Specific embodiment
In order to make the foregoing objectives, features and advantages of the present invention clearer and more comprehensible, with reference to the accompanying drawing to the present invention
Specific embodiment be described in detail.Many details are explained in the following description in order to fully understand this hair
It is bright.But the invention can be embodied in many other ways as described herein, those skilled in the art can be not
Similar improvement is done in the case where violating intension of the present invention, therefore the present invention is not limited to the specific embodiments disclosed below.
It should be noted that it can be directly another when element is referred to as " being fixed on " or " being set to " another element
On one element or there may also be elements placed in the middle.When an element is considered as " connection " another element, it can be with
It is directly to another element or may be simultaneously present centering elements.Term as used herein " vertically ", " level
", "left", "right" and similar statement for illustrative purposes only, be not meant to be the only embodiment.
Unless otherwise defined, all technical and scientific terms used herein and belong to technical field of the invention
The normally understood meaning of technical staff is identical.Term as used herein in the specification of the present invention is intended merely to description tool
The purpose of the embodiment of body, it is not intended that in the limitation present invention.Term " and or " used herein includes one or more
Any and all combinations of relevant listed item.
It should be noted that " proximal end " is proximal part, that is, close to one end of heart after being implanted into, " distal end " is in the application
Distal end, that is, far from one end of heart after being implanted into." axial direction " generally refers to length direction of the overlay film frame when being conveyed, " diameter
To " the overlay film frame direction vertical with its " axial direction " is generally referred to, and the either component of overlay film frame is defined according to this principle
" axial direction " and " radial direction ".
Referring to Fig. 1, the application first embodiment provide overlay film frame 10 include overlay film unit 11 and with overlay film unit
11 connected exposed units 12.The surface of overlay film unit 11 is pasted with diaphragm, forms closed tubular structure among both ends open,
When 10 implantable intravascular of overlay film frame, diaphragm on overlay film unit 11 can by the lesions such as aneurysm on blood vessel and blood every
Absolutely.It is not covered with diaphragm on exposed unit 12.Overlay film unit 11 includes first area 111, and first area 111 is set to overlay film unit
11 connect close to one end of exposed unit 12, first area 11 with exposed unit 12, and the rigidity of first area 11 is greater than exposed list
The rigidity of member 12.
Referring to Figure 2 together, the release process schematic for overlay film frame 10 by conveyer in blood vessel designated position.
As shown in A in Fig. 2, exposed unit 12 is strapped on the anchoring structure of conveyer, and overlay film frame 10 reaches blood vessel by conveyer
Designated position;The sheath of recession conveyer starts to discharge overlay film frame, as shown in B in Fig. 2, the proximal end of overlay film frame 10 portion
Point release, the proximal end of overlay film frame 10 is tapered, and only small part is attached on vascular wall, at this time the anchorage force of overlay film frame 10 compared with
It is weak, the proximal end of overlay film frame 10 can be made to be moved to accurate anchor station by operating conveyer;By the sheath of conveyer
Further recession, overlay film frame 10 further discharges, as shown in C in Fig. 2, the big portion in first area 111 of overlay film frame 10 at this time
Subregion is all adherent, is capable of providing biggish anchorage force, and support is able to bear certain axial force without shifting;Behaviour
Move back the proximal end of exposed unit 12 as conveyer, as shown in D in Fig. 2, the rigidity of exposed unit 12 is smaller, lesser axial force
Can so that the proximal end of exposed unit 12 moves back, at this time since the anchorage force of first area 111 is larger, overlay film frame 10 it is whole
Body will not be displaced, and the proximal end of overlay film frame 10 can attach to vascular wall, while the axial direction that 12 proximal end of exposed unit moves back
Power can be compensated by the bending of exposed unit 12;In this step, if position is not after 12 proximal end of overlay film unit is adherent
Accurately, it can also be returned to heavy after state shown in C in Fig. 2 by exposed 11 proximal end of unit that moves forward, recover part overlay film unit 12
New to adjust anchor station, after the anchoring of 111 proximal end of first area as shown in D in Fig. 2,10 proximal end of overlay film frame will not be released by subsequent
The influence of operation is put, finally discharges exposed unit 12 from conveyer, as shown in E in Fig. 2, shown in E and shown in D
It compares, 12 proximal end of overlay film unit will not move, i.e., overlay film frame 10 can be moved no longer, help to realize overlay film frame 10
Accurate release.
And in the prior art, in order to improve the anchorage force of exposed unit, the rigidity of exposed unit is generally larger than overlay film list
The rigidity of member or the rigidity of exposed unit can also be substantially equal to the rigidity of overlay film unit, referring to Fig. 3, being loaded into conveyer
Afterwards, when exposed unit is bound, the proximal end of overlay film unit will appear vacantly, and profile is curved surface (position of Fig. 3 arrow meaning),
When exposed unit is released, it is straight pipe type that overlay film unit proximal end, which is bonded its profile of blood vessel, therefore rear overlay film unit before releasing
Proximal end is variant in the axial direction, if being positioned with the proximal end of overlay film unit at this time, after bracket discharges completely, often leads to be anchored
It is inaccurate, such as stent anchors length caused by causing part covering aortic branch as proximal end Forward or being moved back as proximal end
It is insufficient;It is rigid due to exposed unit if move back the operation of bare bracket after locally release so that overlay film proximal end is anchored in advance
It spends larger, needs biggish axial force so that exposed unit bending, is likely to result in overlay film frame at this time and integrally moves back, and
Overlay film unit may be tilted with exposed unit junction, may generate the risk for scratching vascular wall.
The overlay film frame of the application, since the rigidity of exposed unit 12 is less than the rigidity of first area 111, in release process
In, exposed unit 12 can prevent overlay film frame 10 from discharging by deformation so that first area 111 is attached to vascular wall completely
Occur the risk shifted in the process, improves release precision;And since the rigidity of first area 111 is larger, can provide larger
Axial support force reduce the risk that is displaced after the implantation of overlay film frame 10.
In one embodiment, the rigidity of exposed unit 12 is A, and the rigidity of first area 111 is B, wherein 0.02≤A/B≤
0.8, if the value of A/B is too small, the rigidity of exposed unit 12 is smaller, is not enough to be fully deployed, and causes more difficult to solve from conveyer
It disengages and release failure.If the value of A/B is excessive, the rigidity of first area 111 is larger, larger to the stimulation of vascular wall, may
Cause the risk of damage vascular wall.Specific in the present embodiment, the rigidity B's of the rigidity A and first area 111 of exposed unit 12
Ratio is 0.03~0.5, i.e. 0.03≤A/B≤0.5.In other embodiments, the value of A/B can also for 0.10,0.15,
0.20,0.25,0.30,0.35,0.40,0.45 and 0.50 etc..In this application, rigidity is that measured section one end of bracket is solid
It is fixed, the other end along axis direction towards bracket when in fixing end compression process, compressing unit distance measured section axis
To counter-force.In one embodiment, in compression process, the rigidity of exposed unit 12 is 0.01~0.2N/mm.It should be noted that
In the application, A/B refers to the ratio in exposed unit 12 and rigidity of the first area 111 in same process, for example, both
Ratio in springback process.Rigidity is the mean rigidity in the region.
Referring to Fig. 1, overlay film unit 11 further includes first connect with first area 111 far from one end of exposed unit 12
Region 112, the rigidity of second area 112 are less than the rigidity of first area 111.Specifically, the rigidity A of exposed unit 12, first
The ratio of the rigidity C of the rigidity B and second area 112 in region 111, A:B:C=(0.02~0.8): 1:(0.4~0.9), it is exposed
The rigidity of unit 12 is smaller, can be by deformation so that first area 111 is sufficiently adherent, and first area 111 can provide larger
Anchorage force guarantee overlay film frame 10 be not displaced during exposed unit 12 moves back, second area 112 can be normal
Anchoring.Specific in the present embodiment, A:B:C=(0.03~0.5): 1:(0.5~0.8).In other embodiments, the value of A/B
Can also be 0.10,0.15,0.20,0.25,0.30,0.35,0.40,0.45 and 0.50 etc., the value of B/C can also for 0.50,
0.55,0.60,0.65,0.70,0.75 and 0.80 etc..
Please continue to refer to Fig. 1, the distal end end face of exposed unit 12 is overlapped with the proximal face of first area 111.Exposed list
Member 12 includes naked wave circle 121, and trough/wave crest of naked wave circle 121 is connect with the proximal end of first area 111, such as naked wave circle 121 exists
Wave trough position is sewn in the proximal face of first area 111 by suture.Naked wave circle 121 is by with good biocompatibility
Metal material (such as NiTi, stainless steel) constitute Z-type wave structure or other can radial compression constituted to lesser waveform.Scheming
In the embodiment shown, exposed unit 12 includes a naked wave circle 121, and the wave crest number of naked wave circle 121 is 3~8.In an embodiment
In, the wave crest number of naked wave circle 121 is 5~8.
Specifically, length of the exposed unit 12 on the axial direction of overlay film frame 10 is L1, the diameter of exposed unit 12
For D1, wherein 0.25≤L1/D1≤0.8, in the illustrated embodiment, i.e., the wave height of naked wave circle 121 and the diameter of naked wave circle 121
Ratio be 0.25~0.8.The value of L1/D1 is too small, and the length of exposed unit 12 is too short, and exposed unit 12 is when conveyer is dropped back
It is more difficult so that first area 111 completely it is adherent, influence the releasing effect of overlay film frame 10.The value of L1/D1 is excessive, exposed unit 12
Length it is too long, then will increase the risk that exposed unit 12 is pierced into branch vessel.In one embodiment, 0.3≤L1/D1≤0.7.
In another embodiment, 0.3≤L1/D1≤0.6.The ratio of L1/D1 can be 0.3,0.35,0.4,0.45,0.5 or 0.55
Deng.It should be noted that in the present embodiment, the curved surface where the outside circumference of exposed unit 12 is cylinder, exposed unit
12 diameter everywhere is equal, the diameter i.e. diameter of the cylinder of exposed unit 12.In other embodiments, exposed unit 12
Outside circumference where curved surface can also be other shapes, such as frustoconical, the diameter of exposed unit 12 is exposed unit 12
Average diameter.Length of the exposed unit 12 on the axial direction of overlay film frame 10 is also exposed unit 12 in overlay film frame.
Referring to Fig. 1, first area 111 includes at least one axially distributed proximal end wave circle 1111, proximal end Bo Quan
1111 constitute Z-type wave structure by the metal material (such as NiTi, stainless steel) with good biocompatibility or other can diameter
It is constituted to lesser waveform is compressed to.The wire that naked wave circle 121 and proximal end wave circle 1111 are all made of same material is made.Example
Such as, naked wave circle 121 and proximal end wave circle 1111 are woven by single titanium-nickel wire or are cut through NiTi pipe.Naked wave circle 121 is adopted
The sectional area S1 of wire, the sectional area for the wire that proximal end wave circle 1111 uses for S2, wherein 0.05≤S1/S2≤
0.8.Preferably, 0.10≤S1/S2≤0.8.The value of S1/S2 can also for 0.15,0.20,0.30,0.40,0.50,0.60 or
0.70 etc..By adjusting exposed unit 12 and the sectional area of the wire of first area 111, exposed unit 12 and the firstth area are realized
The different demands of 111 rigidity of domain.Certainly, the difference of the rigidity of exposed unit 12 and first area 111 can also be by adjusting two
Metal coverage rate of person etc. meets.
Length of the first area 111 on the axial direction of overlay film frame 10 is L2, and the diameter of first area 111 is D2,
Wherein 0.2≤L2/D2≤2, if the value of L2/D2 is too small, the part anchoring relatively difficult to achieve of first area 111, it is more difficult to by adjusting naked
The proximal end of dew unit 12 makes first area 111 completely adherent, if the value of L2/D2 is excessive, the length of first area 111 is larger,
Anchor region is excessive, may cause the position of the more difficult adjustment overlay film frame 10 during release.In one embodiment, 0.5≤
L2/D2≤1.5.The value of L2/D2 can also be 0.6,0.7,0.8,0.9,1.0,1.1,1.2,1.3 or 1.4 etc..In the present embodiment
In, the curved surface where the outside circumference of first area 111 is cylinder, and the diameter of first area 111 everywhere is equal, the firstth area
The diameter in the domain 111 i.e. diameter of the cylinder.Certainly, if curved surface where the outside circumference of first area 111 be diameter not
Equal structure, such as frustoconical, the diameter of first area 111 are the average diameter of the first area 111.
Please continue to refer to Fig. 1, cripetura occurs for first area 111 in order to prevent, also sets up between multiple proximal end wave circles 1111
There is axial connecting part 1112, axial connecting part 1112 connects two neighboring proximal end wave circle 1111.By the way that axial connecting part is arranged
1112, the axial strength of first area 111 can be improved, it can be to avoid the appearance when exposed unit 12 moves back of first area 111
Fold moves back phenomenon, further increases release precision.Axial connecting part 1112 can be more than or equal to two, two axial connecting parts
1112 can be uniformly distributed along the circumferential direction of first area 111.
Referring to Fig. 4, the overlay film frame 20 and the structure of overlay film frame 10 that the application second embodiment provides are essentially identical,
Difference essentially consists in, and the exposed unit 22 of overlay film frame 20 includes that multiple thread strands pass through the naked wave circle for twisting around or being knitted to form
221.Head and the tail both ends can be fixed together by multiple thread strands after the completion of twisting around or weaving by modes such as steel bushing or welding.
Specifically, multiple thread strands directly can be mutually entwined by more one metal wires;It is also possible to more one metal wires first
It is divided into several pieces, the radical of every part of wire is no less than 2, the wire of every portion is mutually first wound in one, then will be more
Stock wire twists around into one;Or multiple thread strands are also possible to have part metals silk and part macromolecule silk thread shuffling to form.?
In the present embodiment, exposed unit 22 by braiding or is twisted around using multiply titanium-nickel wire and to form naked wave circle 221, multiply titanium-nickel wire it is whole
External diameter is 0.2~0.5mm.
In one embodiment, exposed unit 22 is woven or is twisted around by 2~20 titanium-nickel wires and is made.It is single with same diameter
Titanium-nickel wire is compared, and the radical of titanium-nickel wire is fewer, and the rigidity of structure decline after weaving or twisting around is less, and winding stability is relatively low,
The radical of titanium-nickel wire is more, and the rigidity of structure decline after weaving or twisting around is larger, and winding stability is also preferable, but due to radical
More, the every diameter for participating in the titanium-nickel wire for weaving or twisting around also can be smaller, is easy fatigue fracture, may cause braiding or twists around
Structure fall apart.In one embodiment, exposed unit 22 is woven or is twisted around by 3~12 titanium-nickel wires and is made.In another embodiment
In, exposed unit 22 is woven or is twisted around by 3~8 titanium-nickel wires and is made.
In the illustrated embodiment, the sectional area for the wire that exposed unit 22 uses is all for circle, to improve its bending
Anti-fatigue performance.For the circular metal silk of identical material, rigidity is generally directly proportional to the biquadratic of its diameter, in order to obtain
Suitable rigidity, the diameter of each titanium-nickel wire are 0.05~0.2mm.In one embodiment, the diameter of each titanium-nickel wire is
0.07~0.12mm.
Referring to Fig. 5, the overlay film frame 30 and the structure of overlay film frame 10 that the application 3rd embodiment provides are essentially identical,
Difference essentially consists in, and exposed unit 32 extends to part covering first area 311, and exposed unit 32 is located at first area
311 outer surface.Exposed unit 32 can wrap the diaphragm of first area 311, can preferably avoid the firstth area in this way
There is the phenomenon that warpage in 311 proximal end of domain, reduces a possibility that overlay film frame 30 scratches vascular wall, reduces the wind of damage vascular wall
Danger.
Please continue to refer to Fig. 5, exposed unit 32 includes a naked wave circle 321, and first area 311 includes one near exposed
The first proximal end wave circle 3111 that unit 32 is arranged and the diaphragm 3113 that is covered on the first proximal end wave circle 3111, naked wave circle 321 and
First proximal end wave circle 3111 all has wave crest, trough and the wave bar for connecting peaks and troughs, and wave crest is to overlay film unit 31 far from naked
The distance for revealing the one end of the distance of one end of unit 32 than trough to overlay film unit 31 far from exposed unit 32 is bigger, naked wave circle
321 trough at least partly intersects with the trough of the first proximal end wave circle 3111, and naked wave circle 321 can be at wave trough position with first
The wave trough position of proximal end wave circle 3111 is fixed by modes such as sutures, and structure is more stable, can reduce naked wave circle 321 relative to covering
The risk that membrane support 30 shifts.In one embodiment, the first proximal end wave circle 3111 is located at the inner surface of diaphragm 3113, naked wave circle
321 are located at the outer surface of diaphragm 3113, it is possible to reduce the first proximal end wave circle 3111 scratches vascular wall, reduces first area
There is the risk of warpage in 311 proximal ends, and then reduce the risk of loss vascular wall.It should be noted that in other embodiments, the
One proximal end wave circle 3111 can also be folded between two diaphragms 3113, that is, the surfaces externally and internally of the first proximal end wave circle 3111 is all provided with
It is equipped with diaphragm 3113, such as PTFE membrane, the first proximal end wave circle 3111 is wrapped between diaphragm 3113 by being laminated.
Referring to Figure 6 together, the wave bar of naked wave circle 321 at the wave crest of the first proximal end wave circle 3111 with the first proximal end Bo Quan
3111 wave crest intersection, that is, the wave crest of the first proximal end wave circle 3111 can pressed against by the wave bar of naked wave circle 321, when naked wave circle 321
When being bound, the wave bar of naked wave circle 321 can press against the wave crest of the first proximal end wave circle 3111 to center curvature, preferably avoid
There is warpage in the wave crest of the first proximal end wave circle 3111 when the release of part, reduces during release to the stimulation of vascular wall.One
In embodiment, all wave crests of the first proximal end wave circle 3111 intersect with the wave bar of the naked wave circle 321.
Please continue to refer to Fig. 5, exposed unit 32 exposes the part of first area 311 on 30 axial direction of overlay film frame
Length is L3, and the diameter that exposed unit 32 exposes the part of first area 311 is D3, wherein 0.3≤L3/D3≤0.8.L3/D3
Value it is too small, the length that exposed unit 32 exposes the part of first area 311 is too short, exposed unit 32 when conveyer is dropped back compared with
Difficulty makes first area 311 completely adherent, influences the releasing effect of overlay film frame 30.The value of L3/D3 is excessive, and exposed unit 32 reveals
The length of first area 311 is too long out, then will increase the risk that exposed unit 32 is pierced into branch vessel.In one embodiment, 0.3
≤L3/D3≤0.7.In another embodiment, 0.3≤L3/D3≤0.6.The ratio of L3/D3 can for 0.3,0.35,0.4,
0.45,0.5 or 0.55 etc..It should be noted that in the present embodiment, exposed unit 32 exposes the part of first area 311
Curved surface where outside circumference is cylinder, and exposed unit 32 exposes the diameter of the part of first area 311 everywhere and is equal, naked
Reveal the diameter i.e. diameter of the cylinder that unit 32 exposes the part of first area 311.In other embodiments, exposed unit 32
Curved surface where exposing the outside circumference of the part of first area 311 can also be other shapes, such as frustoconical, exposed unit
32 diameters for exposing the part of first area 311 are the average diameter of the part.
Length of the exposed unit 32 on the axial direction of overlay film frame 30 is L1, wherein 0.1≤L3/L1 < 1.It is real one
It applies in example, 0.3≤L3/L1 < 1.In another embodiment, 0.3≤L3/L1 < 0.7.The value of L3/L1 can also be 0.4,0.5
Or 0.6 etc..The wave height (that is, the length of adjacent peaks and trough on overlay film frame axial direction) of naked wave circle 321 be 5~
20mm, in the present embodiment, the wave height of naked wave circle 321 are length of the exposed unit 32 on the axial direction of overlay film frame 30
L1, i.e. 5mm≤L1≤20mm.If wave height is too low, the wave number of naked wave circle 321 is more, and the dress sheath that will increase overlay film frame 30 is difficult
Degree, if wave height is too high, the wave number of naked wave circle 321 is less, influences the adherent effect of naked wave circle 321.In one embodiment, naked wave
The wave height of circle 321 is 8~12mm.
Each technical characteristic of embodiment described above can be combined arbitrarily, for simplicity of description, not to above-mentioned reality
It applies all possible combination of each technical characteristic in example to be all described, as long as however, the combination of these technical characteristics is not deposited
In contradiction, all should be considered as described in this specification.
The embodiments described above only express several embodiments of the present invention, and the description thereof is more specific and detailed, but simultaneously
It cannot therefore be construed as limiting the scope of the patent.It should be pointed out that coming for those of ordinary skill in the art
It says, without departing from the inventive concept of the premise, various modifications and improvements can be made, these belong to protection of the invention
Range.Therefore, the scope of protection of the patent of the invention shall be subject to the appended claims.