Overlay film frame and overlay film frame system
Technical field
The present invention relates to medical instruments fields, and in particular to a kind of overlay film frame and overlay film frame system.
Background technique
Aorta pectoralis endovascular repair (Thoracic endovascular aortic repair's, TEVAR) makes
Radical change has occurred in the therapeutic strategy of the vascular diseases such as artery dissection and aneurysm.In recent years, both at home and abroad outside some blood vessels
Section center begins trying to treat using the technology tired on the basis of skillfully grasping TEVAR technology treatment bow descending aorta disease
And the arterial disease in bow portion.This kind of disease is often caused by stent anchors area is insufficient or lesion involves branch vessel, in operation
It needs to discharge aorta tectorial membrane stent from aorta ascendens, thus covering part branch, at this time in order to guarantee to bend top set's blood vessel
Blood supply is just produced after surgery, needs to be implanted into one or more branch stents to rebuild capped bow top set.
There are many reconstruction techniques of branch vessel, wherein parallel chimney support technology is due to intracavitary technology and equipment preparation
It is required that lower and popularized.But due to aortic stents and bifurcated artery bracket (also known as " chimney bracket ") Cheng Ping
Row arrangement, inevitably gap between bracket, easily causes leakage in I type.As shown in Figure 1, the chimney of the prior art
Bracket 02 and main body rack 01 are the uniform cylindrical structure of overall dimensions, and this support assorted generates the interior risk leaked very
It is high.As shown in Fig. 2, the extruding by vascular wall can generate contraction deformation after main body rack 01 and chimney bracket 02 are implanted into,
The position that main body rack 01 and chimney bracket 02 contact, main body rack 01 can generate the deformation of local inner concave, thus can be two
A marginal position directly fitted generates biggish gap.As shown in dash area in Fig. 2, blood is easy to through gap, from
And generate and leaked in I type, influence therapeutic effect.At the same time, it is maximum when main body rack 01 and chimney bracket 02 are bonded in the blood vessels
Adaptability to changes concentrate on the position of 01 indent of main body rack, local deformation amount is big herein, be easy to cause stress to concentrate, from medium-long term
From the point of view of, it is the high risk point that fatigue fracture occurs for bracket herein.Therefore, the chimney bracket 02 with main body rack 01 of the prior art are matched
Closing is reduced using the fatigue behaviour that will lead to main body rack 01.In addition, 02 main part internal diameter of chimney bracket itself is smaller, by
When the extruding of main body rack 01, chimney bracket 02 is further compressed, and from the point of view of long term, 02 proximal end of chimney bracket is squeezed laminate section
It is possible that there is the narrow risk even occluded, and it is insufficient so as to cause branch vessel supply of blood flow, influence the health of patient very
To being life security.
Based on this, it is necessary to design a kind of overlay film frame system that not will cause interior leakage with the use of after.
Summary of the invention
The present invention provides a kind of overlay film frame, including first support section and second support section, the first support section
Distal end is connected with the proximal end of the second support section;The area of first support section cross section is by proximal end to distally gradually small;Institute
Stating first support section includes the first cambered surface and the second cambered surface, and first cambered surface is enclosed tubular structure with the second arc, together
The radius of first cambered surface is less than the radius of second cambered surface on one cross section.
In one embodiment, the hardness of first cambered surface is greater than the hardness of second cambered surface.
In one embodiment, the distal end of the first support section passes through the proximal end phase of a linkage section and the second support section
Even, the annular overlay film section that the linkage section is recessed for the central axis of outer surface towards the second support section.
In one embodiment, the second support section for hollow cylindrical structure and has a central axis, and described second
Projection of the brace sections on the perspective plane perpendicular to the central axis is inscribed within first cambered surface on the perspective plane
Projection.
In one embodiment, projection of the second support section on the perspective plane and first cambered surface are in the throwing
The midpoint of projection on shadow face is tangent.
In one embodiment, first cambered surface and the bending direction of second cambered surface are identical or opposite.
In one embodiment, second cambered surface is plane.
The present invention also provides a kind of overlay film frame system, including main body rack and branch stent, the branch stent is
Any of the above-described overlay film frame.
In one embodiment, the radius of the radius of the first cambered surface of the branch stent and the main body rack proximal openings
It is equal.
In one embodiment, the hardness of second cambered surface is less than the hardness of the main body rack.
Overlay film frame provided by the invention includes first support section and second support section, by the way that first support section to be designed to
The area of first support section cross section is by proximal end to distally gradually small, and first support includes the first cambered surface and the second cambered surface, same
Radius of the radius of first cambered surface less than the second cambered surface on cross section.Present invention simultaneously provides overlay film frame system include aforementioned
Overlay film frame and main body rack reduced so that fitting is close therebetween after the overlay film frame and main body rack are used cooperatively
The generation of interior leakage, while can guarantee there is sufficient blood to flow into branch vessel.
Detailed description of the invention
Fig. 1 and Fig. 2 is structural schematic diagram when the main body rack of the prior art and chimney support assorted use;
Fig. 3 is the overlay film frame overall structure diagram of the embodiment of the present invention one;
Fig. 4 is overlay film frame side view shown in Fig. 3;
Fig. 5 is overlay film frame partial enlarged view shown in Fig. 4;
Fig. 6 is overlay film frame main view shown in Fig. 3;
Fig. 7 a and Fig. 7 b are the overlay film frame front view of other embodiments of the present invention;
Fig. 8 is the overlay film frame system of one embodiment of the invention, includes overlay film frame shown in Fig. 3;
Fig. 9 is the front view of overlay film frame system shown in Fig. 8;
Figure 10 is the overlay film frame overall structure diagram of the embodiment of the present invention two;
Figure 11 is the top view of overlay film frame shown in Figure 10;
Figure 12 is the main view of overlay film frame shown in Figure 10;
Figure 13 is the overlay film frame system of another embodiment of the present invention, includes overlay film frame shown in Fig. 10;
Figure 14 is the overlay film frame of another embodiment of the present invention.
Specific embodiment
Technical scheme and beneficial effects for a better understanding of the invention do further the present invention below in conjunction with attached drawing
For example, following specific embodiments are only part preferred embodiment, not limitation of the present invention.
In medical instruments field, defining the direction that blood flow flows into is " proximal end ", and the direction of blood outflow is " distal end ".It is following
It is alleged " connected ", it can be and be directly connected between two components, can also be connected by third component.
Overlay film frame of the invention includes supportive body and overlay film, and overlay film is set on supportive body, i.e., overlay film can be set to branch
Support body interior and/or outside.Supportive body both ends are equipped with opening, and the open communication at both ends.Supportive body can be by compiling
The reticular structure that silk is knitted to form is knitted, multiple carrier units that tubing formation is cut by laser first, Duo Gezhi are also possible to
Frame unit is connected again constitutes supportive body.Supportive body should have good support performance and shape-memory properties, and material is optional
For Nitinol.Overlay film can be made of the good high molecular material of biocompatibility, such as PET or PTFE.For convenience of description, with
Lower attached drawing does not distinguish supportive body and overlay film, only shows the overall profile structure of overlay film frame.
In addition, overlay film frame system of the invention includes main body rack and branch stent, wherein branch stent is the present invention
Overlay film frame, for providing blood for branch vessel;Main body rack is the hollow tubular structure for being used to support aorta inner wall,
It also include supportive body and overlay film.
Embodiment one
As shown in Figures 3 to 6, the overlay film frame 100 of the present embodiment include first support section 10, second support section 20 and
Linkage section 30.Wherein, the distal end of first support section 10 and second support section 20 are connected proximally by linkage section 30.Second support
Section 20 provides blood flow for being implanted into branch vessel for branch vessel.Second support section 20 is hollow cylindrical structure and has one
Longitudinal center axis, the range of cylinder radius R20, R20 can be 3mm~10mm.
The area of the cross section of first support section 10 is all larger than proximally to distally gradually becoming smaller in addition to the end face of distal end
The area of the cross section of two brace sections 20.First support section 10 is enclosed to set and be formed by the first cambered surface 11 and the second cambered surface 12, and first
Rounding off between cambered surface 11 and the second cambered surface 12.In addition, the radius R11 of 12 proximal end of the first cambered surface should be less than the second cambered surface proximal end
Radius R12.In this way, the curvature of the second cambered surface 12 is smaller, it is ensured that when overlay film frame is used together with main body rack,
The upper deformation amount of the second cambered surface 12 and main body rack that contact with each other is small, fits closely therebetween, it is possible to reduce interior leakage
Generation.R11's may range from 10~23mm, when predominantly guarantee overlay film frame 100 and main body rack are used cooperatively, first
Cambered surface 11 and the undeformed part of opposite main body rack form complete circle to comply with blood vessel, and interior leakage is avoided to occur;
The value range of R12 can be R12 >=14mm, while guarantee R12 > R11.It, can when the second cambered surface 12 is plane shown in fig. 6
To think R12 for infinity.
It is understood that in other embodiments, the second cambered surface 12a can be structure, i.e. the second arc shown in Fig. 7 a
Face 12a is identical as the bending direction of the first cambered surface 11a, and the two is towards same lateral bend namely the first cambered surface 11a relative to central axis
Line outwardly protrudes, and the second cambered surface 12a is recessed inwardly relative to central axis;Alternatively, the second cambered surface 12b may be shown in Fig. 7 b
Structure, i.e., the bending direction of the second cambered surface 12b and the first cambered surface 11b on the contrary, the two towards to lateral bend namely the first cambered surface
11b and the second cambered surface 12b are outwardly protruded both with respect to central axis, even if at this point, the second cambered surface 12b is to protrude from central axis
, but half due to the second cambered surface 12b is greater than the radius of the first cambered surface 11b, and cooperation main body rack is in use, the second cambered surface
12b remains to fit closely with the outer surface of main body rack, reduces the interior generation leaked.
When in order to be used cooperatively overlay film frame 100 and main body rack, the second cambered surface 12 can better adapt to main body rack
Shape, the hardness of the first cambered surface 11 is set greater than to the hardness of the second cambered surface 12.In this way, the second cambered surface can be made
12 are easier to deform compared to the first cambered surface 11, and the first cambered surface 11 can preferably keep the shape of 10 proximal openings of first support section
Shape guarantees that blood can be flowed into smoothly.Two cambered surface hardness it is different can by control count or the string diameter of braided wires come
It realizes, the count of the first cambered surface 11 can such as be made to be greater than the count of the second cambered surface 12 or the braided wires of the first cambered surface
String diameter be greater than the second cambered surface braided wires string diameter.For by cutting formed bracket, can equally take it is identical or
Similar means.
As shown in Figure 4, the bus of second support section 20 can be tangent with the arc apex of the first cambered surface 11 namely Fig. 6 is shown
Projection of the second support section 20 on the perspective plane perpendicular to center axis thereof be inscribed within the first cambered surface 11 on the perspective plane
Projection.In this way gap can be formed to avoid between first support section 10 and blood vessel.In the present embodiment, which is the first cambered surface
The midpoint of 11 projections.Then A, the range of A may be greater than 0 ° and be less than or equal to second cambered surface 12 at an angle with central axis
50°.After the radius R20 of second support section 20 is determined, the range of angle A is mainly close by the first cambered surface 11 in first support section 10
Hold to the first cambered surface 11 in 10 proximal face of distance L11 and first support of distal end midpoint and the second cambered surface 12 midpoint it
Between distance H determine.Preferably, the range of L11 is 15mm≤L11≤20mm.L11 is unsuitable too long or too short, and L11 is greater than
After 20mm, when overlay film frame and main body rack are used cooperatively, fitting part between the two will be corresponding elongated, is easy to increase
Add the risk of interior leakage;If L11 be less than 15mm will lead to anchoring curtailment of the overlay film frame on main body rack again, influence using
Performance.And the range of H is chosen as the radius R11 less than 11 proximal end of the first cambered surface but is greater than the diameter i.e. 2* of second support section 20
R20.H needs the diameter greater than second support section 20 just to can guarantee the normal blood supply of branch vessel;Meanwhile if H is excessive, first
10 proximal openings of frame are excessive, this meeting is so that main body rack blood flow entrance reduces relatively, to influence aorta main body vascular flow
Supply.So H should be less than the radius R11 of 11 proximal end of the first cambered surface.
As shown in Figure 4 and Figure 5, linkage section 30 is annular overlay film section, and without supportive body at this, to facilitate first support section
It is relatively movable between 10 and second support section 20, improve the whole compliance of overlay film frame 100.The outer surface of linkage section 30 is court
The concave surface being recessed to 20 central axis of second support section, is set as concave surface for linkage section 30, heap can occur to avoid overlay film herein
Product.And the axial length L 30 of linkage section 30 can not be too long, because linkage section 30 is easy if L30 is too long herein without supportive body
By vascular compression or accumulation is generated, causes blood access narrow, is unfavorable for blood circulation.Therefore, the length of L30 is chosen as being less than
The one third length of L11.It is understood that in other embodiments, it can also be not provided with linkage section, first support section
Distal end and the proximal end of second support section are directly connected to.
Fig. 8 and Fig. 9 shows the overlay film frame system 300 of the overlay film frame 100 comprising the present embodiment, and the present embodiment covers
Effect of the membrane support 100 in overlay film frame system 300 mainly guarantees the normal blood supply of branch vessel, therefore, overlay film frame 100
Alternatively referred to as branch stent 100.Overlay film frame system 300 further includes the main body rack 200 for being used to support aorta.Main body rack
200 proximal openings are circle.
When using overlay film frame system 300, it is necessary first to main body rack 200 are implanted to target position, replanted into branch
Bracket 100 needs to guarantee that branch stent 100 is flushed with the proximal face of main body rack 200 at this time, and branch stent 100 will not be by
Main body rack 200 shrivels completely can flow into branch stent 100 with guarantee section blood.Main body rack 200 and branch stent 100 are equal
After implantation, second support section 20 is located in branch vessel, the second cambered surface 12 and the big curved side of main body rack 200 of first support section 10
Outer surface be in contact, and there is a degree of deformation in the two.
Compared to the prior art, the first support 10 of branch stent 100 of the invention is proximally facing similar of big opening
The shape of " funnel ", the contact surface between the second cambered surface 12 and main body rack 200 is bigger, and main body rack 200 not will form part
Indent largely reduces the local maxima dependent variable of main body rack 200, avoids stress from concentrating, to greatly improve main body
The fatigue life of bracket 200.In addition, the part and the of branch stent 100 that main body rack 200 is not contacted with branch stent 100
The combined outer profile of one cambered surface 11 be it is approximate circle or oval, blood can be respectively from the proximal openings of main body rack 200
It is flowed into the proximal openings of branch stent 100.Preferably to avoid interior leakage, preferably the radius R11 of the first cambered surface 11 and main body branch
200 proximal openings radius R200 of frame is equal, to comply with vascular cross-section shape.Further, the hardness of the second cambered surface 12 may be used also
To be set smaller than the hardness of main body rack 200, the second cambered surface 12 is easier to deform, the adaptation with 200 outer surface of main body rack
Property it is more preferable, prevent in leakage effect it is also more preferable.Meanwhile also needing the blood for guaranteeing to enter 200 part of main body rack sufficient, therefore, limit
After branch stent 100 and main body rack 200 are implanted into, the area of 100 proximal openings of branch stent is no more than 200 proximal end of main body rack
The half of opening area.Meanwhile it is sufficient in order to guarantee branch vessel blood supply, and the blood supply of main body rack part is not influenced, first
Brace sections proximal openings area S is limited to S1 < S≤3*S1, and wherein S1 is second support section proximal openings area.
To sum up, the overlay film system and the prior art of the overlay film frame of the present embodiment and the overlay film frame comprising the present embodiment
It compares, by the way that the structure including first support section and second support section, and first support section cross section is arranged in overlay film frame
Area by proximal end to distally gradually small, and first support includes the first cambered surface and the second cambered surface, the first cambered surface on same cross section
Radius less than the second cambered surface radius so that fitting therebetween is more after the overlay film frame and main body rack are used cooperatively
Closely, the generation of interior leakage between overlay film frame and main body rack can be greatly reduced, while can guarantee the blood stream for having sufficient
Enter branch vessel.
Embodiment two
As shown in Figure 10 to Figure 12, the overlay film frame 400 of the present embodiment and 100 structure of overlay film frame of embodiment one are basic
It is identical, it the difference is that only first support section.The proximal face and second support section 50 of the first support section 40 of the present embodiment
Central axis between form certain angle, the angle be acute angle.The first support section 40 of the present embodiment is considered as to implement
It is formed after 100 proximal end of overlay film frame beveling a part of example one.It can be seen that 40 two sides of first support section from the top view of Figure 11
Length L1 and L2 it is unequal, i.e., there is length difference Δ L therebetween, Δ L value can be 0~15mm, preferably 5~10mm.
Δ L is the overlay film frame 100 of 0 when, that is, embodiment one.Meanwhile guaranteeing the value range and one phase of embodiment of short side in L1 and L2
Together, i.e., within the scope of 15mm~20mm.It should be appreciated that the present invention do not limit in 40 two sides of first support section which side be long side which
Side is short side, as long as two side lengths meet conditions above.As seen from Figure 12, in the projection perpendicular to central axis
On face, the projection of second support section 50 is inscribed within projection of the first cambered surface of first support section 40 on the perspective plane, but point of contact
Deviate the midpoint of the first cambered surface.
In the implantation process of actual branch bracket, proximal port is difficult and main body branch when branch stent discharges in the blood vessels
Frame proximal port is concordant, and ordinary circumstance can all deflect certain angle.Therefore, the proximal end of first support section 40 is arranged the present embodiment
At a scarf, after branch stent implantation, as shown in figure 13, the port of 40 proximal end of first support section just with main body rack 500
Proximal port it is concordant.In order to increase the positioning performance of branch stent, can be set in the proximal port position of first support section 40
Some development points are set, are aligned branch stent port and the edge of main body rack proximal end when discharging branch stent.
Compared with embodiment one, the overlay film frame of the present embodiment more meets the practical behaviour that bracket is discharged in stent implantation procedure
Make situation, so that branch stent is concordant with main body rack proximal port, the effective area that blood flows into branch stent can be improved.Separately
On the one hand also highly beneficial to bracket loading sheath, the proximal openings in overlay film frame where first support section are than second support section
The distal openings at place are big, may result in proximal location dress sheath relative difficulty, and the proximal end of first support section is arranged to one tiltedly
Section, the circumferential volume of proximal end can become smaller after bracket compression, be conducive to bracket and be packed into sheath.
It is understood that make for convenience and make overlay film more evenly, in other embodiments, the structure of overlay film frame
Can also be as shown in figure 14, i.e., the proximal end of second support section 70 extend out to first support section 60 from the distal end of first support section 60
It is internal or to the proximal end of first support section 60.In this way, after first support section 60 and second support section 70 being fabricated separately, then
First support section 60 is sewed or is bonded in the outside of second support section 70.
It should be appreciated that above-mentioned specific embodiment is only part preferred embodiment, not limitation of the present invention, this field
Technical staff can do simple replacement to part-structure according to actual needs, doing without departing from the inventive concept of the premise
Unsubstantiality changes within that scope of the present invention, and protection scope of the present invention is subject to claim.