CN201275131Y - Nickel-titanium shape memory alloy non-fusion interspinal fixator - Google Patents
Nickel-titanium shape memory alloy non-fusion interspinal fixator Download PDFInfo
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- CN201275131Y CN201275131Y CNU2007200361043U CN200720036104U CN201275131Y CN 201275131 Y CN201275131 Y CN 201275131Y CN U2007200361043 U CNU2007200361043 U CN U2007200361043U CN 200720036104 U CN200720036104 U CN 200720036104U CN 201275131 Y CN201275131 Y CN 201275131Y
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Abstract
The utility model relates to a novel non-fusion interspinous fixator made of NiTi shape memory alloy (SMA), and belongs to medical body implants. The fixator is used for treating lumbar degenerative diseases and made of NiTi SMA with the content of nickel being 45% to 60% and the shape restoration temperature being (36 plus or minus 4) DEG C. The fixator has an integrated structure and comprises a support part, and an upper wing-retaining part and a lower wing-retaining part which are arranged on both sides; the support part has a cylindrical structure and a 25-degree clearance is reserved; the elasticity and the deformation of the support part depend on the size of the clearance; and the appropriate models can be chosen according to the state of an illness. During the operation, the upper wing-retaining part and the lower wing-retaining part on one side pass through interspinous ligaments after being deformed, so as to enable the support part to be implanted between processus spinosuses. After the implantation, the fixator is warmed by body temperature to be restored to the original form, so that the injury to supraspinous ligaments and the like are reduced. The fixator can be directly implanted through the way of incising supraspinous ligaments and interspinous ligaments, and suturing the supraspinous ligaments. The utility model has the advantages that the structure is simple and reliable, the elasticity and the deformation can be chosen, the implantation is convenient and the trauma is less.
Description
Technical field:
The present invention relates to holder between a kind of novel niti-shaped memorial alloy non-integration spinous process, belong to being implanted into property of medical human orthopaedics internal fixation medical apparatus and instruments.Can be used for light, the moderate regression of lumbar vertebra, behind the huge intervertebral disk hernia Nuclectomy, recurrent intervertebral disc protrusion, light moderate neurogenic intermittent claudication, the regression of merging the back adjacent discs, the discectomy of L5 sacrumization, the treatment of isolated Modic I pathological changes.
Background technology:
(Lumbar degenerative disease LDD) is one of human disease of seeing at most to the degenerative lumbar disease always, and the people of U.S. Hult statistics 80% can be subjected to the LDD puzzlement in life.It is lumbago and skelalgia due to the LDD that the activity below 45 years old of NCHS report limits modal factor, and the expense that is used for the LDD treatment every year reaches hundreds of millions dollars, does not also comprise the loss that absence from work without reason causes.In China, need annual 1 example of general per 1000 people of patient of operation, calculate that sickness rate is annual 1-2%, along with China enters aging society, its sickness rate will be higher.
The early stage performance of LDD is often just because the lumbago due to disorder of intervertebral disc internal structure or the degenerative disc pathological changes; Along with vertebral body hyperosteogeny, zygapophysial joints regression and hypertrophy of ligamentum flavum etc. can further appear in disease progression, so cause that unstable spine is fixed, lumbar spondylolisthesis, lumbar spinal stenosis, thereby mechanicalness flank pain, lumbar spinal stenosis appear.
At present this treatment of diseases is mainly selected operative treatment when expectant treatment is invalid.The operation mainly be intervertebral disc marrow nuclear excising, laminectomy for decompression add bone-graft fusion and (or) internal fixation.But present puzzlement is not improve through the clinical improvement rate of the postoperative of above operative treatment, and Gibson JN etc. sum up the statistics of the perspective randomized controlled trial of Cochrane data base, finds that the raising that is fused into power does not cause the corresponding raising of lumbago and backache clinical improvements rate; Fritzell P etc. thinks not have significant difference between different fusion methods, and uses the painless phase of fusion postoperative of internal fixation to be shorter than the operation of not using internal fixation on the contrary.Present viewpoint thinks that its reason mainly is that strong internal fixation and fusion destroyed lumbar vertebra biomechanics environment, the transmission that causes loading does not meet physiological conditions, and to cause sagittal plane unbalance, can further cause stress shielding to cause loosening, the fatigue break etc. that the bone amount reduces, closes on sections facet joint regression acceleration, internal fixation thus.
Therefore the proposition of non-integration fixed conception has been arranged in recent years.Non-integration fixedly is to change the range of activity of lumbar vertebra motion segment and a kind of fixed form that load does not but merge, ideal non-integration is fixing can to keep useful activity, and stop the algesiogenic direction of motion and plane of movement, physiological load transmits between reservation paragraph, thereby can alleviating pain and prevent the neighbouring section regression.The fixed kind of non-integration is more, comprises fixed system between spinous process, the dynamic property fixed system of pedicle, pedicle nail semi-rigid metal fixed system, artificial intervertebral disc system, zygapophysial joints exchange system.
Wherein holder is implanted between the vertebral body spinous process of two lumbar vertebras between the non-integration spinous process, the implantation sections is maintained a neutral position or the antecurvature position, its design original intention is: 1. share the load of implanting sections intervertebral disc rear portion on mechanics, thereby alleviate flank pain under the property of intervertebral disc source and help the reverse of regression intervertebral disc; 2. the load that will share reduces the load of zygapophysial joints by the spinous process transmission, may alleviate pain that the zygapophysial joints regression causes and the reparation that helps regression; 3. stretch after the restriction, the ligamenta flava when stretching after can alleviating and the gauffer of annulus fibrosus disci intervertebralis trailing edge increase the canalis spinalis sectional area, alleviate the spinal canal stenosis symptom; 4. strut intervertebral foramina, can reduce root compression that intervertebral spinal fusion passes with the intermittent claudication of treatment neurogenic.Fix between the non-integration spinous process and have the following advantages in theory: (1) need not to open vertebral plate so operation wound is little, and complication rate is low; (2) compare with fusion, little to the biomechanics environmental disruption of lumbar vertebra, can not make neighbouring section quicken regression; (3) but Minimally Invasive Surgery under the local anaesthesia, the post-operative recovery activity time is short, saves medical treatment cost and social resources greatly.
IPD has had multiple design to comprise the Wallis system abroad at present, X-stop system and Coflex system.
(1) Wallis
Wallis is the product of Abbott Spine company, and at report in 1986, agent structure was a titanium system to its first generation product by Senegas etc., and the polytetrafluoroethylene polyester thread is fixed between the spinous process; Second-generation system after the improvement is called the Wallis system, and the expanding structure material is used the PEEK macromolecular material instead between the spinous process of main body, on still be fixed between the spinous process with the polytetrafluoroethylene polyester thread.Should fixing can regard the mixture that struts between spinous process with interspinous ligament as.The shortcoming of this system is that the support force of PEEK plastic construction is poor; The anteflexion motion that sections is implanted in the restriction of polytetrafluoroethylene polyester thread is big to the active influence of lumbar vertebra; Need on the excision sour jujube during implantation, interspinal ligaments, and to damage the interspinal ligaments of upper and lower neighbouring section, big to the wound of human body; Complex structure, not only operation technique trouble but also reliability are low.
(2) X-stop
X-stop is by the U.S. St.Francis Medical Technologies company development (patent No. of the U.S.: US6,514,256B2), it is made up of oval liner, tissue expander and block wing, material is a titanium alloy, place between supraspinal ligament and the ligamenta flava, its block wing can prevent displacement of retainer, and supraspinal ligament can move after preventing for apparatus provides to block.There is dispute in the FDA clinical trial clinical observation of X-stop, and 4 years of Kondrashov DG report reach 78% with anti-acceptance rate, reach 58% but Verhoof OJ reports the mortality of following up a case by regular visits to 2 years.Its shortcoming is: the support portion is a solid material, and poor flexibility is so might cause fracture of spinous process when stretching behind lumbar vertebra; Complex structure, the connection of its each several part relies on rivet, and not only operation technique trouble but also resisting fatigue and reliability are low.
(3) Coflex
Coflex is developed by Paradigm Spine company.Coflex is formed by the titanium manufacturing, comes from " U " shape holder between France's spinous process of taking the lead in reporting in 1994, and " U " shape structure spy has higher elasticity and deformation than the static fixation device.Its shortcoming is: its both sides shelves wing is coarse with the chucking spinous process, is provided with circular hole and places rivet, so not only limits rotatablely moving of lumbar vertebra, and lumbar vertebra easy damaged spinous process sidewall sclerotin when moving; " U " support force is not enough though the shape design flexibility is big, and excessive elasticity causes fatiguability, and system reliability is poor; Need excise on the sour jujube of implanting sections during implantation, interspinal ligaments, big to the stability influence of lumbar vertebral posterior, big to the damage of human body.
In sum, develop a kind of simple and reliable for structure, elasticity and support force are suitable, operation is implanted convenient, little to the human body wound, low cost has holder between the non-integration spinous process of China's independent intellectual property right to the degenerative lumbar treatment of diseases, to the Development of Health Service of China, to building novelty country important practical sense is arranged all.
Summary of the invention:
In order to overcome the problems referred to above of holder between existing non-integration spinous process, the purpose of this invention is to provide a kind of simple and reliable for structure, elasticity and deformation can be selected, operation is implanted convenient, little to the human body wound, low cost has holder-" holder between niti-shaped memorial alloy non-integration spinous process " between the non-integration spinous process of China's independent intellectual property right, is used for the degenerative lumbar treatment of diseases.
For achieving the above object, technical scheme of the present invention is:
(1) on the material, the present invention uses nickel-titanium shape memory alloy material.The fixing requirement to material of non-fusion spinous process is to possess high strength simultaneously, low-gravity, and low elastic modulus, fatigue resistance, corrosion-resistant, nontoxic, high-biocompatibility.The medical niti-shaped memorial alloy that the present invention selects for use not only has These characteristics, and has shape-memory properties, can be out of shape under 0 ℃ of low temperature, and the form under the human temperature situation is recovered; Nickel content 45%～60% in the used alloy material of this holder, the form recovery temperature is set in (36 ± 4) ℃, and shape-memory properties can guarantee that in conjunction with our configuration design the present invention is simple and reliable for structure, and elasticity and deformation can be selected, operation is implanted convenient, the characteristics little to the human body wound.
(2) in the configuration design, the present invention is a kind of overall structure of homogenous material rather than many materials of existing holder (metal, plastics) multicomponent structure, be characterized in having comprised eyelid retractor portion, structures such as the portion of block wing up and down of both sides, simple in structure, reduced reaction such as different materials or the direct complicated electrolysis of a plurality of element, friction in human body, so improved biocompatibility and reliability.Eyelid retractor portion, for being stuck in passive structure between the spinous process up and down, be characterized in: be designed to tubular structure in shape, but its also incomplete closure on section leaves big or small 5-25 ° slit, similar " C " shape, the different big I in slit makes the support portion that different elasticity and deformation be arranged, can select suitable model according to different state of an illness needs, elasticity and the selectable characteristics of deformation that support performance has so just been arranged have overcome the excessive fracture of spinous process that easily causes of X-STOP support portion solid construction rigidity, COFLEX's " U " the shape structure need excise the supraspinal ligament and the excessive fatigable shortcoming of deformation of sections fully; Both sides block wing portion is a wings, the shelves wing is a round rectangle, the effect of block wing is to prevent that holder is unsceptered, be characterized in: 1. wings for eyelid retractor be same overall structure, smooth surface, excessively slick and sly with the support portion, low friction, need not to increase auxiliary rivet, structures such as elastic straps, overcome the WALLIS shelves wing and need increase elastic straps not only operation technique complexity but also damage neighbouring section interspinal ligaments, syndetons such as X-STOP block wing and eyelid retractor portion need rivet cause the internal fixation complex structure, and COFLEX block wing surface has latch and rivet can damage the shortcoming of spinous process sidewall sclerotin; 2. utilize the shape-memory properties of material, can use external force to open up into horizontal line on front view under 0 ℃ of low temperature and become angle 0-45 °, can recover shape under human temperature, opening angle reduces, and can increase to 45-90 ° with the angle that becomes of HRL.Under frozen water, block wing can be broken into two with one's hands the implantation that has made things convenient for internal fixation during operation, ideally can be at the little otch of a skidding of lumbar vertebra rear center line, break through interspinous ligament behind 2 block wings up and down of the side that lodges holder is implanted interspinal ideal position up and down, the block wing of implanting the back lodging recovers original shape because of the body temperature heating, play the effect of keeping the holder position, the wound of operation and little to the influence of implanting sections stability, implant more convenient; Also can holder be implanted on the sour jujube, after interspinal ligaments cuts the decompression of part vertebral plate, ligamenta flava excision of the row way of escape, again with the supraspinal ligament suture in situ of cutting, such wound also is lower than COFLEX after the implantation; 3. flank need not to tighten spinous process, and the existing WALLIS of the restriction ratio when lumbar vertebra is rotated, X-STOP, COFLEX holder are little.
The invention has the beneficial effects as follows holder between a kind of novel niti-shaped memorial alloy non-integration spinous process of design, when having overcome existing internal fixation shortcoming, also given full play to the physical characteristic of marmem, the present invention is simple and reliable for structure, elasticity and the deformation supported are controlled, operation is implanted convenient, little to the human body wound, cost is low, it is light to be used for lumbar vertebra, the moderate regression, behind the huge intervertebral disk hernia Nuclectomy, recurrent intervertebral disc protrusion, light moderate neurogenic intermittent claudication, merge the regression of back adjacent discs, the discectomy of L5 sacrumization, the treatment of isolated Modic I pathological changes.
Description of drawings:
The present invention is further described below in conjunction with drawings and Examples.
Fig. 1 is a front view of the present invention.
Fig. 2 is a left view of the present invention.
Fig. 3 is a top view of the present invention.
The specific embodiment:
Among Fig. 1-3,1,2 is respectively the upper and lower block wing of both sides, and 3,4 are respectively the left and right block wing of both sides, and the shelves wing is a round rectangle, and it can be at 45-90 ° with the angle that becomes of HRL on front view, and the effect of block wing is to prevent that holder is unsceptered; 5 is the antetheca of the support portion of holder, and its effect is to prevent that holder from shifting forward too many cutting vertebral plate and ligamenta flava; 6 is the rear wall of anchor support portion, and it contacts with the supraspinal ligament at rear, prevents that holder is to retrodisplacement; 7 is the support portion upper wall of holder, contacts with upper aristate process; 8 is the support portion lower wall of holder, contacts with following spinous process; 9 breach that leave for the support portion, it can increase the elasticity and the deformation of holder.
Each one of 1-8 is the ingredient of holder integral body, and each several part is all smooth excessively.5,6 width is slightly larger than 7,8, in case the front and back of holder are to displacement.
The block wing up and down (as 1,3 block wings) of one side after the bending, can be passed interspinous ligament in frozen water during operation, contact with spinous process up and down up to 7,8, behind the implant into body, holder by the body temperature heating after, 1,3 flanks return to original shape then can finish implantation.Also can cut supraspinal ligament and interspinal ligaments, need not distortion holder is directly implanted between spinous process.
Claims (2)
1. holder between a novel niti-shaped memorial alloy non-integration spinous process, the structure that it is characterized in that holder between the non-integration spinous process has comprised the portion of block wing up and down of tubular eyelid retractor portion and both sides, its material is a niti-shaped memorial alloy.
2. holder between novel niti-shaped memorial alloy non-integration spinous process according to claim 1, the last lower gear wing that it is characterized by both sides is a round rectangle, smooth surface, low friction, no rivet hole, elastic straps pore structure.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNU2007200361043U CN201275131Y (en) | 2007-04-10 | 2007-04-10 | Nickel-titanium shape memory alloy non-fusion interspinal fixator |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNU2007200361043U CN201275131Y (en) | 2007-04-10 | 2007-04-10 | Nickel-titanium shape memory alloy non-fusion interspinal fixator |
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| CN201275131Y true CN201275131Y (en) | 2009-07-22 |
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| CNU2007200361043U Expired - Fee Related CN201275131Y (en) | 2007-04-10 | 2007-04-10 | Nickel-titanium shape memory alloy non-fusion interspinal fixator |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104665961A (en) * | 2013-12-02 | 2015-06-03 | 苏州点合医疗科技有限公司 | Anti-shift integral expansion type intervertebral fusion device |
| CN104873258A (en) * | 2014-06-19 | 2015-09-02 | 李照文 | Interspinous stabilizer |
| CN106943186A (en) * | 2017-04-10 | 2017-07-14 | 苏州海斯凯医疗科技有限公司 | Fixator between flexible spinous process |
| CN110338895A (en) * | 2019-08-20 | 2019-10-18 | 北京大学第三医院（北京大学第三临床医学院） | Support, fixed, fusing device between a kind of vertebral plate |
| CN113171209A (en) * | 2021-04-27 | 2021-07-27 | 山东大学 | Additive manufacturing nickel-titanium alloy femoral stem prosthesis and preparation method thereof |
-
2007
- 2007-04-10 CN CNU2007200361043U patent/CN201275131Y/en not_active Expired - Fee Related
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104665961A (en) * | 2013-12-02 | 2015-06-03 | 苏州点合医疗科技有限公司 | Anti-shift integral expansion type intervertebral fusion device |
| CN104873258A (en) * | 2014-06-19 | 2015-09-02 | 李照文 | Interspinous stabilizer |
| CN104873258B (en) * | 2014-06-19 | 2017-08-25 | 李照文 | Stabilizer between spine |
| CN106943186A (en) * | 2017-04-10 | 2017-07-14 | 苏州海斯凯医疗科技有限公司 | Fixator between flexible spinous process |
| CN110338895A (en) * | 2019-08-20 | 2019-10-18 | 北京大学第三医院（北京大学第三临床医学院） | Support, fixed, fusing device between a kind of vertebral plate |
| CN113171209A (en) * | 2021-04-27 | 2021-07-27 | 山东大学 | Additive manufacturing nickel-titanium alloy femoral stem prosthesis and preparation method thereof |
| CN113171209B (en) * | 2021-04-27 | 2023-10-20 | 山东大学 | Additive manufacturing nickel-titanium alloy femoral stem prosthesis and preparation method thereof |
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| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C17 | Cessation of patent right | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20090722 Termination date: 20110410 |