A kind of novel double-layer overlay film frame
Technical field
The present invention relates to a kind of overlay film frame that is applied to the treatment of arotic disease and related vascular diseases.
Background technology
At present, overlay film frame is that metal rack and covering material are processed to form by sewing up or be cross-linked (such as heat cross-linking, chemical crosslinking etc.).The near-end of overlay film frame provides radial support power by rack body, so that overlay film and blood vessel wall are fitted, thereby produces plugging action.But because blood vessel occurs after some pathological changes (such as calcification etc.), blood vessel wall will follow the string, thus may cause the near-end of overlay film frame and blood vessel wall not to fit completely, thus there is I type internal hemorrhage due to trauma (seeing Fig. 1 and Fig. 2).Fig. 1 is the overlay film frame of the prior art schematic diagram in blood vessel.In Fig. 1, Reference numeral 1 represents internal hemorrhage due to trauma.Fig. 2 is the cross-sectional view of the proximal part of the overlay film frame in Fig. 1.In Fig. 2, Reference numeral 2 represents rack body, and Reference numeral 3 represents blood vessel wall, and Reference numeral 4 represents overlay film, and Reference numeral 5 represents speckle, and Reference numeral 6 represents gap.As seen from Figure 2, between the speckle 5 of blood vessel and overlay film 4, produced gap 6, thereby easily caused I type internal hemorrhage due to trauma.
For the I type internal hemorrhage due to trauma in Fig. 1, in prior art, conventionally there are following two kinds of solutions.
Scheme one:
By the near-end of balloon expandable overlay film frame, by overlay film frame and blood vessel wall laminating.The method preferable operability, but the method only can provide assosting effect to the near-end laminating blood vessel wall of overlay film frame, the more serious blood vessel of calcification especially.Therefore, the effect of the method is poor, uses sacculus simultaneously, also can bring financial burden to patient.
Scheme two:
Near-end adds short section of covered stnet (cuff).The method has reasonable effect to I type internal hemorrhage due to trauma.But need to newly add short section of covered stnet, this not only adds heavy patient's burden economically, may bring new risk simultaneously, for example can bring opisthotonos, displacement equivalent risk.
Ordinary stent of the prior art only has monolayer overlay film, and simultaneously the radial support force rate of support is lower, exists and easily makes near-end adherent bad and often cause the situation of I type internal hemorrhage due to trauma.By the scheme of some prior aries, although can play some, make up effect, can't cover all pathological changes completely, may cause new risk in addition simultaneously.So not only higher to doctor's operation requirements, increase operating time and operation risk, also can bring financial burden to patient simultaneously.
Chinese patent literature CN2741534Y, CN201445575U, CN201602915U and american documentation literature US8118856B2 also disclose some relevant prior aries.
Summary of the invention
Above-mentioned technical problem in view of prior art, the object of the invention is to develop a kind of overlay film frame, and it can increase the adherent property of near-end of support, reduces near-end adherent bad and cause the risk of I type internal hemorrhage due to trauma.
According to the present invention, a kind of overlay film frame is provided, comprising:
Rack body; And
Cover the inner film coating on described rack body,
It is characterized in that:
Described overlay film frame also comprises the outer film coating of the close end office that is arranged on described rack body, described outer film coating is positioned at the outside of described inner film coating, and the near-end of described outer film coating and far-end closely adhere to described inner film coating, and have hole in described inner film coating.
Preferably, the near-end of described outer film coating and far-end are fused to described inner film coating, or the near-end of described outer film coating and far-end adopt suture to be sewn onto described inner film coating.
Preferably, in the proximal part of described inner film coating, the circumferential direction along described inner film coating has several described holes.
Preferably, described hole is circular opening.
Preferably, described outer film coating adopts polytetrafluoroethylmaterial material to form, and described inner film coating adopts polyethylene terephthalate braiding structure to form.
Preferably, described outer film coating adopts polyethylene terephthalate braiding structure to form, and described inner film coating adopts polyethylene terephthalate braiding structure to form.
Preferably, described outer film coating adopts polyethylene terephthalate braiding structure to form, and described inner film coating adopts polytetrafluoroethylmaterial material to form.
Overlay film frame of the present invention can increase the adherent property of near-end of support, reduces near-end adherent bad and cause the risk of I type internal hemorrhage due to trauma.Particularly, overlay film frame of the present invention can reduce the risk of near-end internal hemorrhage due to trauma greatly, thereby overlay film frame of the present invention has solved overlay film frame near-end and the bad I type internal hemorrhage due to trauma causing of blood vessel wall laminating.Overlay film frame of the present invention can be in the situation that the main body overlay film frame overall structure of prior art be constant increases one deck outer film coating and form at skin, can use like this and former the same production technology, do not improve technology difficulty, but but greatly reduce the risk of internal hemorrhage due to trauma, thereby product of the present invention has the market competitiveness more.And overlay film frame of the present invention can cover most aorta cases, can also reduce the use of other auxiliary appliance simultaneously, reduce operation risk and surgery cost.
Accompanying drawing explanation
In order to be illustrated more clearly in the technical scheme of the embodiment of the present invention, below the accompanying drawing of required use during embodiment is described is briefly described.It is evident that, the accompanying drawing in the following describes is only some specific embodiments of recording in the application, and it is not the restriction to protection scope of the present invention.For those of ordinary skills, do not paying under the prerequisite of creative work, certainly can also obtain some other embodiment and accompanying drawing according to these embodiment of the present invention and accompanying drawing thereof.
Fig. 1 is the overlay film frame of the prior art schematic diagram in blood vessel.
Fig. 2 is the cross-sectional view of the proximal part of the overlay film frame in Fig. 1.
Fig. 3 is the cross sectional representation of near-end of the double-deck overlay film frame of one embodiment of the present of invention.
Fig. 4 is the longitudinal cross-section schematic diagram of the double-deck overlay film frame of the present invention in Fig. 3.
Fig. 5 is the longitudinal cross-section schematic diagram of the double-deck overlay film frame of an alternative embodiment of the invention.
The specific embodiment
In order to make those skilled in the art understand better the technical scheme in the application, below in conjunction with the accompanying drawing in the embodiment of the present invention, the technical scheme in the embodiment of the present invention is clearly and completely described.Obviously, described embodiment is only the application's part embodiment, rather than whole embodiment.Specific embodiment based on described in the application, all other embodiment that those of ordinary skills obtain under the prerequisite of not making creative work, within should dropping on design scope of the present invention.
The present invention provides a kind of novel double-layer overlay film frame that is applied to the treatment of arotic disease and relevant disease generally.
Below with reference to Fig. 3~Fig. 5, describe the preferred embodiments of the present invention in detail.
Fig. 3 is the cross sectional representation of near-end of the double-deck overlay film frame of one embodiment of the present of invention.Fig. 4 is the longitudinal cross-section schematic diagram of the double-deck overlay film frame of the present invention in Fig. 3.As shown in Figure 3 and Figure 4, the proximal part of overlay film frame of the present invention includes double-deck overlay film, i.e. inner film coating 14, outer film coating 16.In inner film coating 14, have hole 17, the size of outer film coating 16 is greater than the size of inner film coating 14.The near-end of outer film coating 16 and far-end and inner film coating 14 fit tightly.
As shown in Figure 3 and Figure 4, overlay film frame of the present invention comprises: rack body 12; And cover the inner film coating 14 on described rack body 12.Described overlay film frame also comprises the outer film coating 16 of the close end office that is arranged on described rack body 12, described outer film coating 16 is positioned at the outside of described inner film coating 14, and the near-end of described outer film coating 16 and far-end closely adhere to described inner film coating 14, and in described inner film coating 14, have hole 17.As shown in Figure 4, blood is interior mobile in blood vessel wall 13 along the blood flow direction shown in Reference numeral 11.Due to the existence of hole 17, blood can enter the space between outer film coating 16 and inner film coating 14 by hole 17.Due to the existence of blood blood pressure, outer film coating 16 will be heaved formation compliant balloon, and is close on the speckle 15 of blood vessel.Meanwhile, rack body 12 is positioned at naked section of part outside outer film coating 16 and inner film coating 14 blood vessel wall 13 that also reclines, and the part that outer film coating 16 is not set of inner film coating 14 blood vessel wall 13 that also reclines.
Overlay film frame of the present invention has solved overlay film frame near-end and the bad I type internal hemorrhage due to trauma causing of blood vessel wall laminating.Overlay film frame of the present invention can be in the situation that the main body overlay film frame overall structure of prior art be constant increases one deck outer film coating and form at skin, can use like this and former the same production technology, do not improve technology difficulty, but but greatly reduce the risk of internal hemorrhage due to trauma, thereby product of the present invention has the market competitiveness more.
Below adopt three examples to further illustrate the solution of the present invention.
Example one:
Overlay film frame adopts double-deck structure of film.Outer film coating adopts ePTFE material (polytetrafluoroethylmaterial material) to form, and diameter is 22mm, and length is 25mm; Inner film coating adopts PET(polyethylene terephthalate) braiding structure formation, diameter is 20mm, and along inner film coating near-end, evenly has the circular opening 27 of 4 diameter 5mm, as shown in Figure 5.Inner film coating 24 covers on rack body 22.Blood can enter the space between outer film coating 26 and inner film coating 24 by hole 27.The near-end of the near-end of inner film coating 24 and outer film coating 26 adopts fusion technique to fuse together, and the far-end apart from its near-end 20mm place and outer film coating 26 of inner film coating 24 adopts fusion technique to fuse together.Due to the existence of blood blood pressure, outer film coating 26 will be heaved formation compliant balloon, and is close on blood vessel.
Example two:
Overlay film frame adopts double-deck structure of film.Outer film coating adopts PET(polyethylene terephthalate) braiding structure formation, diameter is 34mm, length is 35mm; Inner film coating adopts PET(polyethylene terephthalate) braiding structure formation, diameter is 30mm, and along inner film coating near-end, evenly has the circular opening of 6 diameter 6mm.Blood can enter the space between outer film coating and inner film coating by hole.The near-end of inner film coating and the near-end of outer film coating are sewed up by suture, and the far-end apart from its near-end 30mm place and outer film coating of inner film coating is sewed up by suture.Due to the existence of blood blood pressure, outer film coating will be heaved formation compliant balloon, and is close on blood vessel.
Example three:
Overlay film frame adopts double-deck structure of film.Outer film coating adopts PET(polyethylene terephthalate) braiding structure formation, diameter is 48mm, length is 45mm; Inner film coating adopts e-PTFE material (polytetrafluoroethylmaterial material) to form, and diameter is 44mm, and in inner film coating, at distance bracket near-end 10mm place, has the circular opening of 8 diameter 6mm.Blood can enter the space between outer film coating and inner film coating by hole.Inner film coating near-end and outer film coating near-end adopt fusion technique to fuse together, the fusing together apart from its near-end 40mm place and outer film coating far-end employing fusion technique of inner film coating.Due to the existence of blood blood pressure, outer film coating will be heaved formation compliant balloon, and is close on blood vessel.
Overlay film frame of the present invention can greatly reduce the risk of near-end internal hemorrhage due to trauma.And overlay film frame of the present invention can cover most aorta cases, can also reduce the use of other auxiliary appliance simultaneously, reduce operation risk and surgery cost.
In addition, should be appreciated that, overlay film frame of the present invention can be applied to the treatment of arotic disease, that is, it can be aorta tectorial membrane stent, but the invention is not restricted to this.Overlay film frame of the present invention also can be applied in the treatment of disease of other blood vessel.
In this application, " near-end " refers to the one end near heart.
The above is only some specific embodiments of the application.Should be understood that; for those skilled in the art; do not departing under the prerequisite of the present application principle and inventive concept; can also carry out various combinations or make some improvement and modification above-described embodiment, within these combinations, improvement and modification also should be considered as dropping on the application's protection domain and inventive concept.