CN201168029Y - Metallic coating type NiTi memory alloy orthopedic device for scoliosis - Google Patents

Metallic coating type NiTi memory alloy orthopedic device for scoliosis Download PDF

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Publication number
CN201168029Y
CN201168029Y CNU2007201907878U CN200720190787U CN201168029Y CN 201168029 Y CN201168029 Y CN 201168029Y CN U2007201907878 U CNU2007201907878 U CN U2007201907878U CN 200720190787 U CN200720190787 U CN 200720190787U CN 201168029 Y CN201168029 Y CN 201168029Y
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CN
China
Prior art keywords
nitinol
pedicle screw
niti
skoliosis
orthotic device
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Expired - Lifetime
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CNU2007201907878U
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Chinese (zh)
Inventor
卢世璧
孙明学
汪爱媛
江霞
张莉
孙元
彭江
郭全义
李永滨
许文静
眭翔
田玥
崔雪梅
赵斌
王鑫
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Chinese PLA General Hospital
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Chinese PLA General Hospital
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Priority to CNU2007201907878U priority Critical patent/CN201168029Y/en
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Abstract

The utility model discloses a metallic coating NiTi shape memory alloy scoliosis orthotic device which belongs to the field of medical device. The orthotic device consists of a NiTi alloy orthotic stick, a NiTi alloy connecting rod and a pedicle screw, the pedicle screw is provided with an U-shaped opening movably matched with the NiTi alloy orthotic stick, the top end of the U-shaped opening is provided with a nail cap that can adjust the locking degree of the NiTi alloy orthotic stick, the surfaces of the NiTi alloy orthotic stick and the NiTi alloy connecting rod are provided with a metal coating. The metallic coating NiTi shape memory alloy scoliosis orthotic device of the utility model has the advantages that the Ti or Ti-Nb coating memory alloy orthotic stick effectively reduces the release of Ni ion in the shape memory alloy and the shape memory alloy scoliosis orthotic device has the advantages of corrosion resistance, fatigue resistance, friction resistance and superior mechanical restoring force performance; the connecting rod can be adjusted flexibly to avoid the potential difference among different metals and can be conveniently installed in operation; the backing of the pedicle screw can improve the firmness between the memory alloy stick and the pedicle screw, so the friction between the stick and the screw is reduced.

Description

Metal coating formula NiTi memorial alloy skoliosis orthotic device
Technical field
This utility model relates to a kind of metal coating formula NiTi memorial alloy skoliosis orthotic device, belongs to medical instruments field.
Background technology
With the idiopathic scoliosis is various types of skoliosis deformity serious harm patients' of representative physical and mental health.Three-dimensional orthopedic in order to realize, the nerve injury that overcomes the stress concentration phenomenon in the prior art and avoid apparatus to cause, Chinese patent application " skoliosis three-dimensional correction device " provides a kind of scoliotic orthotics that is used for the treatment of, and publication number is CN1596836.This device comprises pedicle screw, the process orthopedic rod of the heat treated Nitinol of shape memory and the head of a nail with U-shaped opening, LOCATION OF PEDICLE SCREW FIXATION is in the both sides of lopsided spinal column, the orthopedic rod of Nitinol that is shaped as side convex ridge post shapes through low temperature is inserted respectively in the U-shaped opening of pedicle screw, and, constitute the three-dimensional correction structure by the locking of head of a nail appropriateness.This invention also can be provided with horizontal connection, and clip and the nut of horizontal connection by its two ends is connected and fixed the orthopedic rod of the Nitinol of spinal column both sides and is integral.
Nitinol (hereinafter to be referred as the NiTi alloy) has the unrivaled characteristic of other metals---super-elasticity and shape-memory properties.Yet the NiTi memorial alloy in use constantly discharges nickel ion, and the sensitization of nickel and suspicious carcinogenecity make people produce doubt safely to it, has limited its application in clinical medicine.Main solution is to adopt different process, different materials to carry out finishing both at home and abroad at present, to improve the bio-safety degree.
This utility model adopts new coating to reduce the release of nickel ion in the basic enterprising one-step optimization structure of Chinese patent application " skoliosis three-dimensional correction device ".
The utility model content
The technical problems to be solved in the utility model provides a kind of simple in structure, degree of safety is high, orthopedic interrod spacing is adjustable metal coating formula NiTi memorial alloy skoliosis orthotic device.
For achieving the above object, this utility model is by the following technical solutions:
Metal coating formula NiTi marmem skoliosis orthotic device, form by the orthopedic rod of Nitinol, Nitinol connecting rod and pedicle screw, pedicle screw has and the orthopedic rod of Nitinol U-shaped opening movingly, the U-shaped open top end is provided with the head of a nail that can regulate the orthopedic excellent locking degree of Nitinol, the surface of orthopedic rod of described Nitinol and Nitinol connecting rod is provided with the metal type coating, for example titanium coating or titanium niobium alloy coating etc.
The two ends of described Nitinol connecting rod are provided with C shape structure, the orthopedic rod of Nitinol passes and is fixed from C shape structure central authorities, the central authorities of connecting rod are provided with telescoping structure (concavo-convex relative sliding tray), with body of rod separated into two parts, distance between adjustable link tightens sleeve by shape memory effect.
The orthopedic rod of described Nitinol is through the shape memory heat treatment, and material is the Nitinol of nickeliferous 47.0-51.8at%, and plasma technology spray metal formula coating is adopted on the surface.
Described Nitinol connecting rod material is a Nitinol, and plasma technology spray metal formula coating is adopted on the surface.Pedicle screw and nut material are titanium alloy.
The orthopedic excellent institute of described Nitinol memorized shape is: coronalplane linearly, sagittal plane is the sagittal degree in the wrong of normal human's spinal column.
The diameter of the orthopedic rod of described Nitinol is 6.0-7.5mm, and length is 50-500mm.
The screw diameter of described pedicle screw is 3.5-6.0mm, and the reach of pedicle screw is 25-50mm.
The U-shaped opening outer rim of described pedicle screw is provided with external thread structure, screws by the head of a nail, and it is loosening to prevent to pacify the orthopedic rod that the expansion of rod back nail tail causes.
The U-shaped opening inwall of described pedicle screw is provided with the ultra high molecular polyethylene liner, can strengthen fixed effect.
This device concrete formation in operation process is: finish extensively in the outside behind spinal column, completely behind the soft tissue release, pedicle screw is inserted in the both sides of each sections in scoliotic surgical orthopaedic scope, on wound, place ice cube then, two are carried out moulding according to the form of lopsided spinal column through the orthopedic rod of the heat treated Nitinol of shape memory at low temperatures, under unstress state, finish the orthopedic rod of bilateral inserting in pedicle screw, lock the U-shaped opening of pedicle screw then with head of a nail appropriateness, finish whole internal fixation under the low temperature and insert, constitute the three-dimensional correction device.
This device realization is whole, automatic, the orthopedic process of coordination is: the orthopedic rod while of the bilateral in this device is through 50 ℃ of warm water rewarmings, the orthopedic rod of Nitinol recovers the shape when inserting to the normal anatomy shape of memory, by the three-dimensional orthopedic effect on the direction before, during and after the segmental pedicle screw generation vertebral body, in the recovery process of the orthopedic rod of Nitinol, the whole orthopedic of lopsided spinal column finished automatically.Again according to the orthopedic situation of local deformity, carry out the orthopedic of secondary apparatus behind the whole rewarming, after finally finishing deformity and proofreading and correct, lay the Nitinol connecting rod again, lock whole heads of a nail.
This utility model has carried out following security verification:
1. titanium, titanium niobium coating modifying are to preventing Nitinol Ni 2+The influence of separating out: adopt the normal saline immersion test, sampling in the 1-7 after the test days, the low temperature dry ashing ashesization are with Mg (NO 3) 2Be the matrix modification agent, graphite furnace atomic absorption spectrometry is respectively organized Ni in the normal saline 2+Concentration.The surface is without NiTi Ni in 37 ℃ of calorstats of titanium or titanium niobium coating modifying as a result 2+Have significantly and separate out, former 4 days is main, its eduction rate (10 -7μ gcm -2S -1) be respectively Ni after 18.20,3.45,1.75 and 0.45, the 5 day 2+Do not have and significantly separate out.Ni after titanium, niobium are modified 2+, do not have and significantly to separate out.The response rate of this laboratory sample is 94.6-108.6%.Proof, titanium coating or titanium niobium coating modifying have played and have prevented Ni 2+Separate out effect.(titanium, titanium niobium coating modifying are to preventing Nitinol Ni 2+The influence of separating out, Li Yongbin, Sun Mingxue, Lu Shibi, the People's Liberation Army General Hospital Orthopedic institute, Chinese orthopedics magazine, the 14th the 4th phase of volume, in February, 2006,291-293).
2. Nitinol and titanium niobium coating prevent Ni 2+Experimentation in the body of separating out: adopt 18 of adult dogs, be divided into 4 groups at random, NiTi group, Titanium coating group, titanium niobium alloy coating group and blank group, respectively in the musculus sacrospinalis and femur be implanted into each 10 pieces of cube specimen and cylinder specimens, put to death after 12 months and draw materials, detect Ni in the heart, liver, spleen, lung, kidney, brain, bone, mucous membrane of nasopharynx, blood, muscle, test specimen surrounding bone tissue and the muscular tissue respectively with the sampling Graphite Furnace Atomic Absorption instrument 2+Content.The result shows, the osseous tissue around the NiTi group test specimen of non-modification and the Ni of muscular tissue 2+Ni in content and homologue on the same group, the different group of homologue 2+There were significant differences for content (P<0.05), proves that NiTi surface metal titanium coating or titanium niobium coating have played to prevent Ni 2+The effect that disengages.(Nitinol and titanium niobium coating prevent Ni 2+Experimentation in the body of separating out, Li Yongbin, Sun Mingxue, Lu Shibi, the People's Liberation Army General Hospital Orthopedic institute, Chinese orthopedics magazine, in December, 2005, the 13rd the 23rd phase of volume, 1810-1812).
The utility model has the advantages that: this utility model adopts titanium or titanium niobium alloy coating, and the memorial alloy surface is modified, and has improved its biological safety.Can effectively reduce the release of nickel ion in the memorial alloy through the orthopedic rod of memorial alloy of evidence titanium or titanium niobium coating, and it is corrosion-resistant, endurance, anti-wear and answer mechanics superior performance, be can Secure Application in clinical implant, be better than the coating of other materials.Connecting rod adopts the encircling type memorial alloy connecting rod of scalable adjusting, has avoided the potential difference between different metal to produce, and makes things convenient for the installation in the art.The rod nail boundary groove inwall of pedicle nail adopts the ultra high molecular polyethylene material liners, increases the fix tightly solidity between memorial alloy rod and pedicle nail, reduces the friction between the rod nail simultaneously.The outer rim of pedicle screw U-shaped opening part adopts the external screw thread design, and screws by the head of a nail, and it is loosening to prevent to pacify the orthopedic rod that the expansion of rod back nail tail causes.
Below in conjunction with the specific embodiment utility model of the present invention is described further; be not to qualification of the present utility model; according to prior art well known in the art; embodiment of the present utility model is not limited to this; therefore all this areas of having done according to present disclosure be equal to replacement, all belong to protection domain of the present utility model.
Description of drawings
Fig. 1 is this utility model structural representation.
Fig. 2 is that the A-A of Fig. 1 is to view.
Fig. 3 is that the B-B of Fig. 1 is to view.
Fig. 4 is the sketch map of pedicle screw.
Fig. 5 is a head of a nail side view.
Fig. 6 is a head of a nail vertical view.
The specific embodiment
Embodiment 1
Consult Fig. 1 to shown in Figure 6, metal coating formula NiTi marmem skoliosis orthotic device, form by orthopedic excellent 1, Nitinol connecting rod 2 of Nitinol and pedicle screw 3, pedicle screw has and the orthopedic rod of Nitinol U-shaped opening movingly, U-shaped opening outer rim is provided with external thread structure, screw by the head of a nail, the head of a nail is made up of nut 32 and the top cover 31 that is arranged on nut central authorities.Orthopedic excellent 1 surface of Nitinol is provided with titanium coating or titanium niobium alloy coating 11, and the surface of Nitinol connecting rod 2 is provided with titanium coating or titanium niobium alloy coating 21, and the U-shaped opening inwall of pedicle screw is provided with ultra high molecular polyethylene liner 33.The two ends of Nitinol connecting rod 2 are provided with C shape structure 22, and Nitinol orthopedic excellent 1 passes and is fixed from C shape structure 22 central authorities, and the central authorities of connecting rod 2 are provided with the sliding tray 23 of concaveconvex shape, with body of rod separated into two parts, and the distance between adjustable link.

Claims (9)

1. metal coating formula NiTi marmem skoliosis orthotic device, form by the orthopedic rod of Nitinol, Nitinol connecting rod and pedicle screw, pedicle screw has and the orthopedic rod of Nitinol U-shaped opening movingly, the U-shaped open top end is provided with the head of a nail that can regulate the orthopedic excellent locking degree of Nitinol, it is characterized in that: the surface of orthopedic rod of described Nitinol and Nitinol connecting rod is provided with the metal type coating.
2. metal coating formula NiTi marmem skoliosis orthotic device according to claim 1, it is characterized in that: the two ends of described Nitinol connecting rod are provided with C shape structure, the orthopedic rod of Nitinol passes and is fixed from C shape structure central authorities, the central authorities of connecting rod are provided with telescoping structure, with body of rod separated into two parts, distance between adjustable link tightens sleeve by shape memory effect.
3. metal coating formula NiTi marmem skoliosis orthotic device according to claim 1, it is characterized in that: described Nitinol connecting rod material is a Nitinol, and pedicle screw and nut material are titanium alloy.
4. metal coating formula NiTi marmem skoliosis orthotic device according to claim 1, it is characterized in that: described metal type coating is titanium coating or titanium niobium alloy coating.
5. metal coating formula NiTi marmem skoliosis orthotic device according to claim 1, it is characterized in that: the orthopedic excellent institute of described Nitinol memorized shape is: coronalplane linearly, sagittal plane is the sagittal degree in the wrong of normal human's spinal column.
6. metal coating formula NiTi marmem skoliosis orthotic device according to claim 1, it is characterized in that: the diameter of the orthopedic rod of described Nitinol is 6.0-7.5mm, length is 50-500mm.
7. metal coating formula NiTi marmem skoliosis orthotic device according to claim 1, it is characterized in that: the screw diameter of described pedicle screw is 3.5-6.0mm, the reach of pedicle screw is 25-55mm.
8. metal coating formula NiTi marmem skoliosis orthotic device according to claim 1, it is characterized in that: the U-shaped opening outer rim of described pedicle screw is provided with external thread structure.
9. according to any one described metal coating formula NiTi marmem skoliosis orthotic device in the claim 1 to 9, it is characterized in that: the U-shaped opening inwall of described pedicle screw is provided with the ultra high molecular polyethylene liner.
CNU2007201907878U 2007-12-13 2007-12-13 Metallic coating type NiTi memory alloy orthopedic device for scoliosis Expired - Lifetime CN201168029Y (en)

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Application Number Priority Date Filing Date Title
CNU2007201907878U CN201168029Y (en) 2007-12-13 2007-12-13 Metallic coating type NiTi memory alloy orthopedic device for scoliosis

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105816233A (en) * 2015-01-05 2016-08-03 财团法人金属工业研究发展中心 Bone fixing device
CN106232060A (en) * 2014-04-01 2016-12-14 沃尔德马连接两合公司 Implantation piece connects

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106232060A (en) * 2014-04-01 2016-12-14 沃尔德马连接两合公司 Implantation piece connects
CN105816233A (en) * 2015-01-05 2016-08-03 财团法人金属工业研究发展中心 Bone fixing device

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Granted publication date: 20081224