Laser cut stent patterns for peripheral diseases

Abstract

Laser cut stents for peripheral diseases may be provided by stent a tubular structure formed by a lattice, the lattice comprises a plurality of structural members arranged into a plurality of triangular waveforms each triangular waveform having a plurality of apexes and a plurality of nadirs, a given triangular waveform of the plurality of waveforms is linked to at least one neighboring triangular waveform of the plurality of waveforms via a linking structural member connecting a respective nadir of the plurality of nadirs for the given triangular waveform to a corresponding apex of the plurality of apexes for the subsequent triangular waveform; and the linking structural members are disposed at an acute angle relative to an axial axis of the tubular structure, and at an acute angle relative to a radial plane of the tubular structure.

Description

Attorney Docket No.: 8001535.00143Client Docket No.: 2023-211-PCTTITLELASER CUT STENT PATTERNS FOR PERIPHERAL DISEASESCROSS-REFERENCES TO RELATED DISCLOSURES

[0001] The present disclosure claims priority to U.S. Provisional Patent Application 63 / 690,082, filed on 2024-09-03, titled “LASER CUT STENT PATTERNS FOR PERIPHERAL DISEASES”, which is incorporated herein in its entirety to the extent permitted by law.BACKGROUND

[0002] Patients with chronic venous obstruction have traditionally been managed with compression and limb elevation.SUMMARY

[0003] The present disclosure provides laser cut stent patterns for peripheral diseases which may be provided in a first embodiment by a stent including; a tubular structure formed by a lattice; wherein the lattice comprises a plurality of structural members arranged into a plurality of triangular waveforms each triangular waveform having a plurality of apexes and a plurality of nadirs; a given triangular waveform of the plurality of waveforms is linked to at least one neighboring triangular waveform of the plurality of waveforms via a linking structural member connecting a respective nadir of the plurality of nadirs for the given triangular waveform to a corresponding apex of the plurality of apexes for the subsequent triangular waveform; and the linking structural members are disposed at an acute angle relative to an axial axis of the tubular structure, and at an acute angle relative to a radial plane of the tubular structure.

[0004] Additional features and advantages of the disclosed method and apparatus are described in, and will be apparent from, the following Detailed Description and the Figures. The features and advantages described herein are not all-inclusive and, in particular, many additional features and advantages will be apparent to one of ordinary skill in the art in view of the figures and description. Moreover, it should be noted that the language used in the specification has been principally selected for readability and instructional purposes, and not to limit the scope of the inventive subject matter.15081 14936 1Attorney Docket No.: 8001535.00143Client Docket No.: 2023-211-PCTBRIEF DESCRIPTION OF THE DRAWINGS

[0005] FIG. 1A illustrates a flat pattern of a triangular stent lattice, according to embodiments of the present disclosure.

[0006] FIG. 1 B illustrates a portion of a triangular stent, according to embodiments of the present disclosure.

[0007] FIG. 2A illustrates a flat pattern of a serpentine stent lattice, according to embodiments of the present disclosure.

[0008] FIG. 2B illustrates a portion of a serpentine stent, according to embodiments of the present disclosure.DETAILED DESCRIPTION

[0009] The present disclosure provides laser-cut stent patterns for peripheral diseases, in which a “triangular” lattice pattern, and a “slot” lattice pattern are disclosed. Both patterns, when implemented in a laser-cut stent, may provide improvements over existing stents, as the present designs may increase the strength of a stent for a given amount of material, or require less material to create a stent of equal strength, resulting in reduced manufacturing costs.

[0010] The laser cut stent is implanted to open narrowed regions of veins (e.g., iliofemoral veins) caused by a collection of fibrous blood clots that can form along the walls of veins following deep-vein thrombosis (e.g., post-thrombotic syndrome) or caused by the squeezing of the vein between a bone and an overlying artery (e.g., May-Thurner syndrome). These conditions may limit blood flow from the leg, which can lead to swelling and pain in the leg when walking. The laser cut stent remains permanently implanted in the vein, and acts as a support for the newly opened section of the blood vessel.

[0011] By using laser cutting, rather than conventional wire-based stent fabrication methodologies, a designer may produce a non-woven pattern with different physical properties than woven-wire stents. Such stents may make use of lattice patterns that have repeating elements or units that act independently of, and are non in direct physical contact with, other repeated elements. These repeated elements, when in a unfurled or flattened configuration, can exhibit repeating non-woven patterns that repeat sequentially along a direction transverse to the longitudinal axis of the stent or parallel to the longitudinal axis of the stent.25081 14936 1Attorney Docket No.: 8001535.00143Client Docket No.: 2023-211-PCT

[0012] Figure 1A illustrates a portion of a stent 100 formed from the “triangular” lattice 102, according to embodiments of the present disclosure. In some examples, the stent 100 is substantially tubular, and has a tube diameter in the range of 1 millimeter (mm) to 50 mm. In some examples the length of the stent 100 is in a range of 10 mm to 400 mm. In some examples the stent 100 is laser cut from a tube of nitinol or other suitable metal or alloy for use in medical stents.

[0013] FIG. 1 B is a flat representation of a triangular stent lattice 102, which may be implemented in forming a stent 100, according to embodiments of the present disclosure. The flat representation of the triangular stent lattice 102 may be regarded as a substantially tubular stent 100 axially bisected and “unfurled.”

[0014] The triangular lattice 102 is formed of a plurality of sequential waveforms 120a-120(n) (generally or collectively, waveforms 120), where waveform 120a is the “first” waveform and waveform 120(n) is the “final” waveform, where n corresponds to the total number of waveforms in the lattice, and each waveform 120 is composed of a plurality of triangle waves 110. In some examples, the waveforms 120 may be regarded as triangular waveforms.

[0015] Each triangle wave is formed with two, non-parallel straight members 106 joined by arcuate members 108, which form the apex 112 and nadir 114 of the respective wave 110. In the illustrated embodiment, each triangle wave 110 is illustrated as being defined from a first nadir 114 to a second nadir 114, however the triangle wave 110 may be defined from a first apex 112 to a second apex 112, as an example.

[0016] The waveforms 120 are joined by connecting members 122. In some embodiments the connecting members 122 may be considered linking structural members. In some examples the connection members 122 may be straight, and in other examples the connecting members 122 may possess a degree of curvature. In some examples the connecting members 122 may be regarded as linking structural members.

[0017] Each nadir 114 of the first waveform 120a is linked to an adjacent apex 112 of the second waveform 120b via a respective connecting member 122, and each nadir 114 of the second waveform 120b is linked to a respective apex 112 of the third waveform 120c by a respective connecting member 122, so on and so forth, until the nadirs 114 of the penultimate waveform 120(n-1) are linked to the apexes 112 of the final waveform 120(n).35081 14936 1Attorney Docket No.: 8001535.00143Client Docket No.: 2023-211-PCT

[0018] In the illustrated embodiment, the connecting members 122 connect a given nadir 114 to an apex 112 to the right of the given nadir 114, however in some embodiments the connecting members 122 may be understood to connect a given nadir 114 to an apex 112 to the left of the given nadir 114. In the flat lattice 102, the connecting members 122 are at an acute angle with the propagation direction of the triangle waveforms 120. Stated differently, when formed into a stent 100, the connecting members 122 are at an acute angle relative to the radial plane of the stent 100.

[0019] Stated generally, any given waveform 120 is linked to at least one neighboring waveform 120 by connecting members 122 which connect each nadir 114 of the given waveform 120 to a respective apex 112 of the neighboring waveform 120. In certain orientations, the connecting members 122 connect the apexes 112 of the given waveform 120 to the nadirs 114 of the neighboring waveform 120.

[0020] In some examples, the lattice 102 pattern may be regarded as interconnected “V” or “A” shapes.

[0021] When the lattice 102 is engaged in the stent 100, the lattice 102 defines the circumferential surface of the stent 100, such that the triangular waveforms 120 propagate annularly about the stent 100. In some embodiments, the connecting members 122 join a given nadir 114 to an apex 112 that is less than 45 degrees offset about the circumference of the stent 100.

[0022] Figure 2A illustrates a portion of a stent 200 formed from the “slot” lattice 202, according to embodiments of the present disclosure. In some examples, the stent 200 is substantially tubular, and has a tube diameter in the range of 1 mm to 50 mm. In some examples, the length of the stent 200 is in a range of 10 mm to 400 mm. In some examples, the stent 100 is laser cut from a tube of nitinol or other suitable metal or alloy for use in medical stents.

[0023] FIG. 2B is a flat representation of a slotted stent lattice 202, which may be implemented in forming a stent 200, according to embodiments of the present disclosure. The flat representation of the slot lattice 202 may be regarded as a substantially tubular stent 200 that has been axially bisected and “unfurled.”

[0024] The slot lattice 202 is formed between two bounding waveforms 220A-B (generally, or collectively, bounding waveforms 220). In some examples, the bounding waveforms may be regarded as end structures, arcuate-rectangular waveforms, sinusoidal waveforms, and serpentine structures. Generally, the bounding waveforms45081 14936 1Attorney Docket No.: 8001535.00143Client Docket No.: 2023-211-PCT220 are formed by parallel straight members 206, joined together by arcuate members 208, which alternately form apexes 212 and nadirs 214. When the lattice 202 is formed into a stent 200, the straight members 206 are parallel to the longitudinal axis of the stent 200. In the illustrated embodiment, a wave unit 210 of the bounding waveform 220 is illustrated as being defined from a first nadir 214 to a second nadir 214, however the wave unit 210 may be defined from a first apex 212 to a second apex 212, as an example.

[0025] Between the bounding waveforms 220, the remainder of the lattice 202 is formed with two structural species, ovoid structures 230, and serpentine connectors 240. In some examples, the ovoid structures 230 may be regarded as stadium structures. The ovoid structures 230 are formed by two parallel straight members 206 joined at the both the top and bottom by respectively opposed arcuate members 208, forming a closed shape (e.g. a stadium or oval). In the lattice 202, the ovoid members are oriented such that the straight members 206 are parallel to the longitudinal axis of the stent 200. The serpentine connectors 240 are formed by two arcuate members 208 joined to form an “S” shape.

[0026] The lattice 202 is formed in a series of columns, consisting of alternating serpentine connectors 240 and ovoid structures 230. Each nadir 214 of the first bounding waveform 220A is joined to a respective serpentine connector 240, which is joined to a respective ovoid structure 230, which is joined to another respective serpentine connector, which may be joined to further ovoid structure 230 and serpentine connector 240 pairs until a respective final serpentine connector 240 joins each final ovoid structure 230 to the a respective apex of the second bounding waveform 220B. The serpentine connectors 240 join the arcuate members forming the apexes 212 and nadirs 214 of the arcuate members 208 which form the “caps” of the ovoid structures 230.

[0027] Stated generally, regarding the lattice 202, each nadir 214 of the first bounding waveform 220A is connected to a respective apex 212 of the second bounding waveform 220B by a chain of alternating ovoid structures 230 and serpentine connectors 240. Each column of ovoid structures 230 and arcuate members 208 is held in place between the bounding waveforms 220 such that the ovoid structures 230 and arcuate member 208 of one column are not in direct contact (at least nominally) with the ovoid structures 230 and arcuate member 208 of any neighboring columns.55081 14936 1Attorney Docket No.: 8001535.00143Client Docket No.: 2023-211-PCT

[0028] In various embodiments, each chain of ovoid structures 230 and serpentine connectors 240 may contain between one and one hundred ovoid structures 230 (and by extension, between two and one hundred and one serpentine connectors 240). The total number of chains of ovoid structures 230 and serpentine connectors 240 corresponds to the total number of wave units 210 in the bounding waveforms 220, which, in some embodiments, may be in the range of four to one hundred wave units 210.

[0029] When the lattice 202 is engaged in the stent 200, the lattice 202 defines the circumferential surface of the stent 200, such that the bounding waveforms 220 propagate annularly about the stent and the chains are disposed along the longitudinal axis of the stent 200.

[0030] Certain terms are used throughout the description and claims to refer to particular features or components. As one skilled in the art will appreciate, different persons may refer to the same feature or component by different names. This document does not intend to distinguish between components or features that differ in name but not function.

[0031] As used herein, “about,” “approximately” and “substantially” are understood to refer to numbers in a range of the referenced number, for example the range of - 10% to +10% of the referenced number, preferably -5% to +5% of the referenced number, more preferably -1 % to +1 % of the referenced number, most preferably -0.1 % to +0.1% of the referenced number.

[0032] Furthermore, all numerical ranges herein should be understood to include all integers, whole numbers, or fractions, within the range. Moreover, these numerical ranges should be construed as providing support for a claim directed to any number or subset of numbers in that range. For example, a disclosure of from 1 to 10 should be construed as supporting a range of from 1 to 8, from 3 to 7, from 1 to 9, from 3.6 to 4.6, from 3.5 to 9.9, and so forth.

[0033] As used in the present disclosure, a phrase referring to “at least one of’ a list of items refers to any set of those items, including sets with a single member, and every potential combination thereof. For example, when referencing “at least one of A, B, or C” or “at least one of A, B, and C”, the phrase is intended to cover the sets of: A, B, C, A-B, B-C, A-C, and A-B-C, where the sets may include one or multiple instances of a given member (e.g., A-A, A-A-A, A-A-B, A-A-B-B-C-C-C, etc.) and any ordering65081 14936 1Attorney Docket No.: 8001535.00143Client Docket No.: 2023-211-PCT thereof. For avoidance of doubt, the phrase “at least one of A, B, and C” shall not be interpreted to mean “at least one of A, at least one of B, and at least one of C”.

[0034] As used in the present disclosure, the term “determining” encompasses a variety of actions that may include calculating, computing, processing, deriving, investigating, looking up (e.g., via a table, database, or other data structure), ascertaining, receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), retrieving, resolving, selecting, choosing, establishing, and the like.

[0035] Without further elaboration, it is believed that one skilled in the art can use the preceding description to use the claimed inventions to their fullest extent. The examples and aspects disclosed herein are to be construed as merely illustrative and not a limitation of the scope of the present disclosure in any way. It will be apparent to those having skill in the art that changes may be made to the details of the abovedescribed examples without departing from the underlying principles discussed. In other words, various modifications and improvements of the examples specifically disclosed in the description above are within the scope of the appended claims. For instance, any suitable combination of features of the various examples described is contemplated.

[0036] Within the claims, reference to an element in the singular is not intended to mean “one and only one” unless specifically stated as such, but rather as “one or more” or “at least one”. Unless specifically stated otherwise, the term “some” refers to one or more. No claim element is to be construed under the provision of 35 U.S.C. § 112(f) unless the element is expressly recited using the phrase “means for” or “step for”. All structural and functional equivalents to the elements of the various embodiments described in the present disclosure that are known or come later to be known to those of ordinary skill in the relevant art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed in the present disclosure is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.75081 14936 1

Claims

Attorney Docket No.: 8001535.00143Client Docket No.: 2023-211-PCTCLAIMSThe invention is claimed as follows:

1. A stent comprising; a tubular structure formed by a lattice; wherein the lattice comprises a plurality of structural members arranged into a plurality of triangular waveforms each triangular waveform having a plurality of apexes and a plurality of nadirs; a given triangular waveform of the plurality of waveforms is linked to at least one neighboring triangular waveform of the plurality of waveforms via a linking structural member connecting a respective nadir of the plurality of nadirs for the given triangular waveform to a corresponding apex of the plurality of apexes for a subsequent triangular waveform; and the linking structural members are disposed at an acute angle relative to an axial axis of the tubular structure, and at an acute angle relative to a radial plane of the tubular structure.

2. The stent of claim 1 , wherein a quantity of triangular waveforms in the plurality of triangular waveforms is in a range of 4 to 20.

3. The stent of claim 1 , wherein a quantity of apexes in the plurality of apexes is in a range of 4 to 20.

4. The stent of claim 1 , wherein a diameter of the stent is in a range of 5 millimeters (mm) to 20 mm.

5. The stent of claim 1 , wherein a length of the stent is in a range of 20 millimeters (mm) to 300 mm.

6. The stent of claim 1 , wherein the stent is laser cut from a tubular material7. The stent of claim 1 , wherein the stent is constructed of nitinol.85081 14936 1Attorney Docket No.: 8001535.00143Client Docket No.: 2023-211-PCT8. The stent of claim 1 , where in an unfurled or flat configuration, the stent has a repeating “V” or “A” pattern.

9. A stent, where in a unfurled or flattened configuration, the stent has a repeating non-woven pattern.

10. The stent of claim 9, wherein the repeating non-woven pattern repeats sequentially along a direction transverse to a longitudinal axis of the stent.

11. The stent of claim 9, wherein the repeating non-woven pattern repeats sequentially along a direction parallel to a longitudinal axis of the stent.

12. A venous stent having a lattice pattern, comprising: a plurality of structural members arranged into a plurality of triangular waveforms each triangular waveform having a plurality of apexes and a plurality of nadirs; wherein a given triangular waveform of the plurality of waveforms is linked to at least one neighboring triangular waveform of the plurality of waveforms via a linking structural member connecting a respective nadir of the plurality of nadirs for the given triangular waveform to a corresponding apex of the plurality of apexes for a subsequent triangular waveform.

13. A stent comprising: a tubular structure formed by a lattice; wherein the lattice defines a first bounding waveform and a second bounding waveform, the first bounding waveform and the second bounding waveform each having a plurality of arcuate apexes and a plurality of arcuate nadirs wherein a given arcuate apex is joined to two respective arcuate nadirs by parallel straight members; the lattice defines a plurality of chain structures, a given chain structure comprising a plurality of ovoid structures and a plurality of serpentine connecting members, wherein a given ovoid structure is formed by two parallel straight members joined by arcuate members forming a closed shape,95081 14936 1Attorney Docket No.: 8001535.00143Client Docket No.: 2023-211-PCT a given serpentine connecting member is formed by two opposed arcuate members, and the plurality of chain structure is formed of several ovoid structures joined together via respective serpentine members connecting an arcuate member of the given ovoid member to an arcuate member of a neighboring ovoid structure such that longitudinal axes of the ovoid structures are aligned; the first bounding waveform is joined to the second bounding waveform via a serpentine connector which joins a given nadir of the first bounding waveform to a chain, which is joined to an apex of the second bounding waveform by another serpentine connector.

14. The stent of claim 13, wherein a quantity of ovoid structures in the given chain structure is in a range of 1 to 20.

15. The stent of claim 13, wherein a quantity of apexes in the plurality of arcuate apexes is in a range of 4 to 20.

16. The stent of claim 13, wherein a diameter of the stent is in a range of 5 millimeters (mm) to 20 mm.

17. The stent of claim 13, wherein a length of the stent is in a range of 20 mm to 300 mm.

18. The stent of claim 13, wherein the stent is laser cut from a tubular material.

19. A stent having a lattice pattern, comprising: a plurality of structural members arranged into a plurality of structures; the plurality of structures includes a first end structure, a second end structure, and a plurality of stadium structures; the first and second end structures are arranged into a serpentine waveform, having a plurality of arcuate apexes and a plurality of arcuate nadirs, wherein each nadir is joined to two apexes, and each apex is joined to two nadirs via parallel connecting members;105081 14936 1Attorney Docket No.: 8001535.00143Client Docket No.: 2023-211-PCT each nadir of the first end structure is joined to a respective chain of stadium structures, linked by serpentine connecting members, and a final serpentine connecting member connecting the first end structure to an apex of the second end structure.

20. A stent, comprising: a tubular structure formed by a lattice, wherein: the lattice comprises a plurality of structuring means each having a regular repeating pattern having a plurality of apexes and a plurality of nadirs; each structuring means is connected to at least one of: the plurality of apexes of the regular repeating pattern of a first neighboring structuring means of the plurality of structuring means; and the plurality of nadirs of the regular repeating pattern of a first neighboring structuring means of the plurality of structuring means.

21. The stent of claim 20, wherein the regular repeating pattern is a triangular waveform; and the triangular waveform propagates circumferentially to a longitudinal axis of the tubular structure, and a given structuring means is offset by less than 45 degrees of rotation about a circumference of the tubular structure from a neighboring structuring means.

22. The stent of claim 20, wherein the regular repeating pattern is bounded by two serpentine structures having arcuate apexes joined to arcuate nadirs via parallel straight members and the regular repeating pattern propagates parallel to longitudinal axis, the regular repeating pattern including ovoid structures joined to neighboring ovoid structures and the serpentine structures by sinusoidal connecting members.

23. A stent, comprising: a tubular structure formed by a lattice, wherein: the lattice comprises a plurality of longitudinal structures, each longitudinal structure disposed parallel to a longitudinal axis of the tubular structure, bounded by a first annular structure and a second annular structure, which propagate about a circumference of the tubular structure, perpendicular to the longitudinal axis;115081 14936 1Attorney Docket No.: 8001535.00143Client Docket No.: 2023-211-PCT each longitudinal structure comprises a series of ovoid members joined by serpentine connecting members; the first annular structure and the second annular structure each define a waveform, having a plurality of apexes and nadirs; and each longitudinal structure is connected on a first end to a respective nadir of the first annular structure and connected on a second end to a respective apex of the second annular structure.

24. A stent, comprising: a tubular structure formed by a lattice; wherein the lattice comprises a first annular structure and a second annular structure, disposed about a circumference of the tubular structure, each defining an arcuate-square waveform, such that the arcuate-square waveforms are formed by a plurality of straight members, parallel to a longitudinal axis of the tubular structure and one another, linked to one another propagating via arcuate members forming apexes and nadirs of the arcuate-square waveform; and wherein the lattice further comprises a plurality of longitudinal structures, each longitudinal structure joins a respective nadir of the first annular structure to a respective apex of the second annular structure.125081 14936 1

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