Intravascular device with improved attachment of its components and method of manufacture

Abstract

An intravascular device is provided with improved attachment of its elements. The intravascular device includes a vascular pusher with a distal connection portion, a tool attached to and extending from the distal connection portion of the vascular pusher, the tool including a proximal connection portion comprising a mesh of at least two sets of filaments and having a laser cut proximal end, and an attachment between the tool proximal connection portion and the vascular pusher distal connection portion adapted to keep the tool connected to the vascular pusher, the attachment having an outer diameter substantially equal to an outer diameter of the vascular pusher. A method of manufacturing the intravascular device is also provided.

Description

[Technical field]

[0001] <Technical field> The present invention is generally directed to the field of medical devices for restoring blood flow or removing thrombi. In particular, the present invention relates to an intravascular catheter device with improved attachment of its elements such that the intravascular device is adapted to be safely maneuvered / manipulated during medical intervention. The present invention also relates to a method for connecting a tool to a vascular catheter so that the vascular catheter can manipulate the tool. [Background technology]

[0002] <Background technology> Intravascular catheters for restoring blood flow or removing a blood clot from a blood vessel during a thrombectomy intervention must be advanced, pulled, and kept intact within the vessel during the intervention. Controlling and advancing such devices is difficult as they must be subjected to pushing, pulling, and torqueing motions. Due to the length of these catheter devices, as well as the movements and forces that a user must apply to them during a thrombectomy intervention, it is often difficult to maintain strong attachments / connections of the elements that are part of the catheter.

[0003] WO2019168737 discloses an exemplary catheter including an elongate body with an inner liner, an outer jacket, a structural support member disposed between at least a portion of the inner liner and at least a portion of the outer jacket, and an expandable member distal to the structural support member at a distal portion of the elongate body. The expandable member is configured to expand radially outwardly within a patient's blood vessel, for example, to engage a blood clot. In some embodiments, the outer jacket may be heat shrunk around the structural support member and a proximal portion of the expandable member. In any of the embodiments, the inner liner does not extend beyond the outer jacket to form a distal connection portion secured to the expandable member by an attachment.

[0004] US2021000582 discloses a deployable device useful in embolization procedures that allows substantially unlimited forward flow of blood in a blood vessel and reduces or stops reflux (regurgitation or reverse flow) of an embolization agent introduced into the blood. In some embodiments, the deployable device includes a delivery catheter having a valve fixedly coupled to its distal end. An outer catheter is provided that extends over the valve during delivery to maintain the valve in a collapsed cylindrical shape until the valve is advanced through the patient to the desired vascular destination. Once at the destination, the outer catheter is retracted from over the valve as described above to allow expansion of the valve to an open state. The valve can be attached to the distal end of the catheter by a sleeve that is coupled or mechanically held to the catheter by a heat shrink process or other mechanical process. In another embodiment, the valve is fused into the catheter by a chemical process or by thermally fusing the valve, the catheter, or both. The catheter lacks an inner catheter element that extends beyond the outer jacket and serves as a distal connecting portion that is secured to the expandable valve by an attachment.

[0005] However, current catheter devices for blood flow restoration or thrombus removal often break or separate during use, which can have serious health consequences for the patient.

[0006] Besides the above, today braided meshes are cut using mechanical cutting techniques such as scissors or snip-like shears. These mechanical cuts usually generate tensile, compressive and shear stresses in the object (e.g., wire end). Furthermore, these techniques may generate traumatic ends (e.g., wire end) due to the stress results. For example, mechanical cutting techniques may generate flaring in the wire end, i.e., the wire end is not cut with the same cross-sectional axis, and the wire end may be positioned outward or inward.

[0007] Thus, there is a need for new intravascular devices that have improved navigability and attachment of their elements / components. DISCLOSURE OF THEINVENTION [Problem to be solved by the invention]

[0008] <Disclosure of the Invention> Intravascular devices must be advanced and pulled within blood vessels during interventions and remain intact despite the movements (e.g., pushes, pulls, and torque transfers) that the device must undergo. Such devices must be suitable to navigate through the vasculature without breaking and detaching during use, and cannot contain traumatic elements to avoid health consequences and provide appropriate safety configurations. For all these reasons, it is often difficult to connect / attach the elements of the device while maintaining all these conditions.

[0009] It is therefore an object of the present invention to provide an intravascular device having improved attachment of its elements, as well as a method for connecting a tool to a vessel pusher so that the vessel pusher can operate the tool. [Means for solving the problem]

[0010] The invention is defined by the accompanying independent claims. Embodiments are set out in the dependent claims.

[0011] In one aspect, the present invention provides, inter alia, an intravascular device for advancement through the neurovasculature, with improved attachment of its components, comprising a vascular pusher with a distal connection portion, a tool (e.g., a funnel, an expandable capture element, or other medical device) attached to and extending from the distal connection portion of the vascular pusher, the tool being formed by a mesh of at least two sets of filaments and comprising a proximal connection portion including laser-cut proximal ends of the at least two sets of filaments, and an attachment between the tool proximal connection portion and the vascular pusher distal connection portion adapted to keep the tool connected to the vascular pusher, the attachment having an outer diameter substantially equal to an outer diameter of the vascular pusher.

[0012] Thus, the proposed intravascular medical device for restoring blood flow or removing a thrombus has improved attachment between its elements that enhances navigability through the vessel, avoids damaging the vessel, and allows for movement of a concentric inner medical device, such as a microcatheter, within the intravascular device. This is achieved by the described attachment having an outer diameter substantially the same as or smaller than the outer diameter of the vascular pusher.

[0013] Furthermore, the proposed intravascular device, especially the proximal connection portion, is atraumatic and avoids flaring on the filament (or wire) ends. Furthermore, the intravascular device maintains flexibility at the distal end of the tool, avoiding stretching and dislodgement.

[0014] Indeed, because of the atraumatic end, the connection between the tool and the vessel pusher provides an attachment with a safer and better mechanical connection that avoids separation, stretching, and traumatic elements.

[0015] For the purposes of the present invention, "substantially" means that the diameter of the attachment on the proximal connecting portion of the tool and the distal connecting portion of the vessel pusher must be similar to the diameter of the vessel pusher to achieve the requirements for the desired navigation through the vessel. The safety of the pusher is also improved, thus avoiding damage to the vessel wall and being suitable to navigate through the tortuosity of the path. Substantially different diameters may cause irregularities in the navigability of the pusher through the vessel and induce vessel injury.

[0016] For purposes of this disclosure, "between" refers to a relationship between elements / things (or objects) but does not directly / necessarily refer to their placement.

[0017] In accordance with the present invention, the vascular pusher may comprise either a hypotube, a vascular catheter, or a tubular element.

[0018] In one embodiment, the laser cut proximal end does not extend outwardly or inwardly, but is located within or within the same cylindrical boundary (i.e., an imaginary cylinder concentric with the axial axis of the tool and including the tool proximal connection portion).

[0019] In some embodiments, the laser cut proximal ends are disposed in the same cross-sectional (or radial) plane.

[0020] In some embodiments, the laser cut proximal end comprises a cross section perpendicular to the axial axis of the tool, i.e., the laser cut proximal end terminates in the same cross-sectional plane.

[0021] In one embodiment, the attachment includes a thermoplastic material extending between the proximal connecting portion of the tool and the distal connecting portion of the vessel pusher.

[0022] In another embodiment, the attachment includes a thermoplastic material extending over the proximal connecting portion of the tool and over the distal connecting portion of the vessel pusher.

[0023] The thermoplastic material may extend (as it flows) between and / or over the proximal and distal connecting portions.

[0024] In one embodiment, the inner catheter element (eg, the inner liner and / or braided layer) comprises openings (or cells) and the thermoplastic material of the attachment extends through the openings.

[0025] In one embodiment, the attachment comprises an adhesive (or any other suitable adhesive material) extending between the proximal connecting portion of the tool and the distal connecting portion of the vessel pusher.

[0026] In another embodiment, the attachment includes adhesive (or any other suitable adhesive material) extending over the proximal connecting portion of the tool and the distal connecting portion of the vessel pusher.

[0027] In one embodiment, the mesh comprises two separate tubular sections: a first tubular section (neck) of uniform diameter and a second tubular section (cone-shaped) with a shape with a progressive reduction of diameter to open and create space for the thrombus, the first tubular section comprising the proximal connecting portion of the tool.

[0028] In one embodiment, the mesh further comprises a third tubular section (tubular) of uniform diameter, the third tubular section being disposed at a distal end of the second tubular section, the distal end of the second tubular section having a diameter equal to the proximal end of the third tubular section, and the proximal end of the second tubular section having a diameter equal to the distal end of the first tubular section.

[0029] In one embodiment, the tool includes three sections (tubular, conical, and proximal, neck) with at least two sets of filament meshes / braids, which may be the same or different.

[0030] The filaments may be made from a shape memory material.

[0031] More specifically, the filament is made of a metal, a metal alloy, or a composite material, including, inter alia, Nitinol or Nitinol / Platinum, or even Niti#1-DFT, with a percentage of platinum between 10% and 40%. R (registered trademark) (Drawn Filled Tube), i.e., specifically, the one with 20% platinum (Niti#1-DFT R (registered trademark)-20% Pt) or platinum 40% (Niti#1-DFT R (registered trademark)-40% Pt).

[0032] In some embodiments, the tool is an expandable funnel, more particularly, a self-expandable funnel.

[0033] In one embodiment, the laser cutting proximal end is cut by a laser beam. Mechanical cutting creates cuts of complex shapes, whereas laser cutting allows for creating precise cuts at the proximal end of the tool, affecting only a small area, which results in cleaner edges and minimizes filament warping and distortion. Some other advantages achieved by laser cutting are greater flexibility and precision, repeatability, speed, cost-effectiveness, better quality, non-contact cutting, versatility, and automation.

[0034] In some embodiments, the tool may also include a coating. In some embodiments, the coating may extend over at least a portion of the proximal connection portion, not over the entire proximal connection portion, or over at least a portion of the attachment. In certain embodiments, the coating extends over at least a part of the proximal connection portion. In other specific embodiments, the coating extends over at least a part of the attachment. In some embodiments, the coating may be impermeable, thus allowing blood flow to be partially or completely stopped. In one embodiment, the coating may include an elastomeric or thermoplastic elastomer material, such as polyurethane or silicone, among others.

[0035] According to another aspect, the present invention also provides a method for manufacturing an intravascular device, in particular a method for attaching a tool including a proximal connection portion formed by a mesh of at least two sets of filaments and including laser cut proximal ends of the at least two sets of filaments to a distal connection portion of a vascular pusher (e.g., a hypotube, a vascular catheter, or a tubular element, among others). Specifically, the method includes the steps of attaching the tool to the vascular pusher to extend from the distal connection portion of the vascular pusher, and creating / providing an attachment between the proximal and distal connection portions (i.e., element / object relationship) to keep the tool connected to the vascular pusher, the attachment having an outer diameter substantially equal to the outer diameter of the vascular pusher.

[0036] In one embodiment, the laser-cut proximal end is cut by a laser-cut technique.

[0037] In one embodiment, the laser cut proximal end is cut by a laser device.

[0038] The laser may be a fiber laser, a CO2 laser, or a Nd or Nd-YAG laser, among others. In some embodiments, the laser may operate at a wavelength near 1 micron, a frequency near 100 KHz, and a speed near 100 mm / sec.

[0039] In some embodiments, the proximal end cut time / duration is 1-5 seconds.

[0040] In one embodiment, the wavelength of the laser is 1064 nm, i.e., the laser emits infrared light.

[0041] In one embodiment, the laser-cut proximal ends of the filaments are disposed within or within the same cylindrical (or radial) boundary without extending outwardly or inwardly.

[0042] In one embodiment, the laser cut proximal ends terminate in the same cross-sectional (or radial) plane.

[0043] In one embodiment, the laser cut proximal end includes a cross section perpendicular to the axial axis of the tool.

[0044] In one embodiment, the step of creating / providing the attachment includes applying energy to cause a thermoplastic material to flow between the proximal and distal connection portions. In particular, heat shrinking is applied, for example, using heat shrink tubing (HST), which is placed concentrically over the vascular catheter, pressure is applied to adjust the diameter, and then heat is applied to melt the shrink material and fuse it to other materials (e.g., inner liner or braided layer).

[0045] In some embodiments, the step of creating the attachment may include applying an adhesive to the proximal connecting portion and the distal connecting portion.

[0046] In some embodiments, the step of applying adhesive may include applying adhesive onto the proximal connecting portion and allowing the adhesive to flow through an opening in the proximal connecting portion to the distal connecting portion.

[0047] In some embodiments, the step of applying an adhesive includes applying an adhesive between the proximal connecting portion and the distal connecting portion.

[0048] In some embodiments, the adhesive is cured. This can be done by applying energy, for example, but not limited to, by applying light, such as ultraviolet light. Alternatively, or additionally, curing of the adhesive can be done by other means, for example, by wetting, waiting for a period of time.

[0049] In some embodiments, the method further includes applying a coating to at least a portion of the tool, hi other embodiments, the coating may be applied to the proximal connecting portion of the tool, at least a portion of the proximal connecting portion, or at least a portion of the attachment.

[0050] In another embodiment, an intravascular device comprises a vascular pusher (particularly a vascular catheter) of the previous embodiment and a tool (e.g., a funnel, an expandable capture element, or other medical device). The vascular catheter comprises a catheter jacket and an inner catheter element surrounded by the catheter jacket, and the distal connection portion of the vascular catheter comprises an extension of the inner catheter element extending distally beyond the distal end of the catheter jacket. The tool is attached to and extends from the distal connection portion of the vascular catheter and comprises a proximal connection portion formed by a mesh of at least two sets of filaments and including laser cut proximal ends of the at least two sets of filaments, the laser cut proximal ends abutting the inner catheter element. The intravascular device also comprises an attachment between the tool proximal connection portion and the vascular catheter distal connection portion to keep the tool connected to the vascular catheter, the attachment having an outer diameter substantially equal to the outer diameter of the vascular catheter.

[0051] In one embodiment, the attachment extends over the extension portion of the inner catheter element and over the laser cut proximal end of the proximal connection portion of the tool.

[0052] In one embodiment, the inner catheter element comprises a first element (eg, an inner liner) and a second element, with the laser cut proximal end of the proximal connecting portion of the tool abutting the distal end of the second element.

[0053] In one embodiment, the first component comprises a polymeric material such as polytetrafluoroethylene (PTFE), among others.

[0054] More specifically, an inner liner is disposed within the catheter jacket.

[0055] The catheter jacket may be made from any suitable thermoplastic or elastomeric / elastomer material, for example, polyether block amide (PEBAX®) having a shore of 25, 35, 40, 55, 63, or 72 D. In a particular embodiment, the catheter jacket is made from a thermoplastic material, more specifically PEBAX® 40D.

[0056] In some embodiments, the second section of the inner catheter element can include a braided layer.

[0057] In one embodiment, the inner catheter element further comprises a braided layer disposed within the catheter jacket (i.e., the inner liner is surrounded by the braided layer). In particular, the braided layer is concentrically disposed within the catheter jacket. The braided layer may be made of, for example, stainless steel, Nitinol, liquid crystal polymer (LCP), etc. In particular, it is made of Nitinol.

[0058] In one embodiment, the distal connection portion of the vascular catheter includes a distal portion of the inner liner that extends distally beyond the distal end of the catheter jacket, hi some embodiments, the distal portion of the inner liner extends distally beyond the distal end of the braided layer.

[0059] In one embodiment, the distal connection portion of the vascular catheter includes a portion of the braided layer that extends distally beyond the distal end of the catheter jacket.

[0060] In one embodiment, the laser-cut proximal end of the proximal connection portion of the tool abuts (i.e., there is no substantial gap and no overlap) the distal end of the braided layer, thus avoiding twisting (or kinking) of the intravascular device. [Brief description of the drawings]

[0061] <Brief Description of the Drawings> The foregoing and other advantages and features will be more fully understood from the following detailed description of the embodiments, taken in conjunction with the accompanying drawings, which should be considered in an illustrative and non-limiting manner. [Figure 1A-B] 1A-B show a schematic diagram of an intravascular device according to one embodiment of the present invention, a vascular catheter, and the cross-sectional relationships between tools included in the proposed intravascular device. [Figures 2A-2G] 2A-2G illustrate generally an intravascular device according to one embodiment of the present invention. [Figure 3A-3G] 3A-3G show schematic longitudinal cross-sectional views of the vascular catheter shaft, tools and attachments included in the proposed intravascular device of FIGS. 2A-2G. [Figure 4A-4E] 4A-4E illustrate generally an intravascular device according to one embodiment of the present invention. [Figure 5A-5E] 5A-5E show schematic longitudinal cross-sectional views of the vascular catheter shaft, tools and attachments included in the proposed intravascular device of FIGS. 4A-4E. [Figures 6A-6D]6A-6D illustrate generally another intravascular device according to one embodiment of the present invention. [Figure 7A-7D] 7A-7D show schematic longitudinal cross-sectional views of the vascular catheter shaft, tools and attachments included in the proposed intravascular device of FIGS. 6A-6D. [Figure 8] FIG. 8 illustrates a different embodiment of an intravascular device tool. [Figure 9] FIG. 9 illustrates a funnel tool for restoring blood flow or removing a blood clot, according to certain embodiments. [Figure 10] FIG. 10 illustrates a funnel tool for restoring blood flow or removing a thrombus, according to certain embodiments. [Figure 11] FIG. 11 is a flow chart illustrating a method for attaching a tool to a distal end of a vascular catheter, in accordance with one embodiment of the present invention. [Figure 12] FIG. 12 shows a diagram illustrating the different elements used to automatically operate the proposed intravascular device, according to one embodiment. [Figure 13] 13 shows two views of the proposed intravascular device, showing the difference between the proximal ends being mechanically cut (top view) or laser cut (bottom view). The view shows the axial axis A of the tool, a cylindrical boundary B concentric with the axial axis A, and a cross-sectional plane C. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0062] Detailed Description of the Invention and Specific Embodiments The present disclosure describes an intravascular device configured for advancement through the neurovasculature, with improved attachment between its elements, and corresponding methods for manufacturing such an intravascular device. It is noted that in some of the accompanying figures, the elements / layers are shown with gaps between them, but in the final assembly of the intravascular device, those gaps are not present, as the different materials of the elements / layers flow between and fuse together. Thus, the figures show the arrangement / relationship between the elements, objects, and layers of the invention.

[0063] 1A and 1B, an embodiment of the proposed intravascular device 1 is shown. The intravascular device 1 comprises a vascular device 40 and a tool 10 including a proximal connection portion 33. As seen in FIG. 1B, the tool 10 is attached to and extends from a distal connection portion 43 of the vascular device 40 (in this particular case a vascular catheter) via an attachment 50 using the tool's proximal connection portion 33. The attachment 50 includes an outer diameter substantially equal to the outer diameter of the vascular catheter 40. The diametric relationship between the proximal connection portion 33 and the distal connection portion 43 is shown diagrammatically in FIG. 1A.

[0064] The tool 10 may comprise different medical devices, in particular an expandable funnel, and comprises two tubular sections, namely a second tubular section 20 and a first tubular section 30 proximal to the second tubular section 20. In particular, the first tubular section 30 comprises two subsections, namely a first subsection 32 and a second subsection 31. In the embodiment of Figures 1A and 1B, the second subsection 31 is conical or funnel-shaped and the first subsection 32 comprises a proximal connecting portion 33.

[0065] 2A-2G show schematic diagrams of another embodiment of an intravascular device 1. FIGs. 3A-3G show cross-sectional views of the intravascular device of FIGs. 2A-2G, including a vascular catheter 40 and a tool 10. The vascular catheter 40 includes a catheter jacket 44 formed from a thermoplastic or elastomeric / elastic material, such as PEBAX® having a Shore of 25, 35, 40, 55, 63 or 72D, and an inner catheter element surrounded by the catheter jacket 44. The distal connection portion 43 of the vascular catheter 40 includes an extension portion of the inner catheter element that extends distally beyond the distal end of the catheter jacket 44.

[0066] According to this embodiment, the inner catheter element comprises an inner liner 46 and a braided layer 45 , both concentrically disposed within a catheter jacket 44 .

[0067] In accordance with the present invention, the inner liner 46 is made of a polymeric material. The inner liner 46 is surrounded by a braided layer 45, which is made of a metallic material or metal alloy, such as, but not limited to, stainless steel or Nitinol.

[0068] In some embodiments, the braided layer 45 can extend distally beyond the distal end of the catheter jacket 44 and the inner liner 46 can extend distally beyond the distal end of the braided layer 45.

[0069] In addition to the elements mentioned above, in one embodiment, an inner thermoplastic material or inner jacket 47 is disposed about a portion of the inner catheter element (including the inner liner 46 and / or braided layer 45) that extends distally beyond the distal end of the vascular catheter 44 (see FIGS. 2B and 3B). The inner thermoplastic material or inner jacket 47 is made from, but is not limited to, PEBAX® having a Shore of 25, 35, 40, 55, 63 or 72D, particularly 55D. Heat is applied to cause the inner jacket 47 to flow into the braided layer 45 and over the inner liner 46, as seen diagrammatically in FIGS. 2C and 3C.

[0070] The proximal connection portion 33 of the tool is then placed around the inner jacket 47 (see FIGS. 2D and 3D) and an outer thermoplastic material or outer jacket 48 made of, but not limited to, PEBAX® having a Shore of 25, 35, 40, 55, 63 or 72D is placed around the proximal connection portion 33 of the tool (see FIGS. 2E and 3E). Heat shrink is then applied (see FIGS. 2F and 3F) to fuse the outer jacket 48 and the inner jacket 47 with the proximal connection portion 33 of the tool, thereby creating the attachment 50 (see FIGS. 2G and 3G). Thus, the thermoplastic material (the inner jacket 47 and the outer jacket 48) is placed and extends between and / or over the proximal connection portion 33 of the tool 10 and the distal connection portion 43 of the vascular catheter 40.

[0071] The resulting attachment 50 has an outer diameter that is substantially the same as the outer diameter of the vascular catheter, for example, due to the heat shrinking discussed above. Additionally, the disposal of the proximal end of the tool's proximal connection portion 33 relative to the distal end of the braided layer 45, and the fact that the joint is covered with inner and outer jackets 47 and 48, minimizes kinking of the intravascular device 1 at the distal end of the vascular catheter 40 or at the proximal end of the tool 10 during advancement through the vasculature.

[0072] 4A-4E and 5A-5E show another embodiment of the intravascular device 1. In this embodiment, the vascular catheter 40 is similar to the vascular catheter 40 of the previous embodiment. That is, the vascular catheter 40 (see FIGS. 4A and 5A) has an inner liner 46, for example made of PTFE, surrounded by a braided layer 45, for example made of stainless steel, which is itself surrounded by a PEBAX® catheter jacket 44. An adhesive 49, or any similar adhesive material, is then applied around the portion of the inner liner 46 that extends distally beyond the braided layer 45 (see FIG. 4B). The proximal connecting portion 33 of the tool is placed around the adhesive 49 (see FIGS. 4C and 5C). UV light is then applied to activate the adhesive 49 and bond the proximal connecting portion 33 of the tool to the inner liner 46 (see FIGS. 4D and 5D), thereby creating an attachment 50 between the distal connecting portion 43 of the vascular catheter and the proximal connecting portion 33 of the tool (see FIGS. 4E and 5E). As before, the resulting attachment 50 has an outer diameter that is substantially the same as or smaller than the outer diameter of the vascular catheter.

[0073] In another embodiment, adhesive 49 can be applied around the inner liner 46 and braided layer 45, both of which extend distally beyond the catheter jacket 44 (not shown).

[0074] In the embodiments of Figures 4A-4E and 5A-5E, the braided layer 45 extends beyond the catheter jacket 44. Alternatively, in other embodiments, with reference to Figures 6A-6D and 7A-7D, the braided layer 45 does not extend beyond the catheter jacket 44. This is possible because adhesive 49 may be applied only onto the inner liner 46 (see Figures 4B and 5B) and / or onto the portion of the braided layer 45 that extends distally beyond the catheter jacket 44 (not shown).

[0075] In yet another embodiment of the intravascular device 1 (not shown), different from the embodiments of FIGS. 4A-4E, 5A-5E, 6A-6D, and 7A-7D, a PEBAX® inner jacket 47 can be placed over (or around) a portion of the inner liner 46 and / or the distal end of the braided layer 45 that extends distally beyond the catheter jacket 44 prior to application of the adhesive 49, and heat can be applied to allow the PEBAX® material to flow into the openings (or cells) of the braided layer 45 and onto the inner liner 46 (see, e.g., FIGS. 2C and 3C). Note that the braided layer 45 may or may not extend distally beyond the catheter jacket 44. Additionally, in some embodiments not shown, an outer jacket 48 can be included after application of the adhesive 49.

[0076] In any of the above-described embodiments, the proximal connecting portion 33 of the tool may include openings or cells. Additionally, the braided layer 45 may include openings as well. Thus, the inner and outer jackets 47 and 48 may extend through these openings.

[0077] 8 illustrates various shapes that the tool 10 may adopt, including the proximal connecting portion 33. Similarly, the tool 10 may be manufactured in different sizes.

[0078] In some embodiments, the tool 10 may include a coating. In one embodiment, the coating does not extend over the proximal connecting portion 33. In another embodiment, the coating extends over a portion of the proximal connecting portion 33 or completely covers the proximal connecting portion 33. The coating may be impermeable and / or may include an elastomeric or thermoplastic elastomer material, such as polyurethane or silicone, among others.

[0079] Referring to FIG. 9, a specific embodiment of a tool 10 is shown. The tool 10 is similar to that described in WO2020079082, of the same applicant of the present invention, but is self-expanding and comprises a mesh 13 having two sets of filaments (or wires), which may be the same or different, counter-rotating and intertwining. The filaments may be made of metals (including metal alloys), polymers, composites including Nitinol or Nitinol / Platinum, or DFT® (Drawn Filled Tube), among other materials with suitable mechanical properties. As mentioned above, the tool 10 comprises two separate tubular sections, namely, the second tubular section 20 and the first tubular section 30. The end of the second tubular section 20 comprises a closed loop 23 configured to act as a spring, reducing the possibility of vessel injury and providing a smooth distal end for improving navigability of the device within the vessel.

[0080] 10, another specific embodiment of tool 10 is shown. Tool 10 has working portion 101 and connecting portion 103 that extends proximally from a proximal end of working portion 101 and can be connected to a pusher, such as a vascular catheter 40, that extends proximally from the connecting portion. In particular, connecting portion 103 includes proximal connecting portion 33. Connecting portion 103 can be understood as first subsection 32 (or part thereof) in other described embodiments. Working portion 101 can be understood as second tubular section 20 and second subsection 31 in other described embodiments.

[0081] The working portion 101 of this particular embodiment is arranged and configured to provide an outward radial force at any diameter between and including the diameter of the working portion 101 in a compressed configuration and the diameter of the working portion 101 in an expanded configuration. The working portion 101 includes a plurality of crowns 110 of cells 111 forming a tubular portion forming a cylindrically closed structure. The connecting portion 103 also has a tubular portion forming a cylindrically closed structure, among others. The connecting portion 103 includes at least one crown 120 of cells 121, where each cell 121 has an open area bounded by two proximal cell struts, two distal cell struts, and two middle cell struts. Each of the cells 111 of the working portion 101 has an open area bounded by two proximal cell struts 130 (disposed within the proximal cell strut ring 113), two distal cell struts 132 (disposed within the distal cell strut ring 114), and two middle cell struts 112. Each middle cell strut 112 in each crown abuts two adjacent cells 111 in that crown and is adapted and configured to be more flexible than the distal cell struts 132 and proximal cell struts 130 from which it extends. To achieve said flexibility, in some embodiments, the middle cell strut 112 adjacent each cell 111 may have a width narrower than the width of the distal cell strut 132 adjacent to that cell 111, and narrower than the width of the proximal cell strut 130 adjacent to that cell 111. The middle cell strut 112 is configured to provide flexibility through one or two hinge portions 140 arranged / disposed between the proximal and distal ends of the middle cell strut 112. Each hinge portion can include one or two bends.

[0082] 10, the working portion 101 also includes a tapered portion 102 at its proximal end. The tapered portion 102, which may be understood as the second subsection 31, comprises a plurality of tapered portion struts and has an expanded diameter at its proximal end that is smaller than the expanded diameter of the working portion 101. In these embodiments, the tapered portion 102 has an expanded configuration that defines a frusto-conical shape having a closed configuration.

[0083] The tool 10 of any of the described embodiments can at least adapt its shape and length to the surrounding vessel from a retracted position in a compressed state, particularly from a retracted position inside a carrier (e.g., a delivery catheter), to an extended and expanded position to receive and hold a thrombus in apposition against the inner wall of the vessel.

[0084] The tool 10 may be made from a metal, metal alloy, or composite including Nitinol or Nitinol / Platinum, however, other types of metals or other types of materials may also be used, such as cobalt chromium alloys or iron alloys, such as stainless steel or spring steel, as well as other materials with shape memory properties, such as copper or magnesium alloys.

[0085] Referring to FIG. 11, an embodiment of a proposed method for attaching a tool to a distal end of a vascular catheter is shown. In step 1301, the method includes placing a proximal connection portion of the tool over a distal connection portion of the vascular catheter. In step 1302, the method includes attaching the tool to the vascular catheter by creating an attachment between the proximal connection portion and the distal connection portion. Then, in step 1303A, energy is applied to flow a thermoplastic material between the proximal connection portion and the distal connection portion. Alternatively, or consecutively, in step 1303B, adhesive is applied to the proximal and distal connection portions.

[0086] FIG. 12 shows an example of an intravascular device 1 of the present invention, which allows for its automated manipulation through the vascular system.

[0087] According to this particular embodiment, the automated proximal device 1401 provides a guidance system for deploying the intravascular device 1. Additionally, the imaging device 1402 may detect radiopaque markers disposed in the tool or other elements of the intravascular device 1 and generate an image. A communication channel 1403 may be used to provide a means for transmitting the image to the control module 1404. The control module 1404 is programmed or configured to enable guidance of the deployment of the intravascular device 1 and storage of data on a data storage device 1405. The control module 1404 may be a programmable logic controller, computer, etc. In this particular embodiment, the control module 1404 is guided by a computer-assisted controller 1406. The communication channel 1403 may be Ethernet, Wi-Fi, Bluetooth, etc. The control module 1404 is programmed to guide a physician or technician operating the intravascular device 1, thereby enabling the intravascular device 1 to be used in non-hospital environments such as nursing homes or care facilities.

[0088] By using the intravascular device 1, the time required to perform an intravascular intervention is significantly reduced and patient outcomes are significantly improved. Control may also be via a controller such as those used in other current medical devices. In another embodiment, the system may be manually controlled.

[0089] Referring to FIG. 13 herein, two different tools 10 are shown: one in which the proximal end of the proximal connecting portion 33 is mechanically cut (top image), and one in which the proximal end is laser cut (bottom image).

[0090] In this regard, a particular embodiment of the invention refers to an intravascular device 1 comprising the described tool 10 adapted to be manipulated / steered during a medical intervention via a vascular device 40 (in this particular case a vascular pusher). As in the above described embodiment, the vascular pusher 40 comprises a distal connection portion 43 and the tool 10 comprises a proximal connection portion 33 comprising a mesh formed by a filament (as described above) and having a laser cut proximal end. In order to keep the tool 10 connected to the vascular pusher 40, the above described attachment 50 is provided between the proximal connection portion 33 and the distal connection portion 43.

[0091] Advantageously, due to the laser cut proximal end, the proximal connection portion 33 is atraumatic. Similarly, since the filament of the proximal connection portion 33 is cut using a laser cutting technique or device, the filament end of the proximal connection portion 33 is smooth, has a cross section perpendicular to the axial axis A of the tool 10, and is not flared and / or distorted. In contrast, as can be seen in the top view of FIG. 13, due to the mechanical cut, the filament end 14 is flared and distorted, i.e., the filament end has an outward or inward end configuration, is not located within the cylindrical boundary defined by B, and does not terminate in the same cross-sectional plane C. Furthermore, due to the atraumatic end, the described attachment for connecting the tool 10 and the vessel pusher 40 is safer and avoids mechanical connection problems such as separation, stretching, or traumatic elements.

[0092] Below, we will explain in detail different examples of the performance of the proposed intravascular device 1. The examples and drawings are provided herein for illustrative purposes and are not intended to limit the present invention.

[0093] Example 1: Tensile resistance test of the attachment between the catheter device and the tool of an intravascular device. The purpose of this experimental test was to verify the effectiveness of the catheter device 40 and the tool of the intravascular device 1 of the present invention. The purpose of the test was to measure the tensile resistance of the attachment 50 between the tension rod 10 and the tension rod 50 .

[0094] The standard requirements of ISO_10555-1 call for the measurement of the tensile force at each joint between the tubular segments of an intravascular catheter. A tensile force is applied to each specimen until the tubular structure breaks or the joint separates. The following table defines the minimum peak tensile force required per diameter of the tubular segment: TIFF2025502677000002.tif65169

[0095] Therefore, a peak tensile force of 15N would meet the requirements of any device, considering that the minimum force required for the large diameter is 15N.

[0096] <Method> The materials and equipment used during the procedure are shown in Table 2. TIFF2025502677000003.tif62169

[0097] Different attachment materials were used to assemble the catheter shafts and tools: - Reflow technique using a thermoplastic material (i.e. PEBAX®): 7 trials with an uncoated tool (trials 1-7) and 10 trials with a coated tool (trials 8-17). - Adhesive technique (i.e. Loctite® adhesive): 4 trials with uncoated tools.

[0098] Tensile measurements: The peak tensile force at the connection between the catheter shaft and the braided tool was measured until the shaft or tool material broke or the attachment between the tool and the catheter shaft came off. The tensile force was then recorded.

[0099] <Results and conclusions> Table 3 shows the attachment pull force results for both techniques: TIFF2025502677000004.tif140169

[0100] The results showed a pull force higher than 15 N for all trials / samples including the reflow technique (with coated or uncoated tools) and the adhesive technique trials. As a result, all obtained values ​​are greater than the minimum pull force required by the standard requirements for the use of intravascular catheters.

[0101] These results are relevant to the safety of the intravascular device 1 during clinical use, as high values ​​of tensile strength reduce the possibility of premature failure of the attachment / connection parts due to excessive tension during retrieval or navigation.

[0102] In conclusion, the tested technique meets the requirements so that it can be advanced, pulled and maintained within the vessel during the intervention.

[0103] Example 2: Flexibility testing of the distal portion of an intravascular device including the attachment between the catheter device and a tool. The brain anatomy presents highly irregular paths that intravascular catheters must navigate to extract thrombus from target brain locations. Intravascular devices must be configured to undergo torque and pulling motions. Thus, the elements and element joints of these intravascular devices must exhibit the desired flexibility and strength to avoid kinking and dislodging.

[0104] The purpose of this experimental test was to determine whether the intravascular device 1 of the present invention is configured for advancement through the neurovasculature with respect to the flexibility of its attachment portion between its tool 10 and the catheter shaft 40.

[0105] Flexibility assessment was quantified using the two-point bending (2PB) method, providing quantitative insight into the ultimate behavior of the intravascular device 1 in terms of navigability, trackability, and pushability.

[0106] The intravascular device 1 should provide adequate flexibility to navigate through tortuous paths and to generate good pushability through distal forces transmitted from the proximal portion of the device (i.e., the catheter shaft 40) to the distal portion (i.e., the tool 10).

[0107] High flexibility may improve navigability but reduce pushability, and low flexibility may improve pushability but reduce navigability, so an appropriate flexibility must be selected to accept or reject a device configuration.

[0108] <Method> To quantify the appropriate flexibility to be considered for device development, a load is applied in the vertical direction to a selected zone (e.g., in this case, the attachment 50 or bond zone) to generate a predetermined displacement (1.5 mm movement) of the distal tip of the device (including tool 10). If the load is within the predetermined range, the device achieves the required navigability and pushability (e.g., in terms of the selected flexibility of its elements) and thus the structural configuration of the device is accepted.

[0109] The selected load must be in the range [0.05-0.2N]. The highest value is set according to the load that would be applied to a device that does not navigate at all as intended, and the lowest value is set according to the load that would be applied to a device that is unable to transmit adequate distal force and therefore does not push properly. If the load applied to the sample is within the range, then the device being tested meets the navigability and pushability requirements due to adequate flexibility of its structural configuration.

[0110] The 2PB evaluation was performed on 10 samples with two different outer jacket 44 materials: Configuration A: 5 samples with a Shore value of 40D (less flexible), Samples 1-5; and Configuration B: 5 samples with a Shore value of 35D (more flexible), Samples 6-10. The test point was set at the junction / attachment 50 of the intravascular device 1. A load was applied to the test point in a vertical direction until the distal tip reached a displacement of 1.5mm.

[0111] The 2PB apparatus (e.g., vertical tensile tester) consists of a shaft-holding fixture and a calibrated load cell (50 N) with a distal plunger fixture located 1.5 cm from the shaft-holding fixture. The apparatus is configured to apply and accurately measure load and deflection (i.e., displacement) to a sample attached to the 2PB bending fixture. The catheter was placed on the shaft-holding fixture and the catheter test point was placed at the plunger fixture location. The plunger was loaded by the load cell until the distal end of the apparatus reached a displacement of 1.5 mm from the vertical starting position (i.e., 0° from the horizontal axis), and then the maximum force was recorded, as shown in Table 4. This test method follows standard ASTM D790-17 for testing methods of bending properties, which is similar to standard ASTM F2606-08 (2021) for standard guide for three-point bending.

[0112] <Results and conclusions> TIFF2025502677000005.tif102169

[0113] The 2PB test showed that all recorded load values ​​fell within the predefined inclusion criteria range of 0.5-2.0 N for the applied vertical load. Thus, all tested samples and their configurations (both A and B) exhibited adequate structural properties due to their construction and material flexibility with respect to the average values, and therefore all devices are constructed to achieve good navigability and pushability.

[0114] In conclusion, the intravascular device 1 samples of the present invention are configured to be subjected to torque and pulling motions when navigated through intravascular vessels, and therefore the elements and joints of these intravascular devices are configured to exhibit the desired flexibility and strength to avoid kinking and separation, and to convey adequate pushability when navigated.

[0115] Unless otherwise indicated, all numbers expressing measurements, conditions, and the like used in the specification and claims should be understood to be modified in all instances by the term "about". Thus, unless indicated to the contrary, the numerical parameters set forth in the specification and appended claims are approximations that may vary depending on the desired properties sought to be obtained by the subject matter of the present disclosure. Throughout the specification and claims, the word "comprise" and variations thereof, such as "comprising", are not intended to exclude other technical features, additives, ingredients, or steps. Additional objects, advantages, and features of the present invention will become apparent to those skilled in the art upon examination of the description or can be learned by the practice of the present invention. Moreover, the present invention encompasses all possible combinations of the specific preferred embodiments described herein.

[0116] The present disclosure and / or some other examples have been described above. According to the above description, various modifications can be made. All applications, modifications and changes that are required to be protected in the claims may fall within the protection scope of the present disclosure.

[0117] The scope of the invention is defined in the following set of claims.

Claims

1. a vessel pusher having a distal connection portion; a tool attached to and extending from the distal connection portion of the vessel pusher, the tool comprising a proximal connection portion formed by a mesh of at least two sets of filaments and including laser cut proximal ends of the at least two sets of filaments; an attachment between the proximal connection portion of the tool and the distal connection portion of the vascular pusher, the attachment adapted to keep the tool connected to the vascular pusher and having an outer diameter substantially equal to an outer diameter of the vascular pusher.

2. 10. The device of claim 1, wherein the laser-cut proximal ends of the at least two sets of filaments are disposed within a same cylindrical boundary without extending outwardly or inwardly.

3. The device of claim 1 or 2, wherein the laser cut proximal end comprises a cross section perpendicular to an axial axis of the tool.

4. The device of any one of claims 1 to 3, wherein the laser cut proximal ends terminate in the same cross-sectional plane.

5. The device of any one of claims 1 to 4, wherein the attachment comprises a thermoplastic material extending between or over the proximal connection portion of the tool and the distal connection portion of the vascular pusher.

6. The device of any one of claims 1 to 5, wherein the attachment comprises an adhesive extending between or over the proximal connection portion of the tool and the distal connection portion of the vessel pusher.

7. The device of any one of claims 1 to 6, wherein the vascular pusher comprises a hypotube, a vascular catheter, or a tubular element.

8. 8. The device of claim 1, wherein the mesh comprises at least two separate tubular sections, a first tubular section of uniform diameter and a second tubular section with an opening and a shape that gradually reduces in diameter to create a space for a thrombus, the first tubular section comprising the proximal connection portion of the tool.

9. The device of claim 7 , wherein the mesh further comprises a third tubular section of uniform diameter.

10. providing a vessel pusher comprising a distal connection portion; Attaching a tool to the vessel pusher and extending from the distal connection portion of the vessel pusher, the tool being formed by a mesh of at least two sets of filaments and having a proximal connection portion including laser cut proximal ends of the at least two sets of filaments; providing an attachment between the proximal connection portion of the tool and the distal connection portion of the vascular pusher to keep the tool connected to the vascular pusher, the attachment having an outer diameter substantially equal to an outer diameter of the vascular pusher.

11. The method of claim 10 , wherein the laser-cut proximal end is cut by a laser cutting technique.

12. The method of claim 10 , wherein the laser-cut proximal end is cut by a laser device.

13. 13. The method of any one of claims 10 to 12, wherein the laser-cut proximal ends of the at least two sets of filaments are disposed within the same cylindrical boundary without extending outwardly or inwardly.

14. The method of any one of claims 10 to 13, wherein the laser cut proximal end comprises a cross section perpendicular to an axial axis of the tool.

15. The method of any one of claims 10 to 14, wherein the laser cut proximal ends terminate in the same cross-sectional plane.

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