Intraluminal device with wire braiding configuration

Abstract

To provide: an improved intraluminal device which exhibits sufficient rigidity in operative portions thereof to perform therapeutic operations such as vessel dilation or clot capture at remote body sites, but which also exhibits a sufficiently pliable distal tip in order to avoid potential complications as the device is delivered to a treatment site; and a production method thereof.SOLUTION: An intraluminal device comprises: a first region in which multiple wires are twisted to form a first cable; a second region, distal to the first region, in which the multiple wires are woven to form an expandable mesh segment which is configured to capture a blood clot; and a third region distal to the second region and forming a distal tip of an elongated body, where the multiple wires in the third region are twisted to form a second cable; where at least one wire of the multiple wires extends continuously from the first region to the distal tip of the elongated body.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] SUMMARY The present disclosure relates to intravascular and intraluminal medical devices and systems configured to retrieve obstructing material, such as blood clots, from human blood vessels.

[0002] The present disclosure also relates to methods of manufacturing intravascular and intraluminal medical devices and systems. [Background technology]

[0003] Intravascular and intraluminal medical devices are commonly used to treat a variety of medical conditions within hollow body organs, such as blood vessels. For example, expandable or distensible devices can be utilized to dilate constricted body vessels or provide support to damaged or blocked body lumens. Intravascular and intraluminal devices can also be utilized to capture and remove obstructing material, such as blood clots or stones, from body cavities. For example, wire mesh devices can be expanded within an intravascular obstruction to penetrate and / or capture the obstruction.

[0004] Some vascular systems, such as the intracranial vasculature, include narrow and tortuous vessels. When an occlusion or stenosis occurs in the intracranial vasculature, intravascular therapeutic devices can be threaded through the tortuous anatomical structures to reach the treatment site. These therapeutic devices must have a small enough diameter to fit into the narrow vessels, yet be both rigid enough to perform the desired manipulations at the treatment site and flexible enough to be maneuvered to the treatment site with minimal complications. Complications may include, among others, the difficulty of delivering the devices to the treatment site through tortuous pathways, as well as the potential for damage to healthy vessel walls as a result of the intracranial and intraluminal devices being too rigid. Summary of the Invention [Problem to be solved by the invention]

[0005] The present disclosure relates to improved devices and systems that exhibit sufficient rigidity in their operative portion to perform therapeutic operations such as vasodilation or clot capture at remote body sites, but also exhibit a distal tip that is sufficiently flexible to avoid potential complications when the device is delivered to the treatment site. [Means for solving the problem]

[0006] Disclosed herein are endoluminal devices that have sufficient rigidity at their operative portion to perform therapeutic operations at remote body sites, but also exhibit a distal tip that is sufficiently flexible to avoid potential complications due to insertion of such devices into the body. Also disclosed herein are methods of manufacturing such endoluminal devices.

[0007] According to an exemplary embodiment of the present disclosure, an intraluminal device is provided that includes an elongate body formed of a plurality of wires. The intraluminal device includes a first region in which the plurality of wires are twisted to form a first cable. The intraluminal device also includes a second region distal to the first region in which the plurality of wires are woven to form an expandable mesh segment configured to capture a clot. The intraluminal device also includes a third region distal to the second region and forming a distal tip of the elongate body, the plurality of wires of the third region twisted to form a second cable. At least one wire of the plurality of wires extends continuously from the first region to the distal tip of the elongate body.

[0008] The expandable mesh segment includes at least one expandable filter segment in which a plurality of wires are woven to form a first weave pattern, the first weave pattern having openings formed therein between two or more wires. The expandable mesh segment also includes at least one expandable clot capture zone in which a plurality of wires are woven to form a second weave pattern, the second weave pattern being different from the first weave pattern and having openings formed therein between two or more wires. In the expanded configuration, the openings of the at least one clot capture zone are larger than the openings of the at least one filter segment. The plurality of wires in the at least one clot capture zone are grouped into a plurality of wire groups in the at least one clot capture zone, each wire group of the plurality of wire groups including at least two wires, forming an intertwined wire combination. The openings of the at least one clot capture zone are formed between at least two of the intertwined wire combinations. Each wire group of the plurality of wire groups includes one wire, two wires, three wires, or four wires. The at least one expandable filter segment is configured to capture clots smaller than the at least one expandable clot capture zone. The expandable mesh segment includes a first filter segment, a second filter segment distal to the first filter segment, a first clot capture zone disposed between the first filter segment and a first region of the endoluminal device, and a second clot capture zone disposed between the second filter segment and a third region of the endoluminal device. The plurality of wires includes at least one of an 8 wire, a 10 wire, and a 12 wire set. The at least one wire has a diameter between 40 microns and 200 microns.For example, the at least one wire can have a diameter or range of diameters that are at least one of 40 microns, 45 microns, 50 microns, 55 microns, 60 microns, 65 microns, 70 microns, 75 microns, 80 microns, 85 microns, 90 microns, 95 microns, 100 microns, 105 microns, 110 microns, 115 microns, 120 microns, 125 microns, 130 microns, 135 microns, 140 microns, 145 microns, 150 microns, 155 microns, 160 microns, 165 microns, 170 microns, 175 microns, 180 microns, 185 microns, 190 microns, 195 microns, and 200 microns. For example, the at least one wire can have a diameter in the range of 50 microns to 75 microns. The endoluminal device also includes at least one radiopaque marker disposed at a point along the elongate body, the point along the elongate body being at least one of a point distal to the second region and a point proximal to the second region. The first region of the endoluminal device, the second region of the endoluminal device, and the third region of the endoluminal device are formed as one unitary structure.

[0009] According to another exemplary embodiment of the present disclosure, there is provided a method of manufacturing an endoluminal device including an elongate body formed of a plurality of wires. The method includes twisting the plurality of wires on a first segment of a mandrel to form a first cable of the elongate body. The method also includes weaving the plurality of wires on a second segment of the mandrel to form an expandable mesh segment of the elongate body configured to capture a clot. The method also includes twisting the plurality of wires on a third segment of the mandrel to form a second cable of the elongate body. The second segment of the mandrel is disposed between the first segment of the mandrel and the third segment of the mandrel.

[0010] The method also includes heat treating the expandable mesh segments. The second segment of the mandrel has a larger diameter than the first segment of the mandrel and the third segment of the mandrel. The plurality of wires includes at least one of sets of 8 wires, 10 wires, and 12 wires. At least one wire of the plurality of wires has a diameter between 40 microns and 200 microns. For example, at least one wire can have a diameter or range of diameters that are at least one of 40 microns, 45 microns, 50 microns, 55 microns, 60 microns, 65 microns, 70 microns, 75 microns, 80 microns, 85 microns, 90 microns, 95 microns, 100 microns, 105 microns, 110 microns, 115 microns, 120 microns, 125 microns, 130 microns, 135 microns, 140 microns, 145 microns, 150 microns, 155 microns, 160 microns, 165 microns, 170 microns, 175 microns, 180 microns, 185 microns, 190 microns, 195 microns, and 200 microns. For example, at least one wire of the plurality of wires can have a diameter in a range between 50 microns and 75 microns. The first cable of the elongate body, the expandable mesh segment of the elongate body, and the second cable of the elongate body are formed as one unitary structure.

[0011] According to a further exemplary embodiment of the present disclosure, an intraluminal device is provided that includes an elongate body formed of a plurality of wires. The intraluminal device includes a first region in which the plurality of wires are twisted to form a first cable. The intraluminal device also includes a second region distal to the first region in which the plurality of wires are woven to form an expandable mesh segment configured to capture a clot. The intraluminal device also includes a third region distal to the second region and forming a distal tip of the elongate body, the plurality of wires of the third region twisted to form a second cable. The second cable is configured to be more flexible than the first cable.

[0012] At least one wire of the plurality of wires has a diameter between 40 microns and 200 microns. For example, the at least one wire can have a diameter or range of at least one of 40 microns, 45 microns, 50 microns, 55 microns, 60 microns, 65 microns, 70 microns, 75 microns, 80 microns, 85 microns, 90 microns, 95 microns, 100 microns, 105 microns, 110 microns, 115 microns, 120 microns, 125 microns, 130 microns, 135 microns, 140 microns, 145 microns, 150 microns, 155 microns, 160 microns, 165 microns, 170 microns, 175 microns, 180 microns, 185 microns, 190 microns, 195 microns, and 200 microns. For example, the at least one wire of the plurality of wires can have a diameter in a range between 50 microns and 75 microns. The second cable is configured to have a smaller cable helix winding angle than the first cable. The second cable includes fewer wires than the first cable, and the second cable is treated to reduce the diameter of portions of the wires therein.

[0013] According to yet another exemplary embodiment of the present disclosure, an intraluminal device is provided that includes an elongated body formed of a plurality of wires. The intraluminal device includes a first region in which the plurality of wires are twisted to form a first cable. The intraluminal device also includes a second region distal to the first region in which the plurality of wires are woven to form an expandable mesh segment. The intraluminal device also includes a third region distal to the second region and forming a distal tip of the elongated body, the plurality of wires of the third region being twisted to form a second cable. The plurality of wires in the expandable mesh segment are grouped into a plurality of wire pairs in the expandable mesh segment, each wire pair of the plurality of wire pairs forming an intertwined wire combination. At least a first wire pair of the plurality of wire pairs and at least a second wire pair of the plurality of wire pairs form an intersection within the expandable mesh segment, and at least one wire of the first wire pair passes between each wire of the second wire pair at the intersection.

[0014] A first wire pair of the plurality of wire pairs includes at least a first paired twist proximal to the intersection and at least a second paired twist distal to the intersection. At least one wire of the second wire pair passes between each wire of the first wire pair at the intersection. At least one wire of the first wire pair does not pass between wires of the second wire pair at the intersection. At least one wire of the second wire pair does not pass between wires of the first wire pair at the intersection.

[0015] According to another exemplary embodiment of the present disclosure, an intraluminal device is provided that includes an elongate body formed of a plurality of wires. The intraluminal device includes a first region in which the plurality of wires are twisted to form a first cable. The intraluminal device also includes a second region distal to the first region in which the plurality of wires are woven to form an expandable mesh segment configured to capture a clot. The intraluminal device also includes a third region distal to the second region and forming a distal tip of the elongate body, the plurality of wires of the third region being twisted to form a second cable. The first region includes more wires than one or more of the second and third regions.

[0016] The second region includes the same number of wires as the third region. The second region includes more wires than the third region. The first region includes 11 wires, the second region includes 8 wires, and the third region includes 8 wires. The first region includes 12 wires, the second region includes 8 wires, and the third region includes 8 wires. At least one wire of the plurality of wires extends continuously from the first region to the third region. The first region of the endoluminal device, the second region of the endoluminal device, and the third region of the endoluminal device are formed as one unitary structure.

[0017] According to a further exemplary embodiment of the present disclosure, there is provided a method of manufacturing an endoluminal device including an elongate body formed of a plurality of wires. The method includes twisting the plurality of wires on a first segment of a mandrel to form a first cable of the elongate body. The method also includes cutting at least one wire of the plurality of wires at a distal end of the first cable. The method also includes weaving remaining wires of the plurality of wires on a second segment of the mandrel to form an expandable mesh segment of the elongate body configured to capture a clot. The method also includes twisting remaining wires of the plurality of wires on a third segment of the mandrel to form a second cable of the elongate body. The second segment of the mandrel is disposed between the first segment of the mandrel and the third segment of the mandrel.

[0018] The method also includes cutting at least one wire of the plurality of wires at a distal end of the expandable mesh segment. The method also includes heat treating the expandable mesh segment. The second segment of the mandrel has a larger diameter than the first segment of the mandrel and the third segment of the mandrel. The plurality of wires includes 8 wires, 10 wires, or 12 wires. At least one wire of the plurality of wires has a diameter between 40 microns and 200 microns. For example, at least one wire can have a diameter or range of diameters that are at least one of 40 microns, 45 microns, 50 microns, 55 microns, 60 microns, 65 microns, 70 microns, 75 microns, 80 microns, 85 microns, 90 microns, 95 microns, 100 microns, 105 microns, 110 microns, 115 microns, 120 microns, 125 microns, 130 microns, 135 microns, 140 microns, 145 microns, 150 microns, 155 microns, 160 microns, 165 microns, 170 microns, 175 microns, 180 microns, 185 microns, 190 microns, 195 microns, and 200 microns. For example, at least one wire of the plurality of wires can have a diameter in a range between 50 microns and 75 microns. The first cable of the elongate body, the expandable mesh segment of the elongate body, and the second cable of the elongate body are formed as one unitary structure.

[0019] According to a further exemplary embodiment of the present disclosure, an intraluminal device is provided that includes an elongated body formed of a plurality of wires. The intraluminal device includes a first region in which the plurality of wires are twisted to form a first cable. The intraluminal device also includes the first region in which the plurality of wires are twisted to form the first cable, a second region distal to the first region in which the plurality of wires are woven to form an expandable mesh segment, and a third region distal to the second region and forming a distal tip of the elongated body, the plurality of wires in the third region being twisted to form the second cable. The plurality of wires in the expandable mesh segment includes a first wire group and a second wire group. The first wire group includes two wires and the second wire group includes three wires. Each wire of the plurality of wires includes a first side and a second side opposite the first side. A first wire of the first wire group is configured to cross a first side of both a first wire of the second wire group and a second wire of the second wire group. A first wire of the first wire group is configured to cross a second side of a third wire of the second wire group. A second wire of the first wire group is configured to cross a second side of both a first wire of the second wire group and a second wire of the second wire group. A second wire of the first wire group is configured to cross a first side of a third wire of the second wire group.

[0020] According to a further exemplary embodiment of the present disclosure, an intraluminal device is provided that includes an elongate body formed of a plurality of wires. The intraluminal device includes a first region in which the plurality of wires are twisted to form a first cable, a second region distal to the first region in which the plurality of wires are woven to form an expandable mesh segment, and a third region distal to the second region and forming a distal tip of the elongate body, the plurality of wires in the third region being twisted to form the second cable. The plurality of wires in the expandable mesh segment includes a first wire group and a second wire group. The first wire group includes two wires. The second wire group includes three wires. Each wire of the plurality of wires includes a first side and a second side opposite the first side. A first wire of the first wire group is configured to cross a first side of a first wire of the second wire group and a second side of both a second wire of the second wire group and a third wire of the second wire group. A second wire of the first wire group is configured to cross a first side of each wire of the second wire group.

[0021] According to a further exemplary embodiment of the present disclosure, an intraluminal device is provided that includes an elongate body formed of a plurality of wires. The intraluminal device includes a first region in which the plurality of wires are twisted to form a first cable, a second region distal to the first region in which the plurality of wires are woven to form an expandable mesh segment, and a third region distal to the second region and forming a distal tip of the elongate body, the plurality of wires in the third region being twisted to form the second cable. The plurality of wires in the expandable mesh segment includes a first wire group and a second wire group. The first wire group includes two wires. The second wire group includes three wires. Each wire of the plurality of wires includes a first side and a second side opposite the first side. A first wire of the first wire group is configured to cross a first side of a first wire of the second wire group and cross a second side of both a second wire of the second wire group and a third wire of the second wire group. A second wire of the first wire group is configured to cross a first side of a first wire of the second wire group and cross a second side of both a second wire of the second wire group and a third wire of the second wire group. A third wire of the first wire group is configured to cross a first side of each wire of the second wire group.

[0022] According to a further exemplary embodiment of the present disclosure, an intraluminal device is provided that includes an elongated body formed of a plurality of wires. The intraluminal device includes a first region in which the plurality of wires are twisted to form a first cable, a second region distal to the first region in which the plurality of wires are woven to form an expandable mesh segment, and a third region distal to the second region and forming a distal tip of the elongated body, the third region in which the plurality of wires are twisted to form a second cable. The plurality of wires in the expandable mesh segment are grouped into a plurality of wire groups in the expandable mesh segment. Each wire group of the plurality of wire groups forms an intersection with another wire group of the plurality of wire groups in the expandable mesh segment. A first wire group of the plurality of wire groups includes three wires that form a twisted structure, each of the three wires enveloping the other two wires of the three wires. The twisted structure of the first wire group is disposed within a segment of the expandable mesh segment between two adjacent intersections of the first wire group.

[0023] According to a further exemplary embodiment of the present disclosure, an intraluminal device is provided that includes an elongate body formed of a plurality of wires. The intraluminal device includes a first region in which the plurality of wires are twisted to form a first cable, a second region distal to the first region in which the plurality of wires are woven to form an expandable mesh segment, and a third region distal to the second region and forming a distal tip of the elongate body, the plurality of wires in the third region being twisted to form a second cable. The plurality of wires in the expandable mesh segment are grouped into a plurality of wire groups in the expandable mesh segment. Each wire group of the plurality of wire groups forms an intersection with another wire group of the plurality of wire groups within the expandable mesh segment. The first wire group of the plurality of wire groups includes three wires. A first wire of the three wires and a second wire of the three wires form a twisted structure in which each of the first and second wires wraps around the other. A third wire of the three wires is untwisted with the first and second wires in the twisted structure. The twisted structure is disposed within a segment of the expandable mesh segment between two adjacent intersections of the first group of wires.

[0024] According to a further exemplary embodiment of the present disclosure, an intraluminal device is provided that includes an elongate body formed of a plurality of wires. The intraluminal device includes a first region in which the plurality of wires are twisted to form a first cable, a second region distal to the first region in which the plurality of wires are woven to form an expandable mesh segment, and a third region distal to the second region and forming a distal tip of the elongate body, the plurality of wires in the third region being twisted to form the second cable. The plurality of wires in the expandable mesh segment are grouped into a plurality of wire groups in the expandable mesh segment. Each wire group of the plurality of wire groups forms an intersection with another wire group of the plurality of wire groups within the expandable mesh segment. A first wire group of the plurality of wire groups includes three wires. Each of the three wires has a first side and a second side opposite the first side. The first wire group forms an interlocking structure within a segment of the expandable mesh segment between two adjacent intersections of the first wire group. In the interlocking structure, a first wire of the first wire group is configured to cross a first side of a second wire of the first wire group and cross a second side of a third wire of the first wire group, and in the interlocking structure, the second wire of the first wire group does not contact the third wire of the first wire group. [Brief description of the drawings]

[0025] [Figure 1] 1 illustrates an exemplary intraluminal device consistent with various embodiments of the present disclosure. [Figure 2A] 2 shows an enlarged view of a distal transition region of the endoluminal device of FIG. 1, consistent with various embodiments of the present disclosure. [Figure 2B] 2 shows an expanded view of a distal coil of the intraluminal device of FIG. 1, consistent with various embodiments of the present disclosure. [Figure 3A] 2 shows a close-up view of a proximal transition region of the endoluminal device of FIG. 1, consistent with various embodiments of the present disclosure. [Figure 3B] 2 shows a close-up view of a proximal coil of the intraluminal device of FIG. 1, consistent with various embodiments of the present disclosure. [Figure 4] 1 illustrates another exemplary intraluminal device consistent with various embodiments of the present disclosure. [Diagram 5] 5 shows an enlarged view of a wire crossover of the endoluminal device of FIG. 4, consistent with various embodiments of the present disclosure. [Figure 6A] 1 illustrates an exemplary method of manufacturing an endoluminal device consistent with various embodiments of the present disclosure. [Figure 6B] 1 illustrates an exemplary method of manufacturing an endoluminal device consistent with various embodiments of the present disclosure. [Figure 6C] 1 illustrates an exemplary method of manufacturing an endoluminal device consistent with various embodiments of the present disclosure. [Figure 7] 1 illustrates a further exemplary intraluminal device consistent with various embodiments of the present disclosure. [Figure 8A] 1 illustrates an exemplary wire crossing of an endoluminal device, consistent with various embodiments of the present disclosure. [Figure 8B] 1 illustrates an exemplary wire crossing of an endoluminal device, consistent with various embodiments of the present disclosure. [Figure 9] 1 illustrates another exemplary wire crossing of an endoluminal device, consistent with various embodiments of the present disclosure. [Figure 10] 13 illustrates a further exemplary wire crossing of an endoluminal device, consistent with various embodiments of the present disclosure. [Figure 11A] 1 illustrates an exemplary wire braid pattern for an endoluminal device consistent with various embodiments of the present disclosure. [Figure 11B] 1 illustrates an exemplary wire braid pattern for an endoluminal device consistent with various embodiments of the present disclosure. [Figure 12A] 1 illustrates another exemplary wire braid pattern for an endoluminal device, consistent with various embodiments of the present disclosure. [Figure 12B] 1 illustrates another exemplary wire braid pattern for an endoluminal device, consistent with various embodiments of the present disclosure. [Figure 13A]13 illustrates further exemplary wire braid patterns for an endoluminal device consistent with various embodiments of the present disclosure. [Figure 13B] 13 illustrates further exemplary wire braid patterns for an endoluminal device consistent with various embodiments of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] Exemplary embodiments are described with reference to the accompanying drawings. In figures that are not necessarily drawn to scale, the leftmost digits of the numerals identify the figure in which the numeral first appears. Whenever convenient, the same numerals are used throughout the figures to refer to the same or similar parts. Although examples and configurations of the disclosed principles are described herein, modifications, adaptations, and other implementations are possible without departing from the spirit and scope of the disclosed embodiments. Also, words such as "comprising," "having," "containing," "including," and other similar forms are intended to be equivalent in meaning and open-ended in that they do not imply that the item or items following any of these words are an inclusive list of such item or items or are limited to only the listed item or items. It should also be noted that as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.

[0027] FIELD OF THE DISCLOSURE Embodiments of the present disclosure generally relate to medical devices and methods for treating occlusions in the body. More specifically, embodiments of the present disclosure relate to devices and methods for removing blood clots, including but not limited to emboli and thrombi, from blood vessels. Additionally or alternatively, embodiments of the present disclosure may also be utilized to expand occluded hollow body organs, as well as in other medical procedures in which removal of an occlusion or foreign body is desired.

[0028] According to embodiments of the present disclosure, an intraluminal device may be provided that includes an expandable clot engaging component that may have a mesh or stent-like structure and may be configured to capture, retain, and remove a clot or other obstruction upon deployment and expansion within a hollow body organ, such as a blood vessel.

[0029] FIG. 1 illustrates an exemplary intraluminal device 1000. Device 1000 may include a distal cable 1100, a proximal cable 1200, and an expandable clot engaging component 1300 therebetween. In this disclosure, the term "proximal" refers to the end of the device (e.g., device 1000) that is closer to the device operator during use, and the term "distal" refers to the end of the device that is farther from the device operator during use. Device 1000 may include multiple wires or filaments that extend from proximal cable 1200, through clot engaging component 1300, to distal cable 1100. Device 1000 may include 8 wires, 9 wires, 10 wires, 11 wires, 12 wires, or any other suitable number of wires. For example, but not limited to, the device 1000 can include 6 wires, 7 wires, 8 wires, 9 wires, 10 wires, 11 wires, 12 wires, 13 wires, 14 wires, 15 wires, 16 wires, 17 wires, or 18 wires. In some embodiments, multiple wires can be wound around a cable shaft to form the distal cable 1100 and the proximal cable 1200, such that the cables can be configured to maintain a constant diameter during expansion and contraction of the clot engagement component 1300. The distal cable 1100 can include a distal tip 1110 that can be rounded or otherwise shaped to make the tip 1110 atraumatic to tissue. In some embodiments, the proximal cable 1200 can extend proximally from the clot engagement component 1300 to a control handle (not shown). Alternatively, the device 1000 may also include a tubular shaft disposed proximal to the proximal cable 1200 and extending between the proximal cable 1200 and the control handle.

[0030] In some embodiments, the wires may have a diameter between 40 microns and 200 microns. For example, but not limited to, the diameter of the wires of the device 1000 may be any one of or ranges of 40 microns, 45 microns, 50 microns, 55 microns, 60 microns, 65 microns, 70 microns, 75 microns, 80 microns, 85 microns, 90 microns, 95 microns, 100 microns, 105 microns, 110 microns, 115 microns, 120 microns, 125 microns, 130 microns, 135 microns, 140 microns, 145 microns, 150 microns, 155 microns, 160 microns, 165 microns, 170 microns, 175 microns, 180 microns, 185 microns, 190 microns, 195 microns, and 200 microns. For example, the wires may have a diameter in the range between 50 microns and 75 microns. Advantageously, a wire having a diameter of between 50 microns and 75 microns allows the distal cable 1100 to be flexible and atraumatic to tissue during use, while still providing sufficient stiffness to the device 1000 for therapeutic use within the body.

[0031] In some embodiments, multiple wires can be braided within the clot engagement component 1300 to form an expandable mesh-like or stent-like structure. Within the mesh-like structure, multiple wires can be woven to cross one another without being connected, whereby the wires can be configured to move relative to one another. In some embodiments, the wires can be crossed and bent to form the mesh-like structure such that the proximal and distal ends of the clot engagement component 1300 may not include exposed ends of the wires, such that the lack of exposed ends may reduce trauma to the anatomical structures.

[0032] The clot engaging component 1300 can be configured to radially expand and contract, such that the clot engaging component 1300 can be configured to transition between a radially contracted configuration and a radially expanded configuration. In some embodiments, the clot engaging component 1300 can be self-expanding, at least in part, due to the arrangement of multiple wires and material composition. For example, the intraluminal device 1000 can be delivered to the treatment site within a delivery sheath (not shown), which can hold the clot engaging component 1300 in a contracted configuration. Movement of the device 1000 relative to the sheath (e.g., distal retraction of the sheath) can release the device 1000 and allow expansion of the clot engaging component 1300.

[0033] Additionally or alternatively, device 1000 may include at least one elongated control member (not shown) that may control the expansion and contraction of clot engaging component 1300. The control member may include interwoven, tethered, and / or knotted wires or filaments connected around distal cable 1100 and / or to the distal end of clot engaging component 1300. The control member may be threaded within or parallel to clot engaging component 1300 and proximal cable 1200 to a control handle, and an operator of the device may utilize the control member to expand or contract clot engaging component 1300. The control member may be configured to apply a force to a portion of device 1000 to affect the expansion or contraction of clot engaging component 1300. For example, the control member may be configured to apply a proximal force to the distal end of clot engaging component 1300 to radially expand the clot engaging component. Similarly, the control member can be configured to apply a distal force to a distal end of the clot engagement component 1300 to cause the clot engagement component to radially contract.

[0034] The multiple wires of the intraluminal device 1000 may be constructed of any suitable flexible material known to one of skill in the art. Suitable flexible materials may include, but are not limited to, polymers, metals, metal alloys, and combinations thereof. In some embodiments, for example, the wires may be constructed from a superelastic metal, such as Nitinol. To visualize the clot engaging component 1300 in angiographic images, the wires may further include radiopaque markers and / or materials. For example, in one embodiment, the device 1000 may include multiple Nitinol wires with a core made of tantalum or platinum metal. The radiopaque core may be 20%-50% by volume (e.g., 30% or 40%). In an additional embodiment, the wires may be made radiopaque by depositing a thin layer of a radiopaque metal, such as platinum. In some embodiments, such radiopaque configurations may be located at the proximal and distal ends of the clot engaging component 1300 of FIG. 1.

[0035] As previously mentioned, a delivery sheath may be provided. The sheath may be a hollow tubular structure configured to receive at least a portion of the intraluminal device 1000 therein, thus surrounding and radially compressing the device including the clot engagement component 1300. The sheath may be removable from the device 1000, thereby allowing the clot engagement component 1300 to expand radially within the vessel in which the sheath is deployed. In some embodiments, the device 1000 may be delivered to a treatment site (e.g., a clot site) within the sheath. The sheath may be configured to allow controlled expansion and contraction of the clot engagement component 1300. For example, as previously mentioned, the clot engagement component 1300 may be configured to radially expand upon removal of the sheath (e.g., when the sheath is retracted proximally). The device 1000 may also be returned into the sheath (e.g., by pulling the device 1000 proximally into the sheath), returning the clot engagement component 1300 to the retracted configuration.

[0036] The intraluminal device 1000 may be configured to capture obstructing objects, such as blood clots, and remove them from the body. Additionally or alternatively, the device 1000 may be configured to exert an outward force on a wall of a hollow body organ, such as a blood vessel. In some embodiments, the clot engagement component 1300 may be configured to exhibit a substantially uniform shape when in the expanded configuration. Alternatively, as shown in FIG. 1, the clot engagement component 1300 may be configured to exhibit a substantially asymmetric shape when in the expanded configuration. Consistent with the present disclosure, the asymmetric shape may improve the ability of the clot engagement component 1300 to conform to the anatomy of a vessel.

[0037] In some embodiments, at least a portion of the clot engaging component 1300 can be configured to expand to approximately the inner diameter of the blood vessel at the clot site. Upon expanding to approximately the inner diameter of the blood vessel, the clot engaging component 1300 can exert a force on the vessel wall, causing the clot to separate from the vessel wall. Advantageously, separating the clot from the vessel wall can reduce the amount of force required to further remove the clot from the vessel wall and reduce the tendency of the clot to break up into multiple pieces during removal from the vessel. In the contracted configuration, the clot engaging component 1300 can exert a force on the clot contained therein, retaining the clot within the intraluminal device 1000 and reducing the tendency of the clot to fragment. The clot can then be retrieved from the blood vessel while retained only within the clot engaging component 1300. Alternatively, if the clot is small enough to fit within the delivery sheath, the clot can be drawn into the delivery sheath before being removed from the blood vessel. In this manner, the delivery sheath can exert an additional retaining force on the clot.

[0038] In some embodiments, the clot engagement component 1300 includes one or more clot capture zones 1310, 1320, a distal filter 1330, and / or a proximal filter 1340, each of which may have a weave pattern of wires extending therethrough. In the example of FIG. 1, the clot engagement component 1300 includes two clot capture zones, a distal filter, and a proximal filter. However, in an alternative embodiment, the clot engagement component may not include one or more of the capture zones, distal filter, and proximal filter. Also, in an alternative embodiment, the clot engagement component may include one, three, four, five, or more clot capture zones. The proximal filter 1340 may cross the proximal sheath 1200 at the transition 1205, with multiple wires extending therebetween. Similarly, the distal filter 1330 may cross the distal sheath 1100 at the transition 1105, with multiple wires extending therebetween. The capture zones 1310, 1320 can be disposed between the proximal and distal filters and can have a larger diameter than the proximal and distal filters when the clot engagement component 1300 is in an expanded configuration. In some embodiments, both capture zones can have the same diameter when expanded, or alternatively, one capture zone can have a larger diameter than the other when expanded. The capture zones 1310, 1320 can have the same or different wire weave patterns. For example, one or more of the capture zones 1310, 1320 can have a wire weave pattern in which at least two of the multiple wires are wound around each other to form an intertwined combination of wires, such as the kinks 1312 and 1314 of FIG. 1. In the example of FIG. 1, two wires are wound together to form a kink, but in alternative embodiments, three or more wires can be wound together to form the kink of one or more capture zones. The kinking of the wires can prevent the wires from slipping (e.g., during expansion and contraction of the clot engagement component 1300) and can form a large clot-trapping window 1316 therebetween. The window 1316 can capture and retain larger clots and other obstructions.The distal filter 1330 and the proximal filter 1340 can have the same or different wire weave patterns, which may differ from the weave patterns of the capture zones 1310, 1320. The weave patterns of one or more of the distal filter 1330 and the proximal filter 1340 may provide structural support for the capture zones 1310, 1320. Also, the openings between the wires of the distal and proximal filters may be smaller than the clot capture window 1316, and thus the distal filter 1330 and the proximal filter 1340 may be configured to capture and retain occlusions that may be too small to be captured by the zones 1310, 1320.

[0039] In some embodiments, one or more of the multiple wires can extend continuously through the proximal cable 1200, the clot engagement component 1300, and the distal cable 1100 without connection or attachment (e.g., welding or gluing) to other wires in adjacent segments. That is, the length of the one or more wires can extend from the distal end of the device 1000 to the proximal end of the device 1000. For example, in some embodiments, all of the wires of the device 1000 can extend continuously from the distal end of the device 1000 to the proximal end of the device 1000. As a result, when each wire of the plurality of wires is configured to extend continuously through the proximal cable 1200, the clot engaging component 1300, and the distal cable 1100, as described above, the proximal cable 1200, the clot engaging component 1300, and the distal cable 1100 can be manufactured as one unitary structure, and thus the proximal cable 1200, the clot engaging component 1300, and the distal cable 1100 are not separately manufactured and are not welded, glued, or otherwise connected together. This configuration is shown in FIGS. 1-3B, where each of the plurality of wires can pass continuously along the length of the intraluminal device 1000, including the transitions 1105 and 1205. Also, each of the wires can be free of gaps and discontinuities, such that the body of each of the plurality of wires can extend from the proximal cable 1200 to the distal cable 1100 (e.g., to the distal tip 1110).

[0040] FIG. 2A shows a close-up view of the distal transition region of the intraluminal device 1000. FIG. 2A shows the transition section 1105 as well as a portion of the distal cable 1100 and the distal filter 1330. In some embodiments, due to the continuous braiding of the device 1000, all of the wires in the distal filter 1330 can extend continuously through the transition section 1105 to the distal cable 1100 and distally to the distal tip 1110. As shown in FIG. 2A, the wires can extend through the transition section 1105 without interruptions or gaps. Alternatively, one or more wires can be cut or otherwise disrupted at or near the transition section 1105.

[0041] 2A, the distal filter 1330 may have a wire weave pattern including several openings 2005, 2010 therein for capturing occlusions (e.g., clots). The openings 2005, 2010 may be smaller than the clot capture window 1316 and thus configured to capture occlusions and clots smaller than the clot capture window 1316. In some embodiments, one or more radiopaque markers may be positioned at or near the transition 1105 such that the distal end of the clot engagement component 1300 may be visualized, for example, by a device operator.

[0042] In some embodiments, the wires in the distal cable 1100 can be chemically or electrochemically treated to remove material therefrom, thus forming a softer, more atraumatic tip of the device 1000. This can be accomplished by etching, electropolishing, or any other suitable chemical or electrochemical process. By reducing the diameter of the wires in the distal cable 1100, the wires can be made more flexible and softer, and therefore less damaging to tissue during use within the body.

[0043] FIG. 2B shows a close-up view of the distal cable 1100. As discussed above, the number and diameter of the wires in the distal cable can determine the cable helical wrap angle 2300. As shown in FIG. 2B, the cable helical wrap angle 2300 can be the angle formed between the direction of the wires 2600 and a transverse axis 2500 that is perpendicular to the wire axis 2400. In some embodiments, the distal cable 1100 may include fewer wires (e.g., 8 wires) than the proximal cable 1200 (e.g., 11 or 12 wires), thus allowing for a smaller cable helical wrap angle 2300 and thus a softer, more flexible distal cable.

[0044] 3A shows a close-up view of the proximal transition region of the intraluminal device 1000. FIG. 3A shows the transition section 1205 as well as the proximal filter 1340 and a portion of the proximal cable 1200. In some embodiments, due to the continuous braiding of the device 1000, all of the wires in the proximal cable 1200 can extend continuously through the transition section 1205 to the proximal filter 1340. As shown in FIG. 3A, the wires can extend through the transition section 1205 without interruptions or gaps. Alternatively, one or more wires can be cut or otherwise disrupted at or near the transition section 1205.

[0045] 3A, the proximal filter 1340 may have a wire weave pattern including several openings 3005, 3010 therein for capturing occlusions (e.g., clots). The openings 3005, 3010 may be smaller than the clot capture window 1316 and thus configured to capture occlusions and clots smaller than the clot capture window 1316. In some embodiments, one or more radiopaque markers may be positioned at or near the transition 1205 such that the proximal end of the clot engagement component 1300 may be visualized, for example, by a device operator.

[0046] FIG. 3B shows a close-up view of the proximal cable 1200. The proximal cable 1200 can have a cable helical wrap angle 3300 that is determined by the number and diameter of the wires in the proximal cable. As shown in FIG. 3B, the cable helical wrap angle 3300 can be the angle formed between the direction of the wires 3600 and a transverse axis 3500 that is perpendicular to the wire axis 3400. In some embodiments, the proximal cable helical wrap angle 3300 can be greater than the distal cable helical wrap angle 2300 by the proximal cable 1200 having more wires and / or larger diameter wires than the distal cable 1100. For example, the distal cable helical wrap angle 2300 can be an angle between 5° (e.g., in a single strand cable, as discussed below with reference to FIG. 7, having a very small angle) and 60°, while the proximal cable helical wrap angle 3300 can be an angle between 50° and 60°. As a result, the distal cable 1100 may be softer and more flexible than the proximal cable 1200. In alternative embodiments, the distal cable 1100 may be arranged such that the distal cable helical wrap angle 2300 is between 60° and 70°. For example, but not limited to, the distal cable helical wrap angle 2300 may have an angle of 1°, 2°, 3°, 4°, 5°, 8°, 10°, 12°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, or 70°. Also, but not limited to, the proximal cable helical wrap angle 3300 may have an angle of 40°, 45°, 50°, 51°, 52°, 53°, 54°, 55°, 56°, 57°, 58°, 59°, 60°, 65°, or 70°.

[0047] 4 illustrates another exemplary intraluminal device 4000. The device 4000 can include a distal cable 4100, a proximal cable 4200, and an expandable clot engagement component 4300 therebetween. The device 4000 can be formed of multiple wires that can be braided within the clot engagement component 4300 to form an expandable mesh-like or stent-like structure. In some embodiments, the wires can extend continuously from the proximal end of the device 4000 to the distal end of the device 4000, including through transitions 4105 and 4205.

[0048] The clot engaging component 4300 may include a predetermined number of wires to achieve a desired mesh configuration. The clot engaging component 4300 may include one or more pairs 4330 of coiled wires and / or one or more cables 4320 of three coiled wires. The clot capture window 4316 may be formed between the pairs 4330 and / or the cables 4320. For example, the clot engaging component 4300 may include eight wires formed from four wire pairs 4330. In one alternative example, the clot engaging component 4300 may include ten wires formed from two wire pairs 4330 and two wire cables 4320. In a further example, the clot engaging component 4300 may include twelve wires formed from four wire cables 4320. In yet another example, the clot engaging component 4300 may include twelve wires formed from six wire pairs 4330. Alternatively, the clot engagement component 4300 may be formed from any other suitable number of wires, wire pairs 4330 and / or wire cables 4320.

[0049] FIG. 5 illustrates an exemplary wire crossover 5000 of the intraluminal device 4000. The crossover 5000 may be formed by the meeting of two wire pairs 4330 at a single crossover. Each wire pair may be twisted distally and proximally to the crossover 5000. As shown in FIG. 5, the wires 5102, 5104 may be twisted around each other at a paired twist 5106 distal to the crossover and at a paired twist 5108 proximal to the crossover. Similarly, the wires 5202, 5204 may be twisted around each other at a paired twist 5206 distal to the crossover and at a paired twist 5208 proximal to the crossover.

[0050] At the intersection 5000, each wire pair can only surround one wire of the other wire pair. For example, as shown in FIG. 5, wires 5102, 5104 can surround wire 5204 at the intersection, but not wire 5202. Similarly, wires 5202, 5204 can surround wire 5102 at the intersection, but not wire 5104. Advantageously, this intersection configuration can lock the two wire pairs relative to each other such that each wire pair cannot slide along the other pair, while minimizing friction between the two wire pairs because there is minimal physical engagement between the two wire pairs. For example, the intersection 5000 may be configured to function as a hinge during expansion and contraction of the clot engaging component 4300, with the wires 5102, 5104 configured to pivot relative to the wires 5102, 5104 during expansion and contraction of the component 4300, without the wires 5102, 5104 sliding axially relative to the wires 5202, 5204. Due to the minimal physical engagement between the two wire pairs at the intersection 5000, friction along the pivot direction of each wire may be reduced, allowing the wires to pivot more easily and in response to lower applied forces without disengaging at the intersection 5000. Advantageously, less force may be required to overcome friction at the intersection 5000 and thus expand or contract the clot engaging component 4300. Also, no more than two wires are in contact at any given point within the intersection 5000. As a result, the thickness added to the diameter of the clot engaging component 4300 is no more than the sum of the diameters of the two interacting wires. Advantageously, this may allow the clot engagement component 4300 to have a minimized diameter, such as during delivery within a delivery sheath, so that the device 4000 can pass through small and tortuous anatomical structures.

[0051] 6A-6C illustrate an exemplary method of manufacturing an endoluminal device. The example illustrated in Figures 6A-6C illustrates the manufacture of an exemplary endoluminal device 6000, and one of ordinary skill in the art will appreciate that the manufacturing methods disclosed herein may be used to manufacture any suitable endoluminal device, including, but not limited to, endoluminal devices 1000, 4000, and 7000.

[0052] An exemplary intraluminal device 6000 may include a distal cable 6100, a proximal cable 6200, and an expandable clot engaging component 6300 therebetween. The device 6000 may be formed of multiple wires that may extend continuously from the proximal end of the device 6000 to the distal end of the device 6000, including through transition regions 6105 and 6205. The intraluminal device 6000 may be formed by braiding multiple wires over a mandrel 6500. The mandrel 6500 has a first portion 6510 on which the proximal cable 6200 may be formed, a second portion 6520 on which the clot engaging component 6300 may be formed, and a third portion 6530 on which the distal cable 6100 may be formed, each portion of the mandrel 6500 may have a respective shape and diameter. For example, the mandrel second portion 6520 may have a larger diameter than the mandrel first portion 6510 and the mandrel third portion 6530, respectively. As a result, the clot engaging component 6300, when formed, may have a larger diameter than the distal cable 6100 and the proximal cable 6200, respectively. In some embodiments, the mandrel first portion 6510 and the mandrel third portion 6530 may have substantially equal diameters such that the distal cable 6100 and the proximal cable 6200 also have substantially equal diameters. In some alternative embodiments, the mandrel first portion 6510 may have a larger or smaller diameter than the mandrel third portion 6530 such that the diameters of the distal cable 6100 and the proximal cable 6200 are not equal. However, an exemplary mandrel 6500 consistent with the present disclosure is not limited to a particular shape, size, or configuration. For example, the mandrel 6500 may vary in outer dimension symmetrically or asymmetrically along its longitudinal length, and may be substantially straight, curved, or a combination of both. In some embodiments, the shape, dimensions, and configuration of the mandrel 6500 may be selected to produce a desired shape and size of the endoluminal device 6000 that may be at least partially formed on the mandrel 6500.

[0053] As shown in FIGS. 6A-6C, multiple wires can be continuously braided along the mandrel 6500 to form the intraluminal device 6000 (including the distal cable 6100, the proximal cable 6200, and the clot engagement component 6300) as one unitary structure. For purposes of illustration in FIGS. 6A-6C, a small amount of space is shown between the wires and the mandrel 6500. However, in practice, the mandrel 6500 can function as a form around which the wires can be wound. In some embodiments, such as the example shown in FIGS. 6A-6C, the wires can be continuously braided on the mandrel 6500 starting at the proximal end of the intraluminal device 6000 and working in a distal direction toward the distal end of the device 6000. However, in alternative embodiments, the wires can be continuously braided from the distal end of the device 6000 toward the proximal end of the device 6000.

[0054] As shown in FIG. 6A, the wires may be wrapped around a first mandrel portion 6510 to form the proximal cable 6200. Upon reaching a transition region 6205 (which in some embodiments may be formed at or near the intersection between the first mandrel portion 6510 and the second mandrel portion 6520), multiple wires may be braided in a mesh-like or stent-like arrangement onto the second mandrel portion 6520 to form the clot engaging component 6300. This is shown in FIG. 6B. In some embodiments, all of the wires forming the proximal cable 6200 may pass through the transition region 6205 and extend through the clot engaging component 6300, although the braid pattern of the wires may differ between the proximal cable 6200 and the clot engaging component 6300. Once formation of the clot engaging component 6300 is complete and the transition region 6105 is reached (which in some embodiments may be formed at or near the intersection between the second mandrel portion 6520 and the third mandrel portion 6530), multiple wires may be wrapped around the third mandrel portion 6530 to form the distal cable 6100. In some embodiments, all of the wires forming the clot engaging component 6300 may pass through the transition region 6105 and extend through the distal cable 6100, although the braid pattern of the wires may be different between the distal cable 6100 and the clot engaging component 6300. The wires may be wrapped around the third mandrel portion 6100 until the distal end of the device 6000 is formed. FIG. 6C shows the completed device 6000 on the mandrel 6000.

[0055] Advantageously, the lack of connections or attachments between portions of the device 6000 may result in a smoother device contour. Connection methods such as welding or gluing may result in rough, protruding surface features that may scrape tissue during use of the device within the body. Because the device 6000 may lack such surface features due to the continuous braiding of the wires, the contour of the device may be smooth and therefore less traumatic during delivery through the body and use of the device at the treatment site. Continuous braiding methods are also simpler and require less time than techniques that require connecting different device portions together, such as by welding.

[0056] In some embodiments, at least a portion of the formed endoluminal device 6000 can be heat treated prior to removal from the mandrel 6500. In some embodiments, the entire endoluminal device 6000 can be heat treated. Alternatively, the entire clot engaging component 6300 can be heat treated. For example, the clot engaging component 6300 can be heat treated such that the inner wire portion can have a shape memory at the diameter and shape of the second mandrel portion 6520. In a further alternative, a portion of the clot engaging component 6300 can be heat treated. For example, heat treatment can be performed while the exemplary endoluminal device 6000 remains on the mandrel 6500. Heat treatment can be performed by a hot air blower directed at the device 6000 or a portion thereof, or using heat applied by any other device or method. Other devices or methods for heating can include convection, conduction, or both. For example, the mandrel 6500 can be heated and heat can be applied by conduction to one or more portions of the endoluminal device 6000. One example of heat treatment may include applying heat to the device 6000, or a portion thereof, at at least about 450° C. while the device 6000 is maintained on the mandrel 6500. In another example, heat treatment may include applying heat to the device 6000, or a portion thereof, at about 500° C., or between 480° C. and 550° C. In yet another example, heat treatment may be applied at any temperature that can cause the wire of the device 6000 (e.g., the wire portion within the clot engaging component 6300) to have a full or partial memory of the diameter of the mandrel 6500 (memory being the ability to partially or fully return to that diameter when the device 6000 is subsequently used).

[0057] FIG. 7 illustrates a further exemplary intraluminal device 7000. The device 7000 may include a distal cable 7100, a proximal cable 7200, and an expandable clot engaging component 7300 therebetween. The device 7000 may be formed of multiple wires that may be braided within the clot engaging component 7300 to form an expandable mesh-like or stent-like structure. In some embodiments, one or more wires of the device 7000 may be cut or otherwise interrupted during braiding of the device 7000 (e.g., at transition 7105 or transition 7205), resulting in some portions of the device 7000 having more wires than others. For example, the proximal cable 7200 may have more wires than the distal cable 7100 and the clot engaging component 7300. Additionally or alternatively, the clot engaging component 7300 may have more wires than the distal cable 7100. In the example shown in FIG. 7, the proximal cable 7200 includes 15 wires, while the distal cable 7100 and the clot engaging component 7300 include 12 wires. However, one of ordinary skill in the art will understand that the various sections of the device 7000 (i.e., the distal cable 7100, the proximal cable 7200, and the clot engaging component 7300) may include any desired number of wires. For example, in some embodiments, the proximal cable 7200 can have 11 wires, three of which may be cut at or near the transition 7205, resulting in the clot engaging component 7300 and the distal cable 7100 having 8 wires. In some alternative embodiments, the proximal cable 7200 can have 12 wires, four of which may be cut at or near the transition 7205, resulting in the clot engaging component 7300 and the distal cable 7100 having 8 wires. For example, but not limited to, the distal cable 7100 may have 1 wire, 2 wires, 3 wires, 4 wires, 5 wires, 6 wires, 7 wires, 8 wires, 9 wires, 10 wires, 11 wires, 12 wires, 13 wires, 14 wires, or 15 wires.Also, without limitation, the clot engagement component 7300 can have 6 wires, 7 wires, 8 wires, 9 wires, 10 wires, 11 wires, 12 wires, 13 wires, 14 wires, 15 wires, or 16 wires. Also, without limitation, the proximal cable 7200 can have 8 wires, 9 wires, 10 wires, 11 wires, 12 wires, 13 wires, 14 wires, 15 wires, 16 wires, 17 wires, or 18 wires.

[0058] Advantageously, incorporating different numbers of wires in the segments of the device 7000 may allow each segment to have distinct physical properties including number of wires, wire diameter, cable stiffness, and braid configuration. As a result, each segment of the device 7000 may be configured to have desired physical properties that may differ from the desired physical properties of the other segments. For example, the number of wires forming the coils of the distal cable 7100 and the proximal cable 7200, as well as the diameter of those wires, may determine the cable helical winding angle, which affects the stiffness of the cable. Utilizing a smaller number of wires and / or smaller diameter wires allows for a smaller cable helical winding angle, thus allowing for a less stiff and more flexible cable. Thus, in some embodiments, the distal cable 7100 may include fewer wires and / or smaller diameter wires than the proximal cable 7200, such that the distal cable 7100 is softer and less stiff than the proximal cable 7200. Thus, may allow the device 7000 to have a soft and atraumatic distal.

[0059] Also, the number of wires in the clot engaging component 7300 and transition portions 7105, 7205 can affect the structure and physical properties of the mesh-like structure. For example, utilizing a particular number of wires in the clot engaging component 7300 and transition portions 7105, 7205 can enable the formation of a desired mesh configuration, including mesh size and diameter in contracted and expanded configurations, the pattern and size of openings in the clot engaging component 7300, and the deliverability of the mesh-like structure through a delivery sheath.

[0060] Additionally, the wire helical wrap angle within the proximal cable 7200 may affect the tendency of the cable 7200 to stretch and compress under axially applied forces. As discussed above with reference to FIGS. 2B and 3B, the helical wrap angle of the cable may be the angle formed between the direction of the wires within the cable and the lateral axis of the cable. The resulting helical wrap angle of the cable may be a function of the diameter of the mandrel on which the cable is formed, the number of wires within the cable, and the diameter of the wires within the cable. Specifically, utilizing a larger diameter mandrel, fewer wires, and smaller diameter wires each contribute to a reduction in the helical wrap angle. In some embodiments, but not limited to, the proximal cable 7200 may have a helical wrap angle of 40°, 45°, 50°, 51°, 52°, 53°, 54°, 55°, 56°, 57°, 58°, 59°, 60°, 65°, or 70°. As a result, the proximal cable 7200 may resist axial deformation under an applied tensile force instead of maintaining a constant axial length. Advantageously, during clot retrieval, this wire configuration of the proximal cable 7200 may resist axial elongation when a tensile force is applied, allowing for smooth clot retrieval. In another example where the elongate control member is pulled to apply a tension force to expand and contract the clot engagement component 7300, the proximal cable 7200 may resist shortening under a compressive force applied by the elongate control member.

[0061] The exemplary intraluminal device 7000 may be formed by a manufacturing method similar to that shown in FIGS. 6A-6C with the additional step of cutting or otherwise severing one or more wires at a predetermined portion thereof (e.g., at or near the transition region 7105 and / or the transition region 7205). For example, by cutting or severing at least one wire at or near the transition region 7205, the number of wires extending through the clot engagement component 7300 and the distal cable 7100 may be reduced. One or more wires may be similarly cut or severed at or near the transition region 7105. The remaining uncut wires may be braided to form the remainder of the device 7000. Alternatively, no wires may be cut at one of the transition regions 7105, 7205. In some embodiments, the ends of the cut wires may be covered with glue or adhesive and / or covered with marker bands. As a result, sharp edges caused by the cut wires may be covered to prevent injury to the patient.

[0062] 8A, 8B, 9, and 10 show exemplary wire crossovers 8000, 9000, and 10000 of the wires of the exemplary endoluminal device. In some embodiments, the wire crossovers 8000, 9000, and 10000 may be utilized within mesh or stent-like structures such as clot engagement components 1300, 4300, 6300, and 7300. The wire crossovers 8000, 9000, and 10000 may allow extraneous wires to be embedded or "hidden" within a wire pattern comprised of a predetermined number of wires. For example, if a pattern of eight wires is desired within a device segment, but there are ten wires within the segment, one or more of the exemplary wire crossovers 8000, 9000, and 10000 may be utilized to embed and effectively "hide" two extraneous wires such that a pattern of eight wires may be achieved.

[0063] Wire intersections 8000, 9000, and 10000 can provide an alternative technique for achieving device segments with different physical properties, as discussed above with reference to FIG. 7. For example, if an endoluminal device with a 12-wire proximal cable and a 9-wire pattern mesh segment is desired, one or more of wire intersections 8000, 9000, and 10000 can be utilized within the mesh segment to embed three unrelated wires to achieve the desired 9-wire pattern, which technique can provide an alternative to cutting or severing the three unrelated wires. Advantageously, the desired wire configurations and physical properties can be achieved for different segments of the endoluminal device without the need to cut or sever any of the wires. Also, the incorporation of wire intersections 8000, 9000, and 10000 can also allow multiple wires to extend continuously from the distal end of the endoluminal device to the proximal end of the endoluminal device without connections or attachments (e.g., welding or bonding) between the wires of adjacent segments.

[0064] In some embodiments, one or more of wire intersections 8000, 9000, and 10000 can be utilized in combination with cutting or severing at least one wire. For example, if an endoluminal device is desired with a 10-wire proximal cable and a 6-wire pattern mesh segment, one, two, or three wires can be cut at the transition between the proximal cable and the mesh segment. To achieve the desired 6-wire pattern, one or more of wire intersections 8000, 9000, and 10000 can be utilized within the mesh segment to embed the remaining extraneous wires.

[0065] 8A and 8B show wire crossing 8000. In some embodiments, crossing 8000 can be utilized when one of the three wires 8202, 8204, 8206 is an unrelated wire, i.e., the desired wire pattern includes a crossing instead between two wire pairs. Wire 8102 can cross over wires 8202, 8204 and under wire 8206, while wire 8104 can cross under wires 8202, 8204 and over wire 8206. Wire 8102 can also cross over wire 8104. As used herein, the relative terms "over" and "under" can be replaced with terms that define a "first side" of a wire, and a "second side" of a wire, the "first side" of the wire being opposite the "second side." 8A and 8B, wires 8102 and 8104 can form a first wire group, and wires 8202, 8204, and 8206 can form a second wire group. As shown in FIG. 8A, a first wire 8102 of the first wire group can be configured to cross (e.g., cross over) a first side of a first wire 8202 of the second wire group and a second wire 8204 of the second wire group, and wire 8102 of the first wire group can be configured to cross (e.g., cross under) a second side of a third wire 8206 of the second wire group. Also, the second wire 8104 of the first wire group can be configured to cross (e.g., cross over) a second side of the first wire 8202 of the second wire group and the second wire 8204 of the second wire group, and the second wire 8104 of the first wire group can be configured to cross (e.g., cross over) a first side of the third wire 8206 of the second wire group.

[0066] FIG. 9 illustrates a wire intersection 9000. In some embodiments, the intersection 9000 can be utilized when one of the three wires 9202, 9204, 9206 is an unrelated wire, i.e., when the desired wire pattern instead includes an intersection between two wire pairs. For example, as shown in FIG. 9, wires 9102 and 9104 can form a first wire group, and wires 9202, 9204, and 9206 can form a second wire group. As shown in FIG. 9, the first wire 9102 of the first wire group can be configured to intersect (e.g., intersect below) a second side of the second wire 9204 of the second wire group and the third wire 9206 of the second wire group, and the first wire 9102 of the first wire group can be configured to intersect (e.g., intersect above) a first side of the first wire 9202 of the second wire group. Additionally, the second wire 9104 of the first wire group can be configured to cross (eg, cross over) a first side of each of the wires 9202, 9204, and 9206 of the second wire group.

[0067] Advantageously, intersections 8000 and 9000 can embed or "hide" one or more unrelated wires (e.g., one or more of wires 8202, 8204, and 8206, and one or more of wires 9202, 9204, and 9206) while still configuring intersections 8000 and 9000 to function as hinges. For example, in intersection 8000, wires 8102, 8104 can pivot relative to wires 8202, 8204, 8206 without sliding axially relative to wires 8202, 8204, 8206. Similarly, in intersection 9000, wires 9102, 9104 can pivot relative to wires 9202, 9204, 9206 without sliding axially relative to wires 9202, 9204, 9206. The intersections 8000 and 9000 can also prevent the profile of the endoluminal device from expanding from the presence of one or more extraneous wires, since no more than two wires are in contact at any given point within the intersections 8000 and 9000.

[0068] 10 illustrates a wire intersection 10000. The intersection 10000 may include an intersection between a first group of three wires 10102, 10104, 10106 and a second group of three wires 10202, 10204, 10206. In some embodiments, the intersection 10000 may be utilized when one of the groups of three wires includes one or more unrelated wires, e.g., when the desired wire pattern instead includes an intersection between a wire pair and a group of three wires. In some alternative embodiments, the intersection 10000 may be utilized when both groups of three wires include one or more unrelated wires, e.g., when the desired wire pattern instead includes an intersection between two wire pairs and one wire needs to be buried or "hidden" in each group of three wires. 10, the first wire 10102 of the first wire group can be configured to cross (e.g., cross under) a second side of the second wire 10204 of the second wire group and the third wire 10206 of the second wire group, and the first wire 10102 of the first wire group can be configured to cross (e.g., cross over) a first side of the first wire 10202 of the second wire group. Also, the second wire 10104 of the first wire group can be configured to cross (e.g., cross under) a second side of the second wire 10204 of the second wire group and the third wire 10206 of the second wire group, and the second wire 10104 of the first wire group can be configured to cross (e.g., cross over) a first side of the first wire 10202 of the second wire group. Additionally, the third wire 10106 of the first wire group can be configured to cross (e.g., cross over) a first side of each of the wires 10202, 10204, and 10206 of the second wire group. Similar to crossovers 8000 and 9000, crossover 10000 can allow the wires therein to function as a hinge while minimizing or preventing an expansion of the device profile due to the presence of one or more extraneous wires.

[0069] 11A-11B, 12A-12B, and 13A-13B show exemplary wire braid patterns 11000, 12000, and 13000, respectively, for wire groups of an exemplary endoluminal device. In some embodiments, wire braid patterns 11000, 12000, and 13000 may be utilized for wire groups within a mesh or stent-like structure (such as clot engaging components 1300, 4300, 6300, and 7300) that may include multiple wire groups. Wire braid patterns 11000, 12000, and 13000 may allow one or more extraneous wires within a wire group to be embedded or "hidden" within the wire pattern of the mesh or stent-like structure, particularly within portions of the wire pattern between wire intersections (i.e., between portions of the wire pattern where wire groups intersect, such as intersection 5000). In some embodiments, wire braid patterns 11000, 12000, and 13000 can be utilized in a mesh segment between one or more of wire intersections 8000, 9000, and 10000 to embed or "hide" one or more unrelated wires in the wire grouping to achieve a desired wire pattern for the mesh segment.

[0070] As shown in FIGS. 11A-11B, the wire braid pattern 11000 includes a twist of a first wire group that may include wires 11102, 11104, and 11106. In some embodiments, the term "twist" may refer to a structure in which a wire is sequentially wrapped around other wires. That is, wire 11102 may wrap around two other wires, then wire 11104, then wire 11106, and then wire 11102 may wrap around the other two wires again. The twist of pattern 11000 may secure all three wires 11102, 11104, and 11106 together against inadvertent axial movement or slippage. In some embodiments, pattern 11000 may be utilized in a wire group having one or two unrelated wires. As described above, wires 11102, 11104, and 11106 can be twisted in pattern 11000 in portions of mesh segments where wires 11102, 11104, and 11106 do not cross another wire group (i.e., between two adjacent intersections of a first wire group and another group of wires).

[0071] As shown in Figures 12A-12B, the wire braid pattern 12000 includes a first group of three wires 12102, 12104, and 12106. As shown in Figure 12A, the wires 12104, 12106 may be twisted together to form a twisted structure in which the wires 12104, 12106 wrap around each other. The wires 12104, 12106 may be twisted in the twisted structure in a portion of the mesh segment where the wires 12102, 12104, and 12106 do not cross over with another wire group (i.e., between two adjacent crossings of the first wire group and the other wire group). However, the wire 12102 may be untwisted with the wires 12104 or 12106 within the twisted structure of the wire braid pattern 12000. Advantageously, pattern 12000 can secure wires 12104 and 12106 together against inadvertent axial movement or slippage while leaving wire 12102 free to move axially without hindrance. Additionally, wire braid pattern 12000 can also prevent the profile of the endoluminal device from expanding from the presence of one or more extraneous wires, since no more than two wires are in contact at any given point within pattern 12000. In some embodiments, pattern 12000 can be utilized within a wire group having one or more extraneous wires (e.g., one or more of wires 12102, 12104, or 12106).

[0072] As shown in FIGS. 13A-13B, the wire braid pattern 13000 includes a braid pattern of a first group of three wires 13102, 13104, 13106. The wire braid pattern 13000 may include an interlocking maypole structure of the wires 13102, 13104, 13106. As shown in FIG. 13A, within the interlocking maypole structure, the first wire 13102 may be configured to cross (e.g., cross under) a second side of the second wire 13104. Also, the first wire 13102 may be configured to cross (e.g., cross over) a first side of the third wire 13106. However, the second wire 13104 and the third wire 13106 do not contact or cross each other in the interlocking maypole structure of the pattern 13000. The interlocking maypole structure of pattern 13000 may be formed in a portion of a mesh segment where wires 13102, 13104, 13106 do not cross another wire group (i.e., between two adjacent crossings of a first wire group with the other wire group). Advantageously, pattern 13000 may secure wires 13102, 13104, and 13106 against axial movement or sliding relative to one another, and may prevent the contour of the endoluminal device from being enlarged from the presence of one or more extraneous wires, since no more than two wires are in contact at any given point in pattern 13000. In some embodiments, pattern 13000 may be utilized with wire groups having one or more extraneous wires (e.g., wire 13102, wire 13104, and / or wire 13106).

[0073] The foregoing description has been presented for purposes of illustration. It is not exhaustive and is not limited to the precise forms or embodiments disclosed. Modifications and adaptations of the embodiments will become apparent from consideration of the specification and practice of the disclosed embodiments. Although certain components have been described as being combined with each other, such components may be integrated or distributed with each other in any suitable manner.

[0074] Furthermore, although exemplary embodiments are described herein, the scope includes any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), adaptations, and / or alterations based on this disclosure. The elements of the claims should be interpreted broadly based on the language used in the claims, and not limited to the examples described herein or described during prosecution of this application (which examples should be interpreted as non-exclusive). Furthermore, the steps of the disclosed methods can be modified in any manner, including rearranging and / or inserting or deleting steps of the steps.

[0075] The configuration and advantages of the present disclosure are apparent from the detailed specification, and therefore, the appended claims are intended to cover all systems and methods falling within the true spirit and scope of the present disclosure. As used herein, the indefinite articles "a" and "an" mean "one or more." Similarly, the use of a plural term does not necessarily mean a plural unless it is clear in a given context. Words such as "and" or "or" mean "and / or" unless otherwise specified. Furthermore, since numerous modifications and variations will readily arise from studying this disclosure, it is not desired to limit the disclosure to the exact construction and operation illustrated and described, and therefore, all suitable modifications and equivalents may be included within the scope of the present disclosure.

[0076] Other embodiments will be apparent from consideration of the specification and practice of the embodiments disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the disclosed embodiments being indicated by the following claims.

Claims

1. An intratubular device comprising an elongated body formed of multiple wires, wherein the intratubular device is A first region in which the plurality of wires are twisted together to form a first cable, A second region located distal to the first region, in which the plurality of wires are woven together to form an expandable mesh segment configured to capture blood clots, The present invention has a third region located distal to the second region and forming the distal tip of the elongated body, wherein the plurality of wires in the third region are twisted together to form a second cable, At least one of the plurality of wires extends continuously from the first region to the distal tip of the elongated body, An intraluminal device in which one or more of the plurality of wires are cut during the braiding of the device, thereby providing a device in which the first region consists of more wires than one or more of the second and third regions.

2. The expandable mesh segment is The plurality of wires are woven into at least one expandable filter segment to form a first woven pattern, wherein the first woven pattern has an opening formed between two or more wires inside the at least one expandable filter segment, The plurality of wires are woven into at least one expandable blood clot capture zone to form a second woven pattern, wherein the second woven pattern differs from the first woven pattern in that it has at least one expandable blood clot capture zone having an opening formed between two or more wires. In an extended configuration, the opening of the at least one blood clot capture zone is larger than the opening of the at least one filter segment, as described in claim 1.

3. The intraluminal device according to claim 2, wherein the plurality of wires within the at least one blood clot capture zone are grouped into a plurality of wire groups within the at least one blood clot capture zone, and each of the plurality of wire groups comprises at least two wires, forming a combination of intertwined wires.

4. The intraluminal device according to claim 3, wherein the opening of the at least one blood clot capture zone is formed between at least two of the combinations of entangled wires.

5. The intratubular device according to claim 3, wherein each of the plurality of wire groups includes one wire, two wires, three wires, or four wires.

6. The intraluminal device according to claim 2, wherein the at least one expandable filter segment is configured to capture blood clots smaller than the at least one expandable blood clot capture zone.

7. The expandable mesh segment is The first filter segment and A second filter segment located distal to the first filter segment, A first blood clot capture zone is positioned between the first filter segment and the first region of the in-tube device, The intraluminal device according to claim 2, further comprising: a second blood clot capture zone disposed between the second filter segment and the third region of the intraluminal device.

8. The intraluminal device according to claim 1, further comprising at least one radiopaque marker positioned at a point along the elongated body, wherein the point along the elongated body is at least one of a distal point and a proximal point of the second region.

9. The intraluminal device according to claim 1, wherein the first region of the intraluminal device, the second region of the intraluminal device, and the third region of the intraluminal device are formed as a single structure.

10. A method for manufacturing an intraluminal device having an elongated body formed of multiple wires, wherein the method is: The steps include twisting a plurality of wires on a first segment of a mandrel to form the first cable of the elongated body, The steps include cutting at least one of the plurality of wires at the distal end of the first cable, The steps include weaving the remaining wires of the plurality of wires onto a second segment of the mandrel to form an expandable mesh segment of the elongated body configured to capture blood clots, The steps include: twisting the plurality of wires on a third segment of the mandrel to form a second cable of the elongated body, wherein the expandable mesh segment and the second cable consist of fewer wires than the first cable; The second segment of the mandrel is positioned between the first segment of the mandrel and the third segment of the mandrel. A method wherein the first cable of the elongated body, the expandable mesh segment of the elongated body, and the second cable of the elongated body are formed as a single structure.

11. The method according to claim 10, further comprising the step of heat-treating the expandable mesh segment.

12. The method according to claim 10, wherein the second segment of the mandrel has a larger diameter than the first segment and the third segment of the mandrel.

13. The intraluminal device according to claim 1 or the method according to claim 10, wherein the plurality of wires consist of at least one of sets of eight wires, ten wires, and twelve wires.

14. At least one of the plurality of wires has a diameter between 40 microns and 200 microns. The intraluminal device according to claim 1 or the method according to claim 10, wherein, optionally, at least one of the plurality of wires has a diameter between 50 microns and 75 microns.

Images