The present technology relates to implantable expandable structures for treating small vessels. In particular, the present technology relates to implantable expandable structures for treating vascular conditions.
Generally, stents are used as an alternative to surgery to obtain and maintain the patency of a variety of body passageways, while maintaining the integrity of the passageway. The environments of human vasculature and body passageways are characterized by varied, dynamic, and mobile anatomy. Vessels vary from simple to complex shapes, can be uniform in diameter or change abruptly or gradually from one diameter to another, and are subjected to a range of internal forces exerted by blood or air pressure, and external forces exerted by an assortment of anatomical structures surrounding and adjacent to these body passageways. Stents are typically designed to provide scaffolding and structural support within the affected vessel segment while maintaining a degree of flexibility required by particular indications of use.
Neurovascular conditions can be particularly difficult to treat with stents as the blood vessels are small and tortuous. Current stent designs have difficulty approximating the vessel wall along portions of the neurovasculature that are curved, twisted, or forked. Current designs generally suffer from crimping or kinking when positioned in such tortuous vessels. This can be problematic for several reasons. When using a stent to treat intracranial atherosclerotic disease (ICAD), for example, inconsistent or weak wall apposition prevents the stent from sufficiently opening a stenosis and improving intracranial flow. Stents are also used to bridge wide-necked aneurysms to prevent coils within the aneurysm from protruding through the aneurysm neck into the parent vessel. If the parent vessel is curved, twisted, or forked, current stent designs have difficulty achieving consistent wall apposition across the neck, thereby allowing the coils to protrude and/or allowing blood to flow into the aneurysm.
Accordingly, there exists a need for improved stents for treating neurovascular conditions, such as ICAD and hemorrhagic stroke.
The present technology is directed to expandable structures configured to be positioned in a blood vessel lumen, such as within the neurovasculature, to treat one or more conditions. As discussed in greater detail herein, the expandable structure of the present technology comprises a tubular member formed of a plurality of interconnected struts arranged in a geometry that enable delivery of the expandable structure in a low-profile state with enhanced pushability. The strut geometry also allows the expandable structure to conform to the vessel wall and maintain wall apposition when implanted. The subject technology is illustrated, for example, according to various aspects described below, including with reference to
Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present disclosure.
Many embodiments of the subject technology are directed to expandable structures configured to be implanted in a blood vessel lumen to treat one or more vascular conditions. The expandable structures can comprise a plurality of interconnected struts that together define a tubular sidewall. As detailed below, the size and arrangement of the struts enable the expandable structures of the present technology to maintain apposition with the vessel wall when positioned around tight corners or bends and avoids or eliminates kinking. Moreover, the expandable structures of the present technology have a strut geometry that provides improved column strength when the expandable structure is in a compressed state for delivery, thereby providing improved pushability.
The expandable structure 100 can comprise a tubular member having a first end portion 100a, a second end portion 100b, and a longitudinal axis L (labeled in
As used herein, structures that are “longitudinally adjacent” are immediately adjacent one another along the longitudinal axis L of the expandable structure 100. For example, each of the bands 104 is longitudinally adjacent one or two other bands 104. Likewise, structures that are “circumferentially adjacent” are immediately adjacent one another along a circumference of the expandable structure 100. For example, within a given band 104, each strut 102 is circumferentially adjacent two other struts (as described below).
In some embodiments, the bands 104 can comprise end bands 108 disposed at the first and second end portions 100a, 100b, respectively, and intermediate bands 110 disposed between the end bands 108 along the longitudinal axis L of the expandable structure 100. While each of the intermediate bands 110 comprises a single band 104, each of the end bands 108 can comprise one or more bands 104. In
Within some or all of the bands 104, the struts 102 may be connected end-to-end to form alternating “V's” such that the struts 102 are circumferentially disposed in a zigzag or “Z” pattern. Circumferentially adjacent struts 102 within a given band 104 may connect to one another at apices 106, and the bands 104 may have first apices 106a that point towards the first end portion 100a of the expandable structure 100 and second apices 106b that point towards the second end portion 100b of the expandable structure 100. As such, the first side 104a of each band 104 can be defined by a plurality of first apices 106a and the second side 104b of each band 104 can be defined by a plurality of second apices 106b.
Longitudinally adjacent bands 104 may be connected to one another via bridges 112. In particular, each bridge 112 connects a first apex 106a on one band 104 with a second apex 106b on a longitudinally adjacent band 104. As a result, each bridge 112 occurs at the intersection of four struts 102 (two from one band 104 and two from the longitudinally adjacent band 104). For each intermediate band 110, at least some, but not all, of the individual first apices 106a form bridges 112 with one of the second apices 106b of a longitudinally adjacent band 104 and at least some, but not all, of the individual second apices 106b form bridges 112 with one of the first apices 106b of another longitudinally adjacent band. The first and second apices 106a, 106b of an intermediate band 110 that do not form part of a bridge 112 are referred to herein as “free” apices. Accordingly, each of the first side 104a and the second side 104b of each intermediate band 110 includes one or more bridges 112 (e.g., connected apices 106) and one or more free apices 106.
In some embodiments, some or all of the intermediate bands 110 can have a repeating pattern of two consecutive free first apices 106a followed by a bridge 112 (along the circumference of the expandable structure 100), and two consecutive free second apices 106b followed by a bridge 112. In other embodiments, some or all of the intermediate bands 110 may have a different number or sequence of free apices and bridges.
When the expandable structure 100 is in the compressed configuration, as shown in
As used herein, structures that are “circumferentially aligned,” such as opposing free apices 106a, 106b when the expandable structure 100 is in the compressed configuration, are disposed at the same or substantially the same location along the circumference of the expandable structure 100 such that a line joining such structures is parallel or substantially parallel to a longitudinal axis of the expandable structure 100. With reference to
As previously mentioned, the end bands 108 can comprise a geometry and/or structure that is different than the intermediate bands 110. For example, as shown in
With reference to
In some embodiments, the widths of the struts 102 within a given intermediate band 110 can vary from strut to strut. For example, with reference to
Struts having different widths may be distributed within a given intermediate band 110 and across adjacent intermediate bands 110 in an arrangement that allows longitudinally adjacent free apices to be circumferentially aligned when the expandable structure 100 is in the compressed configuration but forces those free apices to be circumferentially offset when the expandable structure 100 is in the expanded configuration. Having the apices aligned in the compressed configuration advantageously provides increased axial stiffness and pushability during delivery, while the offset in the expanded configuration provides increased stent conformability and wall apposition by reducing the likelihood of apices colliding when the expandable structure 100 is forced around a tight curve.
In some embodiments the struts 102 within some or all of the intermediate bands 110 may be arranged according to width in a pattern that repeats around the circumference of the intermediate band 110. For example, as shown in
As the expandable structure 100 moves towards an expanded configuration and a diameter of the bands 104 increases (such that an arc length between circumferentially adjacent bridges 112 increases), the free apices between circumferentially adjacent bridges 112 will move circumferentially away from one another to a degree determined by the widths of the struts forming the free apices and their polarity. For example, when the expandable structure 100 is in the expanded configuration, the first free apices 140a, 140a′ will be separated by an arc length that is less than the arc length of separation between the second free apices 140b, 140b′. This is because the struts 102 forming the ‘V’ between the first free apices 140a, 140a′ are narrow struts 130 (e.g., lower bending stiffness and more compliant) while the struts 102 forming the ‘V’ between the second free apices 140b, 140b′ are wide struts 134 (e.g., higher bending stiffness and less compliant). As a result, the first free apices 140a, 140a′ move circumferentially away from one another to a lesser extent than the second free apices 140b, 140b′ when the expandable structure 100 expands.
Adjacent intermediate bands 110 can comprise the same pattern of struts 102, but the pattern can be shifted circumferentially so that the second free apices 140b, 140b′ of one intermediate band 100 are circumferentially aligned with the first free apices 104a, 140a′, respectively, of the longitudinally adjacent band 110. As a result, a second free apex 140b, having a polarity in which the wider of the two connected struts is below (clockwise) the second free apex 140b, is circumferentially aligned (in the compressed configuration) with a first free apex 140a having a polarity in which the wider of the two struts is above (counterclockwise) the first free apex 140a. Likewise, another second free apex 140b′, having a polarity in which the wider of the two connected struts is above (counterclockwise) the second free apex 140b′, is circumferentially aligned (in the compressed configuration) with another first free apex 140a′ having a polarity in which the wider of the two struts is below (clockwise) the first free apex 140a′. This asymmetry of strut widths amongst opposing free apices enables non-uniform spacing of the free apices when the expandable structure 100 is in the expanded configuration such that the free apices are no longer circumferentially aligned.
The expandable structures of the present technology can be deployed in any blood vessel. In some embodiments, the expandable structures are configured to be deployed in an intracranial blood vessel. For example, the expandable structures of the present technology can be configured to treat acute or symptomatic ICAD. In such cases, the expandable structure can be configured to be deployed in the blood vessel to open the ICAD stenosis and allow for intracranial blood flow. The expandable structures of the present technology may also be used for stent-assisted coiling to treat hemorrhagic stroke. In such embodiments, the expandable structures can be configured to be positioned across the neck of a wide-necked aneurysm to prevent protrusion of already-delivered coil into the parent vessel. Other neurovascular and non-neurovascular treatments are also possible.
The follow clauses describe embodiment of the present technology:
A treatment device comprising:
The treatment device of Clause 1, wherein the first and second free apices are aligned at a circumferential location when the tubular member is in the compressed configuration, and wherein, when the tubular member is in the expanded configuration, the first free apex of the first band is circumferentially offset from the second free apex of the second band such that the first free apex is positioned counterclockwise of the circumferential location and the second free apex is positioned counterclockwise of the circumferential location.
The treatment device of Clause 1 or Clause 2, wherein the one strut of the second pair of struts has the same width as the other strut of the first pair of struts.
The treatment device of any one of the previous Clauses, wherein the one strut of the first pair of struts is wider than the other strut of the second pair of struts.
The treatment device of any one of the previous Clauses, wherein:
The treatment device of Clause 5, wherein the second and fourth free apices are circumferentially adjacent along the circumference of the tubular member and the first and third free apices are circumferentially adjacent.
The treatment device of Clause 5 or Clause 6, wherein, when the tubular member is in the compressed configuration, the fourth free apex of the first band is circumferentially aligned with the third free apex of the second band.
The treatment device of any one of Clauses 5 to 7, wherein, when the tubular member is in the expanded configuration, the first and third apices are separated by an arc length that is less than an arc length between the second and fourth apices.
The treatment device of any one of Clauses 5 to 8, wherein a width of the one strut of the first pair of struts is the same as a width of the one strut of the third pair of struts.
The treatment device of any one of Clauses 5 to 9, wherein a width of the one strut of the second pair of struts is the same as a width of the one strut of the fourth pair of struts.
The treatment device of any one of Clauses 1 to 10, wherein the struts of the first band include narrow struts, intermediate struts, and wide struts, wherein the wide struts have a width that is greater than a width of the intermediate struts, and the intermediate struts have a width that is greater than a width of the narrow struts.
The treatment device of Clause 11, wherein the one strut of the first pair of struts is a wide strut.
The treatment device of Clause 11 or Clause 12, wherein the other strut of the first pair of struts is an intermediate strut.
The treatment device of any one of Clauses 11 to 13, wherein the one strut of the second pair of struts is an intermediate strut.
The treatment device of any one of Clauses 11 to 13, wherein the other strut of the second pair of struts is a narrow strut.
The treatment device of any one of Clauses 11 to 13, wherein the one strut of the third pair of struts is a wide strut.
The treatment device of any one of Clauses 11 to 13, wherein the other strut of the third pair of struts is an intermediate strut.
The treatment device of any one of Clauses 11 to 13, wherein the one strut of the fourth pair of struts is an intermediate strut.
The treatment device of any one of Clauses 11 to 13, wherein the other strut of the fourth pair of struts is a narrow strut.
A treatment device comprising:
A stent, comprising:
Although many of the embodiments are described above with respect to systems, devices, and methods for treating neurovascular conditions, the technology is applicable to other applications and/or other approaches, such as other vascular applications, including coronary, peripheral vascular, and others. Moreover, other embodiments in addition to those described herein are within the scope of the technology. Additionally, several other embodiments of the technology can have different configurations, components, or procedures than those described herein. A person of ordinary skill in the art, therefore, will accordingly understand that the technology can have other embodiments with additional elements, or the technology can have other embodiments without several of the features shown and described above with reference to
The descriptions of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Where the context permits, singular or plural terms may also include the plural or singular term, respectively. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. For example, while steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.
As used herein, the terms “generally,” “substantially,” “about,” and similar terms are used as terms of approximation and not as terms of degree, and are intended to account for the inherent variations in measured or calculated values that would be recognized by those of ordinary skill in the art.
Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the term “comprising” is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.
This application claims the benefit of and priority to U.S. Provisional Patent Application Ser. No. 63/485,702 filed Feb. 17, 2023, the entire disclosure of which is incorporated by reference herein.
Number | Date | Country | |
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63485702 | Feb 2023 | US |