CN204971705U - Integration multiple -limb type intervenes aortic arch tectorial membrane support - Google Patents

Integration multiple -limb type intervenes aortic arch tectorial membrane support Download PDF

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CN204971705U
CN204971705U CN201520415839.1U CN201520415839U CN204971705U CN 204971705 U CN204971705 U CN 204971705U CN 201520415839 U CN201520415839 U CN 201520415839U CN 204971705 U CN204971705 U CN 204971705U
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China
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bow
branch
overlay film
gong
aortic arch
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CN201520415839.1U
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杨剑
俞世强
刘洋
段维勋
陈文生
左健
李晓峰
程亮
董晓超
杨丽芳
董海龙
徐健
郑敏文
杨秀玲
陈涛
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Fourth Military Medical University FMMU
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Fourth Military Medical University FMMU
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Abstract

The utility model discloses an integration multiple -limb type intervenes aortic arch tectorial membrane support, this tectorial membrane support be for turning the shape structure, including bending proparea, gong bu district and bow back zone: the bow proparea is extended along its one end by one section tubulose tectorial membrane and is formed, and this tectorial membrane begins to be the segment of a circle by bow proparea end buckles to extend and form the gong bu district, the tectorial membrane from the gongbu district terminal continue to extend form the bow back zone, the greater curvature side that gong bu distinguished is the spheroidicity arch, is provided with to fix the branch with human truncus brachiocephalicus complex in the arch, and fixed branch one side has set gradually two and left arteria carotis communis and the trompil of left subclavian artery complex, equal inside lining has the multirow to be used for supporting tectorial membrane and fixed ramose metal frame in tectorial membrane and fixed branch. The utility model has the advantages of can accord with human anatomy aortic arch portion characteristics, utilize the main part support and movable branch support of different models through the combination, cover human aortic arch completely, play the main artery of protection, prevent vascular the continuation to expand and ruptured effect.

Description

Integration multiple branch gets involved aortic arch overlay film frame
Technical field
This utility model belongs to medical cardiovascular surgery technical field, is specifically related to a kind of intervention with integrated multiple branch aortic arch overlay film frame, carries out Endovascular Therapy to aortic arch pathological changes and aortic arch bifurcated artery pathological changes.
Background technology
Cardiovascular disease is the first killer threatening compatriots' health at present, and aortic aneurysm is one of the most dangerous anxious, serious symptom cardiovascular disease.Clinically image be called " time bomb ".True property aortic aneurysm, false aortic aneurysm and dissecting aneurysm can be divided into by structure aortic aneurysm.According to pressing happening part, aortic aneurysm can be divided into Ascending Aortic Aneurysm, Aortic arch aneurysm, descending aortic aneurysm or aneurysm of thoracic aorta (starting point is at the far-end of left subclavian artery) and abdominal aortic aneurysm.Dissection of aorta (aorticdissection, AD) refers to that aorta lumen inner blood enters aortic tunica media from aortic tunica intima tear place, makes middle membrance separation, and along the expansion of aorta long axis direction, forms the interlayer of aorta wall.Aortic aneurysm is that the aorta wall middle level caused due to a variety of causes such as atherosclerosis, Intraarterial pressure rising, wounds is impaired, elastorrhexis replaces fibrous scar tissue, namely arterial wall follows the string, blood flow can not be tolerated impact and cause aorta wall local or diffuse abnormal dilatation, compressing peripheral organs and cause the disease of symptom.Along with the arrival of China's aging society, the sickness rate of the chronic disease such as hypertension, atherosclerosis presents obvious increase trend, and one of consequence at a specified future date of these diseases is exactly cause Secondary cases dissection of aorta or aortic aneurysm pathological changes.Recall rate and the sickness rate of dissection of aorta (AorticDissection, AoD) and aortic aneurysm constantly rise.2 ~ 4,/10 ten thousand people are about according to conservative estimation dissection of aorta annual morbidity, dissection of aorta is one of the most dangerous anxious, serious symptom cardiovascular disease, especially involve the dissection of aorta of ascending aorta and aortic arch and the aneurysm patient dissection of aorta that can happen suddenly to break sudden death, the state of an illness is dangerous, very big to human life health threat, Aortic Dissection 24 hours Natural progression only 40%, after 1 week, Natural progression is 25%, its dangerous degree, far away higher than cerebral infarction, heart infarction and malignant tumor, has become the important medical treatment and the social problem that obviously affect compatriots' health.
At present, treat aortic disease and comprise the methods such as Drug therapy, surgical operation therapy, interventional therapy.Drug treatment is mainly by strictly controlling the incidence rate that blood pressure reduces aneurysm continuation expansion or breaks.Surgical operation therapy aspect is aneurysm excision and artificial or vascular homograft mainly, and the operative mortality of current abdominal aortic aneurysm is lower than 5%, but the age is excessive, and intentionally, brain, kidney or other visceral lesion person, surgical death can more than 25%.The operative mortality of aneurysm of thoracic aorta is 30%, maximum with the surgical risk of Aortic arch aneurysm.But operation is carried out under deep hypothermia cardiopulmonary bypass, and there is the risk of spinal cord, brain and important organ ischemic necrosis, a lot of gerontal patient cannot tolerate and holds surgical operation therapy under breast owing to there is high risk factor and lose therapy apparatus meeting.
Along with progress and the extensive use of intervention material; intracavity recovery technique is used for clinical by Parodi first time in 1991; its ultimate principle is: will be covered with the compressible stent of artificial vascular membrane; discharge after they being transported to vascular lesion position by induction system; utilize the memory characteristic of support self; after Endovascular expansion; diseased region (cut as aneurysm or interlayer) is isolated from outside lumen of vessels; blood is passed through in support; thus protect weakness or alleviate the tension force of lesion vessels wall, reach the object of repairing lesion vessels.Endovascular completely cuts off treatment technology and rises thereupon, present technique has become the main method that initiatively interlayer, descending aortic aneurysm or aneurysm of thoracic aorta, abdominal aortic aneurysm fall in treatment, and the early metaphase result of the clinical experimental study of trunk intracavity technology is satisfactory.
At present for the treatment of the aneurysm or artery dissection that are positioned at ascending aorta and aortic arch, be subject to the restriction of intervention material, can not the interior reparation of an actor's rendering of an operatic tune completely.Most employing is entirely bent replacement or is adopted open chest surgery treatment to implant with type great vessel strut the hybridization surgical technic combined.Although the latter, compared with the former, simplifies aortic arch surgery, reduce operating time, reduce postoperative complication.But still can not be completely free of traditional operation as dependence, greatly limit extensively carrying out of aortic arch disease surgery, only just can complete at the department of cardiac surgery center that minority is large, even need hybridization operating room.Especially older, complication person is many, and this modus operandi risk of the patient of body constitution difference is still larger.This just treats aneurysm or the artery dissection of ascending aorta and aortic arch in the urgent need to a kind of stent, make to perform the operation completely to reach Wicresoft completely, safely, be convenient to carry out.
Also research center is had to be devoted to the research of ascending aorta and bow portion support in blood-vessel in recent years, but support Design is too simple, coarse mostly, to aspect shortcomings such as ascending aorta and bow portion hemodynamics, anatomy, biomechanicss, or support Design is too complicated, complex operation step is not easily grasped, be not suitable for clinical practice, fail to solve blood vessel-support consistency problem.In a word, at present become the important study hotspot of of vascular surgery field about bow portion support in blood-vessel, but owing to there is the practical problems such as releasing mechanism complexity, induction system sheath pipe diameter is excessive, branch stent not easily compresses, do not make substantial breakthroughs all the time.
Summary of the invention
For above-mentioned problems of the prior art, the purpose of this utility model is, a kind of integrated multiple branch is provided to get involved aortic arch overlay film frame, be mainly used in carrying out Endovascular Therapy to diseases such as aortic arch true aneurysm, aortic arch false aneurysm, StanfordA type dissecting aneurysm, part StanfordB type dissecting aneurysm, aortic intramural hematoma, aorta penetrating ulcer, traumatic aortic damage, aortic arch bifurcated artery pathological changes, overcome problems of the prior art.
In order to realize above-mentioned task, this utility model by the following technical solutions:
Integration multiple branch gets involved aortic arch overlay film frame, this overlay film frame is for turning shape structure, comprise bow proparea, Gong Buqu and bow back zone: bow proparea is extended to form along its one end by one section of tubulose overlay film, this overlay film arcuately bends and extends to form Gong Buqu by bending proparea end, and overlay film continues to extend to form bow back zone from Gong Buqu end; The large curved side in Gong Bu district is that elliposoidal is protruding, and projection is provided with the fixing branch of the inner company of passing through with Gong Bu district, and the sidepiece of fixing branch is provided with perforate; The metal rack of many rows for supporting overlay film and fixing branch is lined with in equal in overlay film and fixing branch.
Further, movable in described perforate active branch is installed, in active branch also in be lined with metal rack.
Further, described fixing branch and active branch include tubular film, the tubular film of fixing branch is connected with the overlay film in Gong Bu district and through, the inwall of one end of the tubular film of active branch is provided with becket, becket is provided with a ring shape cloth, and the inner ring diameter of annular cloth is identical with becket and be cemented on becket; The support ring arranged with becket concentric is lined with between the inner ring and outer ring of annular cloth; Described metal rack liner is in the circumference of fixing branch and active branch tubular film.
Further, described metal rack is the closed hoop metal rack of liner on overlay film and tubular film circumference, this annular metal frame is the loop configuration be made up of multiple V-arrangement tinsel adjacent solder, and the angle range of degrees formed between V-arrangement two tinsels wiry is 30 ° ~ 60 °.
Further, in the annular metal frame of described bow proparea, bow back zone and tubular film, V-arrangement size wiry is identical, and all V-arrangements top wiry and bottom lay respectively at two and be parallel to each other circumferentially in loop configuration.
Further, in the annular metal frame in described Gong Bu district, V-arrangement size wiry is increased to the direction of large curved side gradually by the lesser curvature side in Gong Bu district.
Further, described V-arrangement apex portion wiry and adjacent V-arrangement connecting portion wiry are round and smooth shape.
Further, this overlay film frame is provided with positioning guide wire, this positioning guide wire extends to front end, Gong Bu district by bending proparea, then extends to bow back zone end from Gong Buqu end.
Further, the minor axis length 2 ~ 3mm larger than the radius of bow proparea tubulose overlay film of described elliposoidal projection.
Further, the diameter 2mm larger than the diameter bending proparea of described front end, bow back zone, bow back zone entirety, in frustum, reduces gradually along bending the orient diameter of front end, back zone to end; The diameter of bow back zone end is identical with bow proparea diameter, and bow back zone entire length is 10 ~ 15cm.
Further, without the metal rack of liner in the overlay film of described bow back zone end 0.5 ~ 2cm.
Further, the protruding central angle corresponding in the circumferential of described elliposoidal is 120 ° ~ 180 °.
Further, the number of degrees of the central angle that the lesser curvature side in described Gong Bu district is corresponding are 120 ° ~ 160 °.
Further, bow proparea is with in many rows annular metal frame of liner on bow back zone, and the distances between two adjacent row's metal rack are 0.2 ~ 0.8cm.
Further, the distance between described becket to support ring is 0.5 ~ 2cm, and the distance between support ring to annular cloth outer ring is 0.5 ~ 2cm.
Further, the front end in bow proparea is provided with apterium.
This utility model compared with prior art has following technical characterstic:
The utility model has the advantage of and can meet human anatomy aortic arch feature; main body rack and the active branch support of different model is utilized by combination; cover human aortic bow completely, the effect played protection aorta vessel, the expansion of prevention continuous vessel and break.Compared with prior art, this utility model meets human anatomy aortic arch feature, can individuation customization, and various combination mode, at utmost can meet individual variation, meanwhile, conveying and delivery system simple, clinical easy operation.
Main body framework of the present utility model is made up of Nitinol, possesses superpower elasticity, compressible on induction system sheath core, by propelling movement and delivery system, drive in the wrong direction through femoral artery and support is delivered to aortic arch, adjust position of windowing, aim at aortic arch branch vessel.Support is put into lesion, releasing bracket, this product can be used for various forms of aortic blood tuberculation hybridization operation, namely under operating condition, utilizes induction system by stenter to implant to lesion locations.This product has broken traditional bow portion pathological changes can not the taboo of row inner cavity insulation technology (TEVAR), the novel intracavity implant of a kind of brand-new aortic arch disease surgical intervention of design and implementation: the TEVAR technology being about to window is incorporated in the pathological changes inner cavity insulation operation of bow portion and goes, bow portion graft is discharged in art, import branch stent, and the design of the carnival hat of branch stent uniqueness turn avoid tradition windows branch stent internal hemorrhage due to trauma, the shortcoming of easy displacement, the length of getting the two abandons the short of the two, reduce operation technique difficulty, decrease the operation of bow portion, reduce bow portion complication, improve operation safety and success rate.
Accompanying drawing explanation
Fig. 1 is overall structure schematic diagram of the present utility model;
Fig. 2 is the front view of active branch;
Fig. 3 is the upward view of active branch;
The longitudinally cutting schematic diagram in Tu4Wei Gongbu district;
The planar development schematic diagram of Tu5Wei Gongbu district annular metal frame;
Fig. 6 is the use schematic diagram of existing straight shape aortic arch support;
Fig. 7 (A), (B) are contrastographic picture after zoopery row full intracavity aortic arch prothesis;
Fig. 8 (A), (B), (C), (D) carry out the CTA axle position image after full intracavity aortic arch prothesis for experimental dog 2;
Fig. 9 (A), (B) repair immediate postoperative CTA reconstructed image for experimental dog 7 carries out full intracavity aortic arch;
Figure 10 (A), (B) are 8 weeks CTA reconstructed images after experimental dog 9 row full intracavity aortic arch prothesis;
Figure 11 (A), (B), (C), (D), (E), (F) are experimental dog 11 row full intracavity aortic arch prothesis CTA later six months reconstructed image;
Figure 12 (A), (B) are the aortic arch overlay film frame that takes out in experimental dog body postoperative half a year and vascular specimen figure.
Number in the figure represents: 1-apterium, 2-bow proparea, 3-fixing branch, 31-tubular film, 32-annular cloth, 33-support ring, 34-becket, 4-perforate, 5-Gong Buqu, 6-metal rack, 7-overlay film, 8-bow back zone, 9-bow back zone end;
Detailed description of the invention
Traditional aortic arch support is Straight structure, this Straight structure its be bent to arc after, because the intensity of support is low, when bending, kink branch is because the effect of two side force is to the direction of axis line compression of straight tube, the arcuate section of the straight tube after bending is compressed, the cross section ovalize of arcuate section, and make the structure of formation undesirable.
Therefore after also bending in traditional straight shape stenter to implant to aortic arch, the radian of human aortic bow part can not be adapted to well, especially the part that is connected with brachiocephalic trunk, left common carotid artery and left subclavian artery of the bow top of aortic arch, traditional straight shape support and aortic arch top portion can be made to leave space due to bending, can not fit well, internal hemorrhage due to trauma incidence rate is high, causes multiple complications, as shown in Figure 6.Thus, the straight shape support of the type can not carry out good coordinating with aortic branch support, to treat the disease of bifurcated artery.
One, integrated multiple branch gets involved aortic arch overlay film frame introduction about the construction
This utility model provides a kind of integrated multiple branch and gets involved aortic arch overlay film frame, this support is for turning shape structure, as the liner support of aortic arch pathological changes, and the fixing branch 3 arranged on this graft, be then corresponding with patient's brachiocephalic trunk, directly fixing branch 3 extend in patient's brachiocephalic trunk during implantation.The position of two other perforate 4 is adjustable: because the position of the fixing branch 3 of brachiocephalic trunk corresponding on graft is fixed, the relative position that can obtain brachiocephalic trunk and left common carotid artery, left subclavian artery is checked by preoperative row CTA, correspondence position then on overlay film frame of the present utility model arranges perforate 4, to coordinate with two bifurcated arteries, blood is made to flow to bifurcated artery by perforate 4.When left common carotid artery, these two bifurcated arteries of left subclavian artery also produce pathological changes need implant frame time, implant active branch by perforate 4, bifurcated artery played a supporting role, specifically use, depending on conditions of patients.
Therefore the contour structures of overlay film frame contour structures of the present utility model and aortic arch is similar, and for turning shape structure, human aortic of fitting better bends, and this graft comprises bow proparea 2, Gong Bu district 5 and bow back zone 8, and fixing branch 3 is arranged in Gong Bu district 5;
Its structure for convenience of explanation, the entirety of this windowing stent can be regarded as to be extended by one section of tubulose overlay film 7 and form: one section of internal diameter to be slightly less than or similar in the tubulose overlay film 7 of aortic arch part internal diameter, certain distance is extended along its one end, form bow proparea 2, the radial cross-section of this bow proparea 2 arbitrary portion amasss circle identical all.At the close end in bow proparea 2, namely bend proparea 2 near one end of heart, be provided with the thickening overlay film 7 being not less than 1cm, this thickening overlay film 7 adopts artificial blood vessel's material, thicker than the overlay film 7 of this windowing stent remainder, block aorta in being convenient to again to perform the operation and carry out vascular anastomosis.
Front end fixation is mainly played, as the basis of this support monolithic stability in bow proparea 2; Bow proparea 2 can ensure the stability of support entirety, prevents stent migration in support dispose procedure and postoperative.
Shi Gongbu district 5 from the end in bow proparea 2, as shown in Figure 1, this Gong Bu district 5 is the part of coincideing with human aortic Gong Bu district 5.Gong Bu district 5 of the present utility model is the similar arc tubulose overlay film 7 in a segment length and human aortic Gong Bu district 5, and the end that this Gong Bu district 5 can regard the tubulose overlay film 7 in bow proparea 2 as arcuately bends extension and forms; The end in Gong Bu district 5 is identical with the internal diameter in bow proparea 2.The lesser curvature side in Gong Bu district 5, the number of degrees of central angle corresponding inside Ji Gongbu district 5 are 120 ° ~ 160 °, adapt with the radian of human aortic bow step.The large curved side in Gong Bu district 5, the side of three arterial branches is pressed close in Ji Gongbu district 5, in order to make it fit with the bow top of aortic arch better, is provided with elliposoidal projection in this utility model on large curved side, the Gong Bu district 5 of windowing stent.
Elliposoidal in this utility model is protruding, refer to a spheroid (the oval shape rotated along major axis), along passing through its major axis, or the shape that the plane being parallel to major axis is cut off, protruding overlay film 7 smooth engagement with Gong Bu district 5 of this elliposoidal, also can regard as Gong Bu district 5 by lesser curvature side to large curved side to tubulose overlay film 7 radius increase gradually and formed.The protruding central angle corresponding in the circumferential of elliposoidal is 120 ° ~ 180 °, by the Gong Bu district 5 radially crosscut at the protruding place of elliposoidal, in the cross section of Gong Buqu 5, in a circumferential direction, the radian of circumference shared by elliposoidal projection is 120 ° ~ 180 °, namely elliposoidal protruding Gong Zhangongbu district 5 circumference 1/3 ~ 1/2, as shown in Figure 4.When the number of degrees of the central angle corresponding to elliposoidal projection are 180 °, the centre of sphere of elliposoidal projection, namely the major axis of elliposoidal projection, minor axis intersection point are positioned at the center of this Gong Bu district 5 cross section, also namely bend on the extended line of axial line in proparea 2, now the minor axis length of spheroid is identical with the radius of bow proparea 2 tubulose overlay film 7.In this case, the minor axis length of elliposoidal projection comparatively bends the large 2 ~ 3mm of radius of proparea 2 tubulose overlay film 7, and namely the protruding part large height not protruding compared with periphery of elliposoidal is about 2 ~ 3mm.
Elliposoidal projection is provided with fixing branch 3, and in the present embodiment, fixing branch 3 is positioned at the front end in Gong Bu district 5, therefore fixes branch 3 and can be used for supporting brachiocephalic trunk.Fixing branch 3 is arranged on the protruding upper part near bow proparea 2, and fixing branch 3 inside is connected through with inside, Gong Bu district 5.After the position of fixing branch 3 is fixing, be easy to according to visualisation the position determining two other perforate 4.After overlay film frame of the present utility model is implanted to patient's aortic arch, during release, adjustment makes fixing branch 3 just in time extend in the brachiocephalic trunk of patient.Perforate 4 can arrange its position as required, with in requisition for support left common carotid artery and left subclavian artery.
It should be noted that, in this programme, fix the position that branch 3 also can take two other perforate 4.That is, according to aortic arch actual lesion situation, the position of fixing branch 3 on Gong Buqu 5 can be determined in advance.When fixing branch 3 is positioned at centre, for supporting left common carotid artery, now two other perforate 4 is positioned at its both sides; And fixing branch 3 is when being positioned at the rightmost side, two other perforate 4 is positioned at its front end.
The design in this utility model Zhong Gongbu district 5, after making this windowing stent be implanted to human aortic bow, can be fitted better, simulate human anatomy feature completely, be carried out the protection of complete aortic arch by coupling branch stent.Gong Bu district 5 overall width is slightly larger than the diameter of aortic arch part, make Gong Bu district 5 of the present utility model part under the elastic reaction of inner wire, certain pressure is kept between energy and aortic arch inwall, can fit with the inwall of aortic arch to greatest extent, the blood of such aortic arch is in the process of carrying to bifurcated artery by windowing, can not enter between windowing stent and aortic arch inwall, thus eliminate traditional straight shape support owing to bending not tight, the interstitial drawback of laminating brought.
Fix the side of branch 3 in this utility model Gong Bu district 5, be provided with two perforates, 4, corresponding left common carotid artery, another corresponding left subclavian artery.Overlay film 7 in Gong Bu district 5 can be cut off, and according to the practical situation of patient's visualisation, measures the distance between brachiocephalic trunk and left common carotid artery, left subclavian vein, thus accurately sets the position of perforate 4.When the left common carotid artery of patient and left subclavian artery have pathological changes, when needing to support, cut off peritoneum at the correspondence position of Gong Buqu 5 and obtain perforate 4, then in the perforate 4 of correspondence, put into active branch; As without pathological changes, then do not need to put into active branch, make perforate 4 position relative with bifurcated artery.
In this utility model, in active branch also in be lined with metal rack 6.Fixing branch 3 and active branch include tubular film 31, the fixing tubular film 31 of branch 3 is connected with the overlay film 7 in Gong Bu district 5 and through, the inwall of one end of the tubular film 31 of active branch is provided with becket 34, becket 34 is provided with a ring shape cloth 32, and the inner ring diameter of annular cloth 32 is identical with becket 34 and be cemented on becket 34; The support ring 33 arranged with becket 34 concentric is lined with between the inner ring and outer ring of annular cloth 32; Described metal rack 6 liner is in the circumference of fixing branch 3 and active branch tubular film 31.Overlay film 7 adopts ePTFE material to make.
Side active branch tubular film 31 being arranged becket 34 in use, is extend in the perforate 4 in graft Gong Bu district 5.The setting of annular cloth 32 enhances the adaptability of active branch, for different patients and situation, can cut part annular cloth 32 as required, with the demand of applicable different patient.The effect of annular cloth 32 is stuck in perforate 4, protects the stability that overlay film frame entirety is connected with active branch.Therefore, before surgery by the result of CTA, annular cloth 32 edge is pruned, prune and become suitable size, the blood that annular cloth 32 can not be affected in aortic arch enters other normal bifurcated arteries by perforate 4, make again annular cloth 32 active branch can be stuck in perforate 4, to support the bifurcated artery of pathological changes.When arranging two active branch, the annular cloth 32 of two active branch should be kept after pruning can not to block adjacent perforate 4 or lead to the hole of brachiocephalic trunk, preventing it from hindering the normal conveying of blood.The support ring 33 arranged in annular cloth 32 makes the part of branch stent except annular cloth 32 stretch out and windows in being stuck in and windowing.As preferably embodiment, the distance between becket 34 to support ring 33 is 0.5 ~ 2cm, and the distance between support ring 33 to annular cloth 32 outer ring is 0.5 ~ 2cm, conveniently prunes, and its material can adopt politef.The branch stent of this " hat-type ", makes mount proximal end and bow portion main body directly fit more tight, relatively traditional straight barrel type branch stent, fixing more firm, and internal hemorrhage due to trauma and displacement are less likely to occur.
When active branch extend into after in the arterial branch of pathological changes, because the arterial branch internal diameter of the active branch diameter that sets in advance and pathological changes is similar, and the blood vessel of human body maintains certain elasticity, after active branch is stretched into, it can be made to be relatively fixed by the elasticity of blood vessel wall, there will not be the situation of landing.
Be directed to the defect that current support exists, be provided with active branch in this programme, the perforate 4 by main body rack inputs in body, makes blood enter bifurcated artery by active branch completely; Active branch and the maximum difference of conventional stent are, accurate location positioning can be carried out according to visualisation, make support can accomplish to mate accurately for each patient, and can judge whether to need to implant active branch according to the needs of the state of an illness, accomplish effective utilization of support, alleviate the burden of patient.
The end in Gong Bu district 5 is connected to bow back zone 8, the diameter (position of bow back zone 8 largest diameter) of bow front end, back zone 8 comparatively bends the about 2mm of diameter in proparea 2, and bow back zone 8 entirety is in frustum, the diameter of bow back zone 8 reduces gradually from bow terminad direction, front end, back zone 8 internal diameter, and bow back zone end 9 is identical with the diameter in bow proparea 2.Without the metal rack 6 of liner in the overlay film 7 of bow back zone end 90.5 ~ 2cm, be convenient to coincideing when far-end is performed the operation later again.The entire length of bow back zone 8 is 10 ~ 15cm.
Afterbody fixation is mainly played in bow back zone 8, can ensure support stability in the large, in prevention support dispose procedure and postoperative support situation about being subjected to displacement.Bow back zone 8 has certain length, due to vessel wall elasticity effect, can play good supporting role to whole support.Bow back zone 8 is implanted in descending aorta position, can effectively close descending aorta cut, promote false chamber thrombosis, reduces false chamber and to break probability, recover the blood supply of true chamber, promotion descending aorta Vascular remodeling.
In this utility model, tubulose overlay film 7 and fixing branch 3, active branch are all supported by metal rack 6.Bow proparea 2, bow back zone 8 are identical with the metal rack 6 of liner in fixing branch 3 tubular film 31, active branch tubular film 31, be annular metal frame, this annular metal frame liner is bending proparea 2, is bending in the circumference of back zone 8 and tubular film 31, two adjacent row's metal rack 6 are parallel to each other, and each annular metal frame is all independently.Annular metal frame is the loop configuration be made up of multiple V-arrangement tinsel adjacent solder, on the axial line being centrally located at bow proparea 2 or bow back zone 8 overlay film 7 of loop configuration, and all V-arrangements top wiry and bottom lay respectively at two and are parallel to each other circumferentially in loop configuration; The angle range of degrees formed between V-arrangement two tinsels wiry is 30 ° ~ 60 °, and the distance between two adjacent row's metal rack 6 is 0.2 ~ 0.8cm.The setting of annular metal frame makes overlay film 7 and tubular film 31 have good elasticity and restorative.
Different from bow proparea 2, the annular metal shelf structure that bends in back zone 8 and tubular film 31, in Gong Buqu 5, due to the setting of elliposoidal bulge-structure, in the overlay film 7 in this Gong Bu district 5, the metal rack 6 of liner should prop up the elliposoidal structure in district of arch support portion 5, adapt with the radian in whole Gong Bu district 5 again, therefore as still to adopt bow proparea 2 or bow back zone 8 metal rack 6 structure be the arched requirement that can not meet this part.
The metal rack 6 of Gong Bu district 5 liner is be also annular metal frame, but this annular metal frame is formed by multiple V-arrangement tinsel adjacent solder differed in size, and pad is excessively round and smooth, makes pad sharply unlikely; And V-arrangement apex portion wiry also can be round and smooth, as shown in Figure 1; And by Gong Bu district 5 lesser curvature side to large curved side direction on, V-arrangement tinsel increases gradually; V-arrangement tinsel increase gradually refer to lesser curvature side to large curved side direction on, V-arrangement two wire length wiry near large curved side are greater than V-arrangement two length wiry wiry near lesser curvature side, but it is identical to form V-arrangement two sections of length wiry wiry.This density shape is arranged, and Shi Gongbu district 5 constructor closes mechanical characteristic, and the metal rack 6 in Gong Bu district 5 both ensure that the structural strength of elliposoidal projection, made again Gong Bu district 5 contour structures of bending fix, can not be out of shape.In addition, aforesaid V-arrangement metal rack 6 can be replaced U-shaped metal rack 6, and the set-up mode of U-shaped metal rack 6 is identical with V-arrangement metal rack 6.
As shown in Figure 5, be the expanded view in Gong Bu district 5.The middle part of the lesser curvature side in expanded view Shi Conggongbu district 5 launches to both sides and is stretched by annular metal frame to open in a plane.In Fig. 5, the A point in left side and the A point on right side are a point when not launching.Can clearly find out from this figure, from lesser curvature side to large curved side to, V-arrangement tinsel constantly increases, and is a V-arrangement tinsel maximum in the annular metal frame at this tinsel place at the V-arrangement tinsel of large curved side core; The different adjacent connections of V-arrangement tinsel, forms annular metal frame, and such metal rack 6 structure is conducive to the shape keeping Gong Bu district 5, enhances support force simultaneously.
Because this overlay film frame is for intervene operation, therefore the front end in bow proparea 2 is provided with apterium 1, be without overlay film 7, the structure only having annular metal frame, the metal rack 6 of apterium 1 part is opened towards the direction away from bow proparea 2 axial line, and whole overlay film frame is easily fixed when laying.In addition, overlay film frame is provided with positioning guide wire, this positioning guide wire extends to front end, Gong Bu district 5 by bending proparea 2, and then extend to bow back zone end 9 from Gong Buqu 5 end, namely positioning guide wire is not by perforate 4, in order to avoid affect the setting of active branch in perforate 4.Positioning guide wire generally can be arranged at the outermost of overlay film frame, arranges vertically; Positioning guide wire being provided with anchor point, being used for location when implanting.
In this programme, above-mentioned tubular film 31, overlay film 7 can adopt polytetrafluoroethylmaterial material to make, and tinsel, metal rack 6 etc. can adopt dilval or medical stainless steel material, macromolecular material is made; Metal rack 6 has elasticity, is convenient to be placed in apparatus implant.
Two, zoopery
This zooperal object is by application experiment animal, evaluates the safety of this aortic arch overlay film frame, adherent property, support force and compliance, for further clinical practice lays the foundation.
1. given the test agent
In this zoopery, given the test agent is that multiple branch of the present utility model gets involved aortic arch overlay film frame, completes the intracavity repairing and treating of part or full aortic arch.
2. laboratory animal
Select the assorted dog 15 that grows up of more than Xi'an region body weight 20kg, wherein female 5, male 10, average weight 25.7 ± 5.6kg, be responsible for providing and raising by Xijing hospital of The Fourth Military Medical University animal experimental center, for the experimentation that aortic arch overlay film frame is implanted, be numbered experimental dog 1 to experimental dog 15; In the early stage in process of the test, only implant an active branch, sealing treatment (Fig. 7-9) is done in another perforate, in later stage process of the test, implants 2 active branch, covers aortic arch (Figure 10 .11) completely.
3. experimental result
This experiment uses SPSS16.0 to carry out data analysis and statistical test.Morphological indexes CT measurement data and group difference, the t inspection of line description statistical analysis and independent sample; P<0.05 is for there being statistical significance.
1. animal and hands general condition
Article 15, in experimental dog preoperative dead 2: wherein 1 example is dead because namely arrhythmia occurring after anesthesia all rescue measures proved ineffectual; 1 example because of dissociate blood vessel cause hemorrhage death.All the other 13 example operations complete all smoothly, and in operation process, cardiac monitoring prompting animal life is levied steadily, and situation without exception occurs.In art dead 1, because the approach blood vessel of animal is meticulous, support cannot be completed smoothly and import, cause tunica intima to be torn after repeatable operation and dead.The complete group of average 2.8 ± 1.0h of operating time, average 252.4 ± 96.3ml, the DSA irradiation time of intraoperative blood loss amount 10.6 ± 5.2min, in table 1.
The full intracavity aortic arch prothesis Basic Information Table of table 1.
Index Quantity Minima Maximum Meansigma methods
Body weight (kg) 12 21.2 33.6 25.7
DSA irradiation time (min) 12 5.6 18.2 10.6
Operating time (min) 12 93 256 160
Blood loss (ml) 12 150 420 252
2. the adherent performance of support
12 examples are successfully carried out in the experimental dog of intracavity reparation, and after support release, radiography points out the adherent performance of whole support good, does not observe the phenomenons such as stent migration, as shown in Figure 7 in art.Fig. 7 (A): postoperative radiography display head arm vascular flow is unobstructed; Fig. 7 (B) retains DSA image in animal body for overlay film frame.
3. postoperative CTA check
The 12 examples experimental dog that successfully carries out intracavity reparation in immediate postoperative, 8 weeks and half a year row multi-slices CT enhanced ct scans, measurement bracket each position diameter, with or without displacement, internal hemorrhage due to trauma index of correlation.CTA result shows that contrast-agent-free leaks and internal hemorrhage due to trauma, and 2 routine experimental dogs are less than dog diameter of aortic arch because of size between main body, occur and aortic arch angulation situation.All the other branch stent forms are good, comply with dog aortic arch radian and anatomic morphological, do not occur the complication such as iatrogenic interlayer, as shown in Figs. 8 to 11.
4. specimen sampling
After interventional procedure 8 weeks and put to death animal half a year, take out band branch trunk overlay film frame, observe the combination degree etc. of tumor intracavity thrombosis or granulation growing state, the character of graft inner surface covering, graft two ends and host artery intersection.The combination of result display graft two ends and host artery wall is firm, the white fiber tissue covering that surface is thin, has no red thrombus sample tissue, as shown in figure 12.
Experimental specimen checks, has no the adverse events such as metal fracture, overlay film breakage.Demonstrate good biocompatibility with branch's trunk overlay film frame graft, can see newborn " inner membrance " sample tissue and cover, hold graft, it is complete that far-end covers nearer end.
3. experiment conclusion
Different follow up time section after the thoracic aorta of the stenter to implant Canis familiaris L. of this programme, laboratory animal general status, blood, every biochemical indicator are all in normal range, and Long term Animal is survived.Experimental result shows: it is evident in efficacy that multiple branch gets involved aortic arch overlay film frame, have excellent blood and histocompatibility, and its adherent property, compliance, support force and biocompatibility is good.

Claims (10)

1. an integrated multiple branch gets involved aortic arch overlay film frame, it is characterized in that, this overlay film frame is for turning shape structure, comprise bow proparea (2), Gong Buqu (5) and bow back zone (8): bow proparea (2) is extended to form along its one end by one section of tubulose overlay film (7), this overlay film (7) arcuately bends and extends to form Gong Buqu (5) by bow proparea (2) end, and overlay film (7) continues to extend to form bow back zone (8) from Gong Buqu (5) end; The large curved side in Gong Bu district (5) is that elliposoidal is protruding, and projection is provided with the fixing branch (3) of passing through with Gong Bu district (5) inside and connecting, and the sidepiece of fixing branch (3) is provided with perforate (4); The metal rack (6) of many rows for supporting overlay film (7) and fixing branch (3) is lined with in equal in overlay film (7) and fixing branch (3).
2. integrated multiple branch as claimed in claim 1 gets involved aortic arch overlay film frame, it is characterized in that, movablely in described perforate (4) is provided with active branch, is lined with metal rack (6) in active branch.
3. integrated multiple branch as claimed in claim 2 gets involved aortic arch overlay film frame, it is characterized in that, described fixing branch (3) and active branch include tubular film (31), the fixing tubular film (31) of branch (3) is connected with the overlay film (7) of Gong Bu district (5) and through, the inwall of one end of the tubular film (31) of active branch is provided with becket (34), becket (34) is provided with a ring shape cloth (32), the inner ring diameter of annular cloth (32) is identical with becket (34) and be cemented on becket (34), the support ring (33) arranged with becket (34) concentric is lined with between the inner ring and outer ring of annular cloth (32), described metal rack (6) liner is in the circumference of fixing branch (3) and active branch tubular film (31).
4. integrated multiple branch as claimed in claim 2 gets involved aortic arch overlay film frame, it is characterized in that, described metal rack (6) is the closed hoop metal rack of liner on overlay film (7) and tubular film (31) circumference, this annular metal frame is the loop configuration be made up of multiple V-arrangement tinsel adjacent solder, and the angle range of degrees formed between V-arrangement two tinsels wiry is 30 ° ~ 60 °; Described bow proparea (2), bow back zone (8) and tubular film (31) annular metal frame in, V-arrangement size wiry is identical, and all V-arrangements top wiry and bottom lay respectively at two and be parallel to each other circumferentially in loop configuration; In the annular metal frame of described Gong Buqu (5), V-arrangement size wiry is increased to the direction of large curved side gradually by the lesser curvature side of Gong Buqu (5).
5. integrated multiple branch as claimed in claim 1 gets involved aortic arch overlay film frame, it is characterized in that, in many rows annular metal frame of bow proparea (2) and the upper liner of bow back zone (8), the distance between two adjacent rows' metal rack (6) is 0.2 ~ 0.8cm.
6. integrated multiple branch as claimed in claim 1 gets involved aortic arch overlay film frame, it is characterized in that, this overlay film frame is provided with positioning guide wire (10), this positioning guide wire (10) extends to Gong Buqu (5) front end by bow proparea (2), then extends to bow back zone end (9) from Gong Buqu (5) end.
7. integrated multiple branch as claimed in claim 1 gets involved aortic arch overlay film frame, it is characterized in that, the minor axis length 2 ~ 3mm larger than the radius of bow proparea (2) tubulose overlay film (7) of described elliposoidal projection.
8. integrated multiple branch as claimed in claim 1 gets involved aortic arch overlay film frame, it is characterized in that, the diameter 2mm larger than the diameter of bow proparea (2) of described bow back zone (8) front end, bow back zone (8) entirety, in frustum, reduces gradually along bending the orient diameter of back zone (8) front end to end; The diameter of bow back zone end (9) is identical with bow proparea (2) diameter, and bow back zone (8) entire length is 10 ~ 15cm; Without the metal rack (6) of liner in the overlay film (7) of the end 0.5 ~ 2cm of bow back zone (8).
9. integrated multiple branch as claimed in claim 3 gets involved aortic arch overlay film frame, it is characterized in that, distance between described becket (34) to support ring (33) is 0.5 ~ 2cm, and the distance between support ring (33) to annular cloth (32) outer ring is 0.5 ~ 2cm.
10. integrated multiple branch as claimed in claim 1 gets involved aortic arch overlay film frame, it is characterized in that, the number of degrees of the central angle that the lesser curvature side of described Gong Buqu (5) is corresponding are 120 ° ~ 160 °.
CN201520415839.1U 2015-06-16 2015-06-16 Integration multiple -limb type intervenes aortic arch tectorial membrane support Expired - Fee Related CN204971705U (en)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104905892A (en) * 2015-06-16 2015-09-16 中国人民解放军第四军医大学 Integrated multiple-branch interventional aorta arch covered stent
CN105832447A (en) * 2016-05-27 2016-08-10 杨威 Covered stent for aortic dissection surgery, delivery device and use method thereof
CN105943199A (en) * 2016-05-31 2016-09-21 李晓东 Aortic windowing branch covered stent
CN106175983A (en) * 2016-08-03 2016-12-07 上海微创医疗器械(集团)有限公司 Overlay film frame and manufacture method thereof
CN112006811A (en) * 2019-05-28 2020-12-01 上海创心医学科技有限公司 Blood vessel reconstruction device

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104905892A (en) * 2015-06-16 2015-09-16 中国人民解放军第四军医大学 Integrated multiple-branch interventional aorta arch covered stent
CN104905892B (en) * 2015-06-16 2017-06-13 中国人民解放军第四军医大学 Integrated multiple branch intervenes arch of aorta overlay film frame
CN105832447A (en) * 2016-05-27 2016-08-10 杨威 Covered stent for aortic dissection surgery, delivery device and use method thereof
CN105943199A (en) * 2016-05-31 2016-09-21 李晓东 Aortic windowing branch covered stent
CN106175983A (en) * 2016-08-03 2016-12-07 上海微创医疗器械(集团)有限公司 Overlay film frame and manufacture method thereof
CN112006811A (en) * 2019-05-28 2020-12-01 上海创心医学科技有限公司 Blood vessel reconstruction device
CN112006811B (en) * 2019-05-28 2024-02-06 上海创心医学科技有限公司 Vascular reconstruction device

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