Neurovascular access catheter and method of use

Abstract

Intravascular catheters are disclosed herein. In accordance with some embodiments, the present technology includes a catheter including an elongate tubular sidewall defining a lumen extending therethrough and having a proximal end, a distal end, and a length between the proximal end and the distal end. The sidewall may include a plurality of filaments, at least some of which are interwoven with other ones of the plurality of filaments. The catheter may be configured to be positioned about a turn in the blood vessel having a radius of curvature of no greater than 24 mm, and wherein, when the distal end of the catheter is distal to the turn, the lumen remains at least 70% unobstructed while torque applied to the sidewall at the proximal end of the catheter is transmitted to the distal end.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 491,260, filed March 20, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This technology relates to neurovascular access catheters and their usage. Background Technology

[0004] Many interventional neurovascular procedures, such as those treating ischemic or hemorrhagic strokes, require advancing interventional instruments through a slender catheter shaft already positioned at the desired treatment site. For optimal performance, the catheter shaft must strike a balance between various performance parameters, including maneuverability (i.e., column strength), torsion capability (e.g., the ability to transfer torque from the proximal hub to the distal end), kink resistance, and suction. Existing access catheter designs fail to achieve this balance and are often ineffective at navigating the tortuous anatomy of the neurovascular system. Therefore, a access catheter capable of reaching treatment sites within cerebral blood vessels is needed. Summary of the Invention

[0005] This subject matter technology is based, for example, on the various aspects described below (including references). Figures 1A to 4 (Note: For convenience, various examples of aspects of the subject matter are described as numbered embodiments (1, 2, 3, etc.). These are provided as examples and do not limit the subject matter.)

[0006] 1. A neurovascular distal access catheter, comprising:

[0007] An elongated tubular sidewall defines a lumen extending therethrough and has a proximal end, a distal end, and a length between the proximal and distal ends. The sidewall comprises a plurality of filaments, at least some of which are interwoven with other filaments. The catheter is configured to be positioned around a bend in the blood vessel having a radius of curvature not greater than 24 mm. The lumen remains at least 70% patent while torque applied to the sidewall at the proximal end of the catheter is transmitted to the distal end when the distal end of the catheter is distal to the bend.

[0008] 2. The catheter according to Example 1, wherein the torque is at least 12 Nm.

[0009] 3. The catheter according to Embodiment 1 or Embodiment 2, wherein the sidewall includes a longitudinal axis extending along its length, and wherein the torque applied at the proximal end of the catheter is configured to rotate the sidewall 360 degrees about the longitudinal axis.

[0010] 4. The catheter according to any one of Embodiments 1 to 3, wherein the insertion length of the catheter is at least 50% when the catheter is positioned around the bend and the torque is applied while the lumen is maintained at least 70% patency.

[0011] 5. The catheter according to any one of embodiments 1 to 4, wherein the sidewall has at least

[0012] The outer diameter of 8Fr.

[0013] 6. The catheter according to any one of embodiments 1 to 5, wherein the sidewall has at least

[0014] The outer diameter of 12Fr.

[0015] 7. The catheter according to any one of embodiments 1 to 6, wherein the bend in the blood vessel has a bending angle greater than or equal to 120 degrees.

[0016] 8. The catheter according to any one of Embodiments 1 to 7, wherein the sidewall defines a lumen extending along the longitudinal axis, and wherein the proximal end of the catheter is configured to be fluidly coupled to a negative pressure source to aspirate occlusive material within the blood vessel into and through the lumen.

[0017] 9. An intravascular catheter, comprising:

[0018] A tubular sidewall having a longitudinal axis, the sidewall comprising a first number of first guidewires and a second number of second guidewires, the second number being greater than the first number.

[0019] First quantity, of which:

[0020] The first guide wire has a first cross-sectional area and is spirally wound around the longitudinal axis in a first direction without crossing each other, and the second guide wire has a second cross-sectional area smaller than the first cross-sectional area, wherein the second guide wire comprises (a) a first group wound along the first direction without crossing the first guide wire, and (b) a second group wound along a second direction opposite to the first direction, and wherein the guide wire in the second group is interwoven with the first guide wire and the first group of the second guide wire.

[0021] 10. The catheter according to Example 9, wherein the second quantity is at least five times the first quantity.

[0022] 11. The catheter according to Example 9 or Example 10, wherein the cross-sectional shape of the first guidewire is different from the cross-sectional shape of the second guidewire.

[0023] 12. The catheter according to any one of Examples 9 to 11, wherein the first guidewire has a rectangular cross-sectional shape and the second guidewire has a circular cross-sectional shape.

[0024] 13. The catheter according to any one of Examples 9 to 12, wherein the sidewall defines a lumen, and wherein the proximal end of the catheter is configured to be fluidly connected to a negative pressure source to aspirate occlusive material within the blood vessel into and through the lumen.

[0025] 14. An intravascular catheter, comprising:

[0026] The proximal end, the distal end, and the longitudinal axis extending between the proximal end and the distal end;

[0027] A tubular sidewall defining a lumen, the sidewall including a plurality of guidewires embedded in a material, the plurality of guidewires including a first number of first guidewires and a second number of second guidewires, the second number being greater than the first number, wherein:

[0028] The first guidewire is helically wound around the longitudinal axis in the first direction without crossing each other, and the first guidewire is configured to resist radial collapse of the sidewalls.

[0029] The second guidewire comprises (a) a first group wound along the first direction and not intersecting with the first guidewire, and (b) a second group wound along a second direction opposite to the first direction, wherein the second guidewire is configured to engage the first guidewire to resist radial expansion of the first guidewire, thereby providing improved torsional capacity of the sidewall.

[0030] The proximal end of the catheter is configured to be fluidly connected to a negative pressure source to apply suction through the lumen.

[0031] 15. The catheter according to embodiment 14, wherein the material is a first material, and the plurality of guidewires and the first material together form a first layer, and wherein the sidewall further includes a second layer radially inside the first layer.

[0032] 16. The catheter according to embodiment 14, wherein the material is a first material, and the plurality of guidewires and the first material together form a first layer, and wherein the sidewalls further include a second layer radially outside the first layer.

[0033] 17. The catheter according to embodiment 14, wherein the material is a first material, and the plurality of guidewires and the first material together form a first layer, and wherein the sidewall further includes a second layer radially inner to the first layer and a third layer radially outer to the first layer.

[0034] 18. The catheter according to any one of Examples 14 to 17, wherein the proximal end of the catheter is configured to be fluidly connected to a negative pressure source to aspirate occlusive material within the blood vessel into and through the lumen.

[0035] 19. The catheter according to any one of Examples 14 to 18, wherein the tubular sidewall has an outer diameter of at least 8 Fr.

[0036] 20. The catheter according to any one of Examples 14 to 18, wherein the tubular sidewall has an outer diameter of at least 12 Fr.

[0037] 21. A neurovascular access conduit, comprising:

[0038] An elongated tubular sidewall defines a lumen extending therethrough and has a proximal end, a distal end, and a length between the proximal and distal ends. The sidewall includes a coil portion and a braided portion, the braided portion comprising a plurality of filaments, fewer than all of which are interwoven with other filaments among the plurality of filaments. The catheter is configured to be positioned around a bend in a cerebral blood vessel having a radius of curvature not greater than 24 mm. The lumen remains at least 70% patent when the distal end of the catheter is distal to the bend, torque applied to the sidewall at the proximal end of the catheter is transmitted to the distal end.

[0039] 22. The catheter of claim 21, wherein the torque is at least 12 Nm.

[0040] 23. The catheter of claim 21 or claim 22, wherein the sidewall includes a longitudinal axis extending along its length, and wherein the torque applied at the proximal end of the catheter is configured to rotate the sidewall 360 degrees about the longitudinal axis.

[0041] 24. The catheter according to any one of claims 21 to 23, wherein the insertion length of the catheter is at least 50% when the catheter is positioned around the bend and the torque is applied while the lumen is maintained at least 70% patency.

[0042] 25. The catheter according to any one of claims 21 to 24, wherein the coil portion is located proximal to the braided portion along the length of the sidewall.

[0043] 26. The catheter according to any one of claims 21 to 24, wherein the coil portion is located distal to the braided portion along the length of the sidewall.

[0044] 27. The catheter according to any one of claims 21 to 26, wherein the sidewall has an outer diameter of no more than 6 Fr.

[0045] 28. The catheter according to any one of claims 21 to 27, wherein the sidewall defines a lumen extending along the longitudinal axis, and wherein the proximal end of the catheter is configured to be fluidly coupled to a negative pressure source to aspirate occlusive material within the blood vessel into and through the lumen.

[0046] 29. An intravascular catheter, comprising:

[0047] A tubular sidewall having a longitudinal axis, the sidewall comprising:

[0048] The coil portion includes an elongated filament wound around the longitudinal axis of the sidewall; and

[0049] The woven portion includes:

[0050] First guidewire and second guidewire, wherein:

[0051] The first guidewire has a first cross-sectional area and is spirally wound around the longitudinal axis in a first direction without crossing each other, and

[0052] The second guide wire has a second cross-sectional area smaller than the first cross-sectional area, wherein the second guide wire includes (a) a first group wound along the first direction and not intersecting with the first guide wire, and (b) a second group wound along a second direction opposite to the first direction, and wherein the guide wire in the second group is interwoven with the first guide wire and the first group of second guide wires.

[0053] 30. The catheter of claim 29, wherein the coil portion is located proximal to the braided portion along the longitudinal axis of the sidewall.

[0054] 31. The catheter of claim 29, wherein the coil portion is located distal to the braided portion along the longitudinal axis of the sidewall.

[0055] 32. The catheter according to any one of claims 29 to 31, wherein the cross-sectional shape of the first guidewire is different from the cross-sectional shape of the second guidewire.

[0056] 33. The catheter according to any one of claims 29 to 32, wherein the first guidewire

[0057] The first guide wire has a rectangular cross-sectional shape, and the second guide wire has a circular cross-sectional shape.

[0058] 34. An intravascular catheter, comprising:

[0059] The proximal end, the distal end, and the longitudinal axis extending between the proximal end and the distal end;

[0060] A tubular sidewall defining a lumen, the sidewall comprising a coil and a braid embedded in a material, the braid comprising a plurality of guidewires, the plurality of guidewires including a first guidewire and...

[0061] The second guidewire, wherein:

[0062] The first guidewire is helically wound around the longitudinal axis in the first direction without crossing each other, and the first guidewire is configured to resist radial collapse of the sidewalls.

[0063] The second guidewire comprises (a) a first group wound along the first direction and not intersecting with the first guidewire, and (b) a second group wound along a second direction opposite to the first direction, wherein the second guidewire is configured to engage the first guidewire to resist radial expansion of the first guidewire, thereby providing improved torsional capacity of the sidewall.

[0064] The proximal end of the catheter is configured to be fluidly connected to a negative pressure source to apply suction through the lumen.

[0065] 35. The catheter of claim 34, wherein the material is a first material, and the plurality of guidewires and the first material together form a first layer, and wherein the sidewall further comprises a second layer radially inside the first layer.

[0066] 36. The catheter of claim 34 or claim 35, wherein the material is a first material, and the plurality of guidewires and the first material together form a first layer, and wherein the sidewalls further include a second layer radially outside the first layer.

[0067] 37. The catheter according to any one of claims 34 to 36, wherein the material is a first material, and the plurality of guidewires and the first material together form a first layer, and wherein the sidewall further comprises a second layer radially inner to the first layer and a third layer radially outer to the first layer.

[0068] 38. The catheter according to any one of claims 34 to 37, wherein the coil is located proximal to the braid along the longitudinal axis of the catheter.

[0069] 39. The catheter according to any one of claims 34 to 37, wherein the coil is located distal to the braid along the longitudinal axis of the catheter.

[0070] 40. The catheter according to any one of claims 34 to 39, wherein the tubular sidewall has an outer diameter of no more than 6 Fr. Attached Figure Description

[0071] Many aspects of this disclosure can be better understood by referring to the following accompanying drawings. The components in the drawings are not necessarily drawn to scale. Rather, the focus is on clearly illustrating the principles of this disclosure.

[0072] Figure 1A A side view of a catheter constructed according to several embodiments of the present technology.

[0073] Figure 1B For the section taken along line 1B-1B Figure 1A An axial cross-sectional view of the conduit.

[0074] Figure 2 This is an axial cross-sectional view of a conduit constructed according to several embodiments of the present technology.

[0075] Figure 3 A side view of a portion of a catheter constructed according to several embodiments of the present technology.

[0076] Figure 4 A side view of a portion of a catheter constructed according to several embodiments of the present technology. Detailed Implementation

[0077] This technology involves catheters and related usage methods. See below for reference. Figures 1A to 4 Specific details are described for several embodiments of catheter devices, systems, and methods according to the present technology. Many embodiments of the present technology are particularly useful for treating targets in tortuous and / or narrowed vessels located within the neurovascular system. Although the catheter construction disclosed herein is described in the context of mechanical thrombectomy, the present technology can be used in other medical procedures. Similarly, although the catheter construction of the present technology is described in the context of access catheters, the present technology can be used for other types of catheters, including those not intended for and / or unsuitable for access, such as aspiration catheters, support catheters, etc.

[0078] Regarding the terms "distal" and "proximal" in this specification, unless otherwise stated, these terms refer to the relative position of portions of the tube and / or associated device with respect to the operator and / or the vascular system. Furthermore, as used herein with respect to a particular material or layer, the term "thickness" refers to the perpendicular distance between a plane passing through and substantially parallel to the radially outermost surface of the particular material or layer and a plane passing through and substantially parallel to the radially innermost surface of the particular material or layer.

[0079] Figure 1A This is a side view of a catheter 100 constructed according to several embodiments of the present technology, and Figure 1B It is along Figure 1A Axial view of the cross-section taken by line 1B-1B. (See also: [reference needed]) Figure 1A and Figure 1B The catheter 100 includes a handle assembly 102 and an elongated shaft 104 having a proximal portion 104a and a distal portion 104b coupled to the handle assembly 102. The handle assembly 102 includes a hub 106 and a transition portion 108, the hub being configured to facilitate connection to a negative pressure source (not shown) and / or other devices (e.g., a syringe, a Y-adapter, etc.), and the transition portion being configured to provide strain relief at the proximal portion 104a. In other embodiments, the handle assembly 102 may have other suitable configurations based on the desired function and characteristics of the catheter 100.

[0080] Shaft 104 includes a generally tubular sidewall having an inner surface that defines a lumen 110 extending from a proximal portion 104a of shaft 104 to the distal end of a distal portion 104b. Figure 1B The lumen 110 may be configured to slidably receive and facilitate the passage of one or more medical devices, such as guidewires, balloon catheters, implants, intra-balloon occlusion devices (e.g., coils, expandable cages, expandable meshes, etc.), infusion devices, stents and / or stent grafts, endovascular occlusion devices, clot retrieval devices, implantable heart valves, and other suitable medical devices and / or associated delivery systems. Additionally or alternatively, the lumen 110 may be configured to receive one or more fluids passing through it, such as radiopaque dyes, saline, drugs, etc.

[0081] The dimensions of the lumen 110 (or the inner diameter of the shaft 104) can vary depending on the desired characteristics of the conduit 100. In some examples, the shaft 104 may have an inner diameter of about 0.04 inches (3 French) to about 0.08 inches (6 French), about 0.05 inches (4 French) to about 0.07 inches (5 French), not exceeding about 0.07 inches (5 French), or not exceeding about 0.80 inches (6 French). Although Figure 1AThe shaft 104 shown has a generally circular cross-sectional shape; however, it should be understood that the shaft 104 may include other cross-sectional shapes or combinations of shapes. For example, the cross-sectional shape of the shaft 104 may be elliptical, rectangular, square, triangular, polygonal, and / or any other suitable shape and / or combination of shapes.

[0082] The outer diameter of shaft 104 can be constant or vary along its length. For example, in Figure 1A and Figure 1B In the illustrated embodiment, shaft 104 has an outer diameter that is substantially constant along its length. In some embodiments, the outer diameter of shaft 104 decreases (gradually or continuously) in a proximal-to-distal direction. In either case, the outer diameter of shaft 104 can be selected for the desired use of catheter 100. For example, for neurovascular system applications, shaft 104 may have an outer diameter of about 0.053 inches (4 French) to about 0.079 inches (6 French), about 0.017 inches to about 0.079 inches (6 French), about 0.017 inches, about 0.021 inches, or about 0.024 inches.

[0083] like Figure 1A As shown, in some embodiments, shaft 104 may have a pre-shaped bend at its distal portion 104b (e.g., the shape of shaft 104 may be configured to have a desired bend angle), for example, to facilitate navigation through and around various bends in the vascular system. The portion of shaft 104 including the pre-shaped bend may be sufficiently rigid and / or resilient such that the bend angle is substantially maintained when shaft 104 is advanced / extracted through or otherwise manipulated within the vascular system. In some embodiments, the portion of shaft 104 including the pre-shaped bend comprises a composite material that reduces vascular interaction forces (compared to existing commercial catheters). The bend angle can be tailored to specific medical applications, such as the unique curvature used for navigating the pulmonary artery, iliofemoral vein, infrakal artery, and other arteries described herein.

[0084] In some implementations, shaft 104 does not have a pre-formed bend.

[0085] Shaft 104 may be formed of a first layer 114, a second layer 116, and a third layer 118. The first layer 114 may be the radially innermost layer (thus surrounding and defining the lumen 110) and surrounded by the second layer 116, and the second layer 116 may be surrounded by the third layer 118. Therefore, in some embodiments, the third layer 118 comprises the radially outermost layer of shaft 104. Figure 1BAs schematically shown, the second layer 116 may include a braid 120 embedded in material 122. In some embodiments, the second layer 116 includes only the braid 120 that can be positioned between the first layer 114 and the third layer 118 (without including material 122). In some examples where the second layer 116 includes only the braid 120, the material of the third layer 118 may be directly disposed on and around the filaments of the braid 120, such that the braid 120 is embedded within the material of the third layer 118. In some embodiments, the shaft 104 includes more or fewer than three layers (e.g., two, four, five, etc.).

[0086] The first layer 114 may extend from the proximal portion 104a of the axis 104 to a position along the distal portion 104b of the axis 104. For example, in Figure 1A and 1B In the illustrated embodiment, the first layer 114 extends from the proximal portion 104a of the shaft 104 to an opening 112 at the distal end of the distal portion 104b (e.g., the entire length of the shaft 104 or substantially the entire length of the shaft 104). In other embodiments, the first layer 114 extends only a portion of the length of the shaft 104 and / or has proximal and / or distal ends that do not respectively correspond to the proximal and / or distal ends of the shaft 104. The length of the first layer 114 may vary depending on, for example, the length of the shaft 104 and the desired characteristics and function of the catheter 100.

[0087] The first layer 114 can be made of any suitable polymer (and / or a combination of polymers) and by any suitable process. In some embodiments, the first layer 114 comprises a lubricating polymer, such as HDPE or polytetrafluoroethylene (PTFE), for example, or platinum, polyether ether ketone (PEEK), polyethylene (PE), polypropylene (PP), or a copolymer of tetrafluoroethylene, such as FEP, a copolymer of tetrafluoroethylene and perfluoroether, such as perfluoroalkoxyalkane (PFA) (more specifically, perfluoropropyl vinyl ether or perfluoromethyl vinyl ether), etc. Other suitable polymers include, for example, polyoxymethylene (POM), polybutylene terephthalate (PBT), polyether block ester, polyether block amide (PEBA), fluorinated ethylene propylene (FEP), polyvinyl chloride (PVC), polyurethane, polyimide, polyamide, polyphenylene sulfide (PPS), polyphenylene ether (PPO), polysulfone, nylon, perfluoropropyl vinyl ether (PFA), polyether ester, platinum, polymer / metal composites, Pebax, etc. (R) 2533, Pebax (R) 3533, Pebax (R) 4533, Pebax (R) 5533, Pebax (R) 6333 or Pebax (R)The material may contain 7233 or similar materials, or mixtures, blends, or combinations thereof, and may also include or be made of a lubricating polymer having a low coefficient of friction. In some embodiments (not shown), the first layer 114 comprises one or more metals or metal alloys and / or combinations thereof. In certain embodiments, the first layer 114 does not contain any polymeric material and comprises only metals and / or metal alloys.

[0088] like Figure 1B Ideally, the third layer 118 is in direct contact with at least the outer surface of the second layer 116. The third layer 118 extends distally from the proximal portion 104a of the shaft 104 to a location along the distal portion 104b of the shaft 104 (e.g., the entire length of the shaft 104 or substantially the entire length of the shaft 104). The length of the third layer 118 may vary depending on, for example, the length of the shaft 104 and the desired characteristics and function of the conduit 100. In some embodiments, the third layer 118 extends substantially the entire length of the shaft 104. In other embodiments, the third layer 118 extends only a portion of the length of the shaft 104 and / or has proximal and / or distal ends that do not respectively correspond to the proximal and / or distal ends of the shaft 104.

[0089] The third layer 118 (and / or a portion thereof) may be made from any suitable polymer (or composite material or combination thereof) and by any suitable process. Suitable polymers may include, for example, polyoxymethylene (POM), polybutylene terephthalate (PBT), polyether block ester, polyether block amide (PEBA), fluorinated ethylene propylene (FEP), polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polyurethane, polytetrafluoroethylene (PTFE), polyether ether ketone (PEEK), polyimide, polyamide, polyphenylene sulfide (PPS), polyphenylene ether (PPO), polysulfone, nylon, perfluoropropyl vinyl ether (PFA), polyether ester, Pebax. (R) 2533, Pebax (R) 3533, Pebax (R) 4533, Pebax (R) 5533, Pebax (R) 6333 or Pebax (R) 7233, platinum, polymer / metal composites, or mixtures, blends, or combinations thereof. In several embodiments, the third layer 118 is or at least comprises a lubricating polymer and / or a hydrophilic coating to facilitate the advancement of the shaft 104 through larger conduits and / or vascular systems. In some embodiments (not shown), the third layer 118 comprises one or more metals or metal alloys (combinations thereof). In certain embodiments, the third layer 118 does not contain any polymeric material and comprises only metals and / or metal alloys.

[0090] In some embodiments, the stiffness of the third layer 118 (and / or shaft 104) varies along its length. In such embodiments, the stiffness variation can be continuous or stepped by changing the size, shape, thickness, and / or material composition of the third layer 118. For example, in Figure 1A and Figure 1B In the illustrated embodiment, the third layer 118 comprises at least three distinct portions along its length (labeled as first portion 123, second portion 124, and third portion 126 from proximal to distal), wherein the respective stiffness of portions 123, 124, and 126 decreases sequentially from proximal to distal. For example, first portion 123 has a first stiffness, second portion 124 has a second stiffness less than the first stiffness, and third portion 126 has a third stiffness less than the second stiffness. In other embodiments, the stiffness of the third layer 118 and / or the stiffness of each portion 123, 124, and 126 may increase from proximal to distal (e.g., second portion 126 may be stiffer than first portion 124, etc.) or be substantially uniform from proximal to distal. In other embodiments, the third layer 118 may have more or fewer portions with different stiffnesses (e.g., one continuous portion, three portions, four portions, five portions, etc.).

[0091] The first portion 123, the second portion 124, and the third portion 126 may comprise the same or different materials. In some variations, one or more portions of the third layer 118 may be more transparent than one, some, or all of the other portions of the third layer 118 to better visualize that portion. For example, in some embodiments, the second portion 124 of the third layer 118 may be substantially transparent or translucent, while the first portion 123 and the third portion 126 are substantially opaque. In some embodiments, the third portion 126 is more transparent than the first portion 123 and the second portion 124. In some variations, the first portion 123, the second portion 124, and the third portion 126 have the same level of transparency.

[0092] It should be understood that although portions 123, 124, and 126 of the third layer 118 are described herein as separate components relative to the illustrated embodiment, portions 123, 124, and 126 may be configured as a single layer or structure. For example, the first portion 123 and the second portions 124 and 126 may be configured separately, but attached or combined together to physically form a single layer (e.g., a single homogeneous material).

[0093] Still refer to Figure 1A and Figure 1BA third layer 118 may be on and around the second layer 116, and the second layer 116 may be on and around the first layer 114. In some embodiments, some or all of the filaments of the braid 120 of the second layer 116 are in direct contact with at least a portion of the first layer 114, the third layer 118, or both. The second layer 116 may extend distally from the proximal portion 104a of the shaft 104 to a distal end aligned with or just proximal to the distal end of the shaft 104. In other embodiments, the second layer 116 extends the entire length of the shaft 104. The length of the second layer 116 may vary depending on, for example, the length of the shaft 104 and the desired characteristics and function of the conduit 100. The material 122 of the second layer 116 may be made of any suitable polymer (or composite material or combination thereof) and produced by any suitable process. Suitable polymers may include, for example, any polymer disclosed herein, including but not limited to Pebax. (R) 2533, Pebax (R) 3533, Pebax (R) 4533, Pebax (R) 5533, Pebax (R) 6333 or Pebax (R) 7233. In some embodiments, material 122 flows on the filaments of the braid 120, such that material 122 flows on and between the filaments.

[0094] Figure 3 A portion of shaft 104 is shown, in which all parts except for the braid 120 have been removed. The braid 120 may be formed from multiple interlaced filaments (e.g., as shown in the diagram). Figure 1B , Figure 2 and Figure 3 (As shown). The filaments of the braid 120 may include first filaments 130 and second filaments 132 (only a few filaments are labeled) interwoven with the first filaments 130. The first filaments 130 may be advantageously configured to resist radial collapse of the sidewalls of the shaft 104 (thus providing improved kink resistance), and the second filaments 132 may be configured to engage the first filaments 130 to resist radial expansion of the first filaments 130 when torque is applied to the proximal end portion 104a of the shaft 104 (thus providing improved torque transmission along the sidewalls with 1:1 torque control). Reference Figure 1B and Figure 3 The first filament 130 can be spirally wound around the longitudinal axis of the sidewall in a clockwise or counterclockwise direction without crossing each other (e.g., thus forming a coil). In some embodiments, such as... Figure 1BAs shown, the braid 120 may include two first filaments 130 spaced 180 degrees apart circumferentially around the shaft 104. In other embodiments, the braid 120 may include more than two first filaments 130 (e.g., three first filaments 130, four first filaments 130, etc.), provided that the dimensions of the first filaments 130 and / or the second filaments 132 are reduced to account for the smaller space between adjacent turns of the first filaments 130 and such that the filaments 130, 132 do not overlap longitudinally. Interlacing the first filaments 130 and the second filaments 132 can advantageously reduce the total thickness and outer diameter of the shaft 104 compared to placing the braid on the coil, and vice versa. Interlacing the first filaments 130 and the second filaments 132 also speeds up manufacturing, as it can be done in a single process, whereas covering the braid and the coil requires at least two separate manufacturing steps (e.g., braiding the braid tube onto the mandrel and then covering the coil, or placing the coil on the mandrel and braiding the braid tube onto the coil).

[0095] The number of second filaments 132 can be greater than the number of first filaments 130. For example, in some embodiments, the braid 104 may include at least 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 times the number of first filaments 130. In some (but not all) embodiments of a shaft 104 with an outer diameter of 8 Fr, the braid 120 may include two first filaments 130 and 14 second filaments 132. In some (but not all) embodiments of a shaft 104 with an outer diameter of 12 Fr, the braid 120 may include two first filaments 130 and 30 second filaments 132. Other combinations are also possible and are within the scope of this disclosure.

[0096] In some embodiments, the stiffness of the individual first filament 130 may differ from the stiffness of the individual second filament 132. In such embodiments, the stiffness variation can be achieved by changing the size, shape, thickness, and / or material composition of the filaments 130 and 132.

[0097] A single second filament 132 may have a cross-sectional area smaller than that of a single first filament 130. The larger dimension of the first filament 130 advantageously provides greater radial and columnar strength to the shaft 104. In some embodiments, the first filament 130 and the second filament 132 have the same cross-sectional area. The first filament 130 and the second filament 132 may have the same or different cross-sectional shapes (e.g., both are circular, both are elliptical, both are rectangular, etc.). For example, as... Figure 1B and Figure 3 As shown, in some embodiments, the first filament 130 and the second filament 132 have a rectangular cross-sectional shape. Figure 2As shown, in some variations, the first filament 130 and the second filament 132 have a circular cross-sectional shape. In some embodiments, the first filament 130 has a circular cross-sectional shape while the second filament 132 has a rectangular cross-sectional shape, or vice versa. In any case, the filaments 130 and 132 may comprise metals such as stainless steel, platinum, silver, tantalum, hyperelastic and / or shape memory materials (e.g., nitinol, cobalt-chromium alloys, MP35N, 35N LT, etc.) or others. In some embodiments, the filaments 130 and 132 may comprise or be made of non-metallic materials. The first filament 130 and the second filament 132 may be made of the same or different materials.

[0098] In some embodiments, the second filament 132 comprises a first group 134 wound in the same direction (clockwise or counterclockwise) as the first filament 130 and not intersecting the first filament 130, and a second group 136 wound in the opposite direction (clockwise or counterclockwise) to the first group 134 and the first filament 130 and interwoven with the first group 134 and the first filament 130. The second filament 132 of the second group 136 may interweave with the first group 134 and the first filament 130 in a 1-over-1 or 2-over-2 pattern or other patterns. Since the distal end of the first filament 130 is fixed at the distal end of the shaft 104, the torque applied to the proximal end portion 104a of the shaft 104 causes the first filament 130 to expand radially. However, the second filament 132 serves as a locking member that resists the radial expansion of the first filament 130 and prevents kinking.

[0099] The number of second filaments 132 in the first group 134 and the second group 136 may be the same or different. In some embodiments, the number of second filaments 132 in the first group 134 is less than the number of second filaments 132 in the second group 136. In some (but not all) embodiments of the shaft 104 with an outer diameter of 8 Fr, the braid 120 may include two first filaments 130, six first group filaments, and eight second group filaments. In some (but not all) embodiments of the shaft 104 with an outer diameter not exceeding 6 Fr, the braid 120 may include two first filaments 130, 14 first group filaments 134, and 16 second group filaments 136. Other combinations are also possible and are within the scope of this disclosure.

[0100] The catheter 100 of this technology is configured to be positioned around a bend in a blood vessel (or any tube) having a radius of curvature of 24 mm or less, and to withstand a torque of at least 360 degrees (e.g., to guide the distal end of the bend in one direction) or at least 12 Nm, while the sidewalls of the shaft 104 do not collapse inward (e.g., kink) at any point along the length of the shaft 104. In other words, when the distal end of the catheter 100 is located distal to a bend in a blood vessel (or any tube) having a radius of curvature of 24 mm or less, the lumen 110 of the shaft 104 remains at least 70%, at least 80%, at least 90%, or substantially 100% patent while a torque of at least 360 degrees or at least 12 Nm is applied to the sidewalls at the proximal end portion 104a of the shaft 104. Therefore, the catheter 100 of this technology can be positioned around a bend in the blood vessel having a radius of curvature of 24 mm or less, and receive a second elongated device passing through it (such that the distal end of the second elongated device extends distally to the distal end of the shaft 104), wherein the outer diameter of the second elongated device is at least 70%, 80% or 90% of the inner diameter of the shaft 104.

[0101] In some examples, the second layer 116 includes a first length comprising coils and a second length comprising braids, arranged end-to-end along the longitudinal axis of axis 104. For example, Figure 4 A portion of shaft 104 is shown, including a second layer 116 comprising coils 140 and a braid 120. The coils 140 can be formed from elongated filaments 142 wound around a longitudinal axis. The elongated filaments 142 can have any suitable cross-sectional shape, such as rectangular, circular, oval, etc. The coils 140 can be embedded in the same material 122 as the braid 120, or they can be embedded in a different material.

[0102] In some embodiments, coil 140 is positioned proximal to the braid 120 along a longitudinal axis. Coil 140 may extend distally from a proximal end at the proximal end of shaft 104 to a distal end at the proximal end of braid 120. In some examples, the proximal end of coil 140 may not coincide with the proximal end of shaft 104 (e.g., the proximal end of coil 140 is spaced apart from the proximal end of shaft 104), and / or the distal end of coil 140 may not coincide with the proximal end of braid 120 (e.g., the distal end of coil 140 is spaced apart from the proximal end of braid 120). The pitch of coil 140 may vary along the length of coil 140 or be substantially constant.

[0103] In some embodiments, coil 140 is disposed distal to the braid 120 along a longitudinal axis. Coil 140 may extend distally from a proximal end at the distal end of shaft 104 to a distal end at the distal end of shaft 104. In some examples, the proximal end of coil 140 may not coincide with the distal end of braid 120 (e.g., the proximal end of coil 140 is spaced apart from the distal end of braid 120), and / or the distal end of coil 140 may not coincide with the distal end of shaft 104 (e.g., the distal end of coil 140 is spaced apart from the distal end of shaft 104). The pitch of coil 140 may vary along the length of coil 140 or be substantially constant.

[0104] In some examples, the second layer 116 includes one or more coils and one or more braids. For example, the second layer 116 may include a first coil 140, a braid 120 located distal to the first coil 140 along the longitudinal axis of axis 104, and a second coil (not shown) located distal to the braid 120. The first coil and the second coil may have the same pitch or different pitches and / or the same flexibility or different flexibility.

[0105] As previously described, the catheter 100 of this technology can be used in various interventional neurovascular procedures. For example, the catheter 100 of this technology can be used to remove clots from the neurovascular system (e.g., mechanical thrombectomy). In such examples, the catheter 100 can be used to support the advancement of a microcatheter through it. For example, the catheter 100 can be initially advanced on a guidewire to the treatment location, or advanced to a location proximal to the treatment location, and the microcatheter and / or mechanical thrombectomy device can be advanced through the catheter 100. When the treatment is complete, the mechanical thrombectomy device and the captured clot material can be withdrawn through the catheter 100. As another example, the catheter 100 can be used to support the advancement of occlusion and / or shunt devices through it. For example, the catheter 100 can initially be advanced on a guidewire to the treatment location, or advanced to a location proximal to the treatment location, and the microcatheter and / or hemorrhagic stroke device (such as an occlusive intracapsular implant or a shunt device for placement in a tumor-bearing vessel) can be advanced through the catheter 100. When the treatment is complete, the delivery device can be withdrawn through the catheter 100.

[0106] in conclusion

[0107] Although many embodiments of access catheters have been described above, this technology is applicable to other applications and / or other methods, such as aspiration catheters, support catheters, etc. Furthermore, other embodiments besides those described herein are also within the scope of this technology. Additionally, several other embodiments of this technology may have different constructions, components, or procedures than those described herein. Therefore, those skilled in the art will accordingly understand that this technology may have other embodiments with additional elements, or may have embodiments without the above references. Figures 1A to 4 Other implementations of several features shown and described.

[0108] The description of embodiments of this technology is not intended to be exhaustive or to limit the technology to the exact forms disclosed above. Where the context permits, singular or plural terms may also include plural or singular terms respectively. While specific embodiments and examples of this technology have been described above for illustrative purposes, those skilled in the art will recognize that various equivalent modifications can be made within the scope of this technology. For example, although the steps are presented in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide other embodiments.

[0109] As used herein, the terms “overall,” “substantially,” “about,” and similar terms are used as approximate terms rather than as terms of degree, and are intended to take into account the inherent biases of the measured or calculated values ​​that will be recognized by one of ordinary skill in the art.

[0110] Furthermore, unless the word “or” is explicitly limited to meaning only a single item excluding other items when referring to a list having two or more items, its use in such a list should be interpreted as including (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. Additionally, the term “comprising” throughout the document is used to mean at least including the described features, such that no larger number of the same features and / or other features of additional types are excluded. It should also be understood that specific embodiments have been described herein for illustrative purposes, but various modifications may be made without departing from the art. Furthermore, while advantages associated with certain embodiments of the art have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments are required to exhibit such advantages to fall within the scope of the art. Therefore, this disclosure and associated art may cover other embodiments not explicitly shown or described herein.

Claims

1. A neurovascular access conduit, comprising: An elongated tubular sidewall defines a lumen extending therethrough and has a proximal end, a distal end, and a length between the proximal and distal ends. The sidewall includes a coil portion and a braided portion, the braided portion comprising a plurality of filaments, fewer than all of which are interwoven with other filaments among the plurality of filaments. The catheter is configured to be positioned around a bend in a cerebral blood vessel having a radius of curvature not greater than 24 mm. The lumen remains at least 70% patent when the distal end of the catheter is distal to the bend, torque applied to the sidewall at the proximal end of the catheter is transmitted to the distal end.

2. The catheter according to claim 1, wherein the torque is at least 12 Nm.

3. The catheter of claim 1 or claim 2, wherein the sidewall includes a longitudinal axis extending along its length, and wherein the torque applied at the proximal end of the catheter is configured to rotate the sidewall 360 degrees about the longitudinal axis.

4. The catheter according to any one of claims 1 to 3, wherein the insertion length of the catheter is at least 50% when the catheter is positioned around the bend and the torque is applied while the lumen is maintained at least 70% patency.

5. The catheter according to any one of claims 1 to 4, wherein the coil portion is located proximal to the braided portion along the length of the sidewall.

6. The catheter according to any one of claims 1 to 4, wherein the coil portion is located distal to the braided portion along the length of the sidewall.

7. The catheter according to any one of claims 1 to 6, wherein the sidewall has an outer diameter of no more than 6 Fr.

8. The catheter according to any one of claims 1 to 7, wherein the sidewall defines a lumen extending along the longitudinal axis, and wherein the proximal end of the catheter is configured to be fluidly coupled to a negative pressure source to aspirate occlusive material from the blood vessel into and through the lumen.

9. An intravascular catheter, comprising: A tubular sidewall having a longitudinal axis, the sidewall comprising: The coil portion includes an elongated filament wound around the longitudinal axis of the sidewall; and The woven portion includes: First guidewire and second guidewire, wherein: The first guidewire has a first cross-sectional area and is spirally wound around the longitudinal axis in a first direction without crossing each other, and The second guide wire has a second cross-sectional area smaller than the first cross-sectional area, wherein the second guide wire includes (a) a first group wound along the first direction and not intersecting with the first guide wire, and (b) a second group wound along a second direction opposite to the first direction, and wherein the guide wire in the second group is interwoven with the first guide wire and the first group of second guide wires.

10. The catheter of claim 9, wherein the coil portion is located proximal to the braided portion along the longitudinal axis of the sidewall.

11. The catheter of claim 9, wherein the coil portion is located distal to the braided portion along the longitudinal axis of the sidewall.

12. The catheter according to any one of claims 9 to 11, wherein the cross-sectional shape of the first guidewire is different from the cross-sectional shape of the second guidewire.

13. The catheter according to any one of claims 9 to 12, wherein the first guidewire has a rectangular cross-sectional shape and the second guidewire has a circular cross-sectional shape.

14. An intravascular catheter, comprising: The proximal end, the distal end, and the longitudinal axis extending between the proximal end and the distal end; A tubular sidewall defining a lumen, the sidewall comprising a coil and a braid embedded in a material, the braid comprising a plurality of guidewires, the plurality of guidewires including a first guidewire and a second guidewire, wherein: The first guidewire is helically wound around the longitudinal axis in the first direction without crossing each other, and the first guidewire is configured to resist radial collapse of the sidewalls. The second guidewire comprises (a) a first group wound along the first direction and not intersecting with the first guidewire, and (b) a second group wound along a second direction opposite to the first direction, wherein the second guidewire is configured to engage the first guidewire to resist radial expansion of the first guidewire, thereby providing improved torsional capacity of the sidewall. The proximal end of the catheter is configured to be fluidly connected to a negative pressure source to apply suction through the lumen.

15. The catheter of claim 14, wherein the material is a first material, and the plurality of guidewires and the first material together form a first layer, and wherein the sidewall further comprises a second layer radially inside the first layer.

16. The catheter of claim 14 or claim 15, wherein the material is a first material, and the plurality of guidewires and the first material together form a first layer, and wherein the sidewalls further comprise a second layer radially outside the first layer.

17. The catheter according to any one of claims 14 to 16, wherein the material is a first material, and the plurality of guidewires and the first material together form a first layer, and wherein the sidewall further comprises a second layer radially inner to the first layer and a third layer radially outer to the first layer.

18. The catheter according to any one of claims 14 to 17, wherein the coil is located proximal to the braid along the longitudinal axis of the catheter.

19. The catheter according to any one of claims 14 to 17, wherein the coil is located distal to the braid along the longitudinal axis of the catheter.

20. The catheter according to any one of claims 14 to 19, wherein the tubular sidewall has an outer diameter of no more than 6 Fr.

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