Intraluminal device having a braided configuration of wires
阅读说明:本技术 具有丝线编织配置的管腔内装置 (Intraluminal device having a braided configuration of wires ) 是由 A·弗里德曼 M·吉杜尔特 于 2019-07-23 设计创作,主要内容包括:一种管腔内装置可以由多根丝线形成,其包括远侧线圈、近侧线圈以及定位在远侧线圈与近侧线圈之间的可扩张网状段。所述装置可以被形成为单个整体结构,其中,多根丝线中的至少一根丝线从所述近侧线圈连续地延伸到所述远侧线圈。管腔内装置可以包括形成该装置的远侧末端的柔软且无创伤的远侧线圈。管腔内装置可以包括在丝线交叉处会合的两对丝线,并且每对丝线中的一根丝线可以穿过另一对丝线中的丝线之间。在另一实现方式中,与远侧线圈和可扩张网状段相比,近侧线圈可以包括所述多根丝线中的更多丝线。(An intraluminal device may be formed from a plurality of wires including a distal coil, a proximal coil, and an expandable mesh segment positioned between the distal coil and the proximal coil. The device may be formed as a single unitary structure with at least one of a plurality of wires extending continuously from the proximal coil to the distal coil. The intraluminal device may include a soft and atraumatic distal coil forming the distal tip of the device. The intraluminal device may include two pairs of wires meeting at a wire intersection, and one wire of each pair may pass between wires of the other pair. In another implementation, the proximal coil may include more wires of the plurality of wires than the distal coil and the expandable mesh segment.)
1. An intraluminal device comprising an elongated body formed from a plurality of wires, the intraluminal device comprising:
a first region in which the plurality of filaments are twisted to form a first cable;
a second region distal to the first region in which the plurality of wires are braided to form an expandable mesh segment configured to capture blood clots; and
a third region distal to the second region and forming a distal tip of the elongate body, wherein the plurality of wires in the third region are twisted to form a second cable,
wherein at least one wire of the plurality of wires extends continuously from the first region to the distal tip of the elongated body.
2. The intraluminal device of claim 1, wherein the expandable mesh segment comprises:
At least one expandable filter segment in which the plurality of wires are braided to form a first braid pattern having openings formed therein between two or more wires; and
at least one expandable clot capture zone in which the 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 between two or more wires therein,
wherein, in the expanded configuration, the opening of the at least one clot capture zone is larger than the opening of the at least one filter segment.
3. The intraluminal device of claim 2, wherein the plurality of wires in the at least one clot capture zone are grouped into a plurality of wire groupings in the at least one clot capture zone, wherein each wire grouping of the plurality of wire groupings comprises at least two wires and forms an entangled wire combination.
4. The intraluminal device of claim 3, wherein the opening of the at least one clot capture zone is formed between at least two of the intertwined wire combinations.
5. The intraluminal device of claim 3, wherein each wire grouping of the plurality of wire groupings comprises one wire, two wires, three wires, or four wires.
6. The intraluminal device of claim 2, wherein the at least one expandable filter segment is configured to capture less clot than the at least one expandable clot capture zone.
7. The intraluminal device of claim 2, wherein the expandable mesh segment comprises:
a first filter section;
a second filter segment distal to the first filter segment;
a first clot capture zone positioned between the first filter section and the first region of the intraluminal device; and
a second clot capture zone positioned between the second filter section and the third region of the intraluminal device.
8. The intraluminal device of claim 1, wherein the plurality of wires comprise at least one of the following set: eight filaments, ten filaments, and twelve filaments.
9. The intraluminal device of claim 1, wherein the at least one wire has a diameter between 40 and 200 microns.
10. The intraluminal device of claim 9, wherein the at least one wire has a diameter between 50 and 75 microns.
11. The intraluminal device of claim 1, further comprising at least one radiopaque marker positioned 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.
12. The intraluminal device of 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 unitary structure.
13. A method of manufacturing an intraluminal device comprising an elongated body formed from a plurality of wires, the method comprising:
stranding a plurality of wires over a first segment of a mandrel to form a first cable of the elongate body;
braiding the plurality of wires over a second segment of the mandrel so as to form an expandable mesh segment of the elongate body, the expandable mesh segment configured to capture blood clots; and
Stranding the plurality of wires over a third section of the mandrel to form a second cable of the elongate body;
wherein the second section of the mandrel is positioned between the first section of the mandrel and the third section of the mandrel.
14. The method of claim 13, further comprising heat treating the expandable mesh segment.
15. The method of claim 13, wherein the diameter of the second section of the mandrel is greater than the diameter of the first section of the mandrel and the third section of the mandrel.
16. The method of claim 13, wherein the plurality of wires comprise at least one from the set of: eight filaments, ten filaments, and twelve filaments.
17. The method of claim 13, wherein at least one of the plurality of filaments has a diameter between 40 and 200 microns.
18. The method of claim 17, wherein at least one of the plurality of filaments has a diameter between 50 and 75 microns.
19. The method of claim 13, wherein 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 a single unitary structure.
20. An intraluminal device comprising an elongated body formed from a plurality of wires, the intraluminal device comprising:
a first region in which the plurality of filaments are twisted to form a first cable;
a second region distal to the first region in which the plurality of wires are braided to form an expandable mesh segment configured to capture blood clots; and
a third region distal to the second region and forming a distal tip of the elongate body, wherein the plurality of wires in the third region are twisted to form a second cable,
wherein the second cable is configured to be more flexible than the first cable.
21. The intraluminal device of claim 20, wherein at least one of the plurality of wires has a diameter between 40 and 200 microns.
22. The intraluminal device of claim 21, wherein at least one wire of the plurality of wires is between 50 and 75 microns in diameter.
23. The intraluminal device of claim 20, wherein the second cable is configured to have a smaller cable wrap angle than the first cable.
24. The intraluminal device of claim 20, wherein the second cable comprises fewer wires than the first cable.
25. The intraluminal device of claim 20, wherein the second cable is treated to reduce a diameter of portions of the plurality of wires therein.
26. An intraluminal device comprising an elongated body formed from a plurality of wires, the intraluminal device comprising:
a first region in which the plurality of filaments are twisted to form a first cable;
a second region distal to the first region in which the plurality of wires are braided to form an expandable mesh segment; and
a third region distal to the second region and forming a distal tip of the elongate body, wherein the plurality of wires in the third region are twisted to form a second cable,
wherein the plurality of filaments in the expandable mesh segment are grouped into a plurality of filament pairs in the expandable mesh segment, wherein each filament pair of the plurality of filament pairs forms an intertwined filament combination, and
Wherein at least a first pair of the plurality of pairs of wires and at least a second pair of the plurality of pairs of wires form an intersection in the expandable mesh segment, at least one wire of the first pair of wires passing between each wire of the second pair of wires at the intersection.
27. The intraluminal device of claim 26, wherein the first wire pair of the plurality of wire pairs comprises at least a first pair twist proximate to the crossing and comprises at least a second pair twist distal to the crossing.
28. The intraluminal device of claim 26, wherein at least one wire of the second wire pair passes between each wire of the first wire pair at the intersection.
29. The intraluminal device of claim 26, wherein at least one wire of the first wire pair does not pass between the wires of the second wire pair at the intersection.
30. The intraluminal device of claim 26, wherein at least one wire of the second wire pair does not pass between the wires of the first wire pair at the intersection.
31. An intraluminal device comprising an elongated body formed from a plurality of wires, the intraluminal device comprising:
a first region in which the plurality of filaments are twisted to form a first cable;
a second region distal to the first region in which the plurality of wires are braided to form an expandable mesh segment configured to capture blood clots; and
a third region distal to the second region and forming a distal tip of the elongate body, wherein the plurality of wires in the third region are twisted to form a second cable,
wherein the first region comprises more filaments than one or more of the second region and the third region.
32. The intraluminal device of claim 31, wherein the second region comprises the same number of wires as the third region.
33. The intraluminal device of claim 31, wherein the second region comprises more wires than the third region.
34. The intraluminal device of claim 31, wherein the first region comprises eleven wires, the second region comprises eight wires, and the third region comprises eight wires.
35. The intraluminal device of claim 31, wherein the first region comprises twelve wires, the second region comprises eight wires, and the third region comprises eight wires.
36. The intraluminal device of claim 31, wherein at least one of the plurality of wires extends continuously from the first region to the third region.
37. The intraluminal device of claim 31, 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 unitary structure.
38. A method of manufacturing an intraluminal device comprising an elongated body formed from a plurality of wires, the method comprising:
stranding a plurality of wires over a first segment of a mandrel to form a first cable of the elongate body;
cutting at least one wire of the plurality of wires at a distal end of the first cable;
braiding remaining filaments of the plurality of filaments over a second segment of the mandrel so as to form an expandable mesh segment of the elongate body, the expandable mesh segment configured to capture blood clots; and
Stranding remaining filaments of the plurality of filaments on a third segment of the mandrel to form a second cable of the elongate body;
wherein the second section of the mandrel is positioned between the first section of the mandrel and the third section of the mandrel.
39. The method of claim 38, further comprising cutting at least one of the plurality of wires at a distal end of the expandable mesh segment.
40. The method of claim 38, further comprising heat treating the expandable mesh segment.
41. The method of claim 38, wherein the diameter of the second section of the mandrel is greater than the diameter of the first section of the mandrel and the third section of the mandrel.
42. The method of claim 38, wherein the plurality of filaments comprises eight filaments, ten filaments, or twelve filaments.
43. The method of claim 38, wherein at least one of the plurality of filaments has a diameter between 40 and 200 microns.
44. The method of claim 43, wherein at least one of the plurality of wires has a diameter between 50 and 75 microns.
45. The method of claim 38, wherein 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 a single unitary structure.
46. An intraluminal device comprising an elongated body formed from a plurality of wires, the intraluminal device comprising:
a first region in which the plurality of filaments are twisted to form a first cable;
a second region distal to the first region in which the plurality of wires are braided to form an expandable mesh segment; and
a third region distal to the second region and forming a distal tip of the elongate body, wherein the plurality of wires in the third region are twisted to form a second cable,
wherein the plurality of wires in the expandable mesh segment comprise a first set of wires comprising two wires and a second set of wires comprising three wires, wherein each wire in the plurality of wires comprises a first side and a second side opposite the first side;
Wherein a first filament of the first set of filaments is configured to pass over the first side of both a first filament of the second set of filaments and a second filament of the second set of filaments, and the first filament of the first set of filaments is configured to pass over the second side of a third filament of the second set of filaments; and is
Wherein a second filament of the first set of filaments is configured to pass over the second sides of both the first filament of the second set of filaments and the second filament of the second set of filaments, and the second filament of the first set of filaments is configured to pass over the first side of the third filament of the second set of filaments.
47. An intraluminal device comprising an elongated body formed from a plurality of wires, the intraluminal device comprising:
a first region in which the plurality of filaments are twisted to form a first cable;
a second region distal to the first region in which the plurality of wires are braided to form an expandable mesh segment; and
a third region distal to the second region and forming a distal tip of the elongate body, wherein the plurality of wires in the third region are twisted to form a second cable,
Wherein the plurality of wires in the expandable mesh segment comprise a first set of wires comprising two wires and a second set of wires comprising three wires, wherein each wire in the plurality of wires comprises a first side and a second side opposite the first side;
wherein a first filament of the first set of filaments is configured to pass over the first side of a first filament of the second set of filaments and over the second sides of both a second filament of the second set of filaments and a third filament of the second set of filaments; and is
Wherein a second filament of the first set of filaments is configured to pass over the first side of each filament in the second set of filaments.
48. An intraluminal device comprising an elongated body formed from a plurality of wires, the intraluminal device comprising:
a first region in which the plurality of filaments are twisted to form a first cable;
a second region distal to the first region in which the plurality of wires are braided to form an expandable mesh segment; and
a third region distal to the second region and forming a distal tip of the elongate body, wherein the plurality of wires in the third region are twisted to form a second cable,
Wherein the plurality of wires in the expandable mesh segment comprises a first set of wires comprising three wires and a second set of wires comprising three wires, wherein each wire in the plurality of wires comprises a first side and a second side opposite the first side;
wherein a first filament of the first set of filaments is configured to pass over the first side of a first filament of the second set of filaments and over the second sides of both a second filament of the second set of filaments and a third filament of the second set of filaments;
wherein a second filament of the first set of filaments is configured to pass over the first side of the first filament of the second set of filaments and over the second sides of both the second filament of the second set of filaments and a third filament of the second set of filaments; and is
Wherein a third filament of the first set of filaments is configured to pass over the first side of each filament of the second set of filaments.
49. An intraluminal device comprising an elongated body formed from a plurality of wires, the intraluminal device comprising:
A first region in which the plurality of filaments are twisted to form a first cable;
a second region distal to the first region in which the plurality of wires are braided to form an expandable mesh segment; and
a third region distal to the second region and forming a distal tip of the elongate body, wherein the plurality of wires in the third region are twisted to form a second cable,
wherein the plurality of filaments in the expandable mesh segment are grouped into a plurality of filament groupings in the expandable mesh segment, wherein each filament grouping of the plurality of filament groupings crosses another filament grouping of the plurality of filament groupings in the expandable mesh segment;
wherein a first set of wires in the plurality of wire sets comprises three wires forming a twisted structure, wherein each wire in the three wires is wrapped around another two wires in the three wires, wherein the twisted structure of the first wire set is positioned in a section of the expandable mesh segment between two adjacent crossings of the first wire set.
50. An intraluminal device comprising an elongated body formed from a plurality of wires, the intraluminal device comprising:
a first region in which the plurality of filaments are twisted to form a first cable;
a second region distal to the first region in which the plurality of wires are braided to form an expandable mesh segment; and
a third region distal to the second region and forming a distal tip of the elongate body, wherein the plurality of wires in the third region are twisted to form a second cable,
wherein the plurality of filaments in the expandable mesh segment are grouped into a plurality of filament groupings in the expandable mesh segment, wherein each filament grouping of the plurality of filament groupings crosses another filament grouping of the plurality of filament groupings in the expandable mesh segment;
wherein a first filament group of the plurality of filament groups comprises three filaments, wherein a first filament of the three filaments and a second filament of the three filaments form a twisted structure in which each filament of the first and second filaments is twisted around each other, and wherein a third filament of the three filaments is not twisted with the first and second filaments in the twisted structure, the twisted structure being positioned in a section of the expandable mesh segment between two adjacent crossings of the first filament group.
51. An intraluminal device comprising an elongated body formed from a plurality of wires, the intraluminal device comprising:
a first region in which the plurality of filaments are twisted to form a first cable;
a second region distal to the first region in which the plurality of wires are braided to form an expandable mesh segment; and
a third region distal to the second region and forming a distal tip of the elongate body, wherein the plurality of wires in the third region are twisted to form a second cable,
wherein the plurality of filaments in the expandable mesh segment are grouped into a plurality of filament groupings in the expandable mesh segment, wherein each filament grouping of the plurality of filament groupings crosses another filament grouping of the plurality of filament groupings in the expandable mesh segment;
wherein a first set of filaments of the plurality of filament sets comprises three filaments, each filament of the three filaments having a first side and a second side opposite the first side, wherein the first filament set forms an interlocking structure in a section of the expandable mesh section between two adjacent intersections of the first filament set;
Wherein, within the interlocking structure, a first filament of the first filament group is configured to pass over the first side of a second filament of the first filament group and over the second side of a third filament of the first filament group; and is
Wherein, within the interlocking structure, the second wire of the first wire set is not in contact with the third wire of the first wire set.
Technical Field
The present disclosure relates to intravascular and intraluminal medical devices and systems configured to remove obstructions (such as clots) from human blood vessels. The present disclosure also relates to methods of making intravascular and intraluminal medical devices and systems.
Background
Intravascular and intraluminal medical devices are commonly used to treat a variety of medical conditions in hollow body organs, such as blood vessels. For example, inflatable or expandable devices may be used to expand constricted body vessels or to provide support to injured or occluded body lumens. Intravascular and intraluminal devices may also be used to capture and remove obstructions (such as clots or stones) from a body lumen. For example, the wire mesh device may be expanded within an endovascular occlusion to penetrate and/or capture the occlusion.
Some vasculature, such as intracranial vasculature, includes narrow and tortuous blood vessels. When an occlusion or stenosis (stenosis) occurs in the intracranial vasculature, an endovascular treatment device can be passed through tortuous anatomy to the treatment site. While these treatment devices must have a small enough diameter to fit through a stenotic vessel, they must also be both rigid enough to perform the desired procedure at the treatment site, and flexible enough to be maneuverable to the treatment site with minimal complications. Complications may include, among other factors, difficulty in delivering the device to the treatment site via a tortuous path, and possible damage to healthy vessel walls due to intracranial and intraluminal device stiffness.
The present disclosure relates to an improved device and system that exhibits sufficient rigidity in its operative portion to perform a therapeutic procedure such as vasodilation or clot capture at a remote body site, but which also exhibits a distal tip that is sufficiently flexible to avoid potential complications when the device is delivered to the treatment site.
Disclosure of Invention
Disclosed herein are intraluminal devices that have sufficient rigidity in their operative portion to perform therapeutic procedures at distant body sites, but which also exhibit a distal tip that is sufficiently flexible to avoid potential complications of insertion into the body by such devices. Methods of making such intraluminal devices are also disclosed.
According to an exemplary embodiment of the present disclosure, an intraluminal device is provided that includes an elongated body formed from a plurality of wires. The intraluminal device includes a first region in which a plurality of wires are twisted to form a first cable. The intraluminal device also includes a second region distal to the first region, wherein the plurality of wires are braided to form an expandable mesh segment configured to capture blood clots. The intraluminal device also includes a third region distal to the second region and forming a distal tip of the elongate body, wherein the plurality of wires in the third region are 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.
The expandable mesh segment includes at least one expandable filter segment, wherein a plurality of wires are woven to form a 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, wherein the plurality of wires are woven to form a second weave pattern that is different from the first weave pattern and has openings formed therein between two or more wires. In the expanded configuration, the opening of the at least one clot capture zone is larger than the opening 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 groupings in the at least one clot capture zone, wherein each wire grouping of the plurality of wire groupings comprises at least two wires and forms an entangled wire combination. An opening of the at least one clot capture zone is formed between the at least two entangled combinations of wires. Each wire grouping of the plurality of wire groupings includes one wire, two wires, three wires, or four wires. The at least one expandable filter segment is configured to capture smaller clots 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 between the first filter segment and a first region of the intraluminal device, and a second clot capture zone between the second filter segment and a third region of the intraluminal device. The plurality of filaments comprises at least one from the following group: eight, ten and twelve filaments. The diameter of the at least one wire is between 40 and 200 microns. For example, the diameter of the at least one wire may be 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 or ranges thereof. For example, the diameter of the at least one filament may be in a range between 50 microns and 75 microns. The intraluminal device also includes at least one radiopaque marker positioned 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 intraluminal device, the second region of the intraluminal device, and the third region of the intraluminal device are formed as a single unitary structure.
According to another exemplary embodiment of the present disclosure, a method of manufacturing an intraluminal device including an elongated body formed from a plurality of wires is provided. The method includes stranding a plurality of wires over a first segment of a mandrel to form a first cable of an elongate body. The method also includes braiding a plurality of wires over the second segment of the mandrel to form an expandable mesh segment of the elongate body configured to capture a blood clot. The method also includes stranding a plurality of wires over a third section of the mandrel to form a second cable of the elongate body. The second section of the mandrel is positioned between the first section of the mandrel and the third section of the mandrel.
The method further includes heat treating the expandable mesh segment. The second section of the mandrel has a diameter greater than the first section of the mandrel and the third section of the mandrel. The plurality of filaments comprises at least one from the following group: eight, ten and twelve filaments. At least one of the plurality of filaments has a diameter between 40 microns and 200 microns. For example, the diameter of the at least one wire may be 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 or ranges thereof. For example, the diameter of at least one of the plurality of filaments may be 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 a single unitary structure.
According to yet another exemplary embodiment of the present disclosure, an intraluminal device is provided that includes an elongated body formed from a plurality of wires. The intraluminal device includes a first region in which a plurality of wires are twisted to form a first cable. The intraluminal device also includes a second region distal to the first region, wherein the plurality of wires are braided to form an expandable mesh segment configured to capture blood clots. The intraluminal device also includes a third region distal to the second region and forming a distal tip of the elongate body, wherein the plurality of wires in the third region are twisted to form a second cable. The second cable is configured to be more flexible than the first cable.
At least one of the plurality of filaments has a diameter between 40 microns and 200 microns. For example, the diameter of the at least one wire may be 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 or ranges thereof. For example, the diameter of at least one of the plurality of filaments may be in a range between 50 microns and 75 microns. The second cable is configured to have a smaller cable winding angle than the first cable. The second cable contains fewer wires than the first cable. The second cable is processed to reduce a diameter of portions of the plurality of wires therein.
According to yet another exemplary embodiment of the present disclosure, an intraluminal device is provided that includes an elongated body formed from a plurality of wires. The intraluminal device includes a first region in which a plurality of wires are twisted to form a first cable. The intraluminal device also includes a second region distal to the first region, wherein the plurality of wires are braided 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 elongate body, wherein the plurality of wires in the third region are twisted to form a second cable. The plurality of filaments in the expandable mesh section are grouped into a plurality of filament pairs in the expandable mesh section, wherein each filament pair of the plurality of filament pairs forms an entangled filament combination. At least a first pair of the plurality of pairs of wires and at least a second pair of the plurality of pairs of wires form an intersection in the expandable mesh section, at least one wire of the first pair of wires passing between each wire of the second pair of wires at the intersection.
A first wire pair of the plurality of wire pairs includes at least a first pair twist proximate the crossover and includes at least a second pair twist distal the crossover. At least one wire of the second wire pair passes between each wire of the first wire pair at an 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 the wires of the first wire pair at the intersection.
According to another exemplary embodiment of the present disclosure, an intraluminal device is provided that includes an elongated body formed from a plurality of wires. The intraluminal device includes a first region in which a plurality of wires are twisted to form a first cable. The intraluminal device also includes a second region distal to the first region, wherein the plurality of wires are braided to form an expandable mesh segment configured to capture blood clots. The intraluminal device also includes a third region distal to the second region and forming a distal tip of the elongate body, wherein the plurality of wires in the third region are twisted to form a second cable. The first region includes more filaments than one or more of the second region and the third region.
The second region comprises the same number of filaments as the third region. The second region includes more filaments than the third region. The first region comprises eleven filaments, the second region comprises eight filaments, and the third region comprises eight filaments. The first region includes twelve filaments, the second region includes eight filaments, and the third region includes eight filaments. At least one of the plurality of filaments extends continuously from the first region to the third region. 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 unitary structure.
According to yet another exemplary embodiment of the present disclosure, a method of manufacturing an intraluminal device including an elongated body formed from a plurality of wires is provided. The method includes stranding a plurality of wires over a first segment of a mandrel to form a first cable of an elongate body. The method also includes cutting at least one of the plurality of wires at the distal end of the first cable. The method also includes braiding remaining wires of the plurality of wires over a second segment of the mandrel to form an expandable mesh segment of the elongate body configured to capture blood clots. The method also includes stranding remaining filaments of the plurality of filaments on a third section of the mandrel to form a second cable of the elongate body. The second section of the mandrel is positioned between the first section of the mandrel and the third section of the mandrel.
The method also includes cutting at least one of the plurality of wires at the distal end of the expandable mesh segment. The method further includes heat treating the expandable mesh segment. The second section of the mandrel has a diameter greater than the first section of the mandrel and the third section of the mandrel. The plurality of threads comprises eight threads, ten threads or twelve threads. At least one of the plurality of filaments has a diameter between 40 microns and 200 microns. For example, the diameter of the at least one wire may be 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 or ranges thereof. For example, the diameter of at least one of the plurality of filaments may be 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 a single unitary structure.
According to yet another exemplary embodiment of the present disclosure, an intraluminal device is provided that includes an elongated body formed from a plurality of wires. An intraluminal device comprising: a first region in which a plurality of filaments are twisted to form a first cable; a second region distal to the first region, wherein the plurality of wires are braided to form an expandable mesh segment; and a third region distal to the second region and forming a distal tip of the elongate body, wherein the plurality of wires in the third region are twisted to form a second cable. The plurality of filaments in the expandable mesh segment includes a first set of filaments and a second set of filaments. The first set of filaments comprises two filaments and the second set of filaments comprises three filaments. Each of the plurality of filaments includes a first side and a second side opposite the first side. The first filament of the first set of filaments is configured to pass over a first side of both the first filament of the second set of filaments and the second filament of the second set of filaments. A first filament of the first set of filaments is configured to pass over a second side of a third filament of the second set of filaments. The second filament of the first set of filaments is configured to pass over the second side of both the first filament of the second set of filaments and the second filament of the second set of filaments. A second filament of the first set of filaments is configured to pass over a first side of a third filament of the second set of filaments.
According to yet another exemplary embodiment of the present disclosure, an intraluminal device is provided that includes an elongated body formed from a plurality of wires. An intraluminal device comprising: a first region in which a plurality of filaments are twisted to form a first cable; a second region distal to the first region, wherein the plurality of wires are braided to form an expandable mesh segment; and a third region distal to the second region and forming a distal tip of the elongate body, wherein the plurality of wires in the third region are twisted to form a second cable. The plurality of filaments in the expandable mesh segment includes a first set of filaments and a second set of filaments. The first set of filaments includes two filaments. The second set of filaments includes three filaments. Each of the plurality of filaments includes a first side and a second side opposite the first side. The first filament of the first set of filaments is configured to pass over a first side of the first filament of the second set of filaments and over a second side of both the second filament of the second set of filaments and the third filament of the second set of filaments. The second filament of the first set of filaments is configured to pass over a first side of each filament of the second set of filaments.
According to yet another exemplary embodiment of the present disclosure, an intraluminal device is provided that includes an elongated body formed from a plurality of wires. An intraluminal device comprising: a first region in which a plurality of filaments are twisted to form a first cable; a second region distal to the first region, wherein the plurality of wires are braided to form an expandable mesh segment; and a third region distal to the second region and forming a distal tip of the elongate body, wherein the plurality of wires in the third region are twisted to form a second cable. The plurality of filaments in the expandable mesh segment includes a first set of filaments and a second set of filaments. The first set of filaments includes three filaments and the second set of filaments includes three filaments. Each of the plurality of filaments includes a first side and a second side opposite the first side. The first filament of the first set of filaments is configured to pass over a first side of the first filament of the second set of filaments and over a second side of both the second filament of the second set of filaments and the third filament of the second set of filaments. The second filament of the first set of filaments is configured to pass over a first side of the first filament of the second set of filaments and over a second side of both the second filament of the second set of filaments and a third filament of the second set of filaments. The third filament of the first set of filaments is configured to pass over a first side of each filament of the second set of filaments.
According to yet another exemplary embodiment of the present disclosure, an intraluminal device is provided that includes an elongated body formed from a plurality of wires. An intraluminal device comprising: a first region in which a plurality of filaments are twisted to form a first cable; a second region distal to the first region, wherein the plurality of wires are braided to form an expandable mesh segment; and a third region distal to the second region and forming a distal tip of the elongate body, wherein the plurality of wires in the third region are twisted to form a second cable. The plurality of filaments in the expandable mesh segment are grouped into a plurality of filament groups in the expandable mesh segment. Each of the plurality of filament groups crosses another of the plurality of filament groups in the expandable mesh segment. A first filament group of the plurality of filament groups includes three filaments forming a twisted structure, wherein each filament of the three filaments is twisted about the other two filaments of the three filaments. The twisted structure of the first set of wires is positioned in a section of the expandable mesh segment between two adjacent crossings of the first set of wires.
According to yet another exemplary embodiment of the present disclosure, an intraluminal device is provided that includes an elongated body formed from a plurality of wires. An intraluminal device comprising: a first region in which a plurality of filaments are twisted to form a first cable; a second region distal to the first region, wherein the plurality of wires are braided to form an expandable mesh segment; and a third region distal to the second region and forming a distal tip of the elongate body, wherein the plurality of wires in the third region are twisted to form a second cable. The plurality of filaments in the expandable mesh segment are grouped into a plurality of filament groups in the expandable mesh segment. Each of the plurality of filament groups crosses another of the plurality of filament groups in the expandable mesh segment. A first filament group of the plurality of filament groups includes three filaments. A first filament of the three filaments and a second filament of the three filaments form a twisted structure, wherein each of the first and second filaments are twisted around each other. The third wire of the three wires is not twisted with the first and second wires of the twisted structure. The twisted structure is positioned in a section of the expandable mesh segment between two adjacent crossings of the first set of wires.
According to yet another exemplary embodiment of the present disclosure, an intraluminal device is provided that includes an elongated body formed from a plurality of wires. An intraluminal device comprising: a first region in which a plurality of filaments are twisted to form a first cable; a second region distal to the first region, wherein the plurality of wires are braided to form an expandable mesh segment; and a third region distal to the second region and forming a distal tip of the elongate body, wherein the plurality of wires in the third region are twisted to form a second cable. The plurality of filaments in the expandable mesh segment are grouped into a plurality of filament groups in the expandable mesh segment. Each of the plurality of filament groups crosses another of the plurality of filament groups in the expandable mesh segment. A first filament group of the plurality of filament groups includes three filaments. Each of the three filaments has a first side and a second side opposite the first side. The first set of filaments forms an interlocking structure in a section of the expandable mesh segment between two adjacent crossings of the first set of filaments. The first filament of the first filament group is configured to pass over a first side of the second filament of the first filament group and over a second side of the third filament of the first filament group within the interlocking structure. Within the interlocking structure, the second wire of the first wire set is not in contact with the third wire of the first wire set.
Drawings
Fig. 1 illustrates an example intraluminal device according to various embodiments of the present disclosure.
Fig. 2A illustrates an enlarged view of a distal transition region of the intraluminal device of fig. 1, according to various embodiments of the present disclosure.
Fig. 2B illustrates an enlarged view of a distal coil of the intraluminal device of fig. 1, according to various embodiments of the present disclosure.
Fig. 3A illustrates an enlarged view of a proximal transition region of the intraluminal device of fig. 1, according to various embodiments of the present disclosure.
Fig. 3B illustrates an enlarged view of a proximal coil of the intraluminal device of fig. 1, according to various embodiments of the present disclosure.
Fig. 4 illustrates another example intraluminal device according to various embodiments of the present disclosure.
Fig. 5 illustrates an enlarged view of wire crossing of the intraluminal device of fig. 4, according to various embodiments of the present disclosure.
Fig. 6A-6C illustrate an exemplary method of manufacturing an intraluminal device according to various embodiments of the present disclosure.
Fig. 7 illustrates yet another exemplary intraluminal device according to various embodiments of the present disclosure.
Fig. 8A-8B illustrate exemplary wire crossings of an intraluminal device according to various embodiments of the present disclosure.
Fig. 9 illustrates another exemplary wire crossing of an intraluminal device according to various embodiments of the present disclosure.
Figure 10 illustrates yet another exemplary method of manufacturing an intraluminal device according to various embodiments of the present disclosure.
Fig. 11A-11B illustrate exemplary wire weave patterns of intraluminal devices according to various embodiments of the present disclosure.
Fig. 12A-12B illustrate another exemplary wire weave pattern of an intraluminal device according to various embodiments of the present disclosure.
Fig. 13A-13B illustrate yet another exemplary wire weave pattern of an intraluminal device according to various embodiments of the present disclosure.
Detailed Description
Exemplary embodiments are described with reference to the accompanying drawings. In the drawings, which are not necessarily drawn to scale, the left-most digit(s) of a reference number identifies the drawing in which the reference number first appears. Wherever convenient, the same reference numbers will be used throughout the drawings to refer to the same or like parts. Although examples and features of the disclosed principles are described herein, modifications, adaptations, and other implementations can be made without departing from the spirit and scope of the disclosed embodiments. Also, the terms "comprising," "having," "containing," and "including," and other similar forms are intended to be equivalent in meaning and open in a non-limiting sense, as items following any one of these terms are not intended to be exhaustive or limited to only the listed items. It should also be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.
Embodiments of the present disclosure generally relate to medical devices and methods for treating an occlusion in a body. More particularly, embodiments of the present disclosure relate to devices and methods for removing clots (including, but not limited to, emboli and thrombi) from blood vessels. Additionally or alternatively, embodiments of the present disclosure may also be used in dilating occluded hollow body organs, and in other medical procedures where removal of an obstruction or foreign body is desired.
In accordance with embodiments of the present disclosure, an intraluminal device may be provided that includes an expandable clot engaging member. The expandable clot engaging member may have a mesh or stent-like structure and may be configured to capture, retain and remove a blood clot or other obstruction as it is deployed and expanded within a hollow body organ, such as a blood vessel.
Fig. 1 illustrates an exemplary intraluminal device 1000. The device 1000 may include a
In some embodiments, the diameter of the filament may be between 40 microns and 200 microns. For example, but not limiting of, the diameter of the wire in the device 1000 may be any of the following: 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 or ranges thereof. For example, the diameter of the wire may be in a range between 50 microns and 75 microns. Advantageously, wires having diameters between 50 and 75 microns may allow the
In some embodiments, multiple wires may be braided in the clot engaging member 1300 to form an expandable mesh or stent-like structure. Within the mesh structure, a plurality of wires may be woven to cross each other without connecting, such that the wires may be configured to move relative to each other. In some embodiments, the wires may cross and bend to form a mesh structure such that the proximal and distal ends of the clot engaging member 1300 may be free of exposed ends of the wires; the absence of exposed ends may reduce trauma to the anatomy.
The clot engaging assembly 1300 may be configured to radially expand and contract; thus, the clot engaging member 1300 may be configured to transition between a radially contracted configuration and a radially expanded configuration. In some embodiments, the clot engaging member 1300 may self-expand due at least in part to the arrangement and material composition of the plurality of wires. For example, the intraluminal device 1000 may be delivered to the treatment site within a delivery sheath (not shown) that may hold the clot engaging member 1300 in the collapsed 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 member 1300.
Additionally or alternatively, the device 1000 may include at least one elongated control member (not shown) that may control the expansion and contraction of the clot engaging member 1300. The control member may include wires or filaments that are connected to the distal end of the
The plurality of wires of the intraluminal device 1000 may be constructed of any suitable flexible material known to those skilled 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 wire may be constructed of a superelastic metal such as Nitinol (Nitinol). To visualize the clot engaging member 1300 using angiographic imaging, the wire may also include radiopaque markers and/or materials. For example, in one embodiment, device 1000 may include a plurality of nitinol wires having a core made of tantalum or platinum metal. The radiopaque core may comprise 20% to 50% (e.g., 30% or 40%) by volume. In further embodiments, the wire may be rendered radiopaque by depositing a thin layer of radiopaque metal (such as platinum). In some embodiments, such radiopaque features may be positioned at the proximal and distal ends of the clot engaging member 1300 in fig. 1.
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, thereby surrounding and radially compressing the device, including the clot engaging member 1300. The sheath may be removable from the device 1000, thereby enabling the clot engaging member 1300 to radially expand in a blood 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 a sheath. The sheath may be configured to allow controlled expansion and contraction of the clot engaging member 1300. For example, as previously described, the clot engaging member 1300 may be configured to radially expand upon removal of the sheath (e.g., when the sheath is proximally retracted). Additionally, the device 1000 can be returned to the sheath (e.g., by pulling the device 1000 proximally into the sheath) to return the clot engaging member 1300 to the collapsed configuration.
The intraluminal device 1000 may be configured to capture and remove obstructions, such as blood clots, from the body. Additionally or alternatively, the device 1000 may be configured to apply an outward force on a wall of a hollow body organ (such as a blood vessel). In some embodiments, the clot engaging member 1300 may be configured to exhibit a substantially uniform shape when in the expanded configuration. Alternatively, as shown in fig. 1, the clot engaging member 1300 may be configured to exhibit a substantially asymmetric shape when in the expanded configuration. In accordance with the present disclosure, the asymmetric shape may improve the ability of the clot engaging member 1300 to conform to the anatomy of a blood vessel.
In some embodiments, at least a portion of the clot engaging member 1300 may be configured to expand to about the inner diameter of a blood vessel at the site of a blood clot. Expansion to about the inner diameter of the vessel may cause the clot engaging member 1300 to exert a force on the vessel wall, thereby separating the clot from the vessel wall. Advantageously, the separation of 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 into multiple fragments (fragments) during removal from the vessel. In the collapsed configuration, the clot engaging member 1300 may apply a force to a clot contained therein, retaining the clot within the intraluminal device 1000 and mitigating the tendency of the clot to fragment. The clot is then removed from the blood vessel with the clot only remaining within the clot engaging member 1300. Alternatively, for a clot that is small enough to fit within the delivery sheath, the clot may be pulled into the delivery sheath before the clot is removed from the blood vessel. In this manner, the delivery sheath can exert further retention force on the clot.
In some embodiments, the clot engaging component 1300 may include one or more clot capture zones 1310, 1320, distal filter 1330 and/or proximal filter 1340, each having a braided pattern of wires extending therethrough. In the example of fig. 1, the clot engaging component 1300 includes two clot capture zones, a distal filter and a proximal filter. However, in alternative embodiments, the clot engaging component may not include one or more of a capture zone, a distal filter, and a proximal filter. Further, in alternative embodiments, the clot engaging component may include one, three, four, five or more clot capture zones. Proximal filter 1340 can intersect
In some embodiments, one or more of the plurality of wires may extend continuously through the
Figure 2A illustrates an enlarged view of a distal transition region of an intraluminal device 1000. Fig. 2A shows a
As also shown in fig. 2A, the distal filter 1330 may have a wire weave pattern including a plurality of
In some embodiments, the wires in the
Fig. 2B illustrates an enlarged view of the
Figure 3A illustrates an enlarged view of a proximal transition region of an intraluminal device 1000. Fig. 3A shows the
As also shown in fig. 3A, the proximal filter 1340 can have a wire weave pattern including a plurality of
Fig. 3B illustrates an enlarged view of the
Fig. 4 illustrates another exemplary intraluminal device 4000. The device 4000 may include a distal cable 4100, a proximal cable 4200, and an expandable clot engaging member 4300 therebetween. The device 4000 may be formed from multiple wires that may be braided in the clot engaging member 4300 to form an expandable mesh or stent-like structure. In some embodiments, the wire may extend continuously from the proximal end of device 4000 to the distal end of device 4000, including through transitions 4105 and 4205.
The clot engaging component 4300 may include a predetermined number of wires to achieve a desired mesh arrangement. The clot engaging component 4300 may include one or more pairs of coiled wires 4330 and/or one or more cables 4320 of three coiled wires. Clot capture window 4316 may be formed between pair 4330 and/or cable 4320. For example, the clot engaging member 4300 may include eight wires formed from four pairs 4330 of wires. In an alternative example, the clot engaging member 4300 may include ten wires formed by two pairs of wires 4330 and two cables 4320 of wires. In another example, the clot engaging member 4300 may include twelve wires formed from four cables 4320 of wires. In yet another example, the clot engaging member 4300 may include twelve wires formed from six pairs 4330 of wires. Alternatively, the clot engaging member 4300 may be formed of any other suitable number of pairs of wire 4330 and/or wire cables 4320.
Figure 5 illustrates an exemplary wire crossing 5000 of an intraluminal device 4000. The
In
Figures 6A-6C illustrate an exemplary method of manufacturing an intraluminal device. Although the examples shown in fig. 6A-6C illustrate the manufacture of an exemplary
Exemplary
As shown in fig. 6A-6C, multiple wires may be continuously braided along
As shown in fig. 6A, the wire may be coiled around the
Advantageously, the lack of connections or attachments between portions of the
In some embodiments, at least a portion of the formed
Fig. 7 illustrates yet another exemplary
Advantageously, incorporating different numbers of wires in various segments of
Additionally, the number of wires within the
In addition, the angle of the twist of the wires in the
The example
Fig. 8A, 8B, 9, and 10 illustrate
In some embodiments, one or more of the
Fig. 8A and 8B illustrate a wire crossover 8000. In some embodiments, when one of the three filaments 8202, 8204, 8206 is an excess filament; that is, crossover 8000 may be utilized when the desired filament pattern instead includes an intersection between two pairs of filaments. The filaments 8102 may pass over the filaments 8202, 8204 and under the filaments 8206 (cross), while the filaments 8104 may pass under the filaments 8202, 8204 and over the filaments 8206. The filament 8102 may also pass over the filament 8104. As used herein, the relative terms "above" and "below" may be replaced by terms defining a "first side" of the filament and a "second side" of the filament, where the "first side" of the filament is opposite the "second side". For example, as shown in fig. 8A and 8B, the filaments 8102 and 8104 may form a first set of filaments and the filaments 8202, 8204, and 8206 may form a second set of filaments. As shown in fig. 8A, a first filament 8102 of a first set of filaments may be configured to pass over a first side of a first filament 8202 of a second set of filaments and a first side of a second filament 8204 of the second set of filaments (e.g., over), and the first filament 8102 of the first set of filaments may be configured to pass over a second side of a third filament 8206 of the second set of filaments (e.g., under). Additionally, the second filaments 8104 of the first set of filaments may be configured to pass over the second side of the first filaments 8202 of the second set of filaments and the second side of the second filaments 8204 of the second set of filaments (e.g., passing under), and the second filaments 8104 of the first set of filaments may be configured to pass over the first side of the third filaments 8206 of the second set of filaments (e.g., passing over).
Fig. 9 illustrates a
Advantageously, the
Fig. 10 illustrates a
Fig. 11A-11B, 12A-12B, and 13A-13B illustrate exemplary
As shown in fig. 11A-11B, the
As shown in fig. 12A-12B, the
As shown in fig. 13A-13B, the wire weave pattern 13000 includes a weave pattern of a first set of three wires 13102, 13104, 13106. The wire weave pattern 13000 may include an interlocking five-month post (maypole) structure of wires 13102, 13104, 13106. As shown in fig. 13A, within the interlocking pentium structure, the first wire 13102 may be configured to pass over (e.g., pass under) a second side of the second wire line 13104. Additionally, the first filament 13102 may be configured to pass over a first side of the third filament 13106 (e.g., over). However, the second and third filaments 13104, 13106 do not contact or cross each other in the interlocking pentium structure of the pattern 13000. The interlocking pentagonal pillar structure of pattern 13000 can be formed in portions of the mesh segment where the filaments 13102, 13104, 13106 do not intersect another set of filaments (that is, between two adjacent intersections of a first set of filaments with other sets of filaments). Advantageously, the pattern 13000 can secure the wires 13102, 13104, and 13106 from moving or sliding axially relative to one another, and can also prevent the profile of the intraluminal device from becoming larger due to the presence of one or more excess wires, as no more than two wires are in contact at any given point within the pattern 13000. In some embodiments, pattern 13000 can be used in a set of filaments (e.g., filaments 13102, filaments 13104, and/or filaments 13106) that has one or more excess filaments.
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 to the embodiments will be apparent from consideration of the specification and practice of the disclosed embodiments. Although certain components have been described as being coupled to one another, the components may be integrated with or distributed across one another in any suitable manner.
Moreover, although illustrative embodiments have been described herein, the scope includes any and all embodiments, modifications, omissions, combinations (e.g., of aspects across various embodiments), adaptations and/or alterations based on the present disclosure having equivalent elements. The elements of the claims are to be interpreted broadly based on the language employed in the claims and not limited to examples described in the specification or during the prosecution of the application, which examples are to be construed as non-exclusive. Further, the steps of the disclosed methods may be modified in any manner, including reordering steps and/or inserting or deleting steps.
The features and advantages of the present disclosure are apparent from the detailed description, and thus, it is intended by the appended claims to cover all systems and methods that fall 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 plural terms does not necessarily denote the plural unless it is clear from the context given. Unless specifically stated otherwise, words such as "and" or "mean" and/or ". Further, since numerous modifications and variations will readily occur from a study of the present disclosure, it is not desired to limit the disclosure to the exact configuration and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the disclosure.
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.
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