CN109966018A - Overlay film frame - Google Patents
Overlay film frame Download PDFInfo
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- CN109966018A CN109966018A CN201711448602.3A CN201711448602A CN109966018A CN 109966018 A CN109966018 A CN 109966018A CN 201711448602 A CN201711448602 A CN 201711448602A CN 109966018 A CN109966018 A CN 109966018A
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- Prior art keywords
- overlay film
- area
- film frame
- elongation percentage
- waveform
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0029—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in bending or flexure capacity
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0073—Force-limiting means
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Prostheses (AREA)
Abstract
The present invention relates to a kind of overlay film frames, including bare metal stent and the overlay film being covered on the bare metal stent, the overlay film frame along the circumferential direction includes first area and the second area that connect with the first area, along the axially extending of the overlay film frame, the elongation percentage of the overlay film of the first area is less than the elongation percentage of the overlay film of the second area for the first area and the second area.Above-mentioned overlay film frame, after the overlay film uplifting window of first area, since the elongation percentage of the overlay film of first area is smaller, under branch stent long term, the deformation of overlay film at the window's position is smaller, can reduce in this way overlay film frame long term occurs at the window's position in leakage risk, and, the elongation percentage of the overlay film of second area is larger, and flexibility is preferable, so that overlay film frame is easy the form of fitting vascular bending.
Description
Technical field
The present invention relates to medical instruments fields, more particularly to a kind of overlay film frame for orthotopic fenestration.
Background technique
In the recent decade, intracavitary recovery technique has become conjunction because its is curative for effect, wound is small, recovery is fast, few intercurrent disease
The aneurysm of thoracic aorta of suitable dissection, dissection of aorta, abdominal aneurvsm conventional therapy means.But intracavitary recovery technique is from principle
It is required that lesion has adequately proximally and distally anchorage zone, and many aortic aneurysms or the lesion of dissection of aorta are moved close to important
Arteries and veins branch, this lesion are the taboos of conventional intracavitary recovery technique.Such as there are truncus brachiocephalicus, left common carotid artery and a left side on the arch of aorta
How three main artery important branch of subclavian artery, establish important branch on aorta, is current aortic aneurysm endovascular repair
(EVAR) a great problem.
In view of the above-mentioned problems, prior art discloses a kind of orthotopic fenestration (in situ fenestration) technology, first
By overlay film frame be implanted into aorta in, then by the branch vessel that the overlay film frame covers by puncture pin puncture or
Laser boring etc. carries out orthotopic fenestration on the overlay film frame of the branch vessel opening, then the implantation point at the windowing position
Branch bracket, to ensure that the blood flow of the branch vessel is unobstructed.
However, existing orthotopic fenestration technology has the following problems: the window's position active force long-term by branch stent,
It is easy to appear extension and window is made to become larger, the window's position is caused to be easy to appear interior leakage.
Summary of the invention
Based on this, there is the interior risk leaked in view of the above-mentioned problems, can reduce at the window's position it is necessary to provide one kind.
A kind of overlay film frame, including bare metal stent and the overlay film being covered on the bare metal stent, the overlay film branch
Frame along the circumferential direction includes first area and the second area that connect with the first area, the first area and described second
Along the axially extending of the overlay film frame, the elongation percentage of the overlay film of the first area is less than the second area in region
The overlay film elongation percentage.
The angle that the first area covers in a circumferential direction in one of the embodiments, is 60 °~300 °.
The angle that the first area covers in a circumferential direction in one of the embodiments, is 150 °~240 °.
The elongation percentage of the overlay film of the first area and the second area is described in one of the embodiments,
The ratio of the elongation percentage of overlay film is 0.20~0.80.
The elongation percentage of the overlay film of the first area and the second area is described in one of the embodiments,
The ratio of the elongation percentage of overlay film is 0.30~0.70.
The material of the overlay film of the first area is covered with the described of the second area in one of the embodiments,
The material of film is identical, and the thickness of the overlay film of the first area is greater than the thickness of the overlay film of the second area.
The thickness of the overlay film of the first area is covered with the described of the second area in one of the embodiments,
The ratio of the thickness of film is 1.5~4.
The overlay film of the first area is polytetrafluoroethylene film, the first area in one of the embodiments,
The overlay film with a thickness of 0.15~0.30mm.
In one of the embodiments, the overlay film of the first area with a thickness of 0.20~0.25mm.
The wire section product of the bare metal stent of the first area is less than described in one of the embodiments,
The wire section product of the bare metal stent of second area.
Above-mentioned overlay film frame, after the overlay film uplifting window of first area, since the elongation percentage of the overlay film of first area is smaller,
Under branch stent long term, the overlay film deformation at the window's position is smaller, can reduce overlay film frame long term in this way in window
The risk leaked in occurring at position, moreover, the elongation percentage of the overlay film of second area is larger, flexibility is preferable, so that overlay film frame
It is easy the form of fitting vascular bending.
Detailed description of the invention
Fig. 1 is the structural schematic diagram of the overlay film frame of first embodiment of the invention；
Fig. 2 is the structural schematic diagram after the bare metal stent expansion of overlay film frame shown in FIG. 1；
Fig. 3 is overlay film frame shown in FIG. 1 structural schematic diagram after bending；
Fig. 4~Fig. 6 is respectively the structural schematic diagram of overlay film frame shown in FIG. 1 in the course of surgery；
Fig. 7 is the structural schematic diagram of the overlay film frame of second embodiment of the invention；
Fig. 8 is the structural schematic diagram after the bare metal stent expansion of overlay film frame shown in Fig. 7；
Fig. 9 is overlay film frame shown in Fig. 7 structural schematic diagram after bending；
Figure 10 is the structural schematic diagram of the overlay film frame of third embodiment of the invention；
Figure 11 is the partial structural diagram of overlay film frame shown in Fig. 10；
Figure 12 is the structural schematic diagram after the overlay film frame expansion of fourth embodiment of the invention；
The structural schematic diagram of overlay film frame and branch stent cooperation that Figure 13 is Figure 12；
Figure 14 is the structural schematic diagram after the overlay film frame expansion of fifth embodiment of the invention；
Figure 15 is the structural schematic diagram of overlay film frame shown in Figure 14 (after tearing partial outer membrane off)；
Figure 16 is the structural schematic diagram of the another embodiment of overlay film frame of Figure 14；
Figure 17 is structural schematic diagram of the Figure 16 at A.
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.
" overlay film frame " refers to the structure that bare metal stent surface is covered with after film in the application, and bare metal stent refers to
Including there is no the structure of film between multiple wavy annular objects and each wavy annular object.
Referring to Fig. 1, overlay film frame 100 includes bare metal stent 110 and the overlay film being covered on bare metal stent 110
120.Overlay film frame 100 is both ends open, hollow luminal structure, and the lumen of overlay film frame 100 constitutes channel of blood flow.Overlay film
120 be both ends open, intermediate closed luminal structure.Overlay film 120 is using the high molecular material with good biocompatibility, such as
E-PTFE (expanded PTFE), PET etc..The material of bare metal stent 110 is Nitinol or stainless steel, practical preparation
In, bare metal stent 110 is formed using titanium-nickel wire braiding or the cutting sizing of NiTi pipe, in 110 surface coating of bare metal stent,
Bare metal stent 110 is fixed on overlay film 120 by modes such as suture or high-temperature pressurizings.
Referring to Fig. 2, overlay film frame 100 include along the circumferential direction first area 111 and connect with first area 111 the
Two regions 113, first area 111 and second area 113 are along the axially extending of overlay film frame 100.The metal of first area 111
The sectional area of the wire of bare bracket 110 be less than second area 113 bare metal stent 110 wire sectional area, first
The sectional area of the wire of the bare metal stent 110 in region 111 is 0.005~0.1257mm2.In use, by first area 111
Be placed in branch vessel opening, since the sectional area of the wire of the bare metal stent 110 of first area 111 is smaller, rigidity compared with
It is small, it is opened a window under instrument effect in situ, when such as balloon expandable, the wire of first area 111 is easily deformed, can be the
It is formed in one region 111 and is closer to circular window, convenient for windowing, after the completion of windowing, after recalling sacculus, wire, which has, to be restored
Overlay film frame can be reduced to the active force of initial position so that wire fits closely branch stent after implantation branch stent
100 positions being connected with branch stent generate the interior risk leaked.
Further, the angle that first area 111 covers in a circumferential direction is 60 °~300 °.Preferably, first area
The angle of 111 covering in a circumferential direction be 150 °~240 ° so that first area 111 cover in a circumferential direction it is biggish
Angle, the region that overlay film frame 100 can be made to be easy to open a window in a circumferential direction is larger, and overlay film frame 100 discharges as a result,
When, when the circumferential anchor station of overlay film frame 100 and when contemplating that a biggish error, the opening of branch vessel still can be by
First area 111 is covered, and therefore, can be reduced transportation system and circumferentially be discharged precision and the operation requirement of instrument user.More
Preferably, the angle that the angle that first area 111 covers in a circumferential direction covers in a circumferential direction with second area 113 is
0.7~2, to guarantee that overlay film frame 100 has appropriate radial support power.
Referring to Fig. 2, the bare metal stent 110 of first area 111 includes the first waveform of multiple axially spaced arrangements
Segmentation 112, the bare metal stent 110 of second area 113 include the second waveform segments 114 of multiple axially spaced arrangements.?
In the embodiment of diagram, it is closed that each first waveform segmentation 112 with corresponding second waveform segments 114 is interconnected to form one
Ring structure.First waveform segmentation 112 and the second waveform segments 114 are integrated connection structure, that is, first area 111 and second
Region 113 only can be surrounded closed ring structure by a connector (e.g., steel bushing, solder joint etc.), in this way can be so as to
In being packed into sheath, reduce the caliber of sheath.For example, closed ring structure can be formed using the wire of same cross-sectional area,
It is polished again by the wire to first area 111, the sectional area of the wire of first area 111 is made to become smaller.For another example, may be used
To form closed ring structure using one section of metal wire knitted with different cross-sectional, or cutting method can also be used
Obtain the ring structure with different cross-sectional.
It will also be appreciated that in other embodiments, first waveform segmentation 112 and the second waveform segments 114 can also be with
For mutually independent structure, closed ring structure is formed by two connectors.
In the illustrated embodiment, overlay film frame 100 is in a circumferential direction by first area 111 and 113 groups of second area
At the first waveform segmentation 112 of first area 111 and the second waveform segments 114 of second area 113 are directly connected to.It can manage
Solution can also include in other embodiments transition region, first area between first area 111 and second area 113
111 are connected with second area 113 by transition region, and the sectional area of the wire of transition region can be between the gold of first area 111
Belong between the sectional area of silk and the sectional area of the wire of second area 113.
Specifically, the metal of the sectional area of the wire of the bare metal stent 110 of first area 111 and second area 113
The ratio between sectional area of wire of bare bracket 110 is 0.1~0.9, so that overlay film frame 100 has preferable radial support power,
First area 111 is made to be easy to open a window simultaneously.Preferably, the sectional area of the wire of first area 111 and second area 113
The ratio between sectional area of wire is 0.25~0.8.Preferably, the sectional area of the wire of first area 111 and second area 113
The ratio between the sectional area of wire be 0.50~0.70.Preferably, the sectional area and second area of the wire of first area 111
The ratio between 113 sectional area of wire is 0.55~0.65.Specifically, the wire of first area 111 and second area 113
The section of wire is circle, and the string diameter of the wire of first area 111 is 0.20~0.40mm, the gold of second area 113
The string diameter for belonging to silk is 0.40~0.55mm.More preferably, the string diameter of the wire of first area 111 is 0.30~0.35mm, the
The string diameter of the wire in two regions 113 is 0.40~0.50mm.It is understood that the wire of first area 111 and second
The section of the wire in region 113 can also be other shapes, for example, ellipse, semicircle etc., as long as guaranteeing first area
The sectional area of the wire of the sectional area and second area 113 of 111 wire is in suitable ratio.
First waveform segmentation 112 and the second waveform segments 114 can be by Z-shaped wave, sine wave or other compressible waveforms
Structure.Referring to Fig. 2, first waveform segmentation 112 includes that multiple primary peaks 1121, multiple first troughs 1123 and connection are adjacent
First supporter 1122 of primary peak 1121 and the first trough 1123, the angle between two neighboring first supporter 1122 are
80 °~100 °, so that it is larger for the area of windowing between two neighboring first supporter 1122, reduce the first supporter pair
The limitation of the size of windowing.
Please continue to refer to Fig. 2, the wave height of first waveform segmentation 112 is equal, the spacing of adjacent first waveform segmentation 112
It is equal, wherein the wave height of first waveform segmentation 112 refers to edge between adjacent primary peak 1121 and the first trough 1123
Axial distance, the spacing of adjacent first waveform segmentation 112 refer to primary peak 1121 and phase in first waveform segmentation 112
Adjacent first waveform is segmented between 112 corresponding primary peaks 1121 along axial distance.First waveform segmentation 112 wave height with
The ratio of the spacing of adjacent first waveform segmentation 112 is 0.25~1, and first area 111 can be made to have preferable axial branch
Support force, at the same it is larger for the area of windowing.More specifically, the wave height of first waveform segmentation 111 is 4~14mm.Preferably,
The wave height of one waveform segments 111 is 5~7mm, and the spacing of adjacent first waveform segmentation 111 is 11~16mm.
In the present embodiment, the line of all primary peaks 1121 in each first waveform segmentation 112 is respectively positioned on vertically
In in the plane of the vertical central axis of overlay film frame 100, each first waveform is segmented the company of all first troughs 1123 on 112
Line also is located in the plane perpendicular to the vertical central axis of overlay film frame 100.
Continuing with Fig. 2, the phase difference of first waveform segmentation 112 is zero, that is, adjacent first waveform is segmented 112 two correspondences
Primary peak 1121 line it is parallel with the axis of overlay film frame 100, adjacent first waveform is segmented 112 two corresponding first
The line of trough 1123 is parallel with the axis of overlay film frame 100, in this way, any two points in two neighboring first waveform segmentation 112
Between the shortest distance it is larger so that overlay film frame 100 is more uniform for the area distribution of windowing in first area 111, just
It opens a window in each position of the overlay film frame 100 in first area 111.
Further, it being provided with fillet at primary peak 1121 and the first trough 1123, the radius of fillet is 0.8~2mm,
The risk that overlay film frame 100 damages in contraction process can be reduced in this way.
Referring to Fig. 2, the second waveform segments 114 include multiple secondary peaks 1141, multiple second troughs 1143 and connection
Second supporter 1142 of adjacent secondary peak 1141 and the second trough 1143.The wave height of second waveform segments 114 is greater than first
The wave height of waveform segments 112, the angle between two neighboring second supporter 1142 are greater than two neighboring first supporter 1122
Between angle.When overlay film frame 100 is bent towards second area 114, the second waveform segments 114 can be with adjacent second
Waveform segments 114 resist, and play the role of the anti-cripetura of bending.Specifically, two adjacent second supports of the second waveform segments 114
Angle between body 1142 is 45 °~75 °.Preferably, the angle between two neighboring second supporter 1142 is 60 °~75 °.
It is understood that in other embodiments, the wave height of the second waveform segments 114 can also be segmented with first waveform
112 wave height is equal, and the angle between two neighboring second supporter 1142 of the second waveform segments 114 can also be with first waveform
The angle being segmented between 112 two neighboring first supporters 1122 is equal.
In the illustrated embodiment, the phase difference of two neighboring second waveform segments 114 is 45 °, referring to Fig. 3, when covering
When membrane support 100 is bent towards second area 113, the secondary peak 1141 of the second waveform segments 114 can be with the second adjacent wave
The middle part of second supporter 1142 of shape segmentation 114 resists, to increase the anti-cripetura ability in the case of bending, and this situation
Under, stress is more uniform.
It is understood that in other embodiments, the phase differences of adjacent second waveform segments 112 can also 0~
It is adjusted between 180 °, when overlay film frame 100 is bent towards second area 114, the secondary peak 1141 of the second waveform segments 114
It can resist, play with the other positions of the second supporter 1142 of the second adjacent waveform segments 114 or the second trough 1143
It is bent the effect of anti-cripetura.
The elongation percentage of the overlay film 120 of first area 111 is less than the overlay film of second area 113 in one of the embodiments,
120 elongation percentage.After 120 uplifting window of overlay film of first area 111, due to first area 111 overlay film 120 elongation percentage compared with
Small, under branch stent long term, the overlay film deformation at the window's position is smaller, and it is at a specified future date can to reduce overlay film frame 100 in this way
The risk leaked in occurring at the window's position, moreover, the elongation percentage of the overlay film 120 of second area 113 is larger, flexibility is preferable,
So that overlay film frame 100 is easy the form of fitting vascular bending.
Specifically, the ratio of the elongation percentage of the overlay film 120 of the elongation percentage of the overlay film 120 of first area 111 and second area 113
Value is 0.20~0.80.Preferably, the overlay film 120 of the elongation percentage and second area 113 of the overlay film 120 of first area 111 prolongs
The ratio for stretching rate is 0.30~0.70, under conditions of guaranteeing the flexibility of 100 entirety of overlay film frame, reduces window position as far as possible
There is the risk for extending and leading to interior leakage in the place of setting.
Specifically, the elongation percentage of the overlay film 120 of first area 111 is 3%~40%, it is preferred that cover first area 111
The elongation percentage of film 120 is 3%~30%.Specifically, elongation percentage can measure with the following method: the overlay film for giving specification
Overlay film is made into the dumbbell-shaped specimen wide 10mm of its narrow portion, in the overlay film of narrow portion mark lengths L0, in ring by bracket, a diameter of D1
Apply the pulling force of F=25kpa*10mm*D1*0.5 ≈ 0.125*D1 newton, overlay film in the case of 37 DEG C ± 2 DEG C of border temperature to sample
Narrow portion original calibrated length L0 length becomes L1, elongation percentage μ=(L1-L0)/L0 after 48 hours.Wherein, dumbbell-shaped specimen shape can
With I type dumb bell sample in reference standard GB/t528-2009 or ISO 37:2005, the film thickness of dumb bell sample and tested overlay film
Bracket overlay film thickness is identical.
It is understood that the ratio of elongation percentage can also be tested by other methods, as long as guaranteeing first area 111
Overlay film 120 and the overlay film 120 of second area 113 are under equal conditions tested.For example, the elongation percentage of the application can also be using such as
Lower method measures: under original state, the length of the overlay film of first area in a circumferential direction is L1, and the overlay film of second area is in circle
Length in circumferential direction is L2, and overlay film frame is closed at both ends, lead to inside overlay film frame 25 ± 2kpa hydraulic pressure (37 DEG C of water temperature ±
2 DEG C), after being kept for 48 hours, measurement obtains the overlay film of first area length L1 ' in the circumferential direction, the overlay film edge of second area
The length of circumferencial direction is L2 ', then elongation percentage μ 1=(L1 '-L1)/L1 of the overlay film of first area, the overlay film of second area
Elongation percentage μ 2=(L2 '-L2)/L2, the ratio of the elongation percentage of the overlay film of the elongation percentage and second area of the overlay film of first area are μ
1/μ2。
In the present embodiment, the material phase of the overlay film 120 of the material and second area 113 of the overlay film 120 of first area 111
Together.The elongation percentage of the overlay film 120 of the elongation percentage and second area 113 of the overlay film 120 of first area 111 it is different by adjusting
The thickness of the overlay film 120 of the overlay film 120 and second area 113 in one region 111 is realized.The thickness of the overlay film 120 of first area 111
Ratio with the thickness of the overlay film 120 of second area 113 is 1.5~4.Specifically, first area 111 and second area 113
Overlay film 120 is polytetrafluoroethylene film (PTFE).The overlay film 120 of first area 111 with a thickness of 0.15~0.30mm.It is preferred that
, the overlay film 120 of first area 111 with a thickness of 0.16~0.25mm.
It should be noted that if first area 111 is made with second area 113 of same material, first area 111
Overlay film 120 thickness be greater than second area 113 overlay film 120 thickness, then it can be concluded that the overlay film 120 of first area 111
Elongation percentage be less than second area 113 overlay film 120 elongation percentage.
Overlay film 120 includes being set to the inner membrance of 110 inner surface of bare metal stent and being set to 110 outer surface of bare metal stent
Outer membrane, inner membrance and outer membrane are bonded to each other so that bare metal stent 110 to be wrapped between inner membrance and outer membrane.The extension of overlay film 120
Rate refers to that inner membrance and outer membrane are bonded to each other the elongation percentage after forming entirety, and the thickness of overlay film 120 refers to that inner membrance and outer membrane mutually paste
Conjunction forms the thickness after entirety.In actually preparation, the inner surface of bare metal stent 110 and outer surface cover multilayer PTFE
Film is bonded to form overlay film 120 by high-temperature pressurizing.The elongation percentage of overlay film 120 of first area 111 and covering for second area 113
The elongation percentage of film 120 can be realized by changing the number of plies of PTFE.
It is understood that the material of the overlay film 120 of first area 111 can also be adjusted, for example, first area 111
Overlay film 120 uses the lower membrane material of elongation percentage.For another example, can between the multilayer PTFE membrane of first area 111 or side increase
The lower membrane material of elongation percentage.
Referring to Figure 4 together, in actual operation, overlay film frame 100 is implanted in aorta 11, first area is made
111 are located at the big curved side of aorta 11, and second area 113 is located at the lesser curvature side of aorta 11, and seal wire 21 passes through innominate artery 12
With the overlay film 120 of the first area 111 of overlay film frame 100, sacculus 22 is recycled to carry out reaming, due to the gold of first area 111
The sectional area for belonging to silk is smaller, and rigidity is smaller, is easy to happen deformation under the effect of external force, sacculus 22 can be made in overlay film 120
Upper formation is closer to circular window (referring to Fig. 5, it is the structural schematic diagram after omitting sacculus).After windowing, sacculus is removed,
Branch stent is implanted into from innominate artery, wire has the active force restored to initial position and wire is pasted to window
The edge of mouth can reduce overlay film frame 100 with branch stent coupling part and form the interior risk leaked due to being bonded not tight.Most
Afterwards, in the same way, be implanted into branch stent respectively in left common carotid artery 13 and left subclavian artery 14, after the completion of structure
As shown in Figure 6.
Referring to Fig. 7, the structure of the overlay film frame 200 of second embodiment of the invention and the structure of overlay film frame 100 are substantially
Identical, difference essentially consists in: overlay film frame 200 along the circumferential direction further includes being located at first area 211 and second area 213
Between third region 215, third region 215 is axially extending along overlay film frame 200, third region 215 respectively with the firstth area
Domain 211 and second area 213 connect, and bare metal stent is greater than first area 211 in the sectional area of the wire in third region 215
Wire sectional area, the axial cripetura rate in third region 215 is less than the axial cripetura rate of second area 213.
Specifically, the axial cripetura rate in third region 215 is 10%~40%.Wherein, the axial cripetura in third region 215
Rate measures by the following method: third region 215 being extended to whole circumference, the straight pipe type overlay film that length is a, diameter is d is made
Bracket covers the overlay film frame in the inner tube that diameter is 0.9d, applies the pressure along axial 1~2N, overlay film to overlay film frame
Bracket can not again cripetura when the length that (does not give a discount) be b, the axial cripetura rate in third region 215 is (a-b) * 100%/a.
Also referring to Fig. 8, third region 215 includes the third waveform segments 216 of multiple axially spaced arrangements, each
The both ends of third waveform segments 216 are connect with first waveform segmentation 212 and the second waveform segments 214 respectively.Third waveform segments
216 wave height is greater than the wave height of the second waveform segments 214.Preferably, the wave height of third waveform segments 216 and the second waveform segments
The ratio of 214 wave height is not more than 3.Third waveform segments 216 include that third wave crest 2161, third trough 2163 and connection are adjacent
The third supporter 2162 of third wave crest 2161 and third trough 2163.The third trough 2163 of each third waveform segments 216
With the line of the second trough 2143 of corresponding second waveform segments 214 be respectively positioned on perpendicular to overlay film frame 200 axis it is flat
On face.
Please continue to refer to Fig. 8, third region 215 is two, and two third regions 215 are located at first area 211
Two sides prevent overlay film frame 200 from putting under blood flow effect to improve stability of the overlay film frame 200 in bending state
Dynamic and retraction.Preferably, the angle that each third region 215 covers in a circumferential direction is 15 °~45 °, can be to avoid overlay film
Damage when the third wave crest 2161 of bracket 200 is excessively sharp and causes to be bent to overlay film, while overlay film frame can also be reduced
200 there is the risk to give a discount in bending.In the present embodiment, the quantity of the third supporter 2162 of third waveform segments 216
It is two, and angle is 30 °~60 ° between two adjacent third supporters 2162.
In the present embodiment, the sectional area of the wire in third region 215 is equal to the section of the wire of second area 213
Product.Specifically, third waveform segments 216 and the second waveform segments 214 are formed by same metal wire knitted.Certainly, at other
In embodiment, the sectional area of the wire in third region 215 can also be greater than the sectional area of second area 213, to avoid third
The wire in region 215 deforms in bending.
Referring to Fig. 9, third waveform when overlay film frame 200 is bent towards second area 213, in third region 215
Segmentation 216 can form the state being mutually pressed against, and form the axial support structure of a rigidity on overlay film frame 200, make to cover
The no longer cripetura of membrane support 200.
Referring to Fig. 10, the structure of the overlay film frame 300 of third embodiment of the invention and the structure of overlay film frame 100 are substantially
Identical, difference essentially consists in: the adjacent first waveform segmentation 312 of first area 311 is interconnected to form reticular structure.
The ratio of the sectional area of the wire of the sectional area and second area 313 of the wire of first area 311 is 0.05
~0.5.Specifically, the string diameter of the wire of first area 311 is 0.08mm~0.22mm.
Specifically, at least partly primary peak 3121 and the first trough 3123 acts in collusion to form interlocking structure.Please together
Refering to fig. 11, reticular structure includes multiple groups braiding group, and the first of the part primary peak 3121 of a braiding group and another braiding group
Trough 3123 acts in collusion to form interlocking structure.Specifically, the primary peak 3121 of two groups of braiding groups and 3123 phase of the first trough
Multiple intersection points are formed to setting, in adjacent intersection point, a primary peak 3121 and the first trough 3123 act in collusion to be formed mutually
Lock, another primary peak 3121 are not connected to the first trough 3123, i.e., primary peak 3121 is not colluded with the first trough 3123, this
Sample can increase the flexibility of overlay film frame, and when windowing, adjacent establishment group can be subjected to displacement, convenient for windowing.Preferably, it is formed
There is gap, that is, primary peak 3121 and the first trough between the primary peak 3121 of interlocking structure and the first trough 3123
3123 do not contact, and further increase the flexibility of overlay film frame.
It is understood that in other embodiments, can not also act in collusion between adjacent braiding group, for example, adjacent
All point of intersection of braiding group can not form interlocking structure.For another example, setting is spaced between adjacent braiding group, be connected braiding group
Between there is no crosspoint.
In the present embodiment, also referring to Figure 10 and Figure 11, every group of braiding group includes three first waveform segmentations 312,
That is, 312a, 312b and 312c, first waveform be segmented 312a and first waveform segmentation 312b respectively with same second waveform segments
314 connections, first waveform segmentation 312c are connect with another second waveform segments 314, and first waveform is segmented 312a and first waveform
The phase difference for being segmented 312b is 90 °, and first waveform is segmented 312c and is successively alternately segmented 312a and first waveform from first waveform
It is passed through above and below segmentation 312b, forms multiple crosspoints that can be mutually shifted.
It should be noted that the structure of braiding group is not limited to above-described embodiment.In other embodiments, the knot of braiding group
Structure can also be adjusted as needed.
Figure 12 is please referred to, the overlay film frame 400 of fourth embodiment of the invention is roughly the same with the structure of overlay film frame 100,
Difference essentially consists in: first area 411 is discontinuously arranged in circumferencial direction.
In the present embodiment, first area 411 and second area 413 are two, two first areas 411 and two
Two regions 413 are alternatively arranged.In use, overlay film frame 400 is applied to circumferencial direction, and there are two branches also referring to Figure 13
The region (for example, abdominal aorta region) of blood vessel, makes two first areas 411 respectively correspond the opening of branch vessel, can be with
Rebuild two branch vessel accesses respectively on first area 411 by way of orthotopic fenestration.
It is understood that in other embodiments, can also need to design according to the number and position of branch vessel
The number in one region 411 and position.
Please refer to Figure 14, the structure of the structure of the overlay film frame 500 of fifth embodiment of the invention and overlay film frame 100 is substantially
Identical, difference essentially consists in: second area 513 is provided with wiring 530.
Also referring to Figure 15, overlay film 520 includes inner membrance 521 and outer membrane 523, and bare metal stent 510 is arranged in inner membrance 521
And between outer membrane 523, it is provided on an at least surface for inner membrance 521 and outer membrane 523 along the distribution of 500 circumferencial direction of overlay film frame
Wiring 530, the coverage rate of wiring 530 is zero in first area 511, that is, wiring 530 is distributed only in second area 513, and first
Wiring 530 is not provided in region 511.In the illustrated embodiment, wiring 530 is set between inner membrance 521 and outer membrane 523.
Certainly, in other embodiments, wiring 530 also can be set in surface of the inner membrance 521 far from outer membrane 523, alternatively, wiring 530
Also it can be set in surface of the outer membrane 523 far from inner membrance 521.In use, first area 511 is placed in branch vessel opening,
Suitable window can be opened up out in first area 511 under the action of opening a window instrument to guarantee that the blood flow of branch vessel is logical
Freely, and in second area 513 wiring 530 is set, the ability of the circumferential anti-expansion of overlay film frame 500 can be improved, lower due to
Overlay film expands and makes the risk of overlay film frame disabler.
It should be noted that wiring 530 used herein has good heat-resisting quantity and tensile resistance.Wiring
530 elongation percentage is less than the elongation percentage of overlay film 520.Wiring 530 and inner membrance 521, outer membrane 523, bare metal stent 510 inner surface
Or the outer surface of bare metal stent be just bonded to each other, it is slight it is tight, do not loosen.Wiring 530 is by the modes such as being heat-treated, pasting
It is combined together with overlay film 520.
Please continue to refer to Figure 14, wiring 530 include multiple circumferential sections 531 being along the circumferential direction distributed, the two of circumferential sections 531
End is connect with first area 511, and multiple circumferential sections 531 are parallel to each other.Further, wiring 530 further includes two circumferential directions of connection
The linkage section 532 of section 531, linkage section 532 is parallel with the bus of overlay film frame 500, in this way, can increase the two of circumferential sections 531
With the contact area of overlay film 520 at a endpoint, reduces at 531 two endpoints of circumferential sections and overlay film 520 occur and wiring 530 divides
From risk.It should be noted that circumferential sections 531 and the junction of linkage section 532 rounded can be arranged.
In the illustrated embodiment, circumferential sections 531 are parallel to the circumference vertical with the vertical central axis of overlay film frame 500
Face.It is understood that in other embodiments, circumferential sections 531 can also be not parallel to the longitudinal center with overlay film frame 500
The vertical periphery of axis.For example, circumferential sections 531 are across multiple second waveform segments.
Specifically, at least provided with a circumferential sections 531 in every one second waveform segments 514, to further increase second
The anti-expansion character in region 513.It is understood that circumferential sections 531 can fit in the second waveform segments 514 outer surface or
Inner surface.It will also be appreciated that circumferential sections 531 can shuttle in the inner surface and the outer surface of the second waveform segments 514, that is,
Circumferential sections 531 bypass from the side of the outer surface of second supporting section of the second waveform segments 514 and are bonded second support
Section after through another second supporting section inner surface and be bonded with the inner surface, so circulation；Or circumferential sections 531 are from the second waveform
The side of the inner surface of one the second supporting section of segmentation 514 bypasses and supports after being bonded second supporting section through another second
The outer surface of section is simultaneously bonded with the inner surface, is so recycled.
In order to avoid the risk for sliding and leading to anti-swelliong power failure occur in the circumferential in wiring 530 and overlay film 520, ask
Together refering to fig. 16, there are two fixed crosslinking points at least one circumferential sections 531 tool of the second waveform segments 514 and wiring 530
535.It should be noted that the fixation crosslinking points 535 of the application refer to that circumferential sections 531 cannot occur on circumferencial direction in the position
Movement.In the present embodiment, also referring to Figure 17, circumferential sections 531 and the second shape by way of knotting of waveform segments 514
At fixed crosslinking points.It is understood that in other embodiments, circumferential sections 531 can also pass through with the second waveform segments 514
Other modes form fixed crosslinking points.For example, can be fixed by pasting.For another example, it can be punched in the second waveform segments 514,
Circumferential sections 531 are fixed after perforating.For another example, circumferential sections 531 and the second waveform segments 514 can also pass through the side of at least one circle winding
Formula is fixed.
In the illustrated embodiment, circumferential sections 531 and 514 intersection of the second waveform segments are respectively formed fixed crosslinking points 535.
It is understood that circumferential sections 531 only can form fixed crosslinking points, example in the position that part is intersected with the second waveform segment 514
Such as, fixed crosslinking points 535 are arranged with on-fixed crosslinking points interval.For another example, circumferential sections 531 and the second waveform segments 514 are only
Two ends of two waveform segments 514 form fixed crosslinking points.
Further, distance of the two neighboring circumferential sections 531 on 500 axis direction of overlay film frame is 2~15mm, is guaranteed
While 500 bending property of overlay film frame, the bending resistance of overlay film frame 500 is improved.Preferably, two neighboring circumferential sections
531 distance on 500 axis direction of overlay film frame is 3~6mm.
In the present embodiment, wiring 530 is the PTFE line of solid cylindrical shape, has good high temperature resistance and circle
The tensile resistance of circumferential direction, high temperature resistant are greater than 100 DEG C, string diameter 0.01-0.4mm, preferably 0.05-0.2mm.
It is understood that in other embodiments, wiring 530 may be the PTFE line of flat pattern, width is
0.05-2mm, with a thickness of 0.01-0.2mm；Preferable width is 0.1-1mm, with a thickness of 0.02-0.2mm.
It will also be appreciated that in other embodiments, wiring 530 can also be smaller using other high temperature resistants, elongation percentage
Material be made, for example, wiring 530 be FEP line.
It should be strongly noted that the technical solution of above-mentioned each embodiment can carry out without conflicting with each other
Combined application, for example, the wire section product of the bare metal stent of first area is smaller, while the extension of the overlay film of first area
Rate is smaller, alternatively, the wire section product of the bare metal stent of first area is smaller, while second area is provided with wiring, again
Alternatively, the overlay film elongation percentage of first area is smaller, while second area is provided with wiring, or, the bare metal of first area
The wire section product of bracket is smaller, while the overlay film elongation percentage of first area is smaller, and second area is provided with wiring,
Be it is understood that.
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.
Claims (10)
1. a kind of overlay film frame, including bare metal stent and the overlay film being covered on the bare metal stent, which is characterized in that institute
The second area that state overlay film frame along the circumferential direction include first area and is connect with the first area, the first area and
Along the axially extending of the overlay film frame, the elongation percentage of the overlay film of the first area is less than described the second area
The elongation percentage of the overlay film of second area.
2. overlay film frame according to claim 1, which is characterized in that the angle that the first area covers in a circumferential direction
Degree is 60 °~300 °.
3. overlay film frame according to claim 2, which is characterized in that the angle that the first area covers in a circumferential direction
Degree is 150 °~240 °.
4. overlay film frame according to claim 1, which is characterized in that the elongation percentage of the overlay film of the first area with
The ratio of the elongation percentage of the overlay film of the second area is 0.20~0.80.
5. overlay film frame according to claim 4, which is characterized in that the elongation percentage of the overlay film of the first area with
The ratio of the elongation percentage of the overlay film of the second area is 0.30~0.70.
6. overlay film frame according to claim 1, which is characterized in that the material of the overlay film of the first area and institute
The material for stating the overlay film of second area is identical, and the thickness of the overlay film of the first area is greater than the second area
The overlay film thickness.
7. overlay film frame according to claim 6, which is characterized in that the thickness of the overlay film of the first area and institute
The ratio for stating the thickness of the overlay film of second area is 1.5~4.
8. overlay film frame according to claim 1, which is characterized in that the overlay film of the first area is polytetrafluoroethyl-ne
Alkene film, the overlay film of the first area with a thickness of 0.15~0.30mm.
9. overlay film frame according to claim 8, which is characterized in that the overlay film of the first area with a thickness of
0.20~0.25mm.
10. overlay film frame according to claim 1, which is characterized in that the bare metal stent of the first area
Wire section product is less than the wire section product of the bare metal stent of the second area.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711448602.3A CN109966018B (en) | 2017-12-27 | 2017-12-27 | Covered stent |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711448602.3A CN109966018B (en) | 2017-12-27 | 2017-12-27 | Covered stent |
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| CN109966018A true CN109966018A (en) | 2019-07-05 |
| CN109966018B CN109966018B (en) | 2023-04-07 |
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|---|---|---|---|
| CN201711448602.3A Active CN109966018B (en) | 2017-12-27 | 2017-12-27 | Covered stent |
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| CN110393607A (en) * | 2019-07-17 | 2019-11-01 | 深圳市先健畅通医疗有限公司 | Overlay film frame |
| CN112155786A (en) * | 2020-10-27 | 2021-01-01 | 上海源畅医疗科技有限公司 | Operation support capable of opening window |
| CN113116612A (en) * | 2019-12-31 | 2021-07-16 | 深圳市先健畅通医疗有限公司 | Covered stent |
| WO2022007281A1 (en) * | 2020-07-06 | 2022-01-13 | 上海启功医疗科技有限公司 | Stent, stent kit, and stent delivery system |
| WO2023124901A1 (en) * | 2021-12-31 | 2023-07-06 | 先健科技(深圳)有限公司 | Lumen stent |
| WO2023124903A1 (en) * | 2021-12-31 | 2023-07-06 | 先健科技(深圳)有限公司 | Endoluminal stent |
| WO2024125226A1 (en) * | 2021-12-31 | 2024-06-20 | 先健科技(深圳)有限公司 | Covered stent |
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| WO2024125226A1 (en) * | 2021-12-31 | 2024-06-20 | 先健科技(深圳)有限公司 | Covered stent |
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