CN100562297C - The stent grafts that fenestra is arranged - Google Patents

The stent grafts that fenestra is arranged Download PDF

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Publication number
CN100562297C
CN100562297C CNB2004800297116A CN200480029711A CN100562297C CN 100562297 C CN100562297 C CN 100562297C CN B2004800297116 A CNB2004800297116 A CN B2004800297116A CN 200480029711 A CN200480029711 A CN 200480029711A CN 100562297 C CN100562297 C CN 100562297C
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China
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fenestra
stent grafts
stent
ring
grafts according
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CN1867301A (en
Inventor
大卫·E·哈特利
约翰·L·安德森
迈克尔·劳伦斯-布朗
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William A Cook Australia Pty Ltd
Cook Inc
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William A Cook Australia Pty Ltd
Cook Inc
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Abstract

A kind of stent grafts, the tubular wall that comprises bio-compatible transplant material, a plurality of zigzag supports along tubular wall length, with at least one fenestra in the tubular wall, described at least one fenestra comprises periphery and the independent elastic metallic yarn around at least a portion of described periphery, and described thus elastic metallic yarn provides dimensional stability for described fenestra.Can also have the tubulose extension.Side arm comprises support and lid and extends and be communicated with fenestra and stent grafts fluid from fenestra and stent grafts.Described support can be a self-expanding stent.Described ring and/or tubulose extension provide better support and sealing for adjutage.If fenestra can for circle or can be form towards the end of stent grafts with U-shaped of opening.

Description

The stent grafts that fenestra is arranged
Technical field
The present invention relates to a kind of stent grafts (stent graft) that is suitable for (endovascular) configuration in the blood vessel, especially relate to a kind of stent grafts that fenestra is arranged.
Background technology
Be disclosed as in the patent application early of WO99/29262 at us, a kind of stent grafts is disclosed, comprise at least one fenestra (fenestration), so that make that extending the lower limb transplant can the main support transplant from inner chamber extend through fenestra, thereby extension lower limb or arm transplant extended in the arm (branch vessel) of tube chamber.This situation may reside in to be had from the arteriorenal aorta that aorta extends.When having aneurysm in this zone that is comprising aorta and arteriorenal junction, then wish not only to have the aneurysmal main transplant of leap and have extension lower limb or the arm that extends to renal artery or other tremulous pulse from main transplant.
Simple window can not provide support and sealing surfaces fully reliably for extending the lower limb transplant, therefore the objective of the invention is to improve to be used for extension lower limb or arm transplant are supported and be sealed to the intravital ability of main transplanting.
Summary of the invention
Therefore, in one form, the present invention is a kind of stent grafts exactly, the tubular wall that comprises bio-compatible transplant material, along a plurality of zigzag supports of tubular wall length and at least one fenestra in the tubular wall, it is characterized in that, described at least one fenestra comprises periphery and the independent elastic metallic yarn around at least a portion of described periphery, and described thus elastic metallic yarn provides dimensional stability for fenestra.
Preferably, described elastomeric material can be selected from Nitinol (Nitinol TM) (Nitinol), rustless steel, or elastomeric material, and can be form of springs, such as the inflatable loop type of slip ring or a part of elastic metallic yarn.
In one form, the elastomeric material around the described periphery can be the form of ring.
Preferably, described ring comprises at least two circle tinsels, and preferably, the terminal wiry of described ring is provided with ring (loop), thereby described tinsel does not have the tip, and damage may be caused to vascular (vessel) in described tip.
Alternatively, described ring can be the ring such as elastomeric elastomeric material.Described elastomer for example can be silicone elastomer (silicone elastomer).
In an end position adjacent of described fenestra and stent grafts, described fenestra can be the form of the scallop formula (scallop) of a side opening.Elastomeric material around the described periphery can help opening of fenestra for the U-shaped form and during configuration (deployment), thereby the vascular of fenestra back can be inserted into conduit.
In another embodiment, the fenestra that is arranged on the scallop formula of stent grafts far-end or near-end can have the strut (strut) of self-expanding stent, and described strut is as the elastic perimeter reinforcement around a part of fenestra.When support was expansible when disposing, described strut spread apart was so that open fenestra.
Scallop can be positioned at the near-end or the far-end of stent grafts.For example, when configuration during from stent grafts that thorax bow (thoracic arch) extends, fenestra can be configured to prevent that coeliac artery is blocked.For whole embodiment, the labelling (marker) that radiopaque or MRI can not hard radiation can be used to limit the periphery of fenestra.
When stent grafts is configured to aortic bifurcation (aortic bifurcation) the zone in the bottom aorta in the time, the near-end that is desirably in stent grafts is arranged to the fenestra of scallop formula, so that avoid stopping up renal artery or dorsal mesentery (superior mesenteric) tremulous pulse.To together position, become the size of the fenestra of scallop formula to be at these arterial occlusions: described size is extending to described aorta surpassing on one the opening.
The U-shaped elastomeric material can be the Nitinol (Nitinol on the stainless steel metal wire TM) maybe can be a part of elastomeric material such as silicone elastomer.
Fenestra can be centered on to help being undertaken visual by suitable radiography techniques by radiopaque labelling.Alternatively, can in described elastomeric material, comprise gold or other heavy metal silk or band, perhaps that gold or other heavy metal silk or band is related with elastomeric material, so that provide necessary visual.
In one embodiment, fenestra can comprise the tubulose extension between tubular wall and the ring.
Described tubulose extension can comprise the related lining (associated lining) or the lid (covering) of self-expanding stent and biocompatible transplant material.
In optional form, the invention reside in stent grafts with at least one fenestra, described fenestra or each fenestra comprise the tubulose extension, side arm comprises support and extends and be communicated with fenestra and stent grafts fluid from fenestra and stent grafts.
Preferably, the tubulose extension comprises the association lining or the lid of biocompatible transplant material.By this layout, the inner cylindrical surface of tubulose extension provides bigger support and sealing surfaces between the exterior cylindrical surfaces of the main side branch stent grafts of transplanting intravital fenestra and having disposed by fenestra.
Preferably, the support in the tubulose extension is to be Nitinol (Nitinol TM) or stainless self-expanding stent.Alternatively, the support in the tubulose extension can be the expandable stent of sacculus shape.
In one form, described support can be Zhan Tours section (Gianturco) formula zigzag (zigzag) Z support.Alternatively, described support can be the Zilver that is known as that is sold by Cook Incorporated TMNitinol (the Nitinol of cantilever type TM) self-expanding stent.
Biocompatible transplant material can be positioned at the inboard or the outside of support, perhaps can be the lid that extends on the inboard of the above support of tubulose extension and the outside.
May further include the elastomeric material ring around the described periphery of the end of tubulose extension,, thereby help sealing so that for the tubulose extension provides dimensional stability.Described ring can be preferably two and more a plurality of, Nitinol (Nitinol by one or more TM) or the circle of stainless steel silk forms and preferably to have ring in its each end most advanced and sophisticated so that prevent that tinsel from occurring, described tip is may be by the transplant material outstanding and pierce through the chamber wall.
Biocompatible transplant material can be terylene (dacron), Thoralon TM, expanded polytetrafluoroethyl, ne, or other biocompatible synthetic material.
Simultaneously, terylene, expanded polytetrafluoroethyl, ne (ePTFE), or the compatible material of other synthesising biological can be used to make the lid that is used for stent grafts and tubulose extension, biomaterial such as the natural appearance of collagen is very favorable, especially be known as the deutero-especially collagen of extracellular matrix (ECM), as submucous layer of small intestine (SIS), except SIS, the example of ECM comprises pericardium, submucous lamina of stomach, liver basement membrane, submucous layer of bladder, tissue adherence and pachymeninx.
SIS is particularly useful, and can make in the mode of describing in the following document: people's such as Badylak United States Patent (USP) 4,902,508; The intestinal collagen layer of describing among the United States Patent (USP) 5,733,337 of Carr and the 17NatureBiotechnology 1803 (in November, 1999); The open WO 98/22158 of the WIPO in 28 days Mays in 1998 of people such as Cook, it is disclosed application PCT/US97/14855.Do not consider the origin of material (synthetic to Lock-in), described material can be made thicklyer by making multi-ply construction, for example, and United States Patent (USP) 5,968,096; 5,955,110; 5,885,619; With 5,711, the SIS structure of describing in 969.Animal data shows that being used in the intravital SIS of transplanting can replace with little natural fabric to one month.Except kind of a gene biological material,, also can gather in the crops autologous tissue as SIS.In addition, the polypeptide of elastin laminin and elastin-like (ELPs) etc. provides the possibility as the material of structure transplant, so that form the device with special biocompatibility.Another possibility can use the variant (allograph) such as the natural tissues of results.This being organized under the low-temperature preservation state can commerce obtain.
The tubulose extension can be placed on the reduced diameter portion of stent grafts and divide, thereby the whole diameter of stent grafts can not be subjected to remarkable influence.
For this description, the term relevant with side arm " tubulose extension " is meant that the length of tubulose extension is similar to the diameter of tubulose extension substantially on the order of magnitude.Therefore, for the diameter of 6 millimeters tubulose extensions, length can be in 5 to 10 millimeters scope.This tubulose extension diameter is suitable for arteriorenal extension lower limb or the arm transplant that configuration is used for extending from aorta.
Stent grafts can have 20 to 40 millimeters diameter and 100 to 250 millimeters length.The fenestra that needs and the layout of tubulose extension depend on specific body cavity, and each organizes fenestra custom design normally.The main support transplant can comprise that the not covering support of proximal extension remains on such as in the aortal body cavity so that assist.
The main support transplant that wherein is provided with fenestra can be one of them member of composite transplant.
Name is called the U.S. Patent No. 5 of " Expandable transluminal Graft Prosthesis For Repair ofAneurysm (the inflatable percutaneous transplant prosthese that is used for aneurysm repair) ", 387,235 disclose and a kind of transplant have been remained to equipment and method on the inking device.U.S. Patent No. 5,387, the open integral body that disclosed these features and further feature can be used in the present invention and U.S. Patent No. 5,387,235 in 235 is incorporated this description into.
Name is called the U.S. Patent No. 5 of " Barb and Expandable Transluminal Graft Prosthesis forRepair of Aneurysm (barb and the inflatable percutaneous transplant prosthese that is used for aneurysm repair) ", 720,776 disclose a kind of improvement barb with the various ways that is mechanically connected to support.U.S. Patent No. 5,720, the open integral body that disclosed these features and further feature can be used in the present invention and U.S. Patent No. 5,720,776 in 776 is incorporated this description into.
Name is called the U.S. Patent No. 6 of " Graft Prosthesis Materials (transplant prosthetic material) ", 206,931 disclose the method for a kind of transplant prosthetic material and implantation, transplanting replacement and reparation patient's a part, especially disclose the manufacturing and the use of the collagen stroma of the purification of removing from the submucosa tissue source.U.S. Patent No. 6,206, the open integral body that disclosed these features and further feature can be used in the present invention and U.S. Patent No. 6,206,931 in 931 is incorporated this description into.
The PCT patent disclosure No.WO98/53761 that name is called " A Prosthesis and a Method and Means of Deploying aProsthesis (method and apparatus of prosthese and configuration prosthese) " discloses a kind of introducer that is used for prosthese, thereby it keeps each end of prosthese to move independently.The open integral body that disclosed these features and further feature can be used in the present invention and PCT patent disclosure No.WO98/53761 among the PCT patent disclosure No.WO98/53761 is incorporated this description into.
Name be called the U.S. Patent No. 6,524,335 of " Endoluminal Aortic Stents (intracavity aortic stents) " and PCT patent disclosure No.WO99/29262 disclose be used to have intersect the tremulous pulse place placement the fenestra prosthese arranged.U.S. Patent No. 6,524,335 and PCT patent disclosure No.WO99/29262 in disclosed these features and the further feature open integral body that can be used in the present invention and U.S. Patent No. 6,524,335 and PCT patent disclosure No.WO99/29262 incorporate this description into.
Name be called " Prostheses for Curved Lumens (prosthese that is used for the curve inner chamber) " as application in 25 days October in 2002 of U.S. Patent Publication No.US-2003-0088305-A1 and be disclosed as U.S. Patent Application Serial Number No.10/280 on May 8th, 2003,486 and PCT patent disclosure No.WO 03/034948 a kind of prosthese is disclosed, described prosthese has and is used for the layout that bending is placed into curve inner chamber prosthese.U.S. Patent Application Serial Number No.10/280,486, disclosed these features of U.S. Patent Application Publication No.US-2003-0088305-A1 and PCT patent disclosure No.WO03/034948 and further feature can be used in the present invention and U.S. Patent Application Serial Number No.10/280, and 486, the open integral body of U.S. Patent Application Publication No.US-2003-0088305-A1 and PCT patent disclosure No.WO03/034948 incorporates this description into.
Name be called 28 days June in 2002 application of " Trigger Wires (trigger tinsel) " U.S. Provisional Patent Application serial number No.60/392682, the release tinsel system that is used to discharge the stent grafts that remains on the introducer device is disclosed as U.S. Patent Publication No.US-2003-0233140-A1 and December laid-open U.S. Patents patent application serial numbers on the 18th No.10/447406 in 2003 and PCT patent disclosure No.WO 03/101518.U.S. Provisional Patent Application serial number No.60/392682, U.S. Patent Application Serial Number No.10/447406, with U.S. Patent Application Publication No.US-2003-0233140-A1, can be used in the present invention and U.S. Provisional Patent Application serial number No.60/392682 with disclosed these features of PCT patent disclosure No.WO03/101518 and further feature, U.S. Patent Application Serial Number No.10/447406, incorporate this description into the open integral body of U.S. Patent Application Publication No.US-2003-0233140-A1 and PCT patent disclosure No.WO03/101518.
Name is called the U.S. Provisional Patent Application serial number No.60/392667 of the application in 28 days June in 2002 of " Thoracic Deployment Device (breast inking device) ", as U. S. application patent disclosure No.US-2004-0098079-A1 and application in June in 2003 30 and May in 2004 laid-open U.S. Patents patent application serial numbers on the 20th No.10/609846 and PCT patent disclosure No.WO2004/028399 the introducer device that is suitable for the stent grafts in the breast bow is especially disclosed.U.S. Provisional Patent Application serial number No.60/392667, U.S. Patent Application Serial Number No.10/609846, with U. S. application patent disclosure No.US-2004-0098079-A1, can be used in the present invention and U.S. Provisional Patent Application serial number No.60/392667 with disclosed these features of PCT patent disclosure No.WO2004/028399 and further feature, U.S. Patent Application Serial Number No.10/609846, incorporate this description into the open integral body of U. S. application patent disclosure No.US-2004-0098079-A1 and PCT patent disclosure No.WO2004/028399.
Name is called the U.S. Provisional Patent Application serial number No.60/392599 of the application in 28 days June in 2002 of " Thoracic Aortic Aneurysm Stent Graft (aneurysm of thoracic aorta stent grafts) ", as U. S. application patent disclosure No.US-2004-0106978-A1 and application in June in 2003 30 and June in 2004 laid-open U.S. Patents patent application serial numbers on the 3rd No.10/609835 and PCT patent disclosure No.WO2004/002370 disclose and be suitable for being used in the stent grafts for the treatment of the aortic aneurysm in the breast bow especially.U.S. Provisional Patent Application serial number No.60/392599, U.S. Patent Application Serial Number No.10/609835, with U. S. application patent disclosure No.US-2004-0106978-A1, can be used in the present invention and U.S. Provisional Patent Application serial number No.60/392599 with disclosed these features of PCT patent disclosure No.WO2004/002370 and further feature, U.S. Patent Application Serial Number No.10/609835, incorporate this description into the open integral body of U. S. application patent disclosure No.US-2004-0106978-A1 and PCT patent disclosure No.WO2004/002370.
Name is called the U.S. Provisional Patent Application serial number No.60/391737 of the application in 26 days June in 2002 of " Stent-Graft Fastening (stent grafts is fastening) ", the U.S. Patent Application Serial Number No.10/602930 of application on June 24th, 2003 and PCT patent disclosure No.WO2004/002365 disclose and have been used for support is fastened to the layout that is used in particular for exposing support on the transplant.U.S. Provisional Patent Application serial number No.60/391737, U.S. Patent Application Serial Number No.10/602930, can be used in the present invention and U.S. Provisional Patent Application serial number No.60/391737 with disclosed these features of PCT patent disclosure No.WO2004/002365 and further feature, the open integral body of U.S. Patent Application Serial Number No.10/602930 and PCT patent disclosure No.WO2004/002365 is incorporated this description into.
Name is called the U.S. Provisional Patent Application serial number No.60/405367 of the application in 23 days Augusts in 2002 of " Asymmetric Stent Graft Attachment (asymmetric stent grafts connection) ", the U.S. Patent Application Serial Number No.10/647642 of application on August 25th, 2003 and PCT patent disclosure No.WO2004/017868 disclose and have been used for prosthese being remained to the introducer device and arranging from the maintenance that the introducer device discharges.The U.S. Provisional Patent Application serial number No.60/405367 of application on August 23rd, 2002, the U.S. Patent Application Serial Number No.10/647642 of application on August 25th, 2003, can be used in the U.S. Provisional Patent Application serial number No.60/405367 of the present invention and application on August 23rd, 2002 with disclosed this feature of PCT patent disclosure No.WO2004/017868 and further feature, the U.S. Patent Application Serial Number No.10/647642 of application on August 25th, 2003 and the open integral body of PCT patent disclosure No.WO2004/017868 are incorporated this description into.
The Decembers in 2002 that name is called " Stent Graft with Improved Adhesion (have improve agglutinating stent grafts) " applied for and are disclosed as the U.S. Patent Application Serial Number No.10/322862 of No.US2003-0120332 on the 18th, disclose the layout on the stent grafts with PCT patent disclosure No.WO03/053287, it is used to strengthen in the wall that such stent grafts adheres to wherein the vascular that they will be configured.Decembers in 2002 applied for and are disclosed as the U.S. Patent Application Serial Number No.10/322862 of No.US2003-0120332 on the 18th, can be used in the present invention with disclosed this feature of PCT patent disclosure No.WO03/053287 and further feature and December in 2002 applied for and be disclosed as the U.S. Patent Application Serial Number No.10/322862 of No.US2003-0120332 on the 18th and the open integral body of PCT patent disclosure No.WO03/053287 is incorporated this description into.
Name is called the U.S. Provisional Patent Application serial number No.60/405769 of the application in 23 days Augusts in 2002 of " Composite Prostheses (compound prosthese) ", the U.S. Patent Application Serial Number No.10/645095 and the PCT patent disclosure No.WO2004/017867 of application on August 23rd, 2003 disclose prosthese or the stent grafts that is suitable for the intracavity configuration.The U.S. Provisional Patent Application serial number No.60/405769 of application on August 23rd, 2002, the U.S. Patent Application Serial Number No.10/645095 of application on August 23rd, 2003, can be used in the U.S. Provisional Patent Application serial number No.60/405769 of the present invention and application on August 23rd, 2002 with disclosed these prostheses of PCT patent disclosure No.WO2004/017867 and further feature, the U.S. Patent Application Serial Number No.10/645095 of application on August 23rd, 2003 and the open integral body of PCT patent disclosure No.WO2004/017867 are incorporated this description into.
Description of drawings
Describe the present invention below with reference to the accompanying drawing that the preferred embodiment of the present invention is shown, wherein label is in order to understand the present invention, wherein:
Fig. 1 shows an embodiment according to stent grafts of the present invention;
Fig. 2 shows along the sectional view of the stent grafts of the line 2-2 ' among Fig. 1;
Fig. 3 shows the sectional view by the tubulose extension in one embodiment of the present of invention;
Fig. 4 shows partial cross sectional views embodiment illustrated in fig. 3;
Fig. 5 shows the optional embodiment according to stent grafts of the present invention;
Fig. 6 shows the sectional view by the fenestra among Fig. 5;
Fig. 7 shows the partial cross sectional views of fenestra embodiment illustrated in fig. 5;
Fig. 8 shows the detailed view of the inboard of scallop formula fenestra according to an embodiment of the invention;
Fig. 9 shows inner side view embodiment illustrated in fig. 8;
Figure 10 shows the optional embodiment of elasticity elastomeric ring around the fenestra of fenestra periphery;
Figure 11 shows another view of the embodiment of Figure 10;
Figure 12 shows the optional embodiment of the stent grafts with scallop formula (scalloped) fenestra;
Figure 13 shows the detailed interior views of the scallop formula fenestra of Figure 12;
Figure 13 A shows the interior views of the optional layout of scallop formula fenestra;
Figure 14 shows the optional embodiment of the stent grafts with scallop formula fenestra;
Figure 15 shows the detailed interior views of scallop formula fenestra shown in Figure 14.
The specific embodiment
Watch accompanying drawing now in more detail, the embodiment shown in Fig. 1 and Fig. 2 particularly, main support transplant 1 comprises the near-end that is positioned at described stent grafts 1 and the tubular body portion 3 of far-end, mid-diameter reduces part 5 between described structural transplantation end of body, and tapering part 6 and 7 extends to mid-diameter in the each end from tubular body portion 3 and reduces part 5.
It all is bio-compatible transplant material that tubular body portion, tapering part and mid-diameter reduce part, such as terylene, and Thoralon TM, expansible PTFE, or the biomaterial of natural appearance are as extracellular matrix, as the combination of submucous layer of small intestine or other suitable material or these materials.
The formula zigzag Z of Zhan Tours section (Gianturco) support 9 is set in place in the inboard of the transplant material of the tubular body portion 3 of each end, and between described end, the formula zigzag Z of Zhan Tours section (Gianturco) support 11 is arranged on the tapering part 6 and 7 of transplant outer material side and reduced diameter portion is divided on 5.According to the whole length of stent grafts 1, tubular body portion 3 and tapering part 6 and 7 and reduced diameter portion divide in 5 each and can have the other formula zigzag Z of Zhan Tours section (Gianturco) support.
In diameter reduces middle body 5, on the tubular wall of stent grafts, has at least one circular substantially fenestra or hole 13.In the present embodiment, three fenestras are arranged, one of them is used for two renal artery each, and one is used for the dorsal mesentery tremulous pulse.Can use the fenestra of other quantity.Fenestra 13 is roughly circle and tubulose extension 15 extends from fenestra.Tubulose extension 15 comprises the biocompatible material pipe 17 with self-expanding stent 19.In this embodiment, self-expanding stent 19 is arranged on the outer surface of tubulose extension 15, but in optional embodiment, self-expanding stent 19 can be arranged on the inner surface of transplant material 17.
Biocompatible material pipe 15 is bio-compatible transplant materials, such as terylene, and Thoralon TM, expansible PTFE, or the biomaterial of Lock-in are as extracellular matrix, as submucous layer of small intestine or other suitable material.
Stitch 21 is set to be used for the tubulose extension is remained to main transplant.
Radiopaque labelling 23 is arranged on each end of fenestra 13 at the base portion of tubulose extension 15, in order to assist the doctor with respect to the lateral vein pipe location fenestra that extends from main vessel.Radiopaque labelling 23 can be material easily gold or that other is suitable.
In Fig. 3 and embodiment shown in Figure 4, be shown as 30 tubulose extension usually and extend from fenestra or hole 31 in the sidewall of main support transplant 32.Tubulose extension 30 comprises the self-expanding Nitinol (Nitinol with bio-compatible transplant material internal layer 35 and outer 36 TM) support 34.Nitinol (Nitinol around the tubulose extension periphery at terminal 39 places TM) ring 37 is provided so that the far-end to tubulose extension 30 provides good dimensional stability.In optionally arranging, ring 37 can by rustless steel or other easily material make.Stitch (stitching) 41 is set so that the tubulose extension is remained to the terminal 39 that main transplant and stitch 42 are used for ring 37 is remained on tubulose extension 30.
Nitinol (Nitinol TM) ring 37 comprises two circle tinsels, and have ring 38 at each end wiry.Ring 38 is provided for preventing the probability to the damage of internal chamber wall, because the tip of metal is enclosed in the ring effectively.
These different embodiment of the present invention by this form tubulose extension as can be seen provide good supporting and sealing surfaces, another biocompatible material stent grafts can be configured in the described sealing surfaces, so that extend to bifurcated artery from aorta or other body cavity.
Fig. 5 to Fig. 7 shows the optional embodiment according to the stent grafts of this invention.In this embodiment, with Fig. 1 in identical label represent corresponding member.
Main support transplant 1 comprises the far-end that is positioned at stent grafts 1 and the tubular body portion 3 and the central tubular body part 5 of near-end.
All tubular body portion all are bio-compatible transplant materials, such as terylene, and Thoralon TM, expansible PTFE, or the biomaterial of natural appearance are as extracellular matrix, as submucous layer of small intestine or other suitable material.
Zhan Tours section (Gianturco) formula zigzag Z support 9 is arranged within the transplant material of tubular body portion 3 and on the central tubular body part 5 at each end place.The formula zigzag Z of Zhan Tours section (Gianturco) support 11 is arranged on the outside of described transplant material.According to the whole length of stent grafts 1, except shown in the figure, on each that can be in tubular body portion 3 and central tubular body part 5 the other formula zigzag Z of Zhan Tours section (Gianturco) support is set.
In central tubular body part 5, on the tubular wall of stent grafts, has at least one circular substantially fenestra or hole 40.In this embodiment, have two fenestras, when this embodiment was configured in the aorta, fenestra was used for of two renal artery.Placement at stent grafts relates to obstruction can use other quantity such as the position of the probability of other branch vessel of dorsal mesentery tremulous pulse fenestra.Fenestra 40 is roughly circle.Radiopaque labelling 23 is arranged on each end of fenestra 40 so that help the doctor with respect to the lateral vein pipe location fenestra 40 that extends from main vessel.Radiopaque labelling 23 can for gold with other material easily.
Special Nitinol (Nitinol as can be seen from Figures 6 and 7 TM) ring 45 is arranged on around the periphery of fenestra 40 so that good dimensional stability is provided for fenestra 40.In optionally arranging, ring 45 can by rustless steel or other easily material make.Stitch 47 is provided for ring 45 is remained on around the periphery of fenestra 40.
Nitinol (Nitinol TM) ring 45 preferably includes at least two circle tinsels, and have ring 49 at each end wiry.Ring 49 is provided for preventing the damage to the chamber wall, because tip wiry is enclosed in each ring effectively.
Alternatively, one of them tinsel 45 can for gold with other bio-compatible heavy metal silk so that provide the radiophotography of ring to show, so that assist the location of transplant with respect to branch vessel.
In Fig. 5, show the scallop formula fenestra 50 that opens wide towards the end 52 of stent grafts equally.In Fig. 8 and Fig. 9, can see the details of scallop formula fenestra 50.
Fig. 8 shows the external view of the scallop formula fenestra 50 of the far-end that can be placed on stent grafts or near-end, and Fig. 9 shows the interior views of the fenestra among Fig. 8.Described fenestra comprises the scallop of the transplant material that cuts out from the main body of transplant 3.As can be seen from Figure 9, arc elastic metallic yarn 52 be sewn to scallop formula fenestra periphery 54 around.Tinsel 52 has the ring (loop) 56 that is formed on its each end, thereby can not form the tip of tinsel 52, and described tip may be damaged stent grafts and be configured in wherein blood vessel wall.Because it is elastic making tinsel and other material of U-shaped reinforcement 52, therefore fenestra will be closed and is used to be placed into such as in the aortal main cavity when stent grafts is in contraction state, and when being released, will open, so that make blood flow to branch vessel by fenestra.
Arc elastic metallic yarn 52 is preferably by multiply, as three strands, such as Nitinol (Nitinol TM) elastic metallic yarn make.Described tinsel is sewn onto the periphery of fenestra with stitch 53.
Figure 10 and Figure 11 show two views that optional fenestra according to the present invention is arranged.In this embodiment, fenestra 60 be arranged in the wall 5 of stent grafts and by the elastomeric ring of making such as the material of silicone elastomer (silicon elastomer) 62 around fenestra 60 and enhancing is provided.Elastomeric ring 62 is sewn onto in the periphery of fenestra 60 by stitch 62.Elastomeric ring can be out of shape once more so that it can be arranged in the expanding unit and will be opened into the shape of fenestra when being unfolded.Elastomeric ring will provide a certain amount of elasticity in the position at fenestra on the branch vessel, and if by fenestra configuration side arm, then elastomeric ring will provide the blood sealing to a certain degree on branch's stent grafts.
Figure 12 and 13 shows the optional layout of the fenestra on the stent grafts.In Figure 12, stent grafts 68 comprises that the chamber passes through the tubular body 70 of its transplant material.The far-end 72 of stent grafts has away from what extend and exposes support 74, and in tubular body 70, has near-end internal stent 76 and far-end internal stent 78 respectively and be positioned at near-end and intermediary at least one outside support 80 of far-end.Fenestra is arranged on the far-end 72 of stent grafts 68.In this embodiment, 82 one-tenth scallop forms of extending of fenestra from the far-end 72 of stent grafts 68.Fenestra 82 aligns with the strut (strut) 84 and 86 of the inner self-expanding zigzag of far-end support 78, thereby the side of fenestra 90 can be sewn onto strut 84 and 86 by stitch 92 along at least a portion of their length.
Radiopaque or MRI can not hard radiation labelling 94 be arranged on each side of fenestra, another labelling 96 is arranged on the base portion of fenestra, so that can allow fenestra visual, thereby accurately locatees such as the branch vessel of coeliac artery relatively.
Attention is once more, is used for when transfer device is arranged when stent grafts 68 is compressed, and fenestra 82 will be closed, but fenestra will be opened so that the inlet that enters bifurcated artery is provided when discharging.
Figure 13 A shows the optional layout of scallop formula fenestra.In this embodiment, the strut 93 and 95 of zigzag support 97 is bent, thereby more the fenestra 98 of U-shaped can be formed in the stent grafts 99.
Figure 14 shows the optional embodiment of the stent grafts with scallop formula fenestra, and Figure 15 shows the detailed interior views of the scallop formula fenestra among Figure 14.
In Figure 14, stent grafts 100 comprises the tubular body 102 of transplant material, and the chamber is by it.The far-end 104 of stent grafts has away from what extend and exposes support 106, has near-end internal stent 108 and far-end internal stent 110 respectively and be positioned at near-end and intermediary at least one outside support 80 of far-end in tubular body 102.Fenestra is arranged on the far-end 104 of stent grafts 100.In this embodiment, 114 one-tenth scallop forms of extending of fenestra from the far-end 104 of stent grafts 100.Fenestra 114 aligns with the strut that separates 116 and 118 of the inner self-expanding zigzag of far-end support 110, thereby the side of fenestra 114 can be sewn onto strut 116 and 118 by stitch 120 along at least a portion of their length.The zigzag part 112 of the inner self-expanding zigzag of far-end support 110 not mulched ground extends through fenestra, and stitching thread 124 will be attached to the sweep of the inner self-expanding zigzag of far-end support 110 away from the sweep that exposes support 116 (bend) that extends.
As can be seen from Figure 15, arc elastic metallic yarn 130 is sewn onto around the periphery 132 of scallop formula fenestra.Tinsel 130 has the ring 134 that is formed on its each end, thereby tinsel is not provided with the tip, and the described most advanced and sophisticated stent grafts that can damage is arranged the wall that is deployed in vascular wherein.Because it is elastic forming tinsel or other material of U-shaped reinforcement 130, therefore when stent grafts be in contraction state be used to be arranged into such as aortal body cavity in the time, fenestra will be closed, and when being released, fenestra will be opened so that make blood flow to branch vessel by fenestra, guarantee that the periphery 132 of scallop formula fenestra engages and provide sealing with the wall that stent grafts is disposed in vascular wherein this moment simultaneously.
The fenestra of the amplification of this embodiment is shown as its twice along the width of being got in the zone between two pairs of struts of support, but also can be provided as three times of width.The fenestra that amplifies makes stent grafts to be placed to have each other the place of very close several branch vascular, and wherein said vascular will not get clogged.
Figure 12 has been shown in the far-end of stent grafts to the scallop formula fenestra shown in Figure 15, but they also can be arranged on the near-end of stent grafts, and has or do not have the self-expanding stent that is not capped.
The configuration as lower limb or side arm extension of using of the elasticity reinforcement around the fenestra periphery provides the hole of dimensionally stable more.Especially, if use balloon expandable stent as lower limb or side arm extension, the power of inflation will not torn the transplant material, if reinforcement is not set, the situation of tearing the transplant material can take place.But described elasticity permission fenestra during being used to arrange unfolded contraction is closed the size and dimension that is opened to hope when discharging in position.
In whole description, for scope of the present invention, provided different indications, but the present invention is not limited in them any one, but can be that in them two or more combine.The example that provides only is illustration purpose and unrestricted purpose.
In whole description and in the appended claim, unless context requirement, word " comprises " and " comprising " and all " comprise " as described and the variation of " comprising " will be understood to mean and comprise described integer or integer group, but does not get rid of other integer or integer group.

Claims (17)

1, a kind of stent grafts (1), the tubular wall (3) that comprises bio-compatible transplant material, a plurality of zigzag supports (9 along tubular wall length, 11), with at least one fenestra (40) in the tubular wall, it is characterized in that described at least one fenestra comprises periphery and the independent elastic metallic yarn (45) around at least a portion of described periphery, described thus elastic metallic yarn provides dimensional stability for described fenestra.
2, stent grafts according to claim 1 is characterized in that, described elastic metallic yarn is selected from Nitinol or rustless steel.
3, stent grafts according to claim 1 is characterized in that, described elastic metallic yarn is at least a form of selecting from ring, spring and part ring.
4, stent grafts according to claim 1 is characterized in that, described fenestra is the form of selecting from scallop (50) or circular port (40) at least a.
5, stent grafts according to claim 1 is characterized in that, the end of described fenestra and described stent grafts is adjacent, and described fenestra is the scallop form of opening wide in a side.
6, stent grafts according to claim 5 is characterized in that, the elastic metallic yarn around the described fenestra periphery is the form of U-shaped (84), and helps opening of described fenestra during disposing.
7, stent grafts according to claim 1, it is characterized in that, the fenestra of scallop form is arranged on the far-end of tubular wall and in the near-end at least one, and wherein the strut of the self-expanding stent of stent grafts (86) comprises described elastic metallic yarn and provides elastic perimeter to strengthen around at least a portion of fenestra, when support was expansible when disposing, described strut launched to open thus described fenestra thus.
8, stent grafts according to claim 1 is characterized in that, the elastic metallic yarn around the described periphery is the form of ring.
9, stent grafts according to claim 8 is characterized in that, described ring comprises at least two circle tinsels.
10, stent grafts according to claim 9 is characterized in that, the terminal wiry of described ring is provided with ring, thereby the tip wiry of vascular can not appear damaging in described tinsel.
11, stent grafts according to claim 1 is characterized in that, described fenestra comprises from the tubulose extension (30) of tubular wall extension and is positioned at the outer end of tubulose extension, the peripheral elastic metallic yarn of loop type.
12, stent grafts according to claim 11 is characterized in that, described tubulose extension comprises self-expanding stent (34).
13, stent grafts according to claim 11 is characterized in that, described tubulose extension comprises in the lid (36) of at least related lining (35) and bio-compatible transplant material.
14, stent grafts according to claim 12 is characterized in that, described support is the form of the formula zigzag Z of Zhan Tours section (Gianturco) support.
15, stent grafts according to claim 12 is characterized in that, described support is Nitinol (Nitinol TM) self-expanding stent.
16, stent grafts according to claim 15 is characterized in that, wherein said bio-compatible transplant material is positioned on the inboard of the described support on the tubulose extension or on the outside at least one.
17, stent grafts according to claim 11 is characterized in that, described tubulose extension is placed on the reduced diameter portion branch (5) of stent grafts, thereby the whole diameter of stent grafts is not subjected to remarkable influence.
CNB2004800297116A 2003-10-10 2004-10-12 The stent grafts that fenestra is arranged Expired - Lifetime CN100562297C (en)

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