CN102178996B - Centrum injection dilator and manufacture method thereof - Google Patents
Centrum injection dilator and manufacture method thereof Download PDFInfo
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- CN102178996B CN102178996B CN 201110115569 CN201110115569A CN102178996B CN 102178996 B CN102178996 B CN 102178996B CN 201110115569 CN201110115569 CN 201110115569 CN 201110115569 A CN201110115569 A CN 201110115569A CN 102178996 B CN102178996 B CN 102178996B
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Abstract
The invention provides a centrum injection dilator which can effectively prevent a biological material from outwards leaking from gaps on centrum before the biological material is cured and avoids remaining other built-in materials except for the biological material in the centrum. According to the centrum injection dilator provided by the invention, the centrum injection dilator is provided with a saccule, the saccule is provided with an injection port and a saccule body, the saccule is suitable for containing the curable biological material injected from the injection port, the saccule bodyis provided with an opening, the size of the opening is set to be allow the cured biological material in the saccule to separate from the opening, the opening is closed by an adhering material to form a complete saccule shape, and the adhering material has a softening point with a preset temperature value within a heat release temperature range in a curing heat release process of the biological material.
Description
Technical field
The present invention relates to a kind of medical apparatus and instruments that is used for spinal disease, specifically, relate to a kind of injection-pressing dilator of vertebral body that is used in vertebral body, injecting implant.
Background technology
The spinal vertebral compression fracture is that a kind of more common spinal disease, particularly old people colony cause the spinal vertebral compression fracture easily owing to osteoporosis, and Therapeutic Method commonly used is the treatment that undergos surgery.A kind of existing operation method is; In the vertebral body of pathological changes, injecting implant through injection-pressing dilator of vertebral body expands outwardly; Thereby the support force that produces the vertebra joint makes vertebral body return to original height, keeps this support force through filled biomass material in the vertebra joint.
A kind of solution is, through conduit with air bag from the external predetermined position that is incorporated into the vertebral body of human body, make airbag inflation through injecting fluid (gas or liquid); Thereby the vertebral body that fracture is subsided is supported to original form; This air bag forms predetermined notes at the predetermined position of vertebral body and presses cavity simultaneously, then with the fluid evacuation of injecting, in vertebral body, takes out after making air bag be shrunk to minimum state; In the Intrapyramidal cavity that utilizes air bag to form, (for example inject curable biomaterial at last; Commonly used is bone cement), biomaterial is solidified in this cavity, play supporting role to vertebral body.For this method, owing to there is not the constraint of air bag, when filling in the cavity of vertebral body, biomaterial can flow arbitrarily, be difficult to control the shape after the curing, therapeutic effect also can be affected.In addition; Because have a lot of slight gap on the inwall of the cavity that in vertebral body, forms, particularly owing to osteoporotic reason, this slit is more obvious; Cause the biological material (for example bone cement etc.) of injection before solidifying, can penetrate into the slit of vertebral body; Even can be exuded to outside the vertebral body through these slits, and bone cement can not contact with the outer tissue of vertebral body owing to the monomeric cytotoxicity in its constituent material, this has caused danger with regard to seepage to human body.
Another kind of solution is; After being incorporated into air bag in the vertebral body through conduit; Biomaterial is filled in air bag and expansion; Biomaterial after will solidifying then and air bag are retained in the vertebral body together, for example can air bag be separated with conduit through cutting edge in the end of conduit setting or through other disengaging gear or throw off design after biomaterial solidifies with air bag and conduit disengagement, thereby with air bag in biomaterial is stayed vertebral body.Because the constraint of air bag is arranged always, this method can prevent effectively biomaterial before curing from epicentral slit outside seepage, but cause other inner matters that in vertebral body, stay except biomaterial simultaneously.On medical requirement, the for example requirement of U.S. FDA, the consideration from safety does not allow to stay in vivo this inner matter usually, and for example U.S. FDA is not ratified this operation method at present yet.Therefore, this operation method brings people bigger worry.
Also have a kind of method to be, will be incorporated into Intrapyramidal airbag design through conduit and become braiding structure,, can whole braiding structure be disassembled through an end of pulling or extraction litzendraht wire.After being incorporated into air bag in the vertebral body through conduit, make biomaterial filled and expansion in air bag, after biomaterial solidifies,, whole air bag is taken out in vertebral body then through spurring or extract out an end of the litzendraht wire that weaves air bag.This method prevented effectively biomaterial before curing from epicentral slit outside seepage, avoided in vertebral body, staying other inner matters except biomaterial simultaneously, but still there are some problems in this method.Be difficult for extraction opportunity of litzendraht wire grasping, if solidify the end of a thread that extracts litzendraht wire before to a certain degree at biomaterial, then still exist biomaterial from epicentral slit outside leakage problems; And,, can cause the extraction difficulty of litzendraht wire and the problems such as generation of chip because biomaterial can penetrate in the programming structure of air bag if after biomaterial solidifies.In addition, equal more complicated is made in designing of this programming structure, promptly will guarantee to have non-leakage density, takes into account again and extracts requirement easily.
Summary of the invention
The invention provides a kind of injection-pressing dilator of vertebral body, can prevent effectively biomaterial before curing from epicentral slit outside seepage, avoided in vertebral body, staying other inner matters except biomaterial simultaneously.Further, this injection-pressing dilator of vertebral body is simple in structure.
An embodiment according to injection-pressing dilator of vertebral body of the present invention; Said injection-pressing dilator of vertebral body has sacculus; This sacculus has injection port and sacculus body; Said sacculus is suitable for holding the curable biomaterial that is injected by said injection port, and said sacculus body has opening, and being sized to of said opening allows the solidfied material of the biomaterial in the said sacculus to deviate from through said opening; Said opening is closed to form complete sacculus shape through adhesives, and said adhesives has the softening point of the predetermined temperature value in the exothermic temperature scope in the curing exotherm process of said biomaterial.
Above-mentioned embodiment for injection-pressing dilator of vertebral body of the present invention; After being incorporated into the sacculus of injection-pressing dilator of vertebral body in the vertebral body through conduit; Biomaterial is filled in this sacculus and expansion; After reaching predetermined filled shape, stop to fill, biomaterial begins to solidify and in solidification process, carry out heat release then.Because the softening point that said adhesives has the predetermined temperature value in the exothermic temperature scope in the curing exotherm process of said biomaterial; In the curing exotherm process after said biomaterial is injected in the said sacculus; When temperature reaches the softening point of said adhesives; Adhesives begins to soften, and the biomaterial that be in a liquid state this moment originally solidifies basically, can arbitrarily not flow.Because adhesives is softening; Said make bonded together and the opening that seals begins to break by said adhesives and since said opening be sized to allow the solidfied material of the biomaterial in the said sacculus to deviate from through said opening, after opening splits; Through to the outside application of force of the injection port of sacculus (for example sacculus being pulled out in the human body body) through the conduit or the instrument that are connected with injection port; Basically solidified biomaterial can be deviate from from opening in sacculus, thereby from sacculus, deviates from, in other words; Sacculus from basically the solid content of solidified biomaterial deviate from, in the human body body, take out.Therefore; Through technique scheme of the present invention; Can be in the human body body (in the vertebral body) form the solid content of the biomaterial of reservation shape (that is) by the shape constraining of said sacculus, prevent that biomaterial from flowing arbitrarily and be exuded to the vertebral body outside before curing; And, can sacculus be taken out in body with simple mode.
Above-mentioned embodiment according to injection-pressing dilator of vertebral body of the present invention; Because the softening point that said adhesives has the predetermined temperature value in the exothermic temperature scope in the curing exotherm process of said biomaterial; Thereby said sacculus is constructed to a kind of temperature control sacculus, i.e. opening through temperature control and triggering sacculus upper shed.In addition, because sacculus self can be designed to any required form, can constrain in the wherein shape of the solid content of solidified biomaterial, thereby also become a kind of injection device of quantitative setting.Because biomaterial is before being cured to a certain degree or solidifying basically, the opening on the said sacculus generally can not opened, and prevents the seepage of biomaterial, thereby becomes a kind of injection device of antiseep yet.
In an embodiment of the invention, said sacculus body is arranged to the form of a lamellar body, and said opening is formed on the said lamellar body.In this embodiment, can on a complete sacculus body, on the part beyond the injection port, form opening, thereby form the sacculus body of the form of a lamellar body, and on the sacculus body, form opening.Said opening can be an opening, also can be a plurality of openings, makes in the opening at least one can allow the solidfied material of the biomaterial in the said sacculus to deviate to get final product through said opening.
In an embodiment of the invention, said sacculus body comprises at least two lamellar bodies, and each lamellar body all is connected with said injection port, and said at least two lamellar bodies are joined together to form said sacculus body through said adhesives.In this embodiment, adopted the said sacculus main body structure of the combined and spliced formation of multi-disc body, when each lamellar body of splicing, each lamellar body is linked together with described adhesives, form the sacculus body of the sacculus shape of a complete band injection port.
In an embodiment of the invention, said predetermined temperature value is near the exothermic peak temperature of said biomaterial.In this embodiment, because said predetermined temperature value near the exothermic peak temperature of said biomaterial, therefore can make said adhesives after biomaterial is cured heat release a period of time or certain hour, just begin to soften until fusing.Compare the curing exotherm period in early stage, the period in later stage that said adhesives is arranged in curing exotherm softens, and the curing of biomaterial was more abundant when biomaterial curing thing was deviate from from the opening of sacculus.
In an embodiment of the invention, said predetermined temperature value is lower than 5 ℃-10 ℃ of the exothermic peak temperature of said biomaterial.Through experiment; The exothermic peak temperature that said predetermined temperature value is lower than said biomaterial is suitable for 5 ℃-10 ℃; Biomaterial had cured to a certain degree or solidified basically this moment, thereby from sacculus, to deviate from be favourable to the solidfied material that opening on the sacculus body is split allow biomaterial.
In an embodiment of the invention, said predetermined temperature value is in 50 ℃-60 ℃ scope.
In an embodiment of the invention, described biomaterial is a bone cement.Said bone cement can be the bone cement that the various materials in this area constitute, and can be made up of a kind of material that after injection, is cured with heat release, also can inject or inject two or more materials that mix to be cured with heat release the back and constitute by mixing.As an example, can adopt calcium phosphate bone cement or calcium sulfate bone cement etc.
In an embodiment of the invention, said adhesives is a PUR.PUR is a kind of adhesives, and it is solid-state at normal temperatures, and can soften until fusion when arriving uniform temperature.PUR can be made up of various materials, and through allocating the proportioning of various constituents, can control the softening point temperature value and the melting temperature value of this PUR, so PUR is a kind of selection of said adhesives.
In an embodiment of the invention, said adhesives or said PUR are ethylene-vinyl acetate copolymer.As a selection of adhesives, can adopt ethylene-vinyl acetate copolymer.Said ethylene-vinyl acetate copolymer; Be also referred to as EVA,, can regulate and control the temperature value or the temperature range of the softening point and the fusing point of ethylene-vinyl acetate copolymer through changing the ratio of ethylene and vinylacetate; For example; Through the adjustment proportioning, softening point is selected arbitrarily in 40 ℃-60 ℃ scope, and fusing point is selected arbitrarily in 50 ℃-90 ℃ scope.
In an embodiment of the invention, the softening point of said adhesives or said PUR is set to 40 ℃-60 ℃.
In an embodiment of the invention, the fusing point of said adhesives or said PUR is set to 50 ℃-90 ℃.
In an embodiment of the invention, said injection port is designed to be suitable for be connected with a conduit.Through this conduit can with said sacculus from external be incorporated in the vertebral body or can solidify at biomaterial after thing is deviate from from sacculus sacculus is taken out in vertebral body.
The present invention also provides a kind of manufacturing approach of injection-pressing dilator of vertebral body.
An embodiment according to the manufacturing approach of injection-pressing dilator of vertebral body of the present invention; Said injection-pressing dilator of vertebral body has sacculus; Said sacculus is suitable for holding the curable biomaterial that is injected by said injection port, it is characterized in that said manufacturing approach comprises the steps:
Formation has the sacculus of sacculus body and injection port, wherein on said sacculus body, forms opening, and being sized to of said opening allows the solidfied material of the biomaterial in the said sacculus to deviate from through said opening,
Through adhesives with said closure of openings to form complete sacculus shape, wherein said adhesives has the softening point of the predetermined temperature value in the exothermic temperature scope in the curing exotherm process of said biomaterial.
In an embodiment of manufacturing approach of the present invention, said sacculus body is arranged to the form of a lamellar body, and said opening is formed on the said lamellar body.
In an embodiment of manufacturing approach of the present invention; Said sacculus body comprises at least two lamellar bodies; Said opening is formed between the said lamellar body; And each lamellar body all is connected with said injection port, and said at least two lamellar bodies are joined together to form said sacculus body through said adhesives.
In an embodiment of manufacturing approach of the present invention, said predetermined temperature value is near the exothermic peak temperature of said biomaterial.
In an embodiment of manufacturing approach of the present invention, said predetermined temperature value is lower than 5 ℃-10 ℃ of the exothermic peak temperature of said biomaterial.
In an embodiment of manufacturing approach of the present invention, said predetermined temperature value is in 50 ℃-60 ℃ scope.
In an embodiment of manufacturing approach of the present invention, described biomaterial is a bone cement.
In an embodiment of manufacturing approach of the present invention, said adhesives is a PUR.
In an embodiment of manufacturing approach of the present invention, said PUR is an ethylene-vinyl acetate copolymer.
In an embodiment of manufacturing approach of the present invention, the softening point of said PUR is set to 40 ℃-60 ℃.
In an embodiment of manufacturing approach of the present invention, the fusing point of said PUR is set to 50 ℃-90 ℃.
In an embodiment of manufacturing approach of the present invention, said injection port is designed to be suitable for be connected with a conduit.
Description of drawings
Accompanying drawing described here only is used for task of explanation, and is not intended to limit by any way scope disclosed by the invention.In addition, the shape of each parts among the figure and proportional sizes etc. are merely schematically, be used for helping to understanding of the present invention, and be not shape and the proportional sizes that specifically limits each parts of the present invention.Those skilled in the art can select various possible shapes and proportional sizes to come embodiment of the present invention under instruction of the present invention as the case may be.
Fig. 1 is the structural representation of an embodiment (a lamellar body form) of injection-pressing dilator of vertebral body of the present invention;
Fig. 2 is the structural representation of embodiment (a lamellar body form) under the opening open mode shown in Figure 1;
Fig. 3 is the sketch map of an embodiment when using of injection-pressing dilator of vertebral body of the present invention;
Fig. 4 is the sketch map of an embodiment when using of injection-pressing dilator of vertebral body of the present invention;
Fig. 5 is the sketch map of an embodiment when using of injection-pressing dilator of vertebral body of the present invention;
Fig. 6 is the sketch map of an embodiment when using of injection-pressing dilator of vertebral body of the present invention;
Fig. 7 is the structural representation of another embodiment (a plurality of lamellar body form) of injection-pressing dilator of vertebral body of the present invention;
Fig. 8 is the structural representation of overlooking of embodiment (a plurality of lamellar body form) shown in Figure 7.
The specific embodiment
In conjunction with the description of the accompanying drawing and the specific embodiment of the invention, can be well understood to details of the present invention more.But the specific embodiment of the present invention described here only is used to explain the object of the invention, is limitation of the present invention and can not be understood as by any way.Under instruction of the present invention, the technical staff can conceive based on possible distortion arbitrarily of the present invention, and these all should be regarded as and belong to scope of the present invention.
Referring to illustrated in figures 1 and 2, according to an embodiment of injection-pressing dilator of vertebral body of the present invention, said injection-pressing dilator of vertebral body has sacculus 100, and this sacculus 100 has injection port 102 and sacculus body 101.Said sacculus 100 is suitable for holding the curable biomaterial that is injected by said injection port 102.Said sacculus body 101 has opening 103, and said opening 103 is closed to form complete sacculus shape through adhesives 104.Referring to shown in Figure 2, under the state that said opening 103 is opened, being sized to of said opening 103 allows the solidfied material 105 of the biomaterial in the said sacculus 100 to deviate from through said opening 103.Said adhesives 104 has the softening point of the predetermined temperature value in the exothermic temperature scope in the curing exotherm process of said biomaterial.
For the above-mentioned embodiment of injection-pressing dilator of vertebral body of the present invention, its application process can be understood with reference to figure 3-6.
Form passage through Minimally Invasive Surgery at the predetermined position of human body, be incorporated in the vertebral body of the compression of fracturing, referring to Fig. 3 through the sacculus 100 of conduit 201 with injection-pressing dilator of vertebral body.
Then, inject biomaterials, biomaterial is filled in this sacculus 100 and expand, thereby the shape that vertebral body that fracture compresses is reset to normal vertebral body will take place, after reaching predetermined filled shape, stop to fill, referring to Fig. 4 through conduit 201.
After filling, biomaterial begins to solidify and in solidification process, carry out heat release.Because the softening point that said adhesives 104 has the predetermined temperature value in the exothermic temperature scope in the curing exotherm process of said biomaterial; In the curing exotherm process after said biomaterial is injected into said sacculus 100; When temperature reaches the softening point of said adhesives 104; Adhesives 104 begins to soften, and the biomaterial that be in a liquid state this moment originally solidifies basically, can arbitrarily not flow.Because adhesives 104 is softening; Said make bonded together and the opening 103 that seals begins to break by said adhesives 104; Because being sized to of said opening 103 allows the solidfied material 105 of the biomaterial in the said sacculus 100 to deviate from through said opening 103; After opening 103 splits; Through to the outside application of force of the injection port of sacculus 100 (for example through the conduit 201 or the instrument that are connected with injection port sacculus being pulled out in the human body body), solidified basically biomaterial can be deviate from from opening in sacculus 100, thereby from sacculus, deviates from.In other words, sacculus 100 from basically the solid content 105 of solidified biomaterial deviate from, referring to shown in Figure 5.
Then, sacculus 100 is taken out in the human body body, only the solid content 105 of biomaterial is stayed in the vertebral body, referring to Fig. 6.Because this moment, biomaterial had cured, solid content 105 can not be penetrated into the vertebral body outside, can not produce danger; Sacculus self can not be retained in the vertebral body yet simultaneously.
Therefore; Through technique scheme of the present invention; Can be in the human body body (in the vertebral body) form the solid content of the biomaterial of reservation shape (that is) by the shape constraining of said sacculus, prevent that biomaterial from flowing arbitrarily and be exuded to the vertebral body outside before curing; And, can sacculus be taken out in body with simple mode.
As illustrated in fig. 1 and 2, in an embodiment of the invention, said sacculus body 101 is arranged to the form of a lamellar body, and wherein said opening 103 is formed on the said lamellar body.In this embodiment, can on a complete sacculus body, on the part beyond the injection port 102, form opening 103, thereby form the sacculus body 101 of the form of a lamellar body, and on the sacculus body, form opening 103.Said opening 103 can be an opening, also can be a plurality of openings, makes in the opening at least one can allow the solidfied material 105 of the biomaterial in the said sacculus to deviate to get final product through said opening 103, referring to Fig. 2.
Shown in Fig. 7 and 8; In yet another embodiment of the present invention; Said sacculus body 101 comprises that at least two lamellar bodies 1011,1012 (are illustrated as 2; Also can be a plurality of), each lamellar body all is connected with said injection port 102, and said at least two lamellar bodies 1011,1012 are joined together to form said sacculus body 101 through said adhesives 104.In this embodiment; Adopted the said sacculus main body structure of the combined and spliced formation of multi-disc body; When each lamellar body of splicing, with described adhesives 104 each lamellar body 1011/1012 is linked together, form the sacculus body 101 of the sacculus shape of a complete band injection port 102.
In an embodiment of the invention, said predetermined temperature value is near the exothermic peak temperature of said biomaterial.In this embodiment, because said predetermined temperature value near the exothermic peak temperature of said biomaterial, therefore can make said adhesives after biomaterial is cured heat release a period of time or certain hour, just begin to soften until fusing.Compare the curing exotherm period in early stage, the period in later stage that said adhesives is arranged in curing exotherm softens, and the curing of biomaterial was more abundant when biomaterial curing thing was deviate from from the opening of sacculus.
In an embodiment of the invention, said predetermined temperature value is lower than 5 ℃-10 ℃ of the exothermic peak temperature of said biomaterial.Through experiment; The exothermic peak temperature that said predetermined temperature value is lower than said biomaterial is suitable for 5 ℃-10 ℃; Biomaterial had cured to a certain degree or solidified basically this moment, thereby from sacculus 100, to deviate from be favourable to the solidfied material 105 that opening 103 on the sacculus body 101 is split allow biomaterial.As an example, said predetermined temperature value is in 50 ℃-60 ℃ scope.
In an embodiment of the invention, described biomaterial is a bone cement.Said bone cement can be the bone cement that the various materials in this area constitute, and can be made up of a kind of material that after injection, is cured with heat release, also can inject or inject two or more materials that mix to be cured with heat release the back and constitute by mixing.As an example, can adopt calcium phosphate bone cement or calcium sulfate bone cement etc.
In an embodiment of the invention, said adhesives is a PUR.PUR is a kind of adhesives, and it is solid-state at normal temperatures, and can soften until fusion when arriving uniform temperature.PUR can be made up of various materials, and through allocating the proportioning of various constituents, can control the softening point temperature value and the melting temperature value of this PUR, so PUR is a kind of selection of said adhesives.Specifically, PUR is a kind of not moisture, does not need the solid meltability polymer of solvent.PUR is a solid at normal temperatures, is heated to fusion after the uniform temperature, and becoming can flowing liquid.The kind of PUR is a lot, for example plastic of poly vinyl acetate.The main component of PUR is that the resin that forms with ethylene and vinyl acetate copolymerization under high pressure is a basic resin, and it has determined the key property of PUR.Can add that also the viscosifier (Colophonium), gelatin viscosity and the setting rate regulator (paraffin) that improve adhesive strength and small amount of antioxidant (two uncles the material of base to methylbenzene wine and so on) are to slow down the aging speed of PUR.The main feature of PUR is: room temperature is solid down, becomes the liquid of good fluidity during high temperature, and is nonflammable, harmless; PUR can bonding multiple material, and especially the bonding force between the homogeneous material is stronger, and the glued membrane pliability after the curing is good.
In an embodiment of the invention, said adhesives or said PUR are ethylene-vinyl acetate copolymer.As a selection of adhesives, can adopt ethylene-vinyl acetate copolymer.Said ethylene-vinyl acetate copolymer; Be also referred to as EVA,, can regulate and control the temperature value or the temperature range of the softening point and the fusing point of ethylene-vinyl acetate copolymer through changing the ratio of ethylene and vinylacetate; For example; Through the adjustment proportioning, softening point is selected arbitrarily in 40 ℃-60 ℃ scope, and fusing point is selected arbitrarily in 50 ℃-90 ℃ scope.Specifically, ethylene-vinyl acetate copolymer is to be made by ethylene and vinyl acetate copolymerization, is called for short EVA.The EVA fusing point is low, bonding force is strong, nontoxic pollution-free, transparent, easy to use, performance is excellent.The EVA material has following characteristics: excellent water tolerance and rotproofness, workability and good against shock performance, i.e. and resilience and tension stress is high, and toughness is strong.
As an example, the softening point of said adhesives 104 or said PUR is set to 40 ℃-60 ℃.As an example, the fusing point of said adhesives 104 or said PUR is set to 50 ℃-90 ℃.
In an embodiment of the invention, said injection port 102 is designed to be suitable for be connected with a conduit 201.Through this conduit 201 can with said sacculus 100 from external be incorporated in the vertebral body or can solidify at biomaterial after thing 105 is deviate from from sacculus 100 sacculus 100 is taken out in vertebral body.
The present invention also provides a kind of manufacturing approach of injection-pressing dilator of vertebral body.Said injection-pressing dilator of vertebral body has sacculus 100, and said sacculus 100 is suitable for holding the curable biomaterial that is injected by said injection port 102.
According to an embodiment of the manufacturing approach of injection-pressing dilator of vertebral body of the present invention, said manufacturing approach comprises the steps:
Formation has the sacculus 100 of sacculus body 101 and injection port 102.Wherein, on said sacculus body 101, form opening 103, being sized to of said opening 103 allows the solidfied material 105 of the biomaterial in the said sacculus 100 to deviate from through said opening 103;
Through adhesives 104 said opening 103 is sealed to form complete sacculus shape.Wherein, said adhesives 104 has the softening point of the predetermined temperature value in the exothermic temperature scope in the curing exotherm process of said biomaterial.
In an embodiment of manufacturing approach of the present invention, said sacculus body is arranged to the form of a lamellar body, and said opening 103 is formed on the said lamellar body.Structure after it forms can be referring to shown in Fig. 1 and 2.
In another embodiment of manufacturing approach of the present invention; Said sacculus body 101 comprises at least two lamellar bodies 1011,1012; Said opening 103 is formed on said lamellar body 1011, between 1012; And each lamellar body 1011,1012 all is connected with said injection port 102, and said at least two lamellar bodies are joined together to form said sacculus body 101 through said adhesives 104.Structure after it forms can be referring to shown in Fig. 7 and 8.
To the illustrated in detail of above-mentioned each embodiment, its purpose only is the present invention is made an explanation, so that can understand the present invention better; But it is limitation of the present invention that these descriptions can not be construed to any reason, particularly; Each characteristic of in different embodiment, describing (for example; The characteristic of the structure of lamellar body, the characteristic of opening, injection port, each example of adhesives etc.) also combination in any each other, thus form other embodiments, except clear and definite opposite description is arranged; These characteristics should be understood that can be applied in any one embodiment, and also not only are confined to described embodiment.
Claims (24)
1. injection-pressing dilator of vertebral body; This injection-pressing dilator of vertebral body has sacculus; This sacculus has injection port and sacculus body; Said sacculus is suitable for holding the curable biomaterial that is injected by said injection port, and said sacculus body has opening, and being sized to of said opening allows the solidfied material of the biomaterial in the said sacculus to deviate from through said opening; Said opening is closed to form complete sacculus shape through adhesives, and said adhesives has the softening point of the predetermined temperature value in the exothermic temperature scope in the curing exotherm process of said biomaterial.
2. injection-pressing dilator of vertebral body according to claim 1 is characterized in that said sacculus body is arranged to the form of a lamellar body, and said opening is formed on the said lamellar body.
3. injection-pressing dilator of vertebral body according to claim 1; It is characterized in that; Said sacculus body comprises at least two lamellar bodies, and each lamellar body all is connected with said injection port, and said at least two lamellar bodies are joined together to form said sacculus body through said adhesives.
4. injection-pressing dilator of vertebral body according to claim 1 is characterized in that, said predetermined temperature value is near the exothermic peak temperature of said biomaterial.
5. injection-pressing dilator of vertebral body according to claim 4 is characterized in that, said predetermined temperature value is lower than 5 ℃-10 ℃ of the exothermic peak temperature of said biomaterial.
6. injection-pressing dilator of vertebral body according to claim 1 is characterized in that, said predetermined temperature value is in 50 ℃-60 ℃ scope.
7. injection-pressing dilator of vertebral body according to claim 1 is characterized in that, described biomaterial is a bone cement.
8. injection-pressing dilator of vertebral body according to claim 1 is characterized in that, said adhesives is a PUR.
9. injection-pressing dilator of vertebral body according to claim 1 is characterized in that, said adhesives is an ethylene-vinyl acetate copolymer.
10. according to claim 1 or 8 or 9 described injection-pressing dilator of vertebral body, it is characterized in that the softening point of said adhesives is set to 40 ℃-60 ℃.
11., it is characterized in that the fusing point of said adhesives is set to 50 ℃-90 ℃ according to claim 1 or 8 or 9 described injection-pressing dilator of vertebral body.
12. injection-pressing dilator of vertebral body according to claim 1 is characterized in that, said injection port is designed to be suitable for be connected with a conduit.
13. the manufacturing approach of an injection-pressing dilator of vertebral body, this injection-pressing dilator of vertebral body has sacculus, and said sacculus is suitable for holding the curable biomaterial that is injected by said injection port, it is characterized in that said manufacturing approach comprises the steps:
Formation has the sacculus of sacculus body and injection port, wherein on said sacculus body, forms opening, and being sized to of said opening allows the solidfied material of the biomaterial in the said sacculus to deviate from through said opening,
Through adhesives with said closure of openings to form complete sacculus shape, wherein said adhesives has the softening point of the predetermined temperature value in the exothermic temperature scope in the curing exotherm process of said biomaterial.
14. the manufacturing approach of injection-pressing dilator of vertebral body according to claim 13 is characterized in that, said sacculus body is arranged to the form of a lamellar body, and said opening is formed on the said lamellar body.
15. the manufacturing approach of injection-pressing dilator of vertebral body according to claim 13; It is characterized in that; Said sacculus body comprises at least two lamellar bodies; Said opening is formed between the said lamellar body, and each lamellar body all is connected with said injection port, and said at least two lamellar bodies are joined together to form said sacculus body through said adhesives.
16. the manufacturing approach of injection-pressing dilator of vertebral body according to claim 13 is characterized in that, said predetermined temperature value is near the exothermic peak temperature of said biomaterial.
17. the manufacturing approach of injection-pressing dilator of vertebral body according to claim 16 is characterized in that, said predetermined temperature value is lower than 5 ℃-10 ℃ of the exothermic peak temperature of said biomaterial.
18. the manufacturing approach of injection-pressing dilator of vertebral body according to claim 13 is characterized in that, said predetermined temperature value is in 50 ℃-60 ℃ scope.
19. the manufacturing approach of injection-pressing dilator of vertebral body according to claim 13 is characterized in that, described biomaterial is a bone cement.
20. the manufacturing approach of injection-pressing dilator of vertebral body according to claim 13 is characterized in that, said adhesives is a PUR.
21. the manufacturing approach of injection-pressing dilator of vertebral body according to claim 13 is characterized in that, said adhesives is an ethylene-vinyl acetate copolymer.
22. the manufacturing approach according to claim 13 or 20 or 21 described injection-pressing dilator of vertebral body is characterized in that, the softening point of said adhesives is set to 40 ℃-60 ℃.
23. the manufacturing approach according to claim 13 or 20 or 21 described injection-pressing dilator of vertebral body is characterized in that, the fusing point of said adhesives is set to 50 ℃-90 ℃.
24. the manufacturing approach of injection-pressing dilator of vertebral body according to claim 13 is characterized in that, said injection port is designed to be suitable for be connected with a conduit.
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| US9371123B2 (en) * | 2013-12-20 | 2016-06-21 | Google Inc. | System for constructing balloon envelopes |
| US10293913B1 (en) | 2014-07-25 | 2019-05-21 | Loon Llc | Termination assembly for use with balloon envelopes |
| US10086561B1 (en) | 2016-03-24 | 2018-10-02 | X Development Llc | Automated balloon assembly machine |
| CN108771563A (en) * | 2018-06-01 | 2018-11-09 | 赵群 | Bone cement antiseep pushing in device |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101461981A (en) * | 2007-12-20 | 2009-06-24 | 邹德威 | Oriented dilatation balloon and oriented dilatation device |
| CN201658411U (en) * | 2010-02-09 | 2010-12-01 | 常州百隆微创医疗器械科技有限公司 | Vertebral body expanding balloon |
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| US20070010845A1 (en) * | 2005-07-08 | 2007-01-11 | Gorman Gong | Directionally controlled expandable device and methods for use |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101461981A (en) * | 2007-12-20 | 2009-06-24 | 邹德威 | Oriented dilatation balloon and oriented dilatation device |
| CN201658411U (en) * | 2010-02-09 | 2010-12-01 | 常州百隆微创医疗器械科技有限公司 | Vertebral body expanding balloon |
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