CN102813564A - Titanium alloy artificial bone/intramedullary nail compression fixation system and preparation method thereof - Google Patents

Titanium alloy artificial bone/intramedullary nail compression fixation system and preparation method thereof Download PDF

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CN102813564A
CN102813564A CN2012103028936A CN201210302893A CN102813564A CN 102813564 A CN102813564 A CN 102813564A CN 2012103028936 A CN2012103028936 A CN 2012103028936A CN 201210302893 A CN201210302893 A CN 201210302893A CN 102813564 A CN102813564 A CN 102813564A
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bone
titanium alloy
intramedullary pin
artificial bone
alloy artificial
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CN102813564B (en
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孟国林
刘建
李丹
裴国献
高嘉锴
段春光
程建岗
胡蕴玉
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Fourth Military Medical University FMMU
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Fourth Military Medical University FMMU
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

The invention discloses a titanium alloy artificial bone/intramedullary nail compression fixation system and a preparation method thereof. The system consists of a titanium alloy artificial bone segment, an intramedullary nail, a compression nut and lock pins, wherein the titanium alloy artificial bone segment is a cylinder with a cavity; the intramedullary nail interpenetrates the cavity of the titanium alloy artificial bone segment; one end of the intramedullary nail is provided with radial lock pin holes; the other end of the intramedullary nail is provided with a compression thread; the compression nut and the compression thread are arranged in the manner of matching; and the lock pins and the lock pin holes are arranged in the manner of matching. The titanium alloy artificial bone/intramedullary nail compression fixation system can be used for repairing bone defects, so that injured limbs of a patient can be recovered in load bearing function and fine movement function as fast as possible, and the defects, such as ankylosis and infection, in the prior art are prevented.

Description

A kind of titanium alloy artificial bone/intramedullary pin pressurization fixed system and preparation method thereof
Technical field
The invention belongs to medical instruments field, relate to a kind of titanium alloy artificial bone, especially a kind of titanium alloy artificial bone/intramedullary pin pressurization fixed system and preparation method thereof.
Background technology
High speed development along with modern science and technology; Serious high-speed transit is caused trouble, labor protection is ineffective and the use of sophisticated weapon; Make that the incidence rate of extremities serious bone wound is increasingly high, bone is damaged, and particularly the treatment of large segmental bone defect becomes the difficult problem in orthopaedic trauma treatment field.For the large segmental bone defect of length less than 6cm; Through traditional from body cortex spongy bone or the artificial bone graft length and the function of restore limb basically; Reparation for the big segment length's bone that surpasses 6cm is damaged is then comparatively complicated, and using more technology at present has autologous bone transplanting, distraction osteogenesis technology and allogenic bone transplantation technology.
From the body fibular graft: adopt transplant vascular pedicle to repair large segmental bone defect from the body fibula be to use technology comparatively widely at present.Fibular graft through with vascular pedicle on the normal limbs arrives the bone defect; The unobstructed blood vessel that coincide can be fibula and continues to provide nutrition; Accomplish the knitting process with the mode of end end healing between damaged two broken ends of fractured bone of the fibula of the transplanting that makes and bone, finally reach the purpose of repairing large segmental bone defect.Since report in 1975 such as Taybr should technology, this technology and various improving technology were widely used in big section damaged treatment of radius, ulna, tibia and femur, have obtained certain effect.
Although obtained certain clinical effectiveness, also there is a series of problem from the body fibular graft.At first this is the method for a kind of " robbing Peter to pay Paul ", in the treatment large segmental bone defect, has but caused the new wound in other positions and damaged.Secondly; Need certain microsurgery suturing skill from the body fibular graft, influence is more from the uncertain factor that the body fibula becomes to live, after transplanting in case because a variety of causes causes the failure of transplanting; Not only can not reach the damaged purpose of treatment bone, return the patient and cause irretrievable loss.The 3rd, because the moulding again process after the body fibular graft is very long, the fibula diameter is less, and intensity is also less, after therefore transplanting more complication is often arranged, and comprises bone graft fracture (25%) and transplants back one end bone does not connect (20%) etc.These problems, the patient who makes is accepting from often suspecting aspect the body fibular graft.
The distraction osteogenesis technology: the distraction osteogenesis technology is promoted by Llizarov the earliest; Refer to specific lock with retract under the rate, retract two bone surfaces that have blood to supply gradually, new bone formation is arranged between bone surface; And then making it two surfaces of bone of complete bridge joint, final warp is reconstructed and the formation normal configuration.But the advantage of distraction osteogenesis technology is that but three-dimensional correction deformity multi-section position prolongs simultaneously, Non-Invasive is treated bone does not connect and bone is damaged.This technology " tension force-stress rule " theory that has been born in the application in the damaged field of bone makes people to the biological process of limb lengthening new understanding arranged.
The complication of distraction osteogenesis increases along with the increase of extending length with the incidence rate that prolongs failure.Therefore, Yokoyama etc. thinks that the damaged length of bone that need prolong when this technology is applied to tibia should be less than 25% of tibia length overall.Because soft tissue tension is very big in the traction process; Having an intense pain when causing adjacent joints master, passive activity in the distraction procedure with uncomfortable; The patient of willpower difference dare not be movable, might cause stiff (41%) of adjacent joints, and the incidence rate of bone does not connect is also up to 41%! Still have in addition and cause neurovascular damage and psychological problems etc. in fracture end delayed union, muscle contracture, the traction process.
Allogenic bone transplantation: allograph bone has normal bone strength, and difference is less between form, size and the patient, is the good material that substitutes autologous bone transplanting.Consider that treatment bone damaged main target is that the quality of life of improving bone tumor patient postoperative is main; So allogenic bone transplantation is mainly used in the large segmental bone defect that is caused behind the bone tumour resection at present, and in the treatment of the large segmental bone defect that wound caused, use less.The major complications of allogenic bone transplantation comprises infection, ankylosis, bone graft fracture or bone does not connect.The incidence rate that infects is 6~14%, often needs to take out allograph bone, and is serious even need amputation.The incidence rate of allograph bone fracture is up to 17~42%.Simultaneously, certain immunological rejection is arranged behind the allogenic bone transplantation, propagate the risk of diseases such as hepatitis, HIV in addition.In China, because the constraint of traditional view, the Remains Donation ratio is very low, has also caused the restriction of aspect, allograph bone source.
Tissue engineering technique: the organizational project notion is formed at the eighties in 20th century, and its basic meaning is that the natural material of cell, synthetic material, processing and tissue, cytokine and gene therapy are widely used in ground tissue regeneration or external ground tissue construction in the body.Through with 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 sizes in body needs ground, and being transplanted to needed its function of bone defect performance then is the core content of bone tissue engineer research.Through nearly 20 years research, in the Tissue Engineering Study of all organs, the progress that the tissue engineered bone institute is obtained should be the most challenging.On the basis of a large amount of animal experiment studies; All there is through engineering approaches osseous tissue to be applied to report clinical and that succeed at present both at home and abroad with smaller size smaller; But only limit 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 bigger is unsatisfactory.Discover; The seed cell that implants only could be survived through the disperse of nutrition in 150~200 μ m around blood vessel, if can not set up blood vessel fast, just is difficult to make up the osseous tissue that big effective one-tenth is lived; Therefore; For large segmental bone defect, the blood vessel of taking effective method to solve the zone of ossification turns to the key that problem is the survival of through engineering approaches osseous tissue, also is the successful key of the damaged acquisition treatment of bone.At present, the vascularization problem of through engineering approaches osseous tissue still is in conceptual phase, and when the through engineering approaches osseous tissue of vascularization can be applied to the clinical treatment large segmental bone defect still is a unknown number.
No matter large segmental bone defect occurs in upper limb or lower limb, because the forfeiture of limb function is suffered from limb owing to secular useless usefulness and how with heavier osteoporosis.Even adopt from body fibular graft, distraction osteogenesis technology or allogenic bone transplantation technology; The trouble limb braking procedure that all needs the long period after the operation especially for lower limb, needs the load process of exempting from of long period; Cause and suffer from the further deterioration of limb on original disuse osteoporosis basis; The trouble limb bone mass and the bone strength that make seriously descend, and have influenced the rehabilitation of limb function, have also increased the probability that severe complications such as fracture take place.Therefore, the method for seeking more effective treatment large segmental bone defect is clinical the pressing for of orthopaedic trauma.
Summary of the invention
The objective of the invention is to overcome the shortcoming of above-mentioned prior art; A kind of titanium alloy artificial bone/intramedullary pin pressurization fixed system and preparation method thereof is provided; Its choose have good biocompatibility, the titanium alloy biomaterial of fatigue resistance and good biological elastic modelling quantity, adopt the CAD/CAM technology, be the basis with the information of the damaged contralateral limbs normal bone of big segment length's bone bone; Obtain the data of important long bone bone defect; Before art, produce the titanium alloy large segmental bone defect implant of individuation, be aided with simultaneously with the supporting intramedullary pin two ends pressurization fixture of titanium alloy artificial bone and implant the large segmental bone defect district, thereby reach repairing bone defect, make patient's injured limb can recover as early as possible to load weight-bearing function and fine movement function by cnc machine tool; Prevent ankylosis, existing in prior technology defectives such as infection.
The objective of the invention is to solve through following technical scheme:
This titanium alloy artificial bone/intramedullary pin pressurization fixed system; Form by titanium alloy artificial bone section, intramedullary pin, pressurization nut and pinning; Said titanium alloy artificial bone section is the cylinder with cavity; Said intramedullary pin is interspersed in the cavity of titanium alloy artificial bone section, and an end of intramedullary pin is provided with radially locking nail hole, and the other end is provided with the pressurization screw thread; Said pressurization nut is installed with the pressurization threaded engagement; Said pinning cooperates installation with locking nail hole.
One end of above-mentioned intramedullary pin radially is provided with two locking nail holes, and these two locking nail holes are along the intramedullary pin axial distribution.
The present invention also proposes the method for preparing of a kind of above-mentioned titanium alloy artificial bone/intramedullary pin pressurization fixed system; This method is: adopt the CAD/CAM technology; Information with the damaged contralateral limbs normal bone of big segment length's bone bone is the basis; To suffer from the data of limb bone defect, produce titanium alloy artificial bone section as damaged implant by Digit Control Machine Tool, the supporting intramedullary pin of preparation simultaneously and titanium alloy artificial bone section with and the pressurization nut and the pinning at two ends.
Further, above method for preparing specifically may further comprise the steps:
1) obtains the trouble limb to side seam section three-dimensional data by three-dimensional spiral CT, utilize the mirror image reverse technology to obtain to suffer from the three-dimensional data of loss of limb position bone section and pulp cavity thereof;
2) with above-mentioned data input Digit Control Machine Tool, adopt titanium alloy processing two ends netted oversleeve type titanium alloy artificial bone bone section and intramedullary pin;
3) the pressurization nut and the pinning of the above-mentioned intramedullary pin process mating of foundation;
4) artificial bone bone section, intramedullary pin, pressurization nut and the pinning with above preparation encapsulates respectively at the workshop that meets the GMP standard, and carries out the epoxyethane fumigation sterilization.
The present invention has following beneficial effect:
Each parts of titanium alloy artificial bone of the present invention/intramedullary pin pressurization fixed system are tested through biomechanics; Bio-compatible property testing and large animal (goat) femur stage casing bone defect repair experiment confirm, the resisting fatigue of this titanium alloy artificial bone, compressive resistance, shearing resistance and tension stress are much larger than fresh adult normal person's test data; Biocompatibility is good; Big section damaged model of goat femur repaired experiment confirm, and this artificial bone implant procedure is simple, and wound is little, and wound healing early; Implanted second, the goat walking of can standing, walking does not have any untoward reaction as before after three days; Image data shows that visible new callus generates in the artificial skeletal framework shape oversleeve in three week backs, and artificial bone engages with host bone closely, and is fixed; The line of force is satisfied, after three months, is all held and fusion growth by new bone inside and outside the oversleeve structure, and curative effect is very satisfied.
Description of drawings
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 structures and assembling sketch map;
Fig. 3 is femur large segmental bone defect figure;
Fig. 4 is that big section artificial bone section (titanium alloy artificial bone section 1) is implanted sketch map;
Fig. 5 is that intramedullary pin 2 is implanted sketch map;
Fig. 6 is for installing the distal locking nail sketch map;
Fig. 7 installs the configuration state sketch map that pressurization nut 3 makes artificial bone and between the body bone, produces pressurization for near-end.
Wherein: 1 is titanium alloy artificial bone section; 2 is intramedullary pin; 3 are the pressurization nut; 4 is locking nail hole; 5 is pinning.
The specific embodiment
Below in conjunction with accompanying drawing the present invention is done and to describe in further detail:
Referring to Fig. 1 and Fig. 2, titanium alloy artificial bone of the present invention/intramedullary pin pressurization fixed system 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 an end of intramedullary pin 2 is provided with radially locking nail hole 4, and the other end is provided with the pressurization screw thread; Pressurization nut 3 is installed with the pressurization threaded engagement; Pinning 5 cooperates installation with locking nail hole 4.
In preferred embodiment of the present invention, radially be provided with two locking nail holes 4 at an end 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 is used for intramedullary pin 2 is fixed in femur one end, uses two and makes intramedullary pin 2 more stable at the femur internal fixation.
The method for preparing of above-mentioned titanium alloy artificial bone/intramedullary pin pressurization fixed system is following:
Adopt the CAD/CAM technology; Information with the damaged contralateral limbs normal bone of big segment length's bone bone is the basis; Adopt the mirror image reverse technology to obtain to suffer from the data of limb bone defect; Produce titanium alloy artificial bone section 1 as damaged implant by Digit Control Machine Tool, the supporting intramedullary pin 2 of preparation simultaneously and titanium alloy artificial bone section 1 with and the pressurization nut 3 and the pinning at two ends.The concrete steps of this method for preparing are following:
1) obtains the trouble limb to side seam section three-dimensional data by three-dimensional spiral CT, utilize the mirror image reverse technology to obtain to suffer from the three-dimensional data of loss of limb position bone section and pulp cavity thereof;
2) with above-mentioned data input Digit Control Machine Tool, adopt titanium alloy processing two ends netted oversleeve type titanium alloy artificial bone bone section 1 and intramedullary pin 2;
3) the pressurization nut 3 and the pinning of above-mentioned intramedullary pin 2 process mating of foundation;
Artificial bone bone section 1, intramedullary pin 2, pressurization nut 3 and the pinning of above preparation are encapsulated respectively at the workshop that meets the GMP standard, and carry out the epoxyethane fumigation sterilization.
Below specify the use of titanium alloy artificial bone of the present invention/intramedullary pin pressurization fixed system:
Be illustrated in figure 3 as the situation of femur large segmental bone defect, the serious bone wound in intermediate portion causes whole section bone lacks, has had a strong impact on patient's normal walking; Can continue to bring into play the effect of support for the femur that makes wound; Like Fig. 4; Titanium alloy artificial bone section 1 section of the being positioned over position of bone for preparing is put; Intramedullary pin 2 is passed in the joint of titanium alloy artificial bone section 1 and its lower end (being far-end) insertion femur bottom, and femur top joint is passed in the upper end, and is as shown in Figure 5; Be inserted through the locking nail hole 4 of intramedullary pin 2 with pinning 5 by the joint wall of femur bottom this moment, and intramedullary pin 2 is fixed, as shown in Figure 6; Pass the termination of the intramedullary pin 2 of joint then on femur top pressurization nut 3 is installed; And the pressurization of screwing, with the whole system fixation, as shown in Figure 7.

Claims (4)

1. a titanium alloy artificial bone/intramedullary pin pressurization fixed system; It is characterized in that: form by titanium alloy artificial bone section (1), intramedullary pin (2), pressurization nut (3) and pinning (5); Said titanium alloy artificial bone section (1) is for having the cylinder of cavity; Said intramedullary pin (2) is interspersed in the cavity of titanium alloy artificial bone section, and an end of intramedullary pin (2) is provided with radially locking nail hole (4), and the other end is provided with the pressurization screw thread; Said pressurization nut (3) is installed with the pressurization threaded engagement; Said pinning (5) cooperates installation with locking nail hole (4).
2. titanium alloy artificial bone according to claim 1/intramedullary pin pressurization fixed system, it is characterized in that: an end of said intramedullary pin (2) radially is provided with two locking nail holes (4), and these two locking nail holes (4) are along intramedullary pin (2) axial distribution.
3. the method for preparing of the said titanium alloy artificial bone of claim 1/intramedullary pin pressurization fixed system; It is characterized in that; Adopt the CAD/CAM technology, be basis, obtain the data of trouble limb bone defect with the information of the damaged contralateral limbs normal bone of big segment length's bone bone; Produce titanium alloy artificial bone section (1) as damaged implant by Digit Control Machine Tool, preparation simultaneously and the supporting intramedullary pin (2) of titanium alloy artificial bone section (1) with and the pressurization nut (3) and the pinning at two ends.
4. method for preparing according to claim 3 is characterized in that, this method specifically may further comprise the steps:
1) obtains the trouble limb to side seam section three-dimensional data by three-dimensional spiral CT, utilize the mirror image reverse technology to obtain to suffer from the three-dimensional data of loss of limb position bone section and pulp cavity thereof;
2) with above-mentioned data input Digit Control Machine Tool, adopt titanium alloy processing two ends netted oversleeve type titanium alloy artificial bone bone sections (1) and intramedullary pin (2);
3) the pressurization nut (3) and the pinning of foundation above-mentioned intramedullary pin (2) process mating;
4) artificial bone bone section (1), intramedullary pin (2), pressurization nut (3) and the pinning with above preparation encapsulates respectively at the workshop that meets the GMP standard, and carries out the epoxyethane fumigation sterilization.
CN201210302893.6A 2012-08-23 2012-08-23 A kind of preparation method of titanium alloy artificial bone/intramedullary nail compression fixation system Expired - Fee Related CN102813564B (en)

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Cited By (10)

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CN104323875A (en) * 2014-10-14 2015-02-04 刘振东 Bone grafting device for repairing large segmental bone defects
CN106943210A (en) * 2017-04-21 2017-07-14 无锡市第九人民医院 A kind of titanium cage for being used to wrap up long bone cortex bone ectonexine bone grafting
WO2018000580A1 (en) * 2016-07-01 2018-01-04 佟文 Connecting prosthesis for bone defects
CN109984873A (en) * 2019-05-14 2019-07-09 赵滨 It is a kind of for filling up and supporting the ossis implants block of the dry epiphysis defect of long bone of limbs
CN110338943A (en) * 2019-07-17 2019-10-18 天津市天津医院 CAD individuation artificial body of the humerus and production method
CN110678150A (en) * 2017-02-21 2020-01-10 拜欧米特制造有限责任公司 Implant for bridging a bone defect
CN111513889A (en) * 2018-09-05 2020-08-11 郑州大学第一附属医院 Orthopedic mesh forming device
TWI706765B (en) * 2019-08-27 2020-10-11 楊琳敏 Interlocking "ㄡ" type intramedullary double slender steel rods for reduction and fixation of humeral fractures near the elbow joint
CN112807066A (en) * 2020-12-30 2021-05-18 杨润松 Combined intramedullary and extramedullary fixing device for radius head reconstruction and reduction
CN113974914A (en) * 2020-08-27 2022-01-28 北京力达康科技有限公司 Femoral prosthesis for retaining femoral head

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Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104323875A (en) * 2014-10-14 2015-02-04 刘振东 Bone grafting device for repairing large segmental bone defects
WO2018000580A1 (en) * 2016-07-01 2018-01-04 佟文 Connecting prosthesis for bone defects
CN110678150B (en) * 2017-02-21 2021-11-05 拜欧米特制造有限责任公司 Implant for bridging a bone defect
CN110678150A (en) * 2017-02-21 2020-01-10 拜欧米特制造有限责任公司 Implant for bridging a bone defect
US10716603B2 (en) 2017-02-21 2020-07-21 Biomet Manufacturing, Llc Implants for bridging osseous defects
CN106943210A (en) * 2017-04-21 2017-07-14 无锡市第九人民医院 A kind of titanium cage for being used to wrap up long bone cortex bone ectonexine bone grafting
CN111513889A (en) * 2018-09-05 2020-08-11 郑州大学第一附属医院 Orthopedic mesh forming device
CN109984873A (en) * 2019-05-14 2019-07-09 赵滨 It is a kind of for filling up and supporting the ossis implants block of the dry epiphysis defect of long bone of limbs
CN110338943A (en) * 2019-07-17 2019-10-18 天津市天津医院 CAD individuation artificial body of the humerus and production method
CN110338943B (en) * 2019-07-17 2023-11-24 天津市天津医院 Computer aided design individuation humerus prosthesis and manufacturing method
TWI706765B (en) * 2019-08-27 2020-10-11 楊琳敏 Interlocking "ㄡ" type intramedullary double slender steel rods for reduction and fixation of humeral fractures near the elbow joint
CN113974914A (en) * 2020-08-27 2022-01-28 北京力达康科技有限公司 Femoral prosthesis for retaining femoral head
CN112807066A (en) * 2020-12-30 2021-05-18 杨润松 Combined intramedullary and extramedullary fixing device for radius head reconstruction and reduction
CN112807066B (en) * 2020-12-30 2023-05-12 杨润松 Combined type fixing device for rebuilding and resetting radial bone and intramedullary and extramedullary

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