CN207708317U - Vertebral body augmentation formation system - Google Patents

Vertebral body augmentation formation system Download PDF

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Publication number
CN207708317U
CN207708317U CN201720684670.9U CN201720684670U CN207708317U CN 207708317 U CN207708317 U CN 207708317U CN 201720684670 U CN201720684670 U CN 201720684670U CN 207708317 U CN207708317 U CN 207708317U
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China
Prior art keywords
centrum
balloon expandable
sacculus
expandable stent
inner cavity
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CN201720684670.9U
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Chinese (zh)
Inventor
沈碧峰
付亮辉
朱大伟
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Enodar Medical Shanghai Co Ltd
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Ling Xiu Biotechnology (shanghai) Co Ltd
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Abstract

The utility model discloses a kind of vertebral body augmentation formation systems, and specifically, which includes that 1) balloon expandable stent system, the system are made of foley's tube and balloon expandable stent;2) centrum support device, quantity are n, wherein 1≤n≤10, centrum support device are used to support the centrum that compression fracture occurs;3) propulsion device, propulsion device are used to n centrum support device pushing to centrum inner cavity;And 4) guiding catheter, balloon expandable stent system, centrum support device and propulsion device enter centrum inner cavity by guiding catheter.The vertebral body augmentation formation system of the utility model both can significantly alleviate the pain that compression fracture of vertabral body is brought, bone cement leakage can be reduced again, it can also preferably rather than partly restore vertebral height to solve to restore kyphosis deformity vertebral height, to eliminate deformity of spine, finally weaken the anomalous variation for even being eliminated spinal biomechanics significantly.

Description

Vertebral body augmentation formation system
Technical field
The utility model is related to treat the medical instruments field of compression fracture of vertabral body, relate more specifically to a kind of centrum expansion Open formation system.
Background technology
Compression fracture of vertabral body is the most common complication of spine osteoporosis, is common in the elderly, is mainly in T11-L2, It can cause fracture site pain, vertebral height to be lost, and unstable spine results even in spinal anterior approach.With the state of an illness Development, symptom is mainly shown as the constant pain and backbone limitation of activity at fractured vertebral body position, final serious damage patient Quality of life, even result in death.
The therapy of compression fracture of vertabral body mainly has two aspect of expectant treatment and operative treatment at present.Expectant treatment master To include lying up using analgesic drug product, osteosporosis resistant medicament, brace fixation and rehabilitation etc..Operative treatment is main Strengthen art (PVA) using percutaneous vertebral body, including percutaneous vertbroplasty (abbreviation PVP) and it is percutaneous after convex plasty (or cry percutaneously Balloon kyphoplasty, abbreviation PKP), PVP and PKP treatment osteoporotic vertebral fracture can realize quickly alleviating pain, Restore vertebral height, strengthen fractured vertebral body intensity and rigidity and correct kyphosis deformity.
Percutaneous vertbroplasty (PVP) refers to that bone water is percutaneously injected into centrum by approach outside pedicle of vertebral arch or pedicle of vertebral arch The fillers such as mud increase centrum strength and stability to reach, prevent from collapsing, a kind of lenitive Minimally invasive procedure skill Art.PVP operations are commonly used in because osteoporosis, tumour etc. cause compression fracture of vertabral body or have the patient of risk of bone fracture.It is suitable The disease is answered to be mainly:The fresh compression fracture of Thoracolumbar pure of amyelia and nerve root injury;Oldness Spinal compression Fracture Correction of severe kyphosis and with fracture caused by intractable pain;Secondary to Osteoporotic Vertebral Compression Fractures it is upper, Lower adjacent vertebral multi-segmental compression fracture etc..
PVP operations can be relieved pain significantly, but it is abnormal to eliminate backbone to restore kyphosis deformity vertebral height Shape, thus there are still the anomalous variation of spinal biomechanics, long-term effect is undesirable.PVP bone cements percolation ratio is high, easily occurs Bone cement leaks complication.
Percutaneous kyplasty (PKP), is the improvement and development of percutaneous vertbroplasty, it is in C-arm X-ray machine Perspective percutaneously establishes operation path under guiding by approach outside pedicle of vertebral arch or pedicle of vertebral arch, by an expansiveness sacculus merging wound Vertebra, and make balloon inflation by adjusting compression pump, to achieve the purpose that corpus vertebrae replacement, cavity is formed in centrum, then toward hindering vertebra The fillers such as interior injection bone cement can effectively prevent bone cement risk of leakage, reduce postoperative complication, while also having the portion of reaching Divide and restore to hinder vertebra height, plays the role of correcting kyphosis deformity.The operation is generally used for causing vertebra because of osteoporosis, tumour etc. Body compresses or cavity and leads to the symptoms such as convex after non-neurothlipsis pain, centrum.
The expansible centrums collapsed of PKP, vertebral height is restored in part, and (squeezes surrounding cancellous bone in centrum and cause surrounding For the cavity of bone wall) in form cavity, which is directly used in the filling of bone cement.In this way, filling agent can be thicker, bone cement can To be injected under relatively low pressure, unordered flowing possibility is small, and operating time and Cement fixation amount are increased compared with PVP operations, But the most important danger for being the reduction of bone cement leakage, but PKP still has the risk of leakage.
Bone cement is the medical material for bone surgery, its rectification of name is bone cement, and main component is poly- methyl Methyl acrylate is a high molecular material, has the risk of aging, its mechanical performance can be deteriorated after aging.Inject bone cement Afterwards, bone cement cures in human body, has enough support forces to support centrum, but the elasticity modulus of bone cement is only about skin The 1/8 of matter bone, elasticity is poor cannot to provide physiologic radian required when human body jackknifes, and bone cement heat of polymerization can cause pair Perineural damage.
It also found in clinic:Bone cement is solidificated in centrum, and hardness is too hard and has already taken up the space inside centrum, And especially young its postoperative bone of patient of postoperative patient can be grown, the bone to grow out after operation can with it is existing Cured bone cement, which generates, in operation mutually squeezes, be equivalent to so artificially increased to patient's especially young patient it is new Sufferer and sense of discomfort.
In addition, broken bone easily pierces through sacculus during being shaped with balloon expandable so that even failure is interrupted in expansion operation.
Therefore, this field still lacks a kind of clinical surgical instrument for more preferably treating compression fracture of vertabral body at present.
Utility model content
The purpose of this utility model is to provide a kind of vertebral body augmentation formation system, which both can significantly alleviate vertebra The pain that body compression fracture is brought, and bone cement leakage can be reduced, it can also preferably rather than partly restore vertebral height Come solve restore kyphosis deformity vertebral height, to eliminate deformity of spine, finally significantly weaken even be eliminated spinal biomechanics Anomalous variation.
In the utility model in a first aspect, provide a kind of vertebral body augmentation formation system, specifically, the system comprises
1) balloon expandable stent system, the system are made of foley's tube and balloon expandable stent, in the sacculus The end of conduit is equipped with sacculus, and the external pressure of the sacculus possesses the balloon expandable stent, the balloon expandable stent system After system enters centrum, the balloon expandable, the balloon expandable stent is expanded together with the sacculus, and the sacculus expands It is stayed after formula stent-expansion in the centrum, for protecting the sacculus not worn out by described Intrapyramidal spur etc.;
2) quantity of centrum support device, the centrum support device is n, wherein 1≤n≤10, the centrum support Device is used to support the centrum that compression fracture occurs;
3) propulsion device, the propulsion device are used to the n centrum support devices pushing to centrum inner cavity;And
4) guiding catheter, the balloon expandable stent system, the centrum support device and the propulsion device pass through The guiding catheter enters the centrum inner cavity.
In another preferred example, the centrum support device includes expanding stent and spring ball.
In another preferred example, the expanding stent is engraved structure, and there are multiple wave bars, institute in the surface of the expanding stent The shape for stating wave bar is selected from the group:U-shaped, Z-type (zig-zag type), V-type, W types, N shapes, S-shaped, or combinations thereof;
It is connected by connecting rod between the wave bar, the shape of the connecting rod is selected from the group:Positive S-shaped, reversed S-shaped, U It is shape, N shapes, linear type, V-arrangement, Z-shaped, or combinations thereof;
The connecting rod and the wave bar are attached by connection type selected from the group below:Wave crest connects wave crest, wave Peak connection trough, trough connection trough, the arbitrary point that removes on two wave bar curves other than wave crest and trough is connected or it Combination;
The expanding stent is the memory alloy stent of self-expansion type.
In another preferred example, the expanding stent is cylinder barrel shaped, the spindle bodily form, taper, fusiformis or without fixed shape.
In another preferred example, it is linear when the spring ball is inside the guiding catheter, the spring ball quilt When the push rod is released outside the guiding catheter, the spring ball returns to original state, after the spring ball filling is expanded The centrum inner cavity.
In another preferred example, the system also includes filler syringes, and institute is filled in the n centrum support devices In the state of stating centrum inner cavity, filler is injected into the centrum inner cavity, the filler and institute by the filler syringe It states centrum support device and supports the centrum together.
In another preferred example, centrum support device surface is coated with the material conducive to bone growth.
In another preferred example, include hydroxyapatite, bone generation protein or two conducive to the material of bone growth The mixture of person.
In another preferred example, the propulsion device is foley's tube, scissors-type puopulsion arrangement, claw type propulsion dress It sets, support rod-type propulsion device, screw-driven propulsion device or push rod.
In another preferred example, the shape of the surface wave bar of the balloon expandable stent is selected from the group:U-shaped, Z-type (it Font), W types, N shapes, S-shaped, or combinations thereof;
It is connected by connecting rod between the wave bar, the shape of the connecting rod is selected from the group:Positive S-shaped, reversed S-shaped, U It is shape, N shapes, linear type, V-arrangement, Z-shaped, or combinations thereof;
The connecting rod and the wave bar are attached by connection type selected from the group below:Wave crest connects wave crest, wave Peak connection trough, trough connection trough, the arbitrary point that removes on two wave bar curves other than wave crest and trough is connected or it Combination.In another preferred example, the expanding stent is made of the good metal material of medical bioavailability, especially nickel The metals such as titanium, tantalum.
In another preferred example, the material of the spring ball is memorial alloy (such as NiTi).
In another preferred example, the centrum support device (expanding stent and spring ball) is elastomer.
In another preferred example, the filler is liquid.
In another preferred example, the filler is solid matter.
In another preferred example, the filler is bone cement.
In another preferred example, the filler is the biomaterial of bone tissue growth in the induction centrum.
In another preferred example, the filler is steel ball or steel wire lump.
In another preferred example, the steel ball is solid or hollow.
In another preferred example, the filler is the mixture of any of the above liquid.
In another preferred example, the filler is the mixture of any of the above solid matter.
In another preferred example, the filler is the mixing of any of the above liquid and any of the above solid matter Object.
In another preferred example, the filler is injected under low pressure.
In another preferred example, not under by outer force effect, the maximum outside diameter when expanding stent expands naturally is L, The height of the centrum in normal state is H, and L > H.
In another preferred example, not under by outer force effect, the expander that a spring ball of n (1≤n≤10) is formed exists Maximum outside diameter when expanding naturally is D, and the height of the centrum in normal state is H, and D > H.
In another preferred example, L >=0.5cm;Preferably, 4-10cm;More preferably, 5-7cm.
In another preferred example, the wall thickness of the expanding stent is 50 μm of -5mm;Preferably, 0.1mm-2mm;More preferably, 0.2mm-1.2mm。
In another preferred example, when spring ball pulls into linear, linear outer diameter is less than 5mm;Preferably, 0.1mm- 3mm;More preferably, 0.1mm-1mm.
In another preferred example, it is not less than with certain elastic force, pressure when the centrum support device expansion 130kpa。
In another preferred example, the balloon portion is the sacculus of a non-compliance, semi-compliant or compliance.
In another preferred example, the seal wire and the guiding catheter are straight or curved, for assisting the sacculus Enter in the centrum with the holder.
In another preferred example, the spring and the push rod are integrated, the junctions of the spring and the push rod Diameter be less than the spring spring wire diameter and the push rod diameter, and the junction of the spring and the push rod It is disconnected in such a way that electric smelting is disconnected.
In another preferred example, in the junction of the spring and the push rod, one end of the spring wire is to be embedded in The mode for stating one end of push rod is assembled.
In another preferred example, the spring and push rod embedded mode assembly, the push rod is hollow structure, is passed through It is filled with fluid in the middle vacancy of the push rod so that the spring is detached from the push rod.
In another preferred example, the spring and push rod embedded mode assembly, the push rod is hollow structure, is passed through It is pushed in one metal in the middle vacancy of the push rod or the plug of other hard materials so that the spring is de- with the push rod From.
In another preferred example, it is added in the centrum and helps support object, it is described to help support object and the centrum support device one Play the support centrum inner cavity.
In another preferred example, described to help support object for following any substance or combinations thereof:Bone cement, steel ball, steel wire lump, and Conducive to the biomaterial of bone growth.
In another preferred example, when it is described help support the object for the benefit of biomaterial of bone growth when, it is described help support object can On surface coated in the centrum support device, enter the centrum inner cavity together with the centrum support device;And/or After the centrum support device enters the centrum inner cavity, pass through centrum inner cavity described in filler syringe injection fillers.
In another preferred example, when being pushed into the holder by the sacculus, inside the guiding catheter, adjacent two Space between a holder should be greater than the length of the sacculus.
In the second aspect of the utility model, a kind of centrum supporting support expansion formation system is provided, it is specifically, described System includes
Balloon expandable stent system, the balloon expandable stent system are made of foley's tube and balloon expandable stent, It is equipped with sacculus in the end of the foley's tube, the external pressure of the sacculus possesses the balloon expandable stent, the sacculus After expandable stent system enters the centrum, the balloon expandable, the balloon expandable stent with the sacculus together Expansion is stayed after the stent-expansion in the centrum, for protecting the sacculus not worn out by described Intrapyramidal spur etc.;
Expanding stent, the expanding stent are self-expansion type holder, and the expanding stent is engraved structure, and the expansion The quantity of holder is n, wherein 1≤n≤10, the expanding stent are used to support the centrum;
Propulsion device, the propulsion device are used to the n expanding stents pushing to the centrum inner cavity;
Guiding catheter, the balloon expandable stent system, the expanding stent and the propulsion device pass through described draw Conduit enters the centrum inner cavity;And
Filler syringe, in the state that the n expanding stents fill the centrum inner cavity, the filler injection Filler is injected into the centrum inner cavity by device, and the filler and the expanding stent support the centrum inner cavity together.
In the third aspect of the utility model, a kind of centrum support expansion healing system, specifically, the system are provided Including
Balloon expandable stent system, the balloon expandable stent system are made of foley's tube and balloon expandable stent, It is equipped with sacculus in the end of the foley's tube, the external pressure of the sacculus possesses the balloon expandable stent, the sacculus After expandable stent system enters the centrum, the balloon expandable, the balloon expandable stent with the sacculus together Expansion is stayed after the stent-expansion in the centrum, for protecting the sacculus not worn out by described Intrapyramidal spur etc.;
Expanding stent, the expanding stent are self-expansion type holder, and the expanding stent is engraved structure, and the expansion The quantity of holder is n, wherein 1≤n≤10, the expanding stent surface is coated with the material conducive to bone growth, described Expanding stent is used to support the centrum inner cavity;
Propulsion device, the propulsion device are used to the n expanding stents pushing to the centrum inner cavity;And
Guiding catheter, the balloon expandable stent system, the expanding stent and the propulsion device pass through described draw Conduit enters the centrum inner cavity.
In the fourth aspect of the utility model, a kind of centrum spring ball expansion formation system, specifically, the system are provided System includes
Balloon expandable stent system, the balloon expandable stent system are made of foley's tube and balloon expandable stent, It is equipped with sacculus in the end of the foley's tube, the external pressure of the sacculus possesses the balloon expandable stent, the sacculus After expandable stent system enters the centrum, the balloon expandable, the balloon expandable stent with the sacculus together Expansion is stayed after the stent-expansion in the centrum, for protecting the sacculus not worn out by described Intrapyramidal spur etc.;
Guiding catheter, the balloon expandable stent system enter the centrum inner cavity by the guiding catheter;And
Spring push-rod, the spring push-rod include spring and push rod, and the spring push-rod is entered by the guiding catheter The centrum inner cavity is linear when the spring is inside the guiding catheter, and the spring releases institute by the push rod When stating outside guiding catheter, the spring returns to original state and forms spring ball, and the spring ball is filled in the centrum after being expanded Chamber;And
Filler syringe, in the state that the spring ball fills the centrum inner cavity, the filler syringe will Filler is injected into the centrum inner cavity, and the filler and the spring ball support the centrum inner cavity together.
At the 5th aspect of the utility model, a kind of centrum spring ball expansion healing system, specifically, the system are provided System includes
Balloon expandable stent system, the balloon expandable stent system are made of foley's tube and balloon expandable stent, It is equipped with sacculus in the end of the foley's tube, the external pressure of the sacculus possesses the balloon expandable stent, the sacculus After expandable stent system enters the centrum, the balloon expandable, the balloon expandable stent with the sacculus together Expansion is stayed after the stent-expansion in the centrum, for protecting the sacculus not worn out by described Intrapyramidal spur etc.;
Guiding catheter, the balloon expandable stent system enter the centrum inner cavity by the guiding catheter;And
Spring push-rod, the spring push-rod include spring and push rod, and the spring push-rod is entered by the guiding catheter The centrum inner cavity is linear when the spring is inside the guiding catheter, and the spring releases institute by the push rod When stating outside guiding catheter, the spring returns to original state and forms spring ball, and the spring ball is filled in the centrum after being expanded Chamber, and the spring ball surface is coated with the material conducive to bone growth.
It should be understood that in the scope of the utility model, above-mentioned each technical characteristic of the utility model and below (such as implementation Example) in specifically describe each technical characteristic between can be combined with each other, to form a new or preferred technical solution.It is limited to Length, not repeated them here.
Description of the drawings
In order to illustrate the embodiment of the utility model or the technical proposal in the existing technology more clearly, below will be to embodiment Or attached drawing needed to be used in the description of the prior art does and simply introduces, it should be apparent that, the accompanying drawings in the following description is only It is some embodiments of the utility model, for those of ordinary skill in the art, in the premise not made the creative labor Under, other drawings may also be obtained based on these drawings.
Fig. 1 a are that balloon expandable stent in one example of the utility model and sacculus are pushed out guiding catheter, and sacculus Structural schematic diagram when expanding holder and unexpanded sacculus.
Fig. 1 b are balloon expandable stent and sacculus stretching guiding catheter in one example of the utility model, and sacculus expands Open the structural schematic diagram after formula holder and balloon expandable.
Fig. 1 c are that the centrum of the generation compression fracture in one example of the utility model is filled by balloon expandable stent When structural schematic diagram.
Fig. 2 a are the balloon expandable stent structural schematic diagrams under natural conditions in one example of the utility model.
Fig. 2 b are the balloon expandable stent structural representations under by external force compressive state in one example of the utility model Figure.
Fig. 3 be balloon expandable stent in one example of the utility model and sacculus in guiding catheter when structure show It is intended to.
Fig. 4 is part A in Fig. 3, i.e., the enlarged drawing of balloon expandable stent and sacculus in guiding catheter.
Fig. 5 a are the structural schematic diagrams of the self-expansion type stent-expansion state in one example of the utility model.
Fig. 5 b are the structural schematic diagrams of the self-expansion type holder compressive state in one example of the utility model.
Fig. 6 a are the linear type elastic curves of self-expansion type holder/spring ball expander in one example of the utility model Figure.
Fig. 6 b are the decrescence type elastic curves of self-expansion type holder/spring ball expander in one example of the utility model Figure.
Fig. 6 c are the cumulative type elastic curves of self-expansion type holder/spring ball expander in one example of the utility model Figure.
Structural representation when Fig. 7 a are the self-expansion type holder part stretching guiding catheters in one example of the utility model Figure.
Structural representation when Fig. 7 b are the self-expansion type holder whole stretching guiding catheters in one example of the utility model Figure.
Fig. 8 is that four self-expansion type holders in one example of the utility model are placed in centrum by guiding catheter and sacculus The structural schematic diagram of inner cavity.
Fig. 9 a are that four self-expansion type holders in one example of the utility model are promoted by guiding catheter and scissors-type Mechanical device is placed in the structural schematic diagram of centrum inner cavity.
Fig. 9 b are the enlarged drawings of part B in Fig. 9 a.
Fig. 9 c are the enlarged drawings of C portion in Fig. 9 a.
Figure 10 a are that the structure of the front end pawl of the claw type propulsion device in one example of the utility model in a contracted state is shown It is intended to.
Structural representation when Figure 10 b are the front end pawl projected claw sets of the claw type propulsion device in one example of the utility model Figure.
Figure 10 c are the enlarged drawings of the parts D in Figure 10 a.
Figure 10 d are the enlarged drawings of the parts E in Figure 10 a.
Figure 10 e are the enlarged drawings of the parts F in Figure 10 b.
Figure 10 f are the enlarged drawings of the parts G in Figure 10 b.
Figure 10 g are that four self-expansion type holders in one example of the utility model promote dress by guiding catheter and claw type It is placed in centrum inner cavity, and structural schematic diagram when claw type push rod is in contraction state.
Figure 10 h are that four self-expansion type holders in one example of the utility model promote dress by guiding catheter and claw type It is placed in centrum inner cavity, and structural schematic diagram when claw type push rod is in expansion state.
Figure 11 a are knots when support rod-type propulsion device front end in one example of the utility model is in non-softened state Structure schematic diagram.
Figure 11 b are the structural schematic diagrams after the support rod-type propulsion device front end in one example of the utility model struts.
Figure 11 c are that four self-expansion type holders in one example of the utility model are pushed away by guiding catheter and support rod-type Structural schematic diagram when being placed in centrum inner cavity into device, and rod-type propulsion device front end being supported to be in non-softened state.
Figure 11 d are that four self-expansion type holders in one example of the utility model are pushed away by guiding catheter and support rod-type Structural schematic diagram into device merging centrum inner cavity, and after supporting rod-type propulsion device front end to strut.
Figure 12 a are the signals of four self-expansion type holders merging centrum inner cavity process in one example of the utility model Figure.
Figure 12 b are the structural representations behind four self-expansion type holders merging centrum inner cavity in one example of the utility model Figure.
Figure 12 c are the left views of four self-expansion type holders behind the merging centrum inner cavity in one example of the utility model Figure.
Figure 13 a are the structural schematic diagrams of the filler syringe equipped with filler in one example of the utility model.
Figure 13 b are that the filler syringe equipped with filler in one example of the utility model enters the structure of centrum and shows It is intended to.
Figure 13 c are that the packing material in one example of the utility model fills showing inside centrum by filler syringe It is intended to.
Figure 14 a are the structures when spring ball in one example of the utility model is located at lines state inside guiding catheter Schematic diagram.
Figure 14 b are to restore spherical structural representation after the spring ball in one example of the utility model is pushed out guiding catheter Figure.
Figure 15 a are the structural schematic diagrams of three spring balls filling centrum inner cavity in one example of the utility model.
Figure 15 b are the structural schematic diagrams of six spring balls filling centrum inner cavity in one example of the utility model.
Figure 16 a are spring balls in one example of the utility model in a manner of fusing and structural representation that push rod is detached from Figure.
Figure 16 b are that the spring ball in one example of the utility model shows in such a way that fluid extrudes with the structure of push rod disengaging It is intended to.
Figure 16 c are the enlarged drawings of the parts H of Figure 16 b.
Figure 16 d are that the spring ball in one example of the utility model shows in such a way that plug pushes with the structure of push rod disengaging It is intended to.
Figure 16 e are the enlarged drawings of the parts I of Figure 16 b.
Figure 17 a are cuing open for worm drive propulsion device one self-expansion type holder of release in one example of the utility model View.
Figure 17 b are cuing open for worm drive propulsion device three self-expansion type holders of release in one example of the utility model View.
In each attached drawing, each mark is as follows:
1- foley's tubes;
2- sacculus;
4- guiding catheters;
5- seal wires;
6- balloon expandable stents;
7- self-expansion type holders;
8- centrums;
9- scissors-type mechanical devices;
10- push blocks;
11- push rods;
The outer loop bar handles of 12-;
13- springs;
14- claw type propulsion devices;
15- pawls;
16- rotating handles;
17- pawl sets;
18- supports rod-type propulsion device;
19- support elements;
20- rotating handles;
21- filler syringes;
22- spring balls;
23- plugs;
24- screw-driven propulsion devices.
Specific implementation mode
The present inventor after extensive and in-depth study, by largely screening, develops a kind of vertebral body augmentation forming for the first time System, compared with prior art, the vertebral body augmentation formation system of the utility model is at the centrum that compression fracture occurs, in C After shape arm X-ray machine perspective percutaneously establishes operation path under guiding by approach outside pedicle of vertebral arch or pedicle of vertebral arch, first balloon expandable stent System expands centrum, multiple centrum support devices is then filled into centrum inner cavity, and inject filler in centrum inner cavity, made It obtains centrum support device and filler supports centrum inner cavity together, support device is made more to meet ergonomics, support is more stable, branch It is more preferable to support effect, completes the utility model on this basis.
The utility model provides a kind of vertebral body augmentation formation system, it is a kind of a kind of centrum expansion with specific structure Open formation system.
The vertebral body augmentation formation system includes balloon expandable stent system, centrum support device, propulsion device and guiding Conduit.Balloon expandable stent system is entered by seal wire and/or guiding catheter in centrum;Balloon expandable makes balloon expandable stent It is shaped with vertebral body augmentation, foley's tube exits outside human body after the completion of expansion, balloon expandable stent stays in human body;Propulsion device By centrum support device out of guiding catheter push-in centrum, it is used to support the centrum that compression fracture occurs, can also will be filled Object is injected into the centrum inner cavity after expansion, and/or is coated with the material conducive to bone growth on centrum support device surface.
Specifically, the vertebral body augmentation formation system of the utility model first will carry out centrum to the centrum that compression fracture occurs Expansion, for example entered in centrum by balloon expandable stent system (being composed of foley's tube and balloon expandable stent) Then to vertebral body augmentation.Balloon expandable stent is wrapped in the outside of sacculus, controls the sky of balloon expandable stent hollow-out part Gap size keeps the gap of balloon expandable stent hollow-out part sufficiently small, because having the barrier of balloon expandable stent, sacculus not to be It is in direct contact centrum inner cavity and centrum inner cavity includes solid matter in centrum including broken bone, to the solids such as broken bone in centrum Substance is not easy to be in direct contact sacculus and puncture sacculus, reduces the danger that sacculus is ruptured by extraneous factor, improves the disposable of operation Success rate, the time for shortening operation.
To that can be placed in multiple centrum support devices after the completion of vertebral body augmentation, which includes expanding stent And/or spring ball.The expanding stent is self-expansion type holder, and expanding stent is using the good metal material of medical bioavailability It makes, especially the metals such as NiTi, tantalum.Expanding stent clogs most of space of centrum inner cavity to support centrum, such centrum Due to there is the support of self-expansion type holder after expansion, the centrum after expansion will not bounce back or amount of recovery very little.Spring ball is using note Recall alloy (such as NiTi) to make.Spring ball is entwined by an elongated memorial alloy item, spring ball under external force its Memorial alloy item can be by again moulding, for example is shaped into linear.Before being placed in human body, spring ball is by first moulding at linear State is placed in guiding catheter, is placed in guiding catheter and is pushed into centrum in a manner of linear, then from guiding catheter Middle release lines spring, spring are rewound into spring ball.
After being placed in multiple centrum support devices in centrum, can at low pressures it be injected with injection fillers object, filler, Filler can be liquid, and such as the biomaterial of bone tissue growth in bone cement or induction centrum, liquid filler finally exists Solidification in centrum.Packing material can also be solid matter, and such as steel ball or steel wire lump, steel ball can be solid or hollow 's.Packing material can also be the mixture of any of the above liquid, can also be the mixture of any of the above solid matter, It can also be the mixture of any of the above liquid and any of the above solid matter.With packing material syringe by packing material It is injected into centrum, filler is filled since centrum inner most centrum support device inner cavity, and passes through centrum support device Gap toward centrum support device perimetric penetration, diffusion, be finally wrapped in centrum support device, filler and centrum support device Centrum is filled together.It is controlled due to there is multilayer centrum support device, and to the pore size of centrum support device, makes filling Object is slowly permeated inside centrum support device, is spread, and finally substantially reduces the risk that filler leaks into its hetero-organization.
Balloon expandable stent or centrum supporting support (part for being especially close to centrum or more vertebral plate) surface coating Be conducive to the material of bone growth, such as hydroxyapatite, bone generation protein or hydroxyapatite and bone generation protein etc. The mixture of many kinds of substance.Induction human body bone melts towards centrum support device (expanding stent or spring ball) growth inside and with it It is integrated.
The major advantage of the utility model includes:
(a) centrum support device has gap structure, and filler is injected at low pressures, by centrum support device after injection Gap structure limitation and permeate, spread slowly, greatly reduce filler especially liquid filler material leak risk, reduction Postoperative complication.
(b) compared to sacculus is used alone, the centrum support device of the utility model is elastomer, and the centrum of reset is in ball Capsule is withdrawn from after human body because the support of centrum support device does not bounce back or amount of recovery is few, can effectively be reached recovery and be hindered vertebra height, is risen To the effect for correcting kyphosis deformity.
(c) existing percutaneous rear convex plasty (or being Percutaneous kyplasty, abbreviation PKP), is present in after operation Intrapyramidal 100% is bone cement;And the utility model operation after finally there are in it is Intrapyramidal be filler and metal centrum The mixture of support device.In the mixture, metal centrum support device accounts for entire centrum filling spatial volume and is arrived for 5% 95%, preferably 30% to 60%.The mixture is than simple strength of bone cement bigger, after operation more to the support effect of centrum It is good.
(d) replace bone cement to go inside filling centrum with other biological material, cure together with centrum support device One mechanism with physiologic radian of composition, the radian are adapted to the daily bending of human body.
(e) bone cement is high molecular material meeting aging, mechanical degradation after its final aging of simple Cement, branch Support force is insufficient, and can be to avoid such risk with other biological material.
(f) to the surface treatment of centrum support device, i.e., induction bone tissue growth is coated on the surface of centrum support device The growth of biomaterial, induction centrum inner bone tissues especially induces bone tissue to grow into centrum support device.It handles, expands in this way It is the mixture of centrum support device and area of new bone in centrum after, since existing area of new bone has metal centrum support dress again It sets, it is again flexible to the existing support force of centrum, required physiologic radian when human body jackknifes is provided.
(g) in initial vertebral body augmentation, foley's tube expands centrum together with balloon expandable stent, the balloon-expandable Holder is wrapped in outside sacculus, to protect sacculus to be not easy to be punctured by sharp objects such as broken bones.
With reference to specific embodiment, the utility model is expanded on further.It should be understood that these embodiments are merely to illustrate this Utility model rather than limitation the scope of the utility model.In addition, attached drawing is schematic diagram, therefore utility model device and set Standby is not limited by the size or ratio of the schematic diagram.
It should be noted that in the claim and specification of this patent, such as "front", "rear", " front end " and " after The position relationship term at end " etc is known as close to one end of centrum " preceding for the centrum that compression fracture occurs End ", one end far from centrum are known as " rear end ", are used merely to distinguish an entity with another entity, and statement is more It is convenient, but also the content of the utility model more easily understands, exist without necessarily requiring or implying between these entities Any actual relationship or order.Relational terms such as first and second and the like be used merely to an entity or Person operates to be distinguished with another entity or operation, is appointed without necessarily requiring or implying existing between these entities or operation What this actual relationship or sequence.Moreover, the terms "include", "comprise" or its any other variant are intended to non-row His property includes, so that the process, method, article or equipment including a series of elements includes not only those elements, and And further include other elements that are not explicitly listed, or further include for this process, method, article or equipment institute it is intrinsic Element.In the absence of more restrictions, the element limited by sentence " including one ", it is not excluded that wanted including described There is also other identical elements in the process, method, article or equipment of element.
Embodiment 1
The vertebral body augmentation formation system of the present embodiment is as shown in Fig. 1 a-13c and Figure 17 a-17b.It is had an X-rayed in C-arm X-ray machine After percutaneously establishing operation path by approach outside pedicle of vertebral arch or pedicle of vertebral arch under guide, the centrum 8 of the present embodiment expands formation system First the centrum 8 that compression fracture occurs is expanded, as shown in Fig. 1 a-5b, the present embodiment is by by foley's tube 1 and ball Then the 2 expandable stent system of sacculus that capsule expanding holder 6 is composed, which enters in centrum 8, to be expanded centrum 8.Balloon expandable Formula holder 6 is wrapped in the outside of sacculus 2, and the pore size of control 6 hollow-out part of balloon expandable stent makes balloon-expandable branch The gap of 6 hollow-out part of frame is sufficiently small, is not to be in direct contact 8 inner cavity of centrum because having the barrier of balloon expandable stent 6, sacculus 2 And 8 inner cavity of centrum includes the solid matter in centrum 8 including broken bone, to which the solid matters such as broken bone are not easy directly in centrum 8 It contacts sacculus 2 and punctures sacculus 2, reduce the danger that sacculus 2 is ruptured by extraneous factor, improve once success rate, the contracting of operation The time of short operation.Wherein, foley's tube 1 can tolerate high pressure, and the sacculus 2 in foley's tube 1 is the sacculus of a semi-compliant 2。
Above-mentioned 2 expandable stent system of sacculus is moved ahead and reaches in 4 inner cavity of guiding catheter under the assistance of guiding seal wire 5 It needs to expand 8 inner cavity of centrum.Seal wire 5 and guiding catheter 4 are flexible, for assisting sacculus 2 and balloon expandable stent 6 to enter In centrum 8.After arrival, balloon expandable stent system is expanded, and then centrum 8 is strutted, and is strutted the expected centrum 8 of arrival and is expanded Are come back to by unexpanded state and is shunk for 2 release of sacculus, sacculus 2 after Zhang Xiaoguo, foley's tube 1 withdraws from centrum 8 in vitro.Tool Body, balloon expandable stent 6, foley's tube 1, guiding seal wire 5 and 4 entirety of guiding catheter enter centrum 8 together, then sacculus Expanding holder 6, guiding seal wire 5 and 1 opposing vertebral body 8 of foley's tube remain stationary as, and the recession of guiding catheter 4 is until balloon-expandable Guiding catheter 4 is all stretched out in holder 6,2 part of sacculus, at this moment pressurizes, and sacculus 2 is expanded, and then balloon expandable stent 6 is also expanded It is tightly attached to inside centrum 8,2 release of sacculus after the completion of expansion shrinks and withdraws from centrum 8.After balloon expandable stent 6 is due to expansion Will not bounce back rebound, be attached to 8 inner wall of centrum.After the completion of expanding in this way, foley's tube 1 withdraws from external, balloon expandable stent 6 It stays in centrum 8.
After the completion of being expanded to centrum 8, four expanding stents are placed in, which is self-expansion type holder 7, can be cylinder Tubular has the engraved structures such as mesh.Four self-expansion type holders 7 fill the space of 8 inner cavity of centrum to support centrum 8.In this way Due to there is the support of self-expansion type holder 7 after the expansion of centrum 8, the centrum 8 after expansion will not bounce back or amount of recovery very little.Merging is certainly When expansion type holder 7, four self-expansion type holders 7 are placed in by compression inside guiding catheter 4 under the effect of external force, and it is adjacent from Spacing between expansion type holder 7 is more than the length of support pushing device.Guiding catheter 4 gos deep into inside centrum 8, works as in-position Afterwards, as shown in Fig. 7 a-7b, support pushing device is located at first 7 rear of self-expansion type holder and remains stationary as, after guiding catheter 4 It removes and the self-expansion type holder 7 under first compressive state is made to stretch out 4 outside of guiding catheter and 8 inner cavity of intumescent filler centrum, by It does not bounce back in having memory function, first expansion of self-expansion type holder 7 and has the tendency that returning to original state and then generate support force Support centrum 8.Then, support pushing device falls back on the rear of next self-expansion type holder 7, repeats aforesaid operations until whole Self-expansion type holder 7 fills 8 inner cavity of centrum, and multiple self-expandings can be subsequently placed in as needed when 8 inner cavity gap of centrum is larger Formula holder 7.The present embodiment is placed in four self-expansion type holders 7 altogether.
As shown in figure 8, self-expansion type holder 7 can be pushed by foley's tube 1.Specifically, it would be desirable to be placed in centrum 8 Four self-expansion type holders 7 are positioned over inside guiding catheter 4, and the space between two neighboring self-expansion type holder 7 should be greater than ball The length of capsule 2.Guiding catheter 4 is put into the centrum 8 for needing to expand, and ensures that guiding catheter 4 has been placed in before being placed on Intracavitary in the balloon expandable stent 6 of centrum 8, sacculus 2 enter 4 inner cavity of guiding catheter and positioned at the self-expansion type branch for needing to be pushed into The rear of frame 7, dilating sacculus 2, then sacculus 2 is motionless, and guiding catheter 4 is dropped back so that self-expansion type holder 7 reaches guiding and leads 4 outside of pipe and 8 inner cavity of intumescent filler centrum;Then sacculus 2 bounces back, and falls back on next self-expansion type branch in guiding catheter 4 The rear of frame 7.It is repeatedly placed in self-expansion type holder 7 as needed according to the operation of front.
In another preferred example, as shown in figures 9 a-9 c, self-expansion type holder can be pushed by scissors-type mechanical device 9 7.Specifically, it would be desirable to which four self-expansion type holders 7 for being placed in centrum 8 are positioned over inside guiding catheter 4, and two neighboring from swollen Space between expanding holder 7 should be greater than the length of 9 pushing block 10 of scissors-type mechanical device.Guiding catheter 4 is put into what needs were expanded In centrum 8, and ensure that guiding catheter 4 has been placed in intracavitary in the balloon expandable stent 6 of centrum 8, scissors-type before being placed on Mechanical device 9 enters 4 inner cavity of guiding catheter and positioned at the rear for the self-expansion type holder 7 for needing to be pushed into, after pressure holds mechanical device Two outer loop bar handles 12 in portion so that the distance between two outer loop bar handles 12 become smaller, and then push rod 11 is pushed to advance, into And device transmission so that front two push blocks 10 open expand, be expanded to after the comparable distance in 4 inner cavity of guiding catheter, Scissors-type mechanical device 9 is motionless, and guiding catheter 4 is dropped back so that self-expansion type holder 7 reaches 4 outside of guiding catheter and expansion is filled out Fill 8 inner cavity of centrum;Then loosen two outer loop bar handles 12 at 9 rear portion of scissors-type mechanical device that pressure is held, the spring between handle 13 spring back so that being moved after push rod 11, and mechanical transmission makes two push blocks 10 bounce back, and the diminution of push block 10 backs to guiding and leads The rear of next self-expansion type holder 7 in pipe 4.It is repeatedly placed in self-expansion type holder 7 as needed according to the operation of front.
In another preferred example, as shown in Figure 10 a-10h, self-expansion type holder can be pushed by claw type propulsion device 14 7.Specifically, it would be desirable to which four self-expansion type holders 7 for being placed in centrum 8 are positioned over inside guiding catheter 4, two neighboring self-expanding Space between formula holder 7 should be greater than claw type propulsion device 14 and expand required space.First ensure the front end pawl of claw type propulsion device 14 15 contraction states, then guiding catheter 4 is put into the centrum 8 for needing to expand, and ensures that guiding catheter 4 has been placed in before Intracavitary in the balloon expandable stent 6 of centrum 8, claw type propulsion device 14, which enters 4 inner cavity of guiding catheter and is located at, to be needed to be pushed into Self-expansion type holder 7 rear.Rotate the rotating handle 16 of 14 rear end of claw type propulsion device so that 15 projected claw of front end pawl set 17, Then claw type propulsion device 14 is motionless, and it is outside guiding catheter 4 and swollen that the recession of guiding catheter 4 so that self-expansion type holder 7 reaches Swollen 8 inner cavity of filling centrum;Then the rotating handle 16 of 14 rear end of negative direction rotation claw type propulsion device so that front end pawl 15 is retracted pawl set 17 and claw type propulsion device 14 is fallen back on to the rear of next self-expansion type holder 7 in guiding catheter 4.According to the operation root of front It is repeatedly placed in self-expansion type holder 7 according to needs.
It in another preferred example, can be by supporting rod-type propulsion device 18 to be pushed into self-expansion type as shown in Figure 11 a-11d Holder 7.Specifically, it would be desirable to which four self-expansion type holders 7 for being placed in centrum 8 are positioned over inside guiding catheter 4, and two neighboring Space between self-expansion type holder 7 should be greater than support rod-type propulsion device 18 and expand required space.First ensure that support rod-type promotes The front end support 19 of device 18 is in contraction state, is then put into the centrum 8 for needing to expand by guiding catheter 4, and Ensure the intracavitary in the balloon expandable stent 6 for having been placed in centrum 8 before of guiding catheter 4, support rod-type propulsion device 18 Into 4 inner cavity of guiding catheter and positioned at the rear for the self-expansion type holder 7 for needing to be pushed into.After rotation support rod-type propulsion device 18 The rotating handle 20 at end so that its front end support 19 struts, and then supports rod-type propulsion device 18 motionless, after guiding catheter 4 It removes so that self-expansion type holder 7 reaches 4 outside of guiding catheter and 8 inner cavity of intumescent filler centrum;Then negative direction rotation support The rotating handle 20 of 18 rear end of rod-type propulsion device so that front end support 19 shrinks and will support rod-type propulsion device 18 again Fall back on the rear of next self-expansion type holder 7 in guiding catheter 4.It is repeatedly placed in self-expanding as needed according to the operation of front Formula holder 7.
In another preferred example, self-expansion type holder 7 can be pushed by screw-driven propulsion device 22.Specifically, such as Shown in Figure 17 a, screw-driven propulsion device 22 only has single layer cavity, and the single layer cavity is interior, and there are one the self-expansion type branch compressed Frame 7, the rotating handle at 22 rear portion of rotation screw-driven propulsion device, self-expansion type holder 7 are pushed out screw-driven propulsion device 22 And enter centrum 8.As illustrated in fig. 17b, screw-driven propulsion device 22 is there are three layers of cavity, and each in every layer of cavity there are one compressions Good self-expansion type holder 7, the rotating handle at 22 rear portion of rotation screw-driven propulsion device so that outermost self-expansion type holder 7 are pushed out screw-driven propulsion device 22 and enter centrum 8 at first, then the self-expansion type holder 7 of each layer successively from outside to inside It is pushed out screw-driven propulsion device 22 and enters centrum 8.As shown in Figure 12 a-12c, final three self-expansion type holders 7 are successively Into 8 inner cavity of centrum.
As shown in Figure 13 a-13c, 21 injection fillers object of filler syringe, the filler are passed through to the centrum 8 after expansion It is the liquefied mixture of the biomaterial of bone tissue growth in bone cement and induction centrum 8.Material will be filled with packing material syringe Material is injected into centrum 8, and filler is filled since 8 inner most 7 inner cavity of self-expansion type holder of centrum, and passes through self-expansion type Gap on holder 7 is finally wrapped in self-expansion type holder 7 toward 7 perimetric penetration of self-expansion type holder, after solidification with self-expansion type Holder 7 fills 8 inner cavity of centrum after expansion together.Due to there is multilayer self-expansion type holder 7, and to 7 hollow out of self-expansion type holder Partial pore size is controlled, and infiltration, the diffusion of filler are limited by self-expansion type holder 7, in self-expansion type branch Slowly infiltration, the diffusion of 7 inside of frame, finally substantially reduces filler and leaks into the risk of its hetero-organization, while reducing by leaking Cause the risk of complication.Before filler solidification, filler syringe 21 is quickly withdrawn, operation is completed.After a period of time, liquid State filler cures, and self-expansion type holder 7 is together with the liquid filler material after solidification, to compression fracture occurs in centrum 8 Centrum 8 be supported.Compared to former only bone cement after 8 inner support centrum 8 of centrum, self-expansion type holder 7 and solidification Centrum 8 is supported liquid filler material together, and support force is stronger, support is more stable, and support effect is more preferable.
As shown in fig. 6a-6c, the elastic curve of self-expansion type holder 7 can be linear, can also be decrescence type, It can also be cumulative type.Wherein, " L " is maximum outside diameter of the self-expansion type holder 7 when not expanded naturally under by outer force effect; " L1 " is least limit outer diameter of the self-expansion type holder 7 under compression force effect.
It is subnormal that maximum outside diameter L when self-expansion type holder 7 expands naturally under the action of not by external force is more than centrum 8 Cavity heights, the L in the present embodiment is 6cm.The thickness of self-expansion type holder 7 is 0.2mm.Self-expansion type holder 7 has when expanding There is certain elastic force, and its pressure is not less than 130kpa.
In another preferred example, the surface of self-expansion type holder 7 is handled, i.e., is coated on its surface and is conducive to bone group The biomaterial of growth is knitted, the part for being close to about 8 vertebral plate of centrum is especially coated in, induces the life of 8 inner bone tissues of centrum Long especially induction human body bone combines towards 7 growth inside of self-expansion type holder and with it.The biomaterial can be hydroxyl Base apatite or bone generation protein etc. can also be the mixture of many kinds of substance such as hydroxyapatite and bone generation protein.Locate in this way It manages, is the mixture of self-expansion type holder 7 and area of new bone in the centrum 8 after expansion, since existing area of new bone has self-expansion type again Holder 7, it is again flexible to 8 existing support force of centrum, required physiologic radian when human body jackknifes is provided.
Embodiment 2
The centrum 8 of the present embodiment expand formation system be also in the case where C-arm X-ray machine perspective is guided percutaneously by pedicle of vertebral arch or After the outer approach of pedicle of vertebral arch establishes operation path, first the centrum 8 that compression fracture occurs is expanded, as shown in Fig. 1 a-5b, this Embodiment is to enter centrum by the 2 expandable stent system of sacculus being composed of foley's tube 1 and balloon expandable stent 6 Then centrum 8 is expanded in 8.Balloon expandable stent 6 is wrapped in the outside of sacculus 2, controls 6 hollow-out parts of balloon expandable stent The pore size divided keeps the gap of 6 hollow-out part of balloon expandable stent sufficiently small, because there is the barrier of balloon expandable stent 6, Sacculus 2 is not to be in direct contact 8 inner cavity of centrum and 8 inner cavity of centrum includes solid matter in centrum 8 including broken bone, to centrum The solid matters such as broken bone are not easy to be in direct contact sacculus 2 and puncture sacculus 2 in 8, reduce the danger that sacculus 2 is ruptured by extraneous factor, It improves the once success rate of operation, shorten the time of operation.Wherein, foley's tube 1 can tolerate high pressure, in foley's tube 1 Sacculus 2 is the sacculus 2 of a semi-compliant.
Above-mentioned 2 expandable stent system of sacculus is moved ahead and reaches in 4 inner cavity of guiding catheter under the assistance of guiding seal wire 5 It needs to expand 8 inner cavity of centrum.Seal wire 5 and guiding catheter 4 are flexible, for assisting sacculus 2 and balloon expandable stent 6 to enter In centrum 8.After arrival, 2 expandable stent system of sacculus is expanded, and then centrum 8 is strutted, and struts centrum 8 expected from arrival Are come back to by unexpanded state and is shunk for 2 release of sacculus, sacculus 2 after expansion effect, foley's tube 1 withdraws from centrum 8 in vitro. Specifically, balloon expandable stent 6, foley's tube 1, guiding seal wire 5 and 4 entirety of guiding catheter enter centrum 8 together, then ball Capsule expanding holder 6, guiding seal wire 5 and 1 opposing vertebral body 8 of foley's tube remain stationary as, and the recession of guiding catheter 4 is until balloon expandable Guiding catheter 4 is all stretched out in formula holder 6,2 part of sacculus, at this moment pressurizes, and sacculus 2 is expanded, and then balloon expandable stent 6 also expands Tensioning is attached to inside centrum 8, and 2 release of sacculus after the completion of expansion shrinks and withdraws from centrum 8.Balloon expandable stent 6 is due to expansion After will not bounce back rebound, be attached to 8 inner wall of centrum.After the completion of expanding in this way, foley's tube 1 withdraws from external, balloon-expandable branch Frame 6 stays in centrum 8.
After the completion of being expanded to centrum 8, it is placed in three spring balls.The spring ball of the present embodiment is to use memorial alloy (such as nickel Titanium) it makes.Spring ball is entwined by an elongated memorial alloy item, its memorial alloy item can under external force for spring ball With by again moulding, for example it is drawn as linear.When spring ball is drawn as linear, linear outer diameter is 0.5mm.Such as figure Shown in 14a and 14b, before being placed in human body, spring can first pull into lines state and be placed in guiding catheter 4, in a manner of linear It is pushed into centrum 8 with guiding catheter 4, lines spring is then released from guiding catheter 4 is rewound into spring ball.Wherein, When spring ball expands, should have certain elastic force, pressure to be not less than 130kpa.Finally, as shown in fig. 15 a, three spring balls The space of 8 inner cavity of centrum is filled to support centrum 8.In another preferred example, as illustrated in fig. 15b, six spring balls fill centrum 8 The space of inner cavity supports centrum 8, wherein and three spring balls are close to 8 upper wall of centrum, three spring balls are close to 8 lower wall of centrum, and It is close to three spring balls of upper wall and is close to three spring ball plug holes arrangement of lower upper wall.In this way due to there is bullet after the expansion of centrum 8 The support of spring ball, the centrum 8 after expansion will not bounce back or amount of recovery very little.
When being placed in first spring ball, spring ball is led to be placed in guiding by again moulding into strips under external force In pipe 4, it is pushed into centrum 8 with guiding catheter 4 in a linear fashion.Behind in-position, the spring under linear state is released Guiding catheter 4 simultaneously enters in centrum 8, due to having memory function, spring to return to original state and form spring ball and support centrum 8. 8 inner cavity of multiple spring ball filling centrums as needed.
It is placed in subsequent two spring balls:After guiding catheter 4 reaches 8 inside of centrum, the spring of linear is with machinery Mode is released guiding catheter 4 and is entered in centrum 8, and linear spring rear portion is connected with a push rod, when spring release is led Spring rear portion push rod and spring are detached from after pipe 4.In another preferred example, as illustrated in fig 16 a, when spring and push rod are one , then can have that a bit of diameter is smaller than the diameter of other parts in the two junction, when being powered to the junction, diameter Minimal segment is blown, and then achievees the purpose that spring is detached from push rod.In another preferred example, as shown in fig. 16, when The two junction is when being assembled in a manner of spring one end insertion push rod one end, and push rod can be hollow structure, when in push rod Spring is detached from push rod when vacancy is filled with fluid.In another preferred example, as shown in Figure 16 d and 16e, when the two junction be with When the mode of spring one end insertion push rod one end is assembled, push rod can be hollow structure, when one metal in vacancy in push rod Or the plug of other hard materials pushes, and spring is made to be detached from push rod.Since spring ball has memory function, spring to return to original state Spring ball is formed, spring ball fills 8 inner cavity of centrum after being expanded.It can be placed in multiple spring balls as needed to fill expansion 8 inner cavity of centrum afterwards.In the present embodiment, 8 inner cavity of centrum is sequentially entered there are three spring ball altogether.
To the centrum 8 after expansion by 21 injection fillers object of filler syringe, which is bone cement and induction vertebra The liquefied mixture of the biomaterial of bone tissue growth in body 8.Packing material is injected into centrum 8 with packing material syringe, Filler is filled since 8 inner most spring ball inner cavity of centrum, and by the gap of spring ball toward spring ball perimetric penetration, most It is wrapped in spring ball eventually, 8 inner cavity of centrum after solidification together with spring ball after filling expansion.Spring ball can form fine and close knot Structure, and the size in spring ball gap is controlled, so that filler slowly permeated, spread inside spring ball, finally drops significantly Low filler leaks into the risk of its hetero-organization, while reducing the risk for causing complication by leakage.Before filler solidification, Filler syringe 21 is quickly withdrawn, operation is completed.After a period of time, liquid filler cures, spring ball and the liquid after solidification Body filler together, is supported the centrum 8 that compression fracture occurs in centrum 8.Compared to former only bone cement in vertebra 8 inner support centrum 8 of body, spring ball centrum 8 together with the liquid filler material after solidification are supported, and support force is stronger, supports More stable, support effect is more preferable.
In another preferred example, the surface of spring ball is handled, i.e., is coated on its surface and is conducive to bone growth Biomaterial, be especially coated in and be close to the part of about 8 vertebral plate of centrum, the growth of induction 8 inner bone tissues of centrum is special It is that induction human body bone combines together towards spring ball growth inside and with it.The biomaterial can be hydroxyapatite or bone life Long albumen etc. can also be the mixture of many kinds of substance such as hydroxyapatite and bone generation protein.It handles in this way, the vertebra after expansion It is spring ball and the mixture of area of new bone in body 8, since existing area of new bone has spring ball again, has again to 8 existing support force of centrum Elasticity provides required physiologic radian when human body jackknifes.
As shown in fig. 6a-6c, the elastic curve of spring ball can be linear, can also be decrescence type, can be with It is cumulative type.Wherein, " D " is maximum outside diameter of the expander of spring ball formation when not expanded naturally under by outer force effect; " D1 " is least limit outer diameter of the expander of spring ball formation under compression force effect.Spring ball is not under the action of by external force Maximum outside diameter D when expanding naturally is more than 8 subnormal cavity heights of centrum, and the D in the present embodiment is 6cm.
It is incorporated herein by reference in all documents that the utility model refers to, just as each document quilt It is individually recited as reference.In addition, it should also be understood that, after having read the above-mentioned instruction content of the utility model, this field skill Art personnel can make various changes or modifications the utility model, and such equivalent forms equally fall within the application appended claims Book limited range.

Claims (10)

1. a kind of vertebral body augmentation formation system, which is characterized in that the system comprises
(1) balloon expandable stent system, the system are made of foley's tube and balloon expandable stent, in the foley's tube End be equipped with sacculus, the external pressure of the sacculus possesses the balloon expandable stent, the balloon expandable stent system into Enter to after centrum, the balloon expandable, the balloon expandable stent is expanded together with the sacculus, the balloon-expandable It is stayed after stent-expansion in the centrum, for protecting the sacculus not worn out by described Intrapyramidal spur etc.;
(2) quantity of centrum support device, the centrum support device is n, wherein 1≤n≤10, the centrum support dress Set the centrum for being used to support and compression fracture occurring;
(3) propulsion device, the propulsion device are used to the n centrum support devices pushing to centrum inner cavity;And
(4) guiding catheter, the balloon expandable stent system, the centrum support device and the propulsion device pass through described Guiding catheter enters the centrum inner cavity.
2. the system as claimed in claim 1, which is characterized in that the centrum support device includes expanding stent and spring ball.
3. system as claimed in claim 2, which is characterized in that the expanding stent is engraved structure, the expanding stent Surface has multiple wave bars, the shape of the wave bar to be selected from the group:U-shaped, Z-type, V-type, W types, N shapes, S-shaped, or combinations thereof;
It is connected by connecting rod between the wave bar, the shape of the connecting rod is selected from the group:Positive S-shaped, reversed S-shaped, U-shaped, N It is shape, linear type, V-arrangement, Z-shaped, or combinations thereof;
The connecting rod and the wave bar are attached by connection type selected from the group below:Wave crest connects wave crest, wave crest connects Connect that trough, trough connection trough, the arbitrary point that removes on two wave bar curves other than wave crest and trough is connected or its group It closes;
The expanding stent is the memory alloy stent of self-expansion type.
4. system as claimed in claim 3, which is characterized in that the expanding stent be cylinder barrel shaped, the spindle bodily form, taper, Fusiformis or without fixed shape.
5. system as claimed in claim 2, which is characterized in that be linear when the spring ball is inside the guiding catheter , when the spring ball is released by push rod outside the guiding catheter, the spring ball returns to original state, the spring ball filling The centrum inner cavity after being expanded.
6. the system as claimed in claim 1, which is characterized in that the system also includes filler syringes, in the n vertebras In the state that body supporting device fills the centrum inner cavity, filler is injected into the centrum by the filler syringe Chamber, the filler and the centrum support device support the centrum together.
7. the system as claimed in claim 1, which is characterized in that centrum support device surface, which is coated with, is conducive to bone tissue life Long material.
8. the system as claimed in claim 1, which is characterized in that the propulsion device is foley's tube, scissors-type propelling machinery Device, claw type propulsion device, support rod-type propulsion device, screw-driven propulsion device or push rod.
9. the system as claimed in claim 1, which is characterized in that the shape of the surface wave bar of the balloon expandable stent is selected from The following group:U-shaped, Z-type, W types, N shapes, S-shaped, or combinations thereof;
It is connected by connecting rod between the wave bar, the shape of the connecting rod is selected from the group:Positive S-shaped, reversed S-shaped, U-shaped, N It is shape, linear type, V-arrangement, Z-shaped, or combinations thereof;
The connecting rod and the wave bar are attached by connection type selected from the group below:Wave crest connects wave crest, wave crest connects Connect that trough, trough connection trough, the arbitrary point that removes on two wave bar curves other than wave crest and trough is connected or its group It closes.
10. the system as claimed in claim 1, which is characterized in that the sacculus is non-compliance, a semi-compliant or complies with The sacculus of property.
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107320173A (en) * 2017-06-13 2017-11-07 翎秀生物科技(上海)有限公司 Vertebral body augmentation formation system and method
CN112932646A (en) * 2021-01-29 2021-06-11 兰州大学第一医院 Anti-leakage implantation system for vertebroplasty

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107320173A (en) * 2017-06-13 2017-11-07 翎秀生物科技(上海)有限公司 Vertebral body augmentation formation system and method
CN107320173B (en) * 2017-06-13 2023-12-08 依奈德医疗技术(上海)有限公司 Vertebral body expansion shaping systems and methods
CN112932646A (en) * 2021-01-29 2021-06-11 兰州大学第一医院 Anti-leakage implantation system for vertebroplasty

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