WO2021135649A1 - 一种多功能椎体成形器 - Google Patents

一种多功能椎体成形器 Download PDF

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Publication number
WO2021135649A1
WO2021135649A1 PCT/CN2020/127601 CN2020127601W WO2021135649A1 WO 2021135649 A1 WO2021135649 A1 WO 2021135649A1 CN 2020127601 W CN2020127601 W CN 2020127601W WO 2021135649 A1 WO2021135649 A1 WO 2021135649A1
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WIPO (PCT)
Prior art keywords
balloon
distal end
tube
outer tube
handle
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PCT/CN2020/127601
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English (en)
French (fr)
Inventor
喻杰
李东
胡冬
张鹏云
吕世文
Original Assignee
宁波华科润生物科技有限公司
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Priority to EP20909843.3A priority Critical patent/EP4085856A4/en
Publication of WO2021135649A1 publication Critical patent/WO2021135649A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical 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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7061—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant for stabilising vertebrae or discs by improving the condition of their tissues, e.g. using implanted medication or fluid exchange
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3472—Trocars; Puncturing needles for bones, e.g. intraosseus injections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical 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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7097—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical 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
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical 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
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8816—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical 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
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8819—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the introducer proximal part, e.g. cannula handle, or by parts which are inserted inside each other, e.g. stylet and cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical 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
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/885—Tools for expanding or compacting bones or discs or cavities therein
    • A61B17/8852—Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc
    • A61B17/8855—Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc inflatable, e.g. kyphoplasty balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1671—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the spine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B2017/564—Methods for bone or joint treatment

Definitions

  • the invention relates to the field of medical equipment, in particular to a multifunctional vertebroplasty device.
  • the existing PKP kyphoplasty uses percutaneous puncture to place an inflatable balloon into the collapsed vertebral body.
  • the balloon expands to raise the endplate, restore the height of the vertebral body, and correct the kyphotic deformity.
  • a cavity surrounded by a bone shell is formed in the body, and high-viscosity bone cement is poured under lower pressure.
  • it is necessary to establish a working channel with a puncture needle and a working cannula, and then use a bone drill to drill out the working cavity of the balloon before expansion, and then send the balloon into the vertebral body.
  • each vertebral body needs to undergo bilateral balloon expansion and bone cement injection.
  • Surgery needs to be operated under X-ray monitoring. The more cumbersome the operation, the longer the time it will cause the doctor’s health damage, and the higher the requirements for physical strength and operation; bilateral balloon dilation and bone cement injection will cause more trauma and complications to the patient The high chance of occurrence also increases the financial burden of patients.
  • the above-mentioned shortcomings become more prominent in the case of multi-segment vertebral disease.
  • Patent CN109431589A discloses an integrated multifunctional vertebroplasty instrument, including a balloon assembly, a bend angle adjustment assembly and a bend angle opening assembly, but it does not disclose in detail the connection relationship and working mode of the various components of the proximal end to achieve multi-function .
  • Patent CN109745114A discloses a multifunctional vertebroplasty instrument, including a balloon assembly and a cavity opening assembly.
  • the outer tube assembly in the cavity opening assembly includes an outer tube and an outer tube handle.
  • the outer tube axially bears the tissue opening thrust without being deformed.
  • the handle of the outer tube is provided with an interface for injecting bone filler into the cavity.
  • the present invention provides a vertebroplasty device with simple structure and easy operation.
  • the vertebral expansion of the bone drill and the pre-expansion of the balloon catheter are concentrated on one instrument, which simplifies the operation.
  • the operation time is shortened and the operation efficiency is improved. Since all operations need to be operated under X-ray monitoring, shortening the operation time helps reduce the damage to the doctor's health, and at the same time reduces the doctor's physical strength and operational requirements.
  • a multifunctional vertebroplasty device including
  • a balloon structure which includes a balloon outer tube, a balloon handle, and a balloon; the proximal outer surface of the balloon outer tube is sheathed with a balloon handle fitting, the balloon handle and the balloon in order from the inside to the outside
  • the balloon delivery buckle is fixedly connected to each other; wherein the balloon handle and the balloon delivery buckle are rotatably fixed by the buckle; the balloon outer tube is fixedly connected to the distal end of the balloon, and the balloon Distal seal
  • a delivery tube structure including a shape memory alloy tube, a sliding block and an outer tube adjustment handle, the shape memory alloy tube is sleeved on the balloon outer tube and the outside of the balloon, and the shape memory alloy tube is connected to the outer tube.
  • the slider is integrally molded by injection molding; the proximal end of the slider is detachably connected to the balloon delivery buckle through the first bayonet; the outer surface of the slider is provided with a threaded structure, and the outer threaded structure has an inner threaded structure.
  • the tube adjustment handle is sleeved on the outer surface of the slider, and the outer tube adjustment handle is rotated to drive the slider to move back and forth, so as to control the protruding amount and the amount of the distal end of the shape memory alloy tube relative to the distal end of the outer tube.
  • the balloon structure further includes a balloon delivery buckle fitting, which is sleeved outside the balloon delivery buckle, and the second bayonet at the distal end of the balloon delivery buckle is inserted into the balloon delivery
  • a chute is provided at the distal end of the chute; the distal end of the balloon delivery buckle fitting can be buckled with a stopper sleeved on the outside of the slider.
  • the inner circular edge of the distal end of the limiting member extends along the outer surface of the slider toward the distal direction with a plurality of mutually unconnected arc-shaped parts, and the distal end of the arc-shaped part is fixed at the end by a cylindrical pin
  • the end cover is matched and locked with the handle of the working sleeve by a locking ring
  • the outer tube adjustment handle is sleeved on the outside of the arc, and the thread structure on the outer surface of the slider extends out of the arc
  • the gap of the shaped part is matched with the internal thread structure of the outer tube adjusting handle.
  • the locking ring is sleeved outside the distal end of the end cap, and a top block is sleeved between the distal end of the end cap and the locking ring, and is threadedly connected with the distal end of the end cap;
  • the proximal end of the locking ring is fixed by an end cap and the top block, the proximal end of the locking ring can be rotated around the end cap, and the distal end of the locking ring is fixed in cooperation with the handle of the working sleeve by a buckle .
  • the outer tube is sleeved outside the shape memory alloy tube, and the outer tube and the end cap are integrally injection molded.
  • the outer tube has a certain rigidity to assist the distal end of the vertebroplasty device to enter the designated position between the vertebrae.
  • the released shape memory alloy tube shows a certain bending angle at the distal end, it needs to be recycled to the working sleeve. , It can be recycled into the outer tube first.
  • a protrusion extends from the proximal end of the balloon handle relative to the proximal end of the balloon handle fitting and the proximal end of the balloon delivery buckle, and the proximal surface of the protrusion is sealed to form a cavity
  • the side wall of the protruding part is provided with a cavity interface; the balloon outer tube communicates with the outside through the protruding part.
  • the outer side of the proximal end surface of the protrusion is connected to a support wire seat through a thread, the support wire seat is fixedly connected to the proximal end of the support wire, and the support wire is inserted into the proximal end surface of the protrusion in turn.
  • the orifice, the outer tube of the balloon and the balloon, and the distal end of the support wire is in contact with the distal end of the balloon.
  • the support wire is made of plastic material.
  • a force is applied to the support wire to bend it, so that the distal end of the entire balloon structure is bent, and the bending angle and shape The memory alloy tube is the same.
  • the contact part of the balloon inner tube and the balloon handle is bonded with medical grade glue; the contact part of the balloon handle accessory and the balloon handle is bonded with medical grade glue.
  • a balloon inner tube is further provided or not provided between the balloon outer tube and the support wire, and the proximal end of the balloon inner tube is fixed on all the proximal surfaces of the protrusions.
  • the distal end of the balloon inner tube is in contact with the distal end of the balloon.
  • the balloon inner tube is not provided, the balloon outer tube is directly inserted from the proximal end of the balloon to the distal end of the balloon, and both the proximal end and the distal end of the balloon are connected to the balloon.
  • the outer balloon tube is heat-melted or laser welded; the balloon outer tube inside the balloon is provided with an opening; the balloon outer tube at the distal end of the balloon is sealed by UV glue or a PU rod.
  • the distal end of the balloon inner tube and the distal end of the balloon are welded by thermal welding or laser welding, and the inner balloon tube is passed UV
  • the glue is used for sealing, and the support wire is in contact with the UV glue.
  • the distal end of the balloon and the inner balloon tube are thermally welded or laser welded through a transition tube; the proximal end of the plug and the distal end of the support wire After laser welding, the proximal surface of the plug and the distal surface of the balloon are bonded and sealed with medical grade glue.
  • a reinforcing tube is sheathed on the outer surface of the balloon outer tube, the reinforcing tube and the balloon outer tube are bonded by medical grade glue, and the reinforcing tube and the balloon handle fitting are integrally molded by injection molding.
  • the outer tube of the balloon is a relatively soft tube made of PU material.
  • the reinforced tube has two functions: one is to protect the outer tube of the balloon, and the second is to use the rigidity of the reinforced tube to make it easier to send into the balloon. .
  • the distal end of the shape memory alloy tube is provided with a curved part; in the initial state, the balloon is located inside the shape memory alloy tube.
  • the distal end of the shape memory alloy tube can be sealed to a certain extent to prevent
  • the cancellous bone inside the vertebral body enters the shape memory alloy tube, and the vertebral expansion uses the tip end of the shape memory alloy tube to squeeze the cancellous bone inside the vertebral body to establish a balloon channel.
  • the present invention adopts the above technical scheme and has the following technical effects:
  • the multifunctional vertebroplasty device of the present application organically combines the functions of the expansion of the bone drill, the pre-expansion of the balloon catheter and the filling of bone cement, which reduces the number of surgical instruments, simplifies the operation steps, and saves operation time , Which reduces the economic burden of patients;
  • the shape memory alloy tube adopts the threaded structure conveying method, which has high adjustment accuracy and safer operation;
  • the shape memory alloy tube can be directly bent from one side of the vertebral body to the opposite side of the vertebral body through the bending angle, reducing the operation steps and reducing the pressure on the patient's body, so that the vertebral body can be expanded by only one puncture (
  • the balloon channel is established, the balloon is pre-expanded (the cavity filled with bone cement is established), and the bone cement injection kit is directly connected to complete the injection operation of the bone cement.
  • the operation is simple and convenient.
  • Figure 1 is a schematic diagram of the structure of a multifunctional vertebroplasty device of the present invention
  • Figure 2a is a first angle cross-sectional view of a multifunctional vertebroplasty structure of the present invention
  • Fig. 2b is a schematic diagram of the structure of area A in Fig. 2a;
  • Figure 3a is a second angle cross-sectional view of a multifunctional vertebroplasty structure of the present invention.
  • Fig. 3b is a schematic diagram of the structure of area B in Fig. 3a;
  • FIG. 4 is a cross-sectional view of the relative positional relationship of the proximal components of the multifunctional vertebroplasty device of the present invention.
  • Figure 5 is a schematic diagram of the connection between the balloon delivery buckle and the slider of a multifunctional vertebroplasty device of the present invention
  • Figure 6 is a schematic diagram of the slider structure of a multifunctional vertebroplasty device of the present invention.
  • Fig. 7 is a schematic diagram of the structure of the multifunctional vertebroplasty device of the present invention after being inserted into the working sleeve;
  • Figure 8a is a schematic diagram of the buckle position of the multifunctional vertebroplasty device of the present invention before the balloon pre-expansion is achieved;
  • Figure 8b is a schematic diagram of the buckle position of the multifunctional vertebroplasty device of the present invention after the balloon is pre-expanded;
  • Figure 9 is a schematic diagram of a multifunctional vertebroplasty balloon delivery buckle fitting of the present invention.
  • Figure 10a is a schematic diagram of the working mode of establishing a balloon channel in Embodiment 2 of a multifunctional vertebroplasty device of the present invention
  • 10b is a schematic diagram of a second working mode of establishing a balloon channel in Embodiment 3 of a multifunctional vertebroplasty device of the present invention
  • Fig. 11a is a schematic diagram of a working mode for realizing balloon pre-expansion in Embodiment 2 of a multifunctional vertebroplasty device of the present invention
  • Fig. 11b is a schematic diagram of the working mode of realizing balloon pre-expansion in embodiment 3 of a multifunctional vertebroplasty device of the present invention.
  • Figure 12a is a schematic diagram of the working mode of the balloon pulling out structure in embodiment 2 of a multifunctional vertebroplasty device of the present invention
  • FIG. 12b is a schematic diagram of the working mode of the balloon pulling out structure in Embodiment 3 of the multifunctional vertebroplasty device of the present invention.
  • Figure 13a is a cross-sectional view of the relative position of the balloon delivery buckle and the limiting member before the balloon structure of the multifunctional vertebroplasty device of the present invention is pulled out;
  • Figure 13b is a cross-sectional view of the relative position of the balloon delivery buckle and the limiting member after the balloon structure of the multifunctional vertebroplasty device of the present invention is pulled out;
  • Figure 14 is a schematic diagram of the balloon structure of a multifunctional vertebroplasty device of the present invention.
  • 15 is a schematic diagram of the structure of the multifunctional vertebroplasty device of the present invention after the balloon structure is pulled out;
  • Fig. 16a is a schematic diagram of the treatment form of the first balloon distal end of the multifunctional vertebroplasty device of the present invention.
  • Figure 16b is a schematic diagram of the second balloon distal end processing form of a multifunctional vertebroplasty device of the present invention.
  • Fig. 16c is a schematic diagram of the third balloon distal end processing form of the multifunctional vertebroplasty device of the present invention.
  • Fig. 16d is a schematic diagram of a fourth balloon distal end treatment form of the multifunctional vertebroplasty device of the present invention.
  • Fig. 16e is a schematic diagram of a fifth balloon distal end processing form of a multifunctional vertebroplasty device of the present invention.
  • Figure 16f is a schematic diagram of a sixth balloon distal end processing form of a multifunctional vertebroplasty device of the present invention.
  • Figure 17 is a schematic view of the structure of the end cover of a multifunctional vertebroplasty device of the present invention.
  • 2-conveying tube structure 21-shape memory alloy tube, 22-outer tube adjustment handle, 23-slider, 231-first lug, 24-limiting piece, 241-limiting slot, 242-curved part , 25-end cap, 251-cylindrical pin, 26-locking ring, 261-top block, 27-bend, 28-outer tube,
  • 3-Working casing structure 31-working casing handle, 32-working casing;
  • proximal end refers to the direction close to the operator
  • distal end refers to the direction close to the patient
  • clockwise refers to the clockwise direction relative to the operator
  • counterclockwise refers to the counterclockwise direction relative to the operator.
  • This embodiment provides a multifunctional vertebroplasty device, as shown in Figures 1, 2a-2b and 3a-3b, which include
  • a balloon structure 1 which includes a balloon outer tube 16, a balloon handle 11, and a balloon 15; the proximal outer surface of the balloon outer tube 16 is sheathed with a balloon handle fitting 12 and a balloon from the inside to the outside.
  • the grooves are matched to be rotatable and fixed; the balloon handle fitting 12 is fixedly connected to the balloon handle 11; the distal end of the balloon outer tube 16 is fixedly connected to the balloon 15, and the distal end of the balloon 15 is sealed ;
  • a delivery tube structure 2 including a shape memory alloy tube 21, a sliding block 23 and an outer tube adjustment handle 22.
  • the shape memory alloy tube 21 is sleeved on the balloon outer tube 16 and the outside of the balloon 15, so The shape memory alloy tube 21 and the slider 23 are integrally molded by injection molding; the proximal end of the slider 23 is detachably connected to the balloon delivery buckle 13 through the first lug 231; the outer surface of the slider 23 A threaded structure is provided.
  • the outer tube adjusting handle 22 with an internal threaded structure is sleeved on the outer surface of the slider 23.
  • the slider 23 is driven to move back and forth, thereby controlling the The protrusion amount of the distal end of the shape memory alloy tube 21 relative to the distal end of the outer tube 28 and the protrusion amount of the distal end of the balloon 15 relative to the distal end of the shape memory alloy tube 21.
  • the balloon structure 1 further includes a balloon delivery buckle fitting 14, which is sleeved on the outside of the balloon delivery buckle 13, and the balloon
  • the second lug 131 at the distal end of the delivery buckle 13 is inserted into the chute 141 on the inner surface of the balloon delivery buckle fitting 14, and the distal end of the chute 141 is provided with a slot 142;
  • the distal end of the buckle fitting 14 is detachably connected to a limiting member 24 sleeved on the outside of the slider 23 by a buckle; the inner circular edge of the distal end of the limiting member 24 faces along the outer surface of the slider 23
  • a plurality of arc-shaped portions 242 that are not connected to each other extend in the distal direction.
  • the distal end of the arc-shaped portion 242 is fixed to the proximal end of the end cap 25 by a cylindrical pin 251. 31 matching and locking; the outer tube adjustment handle 22 is sleeved outside the arc-shaped portion 242, and the thread structure on the outer surface of the slider 23 extends out of the gap between the arc-shaped portion 242 and the outer tube adjustment handle The internal thread structure of 22 is matched.
  • the locking ring 26 is sleeved outside the distal end of the end cap 25, and a top block 261 is sleeved between the distal end of the end cap 25 and the locking ring 26, and is connected to the end cap 25.
  • the distal end of the cover 25 is threaded; the proximal end of the locking ring 26 is fixed by the end cover 25 and the top block 261, the proximal end of the locking ring 26 can rotate around the end cover 25, and the locking ring 26
  • the distal end is matched and fixed with the working sleeve handle 31 through a buckle.
  • the outer tube 28 is sleeved outside the shape memory alloy tube 21, and the outer tube 28 and the end cap 25 are integrally injection molded.
  • the outer tube 28 has a certain rigidity to assist the distal end of the vertebroplasty device to enter the designated position between the vertebrae.
  • the released shape memory alloy tube 21 shows a certain bending angle at the distal end, it needs to be recycled to the working sleeve.
  • the tube 32 is used, it can be recycled into the outer tube 28 first.
  • the proximal end of the balloon handle 11 extends a protrusion 111 relative to the proximal end of the balloon handle fitting 12 and the proximal end of the balloon delivery buckle 13.
  • the proximal surface of the portion 111 is sealed to form a cavity, and the side wall of the protruding portion 111 is provided with a cavity interface 112; the balloon outer tube 16 communicates with the outside through the protruding portion 111.
  • the proximal end surface of the protruding portion 111 is connected to a supporting wire seat 113 through threads, and the supporting wire seat 113 is connected to the proximal end of the supporting wire 18
  • the supporting wire 118 is sequentially inserted into the channel 114 on the proximal surface of the protrusion 111, the balloon outer tube 16 and the balloon 15, and finally the distal surface of the supporting wire 18 is The distal end of the balloon 15 is in contact; when the distal end of the support wire 18 does not have the plug 151 welded to it, the support wire seat 113 can be rotated to separate from the support seat, and then the entire The supporting wire 18 is drawn out.
  • the distal end of the shape memory alloy tube 21 is provided with a curved portion 27.
  • the balloon 15 is located inside the shape memory alloy tube 21, and can be used for the shape memory alloy tube 21.
  • the distal end plays a certain sealing role to prevent the cancellous bone inside the vertebral body from entering the shape memory alloy tube 21 during the expansion of the vertebral body.
  • the expansion of the vertebral body uses the tip end of the shape memory alloy tube to carry out the cancellous bone inside the vertebral body.
  • the balloon channel is established by extrusion; preferably, the shape memory alloy tube itself is a memory metal, and the shape memory alloy tube can present a 90° bend angle after heat treatment through the shaping angle designed on the shaping die; the shape memory alloy tube passes through
  • the purpose of heat treatment is to reduce its Af point (the temperature when returning to the bend state) to obtain superelasticity. Therefore, the shape memory alloy tube uses its own memory performance and superelasticity after heat treatment to automatically return to the bend after exceeding the outer tube.
  • Angle state further, in this embodiment, the Af point of the shape memory alloy tube is controlled at about 20°C after heat treatment and shaping. When the temperature is higher than the Af point, the shape memory alloy tube can quickly return to the angled state.
  • the shape memory alloy tube When the balloon channel is established, the shape memory alloy tube enters the vertebral body, and the internal temperature of the human body is about 37°C, so when the shape memory alloy tube comes out of the sleeve, it will establish a ball inside the vertebral body in a fixed angle state.
  • the capsule channel so that the shape memory alloy tube can directly pass through the curved part from the puncture side of the vertebral body to the opposite side of the vertebral body.
  • the supporting wire 18 is made of semi-rigid material, which provides sufficient rigidity to the distal end of the balloon structure 1 so that it can enter between the vertebral bodies; the distal end of the shape memory alloy tube 21 has a curved portion 27 As shown in FIG. 10b, when the shape memory alloy tube 21 exhibits a certain bending angle, a force is applied to the support wire 18 to bend it, so that the distal end of the entire balloon structure 1 becomes bent, and the bending angle and shape
  • the memory alloy tube 21 is the same as shown in Fig. 11b.
  • the outer surface of the balloon outer tube 16 is further sheathed with a reinforcing tube 121, and the reinforcing tube 121 and the balloon outer tube 16 are bonded by medical-grade glue.
  • the reinforcing tube 121 and the balloon handle fitting 12 are integrally molded by injection molding.
  • the distal end of the balloon outer tube 16 and the proximal end of the balloon 15 are thermally welded or laser welded; the distal end of the balloon 15 is sealed by UV glue 153.
  • the distal end of the balloon outer tube 16 is thermally welded or laser welded to the proximal end of the balloon 15; the distal end of the balloon 15 passes through a PU rod 154 It is sealed by hot-melt welding or laser welding with the balloon.
  • the balloon outer tube 16 is directly inserted from the proximal end of the balloon 15 to the distal end of the balloon 15, and the proximal and distal ends of the balloon 15 Both are heat-melted or laser welded to the balloon outer tube 16; the balloon outer tube 16 inside the balloon 15 is provided with an outer tube opening 161; the balloon at the distal end of the balloon UV glue 153 is applied inside the outer tube 16 for sealing.
  • the balloon outer tube 16 is directly inserted from the proximal end of the balloon 15 to the distal end of the balloon 15, and the proximal and distal ends of the balloon 15 Both are heat-melted or laser welded to the balloon outer tube 16; the balloon outer tube 16 inside the balloon 15 is provided with an outer tube opening 161; the balloon at the distal end of the balloon The inside of the balloon tube 16 is sealed by the PU rod 154 and the balloon by thermal welding or laser welding.
  • the distal end of the balloon outer tube 16 is thermally welded or laser welded to the proximal end of the balloon 15; the balloon outer tube 16 is welded to the proximal end of the balloon 15; There is a balloon inner tube 17 between the support wires 18, and the proximal end of the balloon inner tube 17 is fixed in the channel 114 on the proximal surface of the protrusion 111.
  • the balloon inner tube 17 The distal end of is fixedly connected to the distal end of the balloon 15.
  • the distal end of the balloon 15 and the inner balloon tube 17 are welded by heat or laser welding through the transition tube 152; the inner balloon tube 17 is welded by UV glue 153 Sealing, the distal end of the supporting wire 18 abuts the UV glue 153.
  • the distal end of the balloon 15 and the inner balloon tube 17 are thermally welded or laser welded through the transition tube 152; the proximal end of the plug 151 is connected to the support wire 18 After the distal end laser welding, the proximal surface of the plug 151 and the distal surface of the balloon 15 are adhesively sealed with medical grade glue.

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Abstract

一种多功能椎体成形器，包括球囊结构（1）和输送管结构（2），其中输送管结构（2）包括形状记忆合金管（21）、滑块（23）和外管调节手柄（22），形状记忆合金管（21）套设于球囊外管（16）和球囊（15）的外部，形状记忆合金管（21）的近端与滑块（23）的远端固定连接；滑块（23）的近端通过第一卡耳（231）与球囊结构（1）可拆卸连接；滑块（23）外表面设有螺纹结构，具有内螺纹结构的外管调节手柄（22）套设于滑块（23）的外表面，通过旋转外管调节手柄（22）带动滑块（23）前后移动，从而控制形状记忆合金管（21）远端相对于外管（28）远端的突出量和球囊（15）远端相对于形状记忆合金管（21）远端的突出量。提供的多功能椎体成形器结构简单、操作容易，将骨钻的扩椎、球囊导管的预扩集中在一个器械上，简化了手术操作，缩短了手术时间，提高了手术效率，同时降低了医生体力要求和患者经济负担。

Description

一种多功能椎体成形器 技术领域
本发明涉及医疗器械领域，尤其涉及一种多功能椎体成形器。
背景技术
现有PKP椎体后凸成形术利用经皮穿刺将一种可膨胀球囊置入塌陷的椎体，通过球囊的扩张抬升终板，回复椎体的高度，矫正后凸畸形，并在椎体内形成一个四周为骨壳的空腔，在较低压力下灌注高粘滞的骨水泥。为了使球囊顺利的进入椎体，需要先用穿刺针和工作套管建立工作通道，然后再使用骨钻钻出球囊在扩张前的工作腔道，再将球囊送入椎体内，在椎体内形成一个四周为骨壳的空腔后撤出球囊，最后注入骨水泥。该操作步骤繁琐，同时由于椎体结构的原因，为了保持椎体生物力学上的受力平衡，每节椎体都需要进行双侧的球囊扩张和注射骨水泥。手术都需要在X光监控下操作，手术过程越繁琐时间越长对医生的健康损坏越大、体力和操作水平要求越高；双侧进行球囊扩张和注射骨水泥对患者创伤大、并发症发生机会高，也增加了患者的经济负担，上述缺点在多节椎体病变的情况下，变得更加突出。
专利CN109431589A公开了一种一体式多功能的椎体成形器械，包括球囊组件、弯角调节组件和弯角开腔组件，但是没有详细公开操近端的各组件连接关系和工作方式以实现多功能。
专利CN109745114A公开了一种多功能的椎体成形器械，包括球囊组件和开腔组件，开腔组件中的外管组件包括外管和外管手柄，外管轴向具有承受组织开腔推力而不变形的刚度，外管手柄设置有骨填充物注入空腔接口。但是没有详细公开操近端的各组件连接关系和工作方式以实现多功能。
因此，提供一种操作容易、结构简单的椎体成形器械，以实现椎体成形器的多功能性，是亟待解决的问题。
发明内容
本发明为解决现有技术中上述缺陷，提供了一种结构简单、操作容易的椎体成形器，将骨钻的扩椎、球囊导管的预扩集中在一个器械上，简化了手术操作，缩短了手术时间，提高了手术效率，由于手术都需要在X光监控下操作，缩短手术时间有助于减少对医生健康的损坏，同时降低了医生体力和操作的要求。
为实现上述目的，本发明采用以下技术方案：
一种多功能椎体成形器，包括
一球囊结构，其包括球囊外管、球囊手柄和球囊；所述球囊外管的近端外表面从内到外依次套设有球囊手柄配件、所述球囊手柄和球囊输送卡扣，并相互固定连接；其中，所述球囊手柄与球囊输送卡扣通过卡扣可旋转固定；所述球囊外管与所述球囊远端固定连接，所述球囊远端密封；
一输送管结构，包括形状记忆合金管、滑块和外管调节手柄，所述形状记忆合金管套设于所述球囊外管和所述球囊的外部，所述形状记忆合金管与所述滑块一体注塑成型；所述滑块的近端通过第一卡耳与所述球囊输送卡扣可拆卸连接；所述滑块外表面设有螺纹结构，具有内螺纹结构的所述外管调节手柄套设于所述滑块的外表面，通过旋转所述外管调节手柄带动所述滑块前后移动，从而控制所述形状记忆合金管远端相对于外管远端的突出量和所述球囊远端相对于所述形状记忆合金管远端的突出量。
优选地，所述球囊结构还包括球囊输送卡扣配件，其套设于所述球囊输送卡扣外部，所述球囊输送卡扣远端的第二卡耳插入所述球囊输送卡扣配件内表面的滑槽中，所述滑槽的远端设置一卡槽；所述球囊输送卡扣配件的远端通过卡扣与套设在所述滑块外部的限位件可拆卸连接；所述限位件远端的内圆边缘沿所述滑块的外表面朝远端方向延伸多个互不相连弧形部，所述弧形部的远端通过圆柱销固定在端盖的近端，所述端盖通过锁定环与工作套管手柄匹配锁定；所述外管调节手柄套设在所述弧形部外部，所述滑块外表面的螺纹结构延伸出所述弧形部的间隙，与所述外管调节手柄的内螺纹结构配合。
进一步地，所述锁定环套设在诉所述端盖远端外部，一顶块套设于所述端盖远端和所述锁定环之间，并与所述端盖远端螺纹连接；所述锁定环的近端通过端盖和所述顶块固定，所述锁定环的近端可环绕所述端盖转动，所述锁定环的远端 通过卡扣与工作套管手柄相配合固定。
优选地，所述外管套设于所述形状记忆合金管外部，所述外管与所述端盖一体注塑成型。
外管带有一定的刚性，辅助所述椎体成形器的远端进入到椎间指定位置，当放出的形状记忆合金管远端呈现一定的弯曲角度，需要再将其回收到工作套管时，可以先将其回收至外管中。
优选地，所述球囊手柄的近端相对所述球囊手柄配件近端和所述球囊输送卡扣近端延伸出一突出部，所述突出部的近端面密闭以形成空腔，所述突出部的侧壁设一空腔接口；所述球囊外管通过所述突出部与外界连通。
进一步地，所述突出部的近端面外侧，通过螺纹连接一支撑丝座，所述支撑丝座与支撑丝近端固定连接，所述支撑丝依次插入所述突出部的近端面上的孔道、所述球囊外管和所述球囊，所述支撑丝的远端与所述球囊的远端接触。
所述支撑丝为塑性材质，在形状记忆合金管呈现出一定的弯曲角度时，对所述支撑丝施加一个使其弯曲的力，从而整个球囊结构的远端都为弯曲，弯曲角度与形状记忆合金管相同。
优选地，球囊内管与球囊手柄接触的部位采用医用级胶水粘接；球囊手柄配件与球囊手柄接触部位采用医用级的胶水粘接。
优选地，所述球囊外管与所述支撑丝之间还设有或不设一球囊内管，所述球囊内管的近端固定于所述突出部的近端面上的所述孔道中，所述球囊内管的远端与所述球囊的远端接触。
进一步地，不设所述球囊内管，所述球囊外管从所述球囊近端直接插入到所述球囊远端，所述球囊的近端和远端均与所述球囊外管热熔焊接或激光焊接；处于所述球囊内部的所述球囊外管上设有开口；在所述球囊远端的所述球囊外管内通过UV胶或PU棒密封。
进一步地，在设有球囊内管的一个实施例中，所述球囊内管的远端与所述球囊的远端通过热熔焊接或激光焊接，并在球囊内管中通过UV胶进行密封，所述支撑丝与所述UV胶接触。
进一步地，在设有球囊内管的一个实施例中，所述球囊远端与所述球囊内管通过过渡管热熔焊接或激光焊接；堵头近端与所述支撑丝远端激光焊接后，所述 堵头的近端面与所述球囊远端面采用医用级胶水进行粘接密封。
优选地，所述球囊外管外表面还套设加强管，所述加强管与所述球囊外管通过医用级胶水粘接，所述加强管与所述球囊手柄配件一体注塑成型。
球囊外管是PU材质的管材相对较软，加强管的作用有两个：一个是对球囊外管起保护作用，第二个是可以利用加强管的刚性在送入球囊时更加容易。
优选地，所述形状记忆合金管的远端设置一段弯曲部；初始状态下，球囊位于形状记忆合金管内部，利用这种方式可以对形状记忆合金管远端起到一定的密封作用，防止在扩椎的过程中椎体内部的松质骨进入形状记忆合金管，而扩椎是利用形状记忆合金管头端对椎体内部的松质骨进行挤压而建立球囊通道。
本发明采用上述技术方案，与现有技术相比，具有如下技术效果：
1、本申请的多功能椎体成形器，有机结合了骨钻的扩椎、球囊导管的预扩和骨水泥填充的功能，减少了手术器械的数量，简化了手术步骤，节省了手术时间，降低了患者的经济负担；
2、形状记忆合金管采用螺纹结构输送的方式，调节精度高，手术更加安全；
3、形状记忆合金管可以直接通过弯曲的角度从椎体穿刺的一侧到达椎体对侧，减少了手术步骤、降低对患者身体的压力，使椎体只需要一次穿刺即可完成扩椎(建立球囊通道)、球囊预扩(建立骨水泥填充的空腔)、直接与骨水泥注射套件连接完成骨水泥的注射操作，操作简单方便。
附图说明
图1为本发明一种多功能椎体成形器结构示意图；
图2a为本发明一种多功能椎体成形器结构第一角度剖视图；
图2b为图2a中A区域结构示意图；
图3a为本发明一种多功能椎体成形器结构第二角度剖视图；
图3b为图3a中B区域结构示意图；
图4为本发明一种多功能椎体成形器近端各组件相对位置关系剖视图；
图5为本发明一种多功能椎体成形器球囊输送卡扣与滑块连接示意图；
图6为本发明一种多功能椎体成形器滑块结构示意图；
图7为本发明一种多功能椎体成形器插入工作套管后结构示意图；
图8a为本发明一种多功能椎体成形器实现球囊预扩前卡扣位置示意图；
图8b为本发明一种多功能椎体成形器实现球囊预扩后卡扣位置示意图；
图9为本发明一种多功能椎体成形器球囊输送卡扣配件示意图；
图10a为本发明一种多功能椎体成形器实施例2中建立球囊通道工作方式示意图；
图10b为本发明一种多功能椎体成形器实施例3中建立球囊通道第二种工作方式示意图；
图11a为本发明一种多功能椎体成形器实施例2中实现球囊预扩工作方式示意图；
图11b为本发明一种多功能椎体成形器实施例3中实现球囊预扩工作方式示意图；
图12a为本发明一种多功能椎体成形器实施例2中拔出球囊结构工作方式示意图；
图12b为本发明一种多功能椎体成形器实施例3中拔出球囊结构工作方式示意图；
图13a为本发明一种多功能椎体成形器拔出球囊结构前球囊输送卡扣与限位件相对位置剖视图；
图13b为本发明一种多功能椎体成形器拔出球囊结构后球囊输送卡扣与限位件相对位置剖视图；
图14为本发明一种多功能椎体成形器球囊结构示意图；
图15为本发明一种多功能椎体成形器拔出球囊结构后结构示意图；
图16a为本发明一种多功能椎体成形器第一种球囊远端的处理形式示意图；
图16b为本发明一种多功能椎体成形器第二种球囊远端的处理形式示意图；
图16c为本发明一种多功能椎体成形器第三种球囊远端的处理形式示意图；
图16d为本发明一种多功能椎体成形器第四种球囊远端的处理形式示意图；
图16e为本发明一种多功能椎体成形器第五种球囊远端的处理形式示意图；
图16f为本发明一种多功能椎体成形器第六种球囊远端的处理形式示意图；
图17为本发明一种多功能椎体成形器端盖结构示意图；
图中标记表示说明：
1-球囊结构，11-球囊手柄，111-突出部，112-空腔接口，113-支撑丝座，114-孔道，12-球囊手柄配件，121-加强管，13-球囊输送卡扣，131-第二卡耳，132-第四卡耳，14-球囊输送卡扣配件，141-滑槽，142-卡槽，143-第三卡耳，15-球囊，151-堵头，152-过渡管，153-UV胶，154-PU棒，16-球囊外管，161-外管开口，17-球囊内管，18-支撑丝，
2-输送管结构，21-形状记忆合金管，22-外管调节手柄，23-滑块，231-第一卡耳，24-限位件，241-限位卡槽，242-弧形部，25-端盖，251-圆柱销，26-锁定环，261-顶块，27-弯曲部，28-外管，
3-工作套管结构，31-工作套管手柄，32-工作套管；
具体实施方式
下面通过具体实施例对本发明进行详细和具体的介绍，以使更好的理解本发明，但是下述实施例并不限制本发明范围。
在下述实施例中，近端表示靠近操作者方向，远端表示靠近患者方向；顺时针为相对于操作者的顺时针方向，逆时针是相对于操作者的逆时针方向。
实施例1
本实施例提供了一种多功能椎体成形器，如图1、2a-2b和3a-3b，其包括
一球囊结构1，其包括球囊外管16、球囊手柄11和球囊15；所述球囊外管16的近端外表面从内到外依次套设有球囊手柄配件12、所述球囊手柄11、球囊输送卡扣13；其中，所述球囊手柄11与球囊输送卡扣13通过球囊输送卡扣13上的第四卡耳132和球囊手柄11上的卡槽相配合可旋转固定；所述球囊手柄配件12与所述球囊手柄11固定连接；所述球囊外管16远端与所述球囊15固定连接，所述球囊15远端密封；
一输送管结构2，包括形状记忆合金管21、滑块23和外管调节手柄22，所述形状记忆合金管21套设于所述球囊外管16和所述球囊15的外部，所述形状记忆合金管21与所述滑块23一体注塑成型；所述滑块23的近端通过第一卡耳231与所述球囊输送卡扣13可拆卸连接；所述滑块23外表面设有螺纹结构，具有内螺纹结构的所述外管调节手柄22套设于所述滑块23的外表面，通过旋转所 述外管调节手柄22带动所述滑块23前后移动，从而控制所述形状记忆合金管21远端相对于外管28远端的突出量和所述球囊15远端相对于所述形状记忆合金管21远端的突出量。
本实施例中，如图2a-2b、3a-3b中，所述球囊结构1还包括球囊输送卡扣配件14，其套设于所述球囊输送卡扣13外部，所述球囊输送卡扣13远端的第二卡耳131插入所述球囊输送卡扣配件14内表面的滑槽141中，所述滑槽141的远端设置一卡槽142；所述球囊输送卡扣配件14的远端通过卡扣与套设在所述滑块23外部的限位件24可拆卸连接；所述限位件24远端的内圆边缘沿所述滑块23的外表面朝远端方向延伸多个互不相连弧形部242，所述弧形部242的远端通过圆柱销251固定在端盖25的近端，所述端盖25通过锁定环26与工作套管手柄31匹配锁定；所述外管调节手柄22套设在所述弧形部242外部，所述滑块23外表面的螺纹结构延伸出所述弧形部242的间隙，与所述外管调节手柄22的内螺纹结构配合。
本实施例中，所述锁定环26套设在所述端盖25远端外部，一顶块261套设于所述端盖25远端和所述锁定环26之间，并与所述端盖25远端螺纹连接；所述锁定环26的近端通过端盖25和所述顶块261固定，所述锁定环26的近端可环绕所述端盖25转动，所述锁定环26的远端通过卡扣与工作套管手柄31相配合固定。
本实施例中，如图1、17中，所述外管28套设于所述形状记忆合金管21外部，所述外管28与所述端盖25一体注塑成型。外管28带有一定的刚性，辅助所述椎体成形器的远端进入到椎间指定位置，当放出的形状记忆合金管21远端呈现一定的弯曲角度，需要再将其回收到工作套管32时，可以先将其回收至外管28中。
本实施例中，如图4中，所述球囊手柄11的近端相对所述球囊手柄配件12近端和所述球囊输送卡扣13近端延伸出一突出部111，所述突出部111的近端面密闭以形成空腔，所述突出部111的侧壁设一空腔接口112；所述球囊外管16通过所述突出部111与外界连通。
本实施例中，如图2a、3a、4、16a-16f中，所述突出部111的近端面外侧，通过螺纹连接一支撑丝座113，所述支撑丝座113与支撑丝18近端固定连接， 所述支撑丝118依次插入所述突出部111的近端面上的孔道114、所述球囊外管16和所述球囊15，最终所述支撑丝18的远端面与所述球囊15的远端接触；当所述支撑丝18的远端没有与之焊接的所述堵头151时，可通过旋转所述支撑丝座113，与所述支撑座分离，然后将整个所述支撑丝18抽出。
本发明的一个实施例中，图10b中，所述形状记忆合金管21的远端设置一段弯曲部27，初始状态下，球囊15位于形状记忆合金管21内部，可以对形状记忆合金管21远端起到一定的密封作用，防止在扩椎的过程中椎体内部的松质骨进入形状记忆合金管21，而扩椎是利用形状记忆合金管头端对椎体内部的松质骨进行挤压而建立球囊通道；优选地，形状记忆合金管本身为记忆性金属，通过定型模具上设计的定型角度，形状记忆合金管经过热处理后能呈现90°的弯角；形状记忆合金管经过热处理的目的是为了降低其Af点(恢复到弯角状态时温度)获得超弹性，所以形状记忆合金管在超出外管后利用其自身的记忆性能和热处理后的超弹性，能自动恢复至弯角状态；更进一步地，本实施例中，形状记忆合金管热处理定型后将其Af点控制在20℃左右，当温度高于Af点时，形状记忆合金管能迅速恢复至弯角状态，在建立球囊通道时形状记忆合金管是进入椎体内部，而人体内部的温度37℃左右，所以当形状记忆合金管从套管中出来时就会以定型的弯角状态在椎体内部建立球囊通道，从而形状记忆合金管可以直接通过弯曲部从椎体穿刺的一侧到达椎体对侧。
本实施例中所述支撑丝18为半刚性材质材质，给球囊结构1的远端提供足够的刚性，使其可以进入到椎体之间；形状记忆合金管21的远端有一弯曲部27如图10b所示，在形状记忆合金管21呈现出一定的弯曲角度时，对所述支撑丝18施加一个使其弯曲的力，从而整个球囊结构1的远端变弯曲，弯曲角度与形状记忆合金管21相同如图11b所示。
本实施例中，如图4、16a-16f中，所述球囊外管16外表面还套设加强管121，所述加强管121与所述球囊外管16通过医用级胶水粘接，所述加强管121与所述球囊手柄配件12一体注塑成型。
本实施例中，如图16a中，所述球囊外管16的远端与所述球囊15的近端热熔焊接或激光焊接；所述球囊15远端通过UV胶153密封。
本发明的一个实施例中，如图16b中，所述球囊外管16的远端与所述球囊 15的近端热熔焊接或激光焊接；所述球囊15远端通过PU棒154与球囊热熔焊接或激光焊接密封。
本发明的一个实施例中，如图16c中，所述球囊外管16从所述球囊15近端直接插入到所述球囊15远端，所述球囊15的近端和远端均与所述球囊外管16热熔焊接或激光焊接；处于所述球囊15内部的所述球囊外管16上设有外管开口161；在所述球囊远端的所述球囊外管16内点UV胶153密封。
本发明的一个实施例中，如图16d中，所述球囊外管16从所述球囊15近端直接插入到所述球囊15远端，所述球囊15的近端和远端均与所述球囊外管16热熔焊接或激光焊接；处于所述球囊15内部的所述球囊外管16上设有外管开口161；在所述球囊远端的所述球囊外管16内通过PU棒154与球囊热熔焊接或激光焊接密封。
本发明的一个实施例中，如图16e-16f中，所述球囊外管16的远端与所述球囊15的近端热熔焊接或激光焊接；所述球囊外管16与所述支撑丝18之间还有一球囊内管17，所述球囊内管17的近端固定于所述突出部111的近端面上的所述孔道114中，所述球囊内管17的远端与所述球囊15的远端固定连接。
本发明的一个实施例中，如图16e中，所述球囊15远端与所述球囊内管17通过过渡管152热熔焊接或激光焊接；球囊内管17中通过UV胶153进行密封，所述支撑丝18的远端抵住所述UV胶153。
本发明的一个实施例中，如图16f中，所述球囊15远端与所述球囊内管17通过过渡管152热熔焊接或激光焊接；堵头151近端与所述支撑丝18远端激光焊接后，所述堵头151的近端面与所述球囊15远端面采用医用级胶水进行粘接密封。
实施例2
本实施例中提供实施例1中所述多功能椎体成形器的工作原理。
(1)操作开始前，如图2a、3a、5、14-15所示，将所述输送管结构2通过卡扣连接在球囊组结构1外，滑块23上的第一卡耳231卡设在球囊输送卡扣13远端的卡槽上，球囊输送卡扣配件14上的第三卡耳143卡设在限位件24上的限位卡槽241上；如图1和图5所示，建立好工作通道后，将实施例1中提供的多功能椎体成形器插入工作套管结构3中，旋转锁定环26将多功能椎体成形器与 工作套管结构3上的工作套管手柄31固定；
(2)如图10a所示，顺时针转动外管调节手柄22，通过外管调节手柄22与滑块23上螺纹传动带动球囊结构1及滑块23向前运动，使球囊15跟随形状记忆合金管21伸入椎体内部，直至形状记忆合金管21伸出至预设部位，以实现扩椎并建立球囊通道；如图9所示，球囊通道建立完成后，球囊输送卡扣13上的第二卡耳131位于球囊输送卡扣配件14的滑槽141底部；
(3)如图8a-8b、图9、图11a所示，逆时针旋转球囊输送卡扣13，使滑块23上的第一卡耳231完全脱离球囊输送卡扣13远端卡槽的限制，使滑块23完全脱离球囊输送卡扣13的限制，并将第二卡耳131旋入球囊输送卡扣配件14的滑槽141底部的卡槽142中；再逆时针旋转外管调节手柄22，使形状记忆合金管21撤回到外管28中，至此将球囊15完全置于建立好的球囊通道中；
(4)通过球囊手柄11上的空腔接口112与压力泵连接，向球囊15内注入造影剂，将压缩性骨折的椎体复位并制造出一个骨水泥填充的空腔，实现单侧球囊预扩；球囊单侧预扩完成后，通过压力泵将注入球囊15内的造影剂抽回；
(5)再使用相同的另一套手术装置，通过对椎体另一侧进行穿刺实现椎体另一侧球囊预扩，球囊预扩完成后，通过压力泵将注入球囊15内的造影剂抽回；
(6)如图13a-13b和12a所示，此时顺时针转动球囊输送卡扣配件14，使球囊输送卡扣配件14上的两个第三卡耳143脱离限位件24的限制，然后向后拔出如图14所示的球囊结构；
(7)将骨水泥注射套件与如图15所示结构中滑块23上的接头连接后向建立的骨水泥填充空腔中注入骨水泥，最后撤出工作套管，完成手术。
实施例3
本实施例中提供实施例1中所述多功能椎体成形器的工作原理。
(1)操作开始前，如图2a、3a、5、14-15所示，将所述输送管结构2通过卡扣连接在球囊结构1外，滑块23上的第一卡耳231卡设在球囊输送卡扣13远端的卡槽上，球囊输送卡扣配件14上的第三卡耳143卡设在限位件24上的限位卡槽241上；如图1和图5所示，建立好工作通道后，将实施例1中提供的多功能椎体成形器插入工作套管结构3中，旋转锁定环26将多功能椎体成形器与工作套管结构3上的工作套管手柄31固定；
(2)如图10b所示，顺时针转动外管调节手柄22，通过外管调节手柄22与滑块23上螺纹结构传动带动球囊结构1及滑块23向前运动，使球囊15跟随形状记忆合金管21伸入椎体内部，直至形状记忆合金管21伸出至预设部位，以实现扩椎并建立球囊通道，形状记忆合金管21可以直接通过弯曲部27从椎体的一侧穿刺到达椎体对侧；如图9所示，球囊通道建立完成后，球囊输送卡扣13上的第二卡耳131位于球囊输送卡扣配件14的滑槽141底部；
(3)如图8a-8b、图9、图11b所示，逆时针旋转球囊输送卡扣13，使滑块23上的第一卡耳231完全脱离球囊输送卡扣13远端卡槽的限制，使滑块23完全脱离球囊输送卡扣13的限制，并将第二卡耳131旋入球囊输送卡扣配件14的滑槽141底部的卡槽142中，此时球囊输送卡扣13与球囊输送卡扣配件14锁紧；再逆时针旋转外管调节手柄22，使形状记忆合金管21撤回到外管28中，至此将球囊15完全置于建立好的球囊通道中；
(4)通过球囊手柄11上的空腔接口112与压力泵连接，向球囊15内注入造影剂，将压缩性骨折的椎体复位并制造出一个骨水泥填充的空腔，实现单侧球囊预扩；球囊单侧预扩完成后，通过压力泵将注入球囊15内的造影剂抽回；
(5)如图12b和13a-13b所示，此时顺时针转动球囊输送卡扣配件14，使球囊输送卡扣配件14上的两个第三卡耳143脱离限位件24的限制，然后向后拔出如图14所示的球囊结构；
(6)将骨水泥注射套件与如图15所示结构中滑块23上的接头连接后向建立的骨水泥填充空腔中注入骨水泥，最后撤出工作套管，完成手术。
以上对本发明的具体实施例进行了详细描述，但其只是作为范例，本发明并不限制于以上描述的具体实施例。对于本领域技术人员而言，任何对本发明进行的等同修改和替代也都在本发明的范畴之中。因此，在不脱离本发明的精神和范围下所作的均等变换和修改，都应涵盖在本发明的范围内。

Claims (10)

  1. 一种多功能椎体成形器，其特征在于，包括
    一球囊结构(1)，其包括球囊外管(16)、球囊手柄(11)和球囊(15)；所述球囊外管(16)的近端外表面从内到外依次套设有球囊手柄配件(12)、所述球囊手柄(11)、球囊输送卡扣(13)；其中，所述球囊手柄(11)与所述球囊输送卡扣(13)通过卡扣可旋转固定连接，所述球囊手柄配件(12)与所述球囊手柄(11)固定连接；所述球囊外管(16)远端与所述球囊(15)固定连接，所述球囊(15)远端密封；
    一输送管结构(2)，包括形状记忆合金管(21)、滑块(23)和外管调节手柄(22)，所述形状记忆合金管(21)套设于所述球囊外管(16)和所述球囊(15)的外部，所述形状记忆合金管(21)与所述滑块(23)一体注塑成型；所述滑块(23)的近端通过第一卡耳(231)与所述球囊输送卡扣(13)可拆卸连接；所述滑块(23)外表面设有螺纹结构，具有内螺纹结构的所述外管调节手柄(22)套设于所述滑块(23)的外表面，通过旋转所述外管调节手柄(22)带动所述滑块(23)前后移动，从而控制所述形状记忆合金管(21)远端相对于外管(28)远端的突出量和所述球囊(15)远端相对于所述形状记忆合金管(21)远端的突出量。
  2. 根据权利要求1所述的多功能椎体成形器，其特征在于，所述球囊结构(1)还包括球囊输送卡扣配件(14)，其套设于所述球囊输送卡扣(13)外部，所述球囊输送卡扣(13)远端的第二卡耳(131)插入所述球囊输送卡扣配件(14)内表面的滑槽(141)中，所述滑槽(141)的远端设置一卡槽(142)；所述球囊输送卡扣配件(14)的远端通过卡扣与套设在所述滑块(23)外部的限位件(24)可拆卸连接；所述限位件(24)远端的内圆边缘沿所述滑块(23)的外表面朝远端方向延伸多个互不相连弧形部(242)，所述弧形部(242)的远端通过圆柱销(251)固定在端盖(25)的近端，所述端盖(25)通过锁定环(26)与工作套管手柄(31)匹配锁定；所述外管调节手柄(22)套设在所述弧形部(242)外部，所述滑块(23)外表面的螺纹结构延伸出所述弧形部(242)的间隙，与所述外管调节手柄(22)的内螺纹结构配合。
  3. 根据权利要求2所述的多功能椎体成形器，其特征在于，所述外管(28)套设于所述形状记忆合金管(21)外部，所述外管(28)与所述端盖(25)一体注塑成型；一顶块(261)套设于所述端盖(25)远端和所述锁定环(26)之间，并与所述端盖25远端螺纹连接；所述锁定环(26)的近端通过所述端盖(25)和所述顶块(261)固定，所述所述锁定环(26)的近端可环绕所述端盖(25)转动，所述锁定环(26)的远端通过卡扣与所述工作套管手柄(31)相配合固定。
  4. 根据权利要求1所述的多功能椎体成形器，其特征在于，所述球囊手柄(11)的近端相对于所述球囊手柄配件(12)近端和所述球囊输送卡扣(13)近端延伸出一突出部(111)，所述突出部(111)的近端面密闭以形成空腔，所述突出部(111)的侧壁设一空腔接口(112)；所述球囊外管(16)通过所述突出部(111)与外界连通。
  5. 根据权利要求4所述的多功能椎体成形器，其特征在于，所述突出部(111)的近端面外侧，通过螺纹连接一支撑丝座(113)，所述支撑丝座(113)与支撑丝(18)近端固定连接，所述支撑丝(18)依次插入所述突出部(111)的近端面上的孔道(114)、所述球囊外管(16)和所述球囊(15)，最终所述支撑丝(18)的远端面与所述球囊(15)的远端接触。
  6. 根据权利要求5所述的多功能椎体成形器，其特征在于，所述球囊外管(16)与所述支撑丝(18)之间还设有或不设一球囊内管(17)，所述球囊内管(17)的近端固定于所述突出部(111)的近端面上的所述孔道(114)中，所述球囊内管(17)的远端与所述球囊(15)的远端固定连接。
  7. 根据权利要求6所述的多功能椎体成形器，其特征在于，不设所述球囊内管(17)，所述球囊外管(16)从所述球囊(15)近端直接插入到所述球囊(15)远端，所述球囊(15)的近端和远端均与所述球囊外管(16)热熔焊接或激光焊接；处于所述球囊(15)内部的所述球囊外管(16)上设有外管开口(161)；在 所述球囊(15)远端的所述球囊外管(16)内通过UV胶(153)或PU棒(154)密封。
  8. 根据权利要求6所述的多功能椎体成形器，其特征在于，设有所述球囊内管(17)，所述球囊(15)远端与所述球囊内管(17)通过过渡管(152)热熔焊接或激光焊接；堵头(151)近端与所述支撑丝(18)远端激光焊接后，所述堵头(151)的近端面与所述球囊(15)远端面采用医用级胶水进行粘接密封。
  9. 根据权利要求1所述的多功能椎体成形器，其特征在于，所述球囊外管(16)外表面还套设加强管(121)，所述加强管(121)与所述球囊外管(16)通过医用级胶水粘接，所述加强管(121)与所述球囊手柄配件(12)一体注塑成型。
  10. 根据权利要求1所述的多功能椎体成形器，其特征在于，所述形状记忆合金管(21)的远端设置一段弯曲部(27)。
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