阅读说明：本技术 多层管腔内假体组件及其制造方法 (Multilayer endoluminal prosthesis component and its manufacturing method ) 是由 亚历山德罗·桑托·博尔托内 于 2018-03-06 设计创作，主要内容包括：本发明涉及一种管腔内假体组件(1),该管腔内假体组件至少部分地界定假体管腔(2),适用于在解剖结构(3)中的植入,该解剖结构至少部分地限定至少一个空腔(4)并且包括至少一个病理部分(13),该管腔内假体(1)包括两层或多层(5、6、7),其中该两层或多层(5、6、7)中的至少一层(5或6或7)包括形成铠装(9)的至少一个线状元件(8)；该管腔内假体(1)包括：至少一个锚固部分(10),适用于锚固到解剖结构(3)的空腔(4)的壁的解剖部分(11)；以及至少一个工作部分(12),适用于面向解剖结构(3)的病理部分(13)；其中该两层或多层(5、6、7)至少在管腔内假体(1)的工作部分(12)中彼此分离,避免在一个层(5或6或7)和至少一个相邻层之间提供连接元件。(The present invention relates to a kind of endoluminal prosthesis components (1), the endoluminal prosthesis component at least partly defines prosthese lumen (2), suitable for the implantation anatomical structure (3), the anatomical structure at least partially defines at least one cavity (4) and including at least one lesion (13), the endoluminal prosthesis (1) includes two or more layers (5,6,7), and wherein at least one layer (5 or 6 or 7) in the two or more layers (5,6,7) includes at least one linear device (8) for forming armouring (9)；The endoluminal prosthesis (1) includes: at least one anchorage part (10), the anatomic part (11) of the wall of the cavity (4) suitable for anchoring to anatomical structure (3)；And at least one working portion (12), it is suitable for the lesion (13) towards anatomical structure (3)；Wherein the two or more layers (5,6,7) are at least separated from each other in the working portion (12) of endoluminal prosthesis (1), avoid providing connecting element between a layer (5 or 6 or 7) and at least one adjacent layer.)

1. a kind of endoluminal prosthesis component (1), the endoluminal prosthesis component at least partly define prosthese lumen (2), the pipe Implantation material of the intraluminal prosthesis component suitable for anatomical structure (3), the anatomical structure at least partially define at least one sky Chamber (4) and including at least one treatment part (13), wherein

The endoluminal prosthesis component (1) includes at least three layers (5,6,7), these layers are coaxially disposed and in unchanged shape There is the main extension of (X-X) in a longitudinal direction when state and be defined as normal to the radial direction (R- of the longitudinal direction (X-X) R) and it is orthogonal to the annular or substantially circumferential direction (C-C) of the longitudinal direction (X-X) and radial direction (R-R)；

When in undeformed state, every layer (5 or 6 or 7) is substantially completely overlapped on adjacent layer (5,6,7)；

Every layer (5 or 6 or 7) at least three layers (5,6,7) include a linear device (8) for forming armouring (9), described Armouring limitedly interweaves at least one described layer (5 or 6 or 7)；

The endoluminal prosthesis (1) includes: at least one working portion (12), is suitable for towards the anatomical structure (3) at least The treatment part (13), and wherein

The endoluminal prosthesis (1) includes: at least two anchorage parts (10), relative at least one described working portion (12) The anatomic part (11) of the wall of cavity (4) that is longitudinally opposed and being suitable for anchoring to the anatomical structure (3)；

Wherein,

At least three layers (5,6,7) geometrically with it is mutually the same in structure；And wherein,

At least three layers (5,6,7) of the endoluminal prosthesis component (1) are at least divided in the working portion (12) each other From to avoid providing connecting element between a layer (5 or 6 or 7) and at least one adjacent layer；And wherein,

At least one described working portion (12) only includes at least one the described linear device (8) for forming the armouring (9), institute The intertexture for stating armouring is merely retained in same layer (5 or 6 or 7), is avoided connection adjacent layer and is avoided that there are other fabrics or knots Structure or graft；And wherein,

When the endoluminal prosthesis component is in undeformed state, the working portion (12) of every layer described (5 or 6 or 7), in addition to Its on the radial direction (R-R) to the support of the possibility of adjacent layer (5 or 6 or 7) except, in structure and geometrically with it is adjacent Layer (5 or 6 or 7) separates, to move freely relative to the adjacent layer (5 or 6 or 7)；And wherein,

At least one described Filamentous or linear device (8,38,48) of every layer (5,6,7) of armouring (9) limits multiple windows (15), these windows are suitable for that the treatment part (13) of the prosthese lumen (2) and the anatomical structure (3) is in fluid communication； And wherein,

When being in undeformed state, every layer (5,6,7) at least one described working portion (12) makes the multiple window (15) mutually the same and be substantially identical in all layers (5,6,7)；And wherein,

When be in undeformed state when, every layer (5,6,7) at least one working portion (12) have at radial direction (R-R) On extension or extension transverse to the longitudinal direction (X-X) or the diameter (D1, D2, D3) that has be less than it is described at least The extension transverse to the longitudinal direction (X-X) of two anchorage parts (10) or diameter (D4)；And wherein,

When being in undeformed state, described at least three layers (5,6,7) are around the longitudinal direction (X-X) along the circumferential direction side It is deviated each other to (C-C)；And wherein,

Every layer (5,6,7) of at least one of the anchorage part (10) is connected to the adjacent anchoring section of adjacent layer (5,6,7) Divide (10).

2. endoluminal prosthesis component (1) according to claim 1 has the shape of substantially dog bone, the shape packet It includes opposed end (26,27), which is greater than the longitudinal between the two opposed ends of the endoluminal prosthesis (1) Part between (26,27)；And/or wherein

At least one described anchorage part (10) is greater than at least one described working portion (12).

3. endoluminal prosthesis component (1) according to claim 1 or 2, wherein at least one anchorage part (10) packet Include at least one attachment device (24) between described three layers (5,6,7).

4. endoluminal prosthesis component (1) according to any one of the preceding claims, wherein in three layers described (5,6,7) Every layer (5 or 6 or 7) include single linear device (8,38,48).

5. endoluminal prosthesis component (1) according to any one of the preceding claims, wherein in the working portion (12) Described three layers (5,6,7) be spaced apart from each other scheduled distance, the distance between the layer be equal to or more than prevent endothelium thin Born of the same parents' adherency, the distance to connect the layer prevent the endothelial cell from forming bridge like connection between said layers, for preventing The layer compression, and wherein, the distance between the adjacent layer forms the entire working portion at least along interior prosthese (12) space uninterruptedly extended.

6. endoluminal prosthesis component (1) according to any one of the preceding claims, wherein described three layers are coaxial； And/or wherein

Described three layers include first layer (5), the second layer (6) and third layer (7), and the first layer has scheduled first layer nominal Bore (D1), the second layer (6) have the scheduled second layer nominal aperture less than the first layer nominal aperture (D1) (D2), the third layer (7) has less than both the first layer nominal aperture (D1) and described second layer nominal aperture (D2) Scheduled third layer nominal aperture (D3)；And/or wherein

The endoluminal prosthesis (1) includes three armourings (9) for forming described three layers (5,6,7).

7. endoluminal prosthesis component (1) according to any one of the preceding claims, wherein first linear device end The longitudinal axis formation angle of the crossing of portion (28) and second linear device end (29) relative to the endoluminal prosthesis (1) (α)；And/or wherein the angle of the crossing (90) between 0.05mm and 0.3mm；And/or wherein

The angle of the crossing (90) is between 40 ° and 50 °.

8. endoluminal prosthesis component (1) according to any one of the preceding claims, wherein the angle of the crossing (α) is basic It is upper to be equal to 45 °.

9. endoluminal prosthesis component (1) according to any one of the preceding claims, wherein by least one of layer The armouring (9) that linear device (8,38,48) is formed is circumferentially offset one in advance relative to the armouring of one or more adjacent layers Fixed amount, the amount of circumferential distance and/or the offset between less than two continuous crossover sites (30) of amount of the offset is less than two The one third of circumferential distance between a continuous crossover sites (30).

10. endoluminal prosthesis component (1) according to any one of the preceding claims, wherein at least one described threadiness Element (8,38,48) is made of super-elasticity and/or shape-memory material；And/or wherein

At least one described linear device (8,38,48) is at least partly made of Nitinol；And/or wherein

At least one described linear device (8,38,48) is by being suitable for keeping the memory of predetermined shape and being subjected to thermal change at it And/or the material of the predetermined shape is regained when mechanical stress and is made；And/or wherein.

11. endoluminal prosthesis component (1) according to any one of the preceding claims, wherein the endoluminal prosthesis (1) It is no stent graft.

12. endoluminal prosthesis component (1) according to any one of the preceding claims, wherein the working portion (12) With shape substantially frustoconical in shape.

13. endoluminal prosthesis component (1) according to any one of the preceding claims, wherein the endoluminal prosthesis (1) Furcation including the prosthese lumen (2).

14. endoluminal prosthesis component (1) according to any one of the preceding claims, wherein

When the endoluminal prosthesis component is in undeformed state, the multiple window (15) is every the layer (5,6,7) Shape and size in layer are identical.

15. endoluminal prosthesis component (1) according to any one of the preceding claims, wherein

When being in undeformed state, at least three layers (5,6,7) are along the radial direction (R-R) in their lateral ruler Very little upper and identical (D1=D2=D3), this causes substantially to abut against each other when being fitted to each other, and if not support , then the effect (R-R) generally radially oriented is avoided, and therefore relative to each other at least along the longitudinal direction and institute Circumferential direction (X-X, C-C) is stated substantially to move freely.

16. endoluminal prosthesis component (1) according to any one of the preceding claims, wherein

When being in undeformed state, at least one of described at least three layers (5,6,7) have transverse to its longitudinal direction (X- X the section of non-circular shape (47))；

And/or wherein

When being in undeformed state, at least one of described at least three layers (5,6,7) have transverse to its longitudinal direction (X- X the section of ellipse or lens-like form or trilobal (47) or quatrefoil), to keep it to circumferentially extend (C-C) Part separates and separates at least one adjacent layer (5,6,7)；

And/or wherein

It is described at least one layer of with transverse to its longitudinal direction side at least three layers (5,6,7) when being in undeformed state To the section of the non-circular shape of (X-X), longitudinal along the layer extends (X-X), has and changes its angle orientation or angular phasing Section, be accurately defined and entire longitudinal extended (X-X) along it or extend at least along the longitudinal direction of its working portion (12) (X-X) it is present in the gap between every layer；

And/or wherein

When being in undeformed state, at least one of described at least three layers (5,6,7) have along the layer (5,6,7) The section transverse to its longitudinal direction (X-X) of longitudinal variable size for extending (X-X).

17. endoluminal prosthesis component (1) according to any one of the preceding claims, wherein

The linear device (8) has the circular cross-section for longitudinally extending (50) transverse to it；

And/or wherein

The linear device (8) has the elliptic cross-section (51) longitudinally extended transverse to it；Or elliptic cross-section (51), have Ellipse diagonal line substantially along the endoluminal prosthesis component circumferential direction (C-C) orient；Or square section (52)；Or rectangular section (53)；Or rectangular section (53), the long side for the rectangle having is substantially along the endoluminal prosthesis group The circumferential direction (C-C) of part orients；Or multinomial section, such as hexagon (54).

18. endoluminal prosthesis component (1) according to any one of the preceding claims, wherein

The linear device (8) has layered body, wherein every layer is made from a different material；

And/or wherein

The linear device (8) has layered body, and wherein innermost layer or core are made of metal material (55), such as by super-elasticity material Material is made, such asAnd outermost layer (56) is made from a variety of materials, such as can by biological absorbable or biology Erosion material is made；

And/or wherein

The linear device (8) includesAt least part；And/or wherein

The linear device (8) includes at least part of chrome-cobalt alloy；And/or wherein

The linear device (8) includes at least part of MP35N；And/or wherein

The linear device (8) includes Ai Erjiluoyi non magneticAt least part；And/or wherein

The linear device (8) includes at least part of polymer material；And/or wherein

The linear device (8) includes at least part of the polymer material of Bio-erodable；And/or wherein

The linear device (8) includes at least part of the polymer material of the Bio-erodable of carrying medicament, such as the medicine Object is dispersed in one of polymer substrate or a variety of drugs.

19. endoluminal prosthesis component (1) according to any one of the preceding claims, wherein

Have with the armouring (9) that linear device (8) interweave by line and the simple weft yarn and warp thread interlacing pattern obtained that interweave, The top for the line that wherein every line (8) is intersected along the linear device (8) in the linear device (8) and then in lower section Pass through；

And/or wherein

Have with the armouring (9) that linear device (8) interweave by single line and the simple weft yarn and warp thread intersection chart obtained that interweave Case, wherein the top for the line that every line (8) is intersected along the linear device (8) in the linear device (8) and then existing Lower section passes through；

And/or wherein

Have with the armouring (9) that linear device (8) interweave by line and the weft yarn and warp thread interlacing pattern obtained that interweave, wherein Every line (8) is along the line (8) by twice and then in lower section by twice above the line of intersection；

And/or wherein

With the armouring (9) that linear device (8) interweave have by First Line (8) and the second line (57) interweave the weft yarn obtained and Warp thread interlacing pattern, the section which has are greater than the First Line；

And/or wherein

There is the weft yarn and warp thread obtained by First Line (8) and the second line intertexture with the armouring (9) that linear device (8) interweave Interlacing pattern, wherein second line (58) includes at least part of Bio-erodable material；

And/or wherein

When the endoluminal prosthesis component is in undeformed state, with linear device (8) interweave the armouring (9) have by The weft yarn and warp thread interlacing pattern that First Line (8) and the line of the constant intertexture angle of stretching, extension intertexture obtain；

And/or wherein

When the endoluminal prosthesis component is in undeformed state, with linear device (8) interweave the armouring (9) have by The weft yarn that the line intertexture of at least one line (8) and the constant intertexture angle that 45 ° are stretched relative to the circumferential direction (CC) obtains With warp thread interlacing pattern；

And/or wherein

When the endoluminal prosthesis component is in undeformed state, with linear device (8) interweave the armouring (9) have by What the line intertexture of at least one line (8) and the constant intertexture angle that 45 ° are extended less than relative to the circumferential direction (C-C) obtained Weft yarn and warp thread interlacing pattern；

And/or wherein

When the endoluminal prosthesis component is in undeformed state, with linear device (8) interweave the armouring (9) have by What at least one line (8) was obtained with the line intertexture relative to constant intertexture angle of the circumferential direction (C-C) stretching, extension greater than 45 ° Weft yarn and warp thread interlacing pattern；

And/or wherein

When the endoluminal prosthesis component is in undeformed state, with linear device (8) interweave the armouring (9) have by The weft yarn and warp thread interlacing pattern that at least one plait (8) obtains, are formed in the direction for being parallel to the longitudinal direction (X-X) Multiple windows (15) of the upper preset width with 3mm.

20. endoluminal prosthesis component (1) according to any one of the preceding claims, wherein

The endoluminal prosthesis component of at least three layers (5,6,7) is formed multiple windows (15), and described at least three layers respectively Including the armouring (9) to interweave with linear device (8), the armouring has the weft yarn obtained by least one plait (8) With warp thread interlacing pattern, when being overlapped and being in undeformed state for described three layers, the window is being parallel to the longitudinal direction side The overlaid windows of total unsupported width of the component with 1mm is upwardly formed to the side of (X-X)；

And/or wherein

The component of the layer (5,6,7) is formed multiple windows (15), and the layer respectively includes described with linear device (8) intertexture Armouring (9), the armouring have the weft yarn and warp thread interlacing pattern obtained by least one plait (8), when the layer is overlapped And when being in undeformed state, the window is upwardly formed in the side for being parallel to the scheduled longitudinal direction (X-X) to be had The overlaid windows of total unsupported width of component；Wherein

In single layer (5,6,7), the number of the window (15) of the single layer is provided by following relationship:

Ncl=π φ/(Nl × Dc), and

Sl=360/ (Ncl × Nl)

Wherein

Ncl: the number of the window (15) of the single layer (5,6,7)；

φ: the diameter of the working portion (12) of the endoluminal prosthesis component；

Nl: the number of the layer (5,6,7) of the endoluminal prosthesis component is formed；

Dc: by the diagonal line for the window that the superposition overlapping of the layer and angle offset generate；

Sl: the angle offset between layer described in the endoluminal prosthesis component.

21. endoluminal prosthesis component (1) according to any one of the preceding claims, wherein

With the armouring (9) that linear device (8) interweave there is the weft yarn obtained by least one plait (8) and warp thread to interweave Pattern, the intertexture are obtained at least some intertextures by the drawing during braiding or elastic threads (8).

Technical field

The present invention relates to a kind of endoluminal prosthesis components.

In particular it relates to a kind of multilayer endoluminal prosthesis.

Interior prosthese according to the present invention is not especially suitable for but being only for aneurysmal treatment.

Background technique

Endoluminal prosthesis is for treating cardiovascular disease, such as aneurysm.Aneurysm is substantially by a part (example of blood vessel The major arteries of cardiovascular system such as artery, such as aorta) section pathological dilatation composition, formed be known as aneurysm The capsule of capsule.From the point of view of hemodynamic viewpoint, the blood flow at this expansion of channel section tends to flow with turbulent flow pattern, And at the same time applying the increased pressure of intensity compared with the pressure found in healthy blood vessel on vascular wall.This leads to vessel segment Unstable increase, this corresponds to the reduction of wall thickness, according to Lapalce's law, so as to cause the chronic dilatation of aneurysmal sack, This can lead to vascular wall rupture.

Particularly, aneurysmal sack wall tension is higher than the tension of healthy blood vessel in equal pressures, according to Lapalce's law, health The tension of blood vessel and the radius of capsule are at twice of inverse ratio, and flowing is turbulent flow rather than laminar flow, has eddy current effect, makes blood It is flowed into from the blood vessel around aneurysmal sack and generates the laminar flow from aorta to blood vessels adjacent.Since outer membrane outer membrane no longer wraps Containing antiotasis, this excessive aneurysmal dilatation leads to aortoclasia, because in the elasticity of muscle therefore film has been degenerated and Aneurysm itself is caused to be expanded.

By in endoluminal prosthesis implantable intravascular, can will locally influence endovascular fluid dynamics, therefore can be with Reduce the turbulent flow of blood flow.This phenomenon is known as shunting.Due to known structure feature, endoluminal prosthesis can guide automatic except coming Blood flow except the blood flow of arteries and veins tumor capsule.In this way, the intracapsular transhipment phenomenon due to caused by blood flow is substantially eliminated, meanwhile, it reduces Blood is applied to the stress on aneurysm cyst wall, to prevent cyst wall from rupturing and to cause aneurysmal sack to be gradually filled with blood solidifying Block.

Known endoluminal prosthesis generally includes the blood of the entrance ring for interior prosthese being inserted into and being located in aneurysmal sack Intraluminal release system of the pipe across side, the self-expanding metal for capableing of anchor themselves by being pressed against the vascular wall influenced by aneurysm Armouring (bracket) forms the tissue (graft) for rebuilding the interior prosthese wall of the pipeline of blood flow of the entrance ring for aneurysmal sack, It repels aneurysm.Such interior prosthese is for example described by document EP-2397112 and US-2015-282967.

The interior prosthese of known type can be various shape.For example, can from document WO-90-04982 and US-5354309 Know, the bore of the close end of interior prosthese and distal portion is greater than the central part of interior prosthese.It can be by being opened from marmem piece Begin laser cutting suture or multiple metals by surrounding mandrel or the interior prosthese of polymer line manufacture, such as document US-5718159 It is described.

Endoluminal prosthesis is intended to keep in implantable intravascular, usually artery, such as aorta, and artery is during cardiac cycle It is subjected to TRANSFER BY PULSATING FLOW state, and generally includes deformable vascular wall, describes path that is curved and distorting sometimes.This Kind phenomenon is especially related with the treatment aneurysm of aorta descending branch, i.e., aorta is far from the arch of aorta and including aortic isthmus The part of portion, aorta pectoralis and abdominal aorta and the collatoral vessel from its branch.The blood flow of aorta is conveyed from Zuo Xinliu The artery of blood out may be influenced by turbulent phenomenon under normal physiological conditions, and be generally characterized as substantially spiral shell The forward travel of rotation, this accordingly results in the endothelial cell of aorta wall in the inclined side in extending longitudinally direction relative to blood vessel Alignment upwards.

Arterial wall includes three layers: outer membrane, it is the outermost layer supplied by so-called " vasa vasorum "；Middle film, it is by flesh Meat elastomer is formed, so as to due to contraction wave and using normal dia is resiliently returned to after expanding, to promote blood Circulation；And inner membrance, it is innermost layer, suitably facilitates diffusion of the nutrient between lumen and middle film.Therefore, in phase cardiac cycle Between, arterial wall is commonly subjected to bending-torsional deflection in the expansion of its normal dia and the three-dimensional in contraction cycle and space.

For example, document US-8192484, EP-1357857 and US-8048139 describe the only multiple layer metal comprising interweaving The endoluminal prosthesis solution of armouring, wherein every layer of intertexture by more one metal wires is formed, and wherein each layer of filament Intersect with the filament of adjacent layer, leads to extensive integration or the interpenetrating between each layer of interior prosthese armouring.

Although being advantageous from the point of view of certain viewpoints, especially in terms of the ability for locally reducing blood flow turbulence, this A little solutions have the shortcomings that, and cannot be fully solved problem.

Although having mutual in fact, multilayered structure can increase the radial pressure that bracket is applied on blood vessel It is extremely rigid for wearing this structure of layer, therefore is not suitable for being effectively adhered to the wall of the bending of blood vessel or " compliance " part On.In other words, implantation rigid structure (interior prosthese) necessarily leads to incompatibility in pulsation and compliance system (main artery), In first stage at least after the implantation, cause interior prosthese to the poor adhesion of arterial wall, at the same have early stage implantation failure and The risk of undesirable interior prosthese migration.

In addition, they become artery parietal vessel when the interpenetrating layer of prosthese solution in these successfully realizes anchoring The ideal substrate of endothelial cell regrowth, the result is that these layers are impregnated in arterial wall, and interior prosthetic part towards aneurysmal sack Layer be usually also incorporated into arterial wall, so that aneurysmal sack be excluded from blood flow, and be also blocked in implant site from The collatoral vessel of arterial branch.In the case where some accidental, growth of the vascular endothelial cell on interior prosthese armouring can good fortune It avoids covering interior prosthese the entire part towards aneurysmal sack to fortune, the unobstructed of collatoral vessel is kept, especially if heavy caliber Blood vessel.

From WO2016124235A1, US2016/0158037, EP1946721A1, US2015/216684, US2013/ 218255, US2013/245745, US2009/270974, US6689162 and BR202013033688-U2 learn other interior prostheses Solution.

Particularly, the solution proposed so far generates mismatch between vascular wall and flowing, because they are It is formed by more support systems interweave and rigidity, more support systems do not meet bending-twisting resistance optimum transfer, therefore not Laminar flow can be re-established, there is no the perfusions for inevitably leading to thrombosis and causing to lack collatoral vessel.

Therefore, it is strongly felt and needs to provide a kind of endoluminal prosthesis solution that can be adhered on vascular wall, During the physiological deformation of blood vessel, endoluminal prosthesis solution is also implanted on vascular wall.

Again it is desirable to provide a kind of endoluminal prosthesis solution, is capable of providing the shunting of blood flow, substantially reduces blood flow Turbulent flow, while being able to maintain from the unobstructed of the collatoral vessel of vessel branch, wherein endoluminal prosthesis is with controlled and predictable Mode is implanted into the blood vessel.

The known endoluminal prosthesis of the above-mentioned type forms barrier, which substantially encapsulates the lesion of blood vessel, such as Aneurysm, and it is isolated with the blood flow being transported in interior prosthese lumen.From the clinical perspective, the effect of these interior prostheses is Promote the accumulation of the blood clot or thrombus in aneurysmal sack.

It is thus known that endoluminal prosthesis solution cannot clearly realize that needs provide can promote by pathology shape The endoluminal prosthesis solution that the progressive for the vascular function that condition such as aneurysm influences restores.

Meanwhile feeling needs by implantation endoluminal prosthesis come the reaction for wall of getting well.

In addition, the needs of the dynamic and structure behavior of restoring the vascular wall influenced by pathological condition are felt strongly, so as to The place that the structure and dynamic for intervening blood vessel have been damaged, restores blood vessel.

Summary of the invention

The purpose of the present invention is eliminating the above-mentioned prior art, and provide a kind of for reference to mentioned by the prior art Requirement solution.

This purpose and other purposes are realized by interior prosthesis assembly according to claim 1.

Some advantageous embodiments are the themes of dependent claims.

According to an aspect of the present invention, endoluminal prosthesis at least partly defines prosthese lumen, is suitable for anatomical structure In implantation material, anatomical structure at least partially defines at least one cavity, forms at least one lesion.In this lumen Prosthese includes two or more interior prosthese layers.At least one layer in two or more layers includes at least one to form frame or armouring Wire-element or linear device.

The endoluminal prosthesis includes: at least one anchorage part, and it is suitable for anchoring to the wall of the cavity of anatomical structure Anatomic part and at least one working portion, it is suitable for the lesions towards anatomical structure.

Advantageously, two or more layers are at least separated from each other in the working portion of endoluminal prosthesis, to avoid at one Connecting element is provided between layer (5 or 6 or 7) and at least one adjacent layer.

Multilayer endoluminal prosthesis or device have the advantages that compliance or extremely flexible, therefore can be implanted into any kind of blood Pipe bending.Its structure is so much so that returning to new middle film, then restoring in optimal manner and transmitting and is normal Bending-twisting resistance slides layer (for example, its manufactured three layers in three spatial axes) normally, thus not only in aorta And laminar flow is rebuild from the collatoral vessel of aortic branch, and there is no thrombus in device and aneurysmal sack, therefore will experience Decompression, and aneurysmal re-absorption and fibrosis effect are therefore undergone, it referred to as shrinks, wherein the endothelialization of spin shape device allows The normal endocrine and antithrombus formation function of laminar flow and endothelium itself in all collatoral vessels.

Detailed description of the invention

The further feature and advantage of interior prosthese according to the present invention and method are with reference to the accompanying drawings according to preferred embodiment Description in be easy to understand, the preferred embodiment is provided only by non-limiting example, in the accompanying drawings:

Fig. 1 shows the side view or vertical front view of endoluminal prosthesis；

Fig. 2A, Fig. 2 B and Fig. 2 C respectively show the vertical front view of the layer of multilayer endoluminal prosthesis；

Fig. 3 shows the multilayer endoluminal prosthesis by operator's plastic deformation；

Fig. 4 shows the figure of the longitudinal cross-section of a part of display multilayer endoluminal prosthesis；

Fig. 5 shows implantation and includes the endoluminal prosthesis in the implant site of lesion；

Fig. 6 shows the vertical front view of the endoluminal prosthesis according to one embodiment；

Fig. 7 and Fig. 8 schematically shows transmission and endoluminal prosthesis transmission in the implant site for including lesion Process some possible steps；

Fig. 9, Figure 10, Figure 11 and Figure 12 schematically show the manufacture of the endoluminal prosthesis according to possible operation mode Some possible steps of method；

Figure 13 shows a part of the armouring of the layer of the multilayer endoluminal prosthesis according to one embodiment；

Figure 14 shows a part of the endoluminal prosthesis according to one embodiment；

Figure 15, Figure 16, Figure 17 and Figure 18 show the manufacturing method of the endoluminal prosthesis according to possible operation mode Some possible steps；

Figure 19 shows the cross section for receiving the support device of release device, which is pacified in the form of radial contraction The armouring of tubulature intraluminal prosthesis layer；

Figure 20 shows the vertical front view of the endoluminal prosthesis according to one embodiment；

Figure 21 shows the possibility step of the manufacturing method of the endoluminal prosthesis according to possible operation mode, in order to clear For the sake of with partial cross section part isometric view；

Figure 22 schematically shows the connecting element of the endoluminal prosthesis according to one embodiment；

Figure 23 schematically shows the possibility step of the manufacturing method of the endoluminal prosthesis according to possible operation mode；

Figure 24 schematically shows the possibility step of the manufacturing method of the endoluminal prosthesis according to possible operation mode, For the sake of clarity there is partial cross section part；

Figure 25 shows five examples of the cross section of linear device, manufactures endoluminal prosthesis component using the linear device Layer armouring；

Figure 26 shows another cross section of linear device, which includes the first material covered by the second material Core；

Figure 27 shows two details of the armouring made of linear device of two embodiments according to the intertexture, line The very best part forms armouring by its intertexture；

Figure 28 shows the details of the armouring made of two linear devices according to the embodiment of the intertexture, the two Linear device forms armouring by their intertexture；

Figure 29 shows the embodiment according to the intertexture and two different time points in the component by two threadiness The details of armouring made of element, the two linear devices form the armouring that they interweave；

Figure 30 shows the longitudinal portion of the layer of component, and the details of the armouring made of linear device is shown, benefit Intertexture to mutually different winding angle forms armouring；

Figure 31 shows the window of three superimposed layers of the overall porosity to form endoluminal prosthesis component；

Figure 32 shows two different time points in component and forms the endoluminal prosthesis group that is made of two linear devices The window of three superimposed layers of the overall porosity of part；

Figure 33 shows four different longitudinal cross-sections of the endoluminal prosthesis component made of three layers of different lateral dimensions Schematic diagram, described three layers generate different gap or cavity at one layer between adjacent layer；

In addition Figure 34 schematically shows the endoluminal prosthesis component made of three layers with different lateral dimensions Three different longitudinal cross-sections, described three layers generate different gap or cavity at one layer between adjacent layer；

Figure 35 schematically shows the longitudinal axis of the endoluminal prosthesis component made of three layers with varying cross-section The viewgraph of cross-section of line, described three layers generate gap or cavity at one layer between adjacent layer；

Figure 36 is schematically shown having lumen made of layer and stent delivery system there are two mutual extensible member Interior prosthesis assembly, stent delivery system are used to for component being transported in blood vessel and by adjusting flexible group with the sequential openings of sheath The desired length of part discharges component；

Figure 37 shows the longitudinal sectional view of the endoluminal prosthesis component made of the layer with same geometry；

Figure 38 shows the details of the armouring made of linear device according to one embodiment, which passes through it Intertexture forms armouring；

Figure 39 schematically shows the isometric view of the longitudinal stretching of the layer of component, and the friendship to form armouring is shown Angle of the window knitted at centre of expansion；

Figure 40 and Figure 41 shows the flowing test of the blood vessel with aneurysm symptom, wherein initially there is no in Figure 40 Endoluminal prosthesis component, and there are the interior prosthesis assembly in Figure 41, highlight flowing be greatly decreased and regularization.

Specific embodiment

According to general embodiment, endoluminal prosthesis 1 is provided.

According to preferred embodiment, endoluminal prosthesis 1 includes bracket.

According to preferred embodiment, endoluminal prosthesis is bracket.

Endoluminal prosthesis 1 at least partly defines prosthese lumen 2, and the implantation material suitable for anatomical structure 3, dissection Structure 3 at least partially defines at least one cavity 4.According to embodiment, anatomical structure 3 is blood vessel, such as artery, such as active Arteries and veins, cavity 4 is the lumen of vessels of blood vessel, and endoluminal prosthesis 1 is the endovascular prosthesis being implanted into suitable for blood vessel.According to reality Example is applied, endoluminal prosthesis 1 has substantially tubular shape shape.

Endoluminal prosthesis 1 especially suitable for, but be not only for treatment aneurysm 17.According to embodiment, endoluminal prosthesis 1 Especially suitable for, but be not only for the treatment arch of aorta 18 or descending aorta 19, such as aorta pectoralis 20, abdominal aorta 21 or The aneurysm of aortic isthmus 22.

According to embodiment variant, anatomical structure 3 is esophagus, and cavity 4 is the chamber of esophagus.

In endoluminal prosthesis 1, longitudinal X-X is limited to be arranged essentially parallel to or the expansion longitudinal axis weight with endoluminal prosthesis 1 It closes, radial R-R is orthogonal to longitudinal X-X, is orthogonal to circumferentially or tangentially both longitudinal X-X and radial direction R-R.Also define outer radial Direction RE and inner radial direction, outer radial direction RE are oriented far from the expansion longitudinal axis of endoluminal prosthesis 1 along radial direction, Inner radial direction is opposite with outer radial direction RE.

Endoluminal prosthesis 1 is multilayer endoluminal prosthesis and including two or more layers 5,6,7.

According to preferred embodiment, two or more layers are exactly three layer 5,6,7.

According to preferred embodiment, endoluminal prosthesis 1 includes three armourings 9 for forming three layer 5,6,7.

According to embodiment, layer (such as but be not necessarily manufacture in three layers of prosthese or device) for example at it towards pathological area It is separated from each other in the part in domain (such as in a stationary situation or under nominal condition), there is between them space or preset distance, I.e. between each layer there, such as between 0.1mm and 3mm change, allow its continuous oscillation and reciprocatingly slide, such as in normal subjects Middle film in occur.The space is the space that do not interrupt at least along the entire working portion 12 of interior prosthese.According to reality Apply example, the distance between layer is defined so that endothelial cell never adheres between, the layers, thus prevent they Bridge like connection is formed between these layers, is prevented it from compressing and is therefore avoided preventing the stream from the collatoral vessel of aortic branch It is dynamic, always it is to ensure that the unobstructed of these collatoral vessels.

According to preferred embodiment, two or more layers include first layer 5, the second layer 6 and third layer 7, and first layer 5 has first The predetermined nominal bore D1 of layer, the second layer 6 have the predetermined nominal bore D2 of the second layer of the nominal aperture D1 less than first layer, And third layer 7 has the pre- calibration of the third layer of both nominal aperture D2 of nominal aperture D1 and the second layer for being less than first layer Claim bore D3.According to embodiment, two or more layers are coaxial.

At least one layer 5 or 6 in two or more layers 5,6,7 or 7 include at least one linear device 8 for forming armouring 9, 38,48.According to embodiment, every layer 5 in two or more layers 5,6,7 or 6 or 7 include at least one linear device 8.

According to embodiment, first layer 5 includes the first linear device 8, and the second layer 6 includes the second linear device 38, and the Three layers include third linear device 48.

According to preferred embodiment, at least one layer 5 or 6 or 7 in two or more layers 5,6,7 include forming the single of armouring 9 Linear device 8,38,48.In this way, the layer with single linear device 8,38,48 can be manufactured.According to embodiment, two layers or more Layer 5,6,7 in every layer 5 or 6 or 7 include single linear device 8,38,48.

According to preferred embodiment, armouring 9 is the intertexture armouring to form grid.

According to embodiment, at least one linear device 8,38,48 is formed in a manner of substantially spiral in armouring 9.

According to embodiment, armouring 9 is the intertexture armouring to form fabric, and according to embodiment, which is weft yarn and warp thread class The fabric of type or the fabric of net-shaped abrasive cloth type, two opposed ends of wherein at least one linear device 8,38,48 28,29 alternately intersect at crossover sites 30.According to embodiment, some crossover sites 30, which have, is radially outward arranged into the second line First linear device end 28 of shape element end 29, and some crossover sites 30 have radially outward be arranged into the first linear device The second linear device end 29 at end 28.

According to embodiment, the longitudinal direction of the first linear device end 28 and the second linear device end 29 relative to endoluminal prosthesis 1 Axis forms angle of the crossing α.According to embodiment, angle of the crossing α is between 30 deg. and 60 deg..According to embodiment, angle of the crossing α is in 40 ° and 50 ° Between, and according to embodiment, angle of the crossing α is substantially equal to 45 °.Due to the provision of angle of the crossing α, natural vessel wall can be simulated The arrangement of the endothelial cell of (for example, a part of native aortic).In fact, as it is known, the endothelium of natural vessel wall is thin Born of the same parents are aligned during the systole phase with average blood flow direction, and the blood flow during the systole phase can substantially spiral or spiral into Row.

According to embodiment, two opposed ends 28,29 of single linear device 8,38,48 by end connecting device 25 that This connection.According to embodiment, end connecting device 25 is suitable for forming rigid connection between two opposed ends 28,29.

Endoluminal prosthesis 1 includes at least one anchorage part 10, and it is suitable for anchoring to the wall of the cavity 4 of anatomical structure 3 Anatomic part 11.Anchorage part 10 is suitable for being formed with the matrix for the vascular endothelial tissue adherency for being conducive to newly be formed, and is similar to Bracket.

Endoluminal prosthesis 1 includes at least one working portion 12, and it is suitable for facing the lesion 13 of anatomical structure 3. For example, lesion 13 is aneurysmal sack.

Due to the provision of at least one anchorage part 10 and at least one working portion 12, endoluminal prosthesis 1 can be anchored To the basic healthy part of anatomical structure 13.Due to the provision of at least one anchorage part 10 and at least one working portion 12, Endoluminal prosthesis 1 is prominent along the lesion of working portion 12, to re-form and be implanted into the healthy diameter of the blood vessel of interior prosthese Equal bore.

According to embodiment, anchorage part 10 is longitudinally separated with working portion 12.In other words, in the longitudinal direction along interior prosthese It is mobile, anchorage part 10 is initially encountered, working portion 12 is then encountered.

Advantageously, according to the embodiment of radial separation, two or more layers 5,6,7 are at least in the work department of endoluminal prosthesis 1 Divide in 12 and is separated from each other.This prevent must provide connection in the working portion 12 between a layer 5 or 6 or 7 and adjacent layer Element.

According to embodiment, when not by radial stress, working portion 12 has and the corresponding dissection of wanting implantation therein Partial healthy diameter D1 similar or equal diameter or bore D1.For example, working portion radial diameter that interior prosthese has or Bore D1 is equal to the inside average diameter D1 of aorta health part, interior when forming aneurysm in the part in aorta Prosthese must implantation therein.

There is provided this endoluminal prosthesis 1 allow manufacture two or more layers 5,6,7, they in working portion 12 substantially that This independence.According to embodiment, at least one anchorage part 10, two or more layers 5,6,7 are adjacent to each other and constrain one another.

It, can be in adjacent layer 16 due to providing two or more layers 5,6,7 separated from each other in working portion 12 Between space is provided, which is adapted to allow for fluid (for example, blood) at least basic at it between two adjacent layers 5,6,7 It is flowed on upper longitudinal direction X-X.According to embodiment, space between adjacent layer 16 substantially circular cross section cylinder in shape, It is defined with surrounding by two adjacent layers.

Due to providing two or more layers 5,6,7 separated from each other in working portion 12, even if in the intracavitary vacation of implant After body 1, also allow the relative motion between two or more layers 5,6,7.In this way, at least in one with more small-bore D2, D3 On a or multiple layers 6,7, and prevented on all layers 5,6,7 of the working portion 12 of endoluminal prosthesis 1 according to embodiment The adherency and growth of vascular endothelial cell.For example, two or more layers 5,6,7 separated from each other can phase in working portion 12 For longitudinally of one another and circumferentially and radially moving.This assigns the improved flexibility of endoluminal prosthesis 1, including reverses soft Property.In this way, allowing extended service life compared with known solution.

Due to providing two or more layers 5,6,7 separated from each other in working portion 12, thus provides to have and improve Endoluminal prosthesis flexible 1, it is suitable in the tortuous anatomical structure 3 of implantation, such as aortic isthmus 22.

According to embodiment, this endoluminal prosthesis 1 is suitable for having increased longitudinal extension compared with known solution Embodiment.

According to embodiment, at least one linear device 8 is made of elastic material.According to embodiment, at least one is linear Element 8 is by being suitable for keeping the memory of predetermined shape and regaining memory when it is subjected to thermal change and/or mechanical stress Material is made.According to embodiment, at least one linear device 8 is at least partly made of Nitinol.According to embodiment, at least one A linear device 8 is at least partly made of Nitinol, which is suitable for regaining in heating and/or mechanical stress Predetermined shape.According to embodiment, at least one linear device 8 includes being suitable for adjusting endoluminal prosthesis 1 and implantation material dissection knot The coating of biological interaction between the wall of structure 3.

According to preferred embodiment, at least one linear device 8,38,48 of every layer 5,6,7 of armouring 9 limits multiple windows 15, window 15 is suitable for that prosthese lumen 2 and the lesion 13 (for example, aneurysmal sack) of anatomical structure 3 is in fluid communication.

According to embodiment, the armouring 9 formed by one layer at least one linear device 8,38,48 is relative to one or more The armouring of adjacent layer circumferentially or angularly deviates the offset of predetermined amount, less than two continuous cross parts of offset of the predetermined amount Circumferential distance between position 30, and the circumferential distance according to embodiment, between less than two continuous crossover sites 30 of offset One third.In this way, one layer of multiple windows 15 are substantially deviated with multiple windows 15 of one or more adjacent layers, but same When, 15 substantial alignment of window of adjacent layer, so that endoluminal prosthesis 1 is suitable for making the pathology of prosthese lumen 2 Yu anatomical structure 3 Part 13 is in fluid communication.According to embodiment, the alignment between the window 15 of adjacent layer selects in this way, that is, filters larger The element of size, such as thrombus, to prevent them to be moved towards lesion 13, example from prosthese lumen by convection current or diffusion Such as, aneurysmal sack.

According to embodiment, space between adjacent layer 16 by the layer 6 of the space interior being radially disposed between adjacent layer 16, 7 multiple windows 15 and prosthese lumen 2 are in fluid communication.In this way, fluid (for example, blood) is allowed to flow from prosthese lumen 2 To lesion 13 (for example, aneurysmal sack), vice versa, flows to prosthese lumen from lesion 13 (for example, aneurysmal sack) 2。

Due to providing the two or more layers 5,6,7 being separated from each other in working portion 12, it can imitate or reproduce The behavior of the structure of the middle film of native blood vessels.

Due to the provision of such endoluminal prosthesis 1, it can produce flowing and shunt, flowing shunting consumingly reduces artery The turbulent flow of blood flow in tumor capsule allows the pressure on aneurysm cyst wall to reduce, to prevent the rupture of aneurysm cyst wall simultaneously therefore advantageous In aneurysmal re-absorption.The setting of multiple windows 15 allows that the blood flow into aneurysmal sack is made to be substantially stratiform, simultaneously Allow to keep aneurysmal sack and from the unobstructed of 23 (if present) of collatoral vessel of its far-end branch.In this way, although In a manner of reduction, the biological tissue towards aneurysmal sack still can be supplied.

According to embodiment, at least one anchorage part 10 includes at least one layer of company between two or more layers 5,6,7 Connection device 24.According to embodiment, the layer attachment device 24 between two or more layers 5,6,7 forms rigid connection, therefore not applicable The relative motion between adjacent layer in permission anchorage part 10.According to embodiment, layer attachment device 24 connects dress with end Setting 25 is identical connecting element 24,25, such as hardware, such as pressure or the sleeve of crimping connection.According to implementation Example, at least one of layer attachment device 24 and end connecting device 25 are made of radiopaque material, so that lumen Interior prosthese 1 can be acquired equipment (for example, radiological installation) detection by bio-imaging later in implantation anatomical structure 3.

According to embodiment, at least one anchorage part 10 of endoluminal prosthesis includes at least two, and according to embodiment Including at least three connecting elements 24,25, these connecting elements are equally spaced and in a longitudinal direction in circumferential direction X-X is substantially placed at identical height.

According to preferred embodiment, endoluminal prosthesis includes longitudinally opposed relative at least one working portion 12 at least two A anchorage part 10.According to embodiment, at least two opposite anchorage parts 10 be located at endoluminal prosthesis 1 opposed end 26, 27.Opposed end 26,27 includes close end 26 and distal portion 27.According to preferred embodiment, at least one anchorage part 10 is opposite There is lesser longitudinal extension in working portion 12.

According to preferred embodiment, at least one anchorage part 10 has bigger mouth relative at least one working portion 12 Diameter.According to preferred embodiment, all layers 5,6,7 of at least one anchorage part 10 have relative at least one working portion 12 Bigger bore.

The setting of anchorage part 10 allows radial thrust to act on the wall of anatomic part 11, this protects endoluminal prosthesis 1 Hold the appropriate location in the anatomical structure 3 of its implantation.According to embodiment, the size and material of at least one anchorage part 10 are suitable For applying radial preload on the wall of anatomic part 11.

According to preferred embodiment, endoluminal prosthesis 1 has the shape of substantially dog bone, including opposed end 26,27, Opposed end 26,27 is bigger than the part of endoluminal prosthesis 1 being longitudinally inserted between two opposed ends 26,27.

According to embodiment, working portion 12 has shape substantially frustoconical in shape.In this way, endoluminal prosthesis 1 is applicable in In the shape for imitating blood vessel (for example, arterial wall), the bore that there is distal end to reduce.According to embodiment, what distal portion 27 had Relative aperture close end 26 is small.

According to embodiment, anchorage part 10 has shape substantially frustoconical in shape, which has towards interior prosthese 1 The increased taper in end.

According to embodiment, at least one linear device 8,38,48 is line.

According to embodiment, at least one linear device 8,38,48 is substantially with the lateral ruler for being significantly greater than its thickness The form of very little band or band.

According to embodiment, endoluminal prosthesis 1 is no stent graft.In other words, it is the lumen of not textile fabric Interior prosthese.

According to embodiment variant, at least one layer in two or more layers 5,6,7 includes graft fabric to be formed in lumen At least part of prosthese 1.According to embodiment, graft fabric is combined with the armouring 9 of layer.According to embodiment, graft fabric It is connected by least one connecting element 24,25 with anchorage part 10.

According to embodiment, endoluminal prosthesis 1 includes the furcation of prosthese lumen 2, to be suitable for implantation anatomical structure 3 In, anatomical structure 3 includes lesion 13, and lesion 13 is equipped with furcation, dynamic for example away from the ilium of the descending branch of aorta The furcation of arteries and veins.

According to preferred embodiment, endoluminal prosthesis is self-expanding.Endoluminal prosthesis 1 is suitable for passing through release device 31 (for example, conduit) is delivered and is discharged into the predetermined implant site in anatomical structure 3, and endoluminal prosthesis 1 is constructed with radial contraction It is mounted in release device 31.For example, release device 31 includes the induction element 41 and loading suitable for receiving endoluminal prosthesis 1 At least one layer of armouring 9 of casing 46 and endoluminal prosthesis 1.

The method that the manufacture multilayer endoluminal prosthesis according to any one of previous embodiment is described below.

The method for manufacturing multilayer endoluminal prosthesis 1 includes at least following steps.

A. arrangement includes the workbench of at least one mandrel 14.

B. at least one first linear device 8 is wound repeatedly around at least one mandrel 14, to form the armour of first layer 5 Fill 9.

Separate the armouring 9 of first layer 5 at least one mandrel 14.The step can be for example by keeping armouring 9 elastic It deforms to carry out.

D. at least one second linear device 38 is wound repeatedly around at least one mandrel 14, to form the second layer 6 Armouring 9.According to embodiment, the mandrel 14 of the armouring 9 for the second layer 6 that interweaves is with the armouring 9 than being used to form first layer 5 The smaller calliper to measure value of mandrel although it can be phase concentric shafts 14 for example with bore adaptation ability, such as passes through shifting Except the mandrel of top.

Separate the armouring 9 of the second layer 6 at least one mandrel 14.The step can be by making 9 flexible deformation of armouring Come carry out.

F. the armouring 9 of first layer 5 is assembled on the armouring of the second layer 6.

According to possible operation mode, before step C, it can provide and be heat-treated so that the armouring 9 of first layer 5 obtains it The memory of shape in mandrel.

According to possible operation mode, before step E, heat treatment can be provided and obtained with the armouring 9 for ensuring the second layer 6 The memory of its shape in mandrel.

According to possible operation mode, the method provides the step of repeating step B to F to third layer 7.

According to possible operation mode, step F includes at least one of following sub-step, but also includes all sub-steps Suddenly.

G. by means of release device 31 or expanding unit, the armouring 9 of the first layer 5 in support device 32, which has, to be suitable for extremely Partially but for example fully adhere to the supporting walls of the armouring 9 of first layer 5.According to embodiment, support device 32 be include can The inverse openable support device for closing device 45.For example, support device 32 is to define the sleeve of device cavity, the device cavity It is advantageously shaped to the shape of the armouring of duplicating layer 5,6,7, in order to take out two or more layers 5,6,7 from support device cavity Armouring.According to embodiment, support device 32 be substantially cupuliform and including bottom wall 36, bottom wall 36 is provided with centre bore 40, Centre bore 40 is suitable for receiving a part of the induction element 41 of release device 31, to provide release device 31 in support device 32 The certainty of interior radial positioning.According to embodiment, induction element 41 includes stopper section 37, which has than centre bore 40 bigger bores, to provide the certainty of longitudinal register of the release device 31 in support device 32.According to further step Suddenly, the armouring 9 of first layer 5 is discharged in support device 32.

H. the armouring 9 of the second layer 6 is transmitted in support device 32 by means of release device 31, the armouring 9 of first layer 5 is It is received in support device 32.

According to further step, the armouring 9 of the second layer 6 is discharged in support device 32, wherein the armouring of first layer 5 has been Through existing.

I. the threadiness of the armouring 9 of first layer 5 and the second layer 6 is for example adjusted by regulating device 33 (for example, Optical devices) Relative position of the element 8,38 before being discharged into support device 32.For example, regulating device 33 includes being arranged in support device Scale element 34 on 32, the scale element 34 cooperate with the indicator 35 being arranged in release device 31.For example, step I permits Perhaps the armouring 9 of two adjacent layers 5,6,7 angularly or is circumferentially offset predetermined angular amount.

J. it links together, according to embodiment but is not required, at least by least one line of the armouring 9 of first layer 5 At least one linear device 8 of the armouring 9 of the very best part 8 and the second layer 6 is (for example, at least one working portion 12 and at least one In coupling part between a anchorage part 10) crimping, to form at least one anchorage part 10.It is according to embodiment, but not Necessary, which is executed by using crimping tool 39.

According to possible operation mode, step J is mutually related layer by opening support device 32 and taking out at least two To execute.According to embodiment, at least two layers are being assembled and is being temporarily fixed at inflatable member associated with release device 31 After on part 38 sacculus of bracket (for example, be used for), at least two taking-ups for being mutually related layer are executed.

According to embodiment, is returned by using at least one with winding device 42 and execute step B, return and winding device 42 can be mobile and associated at least one linear device 8,38,48 relative to mandrel 14.For example, returning and winding device 42 It is suitable for relative to the spindle moving part that is at least longitudinal and circumferentially moving of mandrel 14.According to embodiment, returns and winding device 42 wraps At least two points of spindle moving parts opened are included, spindle moving part can move independently of one another and can be at least longitudinal and circumferential relative to mandrel 14 Ground is mobile.According to embodiment, mandrel 14 is displaceable element, such as suitable for rotating around its longitudinal axis.According to embodiment, return Return and winding device 42 and can relative to mandrel 14 move support construction 46 it is integrally associated.

According to embodiment, step B is by winding two opposed ends 28,29 of single linear device 8,38,48 to be formed Intertexture armouring 9 executes.

According to embodiment, step B winds two opposite ends of single linear device 8,38,48 by circumferentially opposite direction Portion 28,29 executes, and to form intertexture armouring 9, which forms weft yarn and warp type fabric.

According to embodiment, mandrel 14 includes the mandrels stem 43 of such as dog bone shape, returns to finger 44 from the mandrels stem 43 cantilevers stretch out, suitable for being used as the return member of at least one linear device 8,38,48 during at least step B and/or step D Part.

By this method, two or more layers can be fitted to each other in a manner of predictable and accurate, and can be real Now with the endoluminal prosthesis 1 of two or more layers coaxial layer.

Without departing from the scope of the appended claims, those skilled in the art can be used in functionally equivalent Several adjustment and replacement are carried out to element in other elements of above-described embodiment, to meet subsidiary and specific needs.

According to embodiment, endoluminal prosthesis component 1 at least partly defines prosthese lumen 2.The interior prosthesis assembly is suitable for Implantation material in anatomical structure 3, the anatomical structure 3 at least partially define at least one cavity 4 and including at least one treatments Part 13.

According to embodiment, endoluminal prosthesis component 1 includes at least three layer 5,6,7, these layers are coaxially arranged and are in With X-X in a longitudinal direction and the radial direction R-R of longitudinal direction X-X and orthogonal is defined as normal to when undeformed state In the main extension of the annular or substantially circumferential direction C-C in longitudinal X-X He the radial direction direction R-R.

According to embodiment, every layer 5 in undeformed state or 6 or 7 substantially completely it is superimposed upon on adjacent layer 5,6,7.

According to embodiment, three layer 5, every layer 5 in 6,7 or 6 or 7 include at least one linear device 8, the linear device 8 Form the intertexture armouring 9 for being defined at least one layer 5 or 6 or 7.

According to embodiment, endoluminal prosthesis 1 includes at least one working portion 12, and it is suitable for towards anatomical structure 3 At least treatment part 13.

According to embodiment, endoluminal prosthesis 1 includes at least one anchorage part 10, and it is suitable for anchoring to anatomical structure The anatomic part 11 of the wall of cavity 4.

According to embodiment, at least three layer 5,6,7 geometrically mutually the same.

According to embodiment, at least three layer 5,6,7 be at least separated from each other in the working portion 12 of endoluminal prosthesis component 1, To avoid providing connecting element between a layer 5 or 6 or 7 and at least one adjacent layer.

According to embodiment, at least one working portion 12 only includes at least one linear device 8, the linear device 8 formation Armouring 9 with intertexture, the intertexture are only remained in identical layer 5 or 6 or 7, avoid connection adjacent layer.

According to embodiment, when component is in undeformed state, every layer 5 or 6 or 7 working portion 12, in addition to it is in diameter Except being supported on the R-R of direction to the possibility of adjacent layer 5 or 6 or 7, opened in structure and geometrically with adjacent layer 5 or 6 or 7 points. To be moved freely relative to adjacent layer 5 or 6 or 7.

According to embodiment, at least one linear device 8,38,48 of every layer 5,6,7 of armouring 9 limits multiple windows 15, window Mouth 15 is suitable for that the treatment part 13 of prosthese lumen 2 and anatomical structure 3 is in fluid communication.

According to embodiment, when being in undeformed state, every layer 5,6,7 at least one working portion 12 has base each other This identical and mutually the same in all layers 5,6,7 multiple window 15.

According to embodiment, when being in undeformed state, every layer 5,6,7 at least one working portion 12 is in radial direction The extension of R-R or extension or diameter D1, D2, D3 transverse to longitudinal direction X-X, less than at least one anchorage part 10 Extension or diameter D4 transverse to longitudinal direction X-X.

According to embodiment, when being in undeformed state, at least three layer 5,6,7 around the circumferentially side longitudinal direction X-X It is deviated each other to C-C.

According to embodiment, every layer 5,6,7 of at least one of anchorage part 10 is connected to the adjacent anchor of adjacent layer 5,6,7 Gu part 10.

Due to above-described embodiment, blood flow regularization is induced in aneurysm region, generates aneurysm wall immediately after the implantation On stress reduce, and it is long-term in generate the remodeling of aneurysm wall itself.

According to embodiment, every layer 5,6,7 at least one working portion 12 has multiple windows 15.When component is in unchanged When shape state, shape and size of multiple windows 15 in every layer of layer 5,6,7 are identical.

According to embodiment, when being in undeformed state, at least three layer 5,6,7 along radial direction R-R in their cross It is also identical D1=D2=D3 in size, this causes substantially to abut against each other when being fitted to each other, and if not branch Support, then the effect R-R generally radially oriented is avoided, and therefore relative to each other at least along longitudinal direction and circumferential direction side It is substantially moved freely to X-X, C-C.

According to embodiment, when being in undeformed state, at least three layer 5, at least one of 6,7 have it is vertical transverse to it To the section of the non-circular shape 47 of direction X-X.

According to embodiment, when being in undeformed state, at least three layer 5, at least one of 6,7 have it is vertical transverse to it To the ellipse or lens-like form of direction X-X or the section of trilobal 49 or quatrefoil, to keep it to circumferentially extend C-C Part separate and separate at least one adjacent layer 5,6,7.

According to embodiment, when being in undeformed state, at least three layer 5, at least one layer in 6,7 have it is vertical transverse to it Extend X-X to the section of the non-circular shape of direction X-X, and along the longitudinal of this layer, has and change its angle orientation or angle phase The section of position has been accurately defined along its entire longitudinal extension X-X or has extended X-X at least along the longitudinal of its working portion 12 It is present in the gap between every layer.

According to embodiment, when being in undeformed state, at least three layer 5, at least one of 6,7 have along layer 5,6, The section transverse to its longitudinal direction X-X of 7 longitudinal variable size for extending X-X.

According to embodiment, when being in undeformed state, at least three layer 5,6,7 along the circumferential direction C-C it is angularly right Together, so that the multiple windows 15 for being suitable for that prosthese lumen is in fluid communication with the treatment part 13 of anatomical structure 3 be made to be aligned, so that Under the deformation state for the component being implanted into blood vessel to be treated, window deviates between the layers, it is ensured that hole needed for component Rate.

According to embodiment, linear device 8 has the circular cross-section for longitudinally extending 50 transverse to it.

According to embodiment, linear device 8 has the elliptic cross-section for longitudinally extending 51 transverse to it；Or elliptic cross-section 51, oval diagonal line is oriented substantially along the circumferential direction C-C of component；Or square section 52；Or rectangular section 53； Or rectangular section 53, the long side of rectangle are oriented substantially along the circumferential direction C-C of component；Or multinomial section (polynomial section), such as hexagon 54.

According to embodiment, linear device 8 has layered body, wherein every layer is made from a variety of materials.

According to embodiment, linear device 8 has layered body, and wherein innermost layer or core are made of metal material 55, such as by Elastic material is made, such asAnd outermost layer 56 is made from a different material, such as by biological absorbable or life Object erodable material is made.

According to embodiment, linear device 8 includes that its is at least part of

According to embodiment, linear device 8 includes its at least part of chrome-cobalt alloy.

According to embodiment, linear device 8 includes its at least part of MP35N.

According to embodiment, linear device 8 includes that its is at least part of

According to embodiment, linear device 8 includes its at least part of polymer material.

According to embodiment, linear device 8 includes the polymer material of its at least part of Bio-erodable.

According to embodiment, linear device 8 includes the polymer of its at least part of Bio-erodable for being mounted with drug Material, the drug are for example dispersed in one of polymer substrate or a variety of drugs.

According to embodiment, has with the armouring 9 that linear device 8 interweaves and handed over by the weft yarn and warp thread of line and the simple acquisition that interweaves Pattern is knitted, wherein the top for the line that every line 8 intersects along linear device 8 in linear device 8 and then passing through in lower section.

According to embodiment, have with the armouring 9 that linear device 8 interweaves by single line and the simple weft yarn and warp thread obtained that interweave Interlacing pattern, wherein every line 8 above the line that linear device 8 intersects and then passes through in lower section along linear device 8.

According to embodiment, have with the armouring 9 that linear device 8 interweaves by line and the weft yarn and warp thread intersection chart obtained that interweave Case, wherein every line 8 passes through in the top of the line of intersection twice and then in lower section by twice along line 8.

According to embodiment, there is the latitude obtained by First Line 8 and the second line 57 intertexture with the armouring 9 that linear device 8 interweaves Yarn and warp thread interlacing pattern, the second line 57 have the section greater than First Line.

According to embodiment, there is the latitude obtained by First Line 8 and the second line 57 intertexture with the armouring 9 that linear device 8 interweaves Yarn and warp thread interlacing pattern, wherein the second line 58 includes its at least part of Bio-erodable material.

According to embodiment, when component is in undeformed state, have with the armouring 9 that linear device 8 interweaves by First Line 8 The weft yarn and warp thread interlacing pattern obtained with the line intertexture of the constant intertexture angle of stretching, extension.

According to embodiment, when component is in undeformed state, have with the armouring 9 that linear device 8 interweaves by least one Root line 8 and direction C-C with respect to the circumferential direction stretches the weft yarn and warp thread intersection chart that the line intertexture of 45 ° of constant intertexture angle obtains Case.

According to embodiment, when component is in undeformed state, have with the armouring 9 that linear device 8 interweaves by least one The weft yarn and warp thread that the line intertexture that root line 8 and direction C-C with respect to the circumferential direction extends less than 45 ° of constant intertexture angle obtains interweave Pattern.

According to embodiment, when component is in undeformed state, have with the armouring 9 that linear device 8 interweaves by least one The weft yarn and warp thread that the line intertexture of constant intertexture angle of the root line 8 and direction C-C with respect to the circumferential direction stretching, extension greater than 45 ° obtains interweave Pattern.

According to embodiment, when being in undeformed state, has with the armouring 9 that linear device 8 interweaves and handed over by least one The weft yarn and warp thread interlacing pattern for knitting the acquisition of line 8 are formed in the preset width on the direction for being parallel to longitudinal X-X with 3mm Multiple windows 15.

According to embodiment, at least three layer 5,6,7 component form multiple windows 15, at least three layer 5,6,7 respectively include with The armouring 9 that linear device 8 interweaves has the weft yarn and warp thread interlacing pattern obtained by least one plait 8, when three layers of weight When folding and being in undeformed state, window 15 is upwardly formed the total freely width of the component with 1mm in the side for being parallel to longitudinal X-X The overlaid windows of degree.

According to embodiment, the component of layer 5,6,7 forms multiple windows 15, and layer 5,6,7 respectively includes interweaving with linear device 8 Armouring 9, there is the weft yarn and warp thread interlacing pattern that are obtained by least one plait 8, when layer is overlapped and in unchanged When shape state, window 15 is upwardly formed the overlapping of total unsupported width with component in the side for being parallel to predetermined longitudinal direction X-X Window；In single layer 5,6,7, the number of the window 15 of single layer is provided by following relationship:

Ncl=π φ/Nl × Dc, and

Sl=360/Ncl × Nl

Wherein

Ncl: the number of the window 15 of single layer 5,6,7

φ: the diameter of the working portion 12 of component

Nl: the number of the layer 5,6,7 of component is formed

Dc: by the diagonal line for the window that the superposition overlapping of layer and angle offset generate

Sl: the angle offset between component middle layer.

According to embodiment, there is the weft yarn and warp obtained by least one plait 8 with the armouring 9 that linear device 8 interweaves Yarn interlacing pattern interweaves and is obtained at least some intertextures by the drawing during braiding or elastic threads 8.

According to embodiment, at least one layer in layer 5,6,7 includes that first be contained in the second stretchable layer part 60 stretches Layer part 59, X-X is mutually shifted the two along longitudinal direction.

According to embodiment, the line for manufacturing layer is characterized in that circular cross-section.It is various types of other than circular cross-section The section of type can be configured for providing special characteristic for these layers or some of which, for example, bigger radial direction or Axial rigidity；Blood vessel surface and the bigger interface of aneurysm or covering；Particular fluid kinetic effect.

According to embodiment, the feature member of line is the material for manufacturing it.Preferred solution provides useLine.It can be considered alternative materials below: other super-elastic metal alloys (cochrome, MP35N,Deng), polymer, the polymer of Bio-erodable or carrying medicament biology can The polymer of erosion.

Layer can be made of the line of different materials, obtain specific functional performance.Particularly, introduce for manufacture one or The polymer line of the Bio-erodable of a part of multiple layers or layer allows at any time with the component of variable porosity battery rate.From From the point of view of this angle, the particularly interesting shape for manufacturing line is to provide polymerization for example coated with Bio-erodable The shape of the metal core of object.

According to embodiment, the treatment that will allow to implement diversification and customize using the drug of dispersion in the polymer matrix Scheme.

According to embodiment, the line intertexture in preferred embodiment is characterized in that simple weft yarn and warp thread interlacing pattern, latitude Yarn and warp thread interlacing pattern are obtained by single line, and have 45 ° of intersection relative to the longitudinal axis of component.The intertexture of line and its It is characterized in the basic element of the porosity and compliance for limiting device in a broad sense.Determining possibility changing factor is:

Braiding scheme and/or

The diameter and shape of plait and/or

The material of litzendraht wire and/or

The angle of the crossing of plait and/or

The tensioning of plait and/or

The mixing of two or more above-mentioned factors.

According to embodiment, the interlacing pattern used in the formation of these layers can be assigned with the line of same diameter and material The component specific mechanical feature executes the dynamic compliance of micro-shifting and possibility especially with regard to these lines when being exposed in blood flow Property.The two features can by isotropism or it is anisotropic in a manner of obtain, always play a role on interlacing pattern.

According to embodiment, can lead to using the line of different-diameter and/or shape with specific compliance and specific pore rate Layer.These embodiments are the difference is that have the selection for the single line for forming entire layer.

According to embodiment, using such solution, wherein can be changed polymerizeing for alternate metal wire and Bio-erodable The line of object interweaves to obtain low initial porosity, which is intended to the dissolution with polymeric web and increases.

According to embodiment, for changing another design lever of isotropism and/or anisotropy porosity and consistency It is indicated by the intertexture angle of line.It is (other that very big or very small winding angle relative to the component longitudinal axis will provide low porosity Factor is identical).Small winding angle will provide low Radial resistant force, for big winding angle, then exactly the opposite.

According to embodiment, the tension being applied on line in braiding allows to obtain the layer with stringing of changing over to new ways, stringing of changing over to new ways It is characterized in that line has lower compliance and mobile possibility.

According to embodiment, very big design flexibility is given by the mixing of intertexture variant listed above.For diameter More rigid end and the working portion better conformed to upwards, or the central area with low porosity is generated in aneurysm part (biodegradable line may be used), by giving two of special interest with the solution that variable-angle interweaves Example.

According to embodiment, the preferred design of component is provided using 3 equal layers, these layers are on circumferential angle direction It deviates each other at equal intervals.

According to embodiment, the basic parameter of device is the survey of the single window of component or bracket or the diagonal line Dc of unit Amount, the result of the superposition as multiple equal layers.Diagonal line Dc is important, because of the porosity of its measuring device.It is basic The preferable porosity of upper proxy component.

According to embodiment, many layers that can be made of superposition single window or big unit, or by single junior unit Some layers of composition obtain the identical value of diagonal line Dc.The basic relational expression for adjusting these geometries is as follows:

The number of unit of single layer:

Ncl=π φ/(Nl × Dc)

Angle offset between whole device middle layer:

Sl=360/ (Ncl × Nl)

Wherein:

Ncl: the number of unit of single layer；

φ: the diameter of the working portion of entire bracket；

Nl: the number of the layer of intact stent is formed；

Dc: by the diagonal line for the unit that the overlapping and offset of layer generate；

Sl: the angle offset between whole device middle layer.

According to embodiment, Dc is 1mm；Nl is 3；φ is 20mm；Then Ncl=20 and Sl=6 °.

Identical Dc value can be obtained using 4 layers, but Ncl=16 and Sl=5.6 °.

With many loose mesh layers rather than branch can be assigned with identical final porosity value Dc is obtained compared with coarse mesh layer A possibility that bigger compliance of frame and mobile single line, but increase the non-uniform risk in meander region.

Another modification for the design that can be played a role on layer by along axis generate have more or less layer region can It can property expression.

According to embodiment, according to the thickness of net, the diameter of line and shape, the material of line, line winding angle, use difference Layer allow sizable production chains.These variations allow to obtain many performances in terms of mechanical performance and compliance subtle Difference.

In this respect, a possibility that introducing the polymeric layer of Bio-erodable to assign porosity that bracket changes over time It is seemingly particularly interesting.

According to embodiment, these individual layers can by curling bushing (such as in Basic Design) or pass through crimp band, Weld seam, frenulum, dedicated anchor system are connected to each other.

According to embodiment, the number of tie point can change: more " link " layers cause more firmly, and more flexible is rigid Property, the mobility of the bracket less complied with, line is smaller, but more accurate and uniform in terms of porosity.The effect of connection can root It is suitably distributed according to the function to be realized.

Interesting implementation options based on interlayer interconnection pattern is as follows.If each layer is connected to each other, such as excellent In choosing design like that, only not excessive size in end and relative to each other, then the layer in working region will have centainly The opposite circumferential free degree of degree.This freedom will cause the part of gained porosity to change, especially in the case where complications Or it winds under implantation condition under any circumstance.Particularly, three deflection layers are being provided to obtain at least minimum initial institute again In the Basic Design for obtaining porosity, it will lead to by curve and tortuous caused change relative to undeformed state (wider mesh) Inevitably higher local porosity.If overthrowing this viewpoint, that is, the only connection between the retaining layer of end, still For determining the layer of phase completely, will be present with large mesh original undeformed state.Under the conditions of tortuous or winding, produced between layer Raw relative motion will be inevitably generated lesser final mesh, i.e., lower porosity.Because towards aneurysm itself The porosity in region will be less than the porosity of original area, and therefore can enhance required flowing layered effect, so Such device can be useful for the device for being bent implantation, and wherein aneurysm is located at hogback.

In preferred design, three layers " lightly contact " each other, i.e., they are in contact with each other without significant radial force Exchange.By playing the difference of diameter between layer, bracket integrally specific function can be assigned: being exchanged and contacted with significant radial force Layer will generate bracket that is harder, less complying with, and with the fine motion possibility of smaller single line under the action of blood flow；With Non-wetting layer is opposite.There has been described some variants that can be designed.

Layer can be only separated from each other by diameter difference or by separator.

With the separating layer at stable and controlled distance without the use of the particularly interesting solution party of separator Case is to provide the layer of one or more polygonal shapes.For example, central core has rough triangle shape in three layers of form Shape.By the amplitude using this trigonometric ratio, different distances can be obtained between outer layer and internal layer.Other polygonal shapes It can also be used for this purpose.

The bus contacted between layer can be straight line, that is, be parallel to the axis of bracket, or follow specific shape, example Such as spiral, specific track is provided to blood flow in layer.

The axial shape of layer can also be subjected to variation to obtain specific function, for example, with progressive curvature to avoid After the implants in " dog bone " effect of end, or special hydrodynamic effect is generated with bent intermediate layer.

Preferred design provides a kind of bracket, is monoblock type on the whole although being made of layer.It is contemplated that tool There is the solution of two telescoping shoring columns for implantation material, to realize the Optimal coverage to Long lesion.

For above-mentioned solution, endoluminal prosthesis component allows various clinical application:

A) aneurysmal treatment in aorta stretching, extension；

B) aneurysmal treatment in peripheral vessels；

C) treatment of dissection of aorta.

Reference signs list

1 endoluminal prosthesis

2 prosthese lumens

3 anatomical structures

4 anatomical structure cavitys

5 first layers

6 second layers

7 third layer

8 linear devices or the first linear device

9 armourings

The anchorage part of prosthese in 10

The anatomic part of 11 anatomical structures

The working portion of prosthese in 12

The lesion of 13 anatomical structures

14 mandrels

15 windows

Space between 16 adjacent layers

17 aneurysms

18 arch of aortas

19 descending aortas

20 aortas pectoralis

21 abdominal aortas

22 aortic isthmus

23 collatoral vessels

24 layers of attachment device or connecting element

25 end connecting devices or connecting element

Dummy ends in 26 proximal ends

Dummy ends in 27 distal ends

28 first linear device ends

29 second linear device ends

30 crossover sites

31 release devices

32 support devices

33 regulating devices

The scale element of 34 regulating devices

The indicator of 35 regulating devices

The bottom wall of 36 support devices

37 stopper sections

38 second linear devices

39 crimping tools

40 centre bores

The induction element of 41 regulating devices

42 returns and winding device

43 mandrels stems

44 mandrel fingers

45 reversible closing devices

46 support constructions

The circular cross-section of 47 single layer longitudinal direction extended spots

48 third linear devices

The trifoil cross-section of 49 single layer longitudinal direction extended spots

The circular cross section of 50 lines

The oval cross section of 51 lines

The square cross section of 52 lines

The rectangular cross section of 53 lines

The hexagonal cross-section of 54 lines

The metal core of 55 lines

The outer layer of 56 Bio-erodable line of material

57 are greater than the second line of First Line

Second line of 58 Bio-erodable materials

59 first stretchable layer parts

60 second stretchable layer parts

61 stent delivery systems

62 first release sheaths

63 second release sheaths

The number of the window of Ncl single layer

The diameter of the working portion of φ component

Nl forms the number of the layer of component

The diagonal line for the window that Dc is generated by the superposition overlapping of layer and angle offset

Angle offset between Sl component middle layer

D1 first layer bore or nominal diameter

D2 second layer bore or nominal diameter

D3 third layer bore or nominal diameter

The bore or nominal diameter of D4 anchorage part

X-X longitudinal direction

R-R radial direction

C-C circumferential direction

RE outer radial direction