Aortic bare stent and aortic dissection stent

Abstract

An aortic bare stent and an aortic dissection stent are disclosed. The aortic bare stent is in a tubular net structure, with multiple support stents in circles and arranged along an axial direction. Two adjacent support stents are connected by a connector stent. The connector stent is made of a hyper-elastic material. A flexural rigidity of the connector stent is less than that of the support stent. The support stent is made of a single-strand hyper-elastic nickel titanium wire or formed by cutting a nickel titanium tubing. The connector stent is made of a multi-strand composite wire. The multi-strand composite wire is formed by twisting or weaving multiple strands of filaments, and each strand of filament is independently of a nickel titanium material.

Claims

1. An aortic bare stent, in a tubular net structure, comprising: a plurality of support stents, wherein the plurality of support stents are arranged along an axial direction, each of the plurality of support stents independently forms a ring, and each of the plurality of support stents is made of a single-strand nickel titanium wire; and a plurality of connector stents, wherein each of the plurality of connector stents is operable to connect two adjacent support stents among the plurality of support stents, each of the plurality of connector stents is made of multi-strand nickel titanium filaments, a diameter of each of the plurality of connector stents is the same as that of each of the plurality of support stents, and a flexural rigidity of each of the plurality of connector stents is less than that of each of the plurality of support stents.

2. The aortic bare stent of claim 1, wherein the multi-strand nickel titanium filaments are twisted or weaved to form a multi-strand composite wire for constructing each connector stent, and the single-strand nickel titanium wire has a larger diameter than each nickel titanium filament for constructing each connector stent.

3. The aortic bare stent of claim 1, wherein a ratio of the flexural rigidity of each of the plurality of connector stents to the flexural rigidity of each of the plurality of support stents falls within a range of 0.5:10020:100.

4. The aortic bare stent of claim 1, wherein each of the plurality of support stents fluctuates to be in a wave shape along the axial direction while extending circumferentially, and peaks of each two support stents connected to a same connector stent are aligned.

5. The aortic bare stent of claim 4, wherein with adjacent peaks and valleys of each two support stents connected to a same connector stent as connection points, each connector stent is connected to corresponding connection points of two support stents connected to the connector stent.

6. The aortic bare stent of claim 5, wherein each of the plurality of connector stents independently forms a ring, and each of the plurality of connector stents fluctuates to be in a wave shape along the axial direction while extending circumferentially, and is connected to each connection point at two sides of an extending path to form a closed lattice structure.

7. The aortic bare stent of claim 5, wherein each of the plurality of connector stents independently forms a ring, and each of the plurality of connector stents fluctuates to be in a wave shape along the axial direction while extending circumferentially, part of peaks and part of valleys at two sides of an extending path of each of the plurality of connector stents act as connection points to be connected to each of the plurality of connector stents to form an open-loop lattice structure.

8. The aortic bare stent of claim 5, wherein each of the plurality of connector stents is connected to corresponding connection points in a winding manner.

9. The aortic bare stent of claim 2, wherein each nickel titanium filament has a diameter falling within a range of 0.050.2 mm.

10. The aortic bare stent of claim 1, wherein a ratio of an axial length of each of the plurality of connector stents to an axial length of each of the plurality of support stents falls within a range of 1:11:2.5.

11. The aortic bare stent of claim 1, further comprising at least one axial connector, each of the at least one axial connector being connected to corresponding connection points of each of the plurality of support stents in a knotting or winding manner.

12. The aortic bare stent of claim 11, wherein each of the at least one axial connector is connected to all or part of the plurality of support stents contacting the axial connector.

13. The aortic bare stent of claim 11, wherein multiple axial connectors are distributed uniformly along a circumferential direction of the aortic bare stent.

14. An aortic dissection stent, comprising: a covered stent; and an aortic bare stent in a tubular net structure and butted with the covered stent, comprising: a plurality of support stents, wherein the plurality of support stents are arranged along an axial direction, each of the plurality of support stents independently forms a ring, and each of the plurality of support stents is made of a single-strand nickel titanium wire; and a plurality of connector stents, wherein each of the plurality of connector stents is operable to connect two adjacent support stents among the plurality of support stents, each of the plurality of connector stents is made of multi-strand nickel titanium filaments, a diameter of each of the plurality of connector stents is the same as that of each of the plurality of support stents, and a flexural rigidity of each of the plurality of connector stents is less than that of each of the plurality of support stents.

15. The aortic dissection stent of claim 14, wherein and each of the plurality of support stents fluctuates to be in a wave shape along the axial direction while extending circumferentially, and peaks of each two support stents connected to a same connector stent are aligned.

16. The aortic dissection stent of claim 15, wherein with adjacent peaks and valleys of each two support stents connected to a same connector stent as connection points, each connector stent is connected to corresponding connection points of two support stents connected to the connector stent.

17. The aortic dissection stent of claim 16, wherein each of the plurality of connector stents independently forms a ring, and each of the plurality of connector stents fluctuates to be in a wave shape along the axial direction while extending circumferentially, and is connected to each connection point at two sides of an extending path to form a closed lattice structure.

18. The aortic dissection stent of claim 16, wherein each of the plurality of connector stents independently forms a ring, and each of the plurality of connector stents fluctuates to be in a wave shape along the axial direction while extending circumferentially, part of peaks and part of valleys at two sides of an extending path of each of the plurality of connector stents act as connection points to be connected to each of the plurality of connector stents to form an open-loop lattice structure.

19. The aortic dissection stent of claim 14, further comprising at least one axial connector, each of the at least one axial connector being connected to corresponding connection points of each of the plurality of support stents in a knotting or winding manner.

20. The aortic bare stent of claim 5, wherein each of the plurality of connector stents is connected to corresponding connection points in a knotting manner.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 is a schematic view illustrating an aortic bare stent according to an embodiment 1.

(2) FIG. 2a is a schematic view illustrating a support stent of the aortic bare stent according to the embodiment 1.

(3) FIG. 2b is a schematic view illustrating a connector stent of the aortic bare stent according to the embodiment 1.

(4) FIG. 3a is a schematic structural view illustrating a multi-strand nickel titanium wire of a dissection bare stent according to the embodiment 1.

(5) FIG. 3b is an enlarged view of a portion A in FIG. 3a.

(6) FIG. 4 is a schematic structural view illustrating a connection between the support stent and the connector stent according to the embodiment 1.

(7) FIG. 5a, FIG. 5b, FIG. 5c, and FIG. 5d are schematic views illustrating a connection manner of winding fixation between the support stent and the connector stent according to the embodiment 1.

(8) FIG. 6 is a schematic view illustrating a dissection bare stent according to an embodiment 2.

(9) FIG. 7a, FIG. 7b, FIG. 7c, FIG. 7d, and FIG. 7e are schematic views illustrating a connection manner of knotting fixation between a support stent and a connector stent according to the embodiment 2.

(10) FIG. 8a, FIG. 8b, FIG. 8c, FIG. 8d, and FIG. Se are schematic views illustrating another connection manner of knotting fixation between an annular support stent and an annular connector stent according to an embodiment 3.

(11) FIG. 9 is a schematic view illustrating a dissection bare stent according to an embodiment 4.

(12) FIG. 10 is a schematic view illustrating a dissection bare stent according to an embodiment 5.

(13) FIG. 11a is a front view illustrating a dissection bare stent according to an embodiment 6.

(14) FIG. 11b is a rear view illustrating a dissection bare stent according to the embodiment 6.

(15) FIG. 12 is a schematic view illustrating a dissection bare stent according to an embodiment 7.

(16) FIG. 13 is a schematic view illustrating a dissection bare stent according to an embodiment 8.

(17) FIG. 14 is a schematic view illustrating a dissection bare stent according to an embodiment 9.

(18) FIG. 15 is a schematic view illustrating use of the aortic bare stent of the embodiment 2 for treatment of an aortic dissection.

(19) FIG. 16 is a schematic view illustrating a dissection bare stent according to an embodiment 10.

DETAILED DESCRIPTION

(20) Below the present disclosure is described in detail in combination with the accompanying drawings and embodiments. In the text, a proximal end refers to an end close to a position of heart, and a distal end refers to an end away from the position of heart. In the schematic views of various embodiments, an upper side is the proximal end, and a lower side is the distal end.

Embodiment 1

(21) As illustrated in FIG. 1, an aortic bare stent 100 is constituted by multiple annular support stents 110 and multiple annular connector stents 120. The aortic bare stent 100 on the whole is in a tubular net structure, the support stents 110 are in a same structure, and the connector stents 120 are also in a same structure.

(22) The multiple annular support stents 110 are sequentially arranged in parallel at intervals from a proximal end of the aortic bare stent 100 to a distal end of the aortic bare stent 100. One connector stent 120 is arranged between two adjacent support stents 110, that is, the support stents 110 and the connector stents 120 are distributed at intervals along an axial direction of the aortic bare stent 100. In the present embodiment, the support stents 110 and the connector supports 120 have a same diameter, both being 30 mm, that is, a diameter of a tubular shape of the aortic bare stent 100 is 30 mm.

(23) As illustrated in FIG. 2a, each support stent 110 extends along a circumferential direction of the aortic bare stent 100, forming a closed annular shape, and fluctuates along the axial direction of the aortic bare stent 100 while extending circumferentially, forming a wave shape.

(24) The wave shape is a sinusoidal waveform (or a cosine waveform). The wave shape has multiple peaks 111 and multiple valleys 112 distributed at intervals. The adjacent peak 111 and valley 112 are connected by a connecting rod 113. The number of the peaks 111 is twelve. The number of the valleys 112 is also twelve. Each support stent 110 has an axial length of 8 mm.

(25) Each support stent 110 is formed by weaving a hyper-elastic nickel titanium wire. The nickel titanium wire has a relatively thin wire diameter falling within a range of 0.20.4 mm. Each support stent 110 in the present embodiment is formed by weaving a hyper-elastic nickel titanium wire with a diameter of 0.3 mm.

(26) As illustrated in FIG. 2a, each support stent 110 is provided with one connecting steel jacket 114. Two ends of the hyper-elastic nickel titanium wire are located inside the connecting steel jacket 114, and the two ends of the hyper-elastic nickel titanium wire are fixed inside the steel jacket 114 in a mechanical compressing manner or a welding manner.

(27) Compared with a conventional weaving manner of an aortic covered stent, the hyper-elastic nickel titanium wire having a thinner wire diameter is used in the present embodiment to weave the support stent, and the sinusoidal waveform of each support stent has more peaks and more valleys, such that a support three of the whole aortic bare stent 100 in the circumferential direction is distributed more uniformly, with better flexibility, thus better satisfying requirements of cases with a dissection.

(28) As illustrated in FIG. 2b, each connector stent 120 extends along the circumferential direction of the aortic bare stent 100, forming a closed annular shape, and fluctuates along the axial direction of the aortic bare stent 100 while extending circumferentially, forming a wave shape.

(29) The wave shape is a sinusoidal waveform (or a cosine waveform). The wave shape has multiple peaks 121 and valleys 122 distributed at intervals. The adjacent peak 121 and valley 122 are connected by a connecting rod 123. The number of the peaks 121 is twelve. The number of the valleys 122 is also twelve. Each connector stent 120 has an axial length of 4.5 mm.

(30) Each connector stent 120 is formed by weaving one multi-strand nickel titanium wire. The multi-strand nickel titanium wire is formed by mechanically twisting or weaving no less than three hyper-elastic nickel titanium filaments. The multi-strand nickel titanium wire has a wire diameter falling within a range of 0.10.4 mm.

(31) As illustrated in FIG. 3a and FIG. 3b, in the present embodiment, the multi-strand nickel titanium wire is formed by twisting three strands of hyper-elastic nickel titanium monofilaments. The three strands of hyper-elastic nickel titanium monofilaments are a hyper-elastic nickel titanium filament 1201, a hyper-elastic nickel titanium filament 1202, and a hyper-elastic nickel titanium filament 1203, respectively. The three strands of the hyper-elastic nickel titanium monofilaments have a same filament diameter. Each strand of the hyper-elastic nickel titanium monofilament has a filament diameter of 0.07 mm. The twisted multi-strand nickel titanium wire has the wire diameter (a diameter of a circumscribed circle of a cross section) of 0.15 mm. A weaved connector stent 120 is illustrated in FIG. 2b.

(32) Two end portions of the multi-strand nickel titanium wire for fabricating the connector stent 120 are connected together in a knotting manner, in a welding manner or by adding a steel jacket. The two end portions are fixed together in the knotting manner in the present embodiment.

(33) As illustrated in FIG. 4, two adjacent support stents 110 are connected by one connector stent 120, the peaks of the two adjacent support stents 110 are arranged in an aligned manner (the valleys are also arranged in an aligned manner). The peaks 121 of each connector stent 120 are connected to the valleys 112 of an upper adjacent support stent 110, and the valleys 122 of each connector stent 120 are connected to the peaks 111 of a lower adjacent support stent 110. All of the support stents 110 and the connector stents 120 are combined to form the aortic bare stent 100 in a tubular shape, and a circumferential face of the tubular shape is in a net structure with diamond grids.

(34) The aortic bare stent 100 according to the present embodiment is formed by connecting and closing eleven support stents 110 and ten connector stents 120, and has a total axial length of 133 mm.

(35) The aortic bare stent 100 provided in the present embodiment has a uniform, reasonable, and relatively small support force on an outer circumferential surface, which not only can avoid a problem of generating new dissection tears due to a too big radial force, but also can ensure a good bending flexibility of the aortic bare stent 100, thus being adapted to various forms of aortic anatomical structures.

(36) The aortic bare stent 100 according to the present embodiment has a relatively good axial support performance in the axial direction, thus avoiding shortening of the stent due to accumulation.

(37) In addition, the aortic bare stent 100 according to the present embodiment is designed in a closed-loop manner, which can avoid a problem of overturn of a single stent caused by an open-loop connection or puncturing of a blood vessel wall by peaks of an open loop.

(38) As illustrated in FIG. 1 and FIG. 4, a single peak 121 or a single valley 122 of each connector stent 120 is fixedly connected together with a single valley 112 or a single peak 111 of a corresponding support stent 110, and the connector stent 120 and the support stent 110 do not move relatively to each other.

(39) In the present embodiment, each connector stent 120 is fixed, at positions of the peaks or the valleys, on the valleys or the peaks of a corresponding support stent 110 in a winding manner. A process of winding connection is illustrated in FIGS. 5a-5b. The connector stent 120 connects two adjacent support stents 110. When the connector stent 120 is connected to the valleys 112 of the upper support stent 110, a head end 124 of the multi-strand nickel titanium wire goes in from outside of the valley 112 (outside refers to outside of the aortic bare stent, and the same interpretation is applied to outside and inside in the following text, unless otherwise stated), and after winding the valley 112, the head end 124 goes towards the lower support stent 110 and goes to outside of the lower support stent 110, as illustrated in FIG. 5a.

(40) The multi-strand nickel titanium wire is wound on the valley of the support stent 110 by 35 turns in a manner as illustrated in FIG. 5a, three turns in the present embodiment as illustrated in FIG. 5b, thus completing fixed winding connection between one peak of the connector stent 120 and the valley 112 of the support stent 110.

(41) Then, the head end 124 of the nickel titanium wire goes in from outside of the adjacent peak 111 of the lower adjacent support stent 110, and after winding the peak 111, the head end 124 goes towards the upper support stent 110 and goes to outside of the upper support stent 110, as illustrated in FIG. 5c.

(42) The multi-strand nickel titanium wire is wound on the peak of the support stent 110 by 35 turns in a manner as illustrated in FIG. 5c, three turns in the present embodiment as illustrated in FIG. 5d, thus completing fixed winding connection between one valley of the connector stent 120 and the peak 111 of the support stent 110.

Embodiment 2

(43) As illustrated in FIG. 6, an aortic bare stent 200 in the present embodiment is constituted by multiple support stents 210 in circles and multiple connector stents 220 in circles. The present embodiment is distinguished from the embodiment 1 merely in that peaks or valleys of the support stents 210 and valleys or peaks of the connector stents 220 are fixed in a knotting manner.

(44) As illustrated in FIG. 7a-FIG. 7e, in the present embodiment, each connector stent 220 is fixed, at positions of the peaks or the valleys, on the valleys or the peaks of a corresponding support stent 210 in a knotting manner.

(45) As illustrated in FIG. 7a, a head end 224 of a multi-strand nickel titanium wire goes out from inside of a valley 212 of an upper support stent, and after winding the valley, passes through a bottom portion of the nickel titanium wire itself.

(46) As illustrated in FIG. 7b, the head end 224 of the nickel titanium wire goes into inside of the valley from outside of the valley, and a circle 225 is formed between the multi-strand nickel titanium wire and the valley 212 of the support stent 210;

(47) As illustrated in FIG. 7c, the head end 224 of the nickel titanium wire winds the valley and goes out from the circle 225 formed by the nickel titanium wire, thus completing the fixed knotting connection between one peak 221 of the connector stent 220 and one valley 212 of the support stent 210.

(48) As illustrated in FIG. 7d and FIG. 7e, the head end 224 of the nickel titanium wire goes out from inside of an adjacent peak 211 of a lower support stent 210, and a fixed knotting connection between the valley 222 of the connector stent 220 and the peak 211 of the lower adjacent support stent 210 is completed in the manner of knotting the peak 221 of the connector stent 220 and the valley 212 of the support stent 210.

(49) FIG. 15 is a schematic view illustrating treatment of a type B aortic dissection with the aortic bare stent 200 provided in the present embodiment in combination with a proximal covered stent 10, In FIG. 1.5, a is a proximal blood vessel tear, b is a false lumen, and c is an overlapping region of the covered stent 10 and the aortic bare stent 200.

(50) The proximal covered stent 10 blocks the proximal tear of the type B dissection, to reduce a pressure inside the false lumen, and promote thrombosis of blood inside the false lumen the aortic bare stent 200 is placed at a distal end of the covered stent 10, and partially overlaps the covered stent 10, for rebuilding the true lumen of the blood vessel, and ensuring that arterial blood flows fluently in various internal organs.

Embodiment 3

(51) The present embodiment is distinguished from the embodiment 2 merely in that the connector stent 220 and the support stent 210 are fixed in a different knotting manner.

(52) As illustrated in FIGS. 8a-8e, in the present embodiment, each connector stent 220 is fixed, at positions of the peaks or the valleys, on the valleys or the peaks of the corresponding support stent 210 in another knotting manner.

(53) As illustrated in FIG. 8a, the head end 224 of the multi-strand nickel titanium wire goes in from outside of the valley 212 of the upper support stent 210, and after winding the valley, passes through a top portion of the nickel titanium wire.

(54) As illustrated in FIG. 8b, the head end 224 of the nickel titanium wire goes to outside of the valley from inside of the valley, and a circle 226 is formed between the multi-strand nickel titanium wire and the support stent 210.

(55) As illustrated in FIG. 8c, the head end 224 of the nickel titanium wire winds the valley and goes out from the circle 226 formed by the nickel titanium wire, thus completing the fixed knotting connection between one peak 221 of the connector stent 220 and one valley 212 of the support stent 210.

(56) As illustrated in FIG. 8d, and FIG. 8e, the head end 224 of the nickel titanium wire goes in from outside of an adjacent peak 211 of the lower adjacent support stent 210, and the knotting connection between the valley 222 of the connector stent 220 and the peak 211 of the lower adjacent support stent 210 is completed in the manner of knotting the peak 221 of the connector stent 220 and the valley 212 of the support stent 210.

Embodiment 4

(57) An aortic bare stent 300 according to the present embodiment is distinguished from the embodiment 1 merely in that a dissection bare stent 300 further includes one or more axial connectors 330, in addition to multiple support stents 310 in circles and multiple connector stents 320 in circles.

(58) The number of the axial connectors 330 is a divisor of the number of peaks of each support stent 310. The axial connectors 330 are uniformly distributed on the aortic bare stent 300 in a circumferential direction. Each axial connector 330 connects all or part of annular support stents 310 on a same generatrix of a cylinder in a knotting or winding manner.

(59) Corresponding valleys 312 of the support stents 310 are aligned, and corresponding peaks 311 of the support stents 310 are also aligned. The axial connector 330 connects the valleys 312, or connects the peaks 311.

(60) The axial connectors 330 may be made of one multi-strand nickel titanium wire, and also may be made of a high-strength filament and a mix-woven polymer suture, for example, a PET suture, a PP suture, and so on.

(61) As illustrated in FIG. 9, one axial connector 330 is provided in the present embodiment, and is made of a multi-strand nickel titanium wire with the same structure as the annular connector stent 310, The axial connector 330 is fixedly and sequentially connected to ten valleys 312 of ten proximal support stents on the same generatrix. A connecting manner is the knotting manner as illustrated in the embodiment 3.

(62) A most distal support stent 310 is not fixedly connected to the axial connector 330, and is not restricted by the axial connector 330. By adjusting a length of the axial connector 330 arranged between two adjacent support stents 310, a problem of excessive axial elongation of the aortic bare stent 300 in a sheathing process can be avoided, meanwhile, it also facilitates accurate positioning of the aortic bare stent 300 when being released in a surgical process.

Embodiment 5

(63) As illustrated in FIG. 10, an aortic bare stent 400 according to the present embodiment is distinguished from the embodiment 4 merely in that the number of valleys of ten proximal support stents 410 connected to an axial connector 430 is different from that of the valleys of ten proximal support stents 310 connected to the axial connector 330.

(64) In the present embodiment, the axial connector 430 is merely fixed in a knotting manner to two valleys 312, namely, a valley 312 of a first support stent 410 and a valley 312 of a tenth support stent 410, on a same generatrix, while second to ninth support stents 410 are not fixedly connected to the axial connector 430.

Embodiment 6

(65) As illustrated in FIG. 11a and FIG. 11b, an aortic bare stent 500 according to the present embodiment is distinguished from the embodiment 4 merely in the following: three axial connectors 530 are provided in the present embodiment, the three axial connectors 530 are uniformly distributed in a circumferential direction of the aortic bare stent 500, and each axial connector 530 is connected to valleys of support stents 510 in a same manner as illustrated in the embodiment 4.

Embodiment 7

(66) As illustrated in FIG. 12, an aortic bare stent 600 according to the present embodiment is constituted by multiple support stents 610 in circles and multiple connector stents 620 in circles.

(67) The present embodiment is distinguished from the embodiment 1 merely in that the aortic bare stent 600 according to the present embodiment is in a tapered-tube-shape structure, and a proximal end of the aortic bare stent 600 has a diameter of 30 mm, a distal end of the aortic bare stent 600 has a diameter of 26 mm, and the aortic bare stent 600 has an axial length of 180 mm.

Embodiment 8

(68) As illustrated in FIG. 13, an aortic bare stent 700 according to the present embodiment is constituted by multiple support stents 710 in circles and multiple connector stents 720 in circles.

(69) The present embodiment is distinguished from the embodiment 2 merely in the following: the aortic bare stent 700 according to the present embodiment is in a tapered-tube-shape structure, and a proximal end of the aortic bare stent 700 has a diameter of 30 mm, a distal end of the aortic bare stent 700 has a diameter of 26 mm, and the aortic bare stent 700 has an axial length of 180 mm.

Embodiment 9

(70) As illustrated in FIG. 14, an aortic bare stent 800 according to the present embodiment is constituted by multiple support stents 810 in circles, multiple connector stents 820 in circles, and an axial connector 830.

(71) The present embodiment is distinguished from the embodiment 4 merely in the following: the aortic bare stent 800 according to the present embodiment is in a tapered-tube-shape structure, and a proximal end of the aortic bare stent 800 has a diameter of 30 mm, a distal end of the aortic bare stent 800 has a diameter of 26 mm, and the aortic bare stent 800 has an axial length of 180 mm.

Embodiment 10

(72) As illustrated in FIG. 16, an aortic bare stent 900 according to the present embodiment is constituted by multiple support stents 910 in circles and multiple connector stents 920 in circles.

(73) The present embodiment is distinguished from the embodiment 2 merely in that connection points for the support stents 910 and the connector stents 920 are different in the present embodiment.

(74) As illustrated in FIG. 16, among valleys of the upper support stent 910 adjacent to the connector stent 920, each two connection points are spaced by one valley which does not act as a connection point, likewise, among peaks of the lower support stent 910 adjacent to the connector stent 920, each two connection points are spaced by one peak which does not act as a connection point.