CN109009579A - A kind of round bar shape XLIF Invasive lumbar fusion device - Google Patents
A kind of round bar shape XLIF Invasive lumbar fusion device Download PDFInfo
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- CN109009579A CN109009579A CN201810692997.XA CN201810692997A CN109009579A CN 109009579 A CN109009579 A CN 109009579A CN 201810692997 A CN201810692997 A CN 201810692997A CN 109009579 A CN109009579 A CN 109009579A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00359—Bone or bony tissue
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
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- Orthopedic Medicine & Surgery (AREA)
- Neurology (AREA)
- Heart & Thoracic Surgery (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Cardiology (AREA)
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- Life Sciences & Earth Sciences (AREA)
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Abstract
The invention belongs to spines, such as vertebrae, disc technology field, disclose a kind of round bar shape XLIF Invasive lumbar fusion device, and fusion device ontology top and bottom are provided with dentalation;Fusion device main body is made of three pole layers, and there are three pins for pole layer upper and lower side;There are two rectangle chamfering cavity body structures in fusion device main body;Fusion device main body front and back has holding tank.Significantly improve Lumbar Fusion rate and fusion speed.The Invasive lumbar fusion device has biggish intervertebral bone fusion area.XLIF directly enters lumbar vertebrae front pillar from the positive dypass of lumbar vertebrae, and enters Intervertebral space, removes the disc tissue of larger area.Therefore XLIF has bone grafting fusion area big, intervertebral fusion is across intervertebral cortex ring, mechanical strength is larger, XLIF also has tissue damage small, operating time is short, and amount of bleeding is few, the fast advantage of Rehabilitation, the quick recovery of patient can fundamentally be promoted, with excellent patient's function score and clinical satisfaction rate.
Description
Technical field
The invention belongs to spines, such as vertebrae, disc technology field more particularly to a kind of round bar shape XLIF vertebra
Between fusion device.
Background technique
Currently, the prior art commonly used in the trade is such thatDegenerative lumbar illness and lumbar vertebrae caused by aging of population
Infection, wound etc. need the patient of row Lumbar Fusion operation (LIF) very common and are in continue to increase trend.Invasive lumbar fusion device
(cage) be spinal interbody fusion operation core equipment, undertake anterior spinal column load and maintain intervertenral space and Neuroforamen height.
Restore the physiological camber of backbone.The distracting force of merging Cage can make at the muscle, fibrous ring and forward and backward longitudinal ligament of Fusion levels
Under continued tension state, so that Fusion levels and fusion device is reached three-dimensional super statics and fix, while the screw thread of its design can
It is embedded in upper and lower centrum, makes the entirety for constituting a Selfstabilizing between Invasive lumbar fusion device and upper and lower centrum three.Relative to biography
For system bone graft fusion, before the implantation of fusion device can significantly prevent the loss of postoperative intervertenral space and keep the physiology of lumbar vertebrae
It is convex, it can effectively avoid the complication such as compression and the spinal canal stenosis of the nerve root caused therefrom.In addition to this, Invasive lumbar fusion device
Postoperative Initial stability can also be provided, by strut-pinch effect caused by compression be bone uptake create it is good
Biomethanics condition promotes early stage to merge, and improves fusion rate, reduces patient's bed rest time.Common fusion device presses Shape Classification
The types such as spiral shape, rectangle, bullet shaped, physiology anatomical form can be divided into.If according to material it is different can be divided into again metal material,
The types such as carbon fibre material, polyether-ether-ketone (PEEK) material, bioabsorbable material.Different materials is made of different shapes
Fusion device can produce different biology and biomethanics effect, to produce bigger effect to fusion rate, complication etc..It is above-mentioned
Fusion device made of different materials (cage), all there are respective advantage and disadvantage: metal material fusion device: 1 elasticity modulus is much larger than
Normal bone tissues, osteoacusis is poor, is unfavorable for skeletonization and fusion;2 can not penetrate X-ray, and CT, MRI image generate artifact, be difficult
Fusion situation is assessed;The stress plane of 3 spiral shape cage is smaller, be easy to happen terminal plate of vertebral body cutting, cage is collapsed and vertebra
The loss in gap, and then neurothlipsis symptom may be reappeared etc..Carbon fibre material fusion device: carbon fiber cage elasticity modulus
Closer to normal bone tissues, stress shielding is small.Since carbon fiber can penetrate X-ray, such cage biggest advantage is just
It is clearly observe the postoperative fusion situation of patient.But the institutional framework of carbon fiber can be disintegrated in vivo and cause inflammation
Reaction, influences postoperation recovery, and brittleness is big, and fusion device device is be easy to cause just to destroy before bone fusion.Artificial synthesized biology
Absorbable material fusion device: bioabsorbable material is used for Invasive lumbar fusion device as a kind of brand-new material, although there is its distinctive
Advantage, if stress shielding is small, the advantages that can pass through X-ray, can absorb.But there is also such as chronic inflammation, absorption and skeletonization not
The disadvantages of synchronous.Therefore, it is also desirable to be improved to its material, biomechanics characteristic and biocompatibility etc..Meanwhile
It needs more higher-quality researchs to be used for value and Long-Term Clinical effect to be evaluated.Polyether-ether-ketone (PEEK) material melts
Clutch: polyether-ether-ketone resin (polyetheretherketone, PEEK) is a kind of new special thermoplastic engineering plastic, it has
Have following characteristic: high mechanical strength, elasticity modulus is close with cortex bone, and frictional behaviour is excellent, can saturating x-ray, creep compliance is low, inertia
Height, biocompatibility is outstanding, resistant to chemical etching and radiation, and processing method is versatile and flexible etc..PEEK is in late 1980s head
First be applied to the research of orthopedic injury internal fixation device and type femoral bone end prosthesis, middle and later periods the 1990s each manufacturer start by
It is applied to spinal interbody fusion device.But PEEK material cage elasticity modulus is 35 times of cancellous bone, is the 2.3 of autologous ilium
Times, therefore the risk that soleplate cutting and cage are collapsed is not still low (collapsing rate up to 14.8%), the fusion rate in December only has
84.5%, therefore, PEEKcage is also far from comparatively ideal bone grafting fusion cage.Lumbar Fusion operation (LIF) is divided into posterior lumbar
Interbody fusion (PLIF), intervertebral spinal fusion interbody fusion (TLIF), preceding road lumbar intervertebral fusion (ALIF), above-mentioned operation
Mode haves the shortcomings that operating time is long, operative incision is big, bleeding is more, wound is big, post-operative recovery is slow, and for the age compared with
Greatly, the patient that underlying diseases are more, nutrition condition is bad, above-mentioned modus operandi are improper.Therefore Minimally Invasive Surgery mode is used
A kind of certainty as selection of clinical.External Pioneer company, Nuvasive company, Metronic company, Johson & Johnson are equal
There is the PEEK fusion device (cage) of mating XLIF operation, but PEEK material, as a kind of polymeric material, itself does not have skeletonization
Required three-dimensional mesh structure, is unfavorable for the creeping substitution of bone.And it is present in intervertenral space as a kind of foreign matter, occupies people
Space needed for normal bone tissues fusion theoretically necessarily will affect the firmness of fusion.Therefore, PEEK material
It is not the material of perfect production fusion device (cage).Homogeneous allogenic bone fusion device is good with biological capacitive, elasticity modulus is close
People's bone is convenient for the advantages that imaging evaluation.The Allogenous corticals such as " femur ring ", " fibula ring ", " humerus ring " are used both at home and abroad
The fusion device of bone roughing production has more Case report, and document confirms that homogeneous allogenic bone " ring " has as intervertebral fusion material
There are satisfied intervertebral fusion effect and good biological safety.But this kind of fusion device is limited by the natural shape of material, cannot be done
To dissection shape, keep it smaller with the contact area of soleplate, local soleplate is easy to cause to destroy and fusion device sedimentation;In addition, by
It is limited to donor specification, the cause diversified in specifications of this kind of product cannot be placed in from the service aisle of XLIF, keep its clinical scope of application non-
Often limitation, can not adapt to modern spinal surgery, the development need of especially minimally invasive trend.Dissect shape way of escape homogeneous allogenic bone lumbar vertebrae
The fusion device country there is no product and document report, foreign literature report be only limitted to a kind of commercialized product (PLIFSpacer,
Synthes-StratecSpine, USA), the postoperative 1 year fusion rate of 89 patients is 98%.But due to the trade wall of tissue
Building principle cannot be introduced into China's sale, and the product needs bilateral to place in pairs, expensive, equally can not be from the work of XLIF
Channel merging, is not able to satisfy the demand of vertebral column minimally invasive fusion.According to official website of State Intellectual Property Office of China data, remove
Outside this project, it is related to homogeneous allogenic bone Invasive lumbar fusion device there are also 4 patents, wherein " femur ring ", " fibula ring ", " humerus ring " etc.
Annular fusion device three, the ilium fusion device of three face cortex bones one.As previously mentioned, all kinds of annular fusion devices are limited to material
The natural shape clinic scope of application is very limited;The allosome ilium fusion device of three face cortex bones because its biomechanical property deficiency,
Clinical use is less.
In conclusion problem of the existing technology is:The natural shape that all kinds of annular fusion devices are limited to material is clinical
The scope of application is very limited;For the allosome ilium fusion device of three face cortex bones because of its biomechanical property deficiency, clinical use is less;
Traditional fusion mode haves the shortcomings that operating time is long, operative incision is big, bleeding is more, wound is big, post-operative recovery is slow, and
And for older, underlying diseases are more, nutrition condition is bad patient.
Solve the difficulty and meaning of above-mentioned technical problem:Homogeneous allogenic bone intervertebral fusion suitable for XLIF Minimally Invasive Surgery
Device, the fusion device are assembled by the splicing of people's cortex bone, and consistent with human normal intervertenral space in form, compensate for allosome ilium
Or the disadvantage of PEEK fusion device biomechanical property deficiency.The fusion device sheet is as one piece of homogeneous allogenic bone, as intervertebral fusion
Material, it is easier to promote intervertebral fusion, improve success rate of operation.The appearance of the fusion device can greatly improve the minimally invasive hand of XLIF
The idicatio of art makes more patients be subjected to XLIF Minimally Invasive Surgery, promotes the postoperative quick recovery of patient, shortens the hospital stays, subtracts
Light patient economy burden, for social save medical resources.
Difficult point of the invention is the machine-shaping of fusion device.Round bar shape XLIF Invasive lumbar fusion device normal size is 11mm*
18mm*50mm is difficult to get the monolith cortex bone of such size on human body, therefore devises the chimeric of pole and tubulose cortex bone
Structure had both solved the problems, such as fusion device processing dimension, while ensure that the mechanical strength and mechanical stability of fusion device.
Summary of the invention
In view of the problems of the existing technology, the present invention provides a kind of round bar shape XLIF Invasive lumbar fusion devices.
The invention is realized in this way a kind of round bar shape XLIF Invasive lumbar fusion device, the round bar shape XLIF Invasive lumbar fusion device
It is provided with
Fusion device ontology;
Fusion device ontology top and bottom are provided with dentalation;
Fusion device main body is made of three pole layers, and there are three pins for pole layer upper and lower side;
There are two rectangle chamfering cavity body structures in fusion device main body;Fusion device main body front and back has holding tank.
Further, the fusion device ontology front-back is provided with screw hole;Screw is inserted on screw hole.
Further, the fusion device ontology passes through three the first pole layer, the second pole layer, third pole layer bar assembly
Associated cortex bone screws and the first pin, the second pin, third pin are fixed after good.
Further, the first pole layer, the second pole layer, third pole layer upper and lower side have the first pin, the second pin,
Third pin.
Further, the fusion device body tail section has chamfering structure.
In conclusion advantages of the present invention and good effect are as follows:Round bar shape XLIF Invasive lumbar fusion device main body is by allogeneic
Bone is made, and significantly improves Lumbar Fusion rate and fusion speed.The Invasive lumbar fusion device has biggish intervertebral bone fusion area
XLIF directly enters lumbar vertebrae front pillar from the positive dypass of lumbar vertebrae, and enters Intervertebral space, removes the disc tissue of larger area.Cause
This XLIF has bone grafting fusion area big, and for intervertebral fusion across intervertebral cortex ring, mechanical strength is larger, and XLIF also has tissue damage
Hurt small, operating time is short, and amount of bleeding is few, and the fast advantage of Rehabilitation can fundamentally promote the quick recovery of patient, have
Excellent patient's function score and clinical satisfaction rate.It is performed the operation to 600 patients using XLIF, fusion rate 91%-96.6%, patient
Satisfaction rate 90%.Quick postoperative rehabilitation reduces medical resource consumption.XLIF operating time is shorter, each operated level
Operating time is average, and in 35-40min, intraoperative blood loss is less, and each operated level is in 10-20ml, and the hospital stays was on a 2-3 days left sides
It is right.Relatively small number of complication.Relative to fixing bone grafting fusion in traditional way of escape long segment, the complication rate of XLIF compared with
Low, the incidence of most large 600 XLIF operation discovery complication of case is 6.2%.
Detailed description of the invention
Fig. 1 is round bar shape XLIF Invasive lumbar fusion device structural schematic diagram provided in an embodiment of the present invention;
Fig. 2 is screw hole provided in an embodiment of the present invention, clamping slot structure schematic diagram;
Fig. 3 is the first pin provided in an embodiment of the present invention, the second pin, third pin feature schematic diagram;
Fig. 4 is the second pole layer provided in an embodiment of the present invention, third pole schematic diagram of a layer structure;
In figure: 1, fusion device ontology;2, screw;3, the first pin;4, the second pin;5, third pin;6, the first pole
Layer;7, the second pole layer;8, third pole layer;9, dentalation;10, screw hole;11, holding tank;12, chamfering structure;13, it falls
Angle cavity body structure.
Specific embodiment
In order to make the objectives, technical solutions, and advantages of the present invention clearer, with reference to embodiments, to the present invention
It is further elaborated.It should be appreciated that the specific embodiments described herein are merely illustrative of the present invention, it is not used to
Limit the present invention.
As shown in Figure 1, round bar shape XLIF Invasive lumbar fusion device provided in an embodiment of the present invention includes: fusion device ontology 1, screw
2, the first pin 3, the second pin 4, third pin 5, the first pole layer 6, the second pole layer 7, third pole layer 8, dentalation
9, screw hole 10, holding tank 11, chamfering structure 12, chamfering cavity body structure 13.
1 top and bottom of fusion device ontology are provided with dentalation 9;1 front-back of fusion device ontology is provided with screw hole 10;Spiral shell
Screw 2 is inserted in nail hole 10;First pole layer 6, the second pole layer 7,8 upper and lower side of third pole layer have the first pin 3, second pin
Follow closely 4, third pin 5;There are two rectangle chamfering cavity body structures 13 in fusion device main body 1;1 front and back of fusion device main body has folder
Hold slot 11.There is chamfering structure 12 in 1 tail portion of fusion device ontology.
The present invention assembles rear associated cortex by 8 three the first pole layer 6, the second pole layer 7, third pole layer bar
Bone screws 2 and the first pin 3, the second pin 4, third pin 5 are fixed, layer cover after method splicing through number milling or Cutter Body Processing with Machining Center and
At;Fusion device ontology 1 is designed using anatomical form, and upper and lower soleplate shape dissects configuration design, upper and lower soleplate table by the lumbar vertebrae of compatriots
Face is provided with dentalation 9, prevents fusion device ontology 1 from sliding, and sagittal plain segmental lordosis restores lumbar vertebrae physiology lordosis, and is suitble to
The requirement of the channel XLIF Micro-operation.
The foregoing is merely illustrative of the preferred embodiments of the present invention, is not intended to limit the invention, all in essence of the invention
Made any modifications, equivalent replacements, and improvements etc., should all be included in the protection scope of the present invention within mind and principle.
Claims (5)
1. a kind of round bar shape XLIF Invasive lumbar fusion device, which is characterized in that the round bar shape XLIF Invasive lumbar fusion device is provided with
Fusion device ontology;
Fusion device ontology top and bottom are provided with dentalation;
Fusion device main body is made of three pole layers, and there are three pins for pole layer upper and lower side;
There are two rectangle chamfering cavity body structures in fusion device main body;Fusion device main body front and back has holding tank.
2. round bar shape XLIF Invasive lumbar fusion device as described in claim 1, which is characterized in that the fusion device ontology front-back is set
It is equipped with screw hole;Screw is inserted on screw hole.
3. round bar shape XLIF Invasive lumbar fusion device as described in claim 1, which is characterized in that the fusion device ontology passes through first
Three pole layer, the second pole layer, third pole layer bar assemble rear associated cortex bone screws and the first pin, the second pin
Nail, third pin are fixed.
4. round bar shape XLIF Invasive lumbar fusion device as claimed in claim 3, which is characterized in that the first pole layer, the second circle
Stick layer, third pole layer upper and lower side have the first pin, the second pin, third pin.
5. round bar shape XLIF Invasive lumbar fusion device as described in claim 1, which is characterized in that the fusion device body tail section has down
Corner structure.
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CN201810692997.XA CN109009579A (en) | 2018-06-29 | 2018-06-29 | A kind of round bar shape XLIF Invasive lumbar fusion device |
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CN201810692997.XA CN109009579A (en) | 2018-06-29 | 2018-06-29 | A kind of round bar shape XLIF Invasive lumbar fusion device |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN110384572A (en) * | 2019-07-16 | 2019-10-29 | 天津市天津医院 | CAD personalization lumbar intervertebral fusion device and its designing and manufacturing method |
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US4878915A (en) * | 1987-01-22 | 1989-11-07 | Brantigan John W | Surgical prosthetic implant facilitating vertebral interbody fusion |
CN1143488A (en) * | 1995-03-27 | 1997-02-26 | 丹内克医学有限公司 | Interbody fusion device and method for restoration of normal spinal anatomy |
US20020029084A1 (en) * | 1998-08-03 | 2002-03-07 | Paul David C. | Bone implants with central chambers |
CN102612351A (en) * | 2009-09-23 | 2012-07-25 | 捷迈脊柱有限公司 | Composite implant |
CN203263595U (en) * | 2013-05-22 | 2013-11-06 | 广州聚生生物科技有限公司 | Cervical vertebra anterior lumbar interbody fusion cage |
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CN103610523A (en) * | 2013-12-18 | 2014-03-05 | 广州聚生生物科技有限公司 | Minimally invasive lateral approach interbody fusion device |
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CN110384572A (en) * | 2019-07-16 | 2019-10-29 | 天津市天津医院 | CAD personalization lumbar intervertebral fusion device and its designing and manufacturing method |
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