CN103565503A - Expansible elastic interspinous process dynamic fixer - Google Patents
Expansible elastic interspinous process dynamic fixer Download PDFInfo
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- CN103565503A CN103565503A CN201210275091.0A CN201210275091A CN103565503A CN 103565503 A CN103565503 A CN 103565503A CN 201210275091 A CN201210275091 A CN 201210275091A CN 103565503 A CN103565503 A CN 103565503A
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- interspinous process
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
- A61B17/7065—Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00862—Material properties elastic or resilient
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00867—Material properties shape memory effect
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Abstract
The invention discloses an expansible elastic interspinous process dynamic fixer, and belongs to a medical human implant for treating a lumbar degenerative disease. The expansible elastic interspinous process dynamic fixer is expansible and integral, is cylindrical when not expanded and dumbbell-shaped after being expanded, and consists of a support part and wing parts on both sides, wherein the support part has a cylindrical structure with certain support force; the wing parts refer to natural transition wing-shaped structures on both sides of the support part; the diameters of the two wing parts are larger than that of the support part; during surgery, the expansible fixer can be used for performing percutaneous puncture or making a small incision when not expanded, is guided to an ideal interspinous process position via a guide wire, can be expanded by using a balloon or an expander, and automatically fits with a spinal process due to the resistance difference among different positions, the support part has an elastic interspinous process fixing function, the wing parts on both sides are used for preventing the fixer from moving, the entire structure is well combined with the spinal process, the entire fixer is automatically limited in an interspinous process and can be matched with interspinous process anatomy after the balloon is extracted. The expansible elastic interspinous process dynamic fixer has the advantages of simple and reliable structure, selectable elasticity and shape change, convenience in implanting and small traumas.
Description
Technical field:
The present invention relates to a kind of novel Weaving type marmem fusion inter-spinous stabilization devices, belong to the interior fixedly medical apparatus and instruments of being implanted into property of medical human orthopaedics.Can, moderate regression light for lumbar vertebra, after huge intervertebral disk hernia Nuclectomy, recurrent intervertebral disc protrusion, light moderate neurogenic intermittent claudication, the regression of adjacent discs after merging, the discectomy of L5 sacrum, the treatment of isolated Modic I pathological changes.
Background technology:
Degenerative diseases of lumbar vertebrae (Lumbar degenerative disease, LDD) is one of the most common disease of the mankind always, and the people of U.S. Hult statistics 80% can be subject to LDD puzzlement in life.It is lumbago and skelalgia due to LDD that the following activity in 45 years old of NCHS report limits modal factor, and the expense for LDD treatment reaches hundreds of millions dollars every year, does not also comprise the loss that absence from work without reason causes.In China, need general annual 1 example of every 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 manifestation of LDD is often just due to the lumbago due to the disorder of intervertebral disc internal structure or degenerative disc pathological changes; Along with vertebral body hyperosteogeny, zygapophysial joints regression and hypertrophy of ligamentum flavum etc. can further appear in disease progression, and then cause Lumbar spine, lumbar spondylolisthesis, lumbar spinal stenosis, thereby occur mechanicalness flank pain, lumbar spinal stenosis.
At present the treatment of this disease is mainly selected when expectant treatment is invalid operative treatment.Operation is mainly intervertebral disc marrow nuclear excising, laminectomy for decompression add bone-graft fusion and (or) in fixing.But current puzzlement is the postoperative clinical improvement rate through above operative treatment not to improve, and Gibson JN etc. sum up the statistics of the perspective randomized controlled trial of Cochrane data base, find 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 between different fusion methods without significant difference, and in using the fixing postoperative painless phase of fusion be shorter than on the contrary and do not use interior fixing operation.Current viewpoint thinks that its reason is mainly that strong interior fixing and fusion has destroyed lumbar spine: A environment, the transmission that causes load does not meet that physiological conditions causes sagittal and unbalance, can further cause thus that stress shielding causes that bone amount reduces, closes on that the regression of sections facet joint is accelerated, interior fixing loosening, fatigue break etc.
Therefore there is in recent years the dynamically proposition of fixed conception between spinous process.Fixedly dynamically to change the range of activity of lumbar vertebra motion segment and a kind of fixed form that load does not but merge, desirable dynamically fixes and can retain useful activity, and stop the algesiogenic direction of motion and plane of movement, between reservation paragraph, physiological load transmits, thereby can alleviating pain and prevent Adjacent segment degeneration.Dynamically fixing kind 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 between spinous process, dynamically holder is implanted between the vertebral body spinous process of two lumbar vertebras, make to implant that sections maintains a neutral position or antecurvature position, its design original intention is: 1. on mechanics, share the load of implanting sections intervertebral disc rear portion, thereby alleviate flank pain under discogenic and be conducive to the reverse of regression intervertebral disc; 2. the load of sharing is transmitted by spinous process, reduce the load of zygapophysial joints, may alleviate the pain that zygapophysial joints regression causes the reparation that is conducive to regression; 3. after restriction, stretch, the ligamenta flava while stretching after can alleviating and the gauffer of annulus fibrosus disci intervertebralis trailing edge, increase canalis spinalis sectional area, alleviates spinal canal stenosis symptom; 4. strut intervertebral foramina, can reduce root compression that intervertebral spinal fusion passes with the intermittent claudication for the treatment of neurogenic.Between non-integration spinous process, fix and have the following advantages in theory: (1), without opening vertebral plate therefore operation wound is little, complication rate is low; (2) compare with fusion, little to the biomechanics environmental disruption of lumbar vertebra, can not make neighbouring section accelerate regression; (3) Minimally Invasive Surgery under can local anaesthesia, the post-operative recovery activity time is short, greatly Economy type medicine cost and social resources.
IPD has had multiple design to comprise Wallis system abroad at present, X-stop system and Coflex system.
(1) Wallis
Wallis is the product of Abbott Spine company, and its first generation product is by Senegas etc. at report in 1986, and agent structure is titanium system, and polytetrafluoroethylene polyester thread is fixed between spinous process; Second-generation system after improvement, is called Wallis system, and between the spinous process of main body, expanding structure material is used PEEK macromolecular material instead, on be still fixed between spinous process with polytetrafluoroethylene polyester thread.This is fixing can regard the mixture strutting 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 large on the impact of lumbar vertebra activity; During implantation, need excision to implant between supraspinal ligament and sour jujube and be with, and will damage the interspinal ligaments of upper and lower neighbouring section, large 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 comprised of oval liner, tissue expander and block wing, material is titanium alloy, be placed between supraspinal ligament and ligamenta flava, its block wing can prevent displacement of retainer, and supraspinal ligament can move for apparatus provides to block after preventing.There is dispute in the FDA clinical trial clinical observation of X-stop, the following up a case by regular visits to acceptance rate in 4 years and reach 78% of Kondrashov DG report, but Verhoof OJ report reaches 58% with the mortality of anti-2 years.Its shortcoming is: support portion is solid material, and poor flexibility, therefore likely cause fracture of spinous process while stretching after 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 titanium manufacture, comes from " U " shape holder between the French spinous process that takes the lead in reporting in 1994, and " U " shape structure spy has higher elasticity and deformation compared with static(al) holder.Its shortcoming is: its both sides shelves wing is coarse with clamping 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 while moving; " U " support force is inadequate though shape design flexibility is large, and excessive elasticity causes fatiguability, and system reliability is poor; During implantation, need excise on the sour jujube of implanting sections, interspinal ligaments, large to the stability influence of lumbar vertebral posterior, large 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 convenient, little to human body wound, the fusion inter-spinous stabilization devices that low cost has China's independent intellectual property right is to the Development of Health Service for the treatment of ,Dui China of degenerative diseases of lumbar vertebrae, have important realistic meaning to building novelty country.
Summary of the invention:
In order to overcome the problems referred to above of dynamic holder between existing spinous process, the object of this invention is to provide a kind of simple and reliable for structure, elasticity and deformation can be selected, Operation is convenient, little to human body wound, low cost has between the spinous process of China's independent intellectual property right dynamically holder one " between expansible type elasticity spinous process dynamically holder ", for the treatment of degenerative diseases of lumbar vertebrae.
For achieving the above object, technical scheme of the present invention is:
(1) in structure: the present invention is many materials (metal, plastics) the multicomponent structure that adopts elasticity overall structure rather than existing holder, be characterized in: whole holder framework is cylindrical shape, its support portion of being combined with spinous process provides support power, the expansible alar part in both sides provides the restricted of anti-lateral displacement, support portion and alar part are integrally-built ingredient, so improved the reliability of holder, avoided biocompatibility and the reliability decrease of multi-part, many materials.
(2) expansivity: the pore design based on different realizes the expansivity of integral barrel structure.Need to row cutting operation implant and even need to cut the important feature such as interspinous ligament and supraspinal ligament and compare with holder between existing spinous process, holder of the present invention is realized whole expansivity by the hole of its making, be characterized in: being implanted between spinous process by very little wound percutaneous puncture Wicresoft in the situation that the present invention can diameter being less before deformation by the guiding of seal wire, arrive after ideal position, by the dilating effect of sacculus or dilator, make it be expanded to support portion and spinous process fits tightly and two flanks are opened ideal form, realize its function.
(3) support and be combined with position-limiting action: the present invention bears the part of pressure between spinous process and is called support portion, it is stuck between upper and lower spinous process and plays a supportive role, be characterized in: not before expansion, support portion is in the centre of holder cylindrical shape integral body, after expansion, it is in shape for having the tubular structure of certain support force, section configuration is " O " shape, can the different aperture size shape based on this portion adjust its support force, rigidity, deformation.Airfoil structure in the nature transition of both sides, support portion is alar part, be characterized in: not before expansion, two flank section are in the both sides of the support portion of holder cylindrical shape integral body, after expansion, its extensibility is greater than support portion, do not contact and bear load with spinous process, thus its after expanding itself or balloon expandable, diameter is greater than support portion, make holder integral body become " class dumb-bell shape ", after alar part expansion, reach the effect that prevents that holder is unsceptered
(4) whole mechanical property is adjustable: for this holder, different pore design makes its support portion and the corresponding mechanical property of flank and change of shape, can need to select suitable model according to the different state of an illness, the selectable Weaving type overall structure of be in harmonious proportion deformation that has so just had support performance, has overcome supraspinal ligament and the excessive fatigable shortcoming of deformation that solid construction rigidity excessive " U " shape structure that easily causes fracture of spinous process, COFLEX in X-STOP support portion need to be excised sections completely.
(5) Auto-matching spinous process is dissected: the distinctive expansible structure form that holder agrees with spinous process automatically because of the resistance difference of diverse location when using balloon expandable, reach the better combination with spinous process, extract whole holder after sacculus out and be automatic spacing between spinous process and can realize with spinous process between dissect mate, prevent spinous process iatrogenic injury.
(6) allow tissue to grow into: hollow of the present invention and sidewall have a large amount of micropores, it not the entity imporosity structure of the holders such as existing COFLEX, X-stop, can allow so local scar tissue to grow into, scar tissue after growing into prevents that except stablizing holder it is unsceptered, more can play the effect of supplemental support, be conducive to holder lengthen the life and holder failure after autologous spinous process between support.
Between expansible type elasticity spinous process, dynamically the overall structure feature of holder is: 1. adopt overall structure, without increasing the structures such as auxiliary rivet, elastic straps, overcome the WALLIS shelves wing and need increase elastic straps not only operation technique complexity but also damage neighbouring section interspinal ligaments, it is complicated that X-STOP block wing and eyelid retractor portion need the syndetons such as rivet to cause interior fixed structure, and COFLEX block wing surface has latch and rivet can damage the shortcoming of spinous process sidewall sclerotin; 2. utilize the expansivity of holder, when undeformed, can prolong guide wire implants by little percutaneous puncture wound, after implantation under the expansion of sacculus or dilator, reach the upper and lower interspinal ideal position of implantation and start to bring into play its effect, avoided the incision of supraspinal ligament and interspinal ligaments, operation wound and the impact on implantation sections stability have been reduced, can percutaneous puncture implant and make to implant more convenient, its invasive, implant convenience, the performance indications such as the impact of spinal column be all better than to the designs such as existing WALLIS, X-STOP, COFLEX; 3. eyelid retractor by when expansion diverse location resistance Auto-matching spinous process dissect and need clamping spinous process, the existing WALLIS of restriction ratio, X-STOP when lumbar vertebra is rotated, COFLEX holder are little.
The invention has the beneficial effects as follows dynamic holder between a kind of novel expansible type elasticity spinous process of design, when having overcome existing interior fixedly shortcoming, also given full play to its distensible physical characteristic, the present invention is simple and reliable for structure, elasticity and the deformation supported are controlled, Operation is convenient, little to human body wound, cost is low, allow tissue to grow into, can be light for lumbar vertebra, moderate regression, after huge intervertebral disk hernia Nuclectomy, recurrent intervertebral disc protrusion, light moderate neurogenic intermittent claudication, the regression of adjacent discs after merging, the discectomy of L5 sacrum, the treatment of isolated Modic I pathological changes.
Accompanying drawing explanation:
Below in conjunction with drawings and Examples, the present invention is further described.
Fig. 1 is the graphics before the present invention does not expand.
Fig. 2 is the front view before the present invention does not expand.
Fig. 3 is the side view before the present invention does not expand.
Fig. 4 is that the present invention does not expand the interspinal design sketch of front implantation.
Fig. 5 is the graphics after the present invention expands.
Fig. 6 is the front view after the present invention expands.
Fig. 7 is the side view after the present invention expands.
Fig. 8 is that the present invention implants the design sketch that does not surpass spinous process height between spinous process after expansion.
Fig. 9 is that the present invention implants the design sketch that surpasses the highly automated formation flank of spinous process between spinous process after expansion.
The specific embodiment:
In Fig. 1-8,1,2 is respectively two flanks, and its effect is to prevent that holder is unsceptered; 3 is support portion, and its effect is the load of sharing spinous process; 4 is timbering material part, and it has metal material to make, and when using balloon expandable, can open; 5 is brace aperture part, and the existence of hole has guaranteed the deformable performance of support; 6 is the hollow space of support, can allow soft tissue to grow into; 7,8 spinous process that are respectively the vertebral body of implanting sections.
Each portion of 1-6 is the ingredient of holder integral body, and each several part is all smooth excessive.1,2 diameter is consistent with 3 before dilatating and deformable, and after expansion, because 3 are subject to stopping of spinous process and can not continue enlarged diameter, and 1,2 can continue to expand, and causes after dilatating and deformable, and 1,2 diameters are greater than 3, in case the displacement of holder.
During operation, first use seal wire 9 percutaneous through interspinous ligament, again the holder of dilatating and deformable is not implanted between spinous process through seal wire guiding, expansion afterwards can be used sacculus pressurization expansion, or directly in the pressurization of holder two ends rigid pressurized device, make its expansion, also sacculus and rigid pressurized device can be combined with, make its expansion.Take balloon expandable as example; after implanting, use sacculus 10 pressurization expansions to make its distortion; until 3 expanded in diameter is to contacting with upper and lower spinous process; after this continue again pressurization; 3 can not continue expansion; 1,2 continue to expand to become flank; after this can will after balloon pressure subduction, sacculus and seal wire be exited to human body; the Wicresoft that can reach holder implants; after implanting, its hollow structure can allow soft tissue to grow into; local scar tissue can protect holder to prevent its displacement, and can supplemental support, prevents holder failure.
Claims (5)
1. a dynamic holder between novel expansible type elasticity spinous process, it is expansible type elasticity overall structure.
2. profile according to claim 1, is characterized by that it is cylindrical shape before expansion not.
3. profile according to claim 1, is characterized by after expansion, and it comprises the flank of both sides and middle support portion because stressed difference becomes class dumbbell shape.
4. structure according to claim 3, its support portion section configuration is " O " shape, possesses elasticity and the selectable feature of deformation of support performance.
5. structure according to claim 3, its two flank section section configuration is " O " shape, diameter is greater than support portion, possesses the effect of restriction displacement of retainer.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201210275091.0A CN103565503A (en) | 2012-08-01 | 2012-08-01 | Expansible elastic interspinous process dynamic fixer |
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| CN201210275091.0A CN103565503A (en) | 2012-08-01 | 2012-08-01 | Expansible elastic interspinous process dynamic fixer |
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| CN103565503A true CN103565503A (en) | 2014-02-12 |
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| CN201210275091.0A Pending CN103565503A (en) | 2012-08-01 | 2012-08-01 | Expansible elastic interspinous process dynamic fixer |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110545738A (en) * | 2017-04-18 | 2019-12-06 | W.L.戈尔及同仁股份有限公司 | Deployment-constraining sheath enabling staged deployment by device segments |
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2012
- 2012-08-01 CN CN201210275091.0A patent/CN103565503A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110545738A (en) * | 2017-04-18 | 2019-12-06 | W.L.戈尔及同仁股份有限公司 | Deployment-constraining sheath enabling staged deployment by device segments |
| CN110545738B (en) * | 2017-04-18 | 2023-08-29 | W.L.戈尔及同仁股份有限公司 | Deployment constraining sheath enabling staged deployment of device segments |
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Application publication date: 20140212 |