A kind of device that is used for the treatment of vertebral compression fracture
Technical field
The present invention relates to a kind of medical apparatus, particularly a kind of device that is used for the treatment of vertebral compression fracture.
Background technology
The spinal vertebral compression fracture is a kind of common disease, and all ages and classes all has the vertebral fracture of heterogeneity and type.The traditional Therapeutic Method of compression fracture of vertabral body is the way of escape short-segment pedicle instrument screw technology according to spinal column three post theories, screw is implanted and is suffered from the contiguous up and down normal pedicle of vertebral arch of vertebra, by screw and excellent combining, " stretching-compression " principle of utilization vertebral body periphery ligament tissue resets the trouble vertebra; Take out internal fixation after the union of fracture again, go through two operations.
Two more than ten years of way of escape pedicle screw technology clinical practice, receive good clinical effectiveness.But also there are many problems, as fixed normal vertebral body and fixed contiguous two intervertebral disc at least; The broken nail of screw itself; Getting nail back correction degree loses; The inner spongy bone of vertebral body can not heal fully, suffers from vertebra " change of eggshell sample ", collapse of vertebra at a specified future date; The traumatic vertebral compression fracture of the easier generation of senile osteoporosis vertebral body, fragility fractures cause pain, bow-backed deformity; And the fixing osteoporosis centrum of pedicle screw moves back nail or the like easily.
The spinal vertebral plasty is directly to inject bone cement to the pathological changes vertebral body, produces good analgesic effect clinically, after progressively be applied to clinical treatment vertebral body painful diseases, directly thin bone cement is injected the pathological changes vertebral body by conduit.Because the bone cement of vertebral plasty need be injected into vertebral body under sloppy condition, easily cause bone cement to leak, enter to reach blood vessel in vertebral body periphery, the canalis spinalis even enter blood circulation and arrive other positions of health, produce complication such as thromboembolism, compressing spinal cord.
The kyphoplasty art develops on the vertebroplasty basis, with a kind of expansible resin balloon expandable pathological changes vertebral body, bone cement can inject in the bulk phase, lowered inject bone cement pressure, significantly reduced the complication that the bone cement vertebral body leaks outside, simultaneously, the vertebral body to fracture produces certain reset response.But the high withstand voltage sacculus that the kyphoplasty art is used, material is special, external import, cost is big; Need contrast agent in the use; Sacculus has by bony spur broken dangerous in vertebral body, can make contrast agent leak to blood vessel and canalis spinalis.
At present, the percutaneous cervical arc root puncture procedure of clinical usefulness step by step, complex operation, C shape arm X line machine repeatedly monitors, has increased the exposure of patient X line.
Summary of the invention
The objective of the invention is: at the problem of clinical at present existing vertebral compression fracture treatment technology existence, in conjunction with kyphoplasty art material and operational deficiency, according to the pedicle of vertebral arch theory, for the treatment of the compression fracture of vertabral body of impassivity symptom, pathologisch Bruch, old vertebral body osteoporosis provides a kind of by can permanent implanted Intrapyramidal nickel titanium temperature memorial alloy orthopedic repositor and the device that is used for the treatment of vertebral compression fracture that constitutes jointly of special auxiliary ligand cover system.
Technical scheme of the present invention is: a kind of device that is used for the treatment of vertebral compression fracture, this device is made of the property implanted nickel titanium temperature memorial alloy orthopedic repositor and special supporting aid system, and wherein orthopedic repositor is made of body three parts that memory alloy wire converges head, afterbody and the arc memory alloy wire of portion; Supporting aid system is bored, pushes device, working column, protective casing, is injected and manage and inject bar and form by puncture guide pin, graduated puncture with above-mentioned puncture guide pin; The orthopedic repositor shaping is a tubulose under the frozen water state, implant vertebral body by the working column of a thin pedicle after, but under the body temperature condition complex, after the memory alloy wire expansion of orthopedic repositor body, form certain volumetric spaces, and between each memory alloy wire the slit is arranged, form draw-in groove; Orthopedic repositor can produce tension force in vertebral body, with vertebral body spongy bone distraction reduction, recovery vertebral body geometric shape cracked, that loosen, subside.
The integral body of orthopedic repositor described in the present invention is made by the nickel titanium temperature memorial alloy, the head center of this orthopedic repositor have one can by the puncture guide pin the guide pin duct; Body is made of 4~8 strands of memory alloy wires, and is designed to different size according to the different shape of different parts vertebral fracture compression, is shaped as spheroidal or hemispherical or rugby shape or Pear-Shaped; Afterbody is the connection tube of hollow, can mate with the special device top that pushes.
Puncture described in the present invention in the supporting aid system is bored, and its top is flat sharp opening awl, and drill body is an equal diameter self tapping screw tap SANYE traverse drill, and tail end is convenient to operating process and is judged paracentesis depth for having millimeter level scale bar; Puncture has eccentric duct in boring, and can hold the puncture guide pin, and eccentric duct is to design in order more to help the vertebra opening; The boring to pedicle of vertebral arch can be once finished in the design that this puncture is bored, for the working column that enters vertebral body provides a path.
Working column in the described supporting aid system is a hollow pipe, can hold and by being shaped as piped orthopedic repositor under the frozen water in the pipe.
The device that pushes in the described supporting aid system is made up of bar and handle, and the masthead end has a bead and a groove, is connected with the orthopedic repositor afterbody; Push the device axle center have one can by the puncture guide pin guide pinhole.
Protective casing in the described supporting aid system is a hollow pipe, can hold by puncture and bore, and is used for protecting integumentary musculature.
Injecting Guan Weiyi and can in orthopedic repositor, pour into the hollow pipe of bone cement or other biogum material in the described supporting aid system by injecting bar.
The nickel titanium temperature memorial alloy is in wide clinical application, and safety is nontoxic in vivo, does not have rejection.Orthopedic repositor described in the present invention is still in the vertebral body at the inner bonding state of vertebral body, does not does not wear and tear, and no chip produces; Can be gone out by the X ray examination, be convenient to X line supervision in the operation; Can tolerate MRI checks.
Along with the research of biological filler, the implantation of the orthopedic repositor that relates among the present invention can be the between twenty and fifty compression fracture of vertabral body of clinical further treatment new space is provided.
This implantation nickel titanium temperature memorial alloy orthopedic repositor self described in the present invention has certain compressive resistance effect, it is behind the vertebral body intramedullary expansion, certain spacing is arranged between memory alloy wire, can make between packing materials such as dabbling bone cement and biocolloid and spongy bone and interpenetrate, gummed fixedly fractured vertebral body and dabbling bone cement and other gluey biomaterial is strengthened the mechanical property of compression fracture vertebral body jointly, kept the good pain relieving of original vertebral plasty and kyphoplasty simultaneously, Wicresoft's effect has possessed by disposable Minimally Invasive Surgery and has reached the therapeutic purposes advantage.
The present invention compares with existing kyphoplasty art, need not hydraulic test with strut utensil, without contrast agent, the Centesis instrument that relates in the special supporting aid system can disposablely be finished location, puncture, the boring to pedicle of vertebral arch, omit multiple puncture procedure, simplify operating procedure greatly, reduced X line transmiting time, improved the safety of operation.And it is easy to process that the application of metal and processing are compared with plastics, saves production cost, and is beneficial to environmental protection and recovery.
Advantage of the present invention is:
1. but utilize characteristics easily moulding under the memorial alloy low temperature, the following complex of body temperature, directly vertebral body is resetted, change the pedicle screw technology and in contiguous normal vertebral body, carry out distraction reduction, break through traditional spinal trauma compression fracture of vertabral body way of escape pedicle of vertebral arch internal fixation and the treatment viewpoint of getting the internal fixation two operations, disposable Wicresoft finishes operative treatment.
Description of drawings
Below in conjunction with drawings and Examples the present invention is further described:
Fig. 1 is the basic structure sketch map of orthopedic repositor among the present invention;
The structural representation that Fig. 2 bores for puncture among the present invention;
Fig. 3 is for pushing the structural representation of device among the present invention;
Fig. 4 is the structural representation of working column among the present invention;
Fig. 5 is for injecting the structural representation of managing and injecting bar among the present invention;
Fig. 6 is the structural representation of protective casing among the present invention;
Fig. 7 is the sketch map of the different shape of orthopedic repositor among the present invention;
Fig. 8 is used for the treatment of the device operating process sketch map of vertebral compression fracture for the present invention;
Wherein: a finishes the puncture of pedicle of vertebral arch vertebral body for using integumentary musculature protective casing and puncture to bore
B is that the orthopedic repositor of frozen water after moulding implanted vertebral body by the pedicle of vertebral arch working column
C is orthopedic repositor complex in vertebral body
D finishes for operation
Wherein: 1, head; 2, body; 3, afterbody; 4, guide pin duct; 5, opening awl; 6, equal diameter self tapping screw tap SANYE traverse drill; 8, tail end; 10, puncture guide pin; 11, eccentric guide pin duct; 13, bead; 14, guide pinhole; 15, groove; 16, working column; 17, inject pipe; 18, protective casing; 19, spheroidal; 20, hemispherical; 21, rugby shape; 22, Pear-Shaped; 23, inject bar; 24, bar; 25, handle.
The specific embodiment
Embodiment: in conjunction with Fig. 1, Fig. 2, Fig. 3, Fig. 4, Fig. 5 and shown in Figure 6; a kind of device that is used for the treatment of vertebral compression fracture of the present invention is made of the property implanted nickel titanium temperature memorial alloy orthopedic repositor and special supporting aid system, and wherein said supporting aid system is bored, pushes device, working column 16, protective casing 18 and injected pipe 17 and injected bar 23 and formed by puncture guide pin 10, puncture.
According to different parts vertebral body, different compression geometric shape, the present invention designs following parameter, and is selective:
At first as shown in Figure 1, the property implanted nickel titanium temperature memorial alloy orthopedic repositor is made of body 2 three parts that memory alloy wire converges head 1, afterbody 3 and the arc memory alloy wire of portion; Head 1 center of described orthopedic repositor have one can by the puncture guide pin 10 guide pin duct 4.The body 2 of described arc memory alloy wire is made of 4~8 strands of memory alloy wires, further combined with shown in Figure 7, the form of this body 2 can for spheroidal 19 or hemispherical 20 or rugby shape 21 or Pear-Shaped 22 to be applicable to the vertebral compression fracture of different shape.The afterbody 3 of orthopedic repositor is the connection tube of hollow, can mate with the special device top that pushes.
Described orthopedic repositor selects 0.75mm, and the nickel titanium temperature memorial alloy plate that 1.0mm is thick is made, and its entire length design can have three kinds of specification: 20mm, 25mm, 30mm; Wherein head 1 length is decided to be 2mm; Body 2 length can be designed to 14mm, 19mm respectively, 24mm afterbody 3 connection pipe ranges are 4mm, and the pipe thickness of afterbody 3 connection tubes is divided a word with a hyphen at the end of a line and is 0.3mm~0.5mm.
Go out three kinds of specifications in aperture of afterbody 3 connection tubes according to the parameter designing of pedicle of vertebral arch, external diameter/internal diameter is respectively 4.4mm/3.8mm, 5.0mm/4.2mm, 6.0mm/5.2m.
According to the vertebral height of different parts, the height design after corresponding orthopedic repositor struts fully also is three kinds of specification: 10mm, 13mm, 16mm.
As shown in Figure 2, the brill of the puncture in described supporting aid system top is flat sharp opening awl 5; Drill body is an equal diameter self tapping screw tap SANYE traverse drill 6; Tail end 8 has a millimeter scale; Having in this puncture is bored one can be by the eccentric guide pin duct 11 of puncture guide pin 10; Length overall 200mm is bored in this puncture, and opening is bored 5 wide 3.5mm; The long 80mm of drill body, and diameter is 5.5mm, 6.5mm, 7.5mm.The puncture brill can be the working column 16 that enters vertebral body provides a path.
As shown in Figure 3, push device and be made up of bar 24 and handle 25, there are a bead 13 and a groove 15 in bar 24 tops, are connected with orthopedic repositor afterbody 3; Push the device axle center have one can by the puncture guide pin 10 guide pinhole 14.Push the bar 24 long 250mm of device, diameter 4mm; Handle 25 long 100mm, diameter 30mm.
As shown in Figure 4, working column 16 is a hollow pipe, can hold and by being shaped as piped orthopedic repositor under the frozen water in the pipe.The working column 16 long 180mm that are designed to; And three kinds of specifications of corresponding aforementioned orthopedic repositor, the aperture specifications design of this working column 16 is as follows: external diameter/internal diameter 5.2mm/4.6mm, 6mm/5.4mm, 7mm/6.4mm.
As shown in Figure 5, injecting pipe 17 is one can pour into the hollow pipe of bone cement or other biogum material in orthopedic repositor by injecting bar 23.Inject pipe 17 long 250mm external diameter/internal diameter 4.4mm/3.8mm; Inject bar 23 diameter 3.5mm.
As shown in Figure 6, protective casing 18 is a hollow pipe, can hold by puncture and bore, and is used to protect integumentary musculature.Protective casing 18 designs have two kinds of specifications, the long 120mm that is; And external diameter/internal diameter is respectively 9mm/8mm and 7mm/6mm.
With reference to the work process of the present invention shown in the accompanying drawing 8, behind the skin incision, the puncture drill bushing goes into to be used to protect the protective casing 18 of integumentary musculature to arrive the vertebra rear, and hammer hammers into vertebra with opening awl 5.Under C shape X line machine monitors, free-handly pierce puncture and be drilled into the opening awl and arrive at anterior margin of vertebral body cortex rear, insert puncture guide pin 10, take out puncture and bore; Subsequent working sleeve pipe 16 is inserted in the pedicle of vertebral arch.
The property implanted nickel titanium temperature memorial alloy orthopedic repositor is after the effect of external use ice normal saline, it is shaped as tubulose, afterbody 3 connects bar 24 tops that push device, orthopedic repositor passes through working column 16 along puncture guide pin 10, enter vertebral body, take out puncture guide pin 10, orthopedic repositor is kept somewhere in vertebral body.
Under the body temperature condition, orthopedic repositor complex in vertebral body struts the trouble vertebra that subsides of fracturing.
Can take out subsequently and push device, insert and inject pipe 17 and inject bar 23, perfusion bone cement or other biogum material in orthopedic repositor.After treating that pouring material is dry and hard, take out the protective casing 18 of pedicle of vertebral arch working column 16 and integumentary musculature, EO.