Stent with angled struts and crown
By designing angled support bars and crown structures, combined with the waveform winding and laser cutting technology of continuous wire supports, the problem of improving and deforming the support in the balance between radial strength and flexibility was solved, and the stable expansion and flexible delivery of the support were achieved.
Patent Information
- Application Number
- CN202180049532.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2021-07-21
- Filing Date
- 2021-07-23
- Publication Date
- 2026-02-10
- Estimated Expiration
- 2041-07-23
AI Technical Summary
Existing support designs pose risks of support lifting and deformation when balancing characteristics such as radial strength, flexibility, and excessive expansion, and the use of thinner profile support bars reduces holding force.
By employing multiple first and second outer crowns, and through the design of angled support bars and connectors, combined with the waveform winding and laser cutting technology of continuous wire support, a support structure with a specific crown angle is formed, which enhances the stability and flexibility of the support.
This effectively reduces the risk of stent lifting and deformation, while maintaining good radial strength and flexibility, ensuring that the stent does not over-expand during the expansion process.
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Figure CN115811963B_ABST
Abstract
Description
Technical Field
[0001] This invention relates generally to intracavitary prostheses or stents. More specifically, this invention relates to stents with angled struts. Background of the Invention
[0003] A stent is an intraluminal prosthesis. Stents are typically tubular, open-ended structures that provide support for damaged, collapsed, or occluded blood vessels. When deployed at the treatment site of the affected vessel, a stent can radially expand from a radially compressed configuration intended for delivery to the affected vessel site to a radially expanded configuration, wherein the diameter of the radially expanded configuration is larger than that of the radially compressed configuration. Stents are typically inserted in a radially compressed configuration and expanded to a radially expanded configuration via a self-expanding mechanism or by using a balloon catheter or other mechanical expansion method. Summary of the Invention
[0004] Stent design must balance several characteristics. Examples, rather than limitations, include stent deformation, radial strength, overexpansion, cross profile, flexibility, strut / coronary lift, retention, metal-to-artery ratio, drug load, and retention properties, among many others that drive optimization and design decisions. For instance, for a given design, using a thinner profile strut while keeping other variables the same results in reduced radial strength, increased risk of strut / coronary lift, and increased stent retention force. If a thinner profile strut is matched with a reduction in strut length to maintain similar radial strength, the ability of the strut and coronary to open (known as overexpansion) is compromised. Thinner struts are generally desirable for improved flexibility and delivery capability, and are generally considered to improve wound healing. Stut / coronary lift (or stent lift) refers to lifting one or more coronary sections or struts out of plane, making them appear lifted away from the delivery system. This is considered as outward deformation of the coronary section / strut in the radial direction. Stent deformation is the deformation of the stent along its long axis.
[0005] Therefore, there is a need for improved stent designs that can enhance stent characteristics.
[0006] Embodiments of the present invention relate to a stent comprising a radially compressed configuration and a radially expanded configuration. The stent in the radially compressed configuration includes a plurality of first outer crowns and a plurality of second outer crowns, each of the first and second outer crowns being connected by a strut from a plurality of struts. The plurality of first and second outer crowns are configured with crown angles ranging from about 15 degrees to about 35 degrees. The crown angle is defined by a line extending through the midpoint of one of the first or second outer crowns and passing through the radial center of the crown, relative to a line parallel to the central longitudinal axis of the stent.
[0007] Embodiments of the present invention also relate to a stent according to any one of the embodiments herein, wherein the crown angle is in the range of about 25 degrees to about 30 degrees.
[0008] Embodiments of the present invention also relate to a support according to any one of the embodiments herein, wherein the support is a continuous wire support comprising a wire bent into a waveform, the waveform being wound into a plurality of strips, the waveform including a plurality of first outer crowns, a plurality of second outer crowns, and a plurality of support strips.
[0009] Embodiments of the present invention also relate to a support according to any one of the embodiments herein, the support further comprising a connector between adjacent straps of the plurality of straps.
[0010] Embodiments of the present invention also relate to a stent according to any one of the embodiments herein, wherein each connector is located between a first crown portion of one of the plurality of first crown portions of the plurality of straps and a second crown portion of one of the plurality of second crown portions of an adjacent strap.
[0011] Embodiments of the present invention also relate to a bracket according to any one of the embodiments herein, wherein the connector is a fusion connector, a welded connector or a brazed connector.
[0012] Embodiments of the present invention also relate to a bracket according to any one of the embodiments herein, wherein the bracket is a laser-cut bracket.
[0013] Embodiments of the present invention also relate to a stent according to any one of the embodiments herein, wherein the stent includes a plurality of bands, the plurality of bands including a plurality of first outer crown portions, a plurality of second outer crown portions, and a plurality of support bars.
[0014] Embodiments of the present invention also relate to a support according to any one of the embodiments herein, the support further comprising a connector between adjacent straps of the plurality of straps.
[0015] Embodiments of the present invention also relate to a stent according to any one of the embodiments herein, wherein each connector is located between a first crown portion of one of the plurality of first crown portions of the plurality of straps and a second crown portion of one of the plurality of second crown portions of an adjacent strap.
[0016] Embodiments of the present invention also relate to a support according to any one of the embodiments herein, wherein the connector is elongated.
[0017] Embodiments of the invention also relate to a stent comprising a radially compressed configuration and a radially expanded configuration. The stent in the radially compressed configuration includes a plurality of first outer crown portions and a plurality of second outer crown portions, each of the first and second outer crown portions being connected by a strut from a plurality of struts. The plurality of first outer crown portions includes angled first outer crown portions and parallel first outer crown portions, and the plurality of second outer crown portions includes angled second outer crown portions and parallel second outer crown portions. The angled first and second outer crown portions are configured with crown angles ranging from about 15 degrees to about 35 degrees. The crown angle is defined by a line extending through the midpoint of the crown portion of the angled first or second outer crown portion and passing through the radial center of the crown portion relative to a line parallel to the central longitudinal axis of the stent. The parallel first and second outer crown portions are configured parallel to the central longitudinal axis of the stent.
[0018] Embodiments of the present invention also relate to a stent according to any one of the embodiments herein, wherein the crown angle is in the range of about 25 degrees to about 30 degrees.
[0019] Embodiments of the present invention also relate to a stent according to any one of the embodiments herein, the stent further comprising a plurality of central crown portions, each central crown portion being disposed between a parallel first outer crown portion in the parallel first outer crown portion and an angled second outer crown portion in the angled second outer crown portion, or disposed between a parallel second outer crown portion in the parallel second outer crown portion and an angled first outer crown portion in the angled first outer crown portion.
[0020] Embodiments of the present invention also relate to a stent according to any one of the embodiments herein, wherein the stent includes a plurality of bands, the plurality of bands including a plurality of first outer crown portions, a plurality of second outer crown portions, and a plurality of support bars.
[0021] Embodiments of the present invention also relate to a support according to any one of the embodiments herein, the support further comprising a connector between adjacent straps of the plurality of straps.
[0022] Embodiments of the present invention also relate to a stent according to any one of the embodiments herein, wherein each connector is located between a first outer crown portion of one of the parallel first outer crown portions of the plurality of straps and a second outer crown portion of one of the parallel second outer crown portions of an adjacent strap in the plurality of straps.
[0023] Embodiments of the present invention also relate to a bracket according to any one of the embodiments herein, wherein the bracket is a continuous conductor bracket and the plurality of connectors are fusion connectors, welded connectors or brazed connectors.
[0024] Embodiments of the present invention also relate to a bracket according to any one of the embodiments herein, wherein the bracket is a laser-cut bracket and the plurality of connectors are elongated. Attached Figure Description
[0025] The foregoing and other features and advantages of the invention will become apparent from the following description of the invention as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of this specification, further serve to illustrate the principles of the invention and enable those skilled in the art to make and use the invention. The drawings are not drawn to scale.
[0026] Figure 1 This is a perspective view of a continuous wire support in a radially compressed configuration according to an embodiment of the present invention.
[0027] Figure 2 yes Figure 1 A cross-sectional view of a continuous wire support.
[0028] Figure 3 It shows Figure 1 A planar layout of part of a continuous wire support.
[0029] Figure 4 It shows Figure 1 Part of a continuous wire support.
[0030] Figure 5 This is a perspective view of a continuous wire support in a radially compressed configuration according to an embodiment of the present invention.
[0031] Figure 6 yes Figure 5 A cross-sectional view of a continuous wire support.
[0032] Figure 7 It shows Figure 5 A planar layout of part of a continuous wire support.
[0033] Figure 8 It shows Figure 5 Part of a continuous wire support.
[0034] Figure 9 This is a perspective view of a support in a radially compressed configuration according to an embodiment of the present invention.
[0035] Figure 10 yes Figure 9 A cross-sectional view of the support frame.
[0036] Figure 11 It shows Figure 9 The planar layout of part of the support structure.
[0037] Figure 12 It shows Figure 9 Part of the support structure. Detailed Implementation
[0038] Specific embodiments of the invention will now be described with reference to the accompanying drawings, wherein the same reference numerals indicate the same or functionally similar elements.
[0039] The following detailed description is exemplary in nature only and is not intended to limit the invention or its application and uses. Although the description of the invention is made in the context of vascular therapy, the invention can also be used in any other bodily channel in which it is considered useful. Furthermore, one is not intended to be bound by any express or implied theory presented in the foregoing technical field, background art, summary of the invention, or the following detailed description.
[0040] As used herein, the term "continuous wire support" refers to a support formed from wire that is bent into a wave shape and spirally wound around a central longitudinal axis to form a tube. For example, a support is formed by laser-cutting a tube to remove portions, such that the portions not removed from the support are not "continuous wire supports".
[0041] As used in this article, the term "crown" refers to a turning or bending section in a wire or support element.
[0042] As used in this article, the term “bracket” refers to the generally straight portion of a wire or support element that connects two crowns together.
[0043] Figures 1 to 4 A stent 100 according to one embodiment of the present invention is shown. The stent 100 includes a radial compression configuration (e.g., for delivery to the affected site of a blood vessel) for delivery to the blood vessel. Figure 1 (as shown), and its radially expanded configuration when deployed (not shown). The stent 100 is a generally tubular open structure having a first end 110 and a second end 112, and defining a lumen 102 therethrough. The stent 100 may be self-expanding or balloon-expandable. Figures 1 to 4 In one embodiment, the support 100 is a continuous wire support formed of wire 104, which is formed into a waveform and then spirally wound (e.g., around a mandrel) to form the support 100. Other steps may also be included in processing the wire 104 and / or the support 100. By way of example, and not limitation, the wire 104 may be forged before or after forming the waveform. Forging the wire 104 reduces the overall cross-section or diameter of the wire 104. Other steps may also be used in the formation of the support 100, such as joining adjacent strips in the waveform (explained in more detail below), polishing, and other finishing steps.
[0044] Wire 104 is a continuous element or strand of wire bent into a wave shape (such as...). Figure 3As shown), and is wound into a helix with multiple windings, turns or strips 108, which form the hollow cylindrical shape of the entire support 100. As used herein, a “winding,” “turn,” or “strip” is a complete (360-degree) winding of wire 104 around the central longitudinal axis of the support. Figure 1 Ten straps 108 of the support 100 are shown, but the support 100 may include more or fewer straps 108. The straps 108 are generally angled relative to the central longitudinal axis CLA of the support 100, such that the straps or windings 108 are not perpendicular to the central longitudinal axis CLA.
[0045] Figure 3 The waveform shown is for the central portion of the bracket 100, and can also be used for the end portions of the bracket. Figure 3 As best shown, the waveform typically includes a repeating series of a first outer bend or crown 120 and a second outer bend or crown 122. The inner bend or inner arc surface of the first outer crown 120 faces the inner bend or inner arc surface of the second outer crown 122, such that the first outer crown 120 deflects the wave towards the second outer crown 122 and the second outer crown 122 deflects the wave towards the first outer crown 120. In other words, the inner bend or inner arc surface of the first outer crown 120 faces the second end 112 of the support 100, and the inner bend or inner arc surface of the second outer crown 122 faces the first end 110 of the support 100. A first support bar 124a connects the first outer crown 120 to the second outer crown 122. A second support bar 124b connects the second outer crown 122 to the first outer crown 120 in the next wave of the waveform. The first support bar 124a and the second support bar 124b may also be collectively referred to as support bar 124. Therefore, the complete wave of a specific sequence of waveforms, starting from one of the first outer crowns 120, is the first outer crown 120, the first support 124a, the second outer crown 122 (which causes the wave to deflect in a generally opposite direction), and the second support 124b (which connects to another first crown 120 in the next wave of the waveform). This pattern repeats itself at least through the central portion of the support 100.
[0046] exist Figures 1 to 4In one embodiment, the waveform of the support 100 is configured such that when the waveform is wound to form the support 100, the support bar 124 is positioned at an angle α relative to the longitudinal line LA parallel to the central longitudinal axis CLA of the support 100. Therefore, the line 130 extending parallel to the support bar 124 is positioned at an angle α relative to the line LA. Similarly, the line 132 extending through the center of the outer arc surface, the center of the inner arc surface, and the radial center of one of the crowns 120, 122 is positioned at an angle β relative to the line LA parallel to the central longitudinal axis CLA of the support 100. For each crown in the crowns 120, 122, there is a corresponding line 132 such that each crown in the crowns 120, 122 is positioned at an angle β relative to the line parallel to the central longitudinal axis CLA of the support 100. Figure 2 and Figure 3 As will be apparent to those skilled in the art, line LA can be the same line or different lines parallel to the central longitudinal axis LA. Angles α and β are approximately the same, but not necessarily identical. In an embodiment, angles α and β differ from each other by approximately 8 degrees. Angles α and β are each in the range of approximately 15 degrees to approximately 35 degrees, and preferably in the range of approximately 25 degrees to approximately 30 degrees.
[0047] As described in the foregoing summary of the invention, the trade-offs in using thinner profile support bars (wires) in a stent include increased risk of stent lifting and deformation, and reduced stent holding force. However, using the aforementioned angled support bars 124 and crowns 120, 122 can reduce stent lifting and deformation. Figure 3 As can be seen, the length L1 along the strut 124 from one of the first outer crown portions 120 to an adjacent second outer crown portion 122 is greater than the longitudinal length L2 from the first outer crown portion 120 to the second inner crown portion 122. The longitudinal length L2 is defined as parallel to the central longitudinal axis CLA of the stent 100. This shortened longitudinal length L2 increases resistance to forces that could lead to stent lifting, stent deformation, and / or poor stent retention, while maintaining the overall sinusoidal length of each band 108 so that excessive stent expansion is not damaged.
[0048] See Figure 2 and Figure 4The support 100 also includes a plurality of connectors 114 configured to connect selected outer crowns 120, 122 of the band 108 to selected outer crowns 122, 120 of adjacent bands 108. By way of example and not limitation, the connectors 114 can be formed by fusing, welding, or brazing the selected outer crowns together. As used herein, "welding" and "brazing" are defined as heating additional material separated from the selected outer crown and applying the heated additional material to the selected outer crown, such that the selected outer crowns are welded or brazed together when the additional material cools. Furthermore, repeating body units are defined between adjacent connectors 114 along the helical path of the band 108. The use of repeating body units in at least a portion of the continuous wire support 100 allows the support 100 to be easily modified in length. Specifically, the wavy wire 104 may include sufficient repeating body units for multiple continuous wire supports. Depending on the desired length of the bracket 100, the wire 104 can be cut into pieces with more or fewer repeating body units. Therefore, instead of forming a waveform of a specific length for each bracket length, the wire 104 can be bent into a waveform and then cut into different bracket lengths.
[0049] In an embodiment not shown, the first end 110 and / or the second end 112 of the support 100 may be configured to be substantially orthogonal to the central longitudinal axis CLA, for example. Detailed information regarding how the first end 110 and / or the second end 112 of the support 100 are substantially orthogonal to the central longitudinal axis CLA can be found in U.S. Patent No. 9,060,889, assigned to Medtronic Vascular, Inc., which is incorporated herein by reference in its entirety.
[0050] Figures 5 to 8 A stent 200 according to another embodiment of the invention is shown. The stent 200 includes a radial compression configuration (e.g., for delivery to the affected site of a blood vessel) for delivery to the blood vessel. Figure 5 (as shown), and its radially expanded configuration when deployed (not shown). The stent 200 is a generally tubular open structure having a first end 210 and a second end 212, and defining a lumen 202 therethrough. The stent 200 may be self-expanding or balloon-expandable. Figures 5 to 8In one embodiment, the support 200 is a continuous wire support formed from wire 204, which is formed into a waveform and then spirally wound (e.g., around a mandrel) to form the support 200. Other steps may also be included in processing the wire 204 and / or the support 200. By way of example, and not limitation, the wire 204 may be forged before or after forming the waveform. Forging the wire 204 reduces the overall cross-section or diameter of the wire 204. Other steps may also be used in the formation of the support 200, such as joining adjacent strips in the waveform (explained in more detail below), polishing, and other finishing steps.
[0051] Wire 204 is a continuous element or strand of wire bent into a wave shape (such as...). Figure 7 (as shown), and is wound into a spiral with multiple windings, turns or strips 208, which form the hollow cylindrical shape of the entire support 200. Figure 5 Eleven strips 208 of the support 200 are shown, but the support 200 may include more or fewer strips 208. The strips 208 are generally angled relative to the central longitudinal axis CLA of the support 200, such that the strips or windings 208 are not perpendicular to the central longitudinal axis CLA.
[0052] Figure 7 The waveform shown is for the central portion of the bracket 200, and can also be used for the end portions of the bracket. Figure 9Ideally, the waveform typically includes a repeating series of the following: a parallel first outer curve or crown 220, an angled second outer curve or crown 222, an angled third outer curve or crown 224, an angled fourth outer curve or crown 226, an angled fifth outer curve or crown 228, a parallel sixth outer curve or crown 230, an angled seventh outer curve or crown 232, and an angled eighth outer curve or crown 234. The waveform then repeats starting from another parallel first outer curve or crown 220. The inner curves or inner arc surfaces of the first outer crown portion 220, the third outer crown portion 224, the fifth outer crown portion 228, and the seventh outer crown portion 232 generally face the inner curves or inner arc surfaces of the second outer crown portion 222, the fourth outer crown portion 226, the sixth outer crown portion 230, and the eighth outer crown portion 234, such that the first outer crown portion 220, the third outer crown portion 224, the fifth outer crown portion 228, and the seventh outer crown portion 232 respectively deflect the waves to the second outer crown portion 222, the fourth outer crown portion 226, the sixth outer crown portion 230, and the eighth outer crown portion 234, and vice versa. In other words, the inner curves or inner arc surfaces of the first outer crown portion 220, the third outer crown portion 224, the fifth outer crown portion 228, and the seventh outer crown portion 232 face the second end 212 of the support 200, and the inner curves or inner arc surfaces of the second outer crown portion 222, the fourth outer crown portion 226, the sixth outer crown portion 230, and the eighth outer crown portion 234 face the first end 210 of the support 200. The “parallel outer crown portions” 220 and 230 are defined by corresponding lines 270 extending through the middle of the outer arc surface and the middle of the inner arc surface, and the radial centers of the corresponding crown portions 220 and 230 are parallel to the central longitudinal axis CLA of the support 200, as shown below. Figure 7 As shown below, the parallel outer crown portions 220 and 230 are formed by the middle crown portion between adjacent outer crown portions. The "angled outer crown portions" 222, 224, 226, 228, 232, and 234 are defined by a corresponding line 272 extending through the middle of the outer arc surface and the middle of the inner arc surface. The radial centers of the corresponding crown portions 222, 224, 226, 228, 232, and 234 are set at an angle β relative to a line LA parallel to the central longitudinal axis CLA of the support 200. Figure 7 As shown.
[0053] Continuing the description of the waveform, a first central crown portion 236 is disposed between a parallel first outer crown portion 220 and an angled second outer crown portion 222. A parallel first support bar 238 connects the parallel first outer crown portion 220 to the first central crown portion 236, and an angled second support bar 240 connects the first central crown portion 236 to the angled second outer crown portion 222. The parallel first support bar 238 is generally parallel to the central longitudinal axis CLA of the support 200, and the angled second support bar 240 is angled relative to a line LA parallel to the central longitudinal axis CLA of the support 200. Therefore, the first central crown portion 236 serves as a transition from the parallel first support bar 238 to the angled second support bar 240. Continuing the waveform, the angled third support 242 connects the angled second outer crown portion 222 to the angled third outer crown portion 224, and the angled fourth support 244 connects the angled third outer crown portion 224 to the angled fourth outer crown portion 226, and the angled fifth support 246 connects the angled fourth outer crown portion 226 to the angled fifth outer crown portion 228. A second middle crown portion 248 is disposed between the angled fifth outer crown portion 228 and the parallel sixth outer crown portion 230. An angled sixth support 250 connects the angled fifth outer crown portion 228 to the second middle crown portion 248, and a parallel seventh support 252 connects the second middle crown portion 248 to the parallel sixth outer crown portion 230. The second middle crown portion 248 serves as a transition from the angled sixth support 250 to the parallel seventh support 252, allowing the sixth outer crown portion 230 to be a parallel outer crown portion. Continuing the waveform, the third crown portion 248 is disposed between the parallel sixth outer crown portion 230 and the angled seventh outer crown portion 232. A parallel eighth support bar 254 connects the parallel sixth outer crown portion 230 to the third crown portion 256, and an angled ninth support bar 258 connects the third crown portion 256 to the angled seventh outer crown portion 232. The third crown portion 256 serves as a transition from the parallel eighth support bar 254 to the angled ninth support bar 258, allowing the seventh outer crown portion 232 to be an angled outer crown portion.
[0054] Continuing the waveform, the angled tenth support bar 260 connects the angled seventh outer crown portion 232 to the angled eighth outer crown portion 234. A fourth middle crown portion 264 is disposed between the angled eighth outer crown portion 234 and the parallel first outer crown portion 220 of the next wave of the starting waveform. The angled eleventh support bar 262 connects the angled eighth outer crown portion 234 to the fourth middle crown portion 264, and the parallel twelfth support bar 266 connects the fourth middle crown portion 264 to the parallel first outer crown portion 220 of the next wave of the waveform. The fourth middle crown portion 264 serves as a transition from the angled eleventh support bar 262 to the parallel twelfth support bar 266, such that the first outer crown portion 220 in the next wave of the waveform can be a parallel outer crown portion.
[0055] As described above, the angled outer crown portion is disposed at an angle β relative to a line LA parallel to the central longitudinal axis of the support 200, and the parallel crown portion is disposed parallel to the central longitudinal axis CLA of the support 200. The angle β is in the range of about 15 degrees to about 35 degrees, and preferably in the range of about 25 degrees to about 30 degrees.
[0056] Similarly, the aforementioned angled support bars are angled relative to a line LA parallel to the central longitudinal axis CLA of the support 200. The angle of the angled support bars can vary depending on the type of support bar. By way of example and not limitation, an angled support bar (such as an angled third support bar 242) disposed between two angled outer crown portions can be angled α relative to a line LA parallel to the central longitudinal axis CLA of the support 200. Similarly, angled support bars (each having a central crown portion disposed therebetween, such as an eleventh angled support bar 262 and a second angled support bar 240) disposed between a parallel outer crown portion facing the second end 212 of the support 200 and an angled outer crown portion facing the first end 210 of the support 200 can be angled γ and δ respectively relative to a line LA parallel to the central longitudinal axis CLA of the support 200. Similarly, an angled support (such as an angled ninth support 258) disposed between a parallel outer crown portion facing the first end 210 of the support 200 and an angled crown portion facing the second end 212 of the support 200 may be disposed at an angle ε relative to a line LA parallel to the central longitudinal axis CLA of the support 200. Angles α, γ, δ, and ε need not be the same, but each angle may be in the range of about 15 degrees to about 35 degrees, and preferably in the range of about 25 degrees to about 30 degrees.
[0057] See Figure 5 , Figure 6 and Figure 8 The support 200 also includes a plurality of connectors 214 configured to connect the parallel outer crown portions 220, 230 of the band 208 to adjacent parallel outer crown portions 230, 220 of the band 208. By way of example, and not limitation, the connectors 214 can be formed by fusing, welding, or brazing selected outer crown portions together. As used herein, “welding” and “brazing” are defined as heating an additional material separate from the selected outer crown portion and applying the heated additional material to the selected outer crown portion such that, when the additional material cools, the selected outer crown portions are welded or brazed together. In the parallel outer crown portions 214 (e.g. Figure 8 (as shown) rather than the angled outer crown (such as) Figure 4 The connector 214 between the two (shown) provides better alignment of the outer crown portion of the positive connection, thus providing a better connector 214 compared to connector 114.
[0058] Furthermore, repeating body units are defined between adjacent connectors 214 along the spiral path of band 208. The use of repeating body units on at least a portion of the continuous wire support 200 allows the support 200 to be easily varied in length. Specifically, the wire 204, formed as a waveform, may include sufficient repeating body units for multiple continuous wire supports. Depending on the desired length of the support 200, the wire 204 can be cut into pieces with more or fewer repeating body units. Therefore, instead of forming a waveform of a specific length for each support length, the wire 204 can be bent into a waveform and then cut into different support lengths.
[0059] Use a combination of angled and parallel outer crowns (such as...) Figures 5 to 8 (As shown) enables the implementation of the above-mentioned... Figures 1 to 4 The advantages mentioned above include reduced risk of support lifting and deformation, and the ability to form a connector 214 between the parallel outer crown portions 220 and 230 for better alignment. (See above regarding...) Figures 1 to 4 As discussed, the length along the strut from the outer crown portion facing the second end 212 of the support 200 to the adjacent outer crown portion facing the first end 210 of the support 200 is greater than the longitudinal length from the outer crown portion facing the second end 212 of the support 200 to the outer crown portion facing the first end 210 of the support 200, which is defined as parallel to the central longitudinal axis CLA of the support 200. As described above, this shortened longitudinal length increases resistance to forces that may cause support lifting, support deformation, and / or poor support retention, while maintaining the overall sinusoidal length of each band 208 so that excessive expansion of the support does not cause damage.
[0060] In an embodiment not shown, the first end 210 and / or the second end 212 of the stent 200 may be configured to be substantially orthogonal to the central longitudinal axis CLA. Detailed information regarding how the first end 210 and / or the second end 212 of the stent 200 are substantially orthogonal to the central longitudinal axis CLA can be found in U.S. Patent No. 9,060,889, assigned to Medtronic Vascular, Inc., which is incorporated herein by reference in its entirety.
[0061] The wires 104 and 204 in any of the above embodiments can be any material suitable for use as a support. By way of example, and not limitation, wires 104 and 204 can be stainless steel, iridium, platinum, gold, tungsten, tantalum, palladium, silver, niobium, zirconium, aluminum, copper, indium, ruthenium, molybdenum, niobium, tin, cobalt, nickel, zinc, iron, gallium, manganese, chromium, titanium, aluminum, vanadium, and carbon, as well as combinations, alloys, and / or stacks thereof. For example, wires 104 and 204 can be formed from cobalt alloys, such as L605 or... Nickel-Titanium (nickel-titanium shape memory alloy), ABI (palladium-silver alloy), (Cobalt-chromium-nickel alloy), molybdenum-rhenium alloy, and other materials suitable for the support structure. It is also conceivable that the wires could be formed from two or more materials laminated together, such as... Tantalum laminated together. Wires 104 and 204 may also be concentric layers of different materials. By way of example and not limitation, wires 104 and 204 may be drawn filled tubes with a cobalt-chromium alloy outer layer, wherein a platinum-iridium core is disposed within the cobalt-chromium alloy to enhance radiopaqueness and visibility under a fluorescence microscope. The foregoing materials and laminates are intended as examples and not as limitations in any way. Furthermore, the cross-sectional shape of wires 104 and 204 may be circular, oblong, D-shaped, elliptical, or any other suitable shape.
[0062] Figures 9 to 12 A stent 300 according to one embodiment of the present invention is shown. The stent 300 includes a radial compression configuration (e.g., for delivery to the affected site of a blood vessel) for delivery to the blood vessel. Figure 9 (as shown), and its radially expanded configuration when deployed (not shown). The stent 300 is a generally tubular open structure having a first end 310 and a second end 312, and defining a lumen 302 therethrough. The stent 300 may be self-expanding or balloon-expandable. Figures 9 to 12 In the implementation scheme, the support 300 is a laser-cut support. As used herein, the term "laser-cut support" can refer to a support in which a support pattern is cut into a tubular solid material part for use with the material of support 300. Material is removed such that the remaining material forms the support pattern, as... Figure 9 As shown. "Laser-cut bracket" also includes cutting a bracket pattern into flat material pieces for bracket 300, and then rolling up the flat material pieces such that the longitudinal edges of the material are attached together, thereby forming bracket 300. Furthermore, the term "laser-cut bracket" is not limited to laser cutting and removal of unwanted material, but may utilize other methods of material removal, such as, but not limited to, etching.
[0063] Figures 9 to 12 The bracket 300 is similar to Figures 1 to 4 The stent 100. However, the stent 300 does not have the same... Figures 1 to 4 The wire shown is bent into a wave shape, but instead includes struts and crowns formed by removing material from tubular or flat material pieces, as described above. However, Figures 9 to 12 The patterns on the struts and crown are similar to those mentioned above. Figures 1 to 4 The waveform described. Therefore, as Figure 9 , Figure 10 and Figure 12 As shown, the bracket pattern includes multiple 308s. Figure 9Nine bands 308 of the support 300 are shown, but the support 300 may include more or fewer bands 308. The bands 308 are generally angled relative to the central longitudinal axis CLA of the support 300, such that the bands 308 are not perpendicular to the central longitudinal axis CLA.
[0064] Figure 11 A portion of the bracket 300 is shown cut open and laid flat so that the bracket pattern can be seen. Figure 11 The bracket pattern shown is used for the central portion of the bracket 300, and can also be used for the end portions of the bracket 300. For example... Figure 11 As best shown, the stent pattern typically includes a repeating series of a first outer bend or crown 320 and a second outer bend or crown 322. The inner bend or inner arc surface of the first outer crown 320 faces the inner bend or inner arc surface of the second outer crown 322, such that the first outer crown 320 oriented the stent pattern toward the second outer crown 322, and the second outer crown 322 oriented the stent pattern toward the first outer crown 320. In other words, the inner bend or inner arc surface of the first outer crown 320 faces the second end 312 of the stent 300, and the inner bend or inner arc surface of the second outer crown 322 faces the first end 310 of the stent 300. A first support 324a connects the first outer crown 320 to the second outer crown 322. A second support 324b connects the second outer crown 322 to the first outer crown 320 in the next wave of the stent pattern. The first support 324a and the second support 324b may also be collectively referred to as support 324. Therefore, the complete wave of the stent pattern in a specific sequence, starting from one of the first outer crown portions 320, is the first outer crown portion 320, the first support bar 324a, the second outer crown portion 322 (which causes the stent pattern to turn in a generally opposite direction), and the second support bar 324b (which connects to another first crown portion 320 in the next wave of the stent pattern). This pattern repeats itself at least through the central portion of the stent 300.
[0065] exist Figures 9 to 12 In one embodiment, the support pattern of the support 300 is such that the support bar 324 is positioned at an angle α relative to the longitudinal line LA parallel to the central longitudinal axis CLA of the support 300. Therefore, the line 330 extending parallel to the support bar 324 is positioned at an angle α relative to the line LA. Similarly, the line 332 extending through the center of the outer arc surface, the center of the inner arc surface, and the radius center of one of the crowns 320, 322 is positioned at an angle β relative to the line LA parallel to the central longitudinal axis CLA of the support 300. For each crown in the crowns 320, 322, there is a corresponding line 332, such that each crown in the crowns 320, 322 is positioned at an angle β relative to the line parallel to the central longitudinal axis CLA of the support 300. Figure 10 and Figure 11As will be apparent to those skilled in the art, the line CLA can be the same line or different lines parallel to the central longitudinal axis LA. Angles α and β are approximately the same, but not necessarily identical. In an embodiment, angles α and β differ from each other by approximately 8 degrees. Angles α and β are each in the range of approximately 15 degrees to approximately 35 degrees, and preferably in the range of approximately 25 degrees to approximately 30 degrees.
[0066] As described in the background section above, the trade-offs of using thinner profile struts in stents include increased risk of stent lift and deformation, and reduced stent holding force. However, using the aforementioned angled struts 324 and crowns 320, 122 can reduce stent lift and deformation. Figure 11 As can be seen, the length L1 along the strut 324 from one of the first outer crown portions 320 to an adjacent second outer crown portion 322 is greater than the longitudinal length L2 from the first outer crown portion 320 to the second inner crown portion 322. The longitudinal length L2 is defined as parallel to the central longitudinal axis CLA of the stent 300. This shortened longitudinal length L2 increases resistance to forces that could lead to stent lifting, stent deformation, and / or poor stent retention, while maintaining the overall sinusoidal length of each band 308 so that excessive stent expansion will not cause damage.
[0067] See Figure 10 and Figure 12 The bracket 300 also includes a plurality of connectors 314 configured to connect selected outer crown portions 320, 322 of the band 308 to selected outer crown portions 322, 320 of adjacent bands 308. Figures 9 to 12 In the implementation scheme, the connector 314 can be similar to a strut, as it is an elongated piece of material used to form the support 300. In other words, the material surrounding the connector 314 is removed from the tube or flat material piece, leaving the connector 314, as is done with the struts 324 and crowns 320, 322 of the support 300. Using the connector 314 in a laser-cut support allows for greater design flexibility. For example, with... Figures 1 to 4 Compared to the welded connector 114 in the proposed implementation, connector 314 may be longer and thinner, thereby increasing the flexibility of the support 300. Furthermore, different connectors may be used... Figures 9 to 12 Various patterns of the straight connector 314 shown, such as the curved connector 314. Furthermore, the connector 314 does not need to be adjacent to the crowns 320, 322. Alternatively, in some embodiments, the connector 314 may extend at a larger angle relative to the central longitudinal axis CLA than shown, such that the connector extends further in the circumferential direction than shown.
[0068] The material of the support 300 can be any material suitable for use as a support. By way of example, and not limitation, the material of the support 300 can be stainless steel, iridium, platinum, gold, tungsten, tantalum, palladium, silver, niobium, zirconium, aluminum, copper, indium, ruthenium, molybdenum, niobium, tin, cobalt, nickel, zinc, iron, gallium, manganese, chromium, titanium, aluminum, vanadium, and carbon, as well as combinations, alloys, and / or stacks thereof. For example, wires 104, 204, 304, and 404 can be formed from cobalt alloys, such as L605 or... Nickel-Titanium (nickel-titanium shape memory alloy), ABI (palladium-silver alloy), (Cobalt-chromium-nickel alloy), molybdenum-rhenium alloy, and other materials suitable for the support structure. It is also conceivable that the wires could be formed from two or more materials laminated together, such as... Tantalum laminated together. The material may also include layers of different materials. By way of example and not limitation, multiple concentric tubes may be used to form a stent 300 having a cobalt-chromium alloy outer layer, a platinum-iridium intermediate layer, and a cobalt-chromium alloy inner layer, such that the platinum-iridium intermediate layer provides enhanced radiopaqueness and visibility under a fluorescence microscope. The foregoing materials and stacks are intended as examples and not as limitations in any way. Furthermore, the cross-sectional shape of the struts 324, crowns 320, 322, and connectors 314 of the stent 300 may be circular, oblong, D-shaped, elliptical, or any other suitable shape.
[0069] Furthermore, although not described in detail herein, the pattern of bracket 200 can be formed in the laser-cut bracket as described with respect to bracket 300. In such an embodiment, the connector between adjacent bands will resemble connector 314 instead of connector 214.
[0070] Although various embodiments of the invention have been described above, it should be understood that these embodiments are presented by way of illustration and example only and in a non-limiting manner. It will be apparent to those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention. Therefore, the breadth and scope of the invention should not be limited to any of the exemplary embodiments described above, but should be defined only by the appended claims and their equivalents. It should also be understood that each feature of each embodiment discussed herein and each feature of each referenced herein may be used in combination with features of any other embodiment. All patents and publications discussed herein are incorporated herein by reference in their entirety.
Claims
1. A support (200) comprising a radial compression configuration and a radial expansion configuration, wherein the support (200) in the radial compression configuration comprises: A plurality of first outer crown portions (220, 224, 228, 232) and second outer crown portions (222, 226, 230, 234), each of the first and second outer crown portions being connected by a plurality of struts (238, 240, 242, 244, 246, 250, 252, 254, 258, 260, 262, 266), wherein the plurality of first outer crown portions include angled first outer crown portions (224, 228, 234) and parallel first outer crown portions (220), and the plurality of second outer crown portions include angled second outer crown portions (222, 226, 234) and parallel second outer crown portions (230). Multiple central crown portions (236, 248, 256, 264), each central crown portion being disposed between the parallel first outer crown portion (220) of the parallel first outer crown portion and the angled second outer crown portion (222, 234) of the angled second outer crown portion, or disposed between the parallel second outer crown portion (230) of the parallel second outer crown portion and the angled first outer crown portion (228, 232) of the angled first outer crown portion; The angled first outer crown portion (224, 228, 234) and the angled second outer crown portion (222, 226, 234) are configured with a crown angle (β) ranging from about 15 degrees to about 35 degrees. This crown angle is defined by a line extending through the midpoint of the crown portion in either the angled first outer crown portion (224, 228, 234) or the angled second outer crown portion (222, 226, 234) and passing through the radial center of the crown portion, relative to a line (LA) parallel to the central longitudinal axis (CLA) of the support (200). The parallel first outer crown portion (220) and the parallel second outer crown portion (230) are arranged parallel to the central longitudinal axis (CLA) of the support (200); and The bracket includes a waveform comprising a repeating series of the following portions: a parallel first outer crown portion (220); a first angled second outer crown portion (222); a first middle crown portion (236) disposed between the parallel first outer crown portion and the first angled second outer crown portion; a first parallel support bar (238) connecting the parallel first outer crown portion to the first middle crown portion; a first angled support bar (240) connecting the first middle crown portion (236) to the first angled second outer crown portion (222); a first angled first outer crown portion (224); and a second angled support bar. (242), the second angled support bar connects the first angled second outer crown portion to the first angled first outer crown portion; the second angled second outer crown portion (226); the third angled support bar (244), the third angled support bar connects the first angled first outer crown portion to the second angled second outer crown portion; the second angled first outer crown portion (228); the fourth angled support bar (246), the fourth angled support bar connects the second angled second outer crown portion to the second angled first outer crown portion; the parallel second outer crown portion (230); the second middle crown portion (248), the second middle crown portion is disposed in the second angled first outer crown portion. Between an outer crown portion (228) and the parallel second outer crown portion (230); a fifth angled support (250), the fifth angled support connecting the second angled first outer crown portion to the second middle crown portion; a second parallel support (252), the second parallel support connecting the second middle crown portion to the parallel second outer crown portion; a third parallel support (254), the third parallel support connecting the parallel second outer crown portion to the third middle crown portion (256); a sixth angled support, the sixth angled support connecting the third middle crown portion to the third angled first outer crown portion (232); a seventh angled support (260), the seventh angled... A support bar of a third angle connects the first outer crown portion of the third angle to the second outer crown portion of the third angle (234); an eighth angle support bar (262) connects the second outer crown portion of the third angle to the fourth middle crown portion (264); and a fourth parallel support bar (266) connects the fourth middle crown portion to the parallel first outer crown portion of the next wave of the waveform; wherein the inner arc surfaces of the first angled second outer crown portion (222), the second angled second outer crown portion (226), the parallel second outer crown portion (230), and the third angled second outer crown portion (234) face the first end of the support;Furthermore, the inner arc surfaces of the parallel first outer crown portion (220), the first angled first outer crown portion (224), the second angled first outer crown portion (228), and the third angled first outer crown portion (232) face the second end of the bracket.
2. The stent (200) according to claim 1, wherein the coronal angle (β) is in the range of about 25 degrees to about 30 degrees.
3. The stent (200) according to claim 1, wherein the stent (200) comprises a plurality of bands (208), the plurality of bands comprising the plurality of first outer crown portions (220, 224, 228, 232), the plurality of second outer crown portions (222, 226, 230, 234), and the plurality of support bars (238, 240, 242, 244, 246, 250, 252, 254, 258, 260, 262, 266).
4. The bracket (200) according to claim 3, the bracket further comprising a connector (214) between adjacent strips (208) of the plurality of strips (208).
5. The bracket (200) according to claim 4, wherein each connector (214) is located between a first outer crown portion (220) of the parallel first outer crown portion (208) of the plurality of belts and a second outer crown portion (230) of the parallel second outer crown portion (230) of the adjacent belt (208) of the plurality of belts.
6. The bracket (200) according to claim 5, wherein the bracket is a continuous wire bracket and the connector (214) is a fusion connector, a welded connector or a brazed connector.
7. The bracket (200) according to claim 5, wherein the bracket (200) is a laser-cut bracket and the connector (214) is elongated.
Citation Information
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