CN102813564B - A kind of preparation method of titanium alloy artificial bone/intramedullary nail compression fixation system - Google Patents
A kind of preparation method of titanium alloy artificial bone/intramedullary nail compression fixation system Download PDFInfo
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- CN102813564B CN102813564B CN201210302893.6A CN201210302893A CN102813564B CN 102813564 B CN102813564 B CN 102813564B CN 201210302893 A CN201210302893 A CN 201210302893A CN 102813564 B CN102813564 B CN 102813564B
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- titanium alloy
- bone
- artificial bone
- intramedullary pin
- alloy artificial
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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
- A61F2/28—Bones
-
- 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
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
Abstract
The invention discloses a kind of preparation method of titanium alloy artificial bone/intramedullary nail compression fixation system, this system is made up of titanium alloy artificial bone section, intramedullary pin, pressurization nut and pinning, described titanium alloy artificial bone section is for having the cylinder of cavity, described intramedullary pin is interspersed in the cavity of titanium alloy artificial bone section, one end of intramedullary pin is provided with radial locking nail hole, and the other end is provided with pressurized screw; Described pressurization nut coordinates with pressurized screw to be installed; Described pinning coordinates with locking nail hole to be installed.The present invention can repairing bone defect, make patient injury's limbs can recover load weight-bearing function and fine movement function as early as possible, prevent ankylosis, the defects existing for prior art such as infection.
Description
Technical field
The invention belongs to medical instruments field, relate to a kind of titanium alloy artificial bone, especially a kind of preparation method of titanium alloy artificial bone/intramedullary nail compression fixation system.
Background technology
Along with the high speed development of modern science and technology; serious high-speed transit is caused trouble, labor protection is ineffective and the use of sophisticated weapon; make the incidence rate of extremity severe bone wound more and more higher, the treatment of Cranial defect, particularly large segmental bone defect becomes the difficult problem in orthopaedic trauma treatment field.Length is less than to the large segmental bone defect of 6cm, substantially length and the function of suffering limb can be recovered by traditional autologous cortex spongy bone or artificial bone graft, reparation for the large segment length's Cranial defect more than 6cm is then comparatively complicated, and the more technology of application has autologous bone transplanting, Distraction osteogenesis and allogenic bone transplantation technology at present.
Fibula autograft is transplanted: adopting the Fibula autograft transplanting vascular pedicle to repair large segmental bone defect is current widely used technology.By by the fibular autograft of vascular pedicle on normal limb to Cranial defect position, the unobstructed blood vessel coincide can be fibula to be continued to provide nutrition, to hold the mode healed to complete knitting process between the fibula of the transplanting made and two broken ends of fractured bone of Cranial defect, finally reach the object of repairing large segmental bone defect.Since Taybr etc. reports this technology in 1975, this technology and various improving technology are widely used in the treatment of the large section defect of radius, ulna, tibia and femur, achieve certain effect.
Although Fibula autograft is transplanted and achieved certain clinical effectiveness, also there is a series of problem.First this is the method for a kind of " robbing Peter to pay Paul ", while treatment large segmental bone defect, but cause the new wound in other positions and defect.Secondly, Fibula autograft is transplanted needs certain microsurgery suturing skill, affects the uncertain factor that Fibula autograft survives more, after the transfer once cause the failure of transplanting due to a variety of causes, not only can not reach the object for the treatment of Cranial defect, return patient and cause irretrievable loss.3rd, because the moulding process again after Fibula autograft transplanting is very long, fibula diameter is less, and intensity is also less, often has more complication after therefore transplanting, and comprises bone graft fracture (25%) and transplants rear one end bone does not connect (20%) etc.These problems, the patient made is accepting often to suspect in Fibula autograft transplanting.
Distraction osteogenesis: Distraction osteogenesis is promoted by Llizarov the earliest, refer at specific lock with under retracting rate, retract the bone surface that two have blood confession gradually, between bone surface, have new bone formation, and then make it complete bridge joint two surfaces of bone, finally form normal configuration through reconstruction.The advantage of Distraction osteogenesis be can three-dimensional correction deformity, can multiple location extend simultaneously, Non-Invasive treatment bone does not connect and Cranial defect.This technology to be born " tension force in the application in Cranial defect field
-stress rule " theoretical, make the biological process of people to limb lengthening have new understanding.
The incidence rate that the complication of distraction osteogenesis is failed with prolongation increases along with the increase of extending length.Therefore, Yokoyama etc. think that this technology needs the length of the Cranial defect extended should be less than 25% of tibia overall length when being applied to tibia.Because soft tissue tension in traction process is very large, cause adjacent joints in distraction procedure active and passive movable time have an intense pain and discomfort, the patient of willpower difference dare not be movable, likely cause stiff (41%) of adjacent joints, and the incidence rate of bone does not connect is also up to 41%! Still have in fracture end delayed union, muscle contracture, traction process in addition and cause neurovascular damage and psychological problems etc.
Allogenic bone transplantation: allograph bone has normal bone strength, form, between size and patient, difference is less, is the good material of alternative autologous bone transplanting.Consider that the main target for the treatment of Cranial defect is that to improve Patients with Bone Tumor postoperative quality of life be main, so the large segmental bone defect that allogenic bone transplantation causes after being mainly used in bone tumour resection at present, and apply less in the treatment of the large segmental bone defect caused at trauma.The major complications of allogenic bone transplantation comprises infection, ankylosis, bone graft fracture or bone does not connect.The incidence rate infected is 6 ~ 14%, and often need take out allograph bone, serious even needs amputation.The incidence rate of allogeneic bone fracture is up to 17 ~ 42%.Meanwhile, after allogenic bone transplantation, there is certain immunological rejection, propagate the risk of the disease such as hepatitis, HIV in addition.In China, due to the constraint of traditional view, Remains Donation ratio is very low, also result in the restriction of aspect, allograph bone source.
Tissue engineering technique: organizational project concept is formed at the eighties in 20th century, its basic meaning be the natural material of cell, synthetic material, process and tissue, cytokine and gene therapy to be widely used in body tissue regeneration or external ground tissue construction.By by osteoblast, osteogenic induction cytokine and timbering material organic assembling, external or culturing in vivo goes out to meet the through engineering approaches osseous tissue of the different size in body requirement ground, is then transplanted to required Cranial defect position and plays the core content that its function is bone tissue engineer research.By the research of nearly 20 years, in the Tissue Engineering Study of all organs, the progress that tissue engineered bone institute obtains is the most challenging.On the basis of a large amount of animal experiment study, all have at present both at home and abroad and the through engineering approaches osseous tissue of smaller size smaller is applied to the clinical and report succeeded, but be only limitted to the application of the through engineering approaches artificial bone of smaller size smaller, the clinical application effect of the through engineering approaches bone that volume is larger is unsatisfactory.Research finds, the seed cell implanted only just is survived by the disperse of nutrition in 150 ~ 200 μm around blood vessel, if blood vessel can not be set up fast, just be difficult to build the large osseous tissue effectively survived, therefore, for large segmental bone defect, the blood vessel taking effective method to solve zone of ossification turns to the key that problem is the survival of through engineering approaches osseous tissue, is also that Cranial defect acquisition treatment is successfully crucial.At present, the vascularization problem of through engineering approaches osseous tissue is still in conceptual phase, and when the through engineering approaches osseous tissue of vascularization can be applied to clinical treatment large segmental bone defect is still a unknown number.
No matter large segmental bone defect occurs in upper limb or lower limb, and due to the forfeiture of limb function, suffering limb is many with heavier osteoporosis due to long-term useless use.Even if adopt Fibula autograft transplanting, Distraction osteogenesis or allogenic bone transplantation technology, Post operation all needs the suffering limb braking procedure of long period, special in lower limb, what need the long period exempts from load process, cause the further deterioration of suffering limb on original disuse osteoporosis basis, the suffering limb bone mass made and bone strength degradation, have impact on the rehabilitation of limb function, too increases the probability that fracture waits severe complication to occur.Therefore, the method finding more effective treatment large segmental bone defect be orthopaedic trauma clinical in the urgent need to.
Summary of the invention
The object of the invention is to the shortcoming overcoming above-mentioned prior art, a kind of preparation method of titanium alloy artificial bone/intramedullary nail compression fixation system is provided, it is chosen has good biocompatibility, the titanium alloy biomaterial of fatigue resistance and good biological elastic modelling quantity, adopt CAD/CAM technology, based on the information of large section ' Bone Defect of Long Bones contralateral limbs normal bone, obtain the data at important ' Bone Defect of Long Bones position, the titanium alloy large segmental bone defect implant of individuation is produced in the preoperative by cnc machine tool, be aided with the intramedullary pin two ends supporting with titanium alloy artificial bone fixture of pressurizeing simultaneously and implant large segmental bone defect district, thus reach repairing bone defect, make patient injury's limbs can recover load weight-bearing function and fine movement function as early as possible, prevent ankylosis, the defects existing for prior art such as infection.
The object of the invention is to solve by the following technical programs:
This titanium alloy artificial bone/intramedullary nail compression fixation system, be made up of titanium alloy artificial bone section, intramedullary pin, pressurization nut and pinning, described titanium alloy artificial bone section is for having the cylinder of cavity, described intramedullary pin is interspersed in the cavity of titanium alloy artificial bone section, one end of intramedullary pin is provided with radial locking nail hole, and the other end is provided with pressurized screw; Described pressurization nut coordinates with pressurized screw to be installed; Described pinning coordinates with locking nail hole to be installed.
One end radial direction of above-mentioned intramedullary pin is provided with two locking nail holes, and these two locking nail holes are along intramedullary pin axial distribution.
The present invention also proposes a kind of preparation method of above-mentioned titanium alloy artificial bone/intramedullary nail compression fixation system, the method is: adopt CAD/CAM technology, based on the information of large section ' Bone Defect of Long Bones contralateral limbs normal bone, obtain the data at suffering limb Cranial defect position, produce titanium alloy artificial bone section as defect implant by Digit Control Machine Tool, prepare pressurization nut and the pinning at the intramedullary pin supporting with titanium alloy artificial bone section and its two ends simultaneously.
Further, above preparation method specifically comprises the following steps:
1) obtain suffering limb to side seam section three-dimensional data by three-dimensional profilometry, utilize mirror image reverse technology to obtain the three-dimensional data of suffering limb defect bone section and pulp cavity thereof;
2) by above-mentioned data input Digit Control Machine Tool, titanic alloy machining two ends netted oversleeve type titanium alloy artificial bone bone section and intramedullary pin is adopted;
3) according to pressurization nut and the pinning of above-mentioned intramedullary pin process mating;
4) artificial bone bone section, intramedullary pin, pressurization nut and the pinning prepared above are encapsulated respectively at the workshop meeting GMP standard, and carry out epoxyethane fumigation sterilizing.
The present invention has following beneficial effect:
Each parts of titanium alloy artificial bone/intramedullary nail compression fixation system of the present invention are through Biomechanics test, biocompatibility test and the bone defect healing experiment of large animal (goat) femur stage casing confirm, the resisting fatigue of this titanium alloy artificial bone, compressive resistance, shearing resistance and tension stress are much larger than the test data of fresh adult normal person; Biocompatibility is good; Goat femur large section of defect model reparative experiment confirms, this artificial bone implant procedure is simple, and wound is little, wound healing early, implants second day, and goat can be stood walking, walk as before after three days, without any untoward reaction, image data shows, after three weeks, in artificial skeletal framework shape oversleeve, visible new callus generates, and artificial bone engages with host bone closely, fixed, the line of force is satisfied, after three months, all held and fusion growth by new bone inside and outside oversleeve structure, curative effect is satisfaction very.
Accompanying drawing explanation
Fig. 1 is titanium alloy artificial bone section 1 structural representation of the present invention;
Fig. 2 is intramedullary pin 2 of the present invention and pressurization nut 3 structure and assembles schematic diagram;
Fig. 3 is femur large segmental bone defect figure;
Fig. 4 is that large section artificial bone section (titanium alloy artificial bone section 1) implants schematic diagram;
Fig. 5 is that intramedullary pin 2 implants schematic diagram;
Fig. 6 is for installing distal locking nail schematic diagram;
Fig. 7 is the configuration state schematic diagram that near-end installs that pressurization nut 3 makes to produce between artificial bone and autologous bone pressurization.
Wherein: 1 is titanium alloy artificial bone section; 2 is intramedullary pin; 3 is pressurization nut; 4 is locking nail hole; 5 are.
Detailed description of the invention
Below in conjunction with accompanying drawing, the present invention is described in further detail:
See Fig. 1 and Fig. 2, titanium alloy artificial bone/intramedullary nail compression fixation system of the present invention is made up of titanium alloy artificial bone section 1, intramedullary pin 2, pressurization nut 3 and pinning 5.Wherein titanium alloy artificial bone section 1 is for having the cylinder of cavity, and intramedullary pin 2 is interspersed in the cavity of titanium alloy artificial bone section, and one end of intramedullary pin 2 is provided with radial locking nail hole 4, and the other end is provided with pressurized screw; Pressurization nut 3 coordinates with pressurized screw to be installed; Pinning 5 coordinates with locking nail hole 4 to be installed.
In the preferred embodiment, be provided with two locking nail holes 4 in one end radial direction of intramedullary pin 2, these two locking nail holes 4 are along intramedullary pin 2 axial distribution.Locking nail hole 4 of the present invention, for being fixed in femur one end by intramedullary pin 2, using two and makes intramedullary pin 2 more stable at femur internal fixtion.
The preparation method of above-mentioned titanium alloy artificial bone/intramedullary nail compression fixation system is as follows:
Adopt CAD/CAM technology, based on the information of large section ' Bone Defect of Long Bones contralateral limbs normal bone, mirror image reverse technology is adopted to obtain the data at suffering limb Cranial defect position, produce titanium alloy artificial bone section 1 as defect implant by Digit Control Machine Tool, prepare pressurization nut 3 and the pinning at the intramedullary pin 2 supporting with titanium alloy artificial bone section 1 and its two ends simultaneously.The concrete steps of this preparation method are as follows:
1) obtain suffering limb to side seam section three-dimensional data by three-dimensional profilometry, utilize mirror image reverse technology to obtain the three-dimensional data of suffering limb defect bone section and pulp cavity thereof;
2) by above-mentioned data input Digit Control Machine Tool, titanic alloy machining two ends netted oversleeve type titanium alloy artificial bone bone section 1 and intramedullary pin 2 is adopted;
3) according to pressurization nut 3 and the pinning of above-mentioned intramedullary pin 2 process mating;
By the artificial bone bone section 1 prepared above, intramedullary pin 2, pressurization nut 3 and pinning respectively at the workshop encapsulation meeting GMP standard, and carry out epoxyethane fumigation sterilizing.
Below describe the use procedure of titanium alloy artificial bone/intramedullary nail compression fixation system of the present invention in detail:
Be illustrated in figure 3 the situation of femur large segmental bone defect, intermediate portion severe bone wound causes whole section of bone lacks, has had a strong impact on the normal walking of patient; Continue to enable the femur of wound to play the effect supported, as Fig. 4, titanium alloy artificial bone section 1 section of the being positioned over position of bone prepared is put, then make intramedullary pin 2 through titanium alloy artificial bone section 1 and its lower end (i.e. far-end) inserts in the joint of femur bottom, femur top joint is passed in upper end, as shown in Figure 5; Now pinning 5 is inserted through the locking nail hole 4 of intramedullary pin 2 by the joint wall of femur bottom, intramedullary pin 2 is fixed, as shown in Figure 6, then through the termination of the intramedullary pin 2 of joint, pressurization nut 3 is installed on femur top, and screw pressurization, by whole system fixation, as shown in Figure 7.
Claims (1)
1. the preparation method of a titanium alloy artificial bone/intramedullary nail compression fixation system, it is characterized in that: titanium alloy artificial bone/intramedullary nail compression fixation system is made up of titanium alloy artificial bone section (1), intramedullary pin (2), pressurization nut (3) and pinning (5), described titanium alloy artificial bone section (1) is for having the cylinder of cavity, described intramedullary pin (2) is interspersed in the cavity of titanium alloy artificial bone section, one end of intramedullary pin (2) is provided with radial locking nail hole (4), and the other end is provided with pressurized screw; Described pressurization nut (3) coordinates with pressurized screw installs; Described pinning (5) coordinates with locking nail hole (4) to be installed; One end radial direction of described intramedullary pin (2) is provided with two locking nail holes (4), and these two locking nail holes (4) are along intramedullary pin (2) axial distribution; Locking nail hole (4), for being fixed in femur one end by intramedullary pin (2), uses two locking nail holes (4) to make intramedullary pin (2) more stable at femur internal fixtion;
The preparation method of described titanium alloy artificial bone/intramedullary nail compression fixation system, adopt CAD/CAM technology, based on the information of large section ' Bone Defect of Long Bones contralateral limbs normal bone, obtain the data at suffering limb Cranial defect position, produce titanium alloy artificial bone section (1) as defect implant by Digit Control Machine Tool, prepare pressurization nut (3) and the pinning at the intramedullary pin (2) supporting with titanium alloy artificial bone section (1) and intramedullary pin (2) two ends simultaneously; Specifically comprise the following steps:
1) obtain suffering limb to side seam section three-dimensional data by three-dimensional profilometry, utilize mirror image reverse technology to obtain the three-dimensional data of suffering limb defect bone section and pulp cavity thereof;
2) three-dimensional data of suffering limb defect bone section and pulp cavity thereof is inputted Digit Control Machine Tool, adopt titanic alloy machining two ends netted oversleeve type titanium alloy artificial bone bone section (1) and intramedullary pin (2);
3) according to pressurization nut (3) and the pinning of above-mentioned intramedullary pin (2) process mating;
4) the artificial bone bone section (1) prepared above, intramedullary pin (2), pressurization nut (3) and pinning are encapsulated respectively at the workshop meeting GMP standard, and carry out epoxyethane fumigation sterilizing.
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| CN201210302893.6A CN102813564B (en) | 2012-08-23 | 2012-08-23 | A kind of preparation method of titanium alloy artificial bone/intramedullary nail compression fixation system |
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| CN201210302893.6A CN102813564B (en) | 2012-08-23 | 2012-08-23 | A kind of preparation method of titanium alloy artificial bone/intramedullary nail compression fixation system |
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| CN102813564B true CN102813564B (en) | 2015-12-09 |
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Cited By (1)
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| WO2018156563A1 (en) * | 2017-02-21 | 2018-08-30 | William Scott Van Dyke | Implants for bridging osseous defects |
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