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 including a vascular catheter comprising a catheter jacket, an inner catheter element surrounded by the catheter jacket, and a distal connection portion comprising an extension of the inner catheter element extending distally beyond a distal end of the catheter jacket, a tool attached to and extending from the distal connection portion of the vascular catheter, the tool comprising a proximal connection portion, and an attachment between the tool proximal connection portion and the vascular catheter distal connection portion adapted to keep the tool connected to the vascular catheter, the attachment having an outer diameter substantially equal to an outer diameter of the vascular catheter. A method of attaching a tool to a vascular catheter 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 adapted to be maneuvered / manipulated during a 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 thermally melting the valve, the catheter, or both, or by a chemical process. 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] Thus, there is a need for new intravascular devices with improved attachment of their elements / components. DISCLOSURE OF THEINVENTION [Problem to be solved by the invention]

[0007] <Disclosure of the Invention> 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 vascular catheter so that the vascular catheter can manipulate the tool. [Means for solving the problem]

[0008] The invention is defined by the accompanying independent claims. Embodiments are set out in the dependent claims.

[0009] In one aspect, the present invention provides, inter alia, an intravascular device for advancement through the neurovasculature, the device having improved attachment of its components, the intravascular device comprising a vascular catheter comprising a catheter jacket, an inner catheter element surrounded by the catheter jacket, and a distal connection portion including an extended portion of the inner catheter element extending distally beyond the distal end of the catheter jacket, 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 catheter, the tool including a proximal connection portion, the proximal end of the tool proximal connection portion abutting the inner catheter element, and an attachment between the tool proximal connection portion and the vascular catheter distal connection portion adapted to keep the tool connected to the vascular catheter, the attachment having an outer diameter substantially equal to an outer diameter of the vascular catheter.

[0010] Thus, the proposed intravascular medical device for restoring blood flow or removing thrombus has improved attachment between its elements that enhances navigability through the blood 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 catheter.

[0011] Furthermore, the proposed intravascular device is atraumatic and maintains flexibility of the distal end of the tool, avoiding stretching and dislodgement.

[0012] For the purposes of the present invention, "substantially" means that the diameter of the attachment on (or over) the proximal connecting portion of the tool and the distal connecting portion of the vascular catheter must be similar to the diameter of the vascular catheter to achieve the desired navigation requirements through the blood vessel. The safety of the catheter is improved, thereby avoiding damage to the blood vessel wall and making it suitable for navigating through tortuous paths. Substantially different diameters may cause irregularities in the navigability of the catheter through the blood vessel and induce blood vessel damage.

[0013] For purposes of this disclosure, "between" refers to a relationship between elements / things (or objects) but does not directly / necessarily refer to their placement.

[0014] 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.

[0015] In one embodiment, the inner catheter element comprises a first element (eg, an inner liner) and a second element, with the proximal end of the proximal connecting portion of the tool abutting the distal end of the second element.

[0016] In one embodiment, the first component comprises a polymeric material such as polytetrafluoroethylene (PTFE), among others.

[0017] More specifically, an inner liner is disposed within the catheter jacket.

[0018] In some embodiments, the second section of the inner catheter element can include a braided layer.

[0019] In one embodiment, the inner catheter element further comprises a braided layer disposed within the catheter jacket. 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.

[0020] In one embodiment, the proximal end of the proximal connecting 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.

[0021] In one embodiment, the attachment includes a thermoplastic material extending between a proximal connection portion of the tool and a distal connection portion of the vascular catheter.

[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 vascular catheter.

[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 intravascular device of the present invention includes a vascular catheter comprising a catheter jacket, an inner catheter element including a braided layer surrounded by the catheter jacket, and a distal connection portion including an extended portion of the inner catheter element extending distally beyond the distal end of the catheter jacket, a tool attached to and extending from the distal connection portion of the vascular catheter, the tool including a proximal connection portion, the proximal end of the tool proximal connection portion abutting the distal end of the braided layer of the vascular catheter, and an attachment between the tool proximal connection portion and the vascular catheter distal connection portion adapted to keep the tool connected to the vascular catheter, the attachment extending over the extended portion of the inner catheter element and over the proximal end of the tool proximal connection portion.

[0026] In one embodiment, the inner catheter element of the vascular catheter further comprises an inner liner, which is surrounded by the braided layer. 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. In some embodiments, the distal portion of the inner liner extends distally beyond the distal end of the braided layer.

[0027] 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.

[0028] In one embodiment, the proximal connecting portion of the tool comprises a laser-cut tube.

[0029] In some embodiments, the proximal connection portion of the tool can include openings (or cells) through which the thermoplastic material, e.g., PEBAX®, extends. Additionally, the proximal connection portion of the tool can include a braid.

[0030] In some embodiments, the thermoplastic material of the attachment extends to the inner catheter element, hi some embodiments, the thermoplastic material extends through an opening in (or on) the braided layer of the inner catheter element.

[0031] 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 vascular catheter.

[0032] In another embodiment, the attachment comprises an adhesive (or any other suitable adhesive material) extending over the proximal connecting portion of the tool and the distal connecting portion of the vascular catheter.

[0033] In one embodiment, the tool comprises three sections (tubular, conical and proximal neck) with at least two sets of filament braids. The helical filaments are made of metal, metal alloy or composites 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 The ceramic may be made from a Pt-40% composite.

[0034] In some embodiments, the tool comprises a laser cut tube.

[0035] In another embodiment, the tool is manufactured by providing a tube having a longitudinal axis therethrough (i.e. the axis of the tube providing the axis of the tool), providing a stationary laser source, and using the laser radiation source to generate a beam of laser radiation (e.g. by an ultrashort pulsed laser) and cutting a desired pattern (i.e. creating a shape) in the tube by scanning the beam over a desired area of ​​the tube to create a plurality of cells separated by struts. For example, a suitable manufacturing method that may be used is described in US10434605B2.

[0036] In one embodiment, the tool is an expandable funnel.

[0037] 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, may not extend over the entirety of the proximal connection portion, or may extend over at least a portion of the attachment. In a particular embodiment, the coating extends over at least a portion of the proximal connection portion. In another particular embodiment, the coating extends over at least a portion of the attachment. In some embodiments, the coating may be impermeable, thus allowing for the stopping of blood flow. In one embodiment, the coating may include an elastomeric or thermoplastic elastomer material, such as polyurethane or silicone, among others.

[0038] In accordance with another aspect, the present invention provides a method for attaching a tool to a distal end of a vascular catheter, the tool including a proximal connecting portion.

[0039] In one embodiment, the method includes the steps of placing a proximal connection portion over a distal connection portion of a vascular catheter and attaching the tool to the vascular catheter by creating an attachment between the proximal connection portion and the distal connection portion (i.e., an element / object relationship), the attachment having an outer diameter substantially equal to the outer diameter of the vascular catheter.

[0040] In another embodiment, a vascular catheter comprises a catheter jacket, an inner catheter element comprising a braided layer surrounded by the catheter jacket, and a distal connecting portion including an extended portion of the inner catheter element extending distally beyond a distal end of the catheter jacket. Thus, the method includes the steps of placing the proximal connecting portion over the distal connecting portion of the vascular catheter with a proximal end of the proximal connecting portion abutting the distal end of the braided layer, and creating attachments on the proximal connecting portion and the distal connecting portion for attaching a tool to the vascular catheter.

[0041] In one embodiment, the step of creating 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 the other material (e.g., inner liner or braided layer).

[0042] In one embodiment, the thermoplastic material includes an inner jacket, and the step of creating the attachment further includes disposing the inner jacket over a distal connection portion of the vascular catheter.

[0043] In one embodiment, the inner catheter element comprises an inner liner and the distal connection portion comprises an extension of the inner liner, and the step of creating the attachment further comprises fusing (or melting) the inner jacket to the inner liner.

[0044] In one embodiment, the inner catheter element comprises an inner liner disposed within a catheter jacket of the vascular catheter, and the distal connection portion comprises an extended portion of the inner liner extending distally beyond a distal end of the catheter jacket, and the step of creating the attachment further comprises fusing (or melting) the inner jacket to the inner liner.

[0045] Creating the attachment may include flowing a thermoplastic material through openings in (or over) the braided layer and / or over the inner liner.

[0046] In one embodiment, the thermoplastic material comprises an outer jacket, and creating the attachment further includes placing the outer jacket around the proximal connection portion of the tool and / or around the distal connection portion of the vascular catheter, and applying energy to the outer jacket to cause the thermoplastic material to flow over the proximal and distal connection portions.

[0047] In one embodiment, the proximal connecting portion of the tool comprises openings (or cells), and the step of creating the attachment comprises flowing the thermoplastic material through the openings in the proximal connecting portion.

[0048] In one embodiment, the proximal connecting portion of the tool comprises a braid.

[0049] In some embodiments, the step of creating the attachment may include applying an adhesive to the proximal connecting portion and the distal connecting portion.

[0050] 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.

[0051] In some embodiments, the step of applying an adhesive includes applying an adhesive between the proximal connecting portion and the distal connecting portion.

[0052] 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.

[0053] 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. [Brief description of the drawings]

[0054] <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. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0055] 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 and fuse between them. Thus, the figures show the arrangement / relationship between the elements, objects, and layers of the invention.

[0056] 1A and 1B, an embodiment of the proposed intravascular device 1 is shown. The intravascular device 1 comprises a vascular catheter 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 catheter 40 via an attachment 50 with 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 relationship of the diameters of the proximal connection portion 33 and the distal connection portion 43 is shown diagrammatically in FIG. 1A.

[0057] The tool 10 may comprise different medical devices, in particular an expandable funnel, which comprises two tubular sections, namely a first tubular section 20 and a second tubular section 30 proximal to the first tubular section 20. In particular, the second tubular section 30 comprises two subsections, namely a first subsection 31 and a second subsection 32. In the embodiment of Figures 1A and 1B, the first subsection 31 is conical or funnel-shaped and the second subsection 32 comprises a proximal connecting portion 33.

[0058] 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.

[0059] 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 .

[0060] 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.

[0061] 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.

[0062] In addition to the elements mentioned above, in one embodiment, an inner thermoplastic material or inner jacket 47 is disposed around 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 in FIGS. 2C and 3C.

[0063] 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.

[0064] 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.

[0065] 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.

[0066] 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).

[0067] 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).

[0068] 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.

[0069] 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.

[0070] 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.

[0071] 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.

[0072] 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 helical filaments (or wires), which may be the same or different, rotating in opposite directions and intertwining. The helical 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 a first tubular section 20 and a second tubular section 30. The end of the first 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.

[0073] 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 second subsection 32 (or part thereof) in other described embodiments. Working portion 101 can be understood as first tubular section 20 and first subsection 31 in other described embodiments.

[0074] 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.

[0075] 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 first 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.

[0076] 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.

[0077] 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.

[0078] 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.

[0079] FIG. 12 shows an example of an intravascular device 1 of the present invention, which allows for its automated manipulation through the vascular system.

[0080] 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.

[0081] 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.

[0082] 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.

[0083] 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 measure the tensile resistance of the attachment 50 between the catheter device 40 and the tool 10 of the intravascular device 1 of the present invention.

[0084] 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: TIFF2025501729000002.tif62169

[0085] 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.

[0086] <Method> The materials and equipment used during the procedure are shown in Table 2. TIFF2025501729000003.tif62169

[0087] 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.

[0088] 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.

[0089] <Results and conclusions> Table 3 shows the attachment pull force results for both techniques: TIFF2025501729000004.tif139169

[0090] 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.

[0091] 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.

[0092] In conclusion, the tested technique meets the requirements so that it can be advanced, pulled and maintained within the vessel during the intervention.

[0093] 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.

[0094] 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.

[0095] 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.

[0096] 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).

[0097] 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.

[0098] <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.

[0099] 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 as required. 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.

[0100] 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.

[0101] The 2PB apparatus (e.g., vertical tensile tester) consists of a shaft-holding fixture and a calibrated load cell (50 N) with a tip 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 positioned at the plunger fixture location. The plunger was loaded by the load cell until the distal end of the device reached a displacement of 1.5 mm from the vertical starting position (i.e., 0o 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.

[0102] <Results and conclusions> TIFF2025501729000005.tif100169

[0103] 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.

[0104] 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.

[0105] 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 the 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, components, 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.

[0106] 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. The scope of the invention is defined in the following set of claims.

Claims

1. A vascular catheter (40) comprising a catheter jacket (44), an inner catheter element surrounded by said catheter jacket (44), and a distal connecting portion (43), said distal connecting portion (43) including an extension portion of said inner catheter element extending distally beyond a distal end of said catheter jacket (44). a tool (10) attached to and extending from the distal connection portion (43) of the vascular catheter (40), the tool (10) including a proximal connection portion (33), the proximal end of the proximal connection portion (33) of the tool (10) abutting the inner catheter element; and an attachment (50) between the tool proximal connection portion (33) and the vascular catheter distal connection portion (43) adapted to keep the tool (10) connected to the vascular catheter (40), the attachment (50) having an outer diameter substantially equal to an outer diameter of the vascular catheter (40).

2. 2. The device of claim 1, wherein the inner catheter element comprises a first element (46) and a second element (45), and the proximal end of the proximal connecting portion (33) of the tool (10) abuts the distal end of the second element (45).

3. The device of claim 2 , wherein the first element (46) comprises a polymeric material.

4. The device of claim 2 or 3, wherein the second component (45) of the inner catheter element comprises a braided layer.

5. The device of any one of claims 1 to 4, wherein the attachment (50) comprises a thermoplastic material extending over the proximal connection portion (33) of the tool (10) and the distal connection portion (43) of the vascular catheter (40).

6. The device of claim 5, wherein the proximal connecting portion (33) of the tool (10) comprises an opening and the thermoplastic material (47, 48) extends through the opening.

7. The device of claim 6 , wherein the proximal connecting portion (33) of the tool (10) comprises a braid.

8. The device of claim 6, wherein the proximal connecting portion (33) of the tool (10) comprises a laser cut tube.

9. A device according to any one of claims 5 to 8, wherein the thermoplastic material of the attachment extends to the inner catheter element.

10. The device according to any one of claims 5 to 9, wherein the inner catheter element comprises an opening, and the thermoplastic material (47, 48) of the attachment (50) extends through the opening.

11. The device of any one of claims 1 to 10, wherein the attachment (50) comprises an adhesive (49) extending between the proximal connection portion (33) of the tool (10) and the distal connection portion (43) of the vascular catheter (40).

12. The device according to any one of the preceding claims, wherein the tool (10) further comprises a coating.

13. The device of claim 12, wherein the coating extends over at least a portion of the proximal connecting portion (33).

14. 14. The device of claim 12 or 13, wherein the coating extends over at least a portion of the attachment (50).

15. The device of any one of claims 12 to 14, wherein the coating comprises an elastomeric or thermoplastic elastic material.

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