WO2020103710A1 - 一体式多功能椎体成形器械 - Google Patents

一体式多功能椎体成形器械

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Publication number
WO2020103710A1
WO2020103710A1 PCT/CN2019/116828 CN2019116828W WO2020103710A1 WO 2020103710 A1 WO2020103710 A1 WO 2020103710A1 CN 2019116828 W CN2019116828 W CN 2019116828W WO 2020103710 A1 WO2020103710 A1 WO 2020103710A1
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WO
WIPO (PCT)
Prior art keywords
outer tube
balloon
handle
assembly
tube
Prior art date
Application number
PCT/CN2019/116828
Other languages
English (en)
French (fr)
Inventor
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
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 宁波华科润生物科技有限公司 filed Critical 宁波华科润生物科技有限公司
Publication of WO2020103710A1 publication Critical patent/WO2020103710A1/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
    • A61B17/88—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
    • A61B17/885—Tools for expanding or compacting bones or discs or cavities therein

Definitions

  • the invention belongs to the technical field of medical instruments, and particularly relates to an integrated multifunctional vertebral body shaping instrument used in vertebroplasty.
  • Osteoporotic vertebral compression fractures are a common disease that endangers the health of middle-aged and elderly people.
  • traditional treatment methods are mainly conservative, including bed rest, medical pain relief, and external fixation of braces.
  • the further loss of bone mass exacerbates osteoporosis, resulting in a vicious cycle; and open surgery is often due to the patient's poor general health and insufficient screw fixation strength, which can easily lead to internal fixation failure.
  • the Chinese patent with the patent number 201310671713.6 discloses a vertebral balloon expansion system, which is designed with a rigid head to protect the balloon sleeve and liner core.
  • the distal end of the balloon Before the expansion of the working channel, the distal end of the balloon is fixedly connected with a closed head.
  • the head of this technology is set at the distal end of the balloon. The part where the distal end of the balloon and the head are connected involves the ball
  • the sealing problem of balloon expansion has a certain risk of leakage when the balloon is expanded.
  • this technology only realizes the open channel and expansion before expansion, does not achieve the filling function of bone filler, and does not achieve the largest reduction. The financial burden of the patient.
  • the technical problem to be solved by the present invention is to propose an integrated multi-functional vertebral body shaping instrument integrating the establishment of a lumen, expansion and delivery of bone filler in view of the above-mentioned defects in the prior art.
  • the present invention adopts the following technical solutions:
  • the first technical solution of the present invention is to provide an integrated multifunctional vertebroplasty instrument, which includes a balloon component, an angle adjustment component, and an angle opening cavity assembly.
  • the angle opening cavity assembly includes an outer tube component and an opening cavity Lining components, of which:
  • the outer tube assembly includes an outer tube and an outer tube handle, the outer tube handle is disposed at a proximal end of the outer tube, the outer tube has an axial rigidity to withstand tissue open cavity thrust without deformation, and the outer tube handle There is a bone filler injection interface on it;
  • the open cavity liner assembly includes a head, a connector, and a connector handle.
  • the head is disposed at a distal end of the connector.
  • the maximum outer diameter of the head is less than or equal to the inner diameter of the outer tube.
  • the proximal end of the connector is provided on the handle of the connector; and
  • the angle adjustment component includes an adjustment handle and an adjustment tube, the adjustment handle is provided at a proximal end of the adjustment tube, and the fixed angle portion of the outer tube is pre-installed in the adjustment tube;
  • the distal portion of the balloon assembly is inserted into the outer tube assembly along the connector, and the outer tube can be moved back and forth along the axis of the balloon assembly by operating the outer tube handle; By operating the handle of the adjustment tube, the fixed angled portion of the distal end of the outer tube can be released and recovered.
  • the The bone filler injection interface injects bone filler to achieve vertebral body filling.
  • the second technical solution of the present invention is to provide another integrated multifunctional vertebroplasty instrument, which includes a balloon component, an angle adjustment component, and an angle opening cavity assembly.
  • the angle opening cavity assembly includes an outer tube component and an open cavity liner Components, where:
  • the outer tube assembly includes an outer tube and an outer tube handle, the outer tube handle is disposed at a proximal end of the outer tube, the outer tube has an axial rigidity to withstand tissue open cavity thrust without deformation, and the outer tube The distal end is a fixed angle, the distal end of the outer tube is provided with a side hole, and the outer tube handle is provided with a bone filler injection interface;
  • the open cavity liner assembly includes a head and a connector, the head is disposed at a distal end of the connector, and the maximum outer diameter of the head is larger than the inner diameter of the outer tube;
  • the angle adjustment component includes an adjustment handle and an adjustment tube, and the fixed angle part at the distal end of the outer tube is pre-installed in the adjustment tube;
  • the distal portion of the balloon assembly is inserted into the outer tube assembly along the connector, and by operating the outer tube handle, the outer tube can be moved back and forth along the axis of the balloon assembly; Operating the handle of the adjustment tube can release and recover the fixed angled portion of the distal end of the outer tube.
  • bone filling is injected through the bone filler injection interface Objects to achieve vertebral body filling.
  • the distal end of the outer tube is at a fixed bend angle, and the distal end of the connecting member cooperates with the distal end of the outer tube.
  • the balloon assembly includes a balloon body, a developing ring, an inner balloon tube, an outer balloon tube, and a balloon handle, and the balloon body is composed of a single layer of polymer It is made of material or is made of outer mesh bag and inner polymer material balloon.
  • the distal end of the balloon body is fixedly connected to the inner tube, and the proximal end of the balloon body is far away from the outer tube of the balloon.
  • the end of the balloon outer tube is fixedly connected to the balloon handle, the distal end of the balloon inner tube is a curved section, and the proximal end is a straight section, the balloon inner tube and the balloon outer Channels are formed between the tubes.
  • the connector handle and the balloon handle are of an integrated structure.
  • the outer tube handle is detachably connected to the balloon handle or the connector handle.
  • the connecting member is an inner balloon tube of the balloon assembly, and the distal end of the inner balloon tube extends beyond the distal end of the balloon body and is connected to the head .
  • the outer tube is provided with one or more side holes.
  • the outer tube handle is provided with a hole along the axial direction of the outer tube.
  • the proximal end of the connecting member is detachably connected to the hole.
  • the present invention adopts the above technical solution, and compared with the prior art, has the following technical effects:
  • each vertebral body needs to be bilaterally punctured / built a cavity, bilateral expansion and bilateral filling
  • the distal end of the integrated multifunctional vertebroplasty instrument of the present invention can be a fixed curved section, and the distal end of the instrument is sent to the center of the vertebral body or the opposite side of the vertebral body.
  • Unilateral puncture achieves the purpose of bilateral surgery and effectively relieves patients Trauma, reduce the operation time, reduce the occurrence of complications, and reduce the financial burden of patients.
  • each vertebral body needs to use a puncture needle to establish a working channel, and then use a bone drill to establish a cavity in the vertebral body, then withdraw the bone drill, and then send the balloon into the vertebral body Expand and expand the vertebral body to form a cavity, and finally withdraw the balloon and inject bone cement; and the integrated multifunctional vertebral body shaping instrument of the present invention can achieve multiple functions with only one instrument, that is A working channel of a large size, establishes a cavity in the vertebral body, then expands, and finally delivers the bone filler from the bone filler injection port on the outer tube handle under a low pressure environment, the operation is simple and convenient, the operation time is shortened, and the patient is further relieved
  • the sealing head designed by the present invention is fixedly connected to the distal end of the connecting member, which effectively reduces the risk that the connection between the sealing head and the distal end of the balloon may cause insufficient sealing during expansion;
  • the balloon designed by the present invention is made of an outer mesh bag and an inner polymer balloon, this design increases the pressure resistance of the entire balloon and increases the safety of the operation;
  • the fixed angle part of the distal end of the outer tube designed by the present invention is pre-installed in the adjustment tube, so that the instrument passes straight through the working channel, so that the operator does not have to put the instrument into the working channel without difficulty, and realizes the external by operating the adjustment tube handle
  • the release and recovery of the fixed angled part of the distal end of the tube, the thread transmission increases the controllability of the operation, and provides greater propulsion, greatly reducing the difficulty of operating the instrument, allowing the user to operate the instrument more flexibly, and shortening the operation Time to reduce the risk of surgery.
  • FIG. 1 is a schematic structural diagram of a first embodiment of the present invention
  • FIG. 1a is a schematic diagram of the enlarged structure of the balloon assembly and area B of the first embodiment
  • FIG. 1b is a schematic diagram of the structure of the angle-opening cavity assembly of the first embodiment
  • FIG. 1c is a schematic structural diagram of a bend angle adjustment assembly of the first embodiment
  • FIG. 1d is a schematic diagram of the distal structure of the instrument of the first embodiment
  • FIG. 1e is a schematic structural view of the first embodiment of the present invention for establishing a cavity in a vertebral body
  • FIG. 1f is a schematic view of the structure of the balloon withdrawn from the outer tube of the first embodiment
  • FIG. 1g is a schematic structural view of the balloon expansion and expansion of the vertebral body of the first embodiment
  • FIG. 1h is a schematic structural view of the balloon assembly and the open cavity liner assembly withdrawn from the outer tube assembly of the first embodiment
  • FIG. 1i is a schematic structural view of the first embodiment for transporting bone filler along the outer tube
  • FIG. 2 is a schematic structural diagram of a second embodiment of the present invention.
  • FIG. 2a is a schematic diagram of the enlarged structure of the balloon assembly and area B of the second embodiment
  • FIG. 2b is a schematic diagram of the structure of the angle-opening cavity assembly of the second embodiment
  • FIG. 2c is a schematic diagram of the structure of the angle adjustment component of the second embodiment
  • 2d is a schematic diagram of the distal structure of the instrument of the second embodiment
  • 2e is a schematic structural view of the second embodiment of the present invention for establishing a cavity in the vertebral body
  • FIG. 2f is a schematic diagram of the structure of the second embodiment to release the outer tube to release the balloon;
  • 2g is a schematic view of the structure of the balloon expansion and expansion of the vertebral body of the second embodiment
  • 2h is a schematic structural view of the balloon assembly withdrawn from the outer tube assembly of the second embodiment
  • 2i is a schematic structural view of the second embodiment for transporting bone filler along the outer tube and the side hole;
  • FIG. 3 is a schematic structural diagram of a third embodiment of the present invention.
  • FIG. 3a is a schematic diagram of an enlarged structure of a balloon assembly and area B of the third embodiment
  • Fig. 3b is a schematic diagram of the structure of the angle-opening cavity assembly of the third embodiment
  • FIG. 3c is a schematic structural diagram of a bend angle adjustment assembly of a third embodiment
  • FIG. 3d is a schematic diagram of the distal structure of the instrument according to the third embodiment.
  • 3e is a schematic structural view of the third embodiment of the utility model for establishing a cavity in the vertebral body
  • FIG. 3f is a schematic view of the structure of the third embodiment of the outer tube withdrawing the balloon to release the balloon;
  • FIG. 3g is a schematic structural view of the balloon expansion and expansion of the vertebral body of the third embodiment
  • FIG. 3h is a schematic structural view of the balloon assembly and the open cavity liner assembly withdrawn from the outer tube assembly of the third embodiment
  • 3i is a schematic structural view of the third embodiment of transporting bone filler along the outer tube
  • 1-balloon assembly 11-balloon body, 111-mesh bag, 112-balloon, 12-developing ring, 13-inner tube, 14-outer tube, 15-balloon handle, 16-between inner tube and appearance Access, 17-gas or liquid, 2-angle open cavity assembly, 21-open cavity outer tube assembly, 22-open cavity inner liner assembly, 211-outer tube, 2110-side hole, 212-outer tube handle, 2120-bone filling Injection port, 2121-hole, 221-head, 222-connector, 223-connector handle, 23-filler, 3-bend adjustment assembly, 31-adjusting tube, 32-adjusting tube handle, 4- Working channel.
  • this embodiment provides an integrated multifunctional vertebroplasty instrument, which includes a balloon assembly 1, an angle-opening chamber assembly 2 and an angle-adjusting assembly 3.
  • the proximal end refers to the end close to the operator, and the distal end refers to the end far from the operator.
  • the balloon assembly 1 includes a balloon body 11, a developing ring 12, a balloon inner tube 13, a balloon outer tube 14, and a balloon handle 15, the balloon body 11 is made of a single layer of polymer material
  • the distal end of the balloon body 11 is fixedly connected to the inner tube 13, the proximal end of the balloon body 11 is fixedly connected to the distal end of the balloon outer tube 14, the proximal end of the balloon outer tube 14 and
  • the balloon handle 15 is fixedly connected, the distal end of the balloon inner tube 13 is a curved section, and the proximal end is a straight section.
  • Between the balloon inner tube 13 and the balloon outer tube 14 is a passage 16 that can pass through The passage 16 injects gas or liquid 17 into the capsule 11.
  • the cavity opening assembly 2 includes an outer tube assembly 21 and a cavity opening lining assembly 22, the outer tube assembly includes an outer tube 211 and an outer tube handle 212, the cavity opening lining assembly 22 includes a head 221,
  • the connecting piece 222 and the connecting piece handle 223, the outer tube 211 has a rigidity to withstand the tissue cavity pushing force without deformation, the sealing head 221 is fixedly connected to the distal end of the connecting piece 222, the maximum outer diameter of the sealing head 221 Less than or equal to the inner diameter of the outer tube 211, the distal end of the outer tube 211 is a fixed curved section, the outer tube 211 is made of a memory alloy material or a metal material or a combination of both materials,
  • the outer tube handle 212 is provided with a bone filler injection interface 2120.
  • the angle adjustment assembly 3 includes an adjustment handle 32 and an adjustment tube 31, the adjustment handle 32 is detachably connected to the outer tube handle 212, and the fixed angle at the distal end of the outer tube 211 The part is pre-installed in the adjustment tube 31, and the fixed angle part of the distal end of the outer tube 211 is released and recovered by operating the adjustment tube handle 32.
  • the fixed corner part of the distal end of the outer tube 211 is pre-installed in the adjustment tube 31, the bladder 11 is disposed inside the outer tube 211, and the head 221 can be
  • the outer tube 211 slides inside, the outer tube 211, the balloon inner tube 13 and the distal curved section of the connector 221 cooperate, and the distal portion of the balloon assembly 1 is along the connector 222 Inserted inside the outer tube assembly 21 described above.
  • the specific surgical procedure is as follows:
  • the integrated multifunctional vertebroplasty instrument As shown in FIG. 1e, insert the integrated multifunctional vertebroplasty instrument along the working channel 4, and release the fixed angled portion of the distal end of the outer tube 211 into the vertebral body by operating the adjustment tube handle 32, and observe under perspective, Until the head 221 crosses the center of the vertebral body and reaches the opposite side of the vertebral body, the cavity is established.
  • the gas or liquid 17 is injected into the capsule 11 along the passage 16 to expand and expand the vertebral body.
  • the inflation gas or liquid is withdrawn along the passage 16, and then the balloon assembly 1 and the open cavity liner assembly 22 are withdrawn from the outer tube assembly 21, at this time the interior of the vertebral body Leave a cavity.
  • the filler 23 is delivered into the vertebral body along the bone filler injection interface 2120 and the outer tube 211 until the filler 23 fills the internal cavity of the vertebral body, and all instruments are withdrawn, completing surgery.
  • this embodiment provides an integrated multifunctional vertebroplasty instrument, which includes a balloon assembly 1, an angle-opening chamber assembly 2 and an angle-adjusting assembly 3.
  • the proximal end refers to the end close to the operator, and the distal end refers to the end far from the operator.
  • the balloon assembly 1 includes a balloon body 11, a developing ring 12, an inner balloon tube 13, an outer balloon tube 14, and a balloon handle 15, the balloon body 11 is made of a single layer of polymer material
  • the distal end of the balloon body 11 is fixedly connected to the inner tube 13, the proximal end of the balloon body 11 is fixedly connected to the distal end of the balloon outer tube 14, the proximal end of the balloon outer tube 14 and
  • the balloon handle 15 is fixedly connected, the distal end of the balloon inner tube 13 is a curved section, and the proximal end is a straight section.
  • Between the balloon inner tube 13 and the balloon outer tube 14 is a passage 16 that can pass through The passage 16 injects gas or liquid 17 into the capsule 11.
  • the cavity opening assembly 2 includes an outer tube assembly 21 and a cavity opening lining assembly 22, the outer tube assembly includes an outer tube 211 and an outer tube handle 212, and the cavity opening lining assembly 22 includes a head 221 and The connecting piece 222, the outer tube 211 has a rigidity to withstand the thrust of tissue opening without deformation, the head 221 is fixedly connected to the distal end of the connecting piece 222, the outer tube 211 is made of memory alloy material or metal material Made of a combination of the two materials, the maximum outer diameter of the head 221 is greater than the inner diameter of the outer tube 211, the distal end of the outer tube 211 is a fixed bending section or an adjustable bending section, so The distal end of the outer tube 211 is provided with one or more side holes 2110, the outer tube 211 is made of a memory alloy material, the outer tube handle is provided 212 with a bone filler injection interface 2120, the outer tube handle 212 A hole 2121 along the axial direction of the outer tube is provided
  • the angle adjustment assembly 3 includes an adjustment handle 32 and an adjustment tube 31, the adjustment handle 32 is detachably connected to the outer tube handle 212, and the fixed angle at the distal end of the outer tube 211 Part of it is pre-installed in the adjustment tube 31, and the fixed angle part of the distal end of the outer tube 211 is released and recovered in the adjustment tube 31 by operating the outer tube handle 32.
  • the fixed corner part of the distal end of the outer tube 211 is pre-installed in the adjusting tube 31, the balloon 11 is disposed inside the outer tube 211, the outer tube 211, the The inner tube 13 of the balloon is adapted to the curved section of the distal end of the connecting member 221, and the distal end portion of the balloon assembly 1 is inserted into the outer tube assembly 21 along the connecting member 222.
  • the specific surgical procedure is as follows:
  • the integrated multifunctional vertebroplasty instrument As shown in FIG. 2e, insert the integrated multifunctional vertebroplasty instrument along the working channel 4, and release the fixed angled portion of the distal end of the outer tube 211 into the vertebral body by operating the adjustment tube handle 32, and observe under perspective, Until the head 221 crosses the center of the vertebral body and reaches the opposite side of the vertebral body, the cavity is established.
  • the adjustment tube handle 32 is operated, and the outer tube 211 is withdrawn until the balloon 11 is completely exposed.
  • gas or liquid 17 is injected into the capsule 11 along the passage 16, expanding and expanding the vertebral body.
  • the inflation gas or liquid is withdrawn along the passage 16, and then the balloon assembly 1 is withdrawn from the outer tube assembly 21, at which time a cavity is left inside the vertebral body.
  • the adjustment tube handle 32 is operated to make the side hole 2110 enter the cavity, and the proximal end of the connecting member 222 is operated to insert the proximal end of the connecting member into the hole groove 2121 to make the connection
  • the piece 222 is connected and fixed with the outer tube handle 212, along the bone filler injection interface 2120 and the outer tube 211, the bone filler 23 is delivered into the vertebral body through the side hole 2110 until the bone filler 23 is filled Fill the cavity inside the vertebral body, withdraw all the instruments and complete the operation.
  • a multifunctional vertebral body shaping instrument is characterized by comprising a balloon assembly 1, an angle-opening assembly 2 and an angle-adjusting assembly 3.
  • the balloon assembly 1 includes a balloon body 11, a developing ring 12, an inner balloon tube 13, an outer balloon tube 14, and a balloon handle 15, the distal end of the balloon body 11 and the inner tube 13 is fixedly connected, and the proximal end of the balloon body 11 is fixedly connected to the distal end of the balloon outer tube 14, when the balloon body 11 is expanded, as shown in FIG. 3a (1) (FIG.
  • 3a (2) is a balloon
  • the body is made of a single layer of polymer material and is a schematic view when it is stretched), the balloon body 11 is made of an outer mesh bag 111 and an inner polymer material balloon 112, and the outer tube 14 of the balloon is near The end is fixedly connected to the balloon handle 15, the distal end of the inner tube 13 of the balloon is a curved section, and the proximal end is a straight section.
  • a passage 16 Between the inner tube 13 of the balloon and the outer tube 14 of the balloon is a passage 16, which can be The gas or liquid 17 is injected into the capsule 11 through the passage 16.
  • the cavity opening assembly 2 includes an outer tube assembly 21 and a cavity opening lining assembly 22, the outer tube assembly includes an outer tube 211 and an outer tube handle 212, the cavity opening lining assembly 22 includes a head 221,
  • the connecting piece 222 and the connecting piece handle 223, the outer tube 211 has a rigidity to withstand the tissue cavity pushing force without deformation, the sealing head 221 is fixedly connected to the distal end of the connecting piece 222, the maximum outer diameter of the sealing head 221 Less than or equal to the inner diameter of the outer tube 211, the distal end of the outer tube 211 is a fixed curved section, the outer tube 211 is made of memory alloy material or metal material or a combination of both materials,
  • the outer tube handle 212 is provided with a bone filler injection interface 2120.
  • the bend angle adjustment assembly 3 includes an adjustment handle 32 and an adjustment tube 31.
  • the adjustment handle 32 is detachably connected to the outer tube handle 212, and the fixed bend angle at the distal end of the outer tube 211 The part is pre-installed in the adjustment tube 31, and the fixed angle part of the distal end of the outer tube 211 is released and recovered by operating the adjustment tube handle 32.
  • the fixed corner part of the distal end of the outer tube 211 is pre-installed in the adjustment tube 31, the bladder 11 is disposed inside the outer tube 211, and the head 221 can be
  • the outer tube 211 slides inside, the outer tube 211, the balloon inner tube 13 and the distal curved section of the connector 221 cooperate, and the distal portion of the balloon assembly 1 is along the connector 222 Inserted inside the outer tube assembly 21 described above.
  • the specific surgical procedure is as follows:
  • the outer tube handle 212 is adjusted, and the outer tube 211 is withdrawn until the balloon 11 is completely exposed.
  • the gas or liquid 17 is injected into the capsule 11 along the passage 16, expanding and expanding the vertebral body.
  • the inflation gas or liquid is withdrawn along the passage 16, and then the balloon assembly 1 and the open cavity liner assembly 22 are withdrawn from the outer tube assembly 21, at this time the interior of the vertebral body Leave a cavity.
  • the filler 23 is delivered into the vertebral body along the bone filler injection interface 2120 and the outer tube 211 until the filler 23 fills the internal cavity of the vertebral body, and all instruments are withdrawn, completing surgery.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgery (AREA)
  • Medical Informatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

一体式多功能的椎体成形器械，包括球囊组件(1)、弯角调节组件(3)和弯角开腔组件(2)，弯角开腔组件(2)包括外管组件(21)和开腔内衬组件(22)，外管组件(21)包括外管(14)和外管手柄(212)，外管手柄(212)上设置有骨填充物注入接口(2120)；开腔内衬组件(22)包括封头(221)、连接件(222)和连接件手柄(223)，封头(221)的最大外径小于或者等于外管(14)的内径；以及弯角调节组件(3)包括调节手柄(32)和调节管(31)。另一种一体式多功能的椎体成形器械的外管远端设置有侧孔(2110)，开腔内衬组件(22)包括封头(221)和连接件(222)，封头(221)的最大外径大于外管(14)的内径。两种一体式多功能的椎体成形器械，实现了开腔、扩张和注射骨填充物为一体，操作简单灵活，缩短了手术时间，降低了手术风险。

Description

一体式多功能椎体成形器械 技术领域
本发明属于医疗器械技术领域，尤其涉及一种在椎体成形术中使用的一体式多功能椎体成形器械。
背景技术
骨质疏松性椎体压缩性骨折是危害中老年人健康的常见病，对于椎体压缩性骨折，传统的治疗方法以保守为主，包括卧床休息、药物止痛、支具外固定等，易导致骨量的进一步丢失，加重骨质疏松、从而形成恶性循环；而开放手术往往因为病人全身状况不佳，螺钉固定强度不足，易导致内固定失败。
法国医生Deramond等1987年报道了应用经皮椎体成形术(PVP)治疗C2椎体的侵袭性血管瘤，取得了良好的疗效。此后，该技术也被应用于椎体恶性肿瘤与骨质疏松症。该手术的不足之处是只能使伤椎被畸形固定和缓解疼痛，不能恢复椎体高度和纠正脊柱后凸畸形，并且由于在较高压力下向椎体松质骨内直接注射低粘滞性骨水泥，较难控制其流动，骨水泥渗漏率较高，文献报道为30％～67％。到1994年，美国学者Reiley等在PVP基础上，设计了通过球囊扩张来纠正后凸畸形的技术，成为球囊扩张椎体后凸成形术(PKP)，其于1998年通过FDA批准应用于临床。该技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，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。
针对上述缺点，专利号为201310671713.6的中国专利公开了一种椎体球囊扩张***，其设计了坚硬的封头，保护球囊的套管和衬芯，在衬芯的加强作用下，实现开扩张前的工作通道，其球囊的远端固定连接有远端封闭的封头，首先，此技术的封头设置在球囊的远端，球囊远端和封头连接的部位涉及到球囊扩张的密封性问题，在球囊扩张时具有一定渗漏风险，其次，此技术只是实现扩张前的开工作道和扩张，没有实现骨填充物的填充功能，没有做到最大范围内的减少患者的经济负担。
针对现有技术中的问题，亟需一种使用灵活，操作简单，能够缩短手术时间，降低手术风险，降低患者经济负担，开腔、球囊扩张以及注射骨水泥一体的一体式多功能椎体成形器械。
发明内容
本发明所要解决的技术问题是针对上述现有技术中存在的缺陷，提出一种集建立腔道、扩张和输送骨填充物于一体的一体式多功能椎体成形器械。
为实现上述目的，本发明采用以下技术方案：
本发明的第一个技术方案是：提供一种一体式多功能椎体成形器械，包括球囊组件、弯角调节组件和弯角开腔组件，所述弯角开腔组件包括外管组件和开腔内衬组件，其中：
所述外管组件包括外管和外管手柄，所述外管手柄设置于所述外管的近端，所述外管轴向具有承受组织开腔推力而不变形的刚度，所述外管手柄上设置有骨填充物注入接口；
所述开腔内衬组件包括封头、连接件和连接件手柄，所述封头设置于所述连接件的远端，所述封头的最大外径小于或者等于所述外管的内径，所述连接件的近端设置于所述连接件手柄上；以及
所述弯角调节组件包括调节手柄和调节管，所述调节手柄设置于所述调节管的近端，所述外管的固定弯角部分预装在所述调节管内；
所述球囊组件的远端部分沿所述连接件***装在所述外管组件内部，通过操 作外管手柄，可使所述外管能沿所述球囊组件的轴向进行前后移动；通过操作所述调节管手柄，可使所述外管远端的固定弯角部分释放和回收，当所述球囊组件和所述开腔内衬组件撤出所述外管组件后，通过所述骨填充物注入接口注入骨填充物实现椎体填充。
本发明第二个技术方案是提供另一种一体式多功能椎体成形器械，包括球囊组件、弯角调节组件和弯角开腔组件，所述弯角开腔组件包括外管组件和开腔内衬组件，其中：
所述外管组件包括外管和外管手柄，所述外管手柄设置于所述外管的近端，所述外管轴向具有承受组织开腔推力而不变形的刚度，且所述外管远端为固定弯角，所述外管的远端设置有侧孔，所述外管手柄设置有骨填充物注入接口；
所述开腔内衬组件包括封头和连接件，所述封头设置于所述连接件的远端，所述封头的最大外径大于所述外管的内径；以及
所述弯角调节组件包括调节手柄和调节管，所述外管远端的固定弯角部分预装在所述的调节管内；
所述球囊组件的远端部分沿所述连接件***装在所述外管组件内部，通过操作外管手柄，可使所述外管沿所述球囊组件的轴向进行前后移动；通过操作所述调节管手柄，可使所述外管远端的固定弯角部分释放和回收，当所述球囊组件撤出所述外管组件后，通过所述骨填充物注入接口注入骨填充物实现椎体填充。
进一步地，在第一和第二个技术方案中，所述外管的远端为固定弯角，所述连接件的远端与所述外管的远端相配合。
进一步地，在第一和第二个技术方案中，所所述球囊组件包括囊体、显影环、球囊内管、球囊外管和球囊手柄，所述囊体由单层高分子材料制成或者由外层网袋和内层高分子材料球囊共同制成，所述囊体远端与所述内管固定连接，所述囊体的近端与所述球囊外管远端固定连接，所述球囊外管的近端和所述球囊手柄固定连接，所述球囊内管远端为弯曲段、近端为直线段，所述球囊内管和球囊外管之间形成通路。
进一步优选地，在第一个技术方案中，所述连接件手柄和所述球囊手柄为一体式结构。
进一步地，在第一和第二个技术方案中，所述外管手柄与所述球囊手柄或所 述连接件手柄为可拆卸连接。
进一步优选地，在第一个技术方案中，所述连接件为所述球囊组件的球囊内管，所述球囊内管远端伸出所述囊体远端与所述封头连接。
进一步地，在第二个技术方案中，所述外管设置有一个或多个侧孔。
进一步地，在第二个技术方案中，所述外管手柄上设置有沿所述外管的轴向方向的孔槽。
进一步地，在第二个技术方案中，所述连接件的近端与所述孔槽可拆卸连接。
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)现有椎体成形手术中，要想使椎体在术后有较好的力学性能，需要对每节椎体都需进行双侧穿刺/建立腔道、双侧扩张和双侧填充，本发明的一体式多功能椎体成形器械的远端可为固定弯曲段，将器械远端送至椎体中央或椎体对侧，单侧穿刺实现双侧手术的目的，有效的减轻了患者的创伤、减少了手术时间、降低了并发症的发生，同时减轻了患者的经济负担。
2)现有椎体成形手术中，每节椎体都需用穿刺针建立工作通道，然后用骨钻在椎体内建立腔道，然后撤出骨钻，再将球囊送入椎体内扩张和撑开椎体形成空腔，最后撤出球囊，并注入骨水泥；而本发明的一体式多功能椎体成形器械，只用一把器械就能实现多种功能，即可以通过常规尺寸的工作通道，在椎体内建立腔道，然后扩张，最后在低压环境下从外管手柄上的骨填充物注入接口输送骨填充物，手术操作简单方便，缩短手术时间，进一步减轻了患者的经济负担；
3)本发明设计的封头与连接件的远端固定连接，有效的降低了封头与球囊远端连接可能会导致扩张时密封性不够的风险；
4)本发明设计的囊体由外层网袋和内层高分子材料球囊共同制成，此种设计增加了整个囊体的耐压性能，增大了手术的安全性；
5)本发明设计的外管远端的固定弯角部分预装在调节管内，使器械平直的通过工作通道，使操作者不用费力的把器械放入工作通道，通过操作调节管手柄实现外管远端的固定弯角部分的释放和回收，螺纹传输增大了操作的可控性，以及提供更大推进力，大大降低了器械的操作难度，使使用者更加灵活的操作器械，缩短手术时间，降低手术风险。
附图说明
图1为本发明的第一个实施例的结构示意图；
图1a为第一个实施例的球囊组件及B区域放大的结构示意图；
图1b为第一个实施例的弯角开腔组件结构示意图
图1c为第一个实施例的弯角调节组件结构示意图；
图1d为第一个实施例的器械远端结构示意图；
图1e为第一个实施例的本发明在椎体内建立腔道的结构示意图；
图1f为第一个实施例的后撤外管释放球囊的结构示意图；
图1g为第一个实施例的球囊扩张并撑开椎体的结构示意图；
图1h为第一个实施例的球囊组件和开腔内衬组件撤出外管组件的结构示意图；
图1i为第一个实施例的沿外管输送骨填充物的结构示意图；
图2为本发明的第二个实施例的结构示意图；
图2a为第二个实施例的球囊组件及B区域放大的结构示意图；
图2b为第二个实施例的弯角开腔组件结构示意图
图2c为第二个实施例的弯角调节组件结构示意图；
图2d为第二个实施例的器械远端结构示意图；
图2e为第二个实施例的本发明在椎体内建立腔道的结构示意图；
图2f为第二个实施例的后撤外管释放球囊的结构示意图；
图2g为第二个实施例的球囊扩张并撑开椎体的结构示意图；
图2h为第二个实施例的球囊组件撤出外管组件的结构示意图；
图2i为第二个实施例的沿外管和侧孔输送骨填充物的结构示意图；
图3为本发明的第三个实施例的结构示意图；
图3a为第三个实施例的球囊组件及B区域放大的结构示意图；
图3b为第三个实施例的弯角开腔组件结构示意图
图3c为第三个实施例的弯角调节组件结构示意图；
图3d为第三个实施例的器械远端结构示意图；
图3e为第三个实施例的本实用新型在椎体内建立腔道的结构示意图；
图3f为第三个实施例的后撤外管释放球囊的结构示意图；
图3g为第三个实施例的球囊扩张并撑开椎体的结构示意图；
图3h为第三个实施例的球囊组件和开腔内衬组件撤出外管组件的结构示意图；
图3i为第三个实施例的沿外管输送骨填充物的结构示意图；
其中，各附图标记为：
1-球囊组件，11-囊体，111-网袋，112-球囊，12-显影环，13-内管，14-外管，15-球囊手柄，16-内管和外观之间的通路，17-气体或液体，2-弯角开腔组件，21-开腔外管组件，22-开腔内衬组件，211-外管，2110-侧孔，212-外管手柄，2120-骨填充物注入接口，2121-孔槽，221-封头，222-连接件，223-连接件手柄，23-填充物，3-弯角调节组件，31-调节管，32-调节管手柄，4-工作通道。
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。
实施例1
如图1所示，本实施例提供了一种一体式多功能椎体成形器械，包括球囊组件1，弯角开腔组件2和弯角调节组件3。本实施例中所述近端是指接近手术操作者的一端，所述远端是指远离手术操作者的一端。
如图1a所示，所述球囊组件1包括囊体11、显影环12、球囊内管13、球囊外管14和球囊手柄15，所述囊体11由单层高分子材料制成，所述囊体11远端与所述内管13固定连接，所述囊体11的近端与所述球囊外管14远端固定连接，所述球囊外管14的近端和所述球囊手柄15固定连接，所述球囊内管13远端为弯曲段、近端为直线段，所述球囊内管13和球囊外管14之间为通路16，可以通过所述通路16往囊体11注入气体或液体17。
如图1b所示，所述开腔组件2包括外管组件21和开腔内衬组件22，所述外管组件包括外管211和外管手柄212，所述开腔内衬组件22包括封头221、连接件222和连接件手柄223，所述外管211向具有承受组织开腔推力而不变形的刚度，所述封头221固定连接在连接件222的远端，所述封头221的最大外径小于或者等于所述外管211的内径，所述外管211的远端为固定弯曲段， 所述外管211由记忆合金材料制成或金属材料制成或两者的组合型材料制成，所述外管手柄212设置有骨填充物注入接口2120，通过操作外管手柄212实现所述外管211能沿着球囊组件1轴向前后移动，所述外管手柄212与所述球囊手柄15为可拆卸连接。
如图1c所示，所述弯角调节组件3包括调节手柄32和调节管31，所述调节手柄32与所述外管手柄212为可拆卸连接，所述外管211远端的固定弯角部分预装在调节管31内，通过操作调节管手柄32实现外管211远端的固定弯角部分的释放和回收。
如图1d所示，所述外管211的远端固定弯角部分预装在所述调节管31内，所述囊体11设置在所述外管211内部，所述封头221能够在所述外管211内部滑动，所述外管211、所述球囊内管13和所述连接件221的远端弯曲段相配合，所述球囊组件1的远端部分沿所述连接件222***装在所述的外管组件21内部。
具体手术过程如下：
如图1e所示，将一体式多功能椎体成形器械沿工作通道4***,通过操作调节管手柄32将所述外管211的远端固定弯角部分释放到椎体中，透视下观察，直至封头221越过椎体中央，达到椎体对侧，完成腔道建立。
如图1f所示，调节所述外管手柄212，后撤所述外管211，直至所述囊体11完全暴露。
如图1g所示，沿所述通路16往所述囊体11注入所述气体或液体17，扩张并撑开椎体。
如图1h所示，将膨胀气体或液体沿所述通路16撤出，随后将当所述球囊组件1和所述开腔内衬组件22撤出所述外管组件21，此时椎体内部留有空腔。
如图1i所示，沿所述骨填充物注入接口2120和所述外管211向椎体内部输送填充物23，直至所述填充物23填满椎体内部空腔，撤出全部器械，完成手术。
实施例2
如图2所示，本实施例提供了一种一体式多功能椎体成形器械，包括球囊组件1、弯角开腔组件2和弯角调节组件3。本实施例中所述近端是指接近手术操作者的一端，所述远端是指远离手术操作者的一端。
如图2a所示，所述球囊组件1包括囊体11、显影环12、球囊内管13、球囊外管14和球囊手柄15，所述囊体11由单层高分子材料制成，所述囊体11远端与所述内管13固定连接，所述囊体11的近端与所述球囊外管14远端固定连接，所述球囊外管14的近端和所述球囊手柄15固定连接，所述球囊内管13远端为弯曲段、近端为直线段，所述球囊内管13和球囊外管14之间为通路16，可以通过所述通路16往囊体11注入气体或液体17。
如图2b所示，所述开腔组件2包括外管组件21和开腔内衬组件22，所述外管组件包括外管211和外管手柄212，所述开腔内衬组件22包括封头221和连接件222，所述外管211向具有承受组织开腔推力而不变形的刚度，所述封头221固定连接在连接件222的远端，所述外管211由记忆合金材料制成或金属材料制成或两者的组合型材料制成，所述封头221的最大外径大于所述外管211的内径，所述外管211的远端为固定弯曲段或可调弯角段，所述外管211的远端设置有一个或多个侧孔2110，所述外管211由记忆合金材料制成，所述外管手柄设置212有骨填充物注入接口2120，所述外管手柄212上设置有沿外管轴向方向的孔槽2121，通过操作外管手柄212实现所述外管211能沿着球囊组件1轴向前后移动，所述外管手柄212与所述球囊手柄15为可拆卸连接。
如图2c所示，所述弯角调节组件3包括调节手柄32和调节管31，所述调节手柄32与所述外管手柄212为可拆卸连接，所述外管211远端的固定弯角部分预装在调节管31内，通过操作外管手柄32实现外管211远端的固定弯角部分在调节管31内的释放和回收。
如图2d所示，所述外管211的远端固定弯角部分预装在所述调节管31内，所述囊体11设置在所述外管211内部，所述外管211、所述球囊内管13和所述连接件221的远端弯曲段相适应，所述球囊组件1的远端部分沿所述连接件222***装在所述的外管组件21内部。
具体手术过程如下：
如图2e所示，将一体式多功能椎体成形器械沿工作通道4***,通过操作调节管手柄32将所述外管211的远端固定弯角部分释放到椎体中，透视下观察，直至所述封头221越过椎体中央，达到椎体对侧，完成腔道建立。
如图2f所示，操作所述调节管手柄32，后撤所述外管211，直至所述囊体 11完全暴露。
如图2g所示，沿所述通路16往所述囊体11注入气体或液体17，扩张并撑开椎体。
如图2h所示，将膨胀气体或液体沿所述通路16撤出，随后将当所述球囊组件1撤出所述外管组件21，此时椎体内部留有空腔。
如图2i所示，操作所述调节管手柄32使所述侧孔2110进入所述空腔，操作所述连接件222的近端使连接件的近端***到所述孔槽2121，使连接件222与所述外管手柄212连接固定，沿所述骨填充物注入接口2120和所述外管211，骨填充物23通过所述侧孔2110向椎体内部输送，直至骨填充物23填满椎体内部空腔，撤出全部器械，完成手术。
实施例3
如图3所示，一种多功能的椎体成形器械，其特征在于：包括球囊组件1，弯角开腔组件2和弯角调节组件3。
如图3a所示，所述球囊组件1包括囊体11、显影环12、球囊内管13、球囊外管14和球囊手柄15，所述囊体11远端与所述内管13固定连接，所述囊体11的近端与所述球囊外管14远端固定连接，当所述囊体11撑开时如图3a(1)所示(图3a(2)为囊体由单层高分子材料制成且撑开时的示意图)，所述囊体11由外层网袋111和内层高分子材料球囊112共同制成，所述球囊外管14的近端和所述球囊手柄15固定连接，所述球囊内管13远端为弯曲段、近端为直线段，所述球囊内管13和球囊外管14之间为通路16，可以通过所述通路16往囊体11注入气体或液体17。
如图3b所示，所述开腔组件2包括外管组件21和开腔内衬组件22，所述外管组件包括外管211和外管手柄212，所述开腔内衬组件22包括封头221、连接件222和连接件手柄223，所述外管211向具有承受组织开腔推力而不变形的刚度，所述封头221固定连接在连接件222的远端，所述封头221的最大外径小于或者等于所述外管211的内径，所述外管211的远端为固定弯曲段，所述外管211由记忆合金材料制成或金属材料制成或两者的组合型材料制成，所述外管手柄212设置有骨填充物注入接口2120，通过操作外管手柄212实现所述外管211能沿着球囊组件1轴向前后移动，所述外管手柄212与所述球囊手柄15为可拆卸连接。
如图3c所示，所述弯角调节组件3包括调节手柄32和调节管31，所述调节手柄32与所述外管手柄212为可拆卸连接，所述外管211远端的固定弯角部分预装在调节管31内，通过操作调节管手柄32实现外管211远端的固定弯角部分的释放和回收。
如图3d所示，所述外管211的远端固定弯角部分预装在所述调节管31内，所述囊体11设置在所述外管211内部，所述封头221能够在所述外管211内部滑动，所述外管211、所述球囊内管13和所述连接件221的远端弯曲段相配合，所述球囊组件1的远端部分沿所述连接件222***装在所述的外管组件21内部。
具体手术过程如下：
如图3e所示，将多功能椎体成形器械沿工作通道4***,通过操作调节管手柄32将所述外管211的远端固定弯角部分释放到椎体中，透视下观察，直至封头221越过椎体中央，达到椎体对侧，完成腔道建立。
如图3f所示，调节所述外管手柄212，后撤所述外管211，直至所述囊体11完全暴露。
如图3g所示，沿所述通路16往所述囊体11注入所述气体或液体17，扩张并撑开椎体。
如图3h所示，将膨胀气体或液体沿所述通路16撤出，随后将当所述球囊组件1和所述开腔内衬组件22撤出所述外管组件21，此时椎体内部留有空腔。
如图3i所示，沿所述骨填充物注入接口2120和所述外管211向椎体内部输送填充物23，直至所述填充物23填满椎体内部空腔，撤出全部器械，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. 一体式多功能椎体成形器械，其特征在于，包括球囊组件、弯角调节组件和弯角开腔组件，所述弯角开腔组件包括外管组件和开腔内衬组件，其中：
    所述外管组件包括外管和外管手柄，所述外管手柄设置于所述外管的近端，所述外管轴向具有承受组织开腔推力而不变形的刚度，所述外管手柄上设置有骨填充物注入接口；
    所述开腔内衬组件包括封头、连接件和连接件手柄，所述封头设置于所述连接件的远端，所述封头的最大外径小于或者等于所述外管的内径，所述连接件的近端设置于所述连接件手柄上；以及
    所述弯角调节组件包括调节手柄和调节管，所述调节手柄设置于所述调节管的近端，所述外管的固定弯角部分预装在所述调节管内；
    所述球囊组件的远端部分沿所述连接件***装在所述外管组件内部，通过操作外管手柄，可使所述外管能沿所述球囊组件的轴向进行前后移动；通过操作所述调节管手柄，可使所述外管远端的固定弯角部分释放和回收，当所述球囊组件和所述开腔内衬组件撤出所述外管组件后，通过所述骨填充物注入接口注入骨填充物实现椎体填充。
  2. 一体式多功能椎体成形器械，其特征在于，包括球囊组件、弯角调节组件和弯角开腔组件，所述弯角开腔组件包括外管组件和开腔内衬组件，其中：
    所述外管组件包括外管和外管手柄，所述外管手柄设置于所述外管的近端，所述外管轴向具有承受组织开腔推力而不变形的刚度，且所述外管远端为固定弯角，所述外管的远端设置有侧孔，所述外管手柄设置有骨填充物注入接口；
    所述开腔内衬组件包括封头和连接件，所述封头设置于所述连接件的远端，所述封头的最大外径大于所述外管的内径；以及
    所述弯角调节组件包括调节手柄和调节管，所述外管远端的固定弯角部分预装在所述的调节管内；
    所述球囊组件的远端部分沿所述连接件***装在所述外管组件内部，通过操作外管手柄，可使所述外管沿所述球囊组件的轴向进行前后移动；通过操作所述调节管手柄，可使所述外管远端的固定弯角部分释放和回收，当所述球囊组件撤 出所述外管组件后，通过所述骨填充物注入接口注入骨填充物实现椎体填充。
  3. 根据权利要求1或2所述的一体式多功能椎体成形器械，其特征在于，所述外管的远端为固定弯角，所述连接件的远端与所述外管的远端相配合。
  4. 根据权利要求1或2所述的一体式多功能椎体成形器械，其特征在于，所述球囊组件包括囊体、显影环、球囊内管、球囊外管和球囊手柄，所述囊体由单层高分子材料制成或者由外层网袋和内层高分子材料球囊共同制成，所述囊体远端与所述内管固定连接，所述囊体的近端与所述球囊外管远端固定连接，所述球囊外管的近端和所述球囊手柄固定连接，所述球囊内管远端为弯曲段、近端为直线段，所述球囊内管和球囊外管之间形成通路。
  5. 根据权利要求4所述的一体式多功能椎体成形器械，其特征在于，所述连接件手柄和所述球囊手柄为一体式结构。
  6. 根据权利要求4所述的一体式多功能椎体成形器械，其特征在于，所述外管手柄与所述球囊手柄或所述连接件手柄为可拆卸连接。
  7. 根据权利要求1所述的一体式多功能椎体成形器械，其特征在于，所述连接件为所述球囊组件的球囊内管，所述球囊内管远端伸出所述囊体远端与所述封头连接。
  8. 根据权利要求2所述的一体式多功能椎体成形器械，其特征在于，所述外管设置有一个或多个侧孔。
  9. 根据权利要求2所述的一体式多功能椎体成形器械，其特征在于，所述外管手柄上设置有沿所述外管的轴向方向的孔槽。
  10. 根据权利要求9所述的一体式多功能椎体成形器械，其特征在于，所述连接 件的近端与所述孔槽可拆卸连接。
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