SELF-CURVING STENT-GRAFT
20180008394 · 2018-01-11
Assignee
Inventors
Cpc classification
A61F2250/0012
HUMAN NECESSITIES
A61F2210/0014
HUMAN NECESSITIES
International classification
Abstract
An endovascular self-curving stent-graft (20) includes a self-curving longitudinal portion (22), which is curved so as to define an innermost curve (26) and an outermost curve (28), when the stent-graft (20) is unconstrained in a radially-expanded state. The stent-graft (20) includes a plurality of circumferential strut members (30); a compression-generation spring (40), which (a) is in an elongated configuration when the stent-graft (20) is in a radially-compressed state, and (b) overlaps respective first portions (44) of at least two of the circumferential strut members (30); and an anti-buckling spring (50), which overlaps respective second portions (54) of at least two of the circumferential strut members (30). The anti-buckling spring (50) and the compression-generation spring (40) are together configured to curve the self-curving longitudinal portion (22) when the stent-graft (20) is unconstrained in the radially-expanded state, such that a lesser length of the self-curving longitudinal portion (22), measured along the innermost curve (26), is less than 80% of a greater length of the self-curving longitudinal portion (22), measured along the outermost curve (28).
Claims
1. Apparatus comprising a generally tubular endovascular self-curving stent-graft, which (a) comprises a self-curving longitudinal portion having proximal and distal ends, (b) is configured to transition from a radially-compressed delivery state to a radially-expanded state, wherein, when the stent-graft is unconstrained in the radially-expanded state, the self-curving longitudinal portion of the stent-graft is curved so as to define an innermost curve and an outermost curve, and (c) comprises: a plurality of circumferential strut members, disposed at respective axial positions along the self-curving longitudinal portion of the stent-graft, surrounding a central longitudinal axis of the self-curving longitudinal portion of the stent-graft; a graft member, which comprises one or more substantially blood-impervious flexible sheets, and which is fixed to the circumferential strut members; a compression-generation spring, which (a) is in an elongated configuration when the stent-graft is in the radially-compressed state, and (b) overlaps respective first portions of at least two of the circumferential strut members; and an anti-buckling spring, which (a) overlaps respective second portions of at least two of the circumferential strut members, (b) is shaped so as to define a plurality of curves, and (c) is in fixed orientation with respect to the graft member such that the curves reside substantially in a plane that is substantially parallel to the surface of the graft member, wherein the anti-buckling spring and the compression-generation spring are together configured to curve the self-curving longitudinal portion of the stent-graft when the stent-graft is unconstrained in the radially-expanded state, such that a lesser length of the self-curving longitudinal portion of the stent-graft, measured along the innermost curve, is less than 80% of a greater length of the self-curving longitudinal portion of the stent-graft, measured along the outermost curve.
2-3. (canceled)
4. The apparatus according to claim 1, wherein if the stent-graft were to be placed in a right circular cylinder while in the radially-expanded state, each of the compression-generation spring and the anti-buckling spring would be substantially longitudinally-disposed.
5. The apparatus according to claim 1, wherein the anti-buckling spring and the compression-generation spring are together configured such that, when the stent-graft is unconstrained in the radially-expanded state, the lesser length of the self-curving longitudinal portion of the stent-graft is less than 75% of the greater length of the self-curving longitudinal portion of the stent-graft.
6. The apparatus according to claim 1, wherein a length of the compression-generation spring is at least 15% greater when the stent-graft is in the radially-compressed delivery state than when the stent-graft is unconstrained in the radially-expanded state.
7. The apparatus according to claim 6, wherein the length of the compression-generation spring is at least 20% greater when the stent-graft is in the radially-compressed delivery state than when the stent-graft is unconstrained in the radially-expanded state.
8-10. (canceled)
11. The apparatus according to claim 1, wherein a height of each of the circumferential strut members of the self-curving longitudinal portion of the stent-graft, measured along the stent-graft, is greater at the outermost curve than at the innermost curve, when the stent-graft is unconstrained in the radially-expanded state.
12-13. (canceled)
14. The apparatus according to claim 1, wherein the anti-buckling spring is in a substantially relaxed configuration when the stent-graft is unconstrained in the radially-expanded state.
15. The apparatus according to claim 1, wherein the anti-buckling spring is in a longitudinally-compressed configuration when the stent-graft is unconstrained in the radially-expanded state.
16-23. (canceled)
24. The apparatus according to claim 1, wherein a longitudinal spring constant of the compression-generation spring is 70 N/m to 300 N/m.
25. The apparatus according to claim 1, wherein a longitudinal spring constant of the anti-buckling spring is 70 N/m to 300 N/m.
26. The apparatus according to claim 1, wherein, if the stent-graft were to be placed in a right circular cylinder while in the radially-expanded state, an axial compression force exerted by the compression-generation spring against an inner surface of the cylinder would be 3 to 10 N.
27-31. (canceled)
32. The apparatus according to claim 1, wherein each of the circumferential strut members of the self-curving longitudinal portion is shaped so as to define a plurality of proximal peaks, and wherein, when the stent-graft is unconstrained in the radially-expanded state, for at least one of the circumferential strut members of the self-curving longitudinal portion: a first set of the proximal peaks of the circumferential strut member, which includes at least a circumferentially-closest one of the proximal peaks to the outermost curve of the self-curving longitudinal portion, and no more than half of the proximal peaks of the circumferential strut member, are bent radially inward at least an average angle of 20 degrees toward the central longitudinal axis of the self-curving longitudinal portion, and a second set of the proximal peaks of the circumferential strut member, which includes all of the proximal peaks of the circumferential strut member not in the first set, are not bent radially inward by at least an average angle of 20 degrees toward the central longitudinal axis of the self-curving longitudinal portion.
33-46. (canceled)
47. The apparatus according to claim 1, wherein an angle about the central longitudinal axis of the self-curving longitudinal portion of the stent-graft between the anti-buckling spring and the compression-generation spring, averaged along the self-curving longitudinal portion of the stent-graft, is between 140 and 220 degrees, when the stent-graft is unconstrained in the radially-expanded state.
48-71. (canceled)
72. The apparatus according to claim 1, wherein the anti-buckling spring is sinusoidal or serpentine in the plane that is substantially parallel to the surface of the graft member.
73. The apparatus according to claim 32, wherein the first set includes no more than 40% of the proximal peaks of the circumferential strut member.
74. A method for treating a subject, comprising: transvascularly introducing a generally tubular endovascular self-curving stent-graft into a blood vessel of the subject while the stent-graft is in a radially-compressed delivery state, which stent-graft (1) includes a self-curving longitudinal portion having proximal and distal ends, (2) is configured to transition from the radially-compressed delivery state to a radially-expanded state, wherein, when the stent-graft is unconstrained in the radially-expanded state, the self-curving longitudinal portion of the stent-graft is curved so as to define an innermost curve and an outermost curve, and (3) includes: (i) a plurality of circumferential strut members, disposed at respective axial positions along the self-curving longitudinal portion of the stent-graft, surrounding a central longitudinal axis of the self-curving longitudinal portion of the stent-graft; (ii) a graft member, which includes one or more substantially blood-impervious flexible sheets, and which is fixed to the circumferential strut members; (iii) a compression-generation spring, which (a) is in an elongated configuration when the stent-graft is in the radially-compressed state, and (b) overlaps respective first portions of at least two of the circumferential strut members; and (iv) an anti-buckling spring, which (a) overlaps respective second portions of at least two of the circumferential strut members, (b) is shaped so as to define a plurality of curves, and (c) is in fixed orientation with respect to the graft member such that the curves reside substantially in a plane that is substantially parallel to the surface of the graft member, wherein the anti-buckling spring and the compression-generation spring are together configured to curve the self-curving longitudinal portion of the stent-graft when the stent-graft is unconstrained in the radially-expanded state, such that (A) a lesser length of the self-curving longitudinal portion of the stent-graft, measured along the innermost curve, is less than 80% of a greater length of the self-curving longitudinal portion of the stent-graft, measured along the outermost curve; and creating a tight seal between the graft member at the proximal end of the self-curving longitudinal portion of the stent-graft and a wall of the curved blood vessel, by transitioning the stent-graft to the radially-expanded state in the curved blood vessel.
75. The method according to claim 74, wherein the anti-buckling spring is sinusoidal or serpentine in the plane that is substantially parallel to the surface of the graft member.
76. The method according to claim 74, wherein each of the circumferential strut members of the self-curving longitudinal portion is shaped so as to define a plurality of proximal peaks, and wherein, when the stent-graft is unconstrained in the radially-expanded state, for at least one of the circumferential strut members of the self-curving longitudinal portion: a first set of the proximal peaks of the circumferential strut member, which includes at least a circumferentially-closest one of the proximal peaks to the outermost curve of the self-curving longitudinal portion, and no more than half of the proximal peaks of the circumferential strut member, are bent radially inward at least an average angle of 20 degrees toward the central longitudinal axis of the self-curving longitudinal portion, and a second set of the proximal peaks of the circumferential strut member, which includes all of the proximal peaks of the circumferential strut member not in the first set, are not bent radially inward by at least an average angle of 20 degrees toward the central longitudinal axis of the self-curving longitudinal portion.
77. The method according to claim 76, wherein the first set includes no more than 40% of the proximal peaks of the circumferential strut member.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0199]
[0200]
[0201]
[0202]
[0203]
DETAILED DESCRIPTION OF APPLICATIONS
[0204]
[0205]
[0206] Stent-graft 20 comprises self-curving longitudinal portion 22; optionally, one or more straight portions 24 (exactly one distal straight portion 24 is shown in the figures); and, optionally, one or more additional curved portions (not shown in the figures). Self-curving longitudinal portion 22 has proximal and distal ends 23 and 25. For some applications, self-curving longitudinal portion 22 of stent-graft 20 longitudinally extends along less than 100% (e.g., less than 80%) of stent-graft 20 (as shown in
[0207] Stent-graft 20 is configured to transition from a radially-compressed delivery state (not shown in
[0208] Stent-graft 20 comprises a plurality of circumferential strut members 30, disposed at respective axial positions along self-curving longitudinal portion 22 of stent-graft 20, surrounding a central longitudinal axis 36 of self-curving longitudinal portion 22 of stent-graft 20 (labeled in
[0209] Stent-graft 20 also comprises a graft member 32, which is fixed to circumferential strut members 30. For some applications, a centerline length L.sub.C of self-curving longitudinal portion 22 of stent-graft 20 (labeled in
[0210] As used in the present application, including in the claims, a “central longitudinal axis” of an elongate structure is the set of all centroids of transverse cross-sectional sections of the structure along the structure. Thus the cross-sectional sections are locally perpendicular to the central longitudinal axis, which runs along the structure. (If the structure is circular in cross-section, the centroids correspond with the centers of the circular cross-sectional sections.) The central longitudinal axis of a curved elongate structure is curved, rather than straight.
[0211] Self-curving longitudinal portion 22 comprises both a plurality of the circumferential strut members 30 and at least a portion of the graft member 32.
[0212] When stent-graft 20 is unconstrained in the radially-expanded state, as shown in
[0213] Graft member 32 comprises one or more biologically-compatible substantially blood-impervious flexible sheets 34, and is attached (such as by stitching) to at least a portion of circumferential strut members 30, on either side (or a portion inside and a portion outside) of the surfaces defined by circumferential strut members 30, so as to define a lumens through stent-graft 20. For example, the circumferential strut members 30 of self-curving longitudinal portion 22 may be fixed inside of graft member 32, and the circumferential strut members 30 of the one or more straight portions 24 may be fixed outside of graft member 32. The flexible sheets may comprise, for example, a polymeric material (e.g., a polyester, or polytetrafluoroethylene), a textile material (e.g., polyethylene terephthalate (PET), or expanded polytetrafluoroethylene (ePTFE)), natural tissue (e.g., saphenous vein or collagen), or a combination thereof.
[0214] Stent-graft 20 further comprises a compression-generation spring 40, which is in an elongated configuration (i.e., it is longer than when in its relaxed state), when stent-graft 20 is in the radially-compressed state. Compression-generation spring 40 is configured to apply a longitudinally compressive force to the stent-graft. For some applications, stent-graft 20 comprises a plurality of compression-generation springs 40, such as shown in
[0215] Compression-generation spring 40 overlaps respective first portions 44 of at least two of circumferential strut members 30, such as at least three of circumferential strut members 30, or at least four of circumferential strut members 30 (as shown in the figures). For some applications, compression-generation spring 40 is fixed to graft member 32 at a plurality of locations on the graft member. Alternatively or additionally, compression-generation spring 40 is fixed to the respective first portions of the at least two of circumferential strut members 30, thereby indirectly fixing compression-generation spring 40 to graft member 32 via the at least two of circumferential strut members 30. Compression-generation spring 40 typically longitudinally extends along at least 60% (typically along at least 80%, such as along 100%) of self-curving longitudinal portion 22.
[0216] Stent-graft 20 additionally comprises an anti-buckling spring 50. Anti-buckling spring 50 is configured to resist longitudinal compression of the stent-graft along its respective circumferential angle. Anti-buckling spring 50 overlaps respective second portions 54 of at least two of circumferential strut members 30, such as at least three of circumferential strut members 30, or at least four of circumferential strut members 30 (as shown in the figures). The at least two circumferential strut members 30 are optionally, but not necessarily, the same as the at least two circumferential strut members 30 overlapped by compression-generation spring 40. For some applications, anti-buckling spring 50 is fixed to graft member 32 at a plurality of locations on the graft member. Alternatively or additionally, anti-buckling spring 50 is fixed to the respective second portions of the at least two of circumferential strut members 30, thereby indirectly fixing anti-buckling spring 50 to the graft member via the at least two of circumferential strut members 30. For some applications, stent-graft 20 comprises a plurality of anti-buckling springs 50, such as shown in
[0217] In some configurations, anti-buckling spring 50 is in a substantially relaxed configuration when stent-graft 20 is unconstrained in the radially-expanded state. In other configurations, anti-buckling spring 50 is in a longitudinally-compressed configuration when stent-graft 20 is unconstrained in the radially-expanded state. In both of these configurations, anti-buckling spring 50 is biased to resist axial compression, and is typically biased to lengthen when stent-graft 20 is in the radially-expanded state and is longitudinally expanded to the maximum length allowed by graft member 32, but is prevented from lengthening by graft member 32. As mentioned above, anti-buckling spring 50 is directly or indirectly fixed to graft member 32 at a plurality of locations on the graft member, at least near its proximal and distal ends, which prevents the graft member from longitudinally over-collapsing, and prevents anti-buckling spring 50 from lengthening the outermost curve 28 of self-curving longitudinal portion 22.
[0218] For some applications, anti-buckling spring 50 is shaped so as to define a plurality of curves (e.g., is sinusoidal or serpentine), and is in fixed orientation with respect to graft member 32 such that the curves reside substantially in a plane that is substantially parallel to the surface of graft member 32. As a result, if anti-buckling spring 50 is axially deformed during or after deployment, the anti-buckling spring does not press against the wall of the blood vessel or create large inward crests in the graft member, as it might do if the planes of the curves were perpendicular to the surface of the graft member. In addition, the curves define predetermined strain-distribution locations; without such strain-distribution locations, the anti-buckling spring, if axially deformed, might undergo plastic deformation and/or snap.
[0219] Anti-buckling spring 50 and compression-generation spring 40 are together configured to curve self-curving longitudinal portion of stent-graft 20 when stent-graft 20 is unconstrained in the radially-expanded state, as shown in
[0220] For some applications, when stent-graft 20 is unconstrained in the radially-expanded state, as shown in
[0223] (As used in the present application, including in the claims, an angle between two lines is the smaller of the two supplementary angles between the two lines, or equals 90 degrees if the two lines are perpendicular.)
[0224] For some applications, a longitudinal spring constant of compression-generation spring 40 is at least 70 N/m, no more than 300 N/m, and/or 70 N/m to 300 N/m. For some applications in which stent-graft 20 comprises a plurality of compression-generation springs 40, such as shown in
[0225] As labeled in
[0226] For some applications, when stent-graft 20 is in unconstrained in the radially-expanded state, as shown in
[0229] For some applications, a length of compression-generation spring 40 is at least 15% greater, such as at least 20% greater, when stent-graft 20 is in the radially-compressed delivery state than when stent-graft 20 is unconstrained in the radially-expanded state. Alternatively or additionally, for some applications, a length of compression-generation spring 40 is at least 10%, such as least 15% or 20% less, when stent-graft 20 is unconstrained in the radially-expanded state than when stent-graft 20 is in the radially-compressed delivery state.
[0230] For some applications, a length of anti-buckling spring 50 is no more than 10% greater (e.g., no more than 5% greater, or no greater) when stent-graft 20 is in the radially-compressed delivery state than when stent-graft 20 is unconstrained in the radially-expanded state. Alternatively or additionally, for some applications, a length of anti-buckling spring 50 is no less (e.g., is greater) when stent-graft 20 is unconstrained in the radially-expanded state than when stent-graft 20 is in the radially-compressed delivery state.
[0231] For some applications, anti-buckling spring 50 comprises exactly one structural strut element, such as shown in the figures. For these applications, an average circumferential location of anti-buckling spring 50 typically coincides with outermost curve 28 (i.e., a greater curve) of self-curving longitudinal portion 22. Alternatively or additionally, for some applications, compression-generation spring 40 comprises exactly one structural strut element, such as shown in the figures. For these applications, an average circumferential location of compression-generation spring 40 typically coincides with innermost curve 26 (i.e., a lesser curve) of self-curving longitudinal portion 22.
[0232] Typically, circumferential strut members 30, compression-generation spring 40, and/or anti-buckling spring 50 comprise a metal, such as a flexible metal, an elastic metal, stainless steel, or a superelastic alloy (such as Nitinol).
[0233] For some applications, a height H.sub.G at outermost curve 28 of each of circumferential strut members 30 of self-curving longitudinal portion 22 of stent-graft 20, is greater than (e.g., at least 120% of) a height H.sub.G at innermost curve 26, both H.sub.G and H.sub.L measured along stent-graft 20, when stent-graft 20 is unconstrained in the radially-expanded state.
[0234] Reference is again made to
[0235] Reference is now made to
[0238] Such inward bending of at least a portion of proximal peaks 66 on the outer side of self-curving longitudinal portion 22 avoid possible puncturing of the graft member, and/or the wall of the blood vessel by the proximal peaks.
[0239] For some applications, first set 68A includes no more than 40% of proximal peaks 66 of the circumferential strut member 30 (e.g., three of the eight proximal peaks 66 of each of circumferential strut member 30, as shown in
[0240] For some application, one or more of the distal peaks of one or more of circumferential strut members 30 of self-curving longitudinal portion 22 are also be bent radially inward.
[0241] Reference is now made to
[0242] For some applications, such as shown in
[0243] For some applications in which stent-graft 20 comprises a plurality of anti-buckling springs 50, such as shown in
[0244] For some applications in which stent-graft 20 comprises a plurality of anti-buckling springs 50, such as shown in
[0245] For some applications, average circumferential location 70 of anti-buckling springs 50 coincides with outermost curve 28 of self-curving longitudinal portion 22.
[0246] For some applications in which stent-graft 20 comprises a plurality of compression-generation springs 40, such as shown in
[0247] For some applications in which stent-graft 20 comprises a plurality of compression-generation springs 40, such as shown in
[0248] For some applications, average circumferential location 72 of compression-generation springs 40 coincides with innermost curve 26 of self-curving longitudinal portion 22.
[0249] For some applications in which stent-graft 20 comprises a plurality of anti-buckling springs 50 and a plurality of compression-generation springs 40, such as shown in
[0250] Reference is again made to
[0253] As used in the present application, including in the claims, “substantially longitudinally-disposed” means, for each of the springs, that: [0254] if stent-graft 20 were to be (a) placed in right circular cylinder 21 while in the radially-expanded state, such that the right circular cylinder constrains self-curving longitudinal portion 22 of stent-graft 20 into a straight configuration, (b) cut along a cut line parallel to a straightened central longitudinal axis of straightened self-curving longitudinal portion 22, and then (c) unrolled into a flat state, while maintaining the respective constrained lengths of compression-generation spring(s) 40 and anti-buckling spring(s) 50, [0255] then the cut line would form an angle of no more than 30 degrees with a line between the two endpoints of the spring.
[0256] Typically, when stent-graft 20 is unconstrained in the radially-expanded, the springs are substantially aligned with central longitudinal axis 36 of self-curving longitudinal portion 22 of stent-graft 20, yet the stents are typically curved, at least when the springs are directly or indirectly fixed to graft member 32 at a plurality of locations on the graft member. If placed in right circular cylinder 21, the springs would still be longitudinal, but now, also linear (i.e., non-curved), since self-curving longitudinal portion 22 of stent-graft 20 would now be straightened.
[0257] Reference is now made to
[0258] The deployment is typically performed in a transvascular (typically percutaneous) procedure using one or more guidewires and an elongate delivery tube that is sized to hold stent-graft 20 in the radially-compressed delivery state. For some applications, a ratio of (a) an average circumference of stent-graft 20 when in the radially-expanded state to (b) an inner circumference of the delivery tube is at least 5, such as at least 7. Typically, stent-graft 20 is in its most longitudinally elongated configuration when in the delivery tube.
[0259] Typically, after stent-graft 20 is positioned at the desired anatomical site, with at least self-curving longitudinal portion 22 in a curved portion of the blood vessel, the delivery tube is withdrawn proximally, exposing stent-graft 20 and allowing the stent-graft to self-expand into the radially-expanded state. Stent-graft 20 is rotated, typically before deployment from the delivery tube, such that: [0260] compression-generation spring 40 (or average circumferential location 72, if stent-graft 20 comprises a plurality of compression-generation springs 40, as described hereinabove with reference to
[0262] The deployment may be performed using deployment techniques known in the art and/or described in any of the patent applications publications and patents incorporated hereinbelow by reference.
[0263] The average radius of curvature of innermost curve 26 of self-curving longitudinal portion 22 when stent-graft 20 is unconstrained in the radially-expanded state is typically less than the radius of curvature of lesser curve 122 of the curved blood vessel at the implantation site, thereby creating a tight seal between graft member 32 at both proximal and distal ends 23 and 25 of self-curving longitudinal portion 22 and lesser curve 122 of ascending aorta 12, thereby preventing bird-beaking. In addition, the average radius of curvature of curve outermost curve 28 of self-curving longitudinal portion 22 when stent-graft 20 is unconstrained in the radially-expanded state is typically greater than the radius of curvature of greater curve 124 of the curved blood vessel at the implantation site, thereby creating a tight seal between graft member 32 at both proximal and distal ends 23 and 25 of self-curving longitudinal portion 22 and greater curve 124 of ascending aorta 12, thereby preventing bird-beaking on the outer (longer) side of the self-curving longitudinal portion of the stent-graft.
[0264] In addition, the diameter of self-curving longitudinal portion 22 of stent-graft 20 is typically 15-25% greater than the diameter of the site of the curved blood vessel in which the portion is implanted.
[0265] Typically, in order to provide good sealing, the curvature and/or diameter of the blood vessel is assessed, and the stent-graft is chosen from a plurality of self-curving stent-grafts having different respective first and/or second tilt angles, different respective diameters, different respective innermost radii of curvature, and/or different respective outermost radii of curvature, or a desired combination of these parameters.
[0266] For some applications, such as shown in
[0267] The scope of the present invention includes embodiments described in the following patents and patent applications, which are assigned to the assignee of the present application and are incorporated herein by reference. In an embodiment, techniques and apparatus described in one or more of the following patent applications are combined with techniques and apparatus described herein. In particular, the stent-grafts described herein may be used as components of the stent-graft systems described in the following patent and patent applications, and deployed as described as described in the following patent and patent applications, mutatis mutandis. 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[0319] It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.