CN108784890A - Invasive lumbar fusion device and bone cement injection device under a kind of minimally invasive channel - Google Patents

Invasive lumbar fusion device and bone cement injection device under a kind of minimally invasive channel Download PDF

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Publication number
CN108784890A
CN108784890A CN201810730924.5A CN201810730924A CN108784890A CN 108784890 A CN108784890 A CN 108784890A CN 201810730924 A CN201810730924 A CN 201810730924A CN 108784890 A CN108784890 A CN 108784890A
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memory metal
pouch
bone cement
lumbar fusion
fusion device
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CN201810730924.5A
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Chinese (zh)
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林浩
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Individual
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Individual
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Priority to CN201810730924.5A priority Critical patent/CN108784890A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4601Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4611Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4635Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor using minimally invasive surgery

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

Abstract

The invention discloses the Invasive lumbar fusion devices and bone cement injection device under a kind of minimally invasive channel, Invasive lumbar fusion device, including memory metal holder and pouch, the memory metal holder is the hollow polyhedron or cylinder by memory metal material, and the memory metal rack surface has hydroxyapatite coating layer;There are one the opening for filling injection bone cement, pouch is full to be set to memory metal internal stent, and bone cement material is filled in the pouch for the pouch surface setting.The present invention utilizes the structure of memory metal holder combination bone cement pouch, both it had realized and has been put into height by the minimally invasive channel of as low as 5 millimeters of diameter or diameter or transverse diameter reach 14 millimeters of Invasive lumbar fusion devices, enough support forces can be provided again, and fusion device stablize in intervertenral space it is not easily shifted, can also by hydroxyapatite promote Bone Ingrowth long-term stabilization be provided.The probability for greatly reducing nerve root injury provides minimally invasive, efficient, safe operation tool for spinal surgery.

Description

Invasive lumbar fusion device and bone cement injection device under a kind of minimally invasive channel
Technical field
The present invention relates under a kind of medical instrument more particularly to a kind of minimally invasive channel Invasive lumbar fusion device and bone cement injection Device.
Background technology
Protrusion of lumber intervertebral disc is field of spinal surgery common disease/frequently-occurring disease, minimally invasive under recent years various minimally invasive channels Modus operandi emerges one after another.Especially in recent years, under foramen intervertebrale lens disc herniation Disectomy using more and more extensive.Its In, it is unstable between thering are some patients to merge centrum, it needs to carry out intervertebral fusion operation.Because can be put under 7 millimeters of channels The fusion device of intervertenral space, many doctors can only select to cut open modus operandi, and this modus operandi notch is big, there is 7~8 lis Rice is long, and the small of the back muscle dissection scope is wide, and operation wound is big, and recovery time is long, and often leaves the sequelae of lumbago.Previously There is doctor to devise the Invasive lumbar fusion device through being put under channel, but their fusion device diameter or height reach 14 millimeters, to It is put into intervertenral space through channel, needs 20 millimeters of thick service aisles.And service aisle percutaneously reaches interverbebral disc, to be cried by one The anatomical position of triangle of safety.Triangle of safety is the Delta Region that articular process/bottom centrum upper limb/nerve root three surrounds.Work It is excessively thick to make channel, is very easy to injured nerve root, severe one causes patient to paralyse, and limb adynamia, numbness occurs in less serious case, is one non- Normal serious complication.It is doctor absolutely to avoid occurring.So service aisle is thinner, operation carry out process is safer.
Invention content
In order to solve the shortcoming present in above-mentioned technology, the present invention provides the intervertebral fusions under a kind of minimally invasive channel Device and bone cement injection device.
In order to solve the above technical problems, the technical solution adopted by the present invention is:A kind of intervertebral fusion under minimally invasive channel Device, including memory metal holder and pouch, the memory metal holder are the hollow polyhedron or column by memory metal material Body, the memory metal rack surface have hydroxyapatite coating layer;There are one for filling injection bone for the pouch surface setting The opening of cement, pouch is full to be set to memory metal internal stent, and bone cement material is filled in the pouch.
Further, the material of the memory metal holder is niti-shaped memorial alloy, and the memory metal holder becomes Shape temperature is 0~5 DEG C, and recovery temperature is 25~40 DEG C.
Further, the memory metal holder is the tubulose that memory metal grid surrounds, the section of memory metal holder For round, rectangle or polygon.
Further, the memory metal holder is arch-shaped structure, including two symmetrically arranged arch monomers are described The bottom and upper segment that arch monomer head and the tail are separately connected, the top are arch protruding upward, following and length and top phase Together, following surface is provided with one or more upward protrusions;The semi arch to centre protrusion, two arches are provided among top Shape monomer is connected by semi arch.
Further, the memory metal holder includes two elliptical ring monomers disposed in parallel, the elliptical ring monomer Long axis on be provided with horizontal connection portion, the horizontal connection portion is provided with one or more upward or two-way protrusions;It is described The upper and lower side of elliptical ring monomer is respectively set there are two the semi arch to centre protrusion, and two elliptical ring monomers pass through two and half Circular arc is connected.
Further, the memory metal stent outer has outwardly projecting pointed tooth, pointed tooth to penetrate in centrum sclerotin up and down Keep fusion device not easily shifted.
Further, the bone cement is PMMA bone cement or calcium phosphate bone cement or polymethyl Sour methyl esters and the compound bone cement of calcium phosphate.
Further, the pouch opening is equipped with fixed ring.
Further, the material of the pouch is selected from silk, terylene, polytetrafluoroethylene (PTFE), polyurethane, elastic silicone rubber, gathers Amide, polyvinyl alcohol, polyethylene terephthalate, chitin, collagen, polylactic acid, polycaprolactone or above-mentioned material are received One or more of rice hydroxylapatite compound.
Further, the pouch is the film that braiding or the surface being processed and formed at one time carry micropore.
Bag structure and upper and lower centrum sclerotin contact surface thickness are no more than 150 microns, the bag structure and upper hypocentrum Sclerotin contact surface carries micropore, its micro-pore diameter of pouch that non-degradable material makes is 100~400 microns, absorbable and degradable Its micro-pore diameter of the pouch of material making is smaller than 100 microns.The bag structure and upper and lower centrum sclerotin contact surface and other Part can be that identical material is integrally machined molding, or unlike material sutures or is bonded as one.
Further, the memory metal holder is the tubular structure that section is square, and is provided on the outside of the pouch Theca externa, the theca externa are laminated structure, are fixed on three sides of memory metal holder.
Present disclosure further includes a kind of bone water for bone cement material in above-mentioned Invasive lumbar fusion device to be injected to pouch Mud injection device, including injection rod, bone cement injector and the high pressure injector with pressure gauge, in the bone cement injector Equipped with the bone cement mixed;The injection rod includes rubber outer tube, and rubber outer tube front end is equipped with annular groove, for solid Determine pouch, the end of rubber outer tube is provided with escape pipe, and the escape pipe is arranged on the side wall of rubber outer tube, is set on escape pipe It is equipped with openable and closable air valve;Rubber inner tube is provided in rubber outer tube, rubber inner tube length is more than rubber outer tube, rubber outer tube end End is closed and is provided with through-hole, rubber inner tube;The metallic rod isometric with rubber inner tube is provided in rubber inner tube;In the rubber Pipe end is equipped with three-way connection, and wherein one end connects bone cement pusher, and one end connects high pressure injector.
The present invention provides the Invasive lumbar fusion device and bone cement injection device under a kind of minimally invasive channel, the Invasive lumbar fusion device, Using the characteristic of memory metal, memory metal holder compression rear plug is entered into minimally invasive channel in low temperature, is then placed in intervertenral space, temperature Degree resiles after increasing, while having very big rigidity, realizes the purpose that larger Invasive lumbar fusion device is put into minimally invasive channel, The pointed tooth of outer wall penetrates in centrum sclerotin, realizes the stabilization of fusion device.Meanwhile it is insufficient in order to solve memory metal stiffness of support The pouch for being enclosed with bone cement is put into memory metal holder by problem, similar armored concrete spline structure is formed, due to pouch Restriction effect, when injecting bone cement into pouch, the expansion of pouch can upward hypocentrum offer pressure, the support of reinforced support Rigidity;The suspicious promotion Bone Ingrowth of hydroxyapatite coating layer of rack surface.Polymethyl methacrylate and calcium phosphate are compound Bone cement can not only guide osteogenic action, can pass through pouch hole and micropore is contacted with centrum sclerotin, be conducive to the length of area of new bone Enter, while it is good to be utilized polymethyl methacrylate mechanical property, it is non-breakable, as having the advantages that support force effect.
The present invention utilizes the structure of memory metal holder combination bone cement pouch, has both realized by as low as 7 millimeters of diameter, Even 5 millimeters of minimally invasive channel is put into height or diameter or transverse diameter reaches 14 millimeters of Invasive lumbar fusion devices, and can provide enough Support force, and fusion device is stablized not easily shifted in intervertenral space, Bone Ingrowth can also be promoted to provide long-term by hydroxyapatite Stablize.It is revolutionary wound to intervertebral fusion under the foramen intervertebrale lens of millimeter service aisle of intervertebral fusion, especially 7 under minimally invasive channel It lifts, greatly reduces the probability of nerve root injury, minimally invasive, efficient, safe fusion instrument and hand are provided for spinal surgeons Art tool.
Description of the drawings
Fig. 1 is the structural schematic diagram of Invasive lumbar fusion device of the present invention.
Fig. 2 is the structural schematic diagram of the tubulose memory metal holder of the present invention.
Fig. 3 is the schematic diagram of the arch-shaped memory metal holder of the present invention.
Fig. 4 is the schematic diagram that arch-shaped memory metal holder is unfolded.
Fig. 5 is the schematic diagram of the oval ring memory metal holder of the present invention.
Fig. 6 is another structural schematic diagram of Invasive lumbar fusion device of the present invention.
Fig. 7 is the structural schematic diagram of Invasive lumbar fusion device theca externa in Fig. 6.
Fig. 8 is the structural schematic diagram of Invasive lumbar fusion device theca interna in Fig. 6.
Fig. 9 is the structural schematic diagram of bone cement injection device of the present invention.
Figure 10 is the structural schematic diagram of injection rod.
In figure:1, memory metal holder;2, pouch;3, it is open;4, top;5, following;6, semi arch;7, raised;8, interior Film layer;9, theca externa;10, injection rod;11, bone cement injector;12, high pressure injector;13, rubber inner tube;14, metallic rod; 15, annular groove;16, escape pipe;17, air valve;18, rubber outer tube;19, three-way connection.
Specific implementation mode
The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.
【Embodiment 1】
The present embodiment includes the Invasive lumbar fusion device under a kind of minimally invasive channel.
Invasive lumbar fusion device as shown in Figure 1, including memory metal holder 1 and pouch 2, memory metal holder 1 are such as Fig. 2 institutes The tubulose surrounded by memory metal material grid shown, memory metal rack surface are provided with outwardly projecting pointed tooth.2 table of pouch Face setting is there are one the opening 3 for filling injection bone cement, and pouch 2 is full to be set to inside memory metal holder 1, pouch 2 In be filled with bone cement material.
Wherein, memory metal rack surface has hydroxyapatite coating layer, the material of memory metal holder to remember for NiTi shape Recall alloy, the memory metal deformation of timbering temperature is 0~5 DEG C, and recovery temperature is 25~40 DEG C.
The processing method of the memory metal holder can be to work out winding method, plane photoetching process or three-dimensional precise engraving method, Wherein:
1, winding method is woven:It is to be wound, be welded by braiding by one or more Ultimum Ti silk, advantage It is that processing technology is simple, compliance is preferable, but its intensity is poor, and deformation is uneven.
2, plane photoetching process:For the processing to Ultimum Ti plank.Its process, plates in substrate first Sacrificial layer, metal layer and photoresist layer;Then photoresist figure is defined;Then go out metal layer by the photoresist pattern etching defined Required figure;Remove photoresist;Remove sacrificial layer, you can obtain required planar configuration, be then made in a welding manner The holder of thin-wall tube.
3, three-dimensional precise engraving method:Direct engraving goes out the shape of holder on Ultimum Ti tubing.
Memory metal holder mainly divides three classes according to grid and production method:Braided support/tubular bracket/annular support.
Braided support is made of above-mentioned 1 method.Its support stiffness is smaller.
Tubular bracket is made of above-mentioned 2 or 3 method.There is the prismatic of upright post type/arch bridge type/tetra-/no according to mesh shape Prismatic of symmetrical four prismatic/six etc., various configuration has different support stiffness.With arch bridge type and asymmetric four prismatic support stiffness compared with It is good.
Annular support is made of above-mentioned 2 or 3 method.The grid of annular support is by vertical supporter and horizontal connection portion Two parts are constituted.Vertical supporter has Z-shaped or bowstring type.Horizontal connection portion, which also divides, several such as schemes several various configurations.
In comparison, tubular bracket support stiffness is big, but the flexibility being bent is poor.Annular support support stiffness is small, but The flexibility of bending is good.So tubular bracket is suitble to make short holder of the length at 200~260 millimeters, an intervertenral space can be put Two holders.Annular support is suitble to be made 300 to 500 millimeters of long stent, is placed along the bending of vertebral rim in intervertenral space.
Any of the above holder is after the completion of cold working, then surface polishing treatment, then carries out heat treatment memory metal holder So that shape is shaped, it is hydroxyapatite sprayed finally to carry out nano surface.
The material elastic silicone rubber nanometer hydroxyapatite compound of pouch, the shape of pouch are set according to internal stent space Meter, it is desirable that, should be from the gap bulging of holder after bone cement is full of, while it being in close contact the sclerotin of upper hypocentrum, while should not Bulging is too many.Go out mold according to internal stent spatial design.When designing mold, the shrinking percentage of sizing material, shrinking percentage one are considered As be 2%~4%.
Molding/injection (LIM)/may be used to squeeze out these three modes and be processed molding.
Molding is using higher pressure (2000~8000psi) and lower temperature (90~180 DEG C).Specifically regard sizing material class Depending on type.It must be strictly controlled temperature/pressure and time in mold process.Various functions time accurate fit is excellent for producing The full cured members of matter are very crucial.
LIM uses lower pressure (250~2000psi) and higher temperature (110~250 DEG C).LIM gives birth in silicon rubber Have many advantages, such as in production, including cleannes and speed.In injection process, pumping system is under full closeding state by two kinds of groups The fluid silicone rubber (catalyst and crosslinking agent) divided, which is pumped directly into mixing machine, to be homogenized, and is then pumped into membrane cavity.In high temperature In, sizing material is quickly flowed in membrane cavity and vulcanizable cures.Injection only need 3~10 seconds, vulcanization need 10~90 seconds or longer time It can complete.LIM uses closed flow, and pollution can be greatly reduced.It can guarantee the stability of pouch quality.
Silicon rubber can also pass through extrusion molding.When extrusion flow starts, by two-component gum stock (catalyst and crosslinking Agent) it mixes on the double roll mill.Then strip semi-finished product are made to be continuously fed into extruder.After extrusion, pipe fitting passes through heat Wind vulcanizing oven vulcanizes product with hot-air or radiant heat.
Silicon rubber film also needs to that poromerics is made, and is no more than 150 microns with upper and lower centrum sclerotin contact surface thickness, with Upper and lower centrum sclerotin contact surface carries micropore, 100~400 microns of micro-pore diameter.
Using sodium chloride as pore former, using liquid silastic as raw material, through high temperature vulcanized molding, sodium chloride is removed in boiling water Particle leaching method prepare liquid silastic poromerics.To improve the mechanical property of liquid silastic poromerics, use Silica Nanotube reinforcement silicon rubber poromerics.
It after microporous silicon rubber pouch machine-shaping, first cleans, then be surface-treated, then prepares nanometer with bio-mimetic syntheses Hydroxyapatite coating layer.The ectonexine of pouch will prepare nano hydroxyapatite coating.
Bone cement is polymethyl methacrylate and the compound bone cement of calcium phosphate, and preparation method is:Pass through calcium phosphate Phosphorus stone crystal seed is added in bone cement (CPC) material, to improve compression strength and the hardening time of CPC, by reducing solid phase particles ruler Very little acceleration hardening accelerates dissolving-precipitation reaction so as to shorten hardening time, forms tiny crystal grain, and little crystal grain is interlocked Cement can be made to obtain higher mechanical strength;It is utilized respectively sodium dihydrogen phosphate and dibastic sodium phosphate is mixed and made into neutral buffered liquid work For solidify liquid.Select injectable calcium phosphate bone cement (CPC) mixed in different quality ratio with polymethyl methacrylate (PMMA) Close the preparation for carrying out compound bone cement, CPC ingredients can gradually be degraded over time, degradation speed unlike Calcium sulfate is too fast like that, can not be also metabolized throughout one's life unlike PMMA;On the other hand, it also has guiding osteogenic action, is conducive to Area of new bone is grown into.And can not katabolism PMMA ingredients still as with support force effect tissue be present in intervertenral space Between upper hypocentrum, together with holder, play a supporting role.
【Embodiment 2】
The present embodiment includes the Invasive lumbar fusion device under a kind of minimally invasive channel.
The present embodiment is substantially the same manner as Example 1, difference lies in:Memory metal holder is as shown in figure 3, for by memory metal The hollow polyhedron of material, specially arch-shaped structure, including two symmetrically arranged arch monomers, the arch monomer are first The bottom and upper segment that tail is separately connected, top 4 be arch protruding upward, following 5 and length it is identical as top 4, following 5 surface It is provided with one or more upward protrusions 7;The semi arch 6 to centre protrusion is provided among top, two arch monomers are logical Semi arch is crossed to be connected.The surface of arch-shaped monomer is additionally provided with outwardly projecting pointed tooth.
Its production method is:Original shape as shown in Figure 4 is first cut with laser cutting technique with Ultimum Ti plank, so Rear surface polishing treatment, then high temperature bent for shaping, laser welding is carried out after annealing, then carries out heat treatment memory metal holder So that holder is shaped, it is hydroxyapatite sprayed finally to carry out nano surface.
In addition, the material of the pouch of the present embodiment is polyurethane nano hydroxylapatite compound, processing method is:It adopts With in-situ compositing, using polyurethane as matrix, nHA/PU composite materials have been prepared using nanometer hydroxyapatite as reinforcement.
Then by nHA/PU composite materials by way of solution moulding by casting or extrusion molding, blow molding even 3D printing system At the film of Bao Erren.There is this film higher intensity and elasticity, tensile strength to be up to 41.2~54.9MPa, longest energy Elongation 8 times, and return to original size and without apparent deformation.Energy is long-term and keeps its flexibility in wide temperature range, also With good gas permeability, resistance to chemical reagents, resistance to microorganism, radiation resistance, can be made thinner (only 50 μm of most thin thickness).And The nanometer hydroxyapatite on surface also has the characteristic for promoting Bone Ingrowth.
Then it is punched in nHA/PU laminated films and upper and lower centrum sclerotin contact surface with laser boring method, micro-pore diameter 100~400 microns.
Also many methods can prepare microporous polyurethane film, including:Static Spinning weave, solution-cast/salting out method, phase point From method, freeze-drying, laser boring method, phase inversion method etc..
【Embodiment 3】
The present embodiment includes the Invasive lumbar fusion device under a kind of minimally invasive channel.
The present embodiment is substantially the same manner as Example 2, and difference lies in memory metal holder as shown in Figure 5 is two parallel The elliptical ring monomer of setting is provided with horizontal connection portion on the long axis of the elliptical ring monomer, and the horizontal connection portion is provided with One or more upward or two-way protrusions;What the upper and lower side of the elliptical ring monomer was protruded there are two being respectively set to centre Semi arch, two elliptical ring monomers are connected by two semi arches.Elliptical ring monomer side has with upper and lower centrum sclerotin contact position Multiple pointed tooths penetrate sclerotin center rest.
【Embodiment 4】
The present embodiment includes the Invasive lumbar fusion device under a kind of minimally invasive channel as shown in figs 6-8.
The present embodiment is substantially the same manner as Example 1, be section is rectangular tubulose, capsule difference lies in, memory metal frame Bag includes theca interna 8 and theca externa 9, and theca externa 9 is the manufacture layer that woven weaving is formed, and the theca interna is with the thin of micropore Film;The theca externa is laminated structure, is fixed on three sides of memory metal holder, a side of the theca interna is opened If the opening for filling injection bone cement.
Wherein, the processing method that outer membrane layer processing method is similar to artificial blood vessel is processed for woven weaving.When woven weaving Pouch is set to form hole, non-woven film processed forms it into microcellular structure, the purpose is to not only make pouch have enough elastic force, but also So that pouch is had certain porosity, the sclerotin of centrum is facilitated to grow into.Theca interna is the elastic silicone rubber film with micropore.Theca externa Purpose be to pouch except the other faces contacted with centrum are reinforced.
In the present embodiment, one can be made with holder by sewing in memory metal internal stent in theca externa;Theca externa It is integrated with gluing with theca interna, before memory metal holder is sent into intervertenral space, pouch mouth need to be tied up with conveying lever.Also may be used Not sutured with holder, method is sent in holder after being put into memory metal holder in vivo.
【Embodiment 5】
The present embodiment includes the making of the absorbable pouch in the Invasive lumbar fusion device under a kind of minimally invasive channel.
The making of degradable poly lactic acid and polycaprolactone polymer macromolecule pouch:
A. the preparation of solution:P (LLA-CL) (LA/CL=70/30) (i.e. polylactic acid and polycaprolactone polymer) is pressed into matter Amount score is dissolved in for 6% in dichloromethane and n,N-Dimethylformamide solvent (7: 3), and sealing is placed on magnetic stirrer It stirs (room temperature) for 24 hours, is prepared into fully transparent solution.
B. electrostatic spinning:By in the P prepared (LLA-CL) solution implantation glass syringe, syringe needle (No. 4 tack Syringe needle) it is connected with high pressure generator by conducting wire, application voltage is 10-11kV.The flow of P (LLA-CL) solution has micro-injection Pump control, boosting speed are 30 μm/min.Fiber is collected into the moulding good titanium alloy bar being placed in front of syringe needle, and distance is about For 12cm, electrostatic spinning is carried out at ambient temperature, and reticulated macroporous sacculus is made.
【Embodiment 6】
As shown in Figures 9 and 10, the present embodiment includes a kind of for bone cement material in above-mentioned Invasive lumbar fusion device to be injected pouch Bone cement injection device.
Bone cement injection device, including injection rod 10, bone cement injector 11 and the high pressure injector 12 with pressure gauge, Equipped with the bone cement mixed in bone cement injector 11;Injection rod 10 includes rubber outer tube 18, and rubber outer tube front end is equipped with ring Connected in star 15, for fixing pouch 2.The end of rubber outer tube is provided with escape pipe 16, and the escape pipe 16 is arranged outside rubber Openable and closable air valve 17 is provided on the side wall of pipe 18, on escape pipe;Rubber inner tube 13 is provided in rubber outer tube 18, in rubber 13 length of pipe is more than rubber outer tube 18, and 18 end of rubber outer tube is closed and is provided with through-hole;It is provided in rubber inner tube and rubber The isometric metallic rod 14 of inner tube.13 end of rubber inner tube is equipped with three-way connection 19, and wherein one end is for connecting bone cement injector 11;The other end is pierced by from 18 side wall of rubber outer tube, for connecting high pressure injector 12.
In use, pouch 2 is banded in 18 front end of rubber outer tube by cotton rope, the outer pipe end of rubber will prop up at pouch mouth Support is inserted into rubber inner tube with metallic rod, is then integral and is inserted into rubber outer tube, until pouch top, send pouch into holder Behind inside, support metallic rod is taken out from end.Rubber inner tube is connected with bone cement injector, and opens exhaust pipe air valve, The bone cement mixed is injected in pouch by bone cement pusher;Meanwhile air is discharged with rubber outer tube in pouch.Injection Rubber inner tube gradually being extracted out with progress in the process, waiting for that pouch is completely filled with by bone cement, extraction rubber inner tube to pouch tail end is twisted Close-up air cavity tail cap, is then pressurizeed with high pressure injector, until bone cement hardens.Knot is unclamped after bone cement hardening, makes pouch It is detached with rubber pipe, pouch tail portion bone cement is twisted into two parts in rotation, and injection rod is taken out, and completes operation.
【Embodiment 7】
The present embodiment includes the application method of the Invasive lumbar fusion device of embodiment 1 or 2 or 3, specially:
1. selecting memory metal holder of different shapes and pouch by actual demand;2, memory metal holder is cooled to 0 It in that can stretch and reduce diameter at~4 DEG C, is put into the pipe of diameter very little, is pushed into intervertenral space;3, make branch with warm saline flushing Frame rewarming restores to strut shape austenite parent phase state to prop up intervertenral space again to 25 DEG C with upper bracket;4, the bone water of pouch will be tied with Mud injection device one end is inserted into memory metal holder, injects bone cement according to the method for embodiment 4.
The above embodiment is not limitation of the present invention, and the present invention is also not limited to the example above, this technology neck The variations, modifications, additions or substitutions that the technical staff in domain is made within the scope of technical scheme of the present invention, also belong to this hair Bright protection domain.

Claims (12)

1. the Invasive lumbar fusion device under a kind of minimally invasive channel, it is characterised in that:Including memory metal holder and pouch, the memory gold It is the hollow polyhedron or cylinder by memory metal material to belong to holder, and the memory metal rack surface has hydroxyapatite coat Layer;There are one the opening for filling injection bone cement, pouch is full to be set to memory metal holder for the pouch surface setting Inside is filled with bone cement material in the pouch.
2. the Invasive lumbar fusion device under a kind of minimally invasive channel according to claim 1, it is characterised in that:The memory metal branch The material of frame is niti-shaped memorial alloy, and the memory metal deformation of timbering temperature is 0~5 DEG C, and recovery temperature is 25~40 ℃。
3. the Invasive lumbar fusion device under a kind of minimally invasive channel according to claim 2, it is characterised in that:The memory metal branch Frame is the tubulose that memory metal grid surrounds, and the section of memory metal holder is round, rectangle or polygon.
4. the Invasive lumbar fusion device under a kind of minimally invasive channel according to claim 2, it is characterised in that:The memory metal branch Frame is arch-shaped structure, including two symmetrically arranged arch monomers, and the top that the arch monomer head and the tail are separately connected is under Side, the top are arch protruding upward, and following and length is identical as top, and following surface is provided with one or more upward Protrusion;The semi arch to centre protrusion is provided among top, two arch monomers are connected by semi arch.
5. the Invasive lumbar fusion device under a kind of minimally invasive channel according to claim 2, it is characterised in that:The memory metal branch Frame includes two elliptical ring monomers disposed in parallel, and horizontal connection portion, the water are provided on the long axis of the elliptical ring monomer Flushconnection portion is provided with one or more upward or two-way protrusions;The upper and lower side of the elliptical ring monomer is respectively arranged with two A semi arch to centre protrusion, two elliptical ring monomers are connected by two semi arches.
6. the Invasive lumbar fusion device under a kind of minimally invasive channel according to any bar in claim 1-5, it is characterised in that:It is described Memory metal stent outer has outwardly projecting pointed tooth.
7. the Invasive lumbar fusion device under a kind of minimally invasive channel according to claim 1, it is characterised in that:The bone cement is poly- Methyl methacrylate bone cement or calcium phosphate bone cement or polymethyl methacrylate and the compound bone cement of calcium phosphate.
8. the Invasive lumbar fusion device under a kind of minimally invasive channel according to claim 1, it is characterised in that:The pouch opening is set There is fixed ring.
9. the Invasive lumbar fusion device under a kind of minimally invasive channel according to claim 1, it is characterised in that:The material of the pouch Selected from silk, terylene, polytetrafluoroethylene (PTFE), polyurethane, elastic silicone rubber, polyamide, polyvinyl alcohol, polyethylene terephthalate One or more of the nanometer hydroxyapatite compound of fat, chitin, collagen, polylactic acid, polycaprolactone or above-mentioned material.
10. the Invasive lumbar fusion device under a kind of minimally invasive channel according to claim 1, it is characterised in that:The pouch is to compile The surface knitted or be processed and formed at one time carries the film of micropore.
11. the Invasive lumbar fusion device under a kind of minimally invasive channel according to claim 10, it is characterised in that:The memory metal Holder is the tubular structure that section is square, and theca externa is provided on the outside of the pouch, and the theca externa is laminated structure, Gu It is scheduled on three sides of memory metal holder.
12. a kind of bone cement for bone cement material in Invasive lumbar fusion device described in claim 1 to be injected to pouch injects dress It sets, including injection rod, bone cement injector and the high pressure injector with pressure gauge, it is characterised in that:The bone cement injection Equipped with the bone cement mixed in device;The injection rod includes rubber outer tube, and rubber outer tube front end is equipped with annular groove, uses In fixed pouch, the end of rubber outer tube is provided with escape pipe, and the escape pipe is arranged on the side wall of rubber outer tube, escape pipe On be provided with openable and closable air valve;It is provided with rubber inner tube in rubber outer tube, rubber inner tube length is more than rubber outer tube, outside rubber Pipe end is closed and is provided with through-hole, and the metallic rod isometric with rubber inner tube is provided in rubber inner tube;The rubber inner tube end End is equipped with three-way connection, and wherein one end connects bone cement pusher, and one end connects high pressure injector.
CN201810730924.5A 2018-07-05 2018-07-05 Invasive lumbar fusion device and bone cement injection device under a kind of minimally invasive channel Pending CN108784890A (en)

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CN111529128A (en) * 2020-04-27 2020-08-14 复旦大学附属中山医院厦门医院 Intraocular lens capsular bag
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Application publication date: 20181113