage that it can.
  • the present invention is composed of a polyether ether ketone (PEEK) material which is a biopolymer that is harmless to the human body, and has a similar elastic modulus as the cortical bone of the human body. It can increase. Accordingly, since the human body load can be dispersed, there is an advantage that the risk of damage to the spinous processes and the risk of secondary side effects can be reduced.
  • PEEK polyether ether ketone
  • the shape of the separation portion is anatomically similar to the shape of the spine, it is possible to prevent the fracture of the spine due to load load by the spacer during the spinous process during the procedure.
  • FIG. 1 is a partial perspective view showing the main portion of the spine and spinous process spacer according to an embodiment of the present invention.
  • Figure 2 is an exploded perspective view showing a spinous process spacer according to a first embodiment of the present invention.
  • 3A and 3B are schematic cross-sectional views showing shapes at first and second positions of the spinous process spacer according to the first embodiment of the present invention.
  • 4A to 4C are schematic views for explaining the operation of the spinous process spacer according to the first embodiment of the present invention.
  • 5 and 6 are a cross-sectional view and a side view showing the main portion of the spinous process spacer according to the second embodiment of the present invention.
  • FIG. 7 is a cross-sectional view showing the spine of the spinous process spacer according to the second embodiment of the present invention in a state where it is treated.
  • FIG 8 is a plan view showing a spinous process spacer according to a third embodiment of the present invention.
  • 9 to 15 are schematic views for explaining various modifications of the locking structure of the spinous process spacer according to the present invention.
  • FIG. 16 is an exploded perspective view showing a spinous process spacer in accordance with a fourth embodiment of the present invention.
  • 17 is a perspective view showing an appearance at a second position of the spinous process spacer according to the fourth embodiment of the present invention.
  • FIG. 18 is a plan view of FIG. 17 illustrating a coupling relationship of spinous process spacers to spinous processes
  • FIG. 19 is a schematic cross-sectional view of a spinous process spacer according to a fourth embodiment of the present invention, illustrating a surgical tool insertion relationship.
  • FIG. 20 is a partial cross-sectional plan view of FIG. 17 illustrating a surgical tool insertion relationship
  • the first and second positions are defined as positions in which the spinous process spacers are arranged as shown in Figs. 3A and 3B, respectively.
  • FIG. 1 is a partial perspective view showing the main portion of the spine and spinous process spacer according to an embodiment of the present invention.
  • the vertebrae 1 includes a Vertebral body 2 consisting of several nodes, spinous processes 3 and 4 protruding rearwardly of the vertebral body 2 and a transverse protrusion 5. Include.
  • the spine (1) has seven kinds of ligaments (Ligament) to connect the spinal nodes, so that each spine has mobility.
  • the ligament includes an interspinous ligament 7 provided between neighboring spinous processes 3.
  • the spinous process spacer 10 cuts the spinal ligament 7 and is inserted into the cutout portion 7a by a side approach insertion method. That is, the spinous process spacer 10 is inserted between neighboring spinous processes 3 and 4 to prevent stenosis between spinous processes 3 and 4.
  • the spinous process spacer 10 of the present invention may be used in a patient whose narrowing of the spinal canal or intervertebral cavity or a hypertrophy of a yellow ligament (Ligamentum flavum) is confirmed by diagnostic equipment such as X-ray or MRI. That is, when bent forward, it can be applied to patients with a limited physical function, which is symptomatic of relief of pain in legs, hips and groin.
  • the spinous process spacer 10 of the present invention is applied to the minimal incision that is performed without removing the interspinous ligament, thereby minimizing skin incision and removal of biological tissue of the patient.
  • FIG. 2 is an exploded perspective view showing the spinous process spacer according to the first embodiment of the present invention
  • Figures 3a and 3b is a view showing the spinous process spacer at each of the first position and the second position according to the first embodiment A schematic cross section.
  • the spinous process spacer 10 is the main body 20 is inserted between the spinous process (3, 4 of Fig. 1), and the main body 20 is installed in the main body 20 of It includes a departure prevention member 30 for preventing the departure.
  • the main body 20 includes a spaced portion 21 spaced apart from two neighboring spinous processes 3 and 4 by a predetermined interval, and a wing portion 25 provided on one side of the spaced portion 21, and the spaced portion 21. On the other side of the predetermined operating space 23 is formed.
  • Spacer 21 is located in the incision portion of the spinal ligament (7 of FIG. 1) after the procedure, to space between the two spinous process (3, 4).
  • Wing portion 25 is formed to protrude in the longitudinal direction (vertical direction) of the spine on one side of the spaced portion 21, to prevent the spaced portion 21 with the separation prevention member 30 after the procedure.
  • the separation preventing member 30 is rotatably installed in the operating space 23 of the main body 20. That is, the separation preventing member 30 is a first position (an separation prevention member position shown in FIG. 3A), which is an insertable position, and a second position (position prevention prevention shown in FIG. 3B), which is a position which prevents the separation of the main body 20. Member positions) are variably provided in the working space 23. In addition, the release preventing member 30 is locked at the second position, thereby preventing the reverse direction from being changed from the second position to the first position.
  • the anti-separation member 30 includes operating portions 31a and 41a which, when inserted between the spinous processes 3 and 4, change from the first position to the second position by interference with the spinous process.
  • the departure prevention member 30 is the first departure prevention member 31 and the second departure prevention member installed in the operating space 23 so as to rotate in conjunction with each other when the variable from the first position to the second position. 41 may be included.
  • the first departure preventing member 31 may include a first release preventing portion 33 which prevents the main body 20 from being separated from the second position, a first interlocking portion 35 interlocked with the second release preventing portion 43, and And a first locking portion 37 for locking the first departure preventing portion 33 in a second position.
  • the second departure preventing member 41 is installed in the working space 23 so as to be symmetrical with respect to the first departure preventing member 31, and the second departure preventing part for preventing the departure of the main body 20 in the second position ( 43), a second interlocking portion 45 which is interlocked with and interlocked with the first interlocking portion 35, and a second locking portion 47 for locking the second departure preventing portion 43 in the second position. .
  • Each of the first and second departure preventing portions 33 and 43 may be tapered as shown in FIG. 3A to facilitate insertion between the spinous processes 3 and 4 at the first position.
  • the fixing pin instead of the screw 27.
  • the screw 27 or the pin may be made of titanium (Titanium) material to function as a marker (marker).
  • the screw 27 or pin may be made of a polyether ether ketone (PEEK) material which is a kind of biopolymer.
  • Each of the first interlocking part 35 and the second interlocking part 45 may be formed of cog wheels that are geared to each other. Therefore, when the actuating parts 31a and 41a of at least one of the first and second departure preventing members 31 and 41 come into contact with the spinous processes 3 and 4, the first and second departure preventing members 31 are separated. 41 are interlocked with each other and rotated in opposite directions to each other. For example, when the spinous process spacer is arranged as shown in FIGS. 3A and 3B, when the actuating part 31a of the first release preventing member 31 is pressed, the first release preventing member 31 is a clock.
  • the rotational force is such that the second departure preventing member 41 is rotated counterclockwise through the first and second interlocking portions (35, 45).
  • the first release preventing member 31 is rotated in the same manner.
  • first locking portion 37 and the second locking portion 47 fix the first release preventing member 31 and the second release preventing member 41 at the second position, respectively, by hooking and ratcheting. Lock with a combination of screws, etc.
  • first detachment preventing member 31 and the second detachment preventing member 41 are shown to be hooked to each other by way of example, a detailed description of the other coupling method will be described later.
  • the first locking portion 37 protrudes and includes a latch 37a formed on one side of the protruding portion.
  • the second locking portion 47 is formed in a concave shape that can accommodate the first locking portion 37, and includes a locking jaw 47a formed at a position corresponding to the clasp 37a. Therefore, when the separation prevention member is moved from the first position to the second position, the latch 37a is automatically caught by the locking jaw 47a at the second position, thereby preventing the first separation prevention member 31 and the second departure prevention member.
  • the member 41 is locked to each other.
  • the spaced portion 21 of the main body 20 may be made of polyether ether ketone (PEEK) material. Since it has a modulus of elasticity similar to that of the human cortical bone, the absorption rate of the repetitive load of the human body may be increased as compared with the production of titanium material. Accordingly, since the human body load can be dispersed, there is an advantage that the risk of damage to the spinous processes and the risk of secondary side effects can be reduced.
  • PEEK polyether ether ketone
  • At least one of the wing portion 25 and the separation preventing member 30 of the main body 20 may be made of a PEEK material or a titanium material.
  • the titanium material is composed of X-rays after the procedure, unlike PEEK, the shape is revealed, so the position of the spacer can be accurately known.
  • 4A to 4C are schematic views for explaining an operation of the spinous process spacer according to the exemplary embodiment of the present invention.
  • a spacer 10 is inserted between neighboring spinous processes 3 and 4 with the first and second departure preventing members 31 and 41 positioned at the first position.
  • the operating portions 31a and 41a come into contact with each of the spinous processes 3 and 4.
  • the first and second separation prevention members 31 and 41 rotate while interlocking with each other.
  • the first and second departure preventing members 31 and 41 are positioned at the second position, the first and second departures are caused by mutual locking between the first and second locking portions 37 and 47.
  • the prevention members 31 and 41 are fixed.
  • the spinous process spacer 10 according to the embodiment of the present invention configured as described above is to be locked to the release prevention member 20 is automatically changed to the release prevention position during the insertion procedure, thereby greatly reducing the operation time There is an advantage that it can.
  • the spinous process spacer 10 may move the spacer 10 to the spinous processes 3 and 4 at the second position (see FIG. 3B). It may further include a bending member 50 for bending. To this end, bending portions 25a, 33a, 43a are formed in each of the wing portion 25 and the separation preventing member 30 of the main body 20, and the bending portions 25a, 33a, 43a are formed. By using the bending member 50 to be bent through, the spacer 10 inserted between the spinous processes 3 and 4 may be bent.
  • the bending member 50 may be made of a polyester material.
  • the unit 60 may further include.
  • the spike portion 60 is formed at a portion facing the spinous process 3 and 4 of at least one of the spacer 21, the wing 25, and the separation preventing member 30.
  • the spike portion 60 may be formed in a sawtooth shape. By forming the spike portion 60 in this way, it is possible to prevent the spacer 10 from flowing between the spinous processes 3 and 4.
  • the first release preventing member 31 and the second release preventing member 41 may be locked by hooking with each other.
  • the first locking portion 237 is formed to protrude, and includes clasps 237a and 237b respectively formed on both sides of the protruding portion.
  • the second locking portion 247 is formed in a concave shape that can accommodate the first locking portion 237, and includes a pair of locking jaws 247a and 247b formed at positions corresponding to the latch 237a. . Accordingly, when the departure prevention member is moved from the first position to the second position, the latch 237 is automatically caught by the locking jaw 247 at the second position, and the first separation prevention member 31 and the second departure prevention member are moved. The member 41 is locked to each other.
  • first departure preventing member 31 and the second departure preventing member 41 may be fixed by a hook coupling to the main body 20, as shown in Figure 10 to 12b.
  • the first and second locking portions 337 and 347 protrude from the respective first and second release preventing wings 31 and 41 in the opposite direction to the inserting direction of the spacer to function as a latch.
  • the main body 20 includes a locking step 313 formed at a position corresponding to each of the first and second locking portions 337 and 347 at the second position. Therefore, when the first and second departure preventing blades 31 and 41 are rotated from the first position to the second position, each of the first and second locking portions 337 and 347 in the second position engages the locking step ( While automatically caught by 313, each of the first release preventing member 31 and the second release preventing member 41 is locked with respect to the main body 20.
  • each of the first and second locking portions 437 and 447 is formed to be elastically deformable on a plate surface of each of the first and second release barriers 31 and 41.
  • Clasps 437a and 447a are formed at the ends of the first and second locking portions 437 and 447.
  • the engaging groove 413 is formed at the position corresponding to each of the first and second locking portions 437 and 447 at the second position in the portion where the operating space of the main body 20 is formed. Therefore, each of the clasps 437a and 447a is automatically caught by the catching groove 413 in the second position, so that each of the first release preventing member 31 and the second release preventing member 41 with respect to the main body 20. Locked.
  • each of the first and second locking portions 537 and 547 is formed to be elastically deformable on the outer circumference of each of the first and second release preventing wings 31 and 41.
  • Clasps 537a and 547a are formed at the ends of the first and second locking portions 537 and 547.
  • the engaging groove 513 is formed in the operating space of the main body 20 at positions corresponding to the first and second locking portions 537 and 547 at the second position. Accordingly, each of the latches 537a and 537b is automatically caught in the locking groove 513 in the second position, so that each of the first release preventing member 31 and the second release preventing member 41 is relative to the main body 20. Locked.
  • first departure preventing member 31 and the second departure preventing member 41 may be fixed by screwing the main body 20, as shown in Figure 13a to 14b.
  • first fastening holes 637 and 647 penetrating the plate surface are formed in each of the first and second departure preventing wings 31 and 41.
  • each of the pair of second fastening holes 613 is formed at a position corresponding to the first fastening holes 637 and 647 in the working space of the main body 20. Therefore, by fastening the second fastening hole 613 and the first fastening hole 637, 647 through the fastening screw 615 in the second position, the first departure preventing member 31 and the second departure preventing member ( 41) each may be locked relative to the body 20.
  • the first release preventing member 31 and the second release preventing member 41 may be fixed to the main body 20 using one fastening screw 715.
  • fastening grooves 737 and 747 through which the fastening screw 715 penetrate the first and second separation preventing members 31 and 41 are formed, respectively.
  • a fastening hole 713 is formed at a position corresponding to the fastening grooves 737 and 747 in the working space of the main body 20. Therefore, through the fastening screw 715 in the second position, it is screwed through the fastening grooves (737, 747). In this case, as the working space is narrowed, the first release preventing member 31 and the second release preventing member 41 may be pressed to lock the main body 20.
  • first departure preventing member 31 and the second departure preventing member 41 may be fixed by a ratchet coupling to the main body 20, as shown in FIG.
  • ratchet teeth 837 and 847 are formed in each of the first and second departure preventing wings 31 and 41.
  • the main body 20 includes a detent 813 formed at a position corresponding to the ratchet teeth 837 and 847 of the working space. Therefore, when the separation prevention member is moved from the first position to the second position, the ratchet teeth 837 and 847 elastically deform the detent 813 to avoid interference, thereby smoothly moving.
  • the detent 813 suppresses reverse rotation of the first and second release preventing members 31 and 41, thereby preventing the first release preventing member 31 and the second release preventing member 41 in the second position. Each can be locked against the body 20.
  • the present invention has a structure in which the release preventing member is locked after moving to the anti-separation position by the interaction with the spinous process when the spacer is inserted into the injured spinal ligament, or by simple screwing.
  • 16 to 20 are views for explaining the spinous process spacer according to the fourth embodiment of the present invention.
  • the spinous process spacer 10 is the main body 120 is inserted between the spinous process (3, 4 of Fig. 1), and the main body 120 is installed in the main body 120 of It includes a departure prevention member 130 for preventing the departure.
  • the main body 120 includes a spacing portion 121 spaced apart from two neighboring spinous processes 3 and 4 by a predetermined interval, and a wing portion 125 provided on one side of the spacing portion 121, and the spacing portion 121.
  • the other side of the predetermined operating space 123 is formed.
  • Spacer 121 is located in the incision portion of the spinal ligament (7 of Figure 1) after the procedure, to space between the two spinous process (13, 4).
  • the spacer 121 may have a shape as shown in FIG. 18. That is, the widths W1 and W2 of the spacing portions in the transverse direction of the spinous process 3 may be tapered to gradually narrow toward the distal direction of the spinous process 3 at the vertebral body 2. That is, the end width W1 of the vertebral body 2 side of the spacing part 121 is formed wider than the end width W2 of the spacing part 121 end side of the spinous process 3. This takes into account that the widthwise direction of the spinous process 3 becomes narrower toward the distal end from the vertebral body 2 side.
  • the load may be evenly distributed to the spine.
  • the wing portion 125 is formed to protrude in the longitudinal direction (vertical direction) of the spine on one side of the spaced portion 121, thereby preventing the spaced portion 121 from being separated along with the separation preventing member 130 after the procedure.
  • the surgical tool insertion hole 172 may be formed in the wing 125.
  • the wing part 125 is a surgical tool insertion hole 172 which is spaced apart by a predetermined interval in the vertical direction of the wing part 125 and has at least one of a shape and a size different from each other. Insertion holes 127a and 127b may be formed. This is to prevent misinsertion of the spinous process spacer 10 mounted on the surgical tool 200.
  • first and second insertion holes 127a and 127b are different from each other.
  • first and second insertion holes 127a and 127b are formed on one side of the wing portion 125, as shown in Fig. 20, in a diagonal direction with respect to the side surface thereof. Can be formed. This is to prevent the spacer 10 from falling off from the surgical tool 200 when the surgical tool 200 is rotated during the procedure through the surgical tool 200 due to restrictions on the operating space.
  • the separation preventing member 130 is rotatably installed in the operating space 123 of the main body 120. That is, the separation preventing member 130 is a first position (an separation prevention member position illustrated in FIG. 19), which is an insertable position, and a second position (position prevention illustrated in FIG. 17), which is a position which prevents separation of the main body 120. Member positions) are variably installed in the working space 123.
  • the departure preventing member 130 is not locked by a separate locking means in the second position, unlike the departure prevention member (30 in Fig. 1) of the spinous process spacer according to the first embodiment, the reverse direction in the second position
  • the change to the first position is prevented by the spinous processes 3 and 4 pressing the operating part 131a.
  • the operation unit 131a allows the separation preventing member 130 to be changed from the first position to the second position by the interference with the spinous processes 3 and 4 during the procedure.
  • the departure prevention member 130 is the first departure prevention member 131 and the second departure prevention member 131 which is installed in the working space 123 to be rotated in the opposite direction when the variable from the first position to the second position. ) May be included.
  • the first departure preventing member 131 includes a first departure preventing part 133 to prevent the main body 120 from being separated from the second position.
  • the second departure preventing member 141 is installed in the working space 123 so as to be symmetrical with respect to the first departure preventing member 131, and the second departure preventing part for preventing the departure of the main body 120 in the second position ( 143).
  • Each of the first and second departure preventing parts 133 and 143 may be tapered as shown in FIGS. 16, 17 and 19 to facilitate insertion between the spinous processes 3 and 4 at the first position. Can be formed.
  • the fastening holes 131b at predetermined positions of the first and second departure preventing members 131 and 141 and the main body 121 corresponding to the rotation centers of the first and second departure preventing members 131 and 141, respectively. , 141b and 123a, and by coupling the pins 129 to the fastening holes 131b, 141b and 123a, respectively, the first and second release preventing members 131 and 141 to the main body 120.
  • the pin 129 may be formed of a titanium material so as to function as a marker. It is also possible to couple the screws instead of the pins 127.
  • the spinous process spacer 110 further includes a bending member (see 50 in FIG. 7) for bending the spacer 110 to the spinous processes 3 and 4 at the second position (FIG. 18). It may include. To this end, bending grooves 125a, 133a, and 143a are formed in each of the wing portions 125 and the separation preventing member 130 of the main body 120, and the bending grooves 125a, 133a, and 143a are formed.
  • the spacer 110 inserted between the spinous processes 3 and 4 may be bent.
  • the bending groove 125a formed in the wing portion 125 is perpendicular to the wing portion 125 as shown in FIG. 19 to secure a space for inserting the bending member 50 during the procedure. It may be formed in a straight line.

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Abstract

Disclosed is an interspinous process spacer to be interposed between the posterior spinous processes of a vertebral body so as to inhibit stenosis among spinous processes. The disclosed interspinous process spacer comprises a main body having a spacing portion to space interspinous processes apart by a predetermined gap, and a blade portion formed at one side of the spacing portion to prevent the separation of the spacing portion, wherein the main body has a predetermined operating space formed at the other side of the spacing portion, and a separation prevention member installed in the operating space such that the separation prevention member is movable between a first location, which is an insertion location, and a second location for preventing the separation of the main body, wherein the separation prevention member prevents the separation of the spacing portion, and is locked at the second location.

Description

극돌기간 스페이서Dolmen Period spacer
본 발명은 의료용 스페이서에 관한 것으로서, 상세하게는 척추체 후방 극돌기 사이에 삽입되어 극돌기 사이의 협착을 억제하는 극돌기간 스페이서에 관한 것이다.The present invention relates to a medical spacer, and more particularly, to a spinous process spacer inserted between the posterior spinous process of the vertebral body and suppressing stenosis between the spinous processes.
일반적으로 퇴행성 요추부 척추관 협착증은 요추부의 퇴행에 의하여 척추관, 추간공, 신경근간 등이 좁아지는 현상이다. 이로 인한 신경의 압박은 허리와 엉덩이 및 다리에 통증과 마비, 경련 등을 유발시키며 신경계 장애를 유발시키게 된다.In general, degenerative lumbar spinal canal stenosis is a phenomenon in which the spinal canal, intervertebral cavity, nerve roots, etc. are narrowed by the degeneration of the lumbar spine. The resulting pressure on the nerves causes pain, numbness and cramps in the lower back, hips, and legs and causes nervous system disorders.
상기한 질환의 수술적 치료방법으로서 추체간 삽입물 케이지와 후방 척추경 나사못을 사용하는 척추체간 융합술(intervertebra fusion)이 있다. 이 융합술은 척추의 여러 요소 예를 들어, 척추판(Lamina)과 극돌기(spinous process)를 제거하거나 파괴하는 경우가 많기 때문에 척추의 구조적 변형과 각 부위의 불안정을 초래할 수 있다. 또한, 이 융합술은 시술부위의 운동을 완전히 제한함으로써, 상대적으로 인접 분절의 운동이 증가되어 요추부 퇴행이 가속화 되는 문제가 발생할 수 있다.There is an intervertebral fusion using an intervertebral insert cage and a posterior pedicle screw as a surgical treatment for the above diseases. This fusion technique often removes or destroys many elements of the spine, such as the lamina and spinous processes, which can lead to structural deformation of the spine and instability of each region. In addition, the fusion technique completely restricts the movement of the surgical site, which may cause a problem in that the movement of the adjacent segment is increased to accelerate lumbar degeneration.
융합술의 문제점을 보완한 새로운 수술방법으로, 척추체 후방 극돌기 사이에 고정기구(극돌기간 스페이서)를 삽입하는 극돌기간 삽입술이 시행되고 있다. 극돌기간 스페이서는 추간판의 퇴행에 의해 감소된 요추분절의 높이를 정상 요추의 높이로 들어 주는 역할을 한다. 이에 따라 신경다발이 지나는 통로가 더 이상 좁아지지 않도록 신전운동을 제한하고, 약간의 굴곡을 만들어 주어 통증을 감소시킨다.As a new surgical method to solve the problem of the fusion technique, the spinous process inserting the insertion of a fixing mechanism (a spinal process spacer) between the posterior spinal process of the vertebral body is being performed. The spinous process spacer serves to lift the height of the lumbar segment reduced by the degeneration of the intervertebral disc to the height of the normal lumbar spine. Accordingly, the path through which the nerve bundle passes is no longer narrowed, limiting extension movements and making a slight bend to reduce pain.
극돌기간 삽입술에 사용되는 극돌기간 스페이서로서, 프랑스의 Fixano(사)에서 개발한 U자형 고정기구(Interspinous-U)와, 미국의 St. Francis Medical Technologies에서 개발한 X STOP(X STOP)이 개시된 바 있다.A spinous process spacer used for spinous process implantation, the U-shaped fastener (Interspinous-U) developed by Fixano, France, and St. X STOP, developed by Francis Medical Technologies, has been disclosed.
한편, U자형 고정기구는 강성이 매우 커서 신전을 완전히 제한하기 때문에 융합술처럼 다른 인접 요추 분절의 퇴행을 야기할 수 있다는 지적이 있다. X-STOP을 이용한 시술의 경우, 척추를 구성하는 인대들 가운데 가시끝 인대(Spuraspinous ligament)와 가시사이 인대(Interspinous Ligament)를 제거하지 않고, 가시사이 인대를 절개한 후 극돌기간 스페이서(X-STOP)를 척추의 측면에서 삽입한다. 이 X-STOP을 이용한 시술시, 한 쪽 날개를 분리한 상태에서 삽입한 후 분리된 날개를 체결하도록 되어 있어서, 시술이 불편하고 시술 시간이 길어지는 단점이 있다. 또한, X-STOP은 뼈 이상의 강도를 가지는 티타늄 소재로 제조되므로, 시술 후 X-STOP이 인체의 반복하중을 흡수하지 못하므로, 반복하중이 그대로 하부 마디로 전달되어, 가시돌기의 손상과 2차 부작용의 위험을 초래할 수 있다.On the other hand, it is pointed out that the U-shaped fixation mechanism is so rigid that it completely restricts the temple, which may cause degeneration of other adjacent lumbar segments like fusion. In the case of the procedure using X-STOP, the spinal ligament is removed without removing the spuraspinous ligament and interspinous ligament. ) From the side of the spine. When the procedure using the X-STOP, one wing is inserted in a separated state and then the separated wing is fastened, so the procedure is inconvenient and the procedure takes a long time. In addition, since X-STOP is made of a titanium material having strength above bone, since X-STOP does not absorb the cyclic load of the human body after the procedure, the cyclic load is transferred to the lower node as it is, and the spinous processes are damaged and secondary. May cause a risk of side effects.
본 발명은 상기한 바와 같은 문제점을 감안하여 안출된 것으로서, 시술이 용이하고 시술시간을 줄일 수 있도록 하며, 요추 분절의 운동을 방해하지 않고 감압효과를 높임과 아울러 가시돌기 손상 및 2차부작용을 방지할 수 있도록 된 구조의 극돌기간 삽입술에 적용되는 극돌기간 스페이서를 제공하는데 그 목적이 있다.The present invention has been made in view of the above problems, to facilitate the procedure and to reduce the procedure time, and to increase the decompression effect without interfering with the lumbar segment movement, and to prevent spinous process damage and secondary side effects It is an object of the present invention to provide a spinous process spacer applied to spinous process implantation of a structure that can be made.
상기한 목적을 달성하기 위하여 본 발명은, 이웃하는 극돌기 사이에 삽입되어, 상기 극돌기 사이의 협착을 억제하는 극돌기간 스페이서에 있어서, 상기 극돌기 사이를 소정 간격 이격시키는 이격부와, 상기 이격부의 일측에 마련되어 상기 이격부의 이탈을 방지하는 날개부를 구비하며, 상기 이격부의 타측에 소정 작동공간이 형성된 본체와; 삽입 가능 위치인 제1위치와 상기 본체의 이탈을 방지하는 위치인 제2위치 사이에서 가변 가능하게 상기 작동공간에 는 이탈방지부재를 포함하는 것을 특징으로 한다.In order to achieve the above object, the present invention, in the spinous process spacer inserted between the adjacent spinous process to suppress the stenosis between the spinous process, a spacing part for spacing the spacing between the spinous process at a predetermined interval, and on one side of the spacing part A main body provided with a wing to prevent separation of the separation part, and a predetermined working space formed on the other side of the separation part; The operation space is variably between the first position which is an insertable position and the second position which is a position which prevents the detachment of the main body.
상기 이탈방지부재는, 상기 극돌기 사이에 삽입시, 상기 극돌기와의 간섭에 의하여 상기 제1위치에서 상기 제2위치로 가변되도록 하는 작동부를 포함할 수 있다.The detachment preventing member may include an operation unit to be changed from the first position to the second position by the interference with the spinous process when inserted between the spinous processes.
또한, 상기 이탈방지부재는, 상기 제1위치에서 상기 제2위치로 가변시, 상호 반대방향으로 회전되도록 상기 작동공간 내에 설치되는 제1 및 제2이탈방지부재를 포함할 수 있다.The departure preventing member may include first and second departure preventing members installed in the working space to be rotated in opposite directions when varying from the first position to the second position.
상기 제1이탈방지부재는, 상기 제2위치에서 상기 본체의 이탈을 방지하는 제1이탈방지부와; 상기 제2이탈방지부재와 연동되는 제1연동부와; 상기 제1이탈방지부를 상기 제2위치에서 록킹하는 제1록킹부를 포함할 수 있다.The first departure preventing member includes: a first departure preventing part preventing the departure of the main body at the second position; A first interlocking portion interlocked with the second separation preventing member; The first locking part may include a first locking part for locking the first release preventing part at the second position.
상기 제2이탈방지부재는, 상기 제2위치에서 상기 본체의 이탈을 방지하는 제2이탈방지부와; 상기 제1연동부와의 사이에 상호 연동 회전되는 제2연동부와; 상기 제2이탈방지부를 상기 제2위치에서 록킹하는 제2록킹부를 포함할 수 있다.The second departure preventing member includes: a second departure preventing portion preventing the departure of the main body at the second position; A second interlocking unit interlocked with and interlocked with the first interlocking unit; It may include a second locking portion for locking the second departure preventing portion in the second position.
여기서, 상기 제1이탈방지부 및 상기 제2이탈방지부 중 적어도 어느 하나의 단부는, 상기 제1위치에서 상기 극돌기 사이에 삽입이 용이하도록 테이퍼지게 형성된다.Here, an end portion of at least one of the first release preventing portion and the second release preventing portion is formed to be tapered to facilitate insertion between the spinous processes at the first position.
상기 제1연동부와 상기 제2연동부 각각은 상호 기어물림되는 톱니바퀴로 이루어질 수 있다.Each of the first interlocking portion and the second interlocking portion may be formed of cog wheels that are meshed with each other.
또한, 상기 제2위치에서, 상기 제1록킹부와 상기 제2록킹부는 상호 후크결합 될 수 있다.In the second position, the first locking portion and the second locking portion may be hooked to each other.
또한, 상기 제2위치에서, 상기 제1록킹부 및 상기 제2록킹부 중 적어도 어느 하나는 상기 본체에 대하여 후크결합, 래칫결합 내지 나사결합 될 수 있다.Further, in the second position, at least one of the first locking portion and the second locking portion may be hooked, ratcheted or screwed with respect to the main body.
상기 극돌기 가로방향으로의 상기 이격부의 폭은, 척추체 쪽에서 상기 극돌기의 말단 방향으로 갈수록 점진적으로 좁아지도록 테이퍼지게 형성될 수 있다.The width of the spacer in the transverse spinous process may be tapered to gradually narrow toward the distal end of the spinous process toward the spinal body.
또한, 상기 본체의 이격부는 폴리에테르에테르케톤(PEEK) 소재로 이루어지고, 상기 본체의 날개부와 상기 이탈방지부재 중 적어도 어느 하나는 PEEK 소재 또는 티타늄 소재로 이루어질 수 있다.In addition, the separation portion of the main body is made of a polyether ether ketone (PEEK) material, at least one of the wing portion and the separation preventing member of the main body may be made of PEEK material or titanium material.
또한, 본 발명은 상기 본체와 상기 이탈방지부재에는 벤딩부가 형성되고, 상기 제2위치에서 상기 벤딩부를 통하여 상기 극돌기에 대해 벤딩하는 벤딩부재를 더 포함할 수 있다. 상기 벤딩부재는, 폴리에스테르(Polyester) 소재로 이루어질 수 있다.In addition, the present invention may further include a bending member formed on the main body and the separation preventing member, the bending member for bending the spinous process through the bending portion at the second position. The bending member may be made of a polyester material.
또한, 상기 이격부, 상기 날개부, 상기 이탈방지부재 중 적어도 어느 하나의 부재는 상기 극돌기와 대향되는 부분에 형성된 스파이크부를 포함하여, 상기 극돌기와의 사이에 고정력을 높일 수 있다.In addition, at least one of the spaced apart portion, the wing portion, and the separation preventing member may include a spike portion formed at a portion opposite to the spinous process, thereby increasing the fixing force between the spinous process.
또한, 상기 본체의 상기 날개부에는 수술도구 삽입공이 형성될 수 있다. 상기 날개부에는 상기 수술도구 삽입공으로서, 상기 날개부의 상하방향으로 소정 간격 이격되게 배치되며 형상 및 크기 중 적어도 어느 하나가 상이한 제1 및 제2삽입공이 형성되어, 상기 수술도구에 대하여 오삽입을 방지할 수 있다.In addition, a surgical tool insertion hole may be formed in the wing portion of the main body. As the surgical tool insertion hole, the wing portion is spaced apart by a predetermined interval in the vertical direction of the wing portion and is formed with first and second insertion holes different in at least one of a shape and a size, so as to misinsert the surgical tool. You can prevent it.
본 발명에 따른 극돌기간 스페이서는 가시사이 인대를 제거하지 않고 시술하는 최소절개술에 적용됨으로써, 환자의 피부절개와 생체조직의 제거를 최소화할 수 있다. 이에 따라 수술회복시간을 줄이고, 통증을 완화할 수 있다는 이점이 있다.The spinous process spacer according to the present invention is applied to a minimal incision that is performed without removing the spinal ligament, thereby minimizing skin incision and removal of biological tissue. Accordingly, there is an advantage that can reduce the surgical recovery time, and alleviate the pain.
또한, 본 발명은 극돌기간 스페이서를 절개된 가시사이 인대에 삽입시 극돌기와의 상호 작용에 의하여 이탈방지부재가 이탈방지 위치로 이동한 후 록킹되는 구조를 가짐으로써, 시술이 용이하고 시술시간을 줄일 수 있다는 이점이 있다.In addition, the present invention has a structure in which the separation prevention member is locked after moving to the separation prevention position by interaction with the spinous process when inserting the spinous process spacer into the dissected spinal ligament, it is easy to perform the procedure and reduce the procedure time There is an advantage that it can.
또한, 본 발명은 본체의 이격부를 인체에 무해한 생체용 폴리머인 폴리에테르에테르케톤(PEEK) 소재로 구성함으로써, 인체 피질골과 유사한 탄성율을 가지므로, 티타늄 소재로 제조시에 비하여 인체의 반복하중 흡수율을 높일 수 있다. 이에 따라 인체 하중을 분산시킬 수 있으므로, 가시돌기의 손상과 2차 부작용의 위험을 저감시킬 수 있다는 이점이 있다.In addition, the present invention is composed of a polyether ether ketone (PEEK) material which is a biopolymer that is harmless to the human body, and has a similar elastic modulus as the cortical bone of the human body. It can increase. Accordingly, since the human body load can be dispersed, there is an advantage that the risk of damage to the spinous processes and the risk of secondary side effects can be reduced.
또한, 이격부의 형상을 해부학적으로 척추 형상과 유사하게 형성함으로써, 시술 후 극돌기간 스페이서에 의한 하중 쏠림에 의한 척추 골절을 방지할 수 있다.In addition, by forming the shape of the separation portion anatomically similar to the shape of the spine, it is possible to prevent the fracture of the spine due to load load by the spacer during the spinous process during the procedure.
또한, 수술도구를 삽입하는 수술도구 삽입공을 형성함에 있어서, 극돌기간 스페이서의 오삽입을 방지함과 아울러, 시술시 수술도구로부터 극돌기간 스페이서가 빠지는 것을 방지할 수 있다.In addition, in forming the surgical tool insertion hole for inserting the surgical tool, it is possible to prevent the misinsertion of the spinous process spacer, and to prevent the release of the spinous process spacer from the surgical tool during the procedure.
도 1은 척추의 요부 및 본 발명의 실시예에 따른 극돌기간 스페이서를 보인 부분사시도.1 is a partial perspective view showing the main portion of the spine and spinous process spacer according to an embodiment of the present invention.
도 2는 본 발명의 제1실시예에 따른 극돌기간 스페이서를 보인 분리사시도.Figure 2 is an exploded perspective view showing a spinous process spacer according to a first embodiment of the present invention.
도 3a 및 도 3b는 본 발명의 제1실시예에 따른 극돌기간 스페이서의 제1위치와 제2위치 각각에서 모습을 보인 개략적인 단면도.3A and 3B are schematic cross-sectional views showing shapes at first and second positions of the spinous process spacer according to the first embodiment of the present invention.
도 4a 내지 도 4c 각각은 본 발명의 제1실시예에 따른 극돌기간 스페이서의 시술 동작을 설명하기 위한 개략적인 도면.4A to 4C are schematic views for explaining the operation of the spinous process spacer according to the first embodiment of the present invention.
도 5 및 도 6 각각은 본 발명의 제2실시예에 따른 극돌기간 스페이서의 요부를 보인 단면도 및 측면도.5 and 6 are a cross-sectional view and a side view showing the main portion of the spinous process spacer according to the second embodiment of the present invention.
도 7은 본 발명의 제2실시예에 따른 극돌기간 스페이서가 시술된 상태의 척추를 보인 단면도.7 is a cross-sectional view showing the spine of the spinous process spacer according to the second embodiment of the present invention in a state where it is treated.
도 8은 본 발명의 제3실시예에 따른 극돌기간 스페이서를 보인 평면도.8 is a plan view showing a spinous process spacer according to a third embodiment of the present invention.
도 9 내지 도 15 각각은 본 발명에 따른 극돌기간 스페이서의 록킹구조의 다양한 변형예를 설명하기 위한 개략적인 도면.9 to 15 are schematic views for explaining various modifications of the locking structure of the spinous process spacer according to the present invention.
도 16은 본 발명의 제4실시예에 따른 극돌기간 스페이서를 보인 분리사시도.16 is an exploded perspective view showing a spinous process spacer in accordance with a fourth embodiment of the present invention;
도 17은 본 발명의 제4실시예에 따른 극돌기간 스페이서의 제2위치에서의모습을 보인 사시도.17 is a perspective view showing an appearance at a second position of the spinous process spacer according to the fourth embodiment of the present invention.
도 18은 도 17의 평면도로서, 극돌기에 대한 극돌기간 스페이서의 결합관계를 설명하기 위한 도면.FIG. 18 is a plan view of FIG. 17 illustrating a coupling relationship of spinous process spacers to spinous processes; FIG.
도 19는 본 발명의 제4실시예에 따른 극돌기간 스페이서의 개략적인 단면도로서, 수술도구 삽입 관계를 설명하기 위한 도면.19 is a schematic cross-sectional view of a spinous process spacer according to a fourth embodiment of the present invention, illustrating a surgical tool insertion relationship.
도 20은 도 17의 부분단면 평면도로서, 수술도구 삽입 관계를 설명하기 위한 도면.20 is a partial cross-sectional plan view of FIG. 17 illustrating a surgical tool insertion relationship;
이하, 첨부된 도면들을 참조하면서 본 발명의 실시예에 따른 극돌기간 스페이서를 상세히 설명하기로 한다. 본 실시예에 있어서, 제1 및 제2위치는 도 3a 및 도 3b 각각에 도시된 바와 같이 극돌기간 스페이서가 배치된 위치로 정의한다.Hereinafter, the spinous process spacer according to the embodiment of the present invention will be described in detail with reference to the accompanying drawings. In this embodiment, the first and second positions are defined as positions in which the spinous process spacers are arranged as shown in Figs. 3A and 3B, respectively.
도 1은 척추의 요부 및 본 발명의 실시예에 따른 극돌기간 스페이서를 보인 부분 사시도이다.1 is a partial perspective view showing the main portion of the spine and spinous process spacer according to an embodiment of the present invention.
도면을 참조하면, 척추(1)는 여러 마디로 이루어진 척추체(Vertebral body; 2)와, 이 척추체(2)의 후방으로 돌출된 극돌기(3, 4) 및 횡방향으로 돌출된 횡돌기(5)를 포함한다. 또한 척추(1)는 일곱 종류의 인대(Ligament)를 가지고 있어서 척추 마디를 연결하고, 각 척추가 운동성을 가지도록 한다. 인대는 이웃하는 극돌기(3) 사이에 마련된 가시사이인대(Interspinous Ligament; 7)를 포함한다.Referring to the drawings, the vertebrae 1 includes a Vertebral body 2 consisting of several nodes, spinous processes 3 and 4 protruding rearwardly of the vertebral body 2 and a transverse protrusion 5. Include. In addition, the spine (1) has seven kinds of ligaments (Ligament) to connect the spinal nodes, so that each spine has mobility. The ligament includes an interspinous ligament 7 provided between neighboring spinous processes 3.
본 발명의 실시예에 따른 극돌기간 스페이서(10)는 가시사이인대(7)를 절개한 후, 그 절개부분(7a)에 측면접근 삽입방식으로 삽입된다. 즉, 극돌기간 스페이서(10)는 이웃하는 극돌기(3, 4) 사이에 삽입되어, 극돌기(3, 4) 사이의 협착을 방지한다.The spinous process spacer 10 according to the embodiment of the present invention cuts the spinal ligament 7 and is inserted into the cutout portion 7a by a side approach insertion method. That is, the spinous process spacer 10 is inserted between neighboring spinous processes 3 and 4 to prevent stenosis between spinous processes 3 and 4.
본 발명의 극돌기간 스페이서(10)는 X-ray, MRI 등의 진단 장비로 척추관 또는 추간공이 좁아지거나, 황색 인대(Ligamentum flavum)의 비대증이 확인된 환자에게 사용될 수 있다. 즉, 앞으로 구부렸을 때, 다리, 엉덩이, 사타구니의 통증이 완화되는 증상을 보이는 신체적 기능이 다소 제한된 환자들에게 적용될 수 있다. 또한, 본 발명의 극돌기간 스페이서(10)는 가시사이 인대를 제거하지 않고 시술하는 최소절개술에 적용됨으로써, 환자의 피부절개와 생체조직의 제거를 최소화할 수 있다. The spinous process spacer 10 of the present invention may be used in a patient whose narrowing of the spinal canal or intervertebral cavity or a hypertrophy of a yellow ligament (Ligamentum flavum) is confirmed by diagnostic equipment such as X-ray or MRI. That is, when bent forward, it can be applied to patients with a limited physical function, which is symptomatic of relief of pain in legs, hips and groin. In addition, the spinous process spacer 10 of the present invention is applied to the minimal incision that is performed without removing the interspinous ligament, thereby minimizing skin incision and removal of biological tissue of the patient.
도 2는 본 발명의 제1실시예에 따른 극돌기간 스페이서를 보인 분리사시도이고, 도 3a 및 도 3b는 제1실시예에 따른 제1위치와 제2위치 각각에서의 극돌기간 스페이서의 모습을 보인 개략적인 단면도이다.2 is an exploded perspective view showing the spinous process spacer according to the first embodiment of the present invention, Figures 3a and 3b is a view showing the spinous process spacer at each of the first position and the second position according to the first embodiment A schematic cross section.
도면들을 참조하면, 제1실시예에 따른 극돌기간 스페이서(10)는 극돌기(도 1의 3, 4) 사이에 삽입되는 본체(20)와, 이 본체(20)에 설치되어 본체(20)의 이탈을 방지하는 이탈방지부재(30)를 포함한다. Referring to the drawings, the spinous process spacer 10 according to the first embodiment is the main body 20 is inserted between the spinous process (3, 4 of Fig. 1), and the main body 20 is installed in the main body 20 of It includes a departure prevention member 30 for preventing the departure.
본체(20)는 이웃하는 두 극돌기(3, 4) 사이를 소정 간격 이격시키는 이격부(21)와, 이격부(21)의 일측에 마련된 날개부(25)를 구비하며, 이격부(21)의 타측에 소정 작동공간(23)이 형성되어 있다. 이격부(21)는 시술 후 가시사이인대(도 1의 7)의 절개된 부분에 위치되어, 두 극돌기(3, 4) 사이를 이격시킨다. 날개부(25)는 이격부(21)의 일측에 척추의 길이방향(종방향)으로 돌출 형성되어, 시술 후 이탈방지부재(30)와 함께 이격부(21)가 이탈되는 것을 방지한다.The main body 20 includes a spaced portion 21 spaced apart from two neighboring spinous processes 3 and 4 by a predetermined interval, and a wing portion 25 provided on one side of the spaced portion 21, and the spaced portion 21. On the other side of the predetermined operating space 23 is formed. Spacer 21 is located in the incision portion of the spinal ligament (7 of FIG. 1) after the procedure, to space between the two spinous process (3, 4). Wing portion 25 is formed to protrude in the longitudinal direction (vertical direction) of the spine on one side of the spaced portion 21, to prevent the spaced portion 21 with the separation prevention member 30 after the procedure.
이탈방지부재(30)는 본체(20)의 작동공간(23)에 회동 가능하게 설치된다. 즉, 이탈방지부재(30)는 삽입 가능 위치인 제1위치(도 3a에 도시된 이탈방지부재 위치)와 본체(20)의 이탈을 방지하는 위치인 제2위치(도 3b에 도시된 이탈방지부재 위치) 사이에서 가변 가능하게 작동공간(23)에 설치된다. 또한, 이탈방지부재(30)는 제2위치에서 록킹되어, 역방향 즉 제2위치에서 제1위치로 가변되는 것을 방지한다. 이탈방지부재(30)는 극돌기(3, 4) 사이에 삽입시, 극돌기와의 간섭에 의하여 제1위치에서 제2위치로 가변되도록 하는 작동부(31a)(41a)를 포함한다. The separation preventing member 30 is rotatably installed in the operating space 23 of the main body 20. That is, the separation preventing member 30 is a first position (an separation prevention member position shown in FIG. 3A), which is an insertable position, and a second position (position prevention prevention shown in FIG. 3B), which is a position which prevents the separation of the main body 20. Member positions) are variably provided in the working space 23. In addition, the release preventing member 30 is locked at the second position, thereby preventing the reverse direction from being changed from the second position to the first position. The anti-separation member 30 includes operating portions 31a and 41a which, when inserted between the spinous processes 3 and 4, change from the first position to the second position by interference with the spinous process.
또한, 이탈방지부재(30)는 제1위치에서 상기 제2위치로 가변시, 상호 연동하여 회전되도록 상기 작동공간(23) 내에 설치되는 제1이탈방지부재(31)와, 제2이탈방지부재(41)를 포함할 수 있다.In addition, the departure prevention member 30 is the first departure prevention member 31 and the second departure prevention member installed in the operating space 23 so as to rotate in conjunction with each other when the variable from the first position to the second position. 41 may be included.
제1이탈방지부재(31)는 제2위치에서 본체(20)의 이탈을 방지하는 제1이탈방지부(33), 제2이탈방지부(43)와 연동되는 제1연동부(35) 및 제1이탈방지부(33)를 제2위치에서 록킹하는 제1록킹부(37)를 포함한다.The first departure preventing member 31 may include a first release preventing portion 33 which prevents the main body 20 from being separated from the second position, a first interlocking portion 35 interlocked with the second release preventing portion 43, and And a first locking portion 37 for locking the first departure preventing portion 33 in a second position.
제2이탈방지부재(41)는 제1이탈방지부재(31)에 대하여 선대칭되도록 작동공간(23)에 설치되는 것으로서, 제2위치에서 본체(20)의 이탈을 방지하는 제2이탈방지부(43), 제1연동부(35)와의 사이에 상호 연동 회전되는 제2연동부(45), 제2이탈방지부(43)를 제2위치에서 록킹하는 제2록킹부(47)를 포함한다.The second departure preventing member 41 is installed in the working space 23 so as to be symmetrical with respect to the first departure preventing member 31, and the second departure preventing part for preventing the departure of the main body 20 in the second position ( 43), a second interlocking portion 45 which is interlocked with and interlocked with the first interlocking portion 35, and a second locking portion 47 for locking the second departure preventing portion 43 in the second position. .
제1 및 제2이탈방지부(33)(43) 각각은 제1위치에서 극돌기(3, 4) 사이에 삽입이 용이하도록 도 3a에 도시된 바와 같이 테이퍼(taper)지게 형성될 수 있다. Each of the first and second departure preventing portions 33 and 43 may be tapered as shown in FIG. 3A to facilitate insertion between the spinous processes 3 and 4 at the first position.
또한, 제1 및 제2이탈방지부재(31)(41) 각각의 회전 중심에 대응되는 제1 및 제2이탈방지부재(31)(41)와 본체(21)의 소정 위치에 체결공(31b, 41b, 23a)을 형성하고, 이 체결공(31b, 41b, 23a)에 스크류(27)를 결합함에 의하여, 제1 및 제2이탈방지부재(31)(41) 각각을 본체(20)에 회전 가능하게 체결할 수 있다. 여기서, 스크류(27)를 대신 고정용 핀을 결합하는 것도 가능하다. 또한, 스크류(27) 또는 핀은 마커(marker) 기능을 할 수 있도록, 티타늄(Titanium) 재질로 구성될 수 있다. 즉, 스크류 내지 핀을 티타늄 소재로 구성하는 경우는 시술 후 X-레이 촬영시 PEEK 소재로 구성한 경우와는 달리 그 형상이 드러나게 된다. 그러므로 스크류 또는 핀의 위치 파악을 통하여 스페이서의 시술위치를 정확하게 알 수 있다. 또한, 스크류(27) 또는 핀은 생체 폴리머의 일종인 폴리에테르에테르케톤(PEEK) 재질로 구성될 수 있다.In addition, the fastening holes 31b at predetermined positions of the first and second departure preventing members 31 and 41 and the main body 21 corresponding to the rotation centers of the first and second departure preventing members 31 and 41, respectively. , 41b and 23a, and by coupling the screw 27 to the fastening holes 31b, 41b and 23a, respectively, the first and second release preventing members 31 and 41 are attached to the main body 20. It can be fastened rotatably. Here, it is also possible to couple the fixing pin instead of the screw 27. In addition, the screw 27 or the pin may be made of titanium (Titanium) material to function as a marker (marker). That is, when the screw to the pin is made of titanium material, the shape is revealed unlike the case where the screw or pin is made of PEEK material during X-ray imaging. Therefore, the position of the spacer can be accurately known through the location of the screw or pin. In addition, the screw 27 or pin may be made of a polyether ether ketone (PEEK) material which is a kind of biopolymer.
제1연동부(35)와 제2연동부(45) 각각은 상호 기어물림되는 톱니바퀴로 이루어 질 수 있다. 따라서 제1 및 제2이탈방지부재(31)(41) 중 적어도 어느 한 날개의 작동부(31a, 41a)가 극돌기(3, 4)에 접촉시, 제1 및 제2이탈방지부재(31)(41)가 상호 연동되어 서로 반대방향으로 회전된다. 예를 들어, 도 3a 및 도 3b에 도시된 바와 같이 극돌기간 스페이서가 배치된 경우, 제1이탈방지부재(31)의 작동부(31a)를 가압시, 제1이탈방지부재(31)는 시계방향으로 회전되며, 그 회전력은 제1 및 제2연동부(35)(45)를 통하여 제2이탈방지부재(41)가 반시계방향으로 회전되도록 한다. 그 역으로 제2이탈방지부재(41)를 가압하는 경우에도 동일 방식으로 제1이탈방지부재(31)가 회전된다. 상기한 바와 같이 제1 및 제2연동부(35)(45)를 통하여 제1 및 제2이탈방지부재(31)(41)의 움직임을 강제함으로써, 시술시 어느 한 날개가 정상적으로 회전하지 않는 문제점을 근본적으로 방지할 수 있다는 이점이 있다. Each of the first interlocking part 35 and the second interlocking part 45 may be formed of cog wheels that are geared to each other. Therefore, when the actuating parts 31a and 41a of at least one of the first and second departure preventing members 31 and 41 come into contact with the spinous processes 3 and 4, the first and second departure preventing members 31 are separated. 41 are interlocked with each other and rotated in opposite directions to each other. For example, when the spinous process spacer is arranged as shown in FIGS. 3A and 3B, when the actuating part 31a of the first release preventing member 31 is pressed, the first release preventing member 31 is a clock. Direction, the rotational force is such that the second departure preventing member 41 is rotated counterclockwise through the first and second interlocking portions (35, 45). On the contrary, even when the second release preventing member 41 is pressed, the first release preventing member 31 is rotated in the same manner. As described above, by forcing the movement of the first and second departure preventing members 31 and 41 through the first and second interlocking portions 35 and 45, any wing does not rotate normally during the procedure. There is an advantage that can be prevented fundamentally.
또한, 제1록킹부(37)와 제2록킹부(47)는 제2위치에서 제1이탈방지부재(31)와 제2이탈방지부재(41) 각각을 고정시키는 것으로서, 후크결합, 래칫결합, 나사결합 등의 결합방식으로 록킹한다. 본 실시예는 제1이탈방지부재(31)와 제2이탈방지부재(41)가 상호 후크결합 된 모습을 예로 나타내었으며, 다른 결합방식에 대한 상세한 설명은 후술하기로 한다.In addition, the first locking portion 37 and the second locking portion 47 fix the first release preventing member 31 and the second release preventing member 41 at the second position, respectively, by hooking and ratcheting. Lock with a combination of screws, etc. In this embodiment, the first detachment preventing member 31 and the second detachment preventing member 41 are shown to be hooked to each other by way of example, a detailed description of the other coupling method will be described later.
도 3a 및 도 3b를 참조하면, 제1록킹부(37)는 돌출 형성되며, 돌출 부분의 일 측편에 형성된 걸쇠(37a)를 포함한다. 제2록킹부(47)는 제1록킹부(37)를 수용할 수 있는 오목 형상으로 형성되며, 걸쇠(37a)에 대응되는 위치에 형성된 걸림턱(47a)을 포함한다. 따라서 제1위치로부터 제2위치로 이탈방지부재를 이동하는 경우, 제2위치에서 걸쇠(37a)가 걸림턱(47a)에 자동적으로 걸리게 되면서, 제1이탈방지부재(31)와 제2이탈방지부재(41)가 상호 록킹된다.3A and 3B, the first locking portion 37 protrudes and includes a latch 37a formed on one side of the protruding portion. The second locking portion 47 is formed in a concave shape that can accommodate the first locking portion 37, and includes a locking jaw 47a formed at a position corresponding to the clasp 37a. Therefore, when the separation prevention member is moved from the first position to the second position, the latch 37a is automatically caught by the locking jaw 47a at the second position, thereby preventing the first separation prevention member 31 and the second departure prevention member. The member 41 is locked to each other.
본체(20)의 이격부(21)는 폴리에테르에테르케톤(PEEK) 소재로 이루어질 수 있다. 이는 인체 피질골과 유사한 탄성율을 가지므로, 티타늄 소재로 제조시에 비하여 인체의 반복하중 흡수율을 높일 수 있다. 이에 따라 인체 하중을 분산시킬 수 있으므로, 가시돌기의 손상과 2차 부작용의 위험을 저감시킬 수 있다는 이점이 있다.The spaced portion 21 of the main body 20 may be made of polyether ether ketone (PEEK) material. Since it has a modulus of elasticity similar to that of the human cortical bone, the absorption rate of the repetitive load of the human body may be increased as compared with the production of titanium material. Accordingly, since the human body load can be dispersed, there is an advantage that the risk of damage to the spinous processes and the risk of secondary side effects can be reduced.
또한, 본체(20)의 날개부(25) 및 이탈방지부재(30) 중 적어도 어느 하나는 PEEK 소재 내지 티타늄 소재로 이루어질 수 있다. 특히, 티타늄 소재로 구성하는 경우는 시술 후 X-레이 촬영시, PEEK와는 달리 그 형상이 드러나게 되므로, 스페이서의 시술위치를 정확하게 알 수 있다.In addition, at least one of the wing portion 25 and the separation preventing member 30 of the main body 20 may be made of a PEEK material or a titanium material. In particular, when the titanium material is composed of X-rays after the procedure, unlike PEEK, the shape is revealed, so the position of the spacer can be accurately known.
도 4a 내지 도 4c 각각은 본 발명의 일 실시예에 따른 극돌기간 스페이서의 시술 동작을 설명하기 위한 개략적인 도면이다.4A to 4C are schematic views for explaining an operation of the spinous process spacer according to the exemplary embodiment of the present invention.
도 4a를 참조하면, 제1위치에 제1 및 제2이탈방지부재(31)(41)를 위치한 상태로 이웃하는 극돌기(3)(4) 사이에 스페이서(10)를 삽입한다. Referring to FIG. 4A, a spacer 10 is inserted between neighboring spinous processes 3 and 4 with the first and second departure preventing members 31 and 41 positioned at the first position.
이후, 도 4b에 도시된 바와 같이, 스페이서(10)가 극돌기(3)(4) 사이로 삽입되는 과정에서, 작동부(31a)(41a)가 극돌기(3)(4) 각각에 접촉되면서, 제1 및 제2이탈방지부재(31)(41)가 상호 연동되면서 회전한다. 다음으로, 제1 및 제2이탈방지부재(31)(41)가 제2위치에 위치되면서, 제1 및 제2록킹부(37)(47) 사이의 상호 록킹에 의하여 제1 및 제2이탈방지부재(31)(41)가 고정된다.Subsequently, as shown in FIG. 4B, in the process of inserting the spacer 10 between the spinous processes 3 and 4, the operating portions 31a and 41a come into contact with each of the spinous processes 3 and 4. The first and second separation prevention members 31 and 41 rotate while interlocking with each other. Next, while the first and second departure preventing members 31 and 41 are positioned at the second position, the first and second departures are caused by mutual locking between the first and second locking portions 37 and 47. The prevention members 31 and 41 are fixed.
이어서, 도 4c에 도시된 바와 같이 이격부(21)의 중앙부분이 극돌기(3)(4) 사이에 위치되도록 하는 것으로, 스페이서(10) 삽입 시술이 완료된다.Subsequently, as shown in FIG. 4C, the center portion of the spacer 21 is positioned between the spinous processes 3 and 4, thereby completing the insertion of the spacer 10.
상기한 바와 같이 구성된 본 발명의 실시예에 따른 극돌기간 스페이서(10)는 삽입 시술하는 과정에서 이탈방지부재(20)가 자동적으로 이탈방지 위치로 가변됨과 아울러 록킹되도록 함으로써, 수술 시간을 크게 단축할 수 있다는 이점이 있다.The spinous process spacer 10 according to the embodiment of the present invention configured as described above is to be locked to the release prevention member 20 is automatically changed to the release prevention position during the insertion procedure, thereby greatly reducing the operation time There is an advantage that it can.
또한, 본 발명의 실시예에 따른 극돌기간 스페이서(10)는, 도 5 내지 도 7에 도시된 바와 같이, 제2위치(도 3b 참조)에서 스페이서(10)를 극돌기(3, 4)에 대해 벤딩하는 벤딩부재(50)를 더 포함할 수 있다. 이를 위하여, 본체(20)의 날개부(25)와 이탈방지부재(30) 각각에 벤딩부(25a)(33a)(43a)가 형성되고, 이 벤딩부(25a)(33a)(43a)를 통하여 벤딩되는 벤딩부재(50)를 이용하여, 극돌기(3, 4) 사이에 삽입된 스페이서(10)를 벤딩할 수 있다. 상기 벤딩부재(50)는 폴리에스테르(Polyester) 소재로 이루어질 수 있다.In addition, as shown in FIGS. 5 to 7, the spinous process spacer 10 according to the embodiment of the present invention may move the spacer 10 to the spinous processes 3 and 4 at the second position (see FIG. 3B). It may further include a bending member 50 for bending. To this end, bending portions 25a, 33a, 43a are formed in each of the wing portion 25 and the separation preventing member 30 of the main body 20, and the bending portions 25a, 33a, 43a are formed. By using the bending member 50 to be bent through, the spacer 10 inserted between the spinous processes 3 and 4 may be bent. The bending member 50 may be made of a polyester material.
또한, 본 발명의 실시예에 따른 극돌기간 스페이서(10)는, 도 8에 도시된 바와 같이, 제2위치(도 3b 참조)에서 극돌기(3, 4)와의 사이에 고정력을 높일 수 있도록 하는 스파이크부(60)를 더 포함할 수 있다.In addition, the spinous process spacer 10 according to the embodiment of the present invention, as shown in Figure 8, spikes to increase the fixing force between the spinous process (3, 4) in the second position (see Figure 3b) The unit 60 may further include.
도 8을 참조하면, 스파이크부(60)는 이격부(21), 날개부(25) 및 이탈방지부재(30) 중 적어도 어느 하나의 상기 극돌기(3, 4)와 대향되는 부분에 형성된다. 이 스파이크부(60)는 톱니 형상으로 형성될 수 있다. 이와 같이 스파이크부(60)를 형성함으로써, 극돌기(3, 4) 사이에서 스페이서(10)가 유동되지 않도록 할 수 있다.Referring to FIG. 8, the spike portion 60 is formed at a portion facing the spinous process 3 and 4 of at least one of the spacer 21, the wing 25, and the separation preventing member 30. The spike portion 60 may be formed in a sawtooth shape. By forming the spike portion 60 in this way, it is possible to prevent the spacer 10 from flowing between the spinous processes 3 and 4.
이하, 도 9 내지 도 15b를 참조하면서, 제1이탈방지부재(31)와 제2이탈방지부재(41) 각각을 고정하는 다양한 실시예를 상세히 살펴보기로 한다.Hereinafter, various embodiments of fixing each of the first departure preventing member 31 and the second departure preventing member 41 will be described in detail with reference to FIGS. 9 to 15B.
도 9를 참조하면, 제1이탈방지부재(31)와 제2이탈방지부재(41)가 상호 후크결합에 의하여 록킹될 수 있다. 이를 위하여, 제1록킹부(237)는 돌출 형성되며, 돌출 부분의 양 측편에 각각 형성된 걸쇠(237a)(237b)를 포함한다. 제2록킹부(247)는 제1록킹부(237)를 수용할 수 있는 오목 형상으로 형성되며, 걸쇠(237a)에 대응되는 위치에 형성된 한 쌍의 걸림턱(247a)(247b)을 포함한다. 따라서 제1위치로부터 제2위치로 이탈방지부재를 이동하는 경우, 제2위치에서 걸쇠(237)가 걸림턱(247)에 자동적으로 걸리게 되면서, 제1이탈방지부재(31)와 제2이탈방지부재(41)가 상호 록킹된다.Referring to FIG. 9, the first release preventing member 31 and the second release preventing member 41 may be locked by hooking with each other. To this end, the first locking portion 237 is formed to protrude, and includes clasps 237a and 237b respectively formed on both sides of the protruding portion. The second locking portion 247 is formed in a concave shape that can accommodate the first locking portion 237, and includes a pair of locking jaws 247a and 247b formed at positions corresponding to the latch 237a. . Accordingly, when the departure prevention member is moved from the first position to the second position, the latch 237 is automatically caught by the locking jaw 247 at the second position, and the first separation prevention member 31 and the second departure prevention member are moved. The member 41 is locked to each other.
또한, 제1이탈방지부재(31)와 제2이탈방지부재(41)는 도 10 내지 도 12b에 도시된 바와 같이, 본체(20)에 대한 후크결합에 의하여 고정될 수 있다.In addition, the first departure preventing member 31 and the second departure preventing member 41 may be fixed by a hook coupling to the main body 20, as shown in Figure 10 to 12b.
도 10을 참조하면, 제1 및 제2록킹부(337)(347)는 제1 및 제2이탈방지날개(31)(41) 각각으로부터 스페이서의 삽입방향과 반대방향으로 돌출 형성되어 걸쇠로서의 기능을 한다. 여기서, 본체(20)에는 제2위치에서 제1 및 제2록킹부(337)(347) 각각에 대응되는 위치에 형성된 걸림턱(313)을 포함한다. 따라서 제1위치로부터 제2위치로 제1 및 제2이탈방지날개(31)(41)를 회전시키는 경우, 제2위치에서 제1 및 제2록킹부(337)(347) 각각이 걸림턱(313)에 자동적으로 걸리게 되면서, 제1이탈방지부재(31)와 제2이탈방지부재(41) 각각이 본체(20)에 대해 록킹된다.Referring to FIG. 10, the first and second locking portions 337 and 347 protrude from the respective first and second release preventing wings 31 and 41 in the opposite direction to the inserting direction of the spacer to function as a latch. Do it. Here, the main body 20 includes a locking step 313 formed at a position corresponding to each of the first and second locking portions 337 and 347 at the second position. Therefore, when the first and second departure preventing blades 31 and 41 are rotated from the first position to the second position, each of the first and second locking portions 337 and 347 in the second position engages the locking step ( While automatically caught by 313, each of the first release preventing member 31 and the second release preventing member 41 is locked with respect to the main body 20.
도 11a 및 도 11b를 참조하면, 제1 및 제2록킹부(437)(447) 각각은 제1 및 제2이탈방재날개(31)(41) 각각의 판면에 탄성 변형 가능하게 형성된다. 이 제1 및 제2록킹부(437)(447)의 단부에는 걸쇠(437a)(447a)가 형성된다. 여기서, 본체(20)의 작동공간이 형성된 부분에는 걸림홈(413)이 제2위치에서 제1 및 제2록킹부(437)(447) 각각에 대응되는 위치에 형성된다. 따라서 제2위치에서 걸쇠(437a)(447a) 각각이 걸림홈(413)에 자동적으로 걸리게 되면서, 제1이탈방지부재(31)와 제2이탈방지부재(41) 각각이 본체(20)에 대해 록킹된다.11A and 11B, each of the first and second locking portions 437 and 447 is formed to be elastically deformable on a plate surface of each of the first and second release barriers 31 and 41. Clasps 437a and 447a are formed at the ends of the first and second locking portions 437 and 447. Here, the engaging groove 413 is formed at the position corresponding to each of the first and second locking portions 437 and 447 at the second position in the portion where the operating space of the main body 20 is formed. Therefore, each of the clasps 437a and 447a is automatically caught by the catching groove 413 in the second position, so that each of the first release preventing member 31 and the second release preventing member 41 with respect to the main body 20. Locked.
도 12a 및 도 12b를 참조하면, 제1 및 제2록킹부(537)(547) 각각은 제1 및 제2이탈방지날개(31)(41) 각각의 외주연에 탄성 변형 가능하게 형성된다. 이 제1 및 제2록킹부(537)(547)의 단부에는 걸쇠(537a)(547a)가 형성된다. 여기서, 본체(20)의 작동공간에는 걸림홈(513)이 제2위치에서 제1 및 제2록킹부(537)(547) 각각에 대응되는 위치에 형성된다. 따라서 제2위치에서 걸쇠(537a)(537b) 각각이 걸림홈(513)에 자동적으로 걸리게 되면서, 제1이탈방지부재(31)와 제2이탈방지부재(41) 각각이 본체(20)에 대해 록킹된다.12A and 12B, each of the first and second locking portions 537 and 547 is formed to be elastically deformable on the outer circumference of each of the first and second release preventing wings 31 and 41. Clasps 537a and 547a are formed at the ends of the first and second locking portions 537 and 547. Here, the engaging groove 513 is formed in the operating space of the main body 20 at positions corresponding to the first and second locking portions 537 and 547 at the second position. Accordingly, each of the latches 537a and 537b is automatically caught in the locking groove 513 in the second position, so that each of the first release preventing member 31 and the second release preventing member 41 is relative to the main body 20. Locked.
또한, 제1이탈방지부재(31)와 제2이탈방지부재(41)는 도 13a 내지 도 14b에 도시된 바와 같이, 본체(20)에 대한 나사결합에 의하여 고정될 수 있다.In addition, the first departure preventing member 31 and the second departure preventing member 41 may be fixed by screwing the main body 20, as shown in Figure 13a to 14b.
도 13a 및 도 13b를 참조하면, 제1 및 제2이탈방지날개(31)(41) 각각에는 판면을 관통하는 제1체결공(637)(647)이 형성된다. 또한, 본체(20)의 작동공간에는 한 쌍의 제2체결공(613) 각각이 제1체결공(637)(647)에 대응되는 위치에 형성된다. 따라서 제2위치에서 체결나사(615)를 통하여, 제2체결공(613)과 제1체결공(637)(647)을 체결함으로써, 제1이탈방지부재(31)와 제2이탈방지부재(41) 각각이 본체(20)에 대해 록킹되도록 할 수 있다.13A and 13B, first fastening holes 637 and 647 penetrating the plate surface are formed in each of the first and second departure preventing wings 31 and 41. In addition, each of the pair of second fastening holes 613 is formed at a position corresponding to the first fastening holes 637 and 647 in the working space of the main body 20. Therefore, by fastening the second fastening hole 613 and the first fastening hole 637, 647 through the fastening screw 615 in the second position, the first departure preventing member 31 and the second departure preventing member ( 41) each may be locked relative to the body 20. FIG.
도 14a 및 도 14b를 참조하면, 제1이탈방지부재(31)와 제2이탈방지부재(41)는 하나의 체결나사(715)를 이용하여 본체(20)에 대한 결합고정될 수 있다. 이를 위하여, 제1 및 제2이탈방지부재(31)(41) 각각에는 체결나사(715)가 관통하는 체결홈(737)(747)이 형성된다. 또한, 본체(20)의 작동공간에는 체결공(713)이 체결홈(737)(747)에 대응되는 위치에 형성된다. 따라서 제2위치에서 체결나사(715)를 통하여, 체결홈(737)(747)을 관통하여 나사결합한다. 이 경우, 작동공간이 좁아지게되면서 제1이탈방지부재(31)와 제2이탈방지부재(41)를 가압하여, 본체(20)에 대해 록킹되도록 할 수 있다.14A and 14B, the first release preventing member 31 and the second release preventing member 41 may be fixed to the main body 20 using one fastening screw 715. To this end, fastening grooves 737 and 747 through which the fastening screw 715 penetrate the first and second separation preventing members 31 and 41 are formed, respectively. In addition, a fastening hole 713 is formed at a position corresponding to the fastening grooves 737 and 747 in the working space of the main body 20. Therefore, through the fastening screw 715 in the second position, it is screwed through the fastening grooves (737, 747). In this case, as the working space is narrowed, the first release preventing member 31 and the second release preventing member 41 may be pressed to lock the main body 20.
또한, 제1이탈방지부재(31)와 제2이탈방지부재(41)는 도 15에 도시된 바와 같이, 본체(20)에 대한 래칫(ratchet) 결합에 의하여 고정될 수 있다.In addition, the first departure preventing member 31 and the second departure preventing member 41 may be fixed by a ratchet coupling to the main body 20, as shown in FIG.
도 15를 참조하면, 제1 및 제2이탈방지날개(31)(41) 각각에는 래칫 치형(837)(847)이 형성된다. 본체(20)는 작동공간의 래칫 치형(837)(847)에 대응되는 위치에 형성된 멈춤쇠(813)를 포함한다. 따라서 제1위치로부터 제2위치로 이탈방지부재를 이동하는 경우는 래칫 치형(837)(847)이 멈춤쇠(813)를 탄성변형시키면서 간섭을 회피하므로, 원활이 이동하게 된다. 반면, 멈춤쇠(813)는 제1 및 제2이탈방지부재(31)(41)의 역회전을 억제함으로써, 제2위치에서 제1이탈방지부재(31)와 제2이탈방지부재(41) 각각이 본체(20)에 대해 록킹되도록 할 수 있다.Referring to FIG. 15, ratchet teeth 837 and 847 are formed in each of the first and second departure preventing wings 31 and 41. The main body 20 includes a detent 813 formed at a position corresponding to the ratchet teeth 837 and 847 of the working space. Therefore, when the separation prevention member is moved from the first position to the second position, the ratchet teeth 837 and 847 elastically deform the detent 813 to avoid interference, thereby smoothly moving. On the other hand, the detent 813 suppresses reverse rotation of the first and second release preventing members 31 and 41, thereby preventing the first release preventing member 31 and the second release preventing member 41 in the second position. Each can be locked against the body 20.
상기한 바와 같이, 본 발명은 극돌기간 스페이서를 절개된 가시사이 인대에 삽입시 극돌기와의 상호 작용에 의하여 이탈방지부재가 이탈방지 위치로 이동한 후 록킹되는 구조를 가지거나, 단순한 나사결합에 의하여 록킹되는 구조를 가짐으로써, 시술이 용이하고 시술시간을 줄일 수 있다는 이점이 있다.As described above, the present invention has a structure in which the release preventing member is locked after moving to the anti-separation position by the interaction with the spinous process when the spacer is inserted into the injured spinal ligament, or by simple screwing. By having a structure that is locked, there is an advantage that the procedure is easy and the procedure time can be reduced.
도 16 내지 도 20 각각은 본 발명의 제4실시예에 따른 극돌기간 스페이서를 설명하기 위한 도면이다.16 to 20 are views for explaining the spinous process spacer according to the fourth embodiment of the present invention.
도면들을 참조하면, 제4실시예에 따른 극돌기간 스페이서(10)는 극돌기(도 1의 3, 4) 사이에 삽입되는 본체(120)와, 이 본체(120)에 설치되어 본체(120)의 이탈을 방지하는 이탈방지부재(130)를 포함한다. Referring to the drawings, the spinous process spacer 10 according to the fourth embodiment is the main body 120 is inserted between the spinous process (3, 4 of Fig. 1), and the main body 120 is installed in the main body 120 of It includes a departure prevention member 130 for preventing the departure.
본체(120)는 이웃하는 두 극돌기(3, 4) 사이를 소정 간격 이격시키는 이격부(121)와, 이격부(121)의 일측에 마련된 날개부(125)를 구비하며, 이격부(121)의 타측에 소정 작동공간(123)이 형성되어 있다. 이격부(121)는 시술 후 가시사이인대(도 1의 7)의 절개된 부분에 위치되어, 두 극돌기(13, 4) 사이를 이격시킨다. The main body 120 includes a spacing portion 121 spaced apart from two neighboring spinous processes 3 and 4 by a predetermined interval, and a wing portion 125 provided on one side of the spacing portion 121, and the spacing portion 121. The other side of the predetermined operating space 123 is formed. Spacer 121 is located in the incision portion of the spinal ligament (7 of Figure 1) after the procedure, to space between the two spinous process (13, 4).
여기서, 이격부(121)는 도 18에 도시된 바와 같은 형상을 가질 수 있다. 즉, 극돌기(3) 가로방향으로의 이격부의 폭(W1, W2)은 척추체(2) 쪽에서 극돌기(3)의 말단 방향으로 갈수록 점진적으로 좁아지도록 테이퍼지게 형성될 수 있다. 즉, 이격부(121)의 척추체(2) 쪽 단부 폭 W1이 극돌기(3) 말단 쪽 이격부(121)의 단부 폭 W2에 비하여 넓게 형성된다. 이는 극돌기(3)의 폭방향 크기가 척추체(2) 쪽에서 말단으로 갈수록 좁아지는 점을 고려한 것이다.Here, the spacer 121 may have a shape as shown in FIG. 18. That is, the widths W1 and W2 of the spacing portions in the transverse direction of the spinous process 3 may be tapered to gradually narrow toward the distal direction of the spinous process 3 at the vertebral body 2. That is, the end width W1 of the vertebral body 2 side of the spacing part 121 is formed wider than the end width W2 of the spacing part 121 end side of the spinous process 3. This takes into account that the widthwise direction of the spinous process 3 becomes narrower toward the distal end from the vertebral body 2 side.
이와 같이, 이격부(121)를 형성하는 경우, 해부학적으로 척추 형상과 유사한 디자인을 가짐으로써, 척추에 하중이 골고루 분산되도록 할 수 있다.As such, in the case of forming the spaced portion 121, by having an anatomically similar design to the shape of the spine, the load may be evenly distributed to the spine.
날개부(125)는 이격부(121)의 일측에 척추의 길이방향(종방향)으로 돌출 형성되어, 시술 후 이탈방지부재(130)와 함께 이격부(121)가 이탈되는 것을 방지한다. 극돌기간 스페이서를 수술도구(도 19의 200)에 장착하기 위한 방편으로서, 날개부(125)에는 수술도구 삽입공(172)이 형성될 수 있다.The wing portion 125 is formed to protrude in the longitudinal direction (vertical direction) of the spine on one side of the spaced portion 121, thereby preventing the spaced portion 121 from being separated along with the separation preventing member 130 after the procedure. As a means for attaching the spinous process spacer to the surgical tool (200 of FIG. 19), the surgical tool insertion hole 172 may be formed in the wing 125.
도 19를 참조하면, 날개부(125)에는 수술도구 삽입공(172)으로서, 날개부(125)의 상하방향으로 소정 간격 이격되게 배치되며 형상 및 크기 중 적어도 어느 하나가 상이한 제1 및 제2삽입공(127a)(127b)이 형성될 수 있다. 이는 수술도구(200)에 장착되는 극돌기간 스페이서(10)의 오삽입을 방지하기 위한 것이다.Referring to FIG. 19, the wing part 125 is a surgical tool insertion hole 172 which is spaced apart by a predetermined interval in the vertical direction of the wing part 125 and has at least one of a shape and a size different from each other. Insertion holes 127a and 127b may be formed. This is to prevent misinsertion of the spinous process spacer 10 mounted on the surgical tool 200.
도 19는 제1삽입공(127a)과 제2삽입공(127b)의 직경이 다른 것을 예로 들어 나타내었으나, 이는 예시적인 것에 불과한 것으로서 제1 및 제2삽입공(127a)(127b)의 형상이나 깊이를 달리하는 것도 가능하다.또한, 제1 및 제2삽입공(127a)(127b)을 날개부(125)의 일측에 형성시, 도20에 도시된 바와 같이, 그 측면에 대해 사선 방향으로 형성될 수 있다. 이는 수술도구(200)를 통하여 시술시에 있어서, 수술공간 상의 제약 등의 이유로 수술도구(200)가 회동시, 극돌기간 스페이서(10)가 수술도구(200)에서 빠지는 것을 방지하기 위함이다.19 illustrates that the diameters of the first insertion hole 127a and the second insertion hole 127b are different from each other. However, this is merely illustrative, and the shapes of the first and second insertion holes 127a and 127b may be different. It is also possible to vary the depth. Further, when the first and second insertion holes 127a and 127b are formed on one side of the wing portion 125, as shown in Fig. 20, in a diagonal direction with respect to the side surface thereof. Can be formed. This is to prevent the spacer 10 from falling off from the surgical tool 200 when the surgical tool 200 is rotated during the procedure through the surgical tool 200 due to restrictions on the operating space.
이탈방지부재(130)는 본체(120)의 작동공간(123)에 회동 가능하게 설치된다. 즉, 이탈방지부재(130)는 삽입 가능 위치인 제1위치(도 19에 도시된 이탈방지부재 위치)와 본체(120)의 이탈을 방지하는 위치인 제2위치(도 17에 도시된 이탈방지부재 위치) 사이에서 가변 가능하게 작동공간(123)에 설치된다. 여기서, 이탈방지부재(130)는 제1실시예에 따른 극돌기간 스페이서의 이탈방지부재(도 1의 30)와는 달리 제2위치에서 별도의 록킹 수단에 의하여 록킹되지 않으며, 역방향 즉 제2위치에서 제1위치로 가변은 극돌기(3, 4)가 작동부(131a)를 가압함에 의하여 방지된다. 작동부(131a)는 시술시, 이탈방지부재(130)가 극돌기(3, 4)와의 간섭에 의하여 제1위치에서 제2위치로 가변되도록 한다.The separation preventing member 130 is rotatably installed in the operating space 123 of the main body 120. That is, the separation preventing member 130 is a first position (an separation prevention member position illustrated in FIG. 19), which is an insertable position, and a second position (position prevention illustrated in FIG. 17), which is a position which prevents separation of the main body 120. Member positions) are variably installed in the working space 123. Here, the departure preventing member 130 is not locked by a separate locking means in the second position, unlike the departure prevention member (30 in Fig. 1) of the spinous process spacer according to the first embodiment, the reverse direction in the second position The change to the first position is prevented by the spinous processes 3 and 4 pressing the operating part 131a. The operation unit 131a allows the separation preventing member 130 to be changed from the first position to the second position by the interference with the spinous processes 3 and 4 during the procedure.
또한, 이탈방지부재(130)는 제1위치에서 제2위치로 가변시 상호 반대방향으로 회전되도록 작동공간(123) 내에 설치되는 제1이탈방지부재(131)와, 제2이탈방지부재(141)를 포함할 수 있다. 제1이탈방지부재(131)는 제2위치에서 본체(120)의 이탈을 방지하는 제1이탈방지부(133)를 포함한다.In addition, the departure prevention member 130 is the first departure prevention member 131 and the second departure prevention member 131 which is installed in the working space 123 to be rotated in the opposite direction when the variable from the first position to the second position. ) May be included. The first departure preventing member 131 includes a first departure preventing part 133 to prevent the main body 120 from being separated from the second position.
제2이탈방지부재(141)는 제1이탈방지부재(131)에 대하여 선대칭되도록 작동공간(123)에 설치되는 것으로서, 제2위치에서 본체(120)의 이탈을 방지하는 제2이탈방지부(143)를 포함한다.The second departure preventing member 141 is installed in the working space 123 so as to be symmetrical with respect to the first departure preventing member 131, and the second departure preventing part for preventing the departure of the main body 120 in the second position ( 143).
제1 및 제2이탈방지부(133)(143) 각각은 제1위치에서 극돌기(3, 4) 사이에 삽입이 용이하도록 도 16, 도 17 및 도 19에 도시된 바와 같이 테이퍼(taper)지게 형성될 수 있다. Each of the first and second departure preventing parts 133 and 143 may be tapered as shown in FIGS. 16, 17 and 19 to facilitate insertion between the spinous processes 3 and 4 at the first position. Can be formed.
또한, 제1 및 제2이탈방지부재(131)(141) 각각의 회전 중심에 대응되는 제1 및 제2이탈방지부재(131)(141)와 본체(121)의 소정 위치에 체결공(131b, 141b, 123a)을 형성하고, 이 체결공(131b, 141b, 123a)에 핀(129)을 결합함에 의하여, 제1 및 제2이탈방지부재(131)(141) 각각을 본체(120)에 회전 가능하게 체결할 수 있다. 여기서, 핀(129)는 마커(1marker) 기능을 할 수 있도록, 티타늄(Titanium) 재질로 구성될 수 있다. 또한, 핀(127) 대신 스크류를 결합하는 것도 가능하다.In addition, the fastening holes 131b at predetermined positions of the first and second departure preventing members 131 and 141 and the main body 121 corresponding to the rotation centers of the first and second departure preventing members 131 and 141, respectively. , 141b and 123a, and by coupling the pins 129 to the fastening holes 131b, 141b and 123a, respectively, the first and second release preventing members 131 and 141 to the main body 120. It can be fastened rotatably. In this case, the pin 129 may be formed of a titanium material so as to function as a marker. It is also possible to couple the screws instead of the pins 127.
또한, 본 발명의 실시예에 따른 극돌기간 스페이서(110)는 제2위치(도 18 )에서 스페이서(110)를 극돌기(3, 4)에 대해 벤딩하는 벤딩부재(도 7의 50 참조)를 더 포함할 수 있다. 이를 위하여, 본체(120)의 날개부(125)와 이탈방지부재(130) 각각에는 벤딩홈(125a)(133a)(143a)가 형성되고, 이 벤딩홈(125a)(133a)(143a)를 통하여 벤딩되는 벤딩부재(50)를 이용하여, 극돌기(3, 4) 사이에 삽입된 스페이서(110)를 벤딩할 수 있다. 여기서, 날개부(125)에 형성되는 벤딩홈(125a)은 시술 시, 벤딩부재(50)를 삽입하기 위한 공간을 확보하기 위하여, 도 19에 도시된 바와 같이 날개부(125)에 수직방향으로 직선 상으로 형성될 수 있다.In addition, the spinous process spacer 110 according to the embodiment of the present invention further includes a bending member (see 50 in FIG. 7) for bending the spacer 110 to the spinous processes 3 and 4 at the second position (FIG. 18). It may include. To this end, bending grooves 125a, 133a, and 143a are formed in each of the wing portions 125 and the separation preventing member 130 of the main body 120, and the bending grooves 125a, 133a, and 143a are formed. By using the bending member 50 to be bent through, the spacer 110 inserted between the spinous processes 3 and 4 may be bent. Here, the bending groove 125a formed in the wing portion 125 is perpendicular to the wing portion 125 as shown in FIG. 19 to secure a space for inserting the bending member 50 during the procedure. It may be formed in a straight line.
상기한 바와 같이, 이격부의 형상을 해부학적으로 척추 형상과 유사하게 형성함으로써, 시술 후 극돌기간 스페이서에 의한 하중 쏠림에 의한 척추 골절을 방지할 수 있다.As described above, by forming the shape of the separation portion anatomically similar to the shape of the spine, it is possible to prevent the fracture of the spine due to load pull by the spacer during the spinous process during the procedure.
또한, 수술도구를 삽입하는 수술도구 삽입공을 형성함에 있어서, 극돌기간 스페이서의 오삽입을 방지함과 아울러, 시술시 수술도구로부터 극돌기간 스페이서가 빠지는 것을 방지할 수 있다는 이점이 있다.In addition, in forming the surgical tool insertion hole for inserting the surgical tool, there is an advantage that can prevent the insertion of the spinous process spacers, and also prevent the fallout spacer from the surgical tools during the procedure.
상기한 실시예들은 예시적인 것에 불과한 것으로, 당해 기술분야의 통상을 지식을 가진 자라면 이로부터 다양한 변형 및 균등한 타 실시예가 가능하다. 따라서, 본 발명의 진정한 기술적 보호범위는 하기의 특허청구범위에 기재된 발명의 기술적 사상에 의해 정해져야만 할 것이다.The above embodiments are merely exemplary, and various modifications and equivalent other embodiments are possible to those skilled in the art. Therefore, the true technical protection scope of the present invention will be defined by the technical spirit of the invention described in the claims below.

Claims (16)

  1. 이웃하는 극돌기 사이에 삽입되어, 상기 극돌기 사이의 협착을 억제하는 극돌기간 스페이서에 있어서,In the spinous process spacer inserted between neighboring spinous processes to suppress stenosis between the spinous processes,
    상기 극돌기 사이를 소정 간격 이격시키는 이격부와, 상기 이격부의 일측에 마련되어 상기 이격부의 이탈을 방지하는 날개부를 구비하며, 상기 이격부의 타측에 소정 작동공간이 형성된 본체와;A main body having a spacing portion spaced apart from the spinous process by a predetermined interval, and a wing portion provided on one side of the spacing portion to prevent separation of the spacing portion, and a predetermined working space formed on the other side of the spacing portion;
    삽입 가능 위치인 제1위치와 상기 본체의 이탈을 방지하는 위치인 제2위치 사이에서 가변 가능하게 상기 작동공간에 는 이탈방지부재를 포함하는 것을 특징으로 하는 극돌기간 스페이서.And a release preventing member in the operating space variably between a first position which is an insertable position and a second position which is a position which prevents the departure of the main body.
  2. 제1항에 있어서, The method of claim 1,
    상기 이탈방지부재는, The separation preventing member,
    상기 극돌기 사이에 삽입시, 상기 극돌기와의 간섭에 의하여 상기 제1위치에서 상기 제2위치로 가변되도록 하는 작동부를 포함하는 것을 특징으로 하는 극돌기간 스페이서.And an actuating part configured to vary from the first position to the second position by interference with the spinous process when inserted between the spinous processes.
  3. 제1항에 있어서,The method of claim 1,
    상기 이탈방지부재는,The separation preventing member,
    상기 제1위치에서 상기 제2위치로 가변시, 상호 반대방향으로 회전되도록 상기 작동공간 내에 설치되는 제1 및 제2이탈방지부재를 포함하는 것을 특징으로 하는 극돌기간 스페이서.And a first and second release preventing member installed in the working space to rotate in opposite directions when the first position is varied from the first position to the second position.
  4. 제3항에 있어서,The method of claim 3,
    상기 제1이탈방지부재는,The first separation preventing member,
    상기 제2위치에서 상기 본체의 이탈을 방지하는 제1이탈방지부와; 상기 제2이탈방지부재와 연동되는 제1연동부와; 상기 제1이탈방지부를 상기 제2위치에서 록킹하는 제1록킹부를 포함하며,A first departure preventing part for preventing the main body from being separated from the second position; A first interlocking portion interlocked with the second separation preventing member; It includes a first locking portion for locking the first release preventing portion in the second position,
    상기 제2이탈방지부재는,The second departure preventing member,
    상기 제2위치에서 상기 본체의 이탈을 방지하는 제2이탈방지부와; 상기 제1연동부와의 사이에 상호 연동 회전되는 제2연동부와; 상기 제2이탈방지부를 상기 제2위치에서 록킹하는 제2록킹부를 포함하는 것을 특징으로 하는 극돌기간 스페이서.A second departure preventing portion preventing the departure of the main body at the second position; A second interlocking unit interlocked with and interlocked with the first interlocking unit; And a second locking portion for locking the second departure preventing portion at the second position.
  5. 제4항에 있어서,The method of claim 4, wherein
    상기 제1이탈방지부 및 상기 제2이탈방지부 중 적어도 어느 하나의 단부는, 상기 제1위치에서 상기 극돌기 사이에 삽입이 용이하도록 테이퍼지게 형성된 것을 특징으로 하는 극돌기간 스페이서.An end portion of at least one of the first release preventing portion and the second release preventing portion, wherein the spinous process spacer, characterized in that formed in the tapered to facilitate insertion between the spinous process in the first position.
  6. 제4항에 있어서,The method of claim 4, wherein
    상기 제1연동부와 상기 제2연동부 각각은 상호 기어물림되는 톱니바퀴로 이루어진 것을 특징으로 하는 극돌기간 스페이서.Each of the first interlocking portion and the second interlocking portion is a spinous process spacer, characterized in that made of gears that are geared to each other.
  7. 제4항에 있어서,The method of claim 4, wherein
    상기 제2위치에서, 상기 제1록킹부와 상기 제2록킹부는 상호 후크결합 되는 것을 특징으로 하는 극돌기간 스페이서.In the second position, the first locking portion and the second locking portion spacers, characterized in that the hooking between each other.
  8. 제4항에 있어서,The method of claim 4, wherein
    상기 제2위치에서, 상기 제1록킹부 및 상기 제2록킹부 중 적어도 어느 하나는 상기 본체에 대하여 후크결합 내지 래칫결합 되는 것을 특징으로 하는 극돌기간 스페이서.In the second position, at least one of the first locking portion and the second locking portion of the spinous process spacer, characterized in that the hook coupling or ratchet coupling with respect to the main body.
  9. 제4항에 있어서,The method of claim 4, wherein
    상기 제2위치에서, 상기 제1록킹부 및 상기 제2록킹부 중 적어도 어느 하나는 상기 본체에 대하여 나사결합 되는 것을 특징으로 하는 극돌기간 스페이서.At the second position, at least one of the first locking portion and the second locking portion is a spinous process spacer, characterized in that the screwed to the body.
  10. 제1항에 있어서,The method of claim 1,
    상기 극돌기 가로방향으로의 상기 이격부의 폭은, 척추체 쪽에서 상기 극돌기의 말단 방향으로 갈수록 점진적으로 좁아지도록 테이퍼지게 형성된 것을 특징으로 하는 극돌기간 스페이서.The width of the spacer in the spinous process transverse direction, the spinous process spacer, characterized in that the tapered so as to gradually narrow toward the end direction of the spinous process toward the spinous body.
  11. 제1항 내지 제10항 중 어느 한 항에 있어서,The method according to any one of claims 1 to 10,
    상기 본체의 이격부는 폴리에테르에테르케톤(PEEK) 소재로 이루어지고, The spaced portion of the main body is made of a polyether ether ketone (PEEK) material,
    상기 본체의 날개부와 상기 이탈방지부재 중 적어도 어느 하나는 PEEK 소재 또는 티타늄 소재로 이루어진 것을 특징으로 극돌기간 스페이서.At least one of the wing portion and the separation preventing member of the main body spacers, characterized in that made of PEEK or titanium material.
  12. 제1항 내지 제10항 중 어느 한 항에 있어서,The method according to any one of claims 1 to 10,
    상기 본체와 상기 이탈방지부재에는 벤딩부가 형성되고, The main body and the separation preventing member is formed with a bending portion,
    상기 제2위치에서 상기 벤딩부를 통하여 상기 극돌기에 대해 벤딩하는 벤딩부재를 더 포함하는 것을 특징으로 극돌기간 스페이서.And a bending member which bends against the spinous process through the bending part at the second position.
  13. 제12항에 있어서,The method of claim 12,
    상기 벤딩부재는, 폴리에스테르(Polyester) 소재로 이루어진 것을 특징으로 하는 극돌기간 스페이서.The bending member is a spinous process spacer, characterized in that made of polyester (Polyester) material.
  14. 제1항 내지 제10항 중 어느 한 항에 있어서,The method according to any one of claims 1 to 10,
    상기 이격부, 상기 날개부, 상기 이탈방지부재 중 적어도 어느 하나의 부재는 상기 극돌기와 대향되는 부분에 형성된 스파이크부를 포함하여, 상기 극돌기와의 사이에 고정력을 높일 수 있도록 된 것을 특징으로 하는 극돌기간 스페이서.At least one of the spaced apart portion, the wing portion, and the separation preventing member includes a spike portion formed at a portion opposite to the spinous process, the spinous process characterized in that to increase the fixing force between the spinous process Spacer.
  15. 제1항 내지 제10항 중 어느 한 항에 있어서,The method according to any one of claims 1 to 10,
    수술도구 삽입공이 상기 본체의 상기 날개부에 형성된 것을 특징으로 하는 극돌기간 스페이서.Surgical tool insertion hole is a spinous process spacer, characterized in that formed in the wing portion of the body.
  16. 제15항에 있어서,The method of claim 15,
    상기 날개부에는 상기 수술도구 삽입공으로서, 상기 날개부의 상하방향으로 소정 간격 이격되게 배치되며 형상 및 크기 중 적어도 어느 하나가 상이한 제1 및 제2삽입공이 형성되어, 상기 수술도구에 대하여 오삽입을 방지할 수 있도록 된 것을 특징으로 하는 극돌기간 스페이서.As the surgical tool insertion hole, the wing portion is spaced apart by a predetermined interval in the vertical direction of the wing portion and is formed with first and second insertion holes different in at least one of a shape and a size, so as to misinsert the surgical tool. The spinous process spacer, characterized in that it is possible to prevent.
PCT/KR2011/006408 2010-08-30 2011-08-30 Interspinous process spacer WO2012030141A2 (en)

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