Background technology
Minimally Interventional Therapy refers to when not operating on, skin, blood vessel do the passage aisle of diameter several millimeters, or by the original pipeline of human body, under the guiding of image documentation equipment, the Therapeutic Method minimum to the focus local wound for the treatment of, its therapeutic device used generally includes sheath pipe induction system.
Sheath pipe induction system generally includes outer sheath and interior sheath pipe, for blood vessel access, outer sheath extends along human vas passage, build one arrives focus path for implantation instrument, that is: implantation instrument enters outer sheath from outer sheath proximal port, and prolong and be released into correct position through outer sheath from the far distance port of outer sheath, focus local is treated, reaches the object of disease therapy.In implantation instrument dispose procedure, as the case may be, sometimes need to discharge and the implantation instrument launched is retracted in outer sheath again, particularly in operation, run into emergency situation, must race against time and regain implantation instrument as early as possible.
But existing for carrying, the conveying outer sheath of implantation instrument is many to be manufactured by macromolecular material, although the attribute performance of macromolecular material is good, its elasticity and intensity poor.At present, although also having to adopt is applied in macromolecular material by reinforcement material, such as weave webmaster, or elastic tube does and strengthens, macromolecular material peplos is formed outer sheath inside and outside reinforced pipe, but above-mentioned measure all only increases fold resistance and the pressure-bearing property of outer sheath, and the implantation instrument run into when obviously solving outer sheath withdrawal implant is difficult to back enter, the problem of sheath pipe fold.
As shown in Figure 1, due in implantation process, more smooth and easy when entering human body to make outer sheath 10, the diameter of the outer sheath 10 of carrying implant 20 must to coordinate with implant 20 in the compactest mode to be selected.If need in operation, the implant 20 discharging expansion is reclaimed, and in heart, now discharge implant 20 demi-inflation of expansion, state when volume is uncompressed, meanwhile, the recovery power being given to distal head 101 port from outer sheath 10 handle due to operation doctor is limited, distal head 101 port of adding outer sheath 10 is tiny, elastic force is limited, if reclaim by force under these conditions, the internal friction of outer sheath 10 will be very large, thus cause outer sheath 10 distal head 101 fold, bending, cannot complete.
Therefore, existing clinical outer sheath, because its elasticity is bad or shape restore funcitons is not strong, axial support intensity is weak, if reclaim implantation instrument by force, then the outer sheath far-end mouth of pipe has the situation of tearing to occur, or mouth of pipe expansion, cannot meet in intervene operation the requirement of regaining and discharging implantation instrument.
Summary of the invention
Main purpose of the present invention is to provide a kind of and has stronger radial elastic and axial support intensity, can safely, fast regain the multiple tube discharging implant and the intervention apparatus conveying system comprising this multiple tube in intervene operation.
In order to achieve the above object, the present invention proposes a kind of multiple tube, and this multiple tube comprises the internal layer, enhancement Layer and the skin that set gradually, and enhancement Layer is placed between ectonexine, it is characterized in that, described enhancement Layer one end is the structure with axial support power and radial elastic; Described internal layer and skin are the lubrication elastomer of identical or different macromolecular material.
Preferably, described end is the lattice structure with axial support power.
Preferably, described lattice structure radially rounding state.
Preferably, described lattice structure grid length from the termination of described end vertically in progressive shortening.
Preferably, described lattice structure be processed by Nitinol pipe there is hyperelastic structure.
Preferably, described enhancement Layer and described inside and outside layer are bondd by heat fusing or binding agent mode; Or described inside and outside layer is combined with described enhancement Layer by immersion or sprayed coating mode.
Preferably, described lattice structure is that nitinol alloy wire braiding forms, and it is axially at least provided with a supporting wire.
Preferably, described enhancement Layer, along described tubular axle combined interior extension, also comprises second segment and strengthens structure, is specially the spring structure of spring structure or band reinforcement, is connected with the enhancement Layer of described termination.
Preferably, also comprising the 3rd section and strengthen structure, is the reinforcement of more than arranged vertically.
Preferably, described mesh shape is at least rhombus or rectangle.
The present invention also proposes a kind of intervention apparatus conveying system, and comprise outer sheath and interior sheath pipe, described outer sheath adopts multiple tube as above.
Preferably, the surface of described outer sheath scribbles hydrophilic coating.
A kind of multiple tube that the present invention proposes and comprise the intervention apparatus conveying system of this multiple tube, this multiple tube is as the outer sheath of apparatus induction system, in its distal head adopts, in, outer three-decker, wherein, middle level is enhancement Layer, this enhancement Layer one end is the structure with axial support power and radial elastic, internal layer and skin are the lubrication elastomer of identical or different macromolecular material, thus, the far-end of outer sheath is made to have superpower radial elastic power and axial support intensity, in addition, at multiple tube enhancement Layer, at least one supporting wire is set, enhancement Layer is along tubular axle combined interior extension simultaneously, also comprise second segment reinforcement structure to be connected with the enhancement Layer of described termination, structure is strengthened with the 3rd section of reinforcement, further increase the axial support intensity of outer sheath, when reclaiming implant, outer sheath distal tube notch portion can bear very large tension force, axially there is not fold, and implant reclaims successfully, outer sheath distal tube shape can not change, and bending easily, therefore, safety in intervene operation is achieved by said structure, quick withdrawal has discharged the object of implant.
Detailed description of the invention
The solution of the embodiment of the present invention is mainly: the outer sheath of intervention apparatus conveying system adopts multiple tube, in this multiple tube adopts, in, outer three-decker, wherein, middle level is enhancement Layer, one end of this enhancement Layer is the structure with axial support power and radial elastic, internal layer and skin are the lubrication elastomer of identical or different macromolecular material, to make outer sheath far-end, there is superpower radial elastic power and stronger axial support intensity, in addition, at multiple tube enhancement Layer, at least one supporting wire is set, enhancement Layer is along tubular axle combined interior extension simultaneously, also comprise second segment reinforcement structure to be connected with the enhancement Layer of described termination, structure is strengthened with the 3rd section of reinforcement, the axial support intensity of further increase outer sheath.
As shown in Figure 2, Fig. 2 is the structural representation of multiple tube first embodiment of the present invention.
A kind of multiple tube 1 that the present embodiment proposes, as the outer sheath of intervention apparatus conveying system, this multiple tube 1 comprises: the internal layer 11 that the radial direction along multiple tube 1 sets gradually from the inside to the outside, enhancement Layer 12 and outer 13, wherein, an end of enhancement Layer 12 is the structure with axial support power and radial elastic; Internal layer 11 and outer 13 is the lubrication elastomer of identical or different macromolecular material, such as internal layer 11 adopts PTFE (Poly tetra fluoro ethylene, politef) macromolecular material, outer 13 adopt PU (Polyurethane, polyurethanes, is called for short polyurethane), the material such as Pebax (A Kema nylon elastomer), PE (polyethylene), Nylon (nylon).The head of multiple tube 1 enhancement Layer 12 adopts has super-elasticity and the very large material of extension rate, the materials such as such as Latex, silicone (silicone plasties) and PU.
Above-mentioned inside and outside layer 11,13 and enhancement Layer 12 can adopt multiple combination, and such as enhancement Layer 12 and inside and outside layer 11,13 are bondd by heat fusing or binding agent mode; Or inside and outside layer 11,13 realizes combining with enhancement Layer 12 layers by immersion or sprayed coating mode.
In the present embodiment, an end of enhancement Layer 12 is the lattice structure with axial support power, and its lattice structure is rounding state along the radial direction of multiple tube 1, and mesh shape can be rhombus, rectangle etc.
The lattice structure of enhancement Layer 12 can be the elastic reinforcement layer 12 that cutting is formed, and what be cut into as Nitinol pipe has hyperelastic lattice structure, or the lattice structure woven for nitinol alloy wire.Be in radial rounding state due to lattice structure and be placed between inside and outside layer 11,13, enhancement Layer 12 is expanded because lattice structure can comply with inside and outside layer 11,13, promote because the strong layer of Nitinol pipe has shape memory function after expansion to reset, considerably increase the toughness of the radical elasticity of multiple tube 1 thus; Meanwhile, because the diamond-shaped element of lattice structure is in contraction state, make multiple tube 1 axial direction just as a metal pipe sleeve, effectively prevent the generation of outer sheath distal head fold situation.
As shown in Figure 3, Fig. 3 is the structural representation of multiple tube second embodiment of the present invention.
The present embodiment is similar to above-mentioned first embodiment, its difference is, in the present embodiment, the enhancement Layer 12 of multiple tube 1 is elastic weaving lattice structure, specifically can adopt the lattice structure that nitinol alloy wire weaves, meanwhile, a supporting wire 14 is at least provided with at enhancement Layer 12 along the axis of multiple tube 1.According to the needs of multiple tube 1 axial support power, the supporting wire 14 in enhancement Layer 12 can be two, three or more.
In use, as shown in Figure 4, Fig. 4 is the nozzle structure schematic diagram regaining implantation instrument 2 in the present embodiment.An end portion of above-mentioned multiple tube 1 is in whole outer sheath distal head, by in implantation instrument 2 withdrawal process, the mouth of pipe elasticity of multiple tube 1 is opened in bell mouth shape, implantation instrument 2 is not only made easily to get back to outer sheath, but also precommpression implantation instrument 2 (as shown in broken section in Fig. 4 15), implantation instrument 2 is shunk in progressive pattern, reduce and regain resistance, implantation instrument 2 is impelled to regain smoothly, and axially can not buckling phenomena be there is in outer sheath distal head, the present embodiment, by arranging supporting wire 14 in enhancement Layer 12, enhances the axial support power of outer sheath.
As shown in Figure 5, Fig. 5 is the structural representation of multiple tube of the present invention 3rd embodiment.
The present embodiment is similar to above-mentioned second embodiment, its difference is, in the present embodiment, extended along in multiple tube 1 axle by enhancement Layer 12, also comprise second segment and strengthen structure 111, wherein, it is be arranged on the lattice structure that Nitinol pipe cuts or nitinol alloy wire weaves near the distal head of outer sheath that enhancement Layer 12 strengthens structure as first paragraph, it is stainless steel spring structure that second segment strengthens structure 111, is connected with the first paragraph enhancement Layer 12 of described termination.
Said structure, makes outer sheath entirety have better bending pliability, have better axial support power simultaneously, and implantation instrument can be made to regain smoothly, and outer sheath distal head axially buckling phenomena can not occur.
It should be noted that, in the present embodiment, the stainless steel spring structure of second segment reinforcement structure 111 also can be replaced by the spring structure of band reinforcement, can reach the effect strengthening outer sheath integrally bending pliability and axial support power equally.
As shown in Figure 6, Fig. 6 is the structural representation of multiple tube of the present invention 4th embodiment.
The present embodiment is similar to above-mentioned 3rd embodiment, its difference is, it is that at least one reinforcement 3 arranged vertically is coaxially arranged with above-mentioned stainless steel spring structure that the second segment that in the present embodiment, multiple tube 1 comprises strengthens structure 111, its reinforcement 3 length is less than spring structure and strengthens structure, or to strengthen structure length suitable with spring structure; Spring structure is strengthened structure and is connected with the first paragraph enhancement Layer 12 of termination described in it.
There is the multiple tube 1 of the stainless steel spring structure of band reinforcement 3, when using as outer sheath, effectively can strengthen the pardon of outer sheath, and due to the bending property of spring very good, can to the random bending of different directions, thus effectively solve outer sheath in prior art and to contain after implant tube wall fold, damaged phenomenon after dilatating and deformable and bending stretch.And reinforcement 3 enhances the radial force of outer sheath greatly, reclaim at intervene operation in the process of implant, can not there is buckling phenomena in the tube wall of outer sheath, can better reclaim implant.
As shown in Figure 7, Fig. 7 is the structural representation of multiple tube of the present invention 5th embodiment.
Multiple tube 1 in the present embodiment is similar to above-mentioned 4th embodiment multiple tube 1, its difference is, in the present embodiment, multiple tube 1 also comprises the 3rd section and strengthens structure, for at least one reinforcement 4 arranged vertically, reinforcement 4 and the above-mentioned second segment stainless steel spring structure strengthened in structure 111 are coaxially arranged stretches out from the external port of stainless steel spring structure, be arranged in the common tube of multiple tube 1 rear end, thus, the reinforcement 3 strengthened the reinforcement 4 of structure and second segment strengthen in structure 111 by the 3rd section, while guarantee multiple tube 1 compliance, enhance the radial force of multiple tube 1 greatly.
When multiple tube 1 uses as outer sheath, because whole outer sheath is in the process reclaiming implanted object, the radial direction of outer sheath is by very large power, divide still like this in the very long portion of outer sheath near-end, in the prior art, outer sheath rear end part interlayer is suppressed by mesh grid to form, it can not carry very large radial force, and the present embodiment outer sheath is far away, in, in near-end adopts, in, the multiple tube 1 of outer three-decker, and segmentation vertically adopts the different enhancement Layer of band thus achieves in intervene operation quick in multiple tube 1, the object of the implant that safe withdrawal has discharged.
As shown in Figure 8, Fig. 8 is enhancement Layer end view in multiple tube of the present invention 6th embodiment.
The present embodiment can combine with the various embodiments described above and implement, on the basis of the various embodiments described above, the grid length of the lattice structure in the present embodiment from the termination of enhancement Layer 12 end vertically in progressive shortening, as shown in Figure 8, the lattice structure of enhancement Layer 12 end comprises L1, L2 and L3 tri-sections of grids vertically from outside to inside, these three sections of grid length are from termination interior progressive shortening, the i.e. L3<L2<L1 vertically of enhancement Layer 12 end.This kind of enhancement Layer 12 structure is while the axial support power and radial elastic of further reinforced composite pipe end, and formation horn mouth is easily opened in front end.
In addition, the present invention also proposes a kind of intervention apparatus conveying system, comprises outer sheath and interior sheath pipe, and wherein, outer sheath adopts the multiple tube 1 described in above-described embodiment.The construction features of this multiple tube 1 please refer to the various embodiments described above, does not repeat them here.
As a kind of embodiment, the surface of above-mentioned outer sheath can scribble hydrophilic coating, to strengthen outer sheath smoothness of the surface; Scribble the outer sheath water of hydrophilic layer moistening after, there is the smooth of similar Misgurni anguillicaudati surface.
Embodiment of the present invention multiple tube 1 and comprise this multiple tube 1 intervention apparatus conveying system, this multiple tube 1 is as the outer sheath of apparatus induction system, in its distal head adopts, in, outer three-decker, wherein, middle level is enhancement Layer 12, this enhancement Layer 12 1 end is the structure with axial support power and radial elastic, internal layer 11 and outer 13 is the lubrication elastomer of identical or different macromolecular material, thus, the far-end of outer sheath is made to have superpower radial elastic power and axial support intensity, in addition, also comprise second segment spring structure reinforcement structure to be connected with the enhancement Layer 12 of described termination, structure is strengthened with the 3rd section of reinforcement, further increase the axial support intensity of outer sheath, when reclaiming implant, outer sheath distal tube notch portion can bear very large tension force, axially there is not fold, and implant reclaims successfully, outer sheath distal tube shape can not change, and bending easily, therefore, safety in intervene operation is achieved by said structure, quick withdrawal has discharged the object of implant.
The foregoing is only the preferred embodiments of the present invention; not thereby the scope of the claims of the present invention is limited; every utilize description of the present invention and accompanying drawing content to do equivalent structure or flow process conversion; or be directly or indirectly used in other relevant technical field, be all in like manner included in scope of patent protection of the present invention.