CN104873302B - Leakage stent graft system in the anti-I types of attached fluff structures - Google Patents
Leakage stent graft system in the anti-I types of attached fluff structures Download PDFInfo
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- CN104873302B CN104873302B CN201410817578.6A CN201410817578A CN104873302B CN 104873302 B CN104873302 B CN 104873302B CN 201410817578 A CN201410817578 A CN 201410817578A CN 104873302 B CN104873302 B CN 104873302B
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Abstract
The present invention relates to stent graft system is leaked in a kind of anti-I types of attached fluff structures, leaked for closing in I types, it is characterised in that including：The metal net shaped supporting layer to match with arteries shape；The coating being covered on metal net shaped supporting layer；And it is distributed in the proximal part on the outside of coating or is distributed in the tapetum of proximal part and distal end at the same time, tapetum is filled under the action of natural resiliency in the gap formed between blood vessel and coating, wherein, there are more fine hair, the shape of fine hair is linear in tapetum.Leakage stent graft system can close leakage in I types in the anti-I types of the attached fluff structures of the present invention.
Description
Technical field
The present invention relates to stent graft system is leaked in a kind of anti-I types of attached fluff structures, belong to medical instruments field.
Background technology
Aneurysm is that most common initiation one of disables with lethal vascular diseases, it is seen that in any artery of whole body, with
The elderly is common.Aneurysm can have a variety of sizes, shape and distribution, Audit Report special committee of vascular surgery association (the
Ad Hoc Committee on Reporting Standards of the Society for Vascular Surgery)
Defining aneurysm is：The permanent limitation that arteries diameter exceedes natural arterial caliber 50% is expanded, in order to which clinic is determined
Plan and classified and standardized.
It is related to attempt earliest to treat aneurysmal record and comes from 3rd century of Christian era, until 1888, Matas et al. is completed
The aneurysm neoplasty of first case truly, i.e., ligature bifurcated artery in the knurl intracavitary of arteria brachialis knurl.Nineteen fifty-one,
Dubost etc. completes first case aneurysm suture and neoplasty, they cut off the abdominal aneurvsm of a patient, and have selected one
The aorta pectoralis of the 20 years old donator of cadaver in position is transplanted in abdominal aortic aneurysms body, the patient is postoperative as alloplast
Survive 8 years.Repair aneurysmal open surgery gradually to improve and optimize in subsequent 40 years, but its peri-operation period is dead
Die rate and be still up to 5%.1991, Parodi et al. is reported first repaired aortic aneurysm using artificial endovascular stent compound
Experience.Food and Drug Admistraton (FDA) approval endovascular graft thing clinical practice after, aneurysm (including peripheral arterial knurl and
Aortic aneurysm) it experienced from open bypass differentiation of the prosthetic to Endovascular repair.
Compared with conventional therapy, the diseases such as endovascular graft treatment aneurysm, artery dissection are carried out using overlay film frame
Disease has the advantages that operation wound is small, post-operative recovery is fast, the hospital stays is short, but its distinctive complication --- interior leakage, to current
It can not still avoid completely.Interior leakage is one of postoperative most important complication of inner cavity insulation, its incidence is up to 45%.Interior leakage presses it
Mechanism can be divided into I-V types, and only just leakage is introduced in I types related to the present invention below.Leakage refers to due to stent in I types
Overlay film and anchorage zone Wall of Artery docile are bad, cause blood flow to leak out to aneurysm cavity through overlay film frame proximal part or distal end
Interior, its incidence about 10%, can often find in Photographg.Because the presence leaked in I types can cause high pressure in aneurysm cavity, dynamic
Arteries and veins knurl continuous enlargement even has the risk ruptured, so needing to immediately treat in art.It is generally believed that proximal landing zone ＜
10mm, and/or 60 ° of knurl neck angulation ＞, the interior leakage incidence of I types will be significantly raised, and wherein anchorage zone refers to that the near of knurl chamber distally has
The normal blood vessels wall of one section of sufficient length is sufficiently sticked with ensureing that intravascular stent and its have, and the vascular wall of such segment length is determined
Justice is anchorage zone (landing zone, LZ), including proximally and distally LZ；Knurl neck angulation refers to knurl neck central axes and sustainer master
Formed angle between dry central axes.At present, it is for leaking general processing mode in the I types that are found in art：Balloon expandable plus use
The stent graft of short section, bare bracket utilize cyanoacrylate, Onyx glue, spring ring, the embolization technique of Fibrin Glue.
These technologies can handle leakage in most of I types；But in some cases will be extremely difficult, such as：Abdominal aneurvsm near-end grappling
Area is too short, and influence arteria renalis blood supply is possible in near-end plus with the stent graft of short section.The summaries such as Maldonado are above-mentioned at present
The effect of leakage in method processing I types：Cyanoacrylate suppository success rate is 92.3%, and near-end short section graft is 80%,
Spring ring is 75%.The problem of no matter taking above-mentioned any processing mode, not only existing success rate, also there is substantial increase
The problem of operating time and medical expense.Also, operating time extends so that patient's art risk, postoperative infection incidence increase
Height, high medical expense bring the financial burden of great number to patient, while take more social resources.
The content of the invention
To solve the above problems, the present invention has redesigned the stent used in endovascular graft, to avoid what is leaked in I types
Occur.
Present invention employs following technical solution：
<Structure one>
Leakage stent graft system, leaks for closing in I types in a kind of anti-I types of attached fluff structures, it is characterised in that bag
Include：
The metal net shaped supporting layer to match with arteries shape；
The coating being covered on metal net shaped supporting layer；And
The proximal part that is distributed on the outside of coating or the tapetum for being distributed in proximal part and distal end at the same time, tapetum exist
It is filled under the action of natural resiliency in the gap formed between blood vessel and coating,
Wherein, there are more fine hair, the shape of fine hair is linear in tapetum.
In addition, leakage stent graft system in the anti-I types of the attached fluff structures of the present invention, can also have such spy
Sign：
Wherein, the length range of fine hair is that fine hair is about directly 25 microns, and the length range of fine hair is 2 millimeters -6 millimeters.
In addition, leakage stent graft system in the anti-I types of the attached fluff structures of the present invention, can also have such spy
Sign：
Wherein, the material of fine hair is poly (glycolide-lactide).
In addition, leakage stent graft system in the anti-I types of the attached fluff structures of the present invention, can also have such spy
Sign：
Wherein, fine hair is tilted to distal end.
In addition, leakage stent graft system in the anti-I types of the attached fluff structures of the present invention, can also have such spy
Sign：
Wherein, tapetum is without departing from metal net shaped supporting layer and the edge of the upper and lower ends of coating.
In addition, leakage stent graft system in the anti-I types of the attached fluff structures of the present invention, can also have such spy
Sign：
Wherein, tapetum is made of the material that can adsorb the haemocytes such as clotting factor and blood platelet in blood.
<Structure two>
Leakage stent graft system, leaks for closing in I types in a kind of anti-I types of attached fluff structures, it is characterised in that bag
Include：
The metal net shaped supporting layer to match with arteries shape；
It is covered in the coating of metal net shaped supporting layer inner surface；And
It is distributed in the proximal part of metal net shaped supporting layer outer surface or is distributed in the fine hair of proximal part and distal end at the same time
Layer, tapetum are filled under the action of natural resiliency in the gap formed between inner wall and coating, wherein, in tapetum
With more fine hair, the shape of fine hair is linear.
Invention effect
Leakage stent graft system in the anti-I types of attached fluff structures according to the present invention, due to also being adopted on the outside of coating layer
With tapetum, and tapetum is filled under the action of natural resiliency in the gap formed between inner wall and coating,
Prevent blood flow from that directly into knurl chamber, can occur blood clotting, so that will after a period of time has passed in intravillous blood
Knurl chamber completely encloses so that knurl chamber enters stable state.
Brief description of the drawings
Fig. 1 is overall knot of the leakage stent graft system in embodiment one in the anti-I types of the attached fluff structures of the present invention
Structure schematic diagram；
Fig. 2 is the internal structure schematic diagram of leakage stent graft system in the anti-I types of the attached fluff structures of the present invention；
Fig. 3 is the cross-sectional view of leakage stent graft system in the anti-I types of the attached fluff structures of the present invention；
Fig. 4 is the schematic diagram at leakage stent graft system implantable intravascular in the anti-I types of the attached fluff structures of the present invention；
Fig. 5 is the diagrammatic cross-section at BB ' places in Fig. 4；
Fig. 6 is that leakage stent graft system is all provided with proximal part and distal end in the anti-I types of the attached fluff structures of the present invention
Put schematic diagram villous；And
Fig. 7 is that the tapetum of leakage stent graft system in the anti-I types of the attached fluff structures of the present invention is arranged at stent table
The schematic diagram in face.
Embodiment
Due to causing to be leaked in I types, i.e., since stent overlay film and anchorage zone Wall of Artery docile are bad, cause blood flow through overlay film
The reason for stent proximal part or distal end are leaked out in aneurysm cavity is very much, leakage branch in the anti-I types of attached fluff structures of the invention
Frame implant system is respectively provided with the effect of prevention for leakage in the I types caused by a variety of causes.In embodiment only with by
Illustrated exemplified by stent overlay film caused by arteriosclerosis plaque and anchorage zone Wall of Artery docile are bad.
Illustrate the embodiment of the present invention below in conjunction with attached drawing.
<Embodiment one>
Fig. 1 be the present invention attached fluff structures anti-I types in leakage stent graft system overall structure diagram, Fig. 2
It is the internal structure schematic diagram of leakage stent graft system in the anti-I types of the attached fluff structures of the present invention.As depicted in figs. 1 and 2,
Leakage stent graft system 10 includes metal net shaped supporting layer 11, coating layer 12 and tapetum in the anti-I types of attached fluff structures
13.Metal net shaped supporting layer 11 is located at innermost layer, and coating layer 12 is covered in its outer layer, and tapetum 13 is located at the nearly heart of coating layer 12
The outer layer at end.
12 common material of coating layer is terylene, also known as ethylene terephthalate.Tapetum is by multiple linears
Fine hair is covered in overlay film layer surface and is formed, and the material that fine hair uses is poly (glycolide-lactide), chemical name abbreviation PGLA.Fine hair 131
One end be connected to 12 surface of coating layer, other end periphery is stretched out.Poly (glycolide-lactide) material is small with absorption clotting factor and blood
The effect of the haemocytes such as plate.Tapetum 13 can be colonized on coating layer.As shown in Figure 1, A directions Digital arteries blood flow direction, is leaned on
The one end in nearly A directions is proximal part, and one end away from A directions is distal end.Direction away from heart in distal end Digital arteries.Though
The incline direction of single fine hair in right tapetum 13 is not consistent, but fine hair is generally tilted to telecentricity extreme direction.And
The length of tapetum 13 is without departing from metal net shaped supporting layer and the edge of the proximal part of coating layer.The two set the reason for be for
Prevent the edge that fine hair leaks out of anti-I types of the attached fluff structures stent graft system 10 from stretching out, cause blood flow herein to coagulate
Gu form thrombus, the vascular embolization among intravasation under the impact of blood flow.If stretched out without fine hair from edge, blood coagulation is only
Betide between stent and vascular wall, do not have in thrombus intravasation.
Fig. 3 is the cross-sectional view of leakage stent graft system in the anti-I types of the attached fluff structures of the present invention, as shown in figure 3,
Flexible fine hair is in the peripheral protruding of coating layer, and direction is different, but is generally tilted to the distal end of stent.
Fig. 4 is at the aneurysm in the anti-I types of the attached fluff structures of the present invention on leakage stent graft system implantable intravascular
Schematic diagram, Fig. 5 is the diagrammatic cross-section at BB ' places in Fig. 4.As shown in Figure 4 and Figure 5, leaked when in the anti-I types by attached fluff structures
When stent graft system 10 is implanted into the blood vessel of aneurysm point, deposited on the vascular wall of the arteries 14 near knurl chamber 16
There is arteriosclerosis plaque 15, arteriosclerosis plaque 15 is prominent into vascular wall, is moved stent is leaked in the anti-I types of attached fluff structures
Fine hair in the tapetum 13 of botanical system 10 jacks up, certainly, may also can will be metal net shaped if arteriosclerosis plaque is larger
Supporting layer 11 jacks up.Gap is formed between coating layer 12 and blood vessel, since the fine hair 131 in tapetum 13 has bullet
Property, therefore can be filled among gap, and due to fine hair, when being subject to the pressure distortion of inner wall, curved direction has at random
Property, therefore network structure can be formed in gap.Flow velocity of the blood in the gap filled by fine hair is greatly reduced, simultaneously because
The effect of clotting factor in blood, remaining blood can solidify in the gap of fine hair filling after a period of time has passed,
So as to by gap closing.
In the presence of gap also have a harmful effect, precisely due to be constantly at gap blood flow impact it
Under, the endothelial cell in blood vessel can not grow into the inside of stent so that the edge of stent cannot be covered by endothelial cell into
And join together with blood vessel endothelium.Implantation the present embodiment attached fluff structures anti-I types in leak stent graft system 10 it
Afterwards, since the blood flow velocity at gap declines so that epithelial cell of the stent gap nearby on vascular wall have the sufficient time by
The inner surface of leakage stent graft system 10 in the anti-I types of attached fluff structures is gradually grown into, most stent inner surface is completely covered at last,
Join together with the blood vessel endothelium at both ends.So that stent enters stable state, knurl intracavitary will not be re-filled with blood, knurl chamber
The blood clotting posterior tuberosity chamber inside retained can enter stable state, and then endotheli ocytosis, grow into knurl chamber so that knurl chamber is not easy
Rupture.
There are various factors in the PGLA materials biodegradable time, therefore can have the method for a variety of adjustings, here only
A kind of method is provided：Adjusted by the ratio of both monomers of adjusting glycolide and lactide in polymerization, with glycolide
Molar ratio increase in the copolymer, the degradation speed increase of PGLA, works as glycolide：Lactide=50：When 50, degradation time is
50-60 days, work as glycolide：Lactide=85：When 15, degradation time is 150 days.Interior leak blood coagulation is grown into again to fibroblast
Time to the completion of fibrosis can generally complete in two weeks, to ensure that the time for having abundance causes aneurysm cavity and I types
Inside leak into was advisable into stable state, degradation time between 50-150 days, so will not and shadow too short due to PGLA degradation times
Ring the closing of leakage in I types.
The length of poly (glycolide-lactide) microfilament in embodiment one arbitrarily selects between 3.0-4.0mm.
The method for implantation of leakage stent graft system 10 in the anti-I types of attached fluff structures：
It is installed on stent graft system 10 is leaked in the anti-I types of attached fluff structures on bracket conveyer, passes through conveyer
It is transported at vascular lesion, conveyer is gradually uniformly exited with the stent from swollen characteristic, and then attached suede by release device
Leakage stent graft system 10 closes the blood flow of knurl intracavitary in the anti-I types of hair knot structure, then withdraws from transport system so that stent is forever
It is long placed in lesion, achievees the purpose that sealing blood vessels knurl knurl chamber.
In surgical procedure, monitor that conveyer enters in human body from parteriole using DSA (Digital subtraction angiograph) and lead
Artery, finally reaches the overall process of knurl chamber.
The effect of embodiment one
Stent graft system is leaked in the anti-I types of attached fluff structures in embodiment one, due on the outside of coating layer
Proximal part employ tapetum, and tapetum is filled between inner wall and coating layer under the action of natural resiliency and is formed
Gap in, when having arteriosclerosis plaque on vascular wall, flexible tapetum will can be propped by arteriosclerosis plaque
Metal net shaped supporting layer and coating layer and blood vessel between the gap filling that is formed so that blood flow cannot be directly into knurl
Chamber, can solidify after a period of time has passed in intravillous blood, so that knurl chamber be completely enclosed so that knurl chamber enters stable
State.Fine hair interweave the grid to be formed play the role of three aspect, be on the one hand physical barrier so that the flow velocity of blood here is big
Slowing down greatly, be on the other hand chemical action so as to promote blood coagulation, PGLA can adsorb the haemocytes such as clotting factor and blood platelet,
Further promote blood coagulation；Meanwhile network also acts as the matrix of fibrosis formation, contribute to fibroblast to grow into blood coagulation
Block, so as to further stablize knurl chamber.
Further, since fine hair 131 is tilted to telecentricity extreme direction and the length of tapetum 13 is without departing from metal net shaped support
The edge of the proximal part of layer and coating layer, therefore can prevent fine hair from leaking stent graft system out of anti-I types of the attached fluff structures
The edge of system 10 stretches out, and causes blood flow herein to solidify, forms thrombus, the embolism blood among intravasation under the impact of blood flow
Pipe.
<Embodiment two>
In the present embodiment two, to structure same as the previously described embodiments, this variation, which is given, to be identically numbered, and is saved
Identical explanation.
Fig. 6 is that leakage stent graft system is all provided with proximal part and distal end in the anti-I types of the attached fluff structures of the present invention
Schematic diagram villous is put, as shown in fig. 6, different from embodiment one, the tapetum of the present embodiment is respectively arranged at stent
Both ends, i.e. proximal part and distal end, certainly, form thrombus, the tapetum at both ends is arranged to stent in the blood vessel in order to prevent
Intermediate, inclined, and tapetum is arranged to the side of the proximal part and distal end without departing from metal net shaped supporting layer and coating layer
Edge.
It is further prevent distal end from occurring in I types the advantages of proximal part and distal end set tapetum at the same time
The situation of leakage, although the probability that such case occurs is very low, is set as further enhancing the security of stent.
<Embodiment three>
In the present embodiment three, to structure same as the previously described embodiments, this variation, which is given, to be identically numbered, and is saved
Identical explanation.
Fig. 7 is that the tapetum of leakage stent graft system in the anti-I types of the attached fluff structures of the present invention is arranged at stent table
The schematic diagram in face, as shown in fig. 7, leakage stent graft system 30 includes metal net shaped supporting layer in the anti-I types of attached fluff structures
31, the coating layer 32 of metal net shaped 31 inner surface of supporting layer is covered in, and be arranged at leakage stent in the anti-I types of attached fluff structures
The tapetum 33 of implant system outer face surface, tapetum 33 are made of more fine hair 331, and more fine hair 331 are directly connected in
On metal net shaped supporting layer 31.Coating layer 32 is located in supporting rack, and the manufacturing process that tapetum is located at the setting outside stent is simpler
It is single, because the method that fine hair is connected on metallic support is more simple and convenient on metal net shaped supporting layer compared with fine hair is connected to.
In the various embodiments described above, the connection method of fine hair and stent, in addition to fine hair is colonized on coating layer, may be used also
Be colonized fine hair on a conducting wire to first pass through, then on stent as spring spiral winding multi-turn, fine hair is distributed in branch
Frame surface.
The density of fine hair can control every square centimeter in 500-5000 roots in the various embodiments described above.
In addition, the coating layer of the present invention can also be covered in the inner side of metal net shaped supporting layer, so that tapetum and metal
Mesh-supported layer is directly connected to, and such a lamination order can also reach the technique effect of the present invention.
Claims (4)
1. leakage stent graft system, leaks for closing in I types in a kind of anti-I types of attached fluff structures, it is characterised in that bag
Include：
The metal net shaped supporting layer to match with arteries shape；
The coating being covered on the metal net shaped supporting layer；And
The proximal part being distributed on the outside of coating or the proximal part and the tapetum of distal end that are distributed at the same time on the outside of coating,
The tapetum is filled under the action of natural resiliency in the gap formed between blood vessel and the coating,
Wherein, there are more fine hair in the tapetum, the shape of the fine hair is linear,
The material of the fine hair is the poly (glycolide-lactide) that Biodegradation Times are 50 days~150 days,
The fine hair is tilted to distal end, and the tapetum is without departing from the metal net shaped supporting layer and the coating
The edge of proximal part.
2. leakage stent graft system in the anti-I types of attached fluff structures according to claim 1, it is characterised in that：
Wherein, the length range of the fine hair is 2 millimeters -6 millimeters.
3. leakage stent graft system in the anti-I types of attached fluff structures according to claim 1, it is characterised in that：
Wherein, the poly (glycolide-lactide) polymerize to be formed by glycolide and lactide, and the glycolide rubs with the lactide
You are than being 50:50~85:15.
4. leakage stent graft system, leaks for closing in I types in a kind of anti-I types of attached fluff structures, it is characterised in that bag
Include：
The metal net shaped supporting layer to match with arteries shape；
It is covered in the coating of the metal net shaped supporting layer inner surface；And
It is distributed in the proximal part of metal net shaped supporting layer outer surface or is distributed in the near of metal net shaped supporting layer outer surface at the same time
Heart end and the tapetum of distal end, the tapetum are filled in the arterial vascular inner wall and institute under the action of natural resiliency
State in the gap formed between coating, wherein, there are more fine hair, the shape of the fine hair is straight line in the tapetum
Shape,
The material of the fine hair is the poly (glycolide-lactide) that Biodegradation Times are 50 days~150 days,
The fine hair is tilted to distal end, and the tapetum is without departing from the metal net shaped supporting layer and the coating
The edge of proximal part.
Priority Applications (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410817578.6A CN104873302B (en) | 2014-12-19 | 2014-12-19 | Leakage stent graft system in the anti-I types of attached fluff structures |
| PCT/CN2015/097972 WO2016095864A1 (en) | 2014-12-19 | 2015-12-18 | Endoleak-preventing stent graft system |
| US15/537,429 US11007047B2 (en) | 2014-12-19 | 2015-12-18 | Endoleak preventing stent graft system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410817578.6A CN104873302B (en) | 2014-12-19 | 2014-12-19 | Leakage stent graft system in the anti-I types of attached fluff structures |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN104873302A CN104873302A (en) | 2015-09-02 |
| CN104873302B true CN104873302B (en) | 2018-05-08 |
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ID=53941168
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| Application Number | Title | Priority Date | Filing Date |
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| CN201410817578.6A Expired - Fee Related CN104873302B (en) | 2014-12-19 | 2014-12-19 | Leakage stent graft system in the anti-I types of attached fluff structures |
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Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2016095864A1 (en) * | 2014-12-19 | 2016-06-23 | 中国人民解放军第二军医大学 | Endoleak-preventing stent graft system |
| CN107174376A (en) * | 2017-07-11 | 2017-09-19 | 中国医学科学院北京协和医院 | A kind of arteria covering membrane supporter |
| CN108283532A (en) * | 2018-01-15 | 2018-07-17 | 上海长海医院 | Leakage and the art component with spring ring chimney holder in anti- |
| CN111388139B (en) * | 2020-03-19 | 2023-09-01 | 山东天之祐药业有限公司 | Absorbable repairing material for preventing air leakage in operation and preparation method |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6015431A (en) * | 1996-12-23 | 2000-01-18 | Prograft Medical, Inc. | Endolumenal stent-graft with leak-resistant seal |
| US7226474B2 (en) * | 2000-05-01 | 2007-06-05 | Endovascular Technologies, Inc. | Modular graft component junctions |
| US20040215322A1 (en) * | 2001-07-06 | 2004-10-28 | Andrew Kerr | Stent/graft assembly |
| CN1217628C (en) * | 2002-09-28 | 2005-09-07 | 维科医疗器械(苏州)有限公司 | Tectorial membrane rack for aorta without inner leakage |
| DE10327231B3 (en) * | 2003-06-13 | 2005-02-17 | Universitätsklinikum Freiburg | Saugstent |
| US8801777B2 (en) * | 2007-04-18 | 2014-08-12 | David Elmaleh | Intravascular device with netting system |
| CN203263585U (en) * | 2013-05-29 | 2013-11-06 | 郭伟 | Support-type blood vessel treating aortic dissection |
| CN204428205U (en) * | 2014-12-19 | 2015-07-01 | 中国人民解放军第二军医大学 | The anti-I type internal hemorrhage due to trauma support of attached fluff structures |
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