CN104873302A - I type endoleak-preventing stent graft system with villus structure - Google Patents
I type endoleak-preventing stent graft system with villus structure Download PDFInfo
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- CN104873302A CN104873302A CN201410817578.6A CN201410817578A CN104873302A CN 104873302 A CN104873302 A CN 104873302A CN 201410817578 A CN201410817578 A CN 201410817578A CN 104873302 A CN104873302 A CN 104873302A
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- internal hemorrhage
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Abstract
The invention relates to an I type-endoleak-preventing stent graft system with a villus structure. The I type-endoleak-preventing stent graft system for sealing I type endoleak is characterized by comprising a metal mesh support layer matched with the shape of an artery blood vessel, a covering layer covering the metal mesh support layer and villus layers distributed on the proximal part or on both the proximal part and the telecentric part of the outer side of the covering layer. The villus layers fill the gap formed between a blood vessel inner wall and the covering layer under the elasticity of the villus layers. Each villus layer is provided with a plurality of villus inside, and each villus is linear. The I type-endoleak-preventing stent graft system can seal I type endoleak.
Description
Technical field
The present invention relates to a kind of anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures, belong to medical instruments field.
Background technology
Aneurysm is that modal initiation disables and one of lethal angiopathy, is found in any tremulous pulse of whole body, common with old people.Aneurysm can have multiple size, shape and distribution, Audit Report special committee of vascular surgery association (the Ad Hoc Committee onReporting Standards of the Society for Vascular Surgery) defines aneurysm and is: arteries diameter exceedes the permanent limitation expansion of natural arterial caliber 50%, so that clinical decision and carry out classifying and standardization.
Have the earliest and come from 3rd century of Christian era about attempting to treat aneurysmal record, until 1888, the people such as Matas complete first case aneurysm kposthesis truly, namely at the tumor intracavity ligation bifurcated artery of brachial artery tumor.Nineteen fifty-one, Dubost etc. complete first case aneurysm suture and neoplasty, and they excise the abdominal aortic aneurysm of a patient, and the thoracic aorta that have selected 20 years old donator of cadaver is as alloplast, be transplanted in abdominal aortic aneurysms body, this patient's postoperative survival 8 years.Repair aneurysmal open surgery improve gradually in 40 subsequently year and optimize, but its Peri operative mortality is still up to 5%.1991, people's reported first using artificial endovascular stent complex such as Parodi repaired the experience of aortic aneurysm.After Food and Drug Admistraton (FDA) ratifies the clinical practice of endovascular graft thing, aneurysm (comprising peripheral arterial tumor and aortic aneurysm) experienced by by the differentiation of open bypass prothesis to Endovascular repair.
Compared with conventional therapy, use overlay film frame to carry out disease such as endovascular graft treatment aneurysm, artery dissection etc. and there is the advantages such as operation wound is little, post-operative recovery is fast, the hospital stays is short, but its distinctive complication---internal hemorrhage due to trauma, still cannot avoid up till now completely.Internal hemorrhage due to trauma is one of postoperative most important complication of inner cavity insulation, and its incidence rate is up to 45%.Internal hemorrhage due to trauma can be divided into I-V type by its mechanism, and only just I type internal hemorrhage due to trauma related to the present invention is introduced below.I type internal hemorrhage due to trauma refer to due to support overlay film and anchorage zone Wall of Artery docile bad, cause blood flow to leak out in aneurysm cavity through overlay film frame proximal part or distal end, its incidence rate about 10%, often can find at Photographg.Existence because of I type internal hemorrhage due to trauma can cause aneurysm cavity inner high voltage, aneurysm continuous enlargement even has the risk of breaking, so need to process immediately in art.It is generally acknowledged, proximal landing zone < 10mm, and/or tumor neck angulation > 60 °, I type internal hemorrhage due to trauma incidence rate will obviously raise, wherein anchorage zone refers to that the nearly far-end in tumor chamber has the normal blood vessels wall of one section of sufficient length to stick fully to ensure that intravascular stent has with it, the blood vessel wall of such segment length is defined as anchorage zone (landing zone, LZ), comprises near-end and far-end LZ; Tumor neck angulation refers to formed angle between tumor neck axis and aorta trunk axis.At present, to the general processing mode of I type internal hemorrhage due to trauma found in Rhizoma Atractylodis Macrocephalae be: balloon expandable, add stent graft with short section, bare bracket or utilize the embolization technique of cyanoacrylate, Onyx glue, turn, Fibrin Glue.These technology can process most of I type internal hemorrhage due to trauma; But in some cases will be very difficult, as: abdominal aortic aneurysm proximal landing zone is too short, and the stent graft added with short section at near-end likely affects the confession of renal artery blood.Maldonado etc. sum up the effect of current said method process I type internal hemorrhage due to trauma: cyanoacrylate suppository success rate is 92.3%, and near-end short section of graft is 80%, and turn is 75%.No matter take above-mentioned any processing mode, not only there is the problem of success rate, also there is the problem rolling up operating time and medical expense.Further, operating time prolongation makes operation in patients risk, postoperative infection incidence rate increases, and high medical expense brings the financial burden of great number to patient, takies more social resources simultaneously.
Summary of the invention
For solving the problem, the present invention has redesigned the support used in endovascular graft, to avoid the generation of I type internal hemorrhage due to trauma.
Present invention employs following technical scheme:
< structure one >
An anti-I type internal hemorrhage due to trauma stent graft system for attached fluff structures, for closed I type internal hemorrhage due to trauma, is characterized in that, comprising:
With the metal net shaped supporting layer of arteries mating shapes;
Be covered in the cover layer on metal net shaped supporting layer; And
Be distributed in the proximal part outside cover layer or be distributed in the tapetum of proximal part and distal end simultaneously, tapetum is filled in the gap formed between blood vessel and cover layer under the effect of natural resiliency,
Wherein, have many fine hair in tapetum, the shape of fine hair is linear.
In addition, the anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures of the present invention, can also have such feature:
Wherein, the length range of fine hair is that fine hair is directly about 25 microns, and the length range of fine hair is 2 millimeters-6 millimeters.
In addition, the anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures of the present invention, can also have such feature:
Wherein, the material of fine hair is poly (glycolide-lactide).
In addition, the anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures of the present invention, can also have such feature:
Wherein, fine hair tilts to distal end.
In addition, the anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures of the present invention, can also have such feature:
Wherein, tapetum does not exceed the edge at metal net shaped supporting layer and tectal upper and lower two ends.
In addition, the anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures of the present invention, can also have such feature:
Wherein, tapetum is made up of the material of the hemocytees such as the thrombin that can adsorb in blood and platelet.
< structure two >
An anti-I type internal hemorrhage due to trauma stent graft system for attached fluff structures, for closed I type internal hemorrhage due to trauma, is characterized in that, comprising:
With the metal net shaped supporting layer of arteries mating shapes;
Be covered in the cover layer of metal net shaped supporting layer inner surface; And
Be distributed in the proximal part of metal net shaped supporting layer outer surface or be distributed in the tapetum of proximal part and distal end simultaneously, tapetum is filled in the gap formed between inwall and cover layer under the effect of natural resiliency, wherein, have many fine hair in tapetum, the shape of fine hair is linear.
Invention effect and effect
According to the anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures of the present invention, owing to additionally using tapetum outside coating layer, and tapetum is filled in the gap formed between inwall and cover layer under the effect of natural resiliency, blood flow is made can not directly to pour tumor chamber, blood coagulation can be there is after a period of time has passed at intravillous blood, thus tumor chamber is completely closed, make tumor chamber enter stable state.
Accompanying drawing explanation
Fig. 1 is the overall structure schematic diagram of anti-I type internal hemorrhage due to trauma stent graft system in embodiment one of attached fluff structures of the present invention;
Fig. 2 is the internal structure schematic diagram of the anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures of the present invention;
Fig. 3 is the cross-sectional view of the anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures of the present invention;
Fig. 4 is the schematic diagram at the anti-I type internal hemorrhage due to trauma stent graft system implantable intravascular place of attached fluff structures of the present invention;
Fig. 5 is the generalized section at BB ' place in Fig. 4;
Fig. 6 is the anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures of the present invention is provided with fine hair schematic diagram at proximal part and distal end; And
Fig. 7 is the schematic diagram that the tapetum of the anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures of the present invention is arranged at rack surface.
Detailed description of the invention
Owing to causing I type internal hemorrhage due to trauma, namely due to support overlay film and anchorage zone Wall of Artery docile bad, the reason causing blood flow to leak out in aneurysm cavity through overlay film frame proximal part or distal end is a lot, and the anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures of the present invention all has the effect of prevention for the I type internal hemorrhage due to trauma caused by a variety of causes.Only for the support overlay film caused by arteriosclerosis plaque and anchorage zone Wall of Artery docile is bad is described in detailed description of the invention.
Below in conjunction with accompanying drawing, the specific embodiment of the present invention is described.
< embodiment one >
Fig. 1 is the overall structure schematic diagram of the anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures of the present invention, and Fig. 2 is the internal structure schematic diagram of the anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures of the present invention.As depicted in figs. 1 and 2, the anti-I type internal hemorrhage due to trauma stent graft system 10 of attached fluff structures comprises metal net shaped supporting layer 11, coating layer 12 and tapetum 13.Metal net shaped supporting layer 11 is positioned at innermost layer, and coating layer 12 is covered in its skin, and tapetum 13 is positioned at the skin of the proximal part of coating layer 12.
The material that coating layer 12 is conventional is terylene, is also called PETP.Tapetum is covered in coating layer surface by multiple rectilinear fine hair and is formed, and the material that fine hair uses is poly (glycolide-lactide), chemical name abbreviation PGLA.One end of fine hair 131 is connected to coating layer 12 surface, and other end periphery is stretched out.Poly (glycolide-lactide) material has the effect of hemocyte such as absorption thrombin and platelet etc.Tapetum 13 can be colonizated on coating layer.As shown in Figure 1, A direction Digital arteries blood flow direction, be proximal part near the one end in A direction, the one end away from A direction is distal end.Away from the direction of heart in distal end Digital arteries.Although the incline direction of the single fine hair in tapetum 13 is also inconsistent, fine hair is totally tilt to distal end direction.And the length of tapetum 13 does not exceed the edge of the proximal part of metal net shaped supporting layer and coating layer.These two reasons arranged are to prevent fine hair from stretching out from the edge of the anti-I type internal hemorrhage due to trauma stent graft system 10 of attached fluff structures, causing blood flow herein to solidify, and form thrombosis, vascular embolization among intravasation under the impact of blood flow.If do not have fine hair to stretch out from edge, blood coagulation only betides between support and blood vessel wall, does not have in thrombosis intravasation.
Fig. 3 is the cross-sectional view of the anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures of the present invention, as shown in Figure 3, have elastic fine hair protruding in the periphery of coating layer, and direction is different, but tilts to the distal end of support generally.
Fig. 4 is the schematic diagram at the aneurysm place on the anti-I type internal hemorrhage due to trauma stent graft system implantable intravascular of attached fluff structures of the present invention, and Fig. 5 is the generalized section at BB ' place in Fig. 4.As shown in Figure 4 and Figure 5, when the anti-I type internal hemorrhage due to trauma stent graft system 10 of attached fluff structures is implanted in the blood vessel of aneurysm nidus, the blood vessel wall of the arteries 14 near tumor chamber 16 has arteriosclerosis plaque 15, arteriosclerosis plaque 15 is outstanding in blood vessel wall, by the fine hair jack-up in the tapetum 13 of the anti-I type internal hemorrhage due to trauma stent graft system 10 of attached fluff structures, certainly, may also can by metal net shaped supporting layer 11 jack-up if arteriosclerosis plaque is larger.Gap is formed between coating layer 12 and blood vessel, because the fine hair 131 in tapetum 13 has elasticity, therefore can be filled among gap, and there is randomness due to the direction that fine hair is bending when being subject to the pressure distortion of inwall, therefore can form network structure in gap.The flow velocity of blood in the gap of being filled by fine hair declines greatly, and simultaneously due to the effect of the thrombin in blood, the blood remained in the gap that fine hair is filled after a period of time has passed can solidify, thus by gap closing.
Deposit in gap and also have a harmful effect in case, exactly because gap place is under the impact of blood flow always, endotheliocyte in blood vessel cannot be grown into the inside of support, makes the edge of support not covered by endotheliocyte and then to join together with blood vessel endothelium.After the anti-I type internal hemorrhage due to trauma stent graft system 10 of attached fluff structures implanting the present embodiment, because the blood flow rate at gap place declines, the epithelial cell near support gap in blood vessel wall is made to have the sufficient time to grow into gradually the inner surface of anti-I type internal hemorrhage due to trauma stent graft system 10 of attached fluff structures, stent inner surface covers completely the most at last, joins together with the blood vessel endothelium at two ends.Thus making support enter stable state, tumor intracavity can not be filled with blood again, and the blood coagulation posterior tuberosity chamber that tumor intracavity retains can enter steady statue, and then endotheli ocytosis, in tumor of growing into chamber, is not easily broken in tumor chamber.
There is various factors the PGLA material biodegradable time, therefore the method for multiple adjustment can be had, here a kind of method is only provided: regulate by regulating the ratio of Acetic acid, hydroxy-, bimol. cyclic ester and these two kinds of monomers of lactide when being polymerized, along with Acetic acid, hydroxy-, bimol. cyclic ester mol ratio in the copolymer increases, the degradation speed of PGLA increases, and when Acetic acid, hydroxy-, bimol. cyclic ester: during lactide=50:50, degradation time is 50-60 days, when Acetic acid, hydroxy-, bimol. cyclic ester: during lactide=85:15, degradation time is 150 days.Interior leak blood coagulation is grown into fibroblast and is arrived the Fibrotic time completed again and generally can complete in two weeks, aneurysm cavity and I type internal hemorrhage due to trauma is made to enter steady statue for ensuring the sufficient time, degradation time was advisable between 50-150 days, like this can not due to PGLA degradation time too short and affect I type internal hemorrhage due to trauma close.
The length of the poly (glycolide-lactide) microfilament in embodiment one is selected arbitrarily between 3.0-4.0mm.
The method for implantation of the anti-I type internal hemorrhage due to trauma stent graft system 10 of attached fluff structures:
The anti-I type internal hemorrhage due to trauma stent graft system 10 of attached fluff structures is arranged on bracket conveyer, vascular lesion place is transported to by carrier, carrier is made evenly to exit the support had from swollen characteristic gradually by releasing device, and then the anti-I type internal hemorrhage due to trauma stent graft system 10 of attached fluff structures closes the blood flow of tumor intracavity, then induction system is withdrawn from, make support forever be placed in lesion, reach the object in sealing blood vessels tumor tumor chamber.
In operation process, utilize DSA (Digital subtraction angiograph) to monitor that carrier enters aorta from small artery in human body, finally arrive the overall process in tumor chamber.
The effect of embodiment one and effect
According to the anti-I type internal hemorrhage due to trauma stent graft system of the attached fluff structures in embodiment one, because the proximal part outside coating layer have employed tapetum, and tapetum is filled in the gap formed between inwall and coating layer under the effect of natural resiliency, when blood vessel wall having arteriosclerosis plaque, have elastic tapetum can by the metal net shaped supporting layer propped by arteriosclerosis plaque and between coating layer and blood vessel the gap filling that formed, blood flow is made can not directly to pour tumor chamber, can solidify after a period of time has passed at intravillous blood, thus tumor chamber is completely closed, tumor chamber is made to enter stable state.The grid that fine hair intertexture is formed has the effect of three aspects, is physical barrier on the one hand, blood flow velocity is herein slowed down greatly, thus promotion blood coagulation, be chemical action on the other hand, PGLA can adsorb the hemocyte such as thrombin and platelet, promotes blood coagulation further; Meanwhile, network also acts as the substrate that fibrosis is formed, and contributes to fibroblast and to grow into sludged blood, thus stablize tumor chamber further.
In addition, because fine hair 131 to tilt to distal end direction and the length of tapetum 13 does not exceed the edge of the proximal part of metal net shaped supporting layer and coating layer, therefore, it is possible to prevent fine hair from stretching out from the edge of the anti-I type internal hemorrhage due to trauma stent graft system 10 of attached fluff structures, blood flow is herein caused to solidify, form thrombosis, vascular embolization among intravasation under the impact of blood flow.
< embodiment two >
In the present embodiment two, to structure same as the previously described embodiments, this variation gives identical numbering, and saves identical explanation.
Fig. 6 is the anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures of the present invention is provided with fine hair schematic diagram at proximal part and distal end, as shown in Figure 6, different from embodiment one, the tapetum of the present embodiment is arranged at the two ends of support respectively, i.e. proximal part and distal end, certainly, in order to prevent forming thrombosis in the blood vessel, the tapetum at two ends is set to the intermediate, inclined to support, and tapetum is set to not exceed the proximal part of metal net shaped supporting layer and coating layer and the edge of distal end.
The advantage simultaneously arranging tapetum at proximal part and distal end is to prevent distal end from the situation of I type internal hemorrhage due to trauma occurring further, although the probability that this situation occurs is very low, arranges the safety that can strengthen support further like this.
< embodiment three >
In the present embodiment three, to structure same as the previously described embodiments, this variation gives identical numbering, and saves identical explanation.
Fig. 7 is the schematic diagram that the tapetum of the anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures of the present invention is arranged at rack surface, as shown in Figure 7, the anti-I type internal hemorrhage due to trauma stent graft system 30 of attached fluff structures comprises metal net shaped supporting layer 31, be covered in the coating layer 32 of metal net shaped supporting layer 31 inner surface, and be arranged at the tapetum 33 of anti-I type internal hemorrhage due to trauma stent graft system outer face surface of attached fluff structures, tapetum 33 is made up of many fine hair 331, and many fine hair 331 are directly connected on metal net shaped supporting layer 31.Coating layer 32 is positioned at bracing frame, and the manufacturing process that tapetum is positioned at the setting outside support is simpler, because fine hair is comparatively connected on metal net shaped supporting layer more simple and convenient by the method be connected to by fine hair on metal rack.
In the various embodiments described above, the method for attachment of fine hair and support, except fine hair is colonizated in except on coating layer, can also first by field planting fine hair on a wire, then on support as spring spiral winding multi-turn, make fine hair be distributed in rack surface.
In the various embodiments described above, the density of fine hair can control 500-5000 root every square centimeter.
In addition, coating layer of the present invention also can be covered in the inner side of metal net shaped supporting layer, thus tapetum is directly connected with metal net shaped supporting layer, and this kind of lamination order also can reach technique effect of the present invention.
Claims (7)
1. an anti-I type internal hemorrhage due to trauma stent graft system for attached fluff structures, for closed I type internal hemorrhage due to trauma, is characterized in that, comprising:
With the metal net shaped supporting layer of arteries mating shapes;
Be covered in the cover layer on described metal net shaped supporting layer; And
Be distributed in the proximal part outside cover layer or be distributed in the tapetum of proximal part and distal end simultaneously, described tapetum is filled in the gap formed between blood vessel and described cover layer under the effect of natural resiliency,
Wherein, have many fine hair in described tapetum, the shape of described fine hair is linear.
2. the anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures according to claim 1, is characterized in that:
Wherein, the length range of described fine hair is that fine hair is directly about 25 microns, and the length range of fine hair is 2 millimeters-6 millimeters.
3. the anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures according to claim 1, is characterized in that:
Wherein, the material of described fine hair is poly (glycolide-lactide).
4. the anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures according to claim 2, is characterized in that:
Wherein, described fine hair tilts to distal end.
5. the anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures according to claim 1, is characterized in that:
Wherein, described tapetum does not exceed the edge at described metal net shaped supporting layer and tectal upper and lower two ends.
6. the anti-I type internal hemorrhage due to trauma stent graft system of attached fluff structures according to claim 1, is characterized in that:
Wherein, described tapetum is made up of the material of the hemocytees such as the thrombin that can adsorb in blood and platelet.
7. an anti-I type internal hemorrhage due to trauma stent graft system for attached fluff structures, for closed I type internal hemorrhage due to trauma, is characterized in that, comprising:
With the metal net shaped supporting layer of described arteries mating shapes;
Be covered in the cover layer of described metal net shaped supporting layer inner surface; And
Be distributed in the proximal part of metal net shaped supporting layer outer surface or be distributed in the tapetum of proximal part and distal end simultaneously, described tapetum is filled in the gap formed between described inwall and described cover layer under the effect of natural resiliency, wherein, have many fine hair in described tapetum, the shape of described fine hair is linear.
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 |
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| Publication Number | Publication Date |
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| CN104873302A true CN104873302A (en) | 2015-09-02 |
| CN104873302B CN104873302B (en) | 2018-05-08 |
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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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| 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- |
| CN111388139A (en) * | 2020-03-19 | 2020-07-10 | 山东天之祐药业有限公司 | Absorbable repair material for preventing air leakage in operation and preparation method thereof |
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| US6015431A (en) * | 1996-12-23 | 2000-01-18 | Prograft Medical, Inc. | Endolumenal stent-graft with leak-resistant seal |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| 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- |
| CN111388139A (en) * | 2020-03-19 | 2020-07-10 | 山东天之祐药业有限公司 | Absorbable repair material for preventing air leakage in operation and preparation method thereof |
| 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 |
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| Publication number | Publication date |
|---|---|
| CN104873302B (en) | 2018-05-08 |
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