CN106618714A - Filling apparatus for injecting bone filling material - Google Patents

Filling apparatus for injecting bone filling material Download PDF

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Publication number
CN106618714A
CN106618714A CN201510736234.7A CN201510736234A CN106618714A CN 106618714 A CN106618714 A CN 106618714A CN 201510736234 A CN201510736234 A CN 201510736234A CN 106618714 A CN106618714 A CN 106618714A
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CN
China
Prior art keywords
aperture
distribution
mesh bag
pores
region
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Legal status (The legal status 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 status listed.)
Granted
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CN201510736234.7A
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Chinese (zh)
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CN106618714B (en
Inventor
邵卫星
杨文州
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SHANDONG GUANLONG MEDICAL UTENSILS CO Ltd
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SHANDONG GUANLONG MEDICAL UTENSILS CO Ltd
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Priority to CN201510736234.7A priority Critical patent/CN106618714B/en
Publication of CN106618714A publication Critical patent/CN106618714A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802Equipment for handling bone cement or other fluid fillers
    • A61B17/8805Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/885Tools for expanding or compacting bones or discs or cavities therein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (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)
  • Neurology (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The invention discloses a filling apparatus for injecting a bone filling material. The filling apparatus comprises an expansible net bag which is provided with a plurality of pores and a medical grade balloon which is arranged in the net bag. According to the filling apparatus for injecting the bone filling material provided by the invention, the net bag and the balloon are matched in use; in an operation, the balloon and the net bag, which covers the surface of the balloon, simultaneously expand, and the balloon is withdrawn while the net bag is kept in a vertebra body as a predicted height is reached, so that a shortcoming that an intra-operative vertebral height gets lost once again after the balloon is withdrawn in classical kyphoplasty; and in addition, the seepage of the bone filling material is prevented.

Description

A kind of filling device for injecting filling material of bone
Technical field
The present invention relates to a kind of vertebral plasty apparatus, more particularly to for injecting the tucker of filling material of bone Part and its using method.
Background technology
Wound, disease (such as systemic disease, tumour) and osteoporosis can all cause vertebral fracture.Vertebra Body fracture it is caused having an intense pain and limitation of activity declines quality of life of patients, and have secondary other diseases The possibility of change, even results in paraplegia and death.Preferably treatment method should be able to mitigate rapidly because fracture is drawn The pain for rising, can correct the spinal anterior approach caused because of fracture, and patient activity ability is recovered as early as possible.When It is front mainly to have three kinds for the treatment of methods:Traditional conservative therapy, the treatment of conventional surgical open surgery and Minimally Invasive Surgery Treatment.Compare with other two methods, minimal invasive operation treatment time is short, and wound is little, and pain is little, Blood loss is few, and recovery time is short and the hospital stays is short, thus is gradually widely used and will become future Main flow treatment method.
Minimal invasive operation such as percutaneous vertbroplasty (PVP) and Percutaneous kyplasty (PKP) are Puncture needle is percutaneously directly pierced into the centrum of fracture, is noted again after the centrum that fracture is expanded with balloon dilatation catheter Enter bone cement, the vertebral height for making fracture obtains a certain degree of recovery, and rapid reinforcement centrum reaches only Pain and the purpose for reactivating as early as possible.The problem that at present minimal invasive operation is primarily present is that balloon expandable collapses After sunken centrum, balloon dilatation catheter need to be set back and be extracted from centrum, the centrum being propped up after extracting exists Elastic creep lower its of extruding of adjacent upper and lower interverbebral disc highly can not be maintained completely, cause cavity atrophy and Vertebral height is lost again.
Therefore, it is necessary to a kind of new filling device for injecting filling material of bone is provided, it is existing to solve There is the problems of technology.
The content of the invention
Present invention is primarily targeted at a kind of filling device for injecting filling material of bone is provided, its bag Include the inflatable mesh bag with multiple holes and the medical grade sacculus inside the mesh bag..
The present invention also aims to provide a kind of method abnormal for treating bone, it includes:
A) vertebra that subsides will be sent into by the service aisle for pre-setting with the filling device of sacculus comprising mesh bag Body,
B) itself and mesh bag is made to expand together so as to form cavity sacculus pressurization,
C) remove sacculus and retain mesh bag in the original location,
C) filling material of bone is slowly injected into by mesh bag inlet, and
Optionally d) close the mesh bag inlet so that the diameter of the inlet at least with the mesh bag hole Gap is equally little.If the speed of filling material of bone solidification is sufficiently fast, step d) can be omitted.
Above-mentioned bone is selected from extremely:Bone tumour, tumour, caput femoris necrosis, fracture of tibial plateau, backbone Thoracic that compression fracture, osteoporosis or wound cause and the body compression fractures at lumbar vertebrae position and its Any combination.
When filling material of bone is injected, the diameter of above-mentioned mesh bag inlet can be about 0.25mm-10mm, Such as 1mm-5mm.Above-mentioned mesh bag inlet can manually close (such as using bolt) or from Dynamic closure.
The mesh bag of the present invention can be any shape, as long as it can be in diaphysis inner support diaphysis, example As it can be oval, circle, rectangle, or irregular other shapes in diaphysis.
The aperture of the hole of the mesh bag of the present invention can be about 0.25-6mm, 0.5-4mm or 0.5-2mm, Specifically can be 0.25mm, 0.30mm, 0.35mm, 0.40mm, 0.45mm, 0.50mm, 0.55mm、0.60mm、0.65mm、0.70mm、0.75mm、0.80mm、0.85mm、0.90 mm、0.95mm、1.00mm、1.1mm、1.2mm、1.3mm、1.4mm、1.5mm、1.6 mm、1.7mm、1.8mm、1.9mm、2.0mm、2.5mm、3.0mm、3.5mm、4.0mm、 4.5mm, 5.0mm, 5.5mm or 6.0mm.
In another embodiment, there can be the big distribution of pores in one or more apertures on the mesh bag of the present invention Region and the little distribution of pores region in one or more apertures, the little distribution of pores region in the aperture and institute State the big distribution of pores region in aperture to be spaced so that when in use, the filling material of bone base in mesh bag Distribution of pores region that will not be little from aperture in sheet leaks out to diaphysis (such as centrum) outward.Specifically, institute Stating the little distribution of pores region of mesh bag upper density can be placed in the latter half of centrum so that filling material of bone Essentially without leaking to backward outside centrum, so as to avoid enter into canalis spinalis, contact nerve and dural sac etc. and Cause serious complication.
The distribution of pores region big compared to aperture, the distribution of pores region that the aperture of the present invention is little can also It is set to void density less.
Each of the little distribution of pores region in aperture of the invention and the big distribution of pores region in aperture can To there is multiple (including being not limited to 2,3 or 4), both numbers can be with identical, it is also possible to different. For example, the little distribution of pores region in the aperture distribution of pores region big with the aperture is respectively two, And the big distribution of pores region in the little distribution of pores region in two apertures or two apertures is relative to mesh bag center It is symmetrical or symmetrical relative to the longitudinal axis through mesh bag center;Certainly, in certain embodiments, these regions Can also be in mal-distribution, as long as when in use, the filling material of bone in mesh bag is essentially without from hole The little distribution of pores region in footpath leaks out to diaphysis (such as centrum) outward.
From the point of view of through the mesh bag cross section at mesh bag center, any two points of the cross section have to mesh bag center One angle, can also be by the little distribution of pores region in aperture and the big hole in aperture according to the number of degrees of the angle Distributed areas are configured as including but not limited to:
(1) 0-90 degree is the big distribution of pores in aperture for the little distribution of pores region in aperture, 90-360 degree Region;
(2) 0-90 degree is the big distribution of pores in aperture for the little distribution of pores region in aperture, 90-180 degree Region, 180-270 degree are the big distribution of pores in aperture for the little distribution of pores region in aperture, 270-360 degree Region;Or
(3) 0-60 degree is the big distribution of pores in aperture for the little distribution of pores region in aperture, 60-180 degree Region, 180-240 degree are the big distribution of pores in aperture for the little distribution of pores region in aperture, 240-360 degree Region.
The total surface area in the little distribution of pores region in aperture of the present invention account for mesh bag surface area 10%-80%, 20%-50% or 30%-40% specifically can be 10%, 15%, 20%, 25%, 30%, 35%, 40%th, 45%, 50%, 55%, 60%, 65%, 70%, 75% and 80%.
By above-mentioned setting, the big distribution of pores region in the little distribution of pores region in aperture or the aperture can To be distributed in local specific region, so that mesh bag can have the function of orientation when bone material is filled. In the little distribution of pores region in aperture of the invention, the aperture of hole is less than about 0.25mm, 0.01-0.25 Mm, 0.05-0.2mm or 0.1-0.15mm, specifically can be 0.01mm, 0.02mm, 0.03 mm、0.04mm、0.05mm、0.06mm、0.07mm、0.08mm、0.09mm、0.1mm、 0.11mm、0.12mm、0.13mm、0.14mm、0.15mm、0.16mm、0.17mm、0.18 Mm, 0.19mm or 0.2mm.
In the big distribution of pores region in aperture of the invention, the aperture of hole is for about 0.25-6mm, 0.5-4 Mm or 0.5-2mm, specifically can be 0.25mm, 0.30mm, 0.35mm, 0.40mm, 0.45mm、0.50mm、0.55mm、0.60mm、0.65mm、0.70mm、0.75mm、0.80 mm、0.85mm、0.90mm、0.95mm、1.00mm、1.1mm、1.2mm、1.3mm、 1.4mm、1.5mm、1.6mm、1.7mm、1.8mm、1.9mm、2.0mm、2.5mm、3.0 Mm, 3.5mm, 4.0mm, 4.5mm, 5.0mm, 5.5mm or 6.0mm.
The distribution of pores region that the aperture of the present invention is little can manufacture by the following method:(1) in manufacture net When bag, the pore size that the aperture of hole is directly configured to need;Or (2) are big in an aperture Distribution of pores region on cover medical coating and removing and cover the partial coating of the hole and obtain institute State the little distribution of pores region in aperture.
Above-mentioned coating material is PET, silica gel, sodium alginate or their any combination.Preferably PET Material.
The coating of the present invention can close to a certain extent mesh bag, and coating distributed areas can be with the mesh bag Be placed in the latter half of centrum so that filling material of bone essentially without leaking to backward outside centrum, so as to Avoid enter into canalis spinalis, contact nerve and dural sac etc. and cause serious complication.
Beneficial effect:The present invention coordinates for the mesh bag in the filling device for injecting filling material of bone with sacculus Use, sacculus is expanded simultaneously with the mesh bag for being covered in its surface in art, expansion reaches estimated height recession Go out sacculus and retain mesh bag in centrum, classical kyphoplasty operation presence can be overcome to withdraw from art after sacculus The defect that middle vertebral height is lost again, and filling material of bone seepage can be prevented.
Description of the drawings
Fig. 1 shows the filling device for injecting filling material of bone that one embodiment of the invention is provided.
Fig. 2 shows the tucker for injecting filling material of bone that another embodiment of the present invention is provided Part.
Fig. 3 shows the tucker for injecting filling material of bone that another embodiment of the present invention is provided Part.
Specific embodiment
The explanation of following embodiment is, with reference to additional schema, to may be used to what is implemented to illustrate the present invention Specific embodiment.Furthermore, the direction term that is previously mentioned of the present invention, such as upper and lower, top, bottom, it is front, Afterwards, left and right, inside and outside, side, surrounding, central authorities, level, laterally, vertically, longitudinally, axially, Radially, the superiors or orlop etc., are only the directions with reference to annexed drawings.Therefore, use in the direction for using Language is to illustrate and understand the present invention, and is not used to limit the present invention.
Fig. 1 is refer to, one embodiment of the invention provides a kind of filling for injecting filling material of bone Device 10, comprising:Inflatable mesh bag 12 with multiple holes;Wherein, there is macropore on the mesh bag The distribution of pores region 122 in footpath 112 and the distribution of pores region 121 of small-bore 111 so that using When, the filling material of bone in mesh bag 12 from the little distribution of pores region 121 in aperture essentially without leaking out to Diaphysis (such as centrum) is outward.
Wherein, the little distribution of pores region 121 in the aperture accounts for the 30%-40% of the mesh bag surface area. When using, the little distribution of pores region of the mesh bag upper density can be placed in the latter half of centrum so that Filling material of bone essentially without leaking to backward outside centrum, so as to avoid enter into canalis spinalis, contact nerve and Dural sac etc. and cause serious complication.The material of mesh bag 12 should be biocompatible materials, including but Be not limited to, marmem, titanium, stainless steel, polymer, metal alloy, ceramics, fabric or it Any combination.Biocompatible materials is preferably polyethylene terephthalate.
Referring to Fig. 2, another embodiment of the present invention provides a kind of filling for injecting filling material of bone Device 20, it is on the basis of above-mentioned inflatable mesh bag 12 further comprising the doctor inside mesh bag 12 Treat level sacculus 13.Sacculus 13 selected from following material construction at least partly by forming:Rubber, nylon, Thermoplastic elastomer (TPE), polyurethane and its any combination.The present invention is used to inject the tucker of filling material of bone Mesh bag in part is used cooperatively with sacculus, and sacculus is expanded simultaneously with the mesh bag for being covered in its surface in art, expands Open to reach and sacculus reservation mesh bag is withdrawn from after estimated height in centrum, classical kyphoplasty can be overcome Operation is present withdraws from the defect that vertebral height is lost again in art after sacculus.
Referring to Fig. 3, another embodiment of the present invention provides a kind of filling for injecting filling material of bone Device.The difference of the device in the device and Fig. 1 is that the little distribution of pores region in aperture has two (1211,1212), the big distribution of pores region in aperture is also two (1221, another figure not shown in), And the big distribution of pores region in the little distribution of pores region in two apertures or two apertures is relative to mesh bag center It is symmetrical or symmetrical relative to the longitudinal axis through mesh bag center.
The present invention is been described by by above-mentioned related embodiment, but above-described embodiment only implements the present invention Example.It must be noted that, it has been disclosed that embodiment be not limiting as the scope of the present invention.On the contrary, The modification and equivalent setting for being contained in the spirit and scope of claims is included in the scope of the present invention It is interior.

Claims (10)

1. a kind of filling device for injecting filling material of bone, it is characterised in that:The filling device is included:
Inflatable mesh bag with multiple holes;With
Medical grade sacculus inside the mesh bag.
It is 2. as claimed in claim 1 to fill device, it is characterised in that:The aperture of the hole is for about 0.25-6mm, 0.5-4mm or 0.5-2mm.
It is 3. as claimed in claim 1 to fill device, it is characterised in that:There are one or more on the mesh bag The big distribution of pores region in aperture and the little distribution of pores region in one or more apertures, the aperture is little The distribution of pores region distribution of pores region big with the aperture be spaced so that when in use, Filling material of bone in mesh bag from the little distribution of pores region in aperture essentially without leaking out to outside diaphysis.
It is 4. as claimed in claim 3 to fill device, it is characterised in that:The little distribution of pores region in the aperture Total surface area account for 10%-80%, 20%-50% or 30%-40% of the mesh bag surface area.
It is 5. as claimed in claim 3 to fill device, it is characterised in that:The little distribution of pores region in the aperture In, the aperture of hole for less than about 0.25mm, 0.01-0.25mm, 0.05-0.12mm or 0.1-0.15mm。
It is 6. as claimed in claim 3 to fill device, it is characterised in that:The big distribution of pores region in the aperture In, the aperture of hole is for about 0.25-6mm, 0.5-4mm or 0.5-2mm.
It is 7. as claimed in claim 3 to fill device, it is characterised in that:The little distribution of pores region in the aperture Obtain by the following method:(1) when the mesh bag is manufactured, the aperture of hole is directly configured For the pore size for needing;Or (2) cover medical painting on the big distribution of pores region in an aperture Layer and remove and cover the partial coating of the hole and obtain the little distribution of pores region in the aperture.
It is 8. as claimed in claim 7 to fill device, it is characterised in that:The material of the coating is to meet implantation The biocompatible materials of requirement, optional, the biocompatible materials is poly terephthalic acid second Diol ester (PET), silica gel, sodium alginate or their any combination.
It is 9. as claimed in claim 1 to fill device, it is characterised in that:The material of the mesh bag is to meet implantation The biocompatible materials of requirement;Optionally, the biocompatible materials be marmem, Titanium, stainless steel, polymer, metal alloy, ceramics, fabric or their any combination;Optionally, The polymer is polyethylene terephthalate.
It is 10. as claimed in claim 1 to fill device, it is characterised in that:The sacculus is at least partly by selected from such as Under material construction form:Rubber, nylon, thermoplastic elastomer (TPE), polyurethane and its any combination.
CN201510736234.7A 2015-11-02 2015-11-02 Filling device for injecting bone filling material Active CN106618714B (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020244388A1 (en) * 2019-06-05 2020-12-10 山东百多安医疗器械股份有限公司 Surface-drug-loading inflatable balloon for vertebroplasty and preparation method therefor
CN115068689A (en) * 2022-06-17 2022-09-20 北京邦塞科技有限公司 Bone filling capsular bag and preparation method and application thereof

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CN104905868A (en) * 2015-06-23 2015-09-16 上海凯利泰医疗科技股份有限公司 Bone filling bag with nonuniform aperture
CN205411303U (en) * 2015-11-02 2016-08-03 山东冠龙医疗用品有限公司 A pack device for injecting bone filler material
CN205433868U (en) * 2015-11-02 2016-08-10 山东冠龙医疗用品有限公司 A pack device for injecting bone filler material

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CN1259851A (en) * 1997-06-09 2000-07-12 科丰公司 System for treating fractured or diseased bone using expandable bodies
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CN101336094A (en) * 2005-12-08 2008-12-31 新特斯有限责任公司 Apparatus and methods for treating bone
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CN104905868A (en) * 2015-06-23 2015-09-16 上海凯利泰医疗科技股份有限公司 Bone filling bag with nonuniform aperture
CN205411303U (en) * 2015-11-02 2016-08-03 山东冠龙医疗用品有限公司 A pack device for injecting bone filler material
CN205433868U (en) * 2015-11-02 2016-08-10 山东冠龙医疗用品有限公司 A pack device for injecting bone filler material

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020244388A1 (en) * 2019-06-05 2020-12-10 山东百多安医疗器械股份有限公司 Surface-drug-loading inflatable balloon for vertebroplasty and preparation method therefor
CN115068689A (en) * 2022-06-17 2022-09-20 北京邦塞科技有限公司 Bone filling capsular bag and preparation method and application thereof
CN115068689B (en) * 2022-06-17 2024-01-19 北京邦塞科技有限公司 Bone filling bag, and preparation method and application thereof

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