CN202875454U - Bone cement filling balloon device - Google Patents

Bone cement filling balloon device Download PDF

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Publication number
CN202875454U
CN202875454U CN 201220473145 CN201220473145U CN202875454U CN 202875454 U CN202875454 U CN 202875454U CN 201220473145 CN201220473145 CN 201220473145 CN 201220473145 U CN201220473145 U CN 201220473145U CN 202875454 U CN202875454 U CN 202875454U
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CN
China
Prior art keywords
sacculus
bone cement
balloon
bar
prepackage
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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.)
Expired - Fee Related
Application number
CN 201220473145
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Chinese (zh)
Inventor
李庆
曹烽
王�琦
马驰
陈和春
熊成东
庞秀炳
陈栋梁
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ZHEJIANG WEDU MEDICAL EQUIPMENT CO Ltd
Chengdu Organic Chemicals Co Ltd of CAS
Original Assignee
ZHEJIANG WEDU MEDICAL EQUIPMENT CO Ltd
Chengdu Organic Chemicals Co Ltd of CAS
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Application filed by ZHEJIANG WEDU MEDICAL EQUIPMENT CO Ltd, Chengdu Organic Chemicals Co Ltd of CAS filed Critical ZHEJIANG WEDU MEDICAL EQUIPMENT CO Ltd
Priority to CN 201220473145 priority Critical patent/CN202875454U/en
Application granted granted Critical
Publication of CN202875454U publication Critical patent/CN202875454U/en
Anticipated expiration legal-status Critical
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Abstract

The utility model discloses a bone cement filling balloon device which comprises a pipeline type injector and a balloon connected with the lower end of the injector. A preloaded rod extending into the balloon is arranged in an inner cavity of the injector. For instance, the molecular weight of poly-l-lactide, poly-dl-lactide, polyglycolic acid, polycaprolactone, polyethylene glycol, polydioxanone, poly trimethylene carbonate and the like, and the copolymer and the polymer of the poly-l-lactide, the poly-dl-lactide, the polyglycolic acid, the polycaprolactone, the polyethylene glycol, the polydioxanone, the poly trimethylene carbonate and the like is 0.5-1 million. The bone cement filling balloon device can effectively control distribution of cone cement in a vertebral body and is simple and convenient to operate in an operation. Moreover, the bone cement can be prevented from being seriously leaked and can also be absorbed in a human body.

Description

A kind of bone cement fill balloon-system
Technical field
This utility model belongs to medical instruments field, relates in particular to a kind of bone cement fill balloon-system for protruding plasty behind the percutaneous.
Background technology
Vertebroplasty for inject in the vertebral body by pedicle of vertebral arch packing material with the crushing resistance that increases vertebral body, prevent that vertebral body from further subsiding, alleviating a kind of Therapeutic Method of lumbar and back pain and recovery vertebral height, be used at first in the open operation of spinal fracture, with pulp as packing material, but pulp can not be rebuild the Strength and stability of vertebral body immediately.
The Galibert of France in 1984 etc. are at treatment 1 routine C 2During vertebral body aggressive Vertebral Hemangioma, at first adopted percutaneous puncture to enter vertebral body, the polymethyl methacrylate (PMMA) that will be commonly called as " bone cement " injects the method for vertebral body and has obtained success, has started the history of percutaneous vertebroplasty (PVP).Although percutaneous vertebroplasty clinical effectiveness is satisfied, directly injects bone cement and in vertebral body, have the shortcomings such as injections difficult, the bone cement seepage is high, the kyphosis deformity improvement is poor.
In latter stage in 20th century, a kind of expansiveness sacculus is used in the vertebroplasty, i.e. protruding plasty (PKP) behind the initial percutaneous.This plasty has used the pressure of a kind of Kyphon of being called to strut sacculus, its objective is by certain pressure sacculus is strutted in vertebral body, thereby with the corpus vertebrae replacement of damage and form certain space, then takes out and strut sacculus, injects bone cement.Still there are two problems at present in this treatment means, and the one, bone cement is improper as injecting, thereby might seepage produce complication; The another one problem is that because worry the complication that the bone cement seepage causes, the consumption of bone cement is generally comparatively conservative in the clinical operation, the less more caused symptoms of bone cement can occur thereupon.
For the bone cement seepage, a kind of new Vessel-x reticulated bone dilator has appearred again in recent years, this reticulated bone dilator can more effectively be controlled bone cement in Intrapyramidal distribution, further reduces the bone cement seepage, is expected to become the alternative of protruding plasty behind traditional percutaneous; In addition, also have a kind of bone cement nonabsorable fill sacculus, namely scratch sacculus with special instrument behind the fill bone cement and take out, but there is complicated operation in this device, produce easily the hidden danger such as bone cement displacement and sacculus do not take out, thereby do not obtain clinically widely applying.
Publication number is that the Chinese patent of CN2684777Y discloses a kind of sacculus, is comprised of hollow sacculus, sacculus handle, is connected with cotton rope on the sacculus handle end openings wall; Bone cement is inserted in the sacculus, and cotton rope is used for wrapping bundle sacculus mouth, and sacculus is made by absorbable material.This sacculus can effectively be avoided the bone cement seepage, but still has some difficulties in this balloon operation operation, particularly is not suitable for Minimally Invasive Surgery and uses.
Publication number is that the Chinese patent of CN2487345Y discloses a kind of percutaneous kyphoplasty device, comprise that percutaneous needle and the conduit that cooperates with it and sacculus consist of, sacculus is wrapped on the conduit, pore is arranged on the conduit, can make it dilatating and deformable to inflated, but before injecting bone cement, need to withdraw from sacculus, can not be as the purposes of filling bone cement.
Summary of the invention
This utility model provides a kind of bone cement fill balloon-system, can effectively avoid a large amount of seepages of bone cement, and employed sacculus can absorb again in vivo, and simple to operation in operation, and sacculus is promptly placed in the vertebral body.
A kind of bone cement fill balloon-system comprises the sacculus that is duct-like infusion appliance, is connected in the infusion appliance lower end, is provided with the prepackage bar that stretches into sacculus in the inner chamber of described infusion appliance;
Described sacculus is made by absorbable material.
The effect of described prepackage bar be by it rotation with sacculus be rolled in the prepackage bar on, so that sacculus passes the service pipe that Minimally Invasive Surgery uses and enters the vertebral body inner chamber, therefore, in Minimally Invasive Surgery, device of the present utility model can be accurately, promptly sacculus is inserted in the vertebral body; When placing after the vertebral body of sacculus success, take out the prepackage bar, the pipeline by infusion appliance injects bone cement in sacculus; Described sacculus is made by absorbable material, need not sacculus is taken out, so both can inject enough bone cements in this device, keeps stable resetting, and can make again bone cement non-leakage.This utility model can recover its height from recovering in essence the integrity of vertebral body structure, thereby recovers and keep the physiologic radian of spinal column, prevents the bone cement complication that causes in shortage, and fundamentally solves the complication that the bone cement seepage causes.
As preferably, the outer surface of described prepackage bar is provided with scale mark, and the existence of scale mark is so that the more convenient assembling of prepackage bar, makes the sacculus can full extension.
The cross section of described prepackage bar can be the shapes such as circle, rectangle or polygon, be preferably circle or polygon, more preferably circular, at this moment, can by the prepackage bar rotation so that sacculus wrap tightly the prepackage bar on, as further preferred, the lower end of described prepackage bar is threaded, and the existence of screw thread can be so that sacculus more closely be attached on the prepackage bar.
As preferably, the upper end of described infusion appliance is provided with the handle with interface, the top of described prepackage bar is provided with the retaining mechanism that matches with the interface of described handle, the effect of retaining mechanism is to prevent from pre-installing the bar reverse rotation, prepackage bar and sacculus are close to state with maintenance after locking, and be more convenient to operate.
The width of described interface handle and thickness are 4-100mm, and length is 10-200mm, and the overall diameter of described interface is 3-50mm, and interface can adopt thread forms, also can adopt non-threaded form, and the handle of this kind size is fit to operation.
As preferably, the pipeline overall diameter of described infusion appliance is 2-15mm, and the length of described pipeline is 60-300mm, and the injector tube of this kind size can easily pass through service pipe, is fit to the needs of Minimally Invasive Surgery, can inject very easily bone cement simultaneously.
In this utility model, described sacculus can be by routine the plastic shaping mode as extrude, the molding mode processing such as blowing, injection moulding, braiding or electrospinning, described sacculus is connected with infusion appliance and is adopted bonding, snap close, welding or alternate manner to connect, described sacculus can be connected in the outer surface of injector tube, also can be connected in the inner surface of injector tube; The sacculus profile can be sphere, elliposoidal, avette or cylindrical, can be with handle, also can not be with handle; Sacculus can be monolayer, also can be multilamellar.
The diameter of described sacculus is preferably 2-80mm, and length is preferably 2-80mm, and the sacculus of this size can be applicable to protruding plasty behind the percutaneous.As further preferred, it is the 0-3mm hole that described balloon surface has diameter, direct pore-forming when the balloon surface pore-forming can adopt the sacculus molding such as electrospinning, the direct pore-forming of extrusion process, also can adopt laser, machinery and other method pore-forming after the sacculus molding.Micropore is arranged on the balloon wall, can allow bone cement slightly to be exuded to balloon surface, can well play the strong bonded with bone, avoid bone cement Intrapyramidal loosening.Wherein, the diameter in the hole of balloon surface is 0~3mm, to guarantee that bone cement oozes out slightly at balloon surface formation salient point, increase and binding strength from the body bone, can not cause again a large amount of keys that cause bone cement intravasation or canalis spinalis to produce complication of revealing, diameter is crossed conference and is improved a large amount of risks of revealing of bone cement.
The material of described absorbable material for being absorbed fully by human body, be preferably poly-L-lactic acid, poly-DL lactic acid, polyglycolic acid, polycaprolactone, Polyethylene Glycol, poly-two chalk alkane ketone, PTMC and their copolymer or blend, the molecular weight of described absorbable material is 0.5-100 ten thousand.
Sacculus of the present utility model also can add the inorganic material such as hydroxyapatite, calcium phosphate, magnesium phosphate, calcium sulfate and artificial activity glass in absorbable material makes sacculus have the bone conduction performance; Also can add the bioactive materials such as bone induction material makes sacculus have osteogenic activity; Can also add the mixture of inorganic material and bioactive materials.
Compare with prior art, the beneficial effects of the utility model are embodied in:
(1) adopt the absorbable balloon device, can be accurately, promptly sacculus is inserted vertebral body, in insert enough bone cements, keep stable resetting, can make again bone cement non-leakage.
(2) this utility model can shorten operating time, improves operation efficient and success rate, reduces clinician and patient's radiated time under X-ray.To the raising of operation efficient by following 3 guarantees: (a) with the time advance of inserting of bone cement, as adopt polymethyl methacrylate (PMMA) bone cement, can inject immediately (after solidifying 0.5min approximately) behind the bone cement mix and blend and insert, rather than injection after the PMMA toothpaste-like (solidifying approximately 1.5-4.5min) of existing clinical middle employing; (b) shorten inject time, PMMA gruel shape flowability is higher than toothpaste-like far away, and can shorten to 0.5min inject time by existing about 1.5min; (c) device is quick for installation accurately, owing to adopted prepackage locking and labelling technique, this utility model device can accurately enter the position and enter duty by instrumentation tubes fast.
Description of drawings
Fig. 1 is the structural representation of bone cement fill balloon-system of the present utility model;
Fig. 2 is the user mode sketch map of bone cement fill balloon-system of the present utility model.
The specific embodiment
The structural representation of the bone cement fill balloon-system that Fig. 1 provides for this utility model.
As shown in Figure 1, this bone cement fill balloon-system, comprise: be duct-like infusion appliance 2, be connected in the sacculus 1 of infusion appliance 2 lower end outer surfaces, sacculus 1 is elliposoidal, the upper end of infusion appliance 2 is provided with the handle 5 with interface, be provided with the prepackage bar 3 that stretches into sacculus 1 in the inner chamber of infusion appliance 2, prepackage bar 3 can move up and down, and the top of prepackage bar 3 is provided with the retaining mechanism 4 that matches with the seam of described handle 5.
The user mode sketch map of the bone cement fill balloon-system that Fig. 2 provides for this utility model.
As shown in Figure 2, the prepackage bar stretches into sacculus 1 inside, and the rotation by the prepackage bar will pre-install bar and infusion appliance 2 by retaining mechanism 4 and lock so that sacculus 1 is close to sacculus on the surface of prepackage bar, prevent from pre-installing bar and counter-rotate.
Below in conjunction with embodiment this utility model is further described.
Embodiment 1
Take poly-DL lactic acid as raw material (molecular weight 50000), adopt method of electrostatic spinning to prepare sacculus 1, its thickness 0.2mm, volume 3ml, balloon diameter 3.5mm.The hole of the about 0.01mm of uniform diameter on the balloon surface.This absorbable balloon 1 opening is connected to infusion appliance 2 away from outer surface or the inner surface of handle end, and infusion appliance 2 length are 60mm.Sacculus is pre-installed bar 3 stretch into from infusion appliance 2 seams that connect absorbable balloon 1, until the sacculus full extension, rotation prepackage bar is pre-installed bar with 4 lockings of retaining mechanism on the infusion appliance handle 5 until sacculus fully is close to sacculus prepackage bar with sacculus.
Embodiment 2
Be 4mm with example 1 absorbable balloon device by caliber, length is the instrumentation tubes of 100mm, and sacculus is all exposed outside the service pipe, unclamps prepackage bar upper locking device, and the prepackage bar is also taken out in reverse rotation.Allotment bone cement PMMA10ml sucks the q.s bone cement to the external syringe with the pressure display behind the 20s, then connects with bone cement infusion appliance 2 interfaces, and slowly injection, pressure shows 0.5kgf/cm when being 4ml to addition 2, sacculus appearance ne-leakage, sacculus does not break.After bone cement solidifies, grasp the sacculus that fills up bone cement, gently revolve the infusion appliance handle absorbable balloon that bone cement is housed is connected with the infusion appliance disengagement, extract infusion appliance.
Embodiment 3
Take the L lactic acid-ethanol copolymer as raw material (molecular weight 80000), adopt method of electrostatic spinning to prepare sacculus 1, its thickness 0.15mm, volume 8ml, sacculus shank diameter 3.2mm.Form the dozens of hole 6 of the about 1.0mm of diameter in balloon surface with laser-beam drilling machine.This absorbable balloon 1 opening is connected to infusion appliance 2 away from outer surface or the inner surface of handle end, and infusion appliance 2 length are 220mm.Sacculus is pre-installed bar 3 stretch into from infusion appliance 2 seams that connect absorbable balloon 1, until the sacculus full extension, rotation prepackage bar is pre-installed bar with 4 lockings of retaining mechanism on the infusion appliance handle 5 until sacculus fully is close to sacculus prepackage bar with sacculus.Inject bone cement with example 2 operations, pressure shows 0.8kgf/cm when being 8.5ml to addition 2, the sacculus appearance has dozens of Herba Agrimoniae shape projection, and bone cement is without a large amount of leakages, and sacculus does not break.
Embodiment 4
Take polylactic acid-trimethylene carbonate copolymer as raw material (molecular weight 100000), employing melt extrudes the method for forming and prepares sacculus 1, its thickness 0.09mm, volume 8ml, sacculus shank diameter 3.3mm.Form the dozens of hole 6 of the about 2.0mm of diameter in balloon surface with laser-beam drilling machine.This absorbable balloon 1 opening is connected to infusion appliance 2 away from outer surface or the inner surface of handle end, and infusion appliance 2 length are 200mm.Sacculus is pre-installed bar 3 stretch into from infusion appliance 2 seams that connect absorbable balloon 1, until the sacculus full extension, rotation prepackage bar is pre-installed bar with 4 lockings of retaining mechanism on the infusion appliance handle 5 until sacculus fully is close to sacculus prepackage bar with sacculus.Inject bone cement with example 2 operations, pressure shows 0.6kgf/cm when being 9ml to addition 2, the sacculus appearance has dozens of Herba Agrimoniae shape projection, and bone cement is without a large amount of leakages, and sacculus does not break.
Embodiment 5
Take polylactic acid-caprolactone copolymer as raw material (molecular weight 70000), employing melt extrudes the method for forming and prepares sacculus 1, its thickness 0.10mm, volume 7ml, sacculus shank diameter 3.6mm.Form the dozens of hole 6 of the about 2.8mm of diameter in balloon surface with the mechanical punching machine.This absorbable balloon 1 opening is connected to infusion appliance 2 away from outer surface or the inner surface of handle end, and infusion appliance 2 length are 300mm.Sacculus is pre-installed bar 3 stretch into from infusion appliance 2 seams that connect absorbable balloon 1, until the sacculus full extension, rotation prepackage bar is pre-installed bar with 4 lockings of retaining mechanism on the infusion appliance handle 5 until sacculus fully is close to sacculus prepackage bar with sacculus.Inject bone cement with example 2 operations, pressure shows 0.5kgf/cm when being 7.6ml to addition 2, the adhesion of sacculus outer surface dozens of jut, bone cement is without a large amount of leakages, and sacculus does not break.

Claims (7)

1. bone cement fill balloon-system, comprise the sacculus (1) that is duct-like infusion appliance (2), is connected in infusion appliance (2) lower end, it is characterized in that, be provided with the prepackage bar (3) that stretches into sacculus (1) in the inner chamber of described infusion appliance (2).
2. bone cement fill balloon-system according to claim 1 is characterized in that, the outer surface of described prepackage bar (3) is provided with scale mark.
3. bone cement fill balloon-system according to claim 1 is characterized in that, the cross section of described prepackage bar (3) is circle or polygon.
4. bone cement fill balloon-system according to claim 1, it is characterized in that, the upper end of described infusion appliance (2) is provided with the handle (5) with interface, and the top of described prepackage bar (3) is provided with the retaining mechanism (4) that matches with the interface of described handle (5).
5. bone cement fill balloon-system according to claim 1 is characterized in that, the pipeline overall diameter of described infusion appliance (2) is 2-15mm, and the length of described pipeline is 60-300mm.
6. bone cement fill balloon-system according to claim 1 is characterized in that, the diameter of described sacculus (1) is 2-80mm, and length is 2-80mm.
7. according to claim 1 or 6 described bone cement fill balloon-systems, it is characterized in that it is the hole of 0-3mm that there is diameter on the surface of described sacculus (1).
CN 201220473145 2012-09-17 2012-09-17 Bone cement filling balloon device Expired - Fee Related CN202875454U (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106333739A (en) * 2016-09-26 2017-01-18 中国医学科学院北京协和医院 Orthopaedic device used for injection implanting of material
CN111157279A (en) * 2020-01-20 2020-05-15 重庆三峡学院 Geological disaster prevention, control, monitoring and sampling device

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106333739A (en) * 2016-09-26 2017-01-18 中国医学科学院北京协和医院 Orthopaedic device used for injection implanting of material
CN106333739B (en) * 2016-09-26 2018-09-25 中国医学科学院北京协和医院 Orthopaedics injecting type is implanted into the instrument used when material
CN111157279A (en) * 2020-01-20 2020-05-15 重庆三峡学院 Geological disaster prevention, control, monitoring and sampling device

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CF01 Termination of patent right due to non-payment of annual fee

Granted publication date: 20130417

Termination date: 20150917

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