WO2021179628A1 - 一种椎间盘融合器 - Google Patents

一种椎间盘融合器 Download PDF

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Publication number
WO2021179628A1
WO2021179628A1 PCT/CN2020/124584 CN2020124584W WO2021179628A1 WO 2021179628 A1 WO2021179628 A1 WO 2021179628A1 CN 2020124584 W CN2020124584 W CN 2020124584W WO 2021179628 A1 WO2021179628 A1 WO 2021179628A1
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Prior art keywords
support
deformation
intervertebral disc
expansion
disc fusion
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PCT/CN2020/124584
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English (en)
French (fr)
Inventor
李维铭
杨文州
潘会会
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山东冠龙医疗用品有限公司
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Application filed by 山东冠龙医疗用品有限公司 filed Critical 山东冠龙医疗用品有限公司
Priority to KR1020227032698A priority Critical patent/KR20230002328A/ko
Priority to JP2022554183A priority patent/JP7410325B2/ja
Priority to EP20924042.3A priority patent/EP4112012B1/en
Publication of WO2021179628A1 publication Critical patent/WO2021179628A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A61F2/446—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A61F2/4465—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30224—Three-dimensional shapes cylindrical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30471—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30537—Special structural features of bone or joint prostheses not otherwise provided for adjustable
    • A61F2002/30545—Special structural features of bone or joint prostheses not otherwise provided for adjustable for adjusting a diameter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30537—Special structural features of bone or joint prostheses not otherwise provided for adjustable
    • A61F2002/30556—Special structural features of bone or joint prostheses not otherwise provided for adjustable for adjusting thickness
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30579—Special structural features of bone or joint prostheses not otherwise provided for with mechanically expandable devices, e.g. fixation devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2002/4415—Joints for the spine, e.g. vertebrae, spinal discs elements of the prosthesis being arranged in a chain like manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes

Definitions

  • the utility model relates to the technical field of medical equipment, in particular to an intervertebral disc fusion device.
  • the intervertebral disc (intervertebral disc) is divided into the nucleus pulposus at the center, a gelatinous substance rich in elasticity, and the fibrous annulus at the periphery, which is arranged in concentric circles by multiple layers of fibrocartilage rings.
  • the fibrous annulus of the cervical and lumbar region is thick in the front and thin in the back.
  • the nucleus pulposus is easy to protrude posteriorly and protrude into the spinal canal or intervertebral foramen, compressing the spinal cord or spinal nerves to form a herniated disc.
  • intervertebral disc herniation is usually treated by surgical implantation of an intervertebral disc fusion cage.
  • the original shape of the fusion cage is a 6mm columnar structure, made of metal titanium, which has a high degree of biocompatibility and robustness. It can be implanted into the diseased intervertebral space in a channel with an outer diameter of 7mm without excessive damage to the vertebral body structure. After being in a proper position in the intervertebral space, the fusion cage is expanded by rotating the handle of the cage installation tool, and its expansion diameter can reach up to 15mm. With the implantation of autologous or allogeneic bone, it can effectively restore and maintain the height of the intervertebral space.
  • Chinese utility model patent CN207506664U discloses an inflatable intervertebral fusion cage.
  • the expansion joint is designed with a contact piece arranged horizontally, and the expansion piece is used to connect the contact piece with the body of the fusion cage.
  • the expansion piece is bent and expanded outward under the action of external force, and at the same time, it drives the contact piece connected with it to expand outward. Since the contact piece is not directly affected by external force, the contact piece can still maintain a horizontal state after compression.
  • a larger contact area can be provided for the vertebral body, the height and stability of the vertebral body space can be ensured, and the safety during the operation can be ensured, and the patient's injury caused by the skewed expansion joint after compression can be avoided.
  • the expansion degree of the two expansion sheets on both sides of the contact sheet is inconsistent, and the contact sheet is not parallel to the axis. Compression, the support sheet is bent and deformed, and the expansion sequence of the expansion sheet 2 cannot be determined.
  • the expansion sheet 2 will be inclined, which will cause the expanded contact sheet to not be in a horizontal state, and the ridge protrusions will still be skewed. It will be difficult to maintain the height of the intervertebral space and the stability of the vertebral body, and it will still cause unnecessary harm to the patient.
  • a new type of intervertebral disc fusion device is provided to achieve the beneficial effect of ensuring that the intervertebral disc fusion device is expanded in sequence and the contact piece is in a horizontal state after expansion.
  • the utility model provides an intervertebral disc fusion device, which comprises a tube body.
  • a plurality of spaced apart supporting expansion joints and a stable expansion joint are arranged in the axial and circumferential directions of the tube body.
  • the two ends of the length direction are respectively provided with extension support plates.
  • the bottom two sides of the support plate are respectively connected to the pipe body through deformed support plates.
  • the support plate is provided with inward bending stoppers that limit the deformation of the top of the deformation support plate.
  • Between the two adjacent support expansion joints there is an outward bending stopper that restricts the deformation of the bottom end of the deformation support piece.
  • Two oppositely arranged restriction blocks are arranged between the two support expansion joints in the circumferential direction of the pipe body. The deformation support piece When the expansion is maximized, the two restriction blocks abut against each other.
  • a connecting portion is provided between the extension support plate on the support expansion joint and the inward bending stopper, the top end of the deformable support piece is connected to the connecting portion, and both ends of the inward bending stopper extend toward the deformable support piece, respectively,
  • both ends of the outward bending stopper respectively extend to the deformed support piece, and when the deformed support piece expands to the maximum state, the outer side of the deformed support piece abuts on the outward bending stopper.
  • the stable expansion joint includes a plurality of support bars arranged at intervals, a cavity is left between the connected support bars, and two opposite ends of the cavity are provided with oppositely arranged limit blocks.
  • the support bars expand to the maximum, they are arranged oppositely.
  • the two limit blocks abut against each other.
  • a positioning groove is provided at one end of the tube body connected with the cage insertion tool.
  • the number of the support bars is four, which are evenly arranged in the circumferential direction of the tube body.
  • both ends of the support plate along the length direction are respectively provided with extension support plates, which increase the contact area with the upper and lower endplates and reduce the pressure on the support surface of the fusion device, thereby avoiding or It reduces the situation that the endplate is broken by the support surface due to the small support area and strong pressure, which causes the intervertebral space to collapse; the deformed support piece is limited by the inward and outward bend stop during the expansion and deformation process, and realizes After expansion, the support plate and the cage are axially parallel to ensure the fusion space of the intervertebral space; there are two oppositely arranged restriction blocks between the two support expansion joints in the circumferential direction of the tube.
  • the deformed support plate expands to the maximum, two The restraining blocks are pressed together to avoid the transitional expansion of the deformed support sheet, and to ensure that the support sheet and the cage remain parallel in the axial direction; by changing the size of the support sheet, multiple specifications of expansion dimensions can be obtained, which can meet a variety of requirements.
  • the size of the clinical need; the intervertebral disc fusion cage provided by this utility model can make the expansion joints on the tube body expand from the inside to the outside, and they are all in the same expanded size state, which can ensure that the expanded contact piece is in a horizontal state and avoid When the ridges are skewed, the height of the intervertebral gap and the stability of the vertebral body can be maintained, so as not to cause unnecessary harm to the patient.
  • the design principle of the utility model is reliable, the structure is simple, and the utility model has a very wide application prospect.
  • Fig. 1 is a schematic diagram of the structure of an intervertebral disc fusion cage when closed according to an embodiment of the present invention.
  • Fig. 2 is a schematic diagram of the structure of the intervertebral disc fusion cage after expansion according to an embodiment of the present invention.
  • Fig. 3 is a partial structural diagram of the intervertebral disc fusion cage of an embodiment of the present invention when it is closed.
  • Fig. 4 is a schematic diagram of the structure of the intervertebral disc fusion cage in the initial stage of expansion according to an embodiment of the present invention.
  • Fig. 5 is a partial structural diagram of an intervertebral disc fusion cage after expansion according to an embodiment of the present invention.
  • pipe body 2, support expansion joint, 21, support plate, 22, extension support plate, 23, deformation support plate, 24, outer bend stop, 25, inner bend stop, 26, limit block , 3. Stable expansion joint, 31, support bar, 32, limit block, 4. positioning groove, 5. pipe body hole.
  • the intervertebral disc fusion device provided by the utility model includes a tube body 1.
  • Fig. 1 is a schematic diagram of the structure of an intervertebral disc fusion cage when closed according to an embodiment of the present invention.
  • Fig. 2 is a schematic diagram of the structure of the intervertebral disc fusion cage after expansion according to an embodiment of the present invention.
  • Fig. 3 is a partial structural diagram of the intervertebral disc fusion cage of an embodiment of the present invention when it is closed.
  • the pipe body 1 is provided with a plurality of spaced apart supporting expansion joints 2 and a stable expansion joint 3 in the axial and circumferential directions. After the expansion joints are expanded, the initial state shown in Figure 1 The expansion is the expanded state shown in FIG. 2.
  • the supporting expansion joint 2 includes a supporting plate 21. Both ends of the supporting plate 21 along the length direction are respectively provided with an extension supporting plate 22, which increases the contact area with the upper and lower end plates and reduces the pressure on the support surface of the cage. This avoids or reduces the situation that the endplate is broken by the support surface due to the small supporting area and strong pressure, which causes the collapse of the intervertebral space.
  • the two sides of the bottom of the supporting plate 21 are respectively connected to the tube body 1 through deformed supporting plates 23.
  • the deformation support sheet 23 is in the shape of a thin sheet with a certain degree of elasticity, and can be bent and deformed during the deformation process.
  • One end of the deformed support piece 23 is connected to the inner side of the support plate 21, and the other end of the deformed support piece 23 is connected to the pipe body 1.
  • the number of supporting expansion joints 2 in the axial direction of the tube body 1 is set to at least two. Specifically, it can be set according to the needs of treatment. When more than two supporting expansion joints 2 are provided, the supporting expansion joints 2 are aligned with each other, that is, the positions of the supporting plate 21 on the supporting expansion joint 2 are consistent.
  • the support plate 21 is provided with an inward bending stop 25 that restricts the deformation of the top end of the deformed support plate 23, and the inward bending stop 25 and the support plate 21 are integrally formed.
  • An outer bend stop 24 that restricts the deformation of the bottom end of the deformation support piece 23 is provided between two adjacent support expansion joints 2 on the pipe body 1, and the outer bend stopper 24 is integrally formed with the pipe body 1.
  • the deformable support plate 23 is restricted by the inward bending stop 25 and the outward bending stop 24, so that the support plate 21 is axially parallel to the cage after expansion, and the fusion space of the intervertebral space is ensured.
  • Two oppositely arranged restricting blocks 26 are arranged between the two supporting expansion joints 2 in the circumferential direction of the pipe body 1. When the deformed supporting piece 23 expands to the maximum, the two restricting blocks 26 abut against each other.
  • the two restriction blocks 26 abut against each other, which can avoid the transitional expansion of the deformed support sheet 23, and can ensure that the support sheet 21 and the cage remain parallel in the axial direction.
  • a connecting portion is provided between the extending support plate 22 on the support expansion joint 2 and the inward bending block 25.
  • the top end of the deformable support piece 23 is connected to the connecting portion. 23 extends, and both ends of the inward bending stop 25 extend to the outside of the connecting part.
  • the inward bending stop 25 is used to limit the amount of deformation of the deformation supporting piece 23.
  • the two ends of the outward bending stopper 24 respectively extend toward the deformation support sheet 23.
  • the outer side of the deformation support sheet 23 abuts on the outward bending stopper 24, which can effectively control the cage Inflated state.
  • the stable expansion joint 3 includes a plurality of support bars 31 arranged at intervals, and a cavity is left between the connected support bars 31.
  • the two opposite ends of the cavity are provided with oppositely arranged limit blocks 32.
  • the support bar 31 expands to the maximum, the two oppositely arranged limit blocks 32 abut together.
  • the number of the support bars 31 is four, which are evenly arranged in the circumferential direction of the tube body 1.
  • the end of the tube body 1 connected with the cage insertion tool is provided with a positioning groove 4, and the cage is inserted into the positioning groove 4.
  • Fig. 4 is a schematic diagram of the structure of the intervertebral disc fusion cage in the initial stage of expansion according to an embodiment of the present invention.
  • Fig. 5 is a partial structural diagram of an intervertebral disc fusion cage after expansion according to an embodiment of the present invention.
  • the extension support plate 22 on one side deforms first. After the fusion cage is continuously compressed, the extension support plate 22 on the other side deforms.
  • the deformation support plate 23 expands to the maximum state , The inner sides of the two oppositely disposed deformation supporting pieces 23 all abut on the inward bending stop 25.
  • the support bar 31 expands to the maximum, the two oppositely arranged limit blocks 32 abut together.
  • the pull rod of the expansion tool passes through the hole 5 in the pipe body.
  • the support plate 21 expands to both sides until the restriction blocks 26 on both sides are in contact and pressed tightly.
  • the end plates of the body are combined and supported; the four support bars 31 on the stable expansion joint 3 bulge in four oblique directions when they are expanded and then bend until the stop block 32 contacts and is compressed.
  • the support plate 21 is not parallel to the axis of the tube body 1.
  • the support plate 21 Gradually bend and deform. Under the restriction of the outer bend stop 24 and the inner bend stop 25, when one side of the supporting plate 21 is bent to the limit, the other side will continue to bend and deform until the two sides are consistent.
  • the two ends of the support plate 21 along the length direction are respectively provided with extension support plates 22, which increase the contact area with the upper and lower endplates and reduce the pressure on the support surface of the fusion device, thereby It is avoided or reduced that due to the small supporting area and strong pressure, the end plate is broken by the supporting surface, causing the intervertebral space to collapse; the deformed supporting piece 23 is subjected to the inward bending stop 25 and the outward bending stop 24 during the expansion and deformation process.
  • the support plate 21 and the cage are axially parallel after expansion, ensuring the fusion space of the intervertebral space; two oppositely arranged restricting blocks 26 are arranged between the two supporting expansion joints 2 in the circumferential direction of the tube body 1 to deform.
  • the two restriction blocks 26 abut against each other, which can avoid the transitional expansion of the deformed support sheet 23, and can ensure that the support sheet 21 and the cage remain parallel in the axial direction; by changing the size of the support sheet 21 Multiple specifications of expansion sizes can be obtained, which can meet the clinical needs of multiple sizes; the intervertebral disc fusion cage provided by the present invention can make the expansion joints on the tube body expand sequentially from the inside to the outside, and they are all in the same expansion size. The state can ensure that the expanded contact piece is in a horizontal state, avoid the skewing of the ridges, and can maintain the height of the intervertebral gap and the stability of the vertebral body, so as not to cause unnecessary harm to the patient.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

一种椎间盘融合器，涉及医疗器械技术领域，包括管体(1)，管体(1)的轴向和周向上设有多个间隔分布的支撑膨胀节(2)和一个稳定膨胀节(3)，支撑膨胀节(2)包括支撑片板(21)，支撑片板(21)沿长度方向的两端分别设有延伸支撑板(22)，支撑片板(21)底部两侧分别通过变形支撑片(23)与管体(1)相连，支撑片板(21)上设有限制变形支撑片(23)顶端变形的内弯挡块(25)，管体(1)上相邻设置的两个支撑膨胀节(2)之间设有限制变形支撑片(23)底端变形的外弯挡块(24)，管体(1)的周向上两个支撑膨胀节(2)之间设有两个相对设置的限制块(26)，变形支撑片(23)膨胀至最大时，两个限制块(26)抵靠在一起。该椎间盘融合器，可以确保椎间盘融合器按照次序依次膨胀，并且确保能膨胀后接触片处于水平状态的有益效果。

Description

一种椎间盘融合器 技术领域
本实用新型涉及医疗器械技术领域，具体涉及一种椎间盘融合器。
背景技术
椎间盘(intervertebral disc)分为中央部的髓核，富于弹性的胶状物质，周围部的纤维环，由多层纤维软骨环按同心圆排列。颈腰部纤维环前厚后薄，髓核易向后外侧脱出，突入椎管或椎间孔，压迫脊髓或脊神经形成椎间盘脱出症。现有技术中，椎间盘脱出症通常采用手术植入椎间盘融合器进行治疗。
融合器原始形态为6mm柱状结构，由金属钛制成，具有高度的生物兼容性和坚固性，能够在外径7mm的通道内植入病变椎间隙，无需过多的破坏椎体结构，当融合器处于椎间隙的适当位置后，通过旋转融合器安装工具的手柄，使融合器膨胀，其膨胀直径最大可达15mm。配合植入自体或异体骨，有效恢复并保持椎间隙高度。
中国实用新型专利CN207506664U公开了一种椎间可膨胀融合器，通过设计带有水平设置的接触片的膨胀节，并利用膨胀片将接触片与融合器管体连接，手术治疗中，当对融合器管体进行压缩时，膨胀片在外力作用下向外折弯膨胀，同时带动与其连接的接触片向外膨胀，由于接触片不直接受外力作用，当压缩后接触片仍可保持水平状态，进而可对椎体提供较大的接触面积，在保证椎体间隙高度和稳定性的同时能够确保手术中的安全，并可避免由于压缩后膨胀节歪斜对患者造成的伤害。但是，在实际手术的膨胀过程中，由于外部压力的不一致等因素，会出现接触片两侧的膨胀片二膨胀的程度不一致，接触片不与轴线平行的情况，随着融合器轴向的不断压缩，支撑片发生弯曲变形，膨胀片二的膨胀顺序也不能确定，膨胀片二会出现倾斜状态，从而导致膨胀后的接触片 不能处于水平状态，依然会出现脊状突部歪斜的情况，这样会很难保持椎间的间隙高度和椎体稳定，仍然会对患者造成不必要的伤害。
实用新型内容
针对现有技术中存在的对植入主体的融合器的膨胀状态难以把握，膨胀片二的膨胀顺序不能确定，膨胀片二会出现倾斜状态，从而导致出现脊状突部歪斜的问题，本实用新型提供一种椎间盘融合器，以达到确保椎间盘融合器按照次序依次膨胀，并且确保能膨胀后接触片处于水平状态的有益效果。
本实用新型提供一种椎间盘融合器，包括管体，管体的轴向和周向上设有多个间隔分布的支撑膨胀节和一个稳定膨胀节，支撑膨胀节包括支撑片板，支撑片板沿长度方向的两端分别设有延伸支撑板，支撑片板底部两侧分别通过变形支撑片与管体相连，支撑片板上设有限制变形支撑片顶端变形的内弯挡块，管体上相邻设置的两个支撑膨胀节之间设有限制变形支撑片底端变形的外弯挡块，管体的周向上两个支撑膨胀节之间设有两个相对设置的限制块，变形支撑片膨胀至最大时，两个限制块抵靠在一起。
进一步的，所述支撑膨胀节上延伸支撑板与内弯挡块之间设有连接部，变形支撑片的顶端与连接部相连，所述内弯挡块的两端分别向变形支撑片延伸，变形支撑片膨胀至最大状态时，两个相对设置的变形支撑片的内侧均抵靠在内弯挡块上。
进一步的，所述外弯挡块的两端分别向变形支撑片延伸，变形支撑片膨胀至最大状态时，变形支撑片的外侧抵靠在外弯挡块上。
进一步的，所述稳定膨胀节包括多根间隔设置的支撑条，相连支撑条之间留有空腔，空腔的两端设有相对设置的限位块，支撑条膨胀至最大时，相对设置的两个限位块抵靠的一起。
进一步的，所述管体与融合器置入工具相连的一端设有定位槽。
进一步的，所述支撑条的数量为四个，均匀的设置在管体的周向上。
本实用新型的有益效果如下：
本实用新型提供的椎间盘融合器，支撑片板沿长度方向的两端分别设有延伸支撑板，增大了与上下终板的接触面积，减小了融合器支撑面上的压强，从而避免或减少了由于支撑面积小，压强大，出现终板被支撑面顶破，造成椎间隙塌陷的情况；变形支撑片在膨胀变形过程中，受到内弯挡块和外弯挡块的限制，实现了膨胀后支撑片板与融合器轴向平行，保证椎间隙的融合空间；管体周向上两个支撑膨胀节之间设有两个相对设置的限制块，变形支撑片膨胀至最大时，两个限制块抵靠在一起，能够避免变形支撑片的过渡膨胀，能够确保支撑片板与融合器轴向保持平行；通过改变支撑片板的尺寸可以获得多个规格的撑开尺寸，能够满足多种尺寸的临床需要；本实用新型提供的椎间盘融合器能够使得管体上的膨胀节从里到外依次膨胀开，并且均处于膨胀尺寸相同的状态，能够确保膨胀后的接触片处于水平状态，避免出现脊状突部歪斜的情况，能够保持椎间的间隙高度和椎体稳定，从而不会对患者造成不必要的伤害。
此外，本实用新型设计原理可靠，结构简单，具有非常广泛的应用前景。
附图说明
为了更清楚地说明本实用新型实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，对于本领域普通技术人员而言，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1是本实用新型一个实施例的椎间盘融合器闭合时的结构示意图。
图2是本实用新型一个实施例的椎间盘融合器膨胀后的结构示意图。
图3是本实用新型一个实施例的椎间盘融合器闭合时的部分结构示意图。
图4是本实用新型一个实施例的椎间盘融合器膨胀初期的结构示意图。
图5是本实用新型一个实施例的椎间盘融合器膨胀后的部分结构示意图。
图中，1、管体，2、支承膨胀节，21、支撑片板，22、延伸支撑板，23、变形支撑片，24、外弯挡块，25、内弯挡块，26、限制块，3、稳定膨胀节，31、支撑条，32、限位块，4、定位槽，5、管体内孔。
具体实施方式
为了使本技术领域的人员更好地理解本实用新型中的技术方案，下面将结合本实用新型实施例中的附图，对本实用新型实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本实用新型一部分实施例，而不是全部的实施例。基于本实用新型中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都应当属于本实用新型保护的范围。
下面对本实用新型中出现的关键术语进行解释。
本实用新型提供的椎间盘融合器，包括管体1。
图1是本实用新型一个实施例的椎间盘融合器闭合时的结构示意图。图2是本实用新型一个实施例的椎间盘融合器膨胀后的结构示意图。图3是本实用新型一个实施例的椎间盘融合器闭合时的部分结构示意图。如图1-图3所示，所述管体1的轴向和周向上设有多个间隔分布的支撑膨胀节2和一个稳定膨胀节3，膨胀节膨胀后由图1所示的初始状态膨胀为图2所示的胀开状态。
支撑膨胀节2包括支撑片板21，支撑片板21沿长度方向的两端分别设有延伸支撑板22，增大了与上下终板的接触面积，减小了融合器支撑面上的压强，从而避免或减少了由于支撑面积小，压强大，出现终板被支撑面顶破，造成椎间隙塌陷的情况。
支撑片板21底部两侧分别通过变形支撑片23与管体1相连。变形支撑片23为薄片状，具有一定弹性，在变形过程中，能够发生弯曲变形。
变形支撑片23的一端与支撑片板21的内侧相连，变形支撑片23的另一端与管体1相连。
沿管体1轴向上支撑膨胀节2的数量设置至少为两个，具体的，可以根据治疗的需要进行设置。当设置两个以上的支撑膨胀节2时，各支撑膨胀节2相互对齐，即支撑膨胀节2上的支撑片板21的位置一致。
支撑片板21上设有限制变形支撑片23顶端变形的内弯挡块25，内弯挡块25与支撑片板21一体成型设计。管体1上相邻设置的两个支撑膨胀节2之间设有限制变形支撑片23底端变形的外弯挡块24，外弯挡块24与管体1一体成型设计。
变形支撑片23在膨胀变形过程中，受到内弯挡块25和外弯挡块24的限制，实现了膨胀后支撑片板21与融合器轴向平行，保证椎间隙的融合空间。
管体1的周向上两个支撑膨胀节2之间设有两个相对设置的限制块26，变形支撑片23膨胀至最大时，两个限制块26抵靠在一起。
变形支撑片23膨胀至最大时，两个限制块26抵靠在一起，能够避免变形支撑片23的过渡膨胀，能够确保支撑片板21与融合器轴向保持平行。
所述支撑膨胀节2上延伸支撑板22与内弯挡块25之间设有连接部，变形支撑片23的顶端与连接部相连，所述内弯挡块25的两端分别向变形支撑片23延伸，内弯挡块25的两端均伸出至连接部的外侧。
变形支撑片23膨胀至最大状态时，两个相对设置的变形支撑片23的内侧均抵靠在内弯挡块25上。内弯挡块25用于限制变形支撑片23的变形量。
所述外弯挡块24的两端分别向变形支撑片23延伸，变形支撑片23膨胀至最大状态时，变形支撑片23的外侧抵靠在外弯挡块24上，能够有效的控制融合器的膨胀状态。
所述稳定膨胀节3包括多根间隔设置的支撑条31，相连支撑条31之间留有空腔。
为了保持融合器的膨胀状态不变，空腔的两端设有相对设置的限位块32，支撑条31膨胀至最大时，相对设置的两个限位块32抵靠的一起。
本实施例中，所述支撑条31的数量为四个，均匀的设置在管体1的周向上。
所述管体1与融合器置入工具相连的一端设有定位槽4，融合器插入到定位槽4中。
图4是本实用新型一个实施例的椎间盘融合器膨胀初期的结构示意图。图5是本实用新型一个实施例的椎间盘融合器膨胀后的部分结构示意图。如图4所示，椎间盘融合器膨胀初期，一侧的延伸支撑板22首先发生变形，融合器被继续压缩后，另一侧的延伸支撑板22发生变形，变形支撑片23膨胀至最大状态时，两个相对设置的变形支撑片23的内侧均抵靠在内弯挡块25上。支撑条31膨胀至最大时，相对设置的两个限位块32抵靠的一起。
本实施例的实施方式为：
膨胀工具拉杆穿过管体内孔5，当拉杆沿轴向拉压时，支撑板21向两侧膨胀，直至两边的限制块26接触压紧，两个支撑片板21向外膨胀，与上下椎体的终板结合、支撑；稳定膨胀节3上的四个支撑条31膨胀时向四个斜方向膨出后弯曲，直至限位块32接触压紧。在膨胀过程中，由于外部压力的不一致等因素，会出现支撑膨胀节2两侧膨胀不一致和支撑片板21不与管体1轴线平行的情况，随着融合器轴向压缩，支撑片板21逐步弯曲变形，在外弯挡块24和内 弯挡块25的限制作用下，当一边支撑片板21弯曲达到极限后，另一边将会继续弯曲变形，直至达到两边一致的状态。
本实用新型提供的椎间盘融合器，支撑片板21沿长度方向的两端分别设有延伸支撑板22，增大了与上下终板的接触面积，减小了融合器支撑面上的压强，从而避免或减少了由于支撑面积小，压强大，出现终板被支撑面顶破，造成椎间隙塌陷的情况；变形支撑片23在膨胀变形过程中，受到内弯挡块25和外弯挡块24的限制，实现了膨胀后支撑片板21与融合器轴向平行，保证椎间隙的融合空间；管体1周向上两个支撑膨胀节2之间设有两个相对设置的限制块26，变形支撑片23膨胀至最大时，两个限制块26抵靠在一起，能够避免变形支撑片23的过渡膨胀，能够确保支撑片板21与融合器轴向保持平行；通过改变支撑片板21的尺寸可以获得多个规格的撑开尺寸，能够满足多种尺寸的临床需要；本实用新型提供的椎间盘融合器能够使得管体上的膨胀节从里到外依次膨胀开，并且均处于膨胀尺寸相同的状态，能够确保膨胀后的接触片处于水平状态，避免出现脊状突部歪斜的情况，能够保持椎间的间隙高度和椎体稳定，从而不会对患者造成不必要的伤害。
尽管通过参考附图并结合优选实施例的方式对本实用新型进行了详细描述，但本实用新型并不限于此。在不脱离本实用新型的精神和实质的前提下，本领域普通技术人员可以对本实用新型的实施例进行各种等效的修改或替换，而这些修改或替换都应在本实用新型的涵盖范围内/任何熟悉本技术领域的技术人员在本实用新型揭露的技术范围内，可轻易想到变化或替换，都应涵盖在本实用新型的保护范围之内。因此，本实用新型的保护范围应所述以权利要求的保护范围为准。

Claims (6)

  1. 一种椎间盘融合器，包括管体(1)，其特征在于：所述管体的轴向和周向上设有多个间隔分布的支撑膨胀节(2)和一个稳定膨胀节(3)，支撑膨胀节(2)包括支撑片板(21)，支撑片板(21)沿长度方向的两端分别设有延伸支撑板(22)，支撑片板(21)底部两侧分别通过变形支撑片(23)与管体(1)相连，支撑片板(21)上设有限制变形支撑片(23)顶端变形的内弯挡块(25)，管体上相邻设置的两个支撑膨胀节(2)之间设有限制变形支撑片(23)底端变形的外弯挡块(24)，管体(1)的周向上两个支撑膨胀节(2)之间设有两个相对设置的限制块(26)，变形支撑片(23)膨胀至最大时，两个限制块(26)抵靠在一起。
  2. 根据权利要求1所述的椎间盘融合器，其特征在于：所述支撑膨胀节(2)上延伸支撑板(22)与内弯挡块(25)之间设有连接部，变形支撑片(23)的顶端与连接部相连，所述内弯挡块(25)的两端分别向变形支撑片(23)延伸，变形支撑片(23)膨胀至最大状态时，两个相对设置的变形支撑片(23)的内侧均抵靠在内弯挡块(25)上。
  3. 根据权利要求1所述的椎间盘融合器，其特征在于：所述外弯挡块(24)的两端分别向变形支撑片(23)延伸，变形支撑片(23)膨胀至最大状态时，变形支撑片(23)的外侧抵靠在外弯挡块(24)上。
  4. 根据权利要求1所述的椎间盘融合器，其特征在于：所述稳定膨胀节(3)包括多根间隔设置的支撑条(31)，相连支撑条(31)之间留有空腔，空腔的两端设有相对设置的限位块(32)，支撑条(31)膨胀至最大时，相对设置的两个限位块(32)抵靠的一起。
  5. 根据权利要求1所述的椎间盘融合器，其特征在于：所述管体(1)与融合器置入工具相连的一端设有定位槽(4)。
  6. 根据权利要求4所述的椎间盘融合器，其特征在于：所述支撑条(31)的数量为四个，均匀的设置在管体(1)的周向上。
PCT/CN2020/124584 2020-03-09 2020-10-29 一种椎间盘融合器 WO2021179628A1 (zh)

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EP4112012A4 (en) 2023-08-23
CN212234811U (zh) 2020-12-29
EP4112012B1 (en) 2024-05-01
KR20230002328A (ko) 2023-01-05

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