Introducer tool for aspiration catheter

Abstract

An introducer tool for use with a vascular access channel system and method is provided. The aspiration catheter is pre-assembled into the expanded proximal section of the introducer tool when the radially self-expanding distal section of the aspiration catheter is in a radially uncompressed state. The introducer tool and a suction catheter pre-assembled in the introducer tool together are guided as a single unit into the hemostasis valve and the tapered guide sheath luer taper. The suction catheter is pushed through the introducer tool. The radially self-expanding distal section of the aspiration catheter is radially compressed so as to be receivable in the lumen of the guide sheath catheter when passed through the lumen of the shaft of the introducer tool and / or the compression section of the tapered inner profile of the tapered guide sheath luer taper. When the radially self-expanding distal section is radially compressed, the aspiration catheter slides into the lumen of the guide sheath catheter.

Description

[0001] Cross-references to related patent applications

[0002] This patent application claims the benefit of U.S. Provisional Application Serial No. 63 / 347,526, filed on May 31, 2022, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates to an introducer tool for an aspiration catheter, such as a funnel catheter. In particular, the present disclosure relates to an introducer tool for guiding an aspiration catheter through a hemostatic valve and into the lumen of a sheath catheter.

[0004] Related technologies

[0005] Suction catheters are often used to apply vacuum pressure to capture target obstructions in blood vessels during endovascular treatments or surgeries such as thrombectomy. Suction catheters can be used in combination with mechanical thrombectomy devices (e.g., stent retrievers). When the suction catheter is passed through a hemostatic valve and into a guide catheter, it would be beneficial to protect the relatively soft, open, flexible distal tip, which is susceptible to damage if it is caught on an edge when being guided into the lumen of the guide sheath catheter. It is also advantageous to minimize friction, maintain the wetted outer diameter of the suction catheter to prevent the hydrophilic coating from drying out, thereby minimizing surface contact and preventing axial loading of the suction catheter.

[0006] It would be desirable to develop an improved introducer tool for guiding an aspiration catheter through a hemostatic valve and into the lumen of an introducer sheath catheter that addresses all of these issues. Summary of the invention

[0007] One aspect of the present disclosure is directed to an introducer tool for guiding an aspiration catheter (eg, a funnel catheter) through a hemostasis valve and into the lumen of an introducer sheath catheter.

[0008] Another aspect of the present disclosure relates to an introducer for guiding an aspiration catheter (e.g., a funnel catheter) through a hemostatic valve and into the lumen of a guide sheath catheter while protecting a relatively soft, open, flexible distal tip that is susceptible to damage if it becomes stuck on an edge when being guided into the lumen of the guide sheath catheter.

[0009] Yet another aspect of the present disclosure relates to an introducer tool for guiding an aspiration catheter (eg, a funnel catheter) through a hemostatic valve and into the lumen of an introducer sheath catheter while maintaining a wetted outer diameter of the funnel catheter to prevent drying of the hydrophilic coating.

[0010] Yet other aspects of the present disclosure relate to an introducer for guiding an aspiration catheter (e.g., a funnel catheter) through a hemostatic valve and into the lumen of a guide sheath catheter while minimizing friction, maintaining a wetted outer diameter of the aspiration catheter to prevent the hydrophilic coating from drying out, thereby minimizing surface contact and preventing axial loading of the aspiration catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The foregoing and other features of the present disclosure will become more apparent from the following detailed description and illustrative drawings, wherein like reference numerals refer to similar elements throughout the several views, and wherein:

[0012] Figure 1A is an axial / longitudinal cross-sectional view of a vascular access channel system including a first example of an introducer tool according to the present disclosure having a shaft member having a straight (i.e., cylindrical—uniform in both inner and outer diameters) distal segment and a lumen defined therethrough into which a funnel catheter is inserted unimpeded, the distal segment of the funnel catheter being in an expanded (i.e., open biased, radially enlarged, radially uncompressed at maximum outer diameter) state; the introducer tool and the funnel catheter preassembled in the introducer tool being introduced together as a single unit into an assembly including a hemostasis valve attached to an introducer sheath catheter via a tapered introducer sheath luer / hub;

[0013] Figure 1B yes Figure 1A An axial / longitudinal cross-sectional view of a vascular access channel system of the present invention, depicting a distal segment of the funnel catheter in a radially compressed state with a reduced outer diameter after direct physical engagement with an inner wall / inner contour of a tapered introducer sheath luer connector / hub, the distal segment being able to be accommodated in a smaller inner diameter lumen of the introducer sheath catheter;

[0014] Figure 1C Is has Figure 1A an axial / longitudinal cross-sectional view of a vascular access channel system of a modified configuration of an introducer tool having a shaft member having a straight (i.e., cylindrical—uniform in both inner and outer diameters) distal segment and a lumen defined therethrough, the lumen having an inner diameter sized to radially compress (i.e., reduce the outer diameter of) the expanded distal segment of a funnel catheter when the expanded distal segment is inserted therein; the introducer tool and the funnel catheter preassembled in the introducer tool being introduced together as a single unit into an assembly (including a hemostasis valve attached to the introducer sheath catheter via a tapered introducer sheath luer connector / hub);

[0015] Figure 1D yes Figure 1Can axial / longitudinal cross-sectional view of a vascular access channel system of the present invention, depicting a distal segment of the funnel catheter in a radially compressed state with a reduced outer diameter after passing through the distal segment of the introducer tool, the distal segment being able to be accommodated in a smaller inner diameter lumen of an introducer sheath catheter without directly physically contacting an inner wall / inner contour of a tapered introducer sheath luer connector / hub;

[0016] Figure 2A is an axial / longitudinal cross-sectional view of a vascular access channel system having a second example of an introducer tool according to the present disclosure, the introducer tool having a shaft member having a distal section that is tapered only in outer diameter and a lumen defined through the shaft member into which a funnel catheter is inserted unimpeded, the distal section of the funnel catheter being in an expanded (i.e., open biased, radially enlarged, radially uncompressed at maximum outer diameter) state; the introducer tool and the funnel catheter preassembled in the introducer tool being introduced together as a single unit into an assembly (including a hemostasis valve attached to the introducer sheath catheter via a tapered introducer sheath luer connector / hub);

[0017] Figure 2B yes Figure 2A An axial / longitudinal cross-sectional view of a vascular access channel system of , depicting a distal segment of the funnel catheter in a radially compressed state with a reduced outer diameter, the distal segment being able to be accommodated in a smaller inner diameter lumen of an introducer sheath catheter;

[0018] Figure 3A is an axial / longitudinal cross-sectional view of a third example of an introducer tool according to the present disclosure, the introducer tool having a shaft member having a lumen defined therethrough; a distal section of the shaft member being tapered in both its inner and outer diameters;

[0019] Figure 3B is an axial / longitudinal cross-sectional view of a funnel catheter with its distal segment in an expanded (i.e., open biased, radially enlarged, radially uncompressed at maximum outer diameter) state, the distal segment being inserted unimpeded prior to entering the distal segment which is tapered in both its inner and outer diameters Figure 3A within a lumen of a shaft member of an introducer tool;

[0020] Figure 3C Is has Figure 3A an axial / longitudinal cross-sectional view of a vascular entry channel system of an introducer tool of , wherein an expanded (i.e., opening offset, radially enlarged, radially uncompressed at maximum outer diameter) distal segment of the infundibulum catheter is depicted as unobstructed (radially uncompressed) in the introducer tool;

[0021] Figure 3D yes Figure 3Can axial / longitudinal cross-sectional view of a vascular access channel system of the present invention, depicting a distal segment of the funnel catheter being radially compressed (having its outer diameter reduced) after passing through a tapered distal segment of an introducer tool, the tapered distal segment being able to be accommodated within the inner diameter of the lumen of an introducer sheath catheter without directly physically contacting the tapered inner wall of the introducer sheath luer connector / hub;

[0022] Figure 4A yes Figure 3A An axial / longitudinal cross-sectional view of a modified example of an introducer tool having a distal section that is tapered in both inner and outer diameters and a plurality of flushing ports defined in an outer wall of a shaft member;

[0023] Figure 4B is an axial / longitudinal cross-sectional view of a funnel catheter with its distal segment in an expanded (i.e., open biased, radially enlarged, radially uncompressed at maximum outer diameter) state, the distal segment passing unimpeded prior to entering a distal segment tapered in both its inner and outer diameters. Figure 4A a lumen of an introducer tool;

[0024] Figure 4C Is has Figure 4A An axial / longitudinal cross-sectional view of a vascular access channel system of an introducer tool of FIG. 1 , the introducer tool and a funnel catheter preassembled in the introducer tool being introduced together as a single unit into an assembly including a hemostasis valve attached to an introducer sheath catheter via a tapered introducer sheath Luer connector / hub;

[0025] Figure 4D yes Figure 4C an axial / longitudinal cross-sectional view of a vascular access channel system of the present invention, depicting a distal segment of the funnel catheter being radially compressed (i.e., having its outer diameter reduced) after passing through a distal segment of an introducer tool that is tapered in both inner and outer diameters and being received within the lumen of an introducer sheath catheter without directly physically contacting the tapered inner wall / inner contour of the introducer sheath luer connector / hub;

[0026] Figure 5A yes Figure 3A An axial / longitudinal cross-sectional view of a modified example of an introducer tool having a distal section that is tapered in both inner and outer diameters and defines an axial / longitudinal slit in an outer wall of a shaft member that separates the introducer tool for removal from around a funnel catheter;

[0027] Figure 5B yes Figure 5A an axial / longitudinal cross-sectional view of a further modification of an introducer tool having a series of flushing ports aligned with the axial / longitudinal slit;

[0028] Figure 5C yes Figure 3A An axial / longitudinal cross-sectional view of another modified example of an introducer tool having a single longitudinal slot defined in an outer wall of a shaft member, the axial / longitudinal edges of the single longitudinal slot being radially separated from each other to form an opening allowing fluid to pass therethrough;

[0029] Figure 5D yes Figure 3A An axial / longitudinal cross-sectional view of yet another modified example of an introducer tool of , wherein a single axial / longitudinal slit is defined in the outer wall of the shaft member, the longitudinal edges of the single axial / longitudinal slit radially overlapping each other;

[0030] Fig. 6A yes Figure 3A An axial / longitudinal cross-sectional view of yet another modified example of an introducer tool of the type shown in FIG. 1 , wherein the distal section of the introducer tool is tapered in both the inner diameter and the outer diameter and has one or more axially / longitudinally extending weakened regions (e.g., perforations) in the outer wall of the shaft member, thereby allowing one or more axial / longitudinal sections between adjacent weakened regions to be independently peeled away while the funnel catheter is retained in the assembly;

[0031] Figure 6B yes Fig. 6A an axial / longitudinal cross-sectional view of a further modification of an introducer tool having a series of flushing ports aligned with weakened areas (e.g., perforations) defined in an outer wall of a shaft member;

[0032] Fig. 7A Is has Figure 3A An axial / longitudinal cross-sectional view of an alternative form of a vascular access channel system of an introducer tool comprising a funnel / cone shaped proximal segment that is nestable within an identical funnel / cone shaped proximal segment of a funnel catheter when fully inserted into the assembly;

[0033] Figure 7B yes Fig. 7A an axial / longitudinal cross-sectional view of a vascular access channel system of , depicting further advancement of the funnel catheter in the distal direction (i.e., partial insertion) with the distal segment of the funnel catheter being radially compressed (having its outer diameter reduced) after passing through the tapered inner diameter of the distal segment of the introducer tool and being received in the lumen of the introducer sheath catheter;

[0034] Figure 7C yes Figure 7B axial / longitudinal cross-sectional view depicting the funnel catheter being advanced further in the distal direction with its distal segment fully inserted into the lumen of the introducer sheath catheter; over-insertion of the funnel catheter into the assembly is prevented by physically seating the proximal segment funnel / cone of the funnel catheter within the proximal segment funnel / cone of the introducer tool;

[0035] Fig. 8A is a side view of yet another example of an introducer tool comprising a one-way transition segment that inhibits over-insertion into an introducer sheath tapered Luer connector / hub, thereby preventing compression of the distal tip and lumen narrowing; the one-way transition segment provides a tapered or stepped junction between: (i) a non-insertable straight (i.e., cylindrical—uniform in both inner and outer diameters) segment having an inner diameter capable of accommodating an expanded (i.e., open) portion of a funnel catheter unimpeded therein; and (ii) an insertable straight (i.e., cylindrical—uniform in both inner and outer diameters) segment having a smaller outer diameter relative to the non-insertable straight (cylindrical—uniform in both inner and outer diameters) segment, the insertable straight segment being receivable in the lumen of the introducer sheath catheter; wherein the expanded distal segment of the funnel catheter is radially compressed when advanced through the insertable straight segment of the introducer tool;

[0036] Figure 8B is an axial / longitudinal cross-sectional view of a vascular access channel system including an introducer tool, the introducer tool including a one-way transition segment that inhibits over-insertion into an introducer sheath tapered Luer connector / hub, thereby preventing compression of the distal end / tip; the one-way transition segment provides a tapered junction or a stepped junction between: (i) a non-insertable straight (i.e., cylindrical—uniform in both inner and outer diameters) segment having an inner diameter capable of accommodating expansion of a funnel catheter (i.e., the distal section of the funnel catheter being able to be advanced unimpeded (i.e., radially uncompressed) through both the non-insertable straight section and the insertable straight section;

[0037] Figure 8Cis an axial / longitudinal cross-sectional view of a vascular access channel system having an introducer tool including a bidirectional transition segment that inhibits over-insertion into an introducer sheath tapered Luer connector / hub, thereby preventing compression of the distal tip; the bidirectional transition segment provides a tapered junction or a stepped-down junction in opposite directions between: (i) a non-insertable straight (i.e., cylindrical—uniform in both inner and outer diameters) segment; and (ii) an insertable straight (i.e., cylindrical—uniform in both inner and outer diameters) segment having an outer diameter equal to the outer diameter of the non-insertable straight segment; depicting the distal segment of the funnel catheter in an expanded (i.e., open biased, radially enlarged, radially uncompressed at maximum outer diameter) state being able to be advanced unimpeded while advancing through both the non-insertable straight segment and the insertable straight segment;

[0038] Fig.8D is an axial / longitudinal cross-sectional view of a vascular access channel system having another introducer tool, the introducer tool including a one-way transition segment that provides a tapered junction or a stepped junction between: (i) a proximal straight (i.e., cylindrical—uniform in both inner and outer diameters) segment having an inner diameter capable of accommodating an expanded (i.e., opening offset, radially enlarged, radially uncompressed at maximum outer diameter) distal segment of a funnel catheter unimpeded therein; and (ii) a distal straight (i.e., a cylindrical—uniform in both inner and outer diameters) segment, the distal straight segment having a smaller outer diameter relative to the proximal straight (i.e., cylindrical—uniform in both inner and outer diameters) segment; depicting the distal segment of the funnel catheter in an expanded, open-biased state being able to advance unimpeded (i.e., radially uncompressed) while traveling through the proximal straight segment (prior to being radially compressed (reducing outer diameter) while traveling through the distal straight (cylindrical) segment); the proximal segment of the funnel catheter comprising a stiffer proximal region X;

[0039] Fig. 8Eis an axial / longitudinal cross-sectional view of a vascular access channel system having an introducer tool including a one-way transition segment providing a tapered junction or a stepped junction between: (i) a proximal straight (i.e., cylindrical—uniform in both inner and outer diameters) segment having an inner diameter capable of accommodating an expanded (i.e., open offset, radially enlarged, radially uncompressed at maximum outer diameter) distal segment of a funnel catheter unimpeded therein; and (i i) a distal straight (i.e., cylindrical—uniform in both inner and outer diameters) segment having a smaller outer diameter relative to a proximal straight (i.e., cylindrical—uniform in both inner and outer diameters) segment; depicting the distal segment of the funnel catheter in an expanded, open-biased state being able to advance unimpeded (i.e., radially uncompressed) as it travels through the proximal straight segment (prior to being radially compressed (reduced in outer diameter) as it travels through the distal straight (cylindrical) segment); and Fig.8D The length of the proximal straight (cylindrical) section of the introducer tool is longer than the length of the inlet catheter, thereby providing additional support for the more flexible region of the funnel catheter disposed distally to the stiffer proximal region X;

[0040] Fig.8F is an axial / longitudinal cross-sectional view of a vascular access channel system having a further introducer tool, the inner and outer contours of the introducer tool having a continuous taper to a proximal expansion section thereof;

[0041] Fig. 9 Is has Figure 3A an axial / longitudinal cross-sectional view of a vascular access channel system of an introducer tool of claim 1, wherein the introducer tool and a funnel catheter preassembled in the introducer tool are advanced together as a single unit through an assembly (including a hemostasis valve connected to an introducer sheath catheter via a tapered introducer sheath luer connector / hub), and a removable extension retainer is secured around a dilated / tapered proximal section of the introducer tool, thereby providing additional length to protect a distal soft, flexible section of the funnel catheter as the tip is advanced through the introducer tool, and is removable to allow the funnel catheter length to be fully inserted into the assembly;

[0042] Fig.10 yes Figure 3C axial / longitudinal cross-sectional view of a vascular access channel system of , showing undesirable compression of the distal end / tip and narrowing of the lumen of the introducer tool due to direct physical contact with the tapered inner wall of the introducer sheath luer connector / hub caused by over-insertion in the assembly;

[0043] Fig.11Ais a side view of an exemplary introducer tool having a radially expandable compression force absorbing component including radially expandable corrugations that prevent compression of the distal end / tip and lumen narrowing when subjected to excessive force (i.e., over-insertion), wherein the radially expandable corrugations are depicted in an undeployed state (i.e., an axially / longitudinally uncompressed state not subjected to over-insertion);

[0044] Fig. 11B Yes Fig.11A axial / longitudinal cross-sectional view of a vascular access channel system of an introducer tool of FIG. 1 , the introducer tool being inserted as a unit into an assembly (including a hemostasis valve connected to an introducer sheath catheter via a tapered introducer sheath Luer connector / hub) with a funnel catheter preassembled therein; wherein the radially expandable corrugations are depicted in an undeployed state (i.e., an axially / longitudinally uncompressed state not subject to over-insertion);

[0045] Fig. 11C yes Fig.11A A side view of an introducer tool of , wherein the radially expandable corrugations are depicted in an expanded state (ie, an axially / longitudinally compressed state subjected to over-insertion);

[0046] Fig.11D Yes Fig. 11C axial / longitudinal cross-sectional view of a vascular access channel system of an introducer tool of FIG. 1 , the introducer tool together with a funnel catheter preassembled therein being inserted as a unit into an assembly (including a hemostasis valve connected to an introducer sheath catheter via a tapered introducer sheath Luer connector / hub); wherein the radially expandable corrugations are depicted in an expanded state (i.e., an axial / longitudinal compressed state subjected to over-insertion);

[0047] Fig. 12A is a side view of an exemplary introducer tool having a radially expandable compression force absorbing component that prevents compression of the distal end / tip when subjected to excessive force (over-insertion), wherein the radially expandable compression force absorbing component includes radially expandable arms formed in areas between adjacent axial / longitudinal slits defined in the shaft of the introducer tool; wherein the radially expandable arms are depicted in an undeployed state (i.e., an axially / longitudinally uncompressed state not subjected to over-insertion, having a uniform minimum outer diameter);

[0048] Fig. 12B Is has Fig. 12Aaxial / longitudinal cross-sectional view of a vascular access channel system of an introducer tool of FIG. 1 , the introducer tool and a funnel catheter preassembled in the introducer tool being inserted as a unit into an assembly (including a hemostasis valve connected to an introducer sheath catheter via a tapered introducer sheath Luer connector / hub); wherein the radially expandable arms are depicted in an undeployed state (i.e., an axial / longitudinal uncompressed state not subjected to over-insertion);

[0049] Fig. 12C yes Fig. 12A A side view of an introducer tool of , wherein the radially expandable arms are depicted in an expanded state (ie, an axially / longitudinally compressed state undergoing over-insertion, having a non-uniform maximum outer diameter);

[0050] Fig.12D Is has Fig. 12C axial / longitudinal cross-sectional view of a vascular access channel system of an introducer tool of FIG. 1 , the introducer tool being inserted as a unit into an assembly (including a hemostasis valve connected to an introducer sheath catheter via a tapered introducer sheath Luer connector / hub) with the funnel catheter preassembled therein; wherein the radially expandable arms are depicted in an expanded state (i.e., an axial / longitudinal compressed state subjected to over-insertion, having a non-uniform maximum outer diameter);

[0051] Fig.13A is a side view of an exemplary introducer tool having a radially expandable compression force absorbing component that prevents compression of the distal end / tip when subjected to excessive force (over-insertion), wherein the radially expandable compression force absorbing component includes angled radially expandable arms formed in areas between adjacent angled slots defined in the shaft of the introducer tool; wherein the angled radially expandable arms are depicted in an undeployed state (i.e., an axially / longitudinally uncompressed state not subjected to over-insertion, having a uniform minimum outer diameter);

[0052] Fig. 13B Is has Fig.13A axial / longitudinal cross-sectional view of a vascular access channel system of an introducer tool of FIG. 1 , the introducer tool and a funnel catheter preassembled therein being inserted as a unit into an assembly (including a hemostasis valve connected to an introducer sheath catheter via a tapered introducer sheath Luer connector / hub); wherein the angled radially expandable arms are depicted in an undeployed state (i.e., an axially / longitudinally uncompressed state not subject to over-insertion);

[0053] Fig. 13C yes Fig.13A A side view of an introducer tool of , wherein the angled radially expandable arms are depicted in an expanded state (ie, an axially / longitudinally compressed state undergoing over-insertion, having a non-uniform maximum outer diameter);

[0054] Fig.13D Is has Fig. 13C axial / longitudinal cross-sectional view of a vascular access channel system of an introducer tool of FIG. 1 , the introducer tool being inserted as a unit into an assembly (including a hemostasis valve connected to an introducer sheath catheter via a tapered introducer sheath Luer connector / hub); wherein the angled radially expandable arms are depicted in an expanded state (i.e., an axial / longitudinal compressed state subjected to over-insertion, having a non-uniform maximum outer diameter);

[0055] Fig.14A is a side view of an exemplary introducer tool having a radially expandable compression force absorbing component that prevents compression of the distal end / tip when subjected to excessive force (over-insertion), wherein the radially expandable compression force absorbing component includes radially expandable arms formed in areas between adjacent series of axial / longitudinal slits defined in an alternating pattern in the shaft of the introducer tool; wherein the radially expandable arms are depicted in an undeployed state (i.e., an axially / longitudinally uncompressed state not subjected to over-insertion, having a uniform minimum outer diameter);

[0056] Fig. 14B Is has Fig.14A axial / longitudinal cross-sectional view of a vascular access channel system of an introducer tool of FIG. 1 , the introducer tool and a funnel catheter preassembled in the introducer tool being inserted as a unit into an assembly (including a hemostasis valve connected to an introducer sheath catheter via a tapered introducer sheath Luer connector / hub); wherein the radially expandable arms are depicted in an undeployed state (i.e., an axial / longitudinal uncompressed state not subjected to over-insertion);

[0057] Fig. 14C yes Fig.14A A side view of an introducer tool of , wherein the radially expandable arms are depicted in an expanded state (ie, an axially / longitudinally compressed state undergoing over-insertion, having a non-uniform maximum outer diameter);

[0058] Fig.14D Is has Fig. 14C axial / longitudinal cross-sectional view of a vascular access channel system of an introducer tool of FIG. 1 , the introducer tool being inserted as a unit into an assembly (including a hemostasis valve connected to an introducer sheath catheter via a tapered introducer sheath Luer connector / hub) with the funnel catheter preassembled therein; wherein the radially expandable arms are depicted in an expanded state (i.e., an axial / longitudinal compressed state subjected to over-insertion, having a non-uniform maximum outer diameter);

[0059] Fig.15Ais a side view of an exemplary introducer tool having a radially expandable compression force absorbing component comprising a material having a relatively low stiffness that tends to expand radially outward (i.e., bulge) relative to the material comprising the remainder of the shaft member of the introducer tool when subjected to compressive forces, thereby preventing compression of the distal end / tip and lumen narrowing when subjected to excessive forces (over-insertion), wherein the radially expandable compression force absorbing component is depicted in an undeployed state (i.e., an axially / longitudinally uncompressed state not subjected to over-insertion);

[0060] Fig. 15B Yes Fig.15A axial / longitudinal cross-sectional view of a vascular access channel system of an introducer tool of FIG. 1 , the introducer tool being inserted as a unit into an assembly (including a hemostasis valve connected to an introducer sheath catheter via a tapered introducer sheath Luer connector / hub) with a funnel catheter preassembled therein; wherein the radially expandable compression force absorbing component is depicted in an undeployed state (i.e., an axial / longitudinal uncompressed state not subject to over-insertion);

[0061] Fig. 15C yes Fig.15A a side view of an introducer tool of , wherein a material having a lower stiffness that tends to expand radially outward (i.e., bulge) when subjected to a compressive force relative to the material constituting the remainder of the shaft member of the introducer tool is depicted in an expanded state (i.e., an axially / longitudinally compressed state subjected to over-insertion);

[0062] Fig.15D Yes Fig. 15C axial / longitudinal cross-sectional view of a vascular access channel system of an introducer tool of FIG. 1 , the introducer tool together with a funnel catheter preassembled therein being inserted as a unit into an assembly (including a hemostasis valve connected to an introducer sheath catheter via a tapered introducer sheath Luer connector / hub); wherein the radially expandable compression force absorbing component is depicted in an expanded state (i.e., an axial / longitudinal compressed state subjected to over-insertion);

[0063] Fig.16A is a perspective view of a distal end of an introducer tool according to the present disclosure, showing axial / longitudinal internal ribs projecting radially inwardly along the inner wall of a lumen;

[0064] Fig. 16B yes Fig.16A a perspective view of one half of an introducer tool in an axial / longitudinal direction to illustrate an axial / longitudinal internal rib protruding radially inwardly along the inner wall of the distal segment of the lumen;

[0065] FIG. 17A to FIG. 17G is a radial cross-sectional view through the distal segment of the introducer tool, depicting various non-circular geometries of the lumen; wherein Fig.17E It is along Fig.16A A radial cross-sectional view of line 17(E)-17(E) through the internal rib;

[0066] Fig.18A is an axial / longitudinal cross-sectional view of a vascular access channel system including an introducer tool having an axially / longitudinally retractable segment including a telescoping tube, the telescoping tube being depicted in an axially / longitudinally expanded (uncontracted) state (i.e., a maximum axial / longitudinal length L1);

[0067] Fig.18B yes Fig.18A axial / longitudinal cross-sectional view of a vascular access channel system of , wherein the telescoping tube of the axially / longitudinally retractable section of the introducer tool is depicted in an axially / longitudinally retracted state (i.e., a minimum axial / longitudinal length L2);

[0068] Fig.19A is an axial / longitudinal cross-sectional view of a vascular access channel system including an introducer tool having an axially / longitudinally collapsible segment including a plurality of bellows depicted in an axially / longitudinally expanded (uncollapsed) state (i.e., a maximum axial / longitudinal length L1);

[0069] Fig.19B yes Fig.19A an axial / longitudinal cross-sectional view of a vascular access channel system of FIG. 1 , wherein the plurality of bellows of the axially / longitudinally contractible section of the introducer tool are depicted in an axially / longitudinally contracted state (i.e., a minimum axial / longitudinal length L2);

[0070] Fig. 20A is a side view of yet another example of an introducer tool according to the present disclosure having two transition segments and a proximal segment that is peelably separated along a longitudinal / axial direction to form a handle / tab for a manipulation device;

[0071] Fig. 20B yes Fig. 20A a proximal end view of an introducer tool;

[0072] Fig. 20C yes Fig. 20A An axial / longitudinal cross-sectional view of the introducer tool along line 20(A)-20(A);

[0073] Fig.20D yes Fig. 20A An enlarged axial / longitudinal cross-sectional view of section 20(D)-20(D) showing a distal tapered end having a uniform inner diameter and a tapered outer diameter;

[0074] Fig.20E yes Fig. 20AA perspective view of an introducer tool;

[0075] Fig.21A is a side view of yet another example of a semi-split introducer tool according to the present disclosure, wherein one of the peelably separable handles / tabs is cut away to show an interior area of ​​the remaining handle / tab;

[0076] Fig.21B yes Fig.21A an enlarged side view of a portion of the unseparated segment "A" of the introducer tool identified as segment 21 (B);

[0077] Fig. 21C yes Fig.21A An enlarged side view of a transition segment of the introducer tool identified as segment 21 (C);

[0078] Fig.22A is a side view of yet another example of a semi-detached introducer tool according to the present disclosure, wherein one of the peelably detachable handles / tabs is cut away to show an interior region of the remaining handle / tab; wherein the introducer tool has a proximal section with increased stiffness;

[0079] Fig. 22B is through the segment identified as segment 22 (B) Fig.22A An enlarged cross-sectional view of an introducer tool;

[0080] Fig. 22C is through the segment identified as segment 22 (C) Fig.22A An enlarged cross-sectional view of an introducer tool;

[0081] Fig.23A is yet another example of a semi-detached introducer tool according to another aspect of the present disclosure, wherein the rigid proximal segment is maximized by eliminating the peelably detachable handle / tab;

[0082] Fig. 23B is through the segment identified as segment 23 (B) Fig.23A An enlarged axial / longitudinal cross-sectional view of an introducer tool;

[0083] Fig.23C is through the segment marked as segment 23 (C) Fig.23A an enlarged axial / longitudinal cross-sectional view of an introducer tool; and

[0084] Fig.23D Depicted Fig.23A An introducer tool wherein an aspiration catheter and a strain relief are housed within a lumen of the introducer tool and over-insertion is prevented by a proximal interface. DETAILED DESCRIPTION

[0085] In the specification, the terms "distal" or "proximal" are used in the following descriptions of positions or directions relative to a treating physician or medical interventionist. "Distal" or "distalward" is a position away from or in a direction away from the physician or interventionist. "Proximal" or "proximalward" or "on the proximal side" is a position close to or in a direction toward the physician or interventionist. The terms "blockage", "clot" or "occlusion" are used interchangeably.

[0086] The suction catheter (e.g., a funnel catheter) has a radially self-expanding, open, open-biased, expanded distal segment (including a distal end) having an integral shaft extending from it in a proximal direction. In order to track through a tortuous vascular system, the expanded distal segment of the suction catheter is more conformable, and the distal shaft segment is more flexible relative to the segment of the proximal shaft. Preferably, the axial length of the flexible distal shaft segment of the funnel catheter is 1 cm to 30 cm, and the conformable expanded distal segment is 2 mm to 10 mm. This increased stiffness (less flexibility) of the proximal shaft of the funnel catheter can be achieved by an embedded braid pattern or a polymer sheath having a desired hardness. When the suction catheter is passed through the hemostatic valve and enters the guide catheter, an introducer tool can be used to protect the relatively soft, open, radially expandable, conformable expanded distal segment and flexible distal shaft segment, which is easy to get stuck on the edge when being pushed forward, and the flexible distal shaft segment is easy to bend under axial compression load when the expanded distal segment collapses and advances through the guide catheter. The design of the introducer tool also solves the challenge of inserting the radially self-expanding, expanded (i.e., opening bias, opening, radial expansion, radial non-compression of the maximum outer diameter) distal expansion segment of the suction catheter into the smaller inner diameter lumen of the guide sheath catheter. In addition, in the art, the doctor preferably preassembles the suction catheter into the introducer tool in vitro, and then they can be quickly inserted and enter the guide sheath catheter as a single unit together through the hemostatic valve to minimize blood loss. Keeping the outer diameter of the suction catheter moistened to activate the hydrophilic coating is challenging because the opening design of the introducer tool allows any flushing fluid to be quickly discharged, thereby causing the hydrophilic coating to dry out. In the case where the catheter has a uniform outer profile / outer diameter, this is not a problem because the outer diameter of the catheter is less than the inner diameter of the introducer tool and the guide sheath, thereby allowing flushing between them. However, for the suction catheter, the outer diameter of the self-expanding opening (enlarged / expanded distal end) is larger than the conventional inner diameter of the guide sheath. If a conventional introducer tool with a uniform inner diameter close to the inner diameter of the lumen of the guide sheath catheter is used, the distal segment of the expansion / expansion of the suction catheter must be radially compressed (i.e., the outer diameter is collapsed / reduced) so as to pass therethrough, if a preloaded auxiliary device (e.g., microcatheter / mechanical thrombectomy device) is preloaded, air is likely to be trapped in the expanded catheter. However, due to the described difficulties associated with flushing the introducer tool and keeping the hydrophilic coating wet, friction may accumulate, thereby limiting the expansion / expansion of the distal segment of the aspiration catheter from passing through the introducer tool. In addition, the advancement of the aspiration catheter through the introducer tool may cause the expansion / expansion of the distal segment to collapse. In addition, when the flexible expansion / expansion of the aspiration catheter is advanced through the introducer tool, a compression resistance is generated, so another problem when overcoming this force is the risk of damaging the shaft of the introducer tool if it is gripped too tightly.The introducer tool of the present invention adapted for use with aspiration catheters solves these problems. By way of example, the introducer tool of the present invention is shown and described as being used with a funnel catheter; however, the introducer tool of the present invention is applicable to other types of aspiration catheters.

[0087] For each configuration of the introducer tool of the present invention shown and described herein, the funnel catheter is preassembled in the introducer tool while in vitro prior to being introduced in vivo (i.e., prior to being inserted into an assembly (i.e., including a hemostatic valve connected to a guide sheath catheter via a tapered guide sheath Luer connector / interface)). Thereafter, the introducer tool and the funnel catheter preassembled in the introducer tool are inserted together as a single unit into an assembly including a hemostatic valve attached to the guide sheath catheter via a tapered guide sheath Luer connector / interface. The inner wall / inner profile of the tapered guide sheath Luer connector / interface is tapered at its distal end, having a minimum inner diameter that is preferably substantially equal to or close to the inner diameter of the lumen of the guide sheath catheter.

[0088] refer to Figure 1A In the first example shown, the assembly includes a hemostatic valve 105 having a hemostatic seal 110 and a hemostatic side port 115. Attached to the distal end of the hemostatic valve 105 is a tapered introducer sheath luer connector / hub 120, the inner wall / inner profile of which is tapered with a minimum inner diameter substantially equal to the inner diameter of a lumen 125' of an introducer sheath catheter 125 connected to the tapered introducer sheath luer connector / hub.

[0089] exist Figure 1AIn the example shown, the introducer tool 150 of the present invention has the proximal section 150a of cone / expansion, and the proximal section of this cone / expansion is integrated with the shaft arranged at its distal end.The shaft of the introducer tool comprises straight (that is, cylindrical, both internal diameter and external diameter are all uniform) section 150c, and this straight section 150c terminates in straight (that is, cylindrical, both internal diameter and external diameter are all uniform) distal section 150b, and these sections are as single integral unit or are connected to each other.Along its whole length (in axial / longitudinal direction), the internal diameter of the lumen of the shaft of the introducer tool 150 is greater than the external diameter of the distal section when being in expansion (that is, opening bias, radial expansion, radial uncompressed of maximum outer diameter) state of funnel catheter 175. Thus, when the distal segment of the funnel catheter 175 is in an expanded (i.e., open biased, radially enlarged, radially uncompressed at maximum outer diameter) state, the funnel catheter can be advanced unimpeded (i.e., without radial compression) within the introducer tool 150. The introducer tool 150 and the funnel catheter 175 preassembled therein are advanced together as a single unit in a distal direction through the assembly (i.e., including the hemostasis valve 105, the tapered guide sheath catheter Luer connector / interface 120, and the guide sheath catheter 125) until the distal end / tip of the introducer tool 150 is in direct physical contact (i.e., abutting) with the tapered inner wall / inner contour of the guide sheath Luer connector / interface 120. Figure 1A As shown by the directional arrow pointing in the proximal direction, when being advanced through the introducer tool 150 in the distal direction, the hydrophilic coating of the funnel catheter 175 is automatically hydrated by the back pressure of the fluid (e.g., blood) passing in the proximal direction around the distal segment in the expanded (i.e., opening biased, radially expanded, radially uncompressed at maximum outer diameter) state. Any gap or space greater than zero between the outer diameter of the distal segment of the funnel catheter 175 and the inner diameter of the introducer tool 150 when in the expanded (i.e., opening biased, radially expanded, radially uncompressed at maximum outer diameter) state can be set to allow the back pressure fluid to flow in the proximal direction around the expanded distal segment of the funnel catheter 175. Preferably, a nominal gap range of about 0.002" to 0.005" is provided to allow for manufacturing tolerances between the inner diameter of the introducer tool 150 and the outer diameter of the distal segment of the funnel catheter 175 when in the expanded (i.e., opening biased, radially expanded, radially uncompressed at maximum outer diameter) state. After exiting from the distal end / tip of the introducer tool 150, the expanded distal segment of the funnel catheter 175 collapses / compresses radially (i.e., reduces the outer diameter) when in direct physical engagement with the tapered inner wall / inner profile of the guide sheath luer connector / interface 120, allowing the distal segment to be sufficient to pass through the lumen 125' of the guide sheath catheter 125 (a lumen having a smaller inner diameter than the straight distal segment 150b of the introducer tool 150).

[0090] Regardless of the specific example of the introducer tool, when selecting the desired axial / longitudinal length (from the proximal end / tip to the opposite distal end / tip), one or more factors may be considered: (i) the shorter the length, the easier it is for the interventionalist to manipulate; (ii) when the introducer tool and the funnel catheter preassembled in the introducer tool are inserted together as a single unit through the hemostatic valve, sufficient length is required to be grasped between the thumb and index finger; and (iii) when pushing to collapse the expanded distal segment (i.e., reduce the outer diameter) before entering the smaller inner diameter of the lumen of the guide sheath catheter, the longer length provides more reinforcement for the relatively soft / flexible / expandable distal segment of the funnel catheter. Preferably, the axial / longitudinal length of the introducer tool from the proximal end / tip to the opposite end / tip is in the range of 4 cm to 50 cm. In addition, each configuration of the introducer tool of the present invention shown and described herein preferably has a conical / expanded proximal segment 150a (including the proximal end / tip) with both the outer diameter and the inner diameter being the largest at its proximal end / tip to allow easy, unimpeded insertion of the funnel catheter without radially compressing / collapsing / reducing the expanded (i.e., open biased, radially enlarged, radially uncompressed at maximum outer diameter) distal segment. The conical / expanded proximal segment 150a also serves as a stop to prevent over-insertion of the introducer tool 150 into the hemostatic valve 105.

[0091] Figure 1A and Figure 1B The lumen of the shaft of the introducer tool 150 shown has an inner diameter that is greater than the inner diameter of the guide sheath catheter 125. Therefore, the funnel catheter 175 can be advanced unimpeded (i.e., without radial compression) through the lumen of the introducer tool from the proximal end / tip of the introducer tool 150 to its opposite distal end / tip when its distal segment is in an expanded (i.e., open biased, radially enlarged, radially uncompressed at maximum outer diameter) state. When emerging from the distal end / tip of the introducer tool 150, the expanded distal segment of the funnel catheter 175 is radially compressed (i.e., reduced in outer diameter) when directly physically engaged with the tapered inner wall / inner profile of the guide sheath hub / Luer connector 120 until it is sufficiently radially compressed (i.e., reduced in outer diameter) to be received within the lumen 125' of the guide sheath catheter 125. However, the introducer tool 150 having a straight segment 150c and a straight distal segment 150b (similar to Figure 1A and Figure 1BThe inner diameter of the shaft 150c of the funnel catheter 175 (i.e., the inner diameter of the shaft 150c of the funnel catheter 175) can also be closer in size (preferably, substantially equal in size) to the inner diameter of the lumen 125' of the guide sheath catheter 125. In this case, the outer diameter of the expanded (i.e., open offset, radially uncompressed at maximum outer diameter) distal segment of the funnel catheter 175 is larger than the inner diameter of the lumen of the straight (i.e., cylindrical, uniform in both inner and outer diameters) segments 150b, 150c passing through the introducer tool. Therefore, when being advanced through the straight segments 150b, 150c of the introducer tool, the expanded distal segment of the funnel catheter 175 is radially compressed (i.e., reduced in outer diameter) ( Figure 1C Because the inner diameter of the distal segment 150b of the introducer tool 150 is equal to the inner diameter of the lumen 125' of the guide sheath catheter 125, the funnel catheter 175 is directly transferred from the introducer tool 150' into the guide sheath catheter 125 without further radial compression of the expanded distal segment or direct physical engagement with the tapered inner wall of the guide sheath hub / Luer connector 120 ( Figure 1D ).

[0092] Insertion of the introducer tool 150 having straight (i.e., cylindrical, non-tapered, uniform in both inner and outer diameters) segments 150b, 150c ( Figure 1A and Figure 1B ). Figure 2A and Figure 2B A modified structure of the introducer tool of the present invention is shown in FIG, which allows further insertion. Figure 1A and Figure 1B The configuration and Figure 2A and Figure 2B In comparing the configurations, all features are identical with one notable exception. Figure 1A and Figure 1B The distal segment 150b (including the distal tip / end) of the introducer tool 150 in FIG. 1 has a straight (i.e., cylindrical, non-tapered, uniform in both inner and outer diameters) configuration, while Figure 2A and Figure 2BIn an alternative example, only the outer diameter of the distal segment 250b of the introducer tool 250 is tapered. The inner diameter of the distal segment 250b of the introducer tool 250 remains uniform (i.e., non-tapered), thereby allowing the funnel catheter to travel unimpeded (i.e., without radial compression) through the entire axial / longitudinal length of the introducer tool 250 with its distal segment in an expanded (i.e., open biased, radially uncompressed at maximum outer diameter) state. The taper of the outer profile of the distal segment 250b of the introducer tool 250 is preferably the same as the taper of the tapered inner wall of the guide sheath luer connector / interface 120 so as to minimize the gap between the distal surface of the introducer tool and the inner tapered surface of the guide catheter luer connector / interface. Similar to Figure 1A and Figure 1B The introducer tool 150, Figure 2A and Figure 2B The introducer tool 250 of the embodiment of the present invention also has an inner diameter large enough to accommodate the insertion of the funnel catheter 175 unimpeded (i.e., without radial compression) when the distal segment of the funnel catheter 175 is in an expanded (i.e., open biased, radially uncompressed at maximum outer diameter) state. The tapered outer profile / outer diameter of the distal segment 250b allows the introducer tool 250 to be inserted / pushed further into the assembly in the distal direction (with the guide sheath luer connector / hub 120) before directly physically engaging the tapered inner wall. Figure 1A and Figure 1B ), thereby providing a smoother (ie, minimized obstruction) passage / transfer of the funnel catheter 175 through the junction between the introducer tool 250 and the guide sheath catheter 125.

[0093] Figure 1A and Figure 1B The straight (i.e., cylindrical, non-tapered, uniform outer contour) distal segment 150b of the introducer tool 150 in the introducer tool 150 creates a step joint, transition, or edge between the distal end of the introducer tool 150 and the tapered inner contour of the guide sheath luer connector / interface 120. When force is applied in the proximal direction on the proximal end of the funnel catheter 175 (i.e., pushing), as the funnel emerges from the distal end of the introducer tool 150 and encounters the tapered inner wall of the guide sheath luer connector / interface 120, the step joint, transition, or edge between the distal end and the tapered inner wall provides space (I1), thereby allowing an undesirable slight additional radial expansion of the distal segment of the funnel catheter 175 (i.e., more expansion than when set in the introducer tool 150). Figure 2A and Figure 2BIn the distal segment 250b of the tapered outer profile of the introducer tool 250, such undesirable stepped joints, transitions, or edges are minimized or eliminated completely, where the transfer of the funnel catheter 175 between the introducer tool 250 and the guide sheath luer connector / interface 120 occurs without dilation (i.e., there is no additional radial outward expansion of the distal segment relative to when it is unobstructed in the introducer tool 250). Thus, by Figure 2A and Figure 2B the tapered outer profile of the distal segment 250b of the introducer tool 250 provides a smooth transfer of the funnel catheter 175 from the introducer tool 250 to the guide sheath luer connector / interface 120 (i.e., without additional radial outward expansion of the distal segment). Figure 2A and Figure 2B The tapered outer profile design of the distal segment 250b of the introducer tool 250 in Figure 2A and Figure 2B has the additional advantage of maximizing the degree of insertion in the axial / longitudinal direction (I1 > I2), or in other words, maximizing the axial / longitudinal length (L1 < L2) of the introducer tool 250 inserted into the assembly (i.e., the hemostatic valve 105, the tapered guide sheath luer connector / interface 120, and the guide sheath catheter 125). Maximizing the axial / longitudinal length of the introducer tool 250 inserted into the assembly (i.e., the hemostatic valve 105, the tapered guide sheath luer connector / interface 120, and the guide sheath catheter 125) advantageously maximizes the travel distance of the funnel catheter 175 in the axial / longitudinal direction unobstructed when its distal segment is in a dilated (i.e., open-biased, radially expanded, radially uncompressed at the maximum outer diameter) state. In other words, by maximizing the travel distance (axially / longitudinally in the distal direction) through the introducer tool 250 unobstructed, the subsequent travel distance of the funnel catheter 175 is advantageously minimized when it emerges from the distal end / tip of the introducer tool and transitions to a constrained / compressed (i.e., non-dilated, non-open-biased with a reduced outer diameter) state.

[0094] while FIG. 3A to FIG. 3D shows yet another example of an introducer tool 350, whose distal segment 350b is tapered and non-uniform in both outer diameter and inner diameter, with the smallest corresponding diameters (both inner and outer diameters) being set at the distal end / tip. As with other examples, the introducer tool 350 ( Figure 3A ) has a dilated proximal segment 350a for easy and unobstructed (i.e., without radial compression) pre-assembly therein when the distal segment of the funnel catheter 175 is in a dilated (i.e., open-biased, radially expanded, radially uncompressed at the maximum outer diameter) state. Similar to Figure 2A and Figure 2B , Figure 3AThe distal segment 350b of the introducer tool 350 in the funnel 175 also has a tapered outer diameter (i.e., smallest at the distal end / terminus), thereby maximizing the insertion length (L2) of the insertion assembly (i.e., hemostatic valve 105, tapered guide sheath Luer connector / interface 120, and guide sheath catheter 125) in the axial / longitudinal direction. When traveling through the tapered (uneven) inner diameter of the distal segment 350b of the introducer tool 350, the outer diameter of the distal segment of the funnel catheter 175 is radially compressed / collapsed / reduced. At its distal end / terminus, the inner diameter of the introducer tool 350 is preferably substantially equal to the inner diameter of the lumen 125' of the guide sheath catheter 125, thereby providing a smooth, unimpeded travel or passage of the funnel catheter 175 between the two components 350, 125. Between the respective proximal and distal segments 350a, 350b of the introducer tool 350 is a straight (i.e., cylindrical, non-tapered, uniform in both outer and inner diameters) segment 350c, segment 350c having an inner diameter that is greater than the maximum outer diameter of the distal segment of the funnel catheter 175 in an expanded (i.e., open offset, radially enlarged, radially uncompressed at maximum outer diameter) state, thereby allowing the funnel catheter 175 to travel unimpeded (i.e., without radial compression) therethrough. Figure 3B The funnel catheter 175 is shown preassembled unimpeded (i.e., radially uncompressed) insertion with its distal segment in an expanded (i.e., opening biased, radially enlarged, radially uncompressed at maximum outer diameter) state through the proximal segment 350a and the straight (i.e., cylindrical, uniform in both inner and outer diameters) segment 350c (before entering the tapered distal segment 350b) of the introducer tool 350. Preassembling the funnel catheter 175 in vitro in this manner in the introducer tool 350 prior to inserting the introducer tool 350 into the hemostasis valve 105 minimizes the risk of blood loss through the hemostasis valve 105. The straight (i.e., cylindrical, uniform in both inner and outer diameters) segment 350c of the introducer tool 350 has an inner diameter that is larger than the outer diameter of the funnel catheter 175 when the distal segment of the funnel catheter is in an expanded (i.e., open biased, radially enlarged, radially uncompressed at maximum outer diameter) state to allow unimpeded travel therethrough, thereby mitigating friction even when the hydrophilic coating of the funnel catheter 175 dries. When the introducer tool 350 and the funnel catheter 175 preassembled therein are inserted into the hemostatic valve 105 together as a single unit ( Figure 3C), the back pressure of the blood (as indicated by the directional arrows around the expanded distal segment of the funnel catheter) automatically flushes / hydrates the lumen of the introducer tool 350, thereby ensuring complete hydration (i.e., wetting) of the hydrophilic coating, thereby minimizing friction of the funnel catheter 175 while optimizing advancement into the guide sheath catheter 125. As the funnel catheter 175 passes through the tapered inner diameter of the distal segment 350b of the introducer tool 350, the outer diameter of its expanded distal segment is radially compressed / collapsed / reduced to a size substantially equal to the inner diameter of the lumen 125' of the guide sheath catheter 125, thereby allowing smooth passage or transfer between the introducer tool and the guide sheath catheter ( Figure 3D ). Preferably, the axial / longitudinal length of the introducer tool 350 is minimized to maximize the insertion length of the funnel catheter 175 through the hemostasis valve 105 and into the introducer sheath catheter 125.

[0095] And in FIG. 4A to FIG. 4D 4 shows another modification of the introducer tool 450. This design of the introducer tool 450 has the same FIG. 3A to FIG. 3D The same tapered distal segment 450b as in the introducing tool 450 (i.e., tapered in both the inner diameter and the outer diameter), but differs in having a plurality of venting or flushing ports (i.e., holes, holes, openings) 455 defined in its outer surface in fluid communication with the axial / longitudinal lumen. Any number of one or more flushing ports 455 are defined in the introducer tool 450 to allow entrained air to escape / exhaust therethrough as the funnel catheter 175 is advanced in the distal direction. Fluid (e.g., back pressure of blood and / or a positive saline flush directed through the side port 115 of the hemostasis valve 105) also passes through the flushing ports 455 of the introducer tool 450. The flushing ports 455 can be arranged as desired (e.g., randomly, spirally, aligned in the axial / longitudinal direction, radially aligned, radially offset). The location of the flush port can be anywhere from the proximal end / end to the distal end / end of the introducer tool (i.e., including the proximal segment 450a, the straight (cylindrical) segment 450c, and / or the distal segment 450b). When selecting the number, arrangement, and size of each flush port in the flush ports 455, consideration is given to maintaining the structural strength and integrity of the introducer tool. The diameter and number of each flush port (i.e., hole) are selected to allow blood cells to pass through without shear stress damaging the cells. Preferably, the diameter of each flush port is ≥ about 50um. The operation of the introducer tool 450 is similar to that described above with respect to FIG. 3A to FIG. 3D The same as described. Specifically, Figure 4BThe funnel catheter 175 is shown preassembled or inserted into the proximal segment 450a and the straight (cylindrical) segment 450c of the introducer tool 450 with its distal segment in an expanded (i.e., opening offset, radially enlarged, radially uncompressed at maximum outer diameter) state (i.e., unimpeded, radially uncompressed). Preassembling the funnel catheter 175 in vitro in the introducer tool 450 in this manner prior to insertion together as a single unit into the hemostatic valve 105 minimizes the risk of loss of blood through the hemostatic valve 105. The straight (i.e., cylindrical, uniform in both inner and outer diameters) segment 450c of the introducer tool 450 has an inner diameter that is larger than the outer diameter of the distal segment of the funnel catheter 175 when in the expanded (i.e., opening offset, radially enlarged, radially uncompressed at maximum outer diameter) state to allow unimpeded (i.e., without radial compression) travel therethrough. This unimpeded passage mitigates the high friction between the components even if the hydrophilic coating of the funnel catheter dries out after flushing / wetting and before insertion into the introducer tool. Figure 4C ), the back pressure of the blood and / or the positive flushing with saline via the side port 115 of the hemostasis valve automatically flushes the lumen of the introducer tool 450 via the flush port 455. Due to this flushing, complete hydration of the hydrophilic coating is ensured while minimizing the friction of the funnel catheter 175 and optimizing the advancement through the guide sheath catheter 125. As the funnel catheter 175 advances through the tapered inner diameter of the distal segment 450b of the introducer tool 450, the outer diameter of its expanded distal segment is radially compressed / collapsed / reduced to a size substantially equal to the inner diameter of the lumen of the guide sheath catheter 125, thereby allowing smooth passage or transfer between the introducer tool and the guide sheath catheter ( Figure 4D A disadvantage associated with the use of the flush port 455 is that when the funnel catheter 175 is advanced in the distal direction through the introducer tool 450 with its distal section in the expanded state, there is a risk that its leading distal edge may hook or become stuck on the edge of the flush port 455.

[0096] And in FIG. 5A to FIG. 5D Still another alternative example of an introducer tool 550 having a single axial / longitudinal separation seam 560 is shown in FIG. Figure 5A In the side view of FIG. 5 , the introducer tool 550 is similar in design to Figure 3A The only exception is a single slit 560 extending in the axial / longitudinal direction from the proximal end to the opposite distal end. The introducer tool 550 that can be separated along the separation slit 560 so as to be easily removed from around the funnel catheter after insertion into the assembly (i.e., the hemostasis valve 105, the tapered introducer sheath luer connector / hub 120 and the introducer sheath catheter 125) is suitable for reuse. Figure 5B It is similar in design to Figure 5A 550, but with a single axial / longitudinal separation slit 560 aligned with (ie, intersecting) the flush port 555 (eg, intersecting the center of the flush port). Figure 5B The flush port 555, shown in the example of FIG. 1 , aligned with the single axial / longitudinal separation slit 560, allows entrained air to escape through the flush port as the funnel catheter 175 is advanced in the distal direction through the introducer tool 550. In addition to air, fluid can also enter the lumen introducer tool 550 via the flush port 555 by the back pressure of blood in the proximal direction and / or by a positive saline flush through the hemostatic side port 115.

[0097] Figure 5C is with Figure 5A A further variation of the axial / longitudinal separation seam design of a similar introducer tool 550'. Figure 5A In the embodiment, the two axial / longitudinal edges along a single separation seam 560' are in direct physical contact with each other, while in Figure 5C In the separation seam 560', there is a radial opening or spacing Δr between the complementary axial / longitudinal edges (not touching each other - thus having a "C" shaped radial cross section). The radial opening or spacing allows entrained air, back pressure of blood, and / or positive saline flushing through the hemostatic side port 115 to pass therethrough and into the lumen of the introducer tool 550. Figure 5D A final variation of the separation slit design of the "introducer tool 550" in FIG. 5 has complementary axial / longitudinal edges that radially overlap one another along a single separation slit 560". The radial overlap of the edges along the slit 560" prevents contact with the FIG. 5A to FIG. 5C The risk associated with variations of the present invention is the possible entrapment of the expanded distal end / tip of the funnel catheter along the slit 560" when being advanced through the introducer tool 550". Although an introducer tool is described whose distal section is tapered (in both inner and outer diameters), FIG. 5A to FIG. 5D Any separation seam design configuration in is also applicable to an introducer tool having any alternative design, such as but not limited to Figure 1A to Figure 1B a straight (ie, cylindrical, uniform in both inner and outer diameters, non-tapered) distal segment; Figure 2A and Figure 2B or any other design of the introducer tool shown and described herein.

[0098] As yet another alternative example, Fig. 6AThe introducer tool 650 in the embodiment of the present invention can be peeled off in one or more axial / longitudinal sections without having to remove the funnel catheter from the components (i.e., hemostasis valve 105, tapered guide sheath luer connector / hub 120 and guide sheath catheter 125). Along one or more weakened axial / longitudinal sections 660, the introducer tool 650 can be separated / torn apart for easy removal from around the funnel catheter. The weakened sections can be: (i) a series of perforations (e.g., Fig. 6A and Figure 6B ); (ii) a segment of weaker material (e.g., an axial / longitudinal segment of material that is weaker than the remainder / rest of the tube diameter forming the introducer tool 650); and / or (iii) a segment of thinner wall (e.g., an axial / longitudinal segment of material having a wall that is thinner than the material that forms the remainder / rest of the tube diameter forming the introducer tool 650). Alternatively, the introducer tool may be made of a material having linear tear properties, wherein the tearing is initiated by a cut at one end of the introducer (e.g., at the notch 651) and propagates axially / longitudinally. By way of illustrative example, the introducer tool 650 may include two weakened segments 660 radially separated by 180° from each other, thereby allowing two axial / longitudinal strips of the introducer tool 650 to be torn / stripped along the respective weakened segments 660. There may be more than two weakened segments radially separated from each other at equal or unequal distances. It is also conceivable to have a single weakened section 660, and when torn along the weakened section, the introducer tool as a single thin sheet can be disassembled or peeled away from around the funnel catheter. The weakened section 660 can be arranged in an axial / longitudinal direction or spirally. The advantage associated with the peeling design is that since there is no axial / longitudinal separation seam in the introducer tool, the leading distal edge of the funnel catheter will not get stuck when being advanced through the introducer tool in the distal direction. Figure 6B An introducer tool 650' is depicted, which is again strippable in the axial / longitudinal direction along one or more weakened segments 660' aligned with multiple flush ports 655 (e.g., aligned with the centers of the multiple flush ports). The alignment of the weakened segment with some or all of the multiple flush ports reduces the force required to tear the introducer tool along the segment, but the multiple flush ports do not have to be aligned with each other. As mentioned in other previous examples employing flush ports 655, entrained air is allowed to escape when the funnel catheter is advanced in the distal direction. Fluid (e.g., back pressure of blood and / or positive saline flush through the hemostatic side port 115) can also enter the introducer tool 650' via the flush port 655. Although an introducer tool whose distal segment (both in inner diameter and outer diameter) is described as tapered, any stripping design configuration ( Fig. 6A and Figure 6B ) is also applicable to introducer tools having the following designs: Figure 1A to Figure 1Ba straight (i.e., cylindrical, uniform inner and outer diameters, non-tapered) distal segment in the Figure 2A and Figure 2B or any other design of the introducer tool shown and described herein. Fig. 6A and Figure 6B The dissection design configuration of the introducer tools 650, 650' in also preferably includes a notch 651 that coincides with the tapered / flared proximal sections 650a, 650b to facilitate initial dissection and visually indicate the area to be held and pulled apart.

[0099] In the previous example, as soon as the funnel catheter is advanced into the guide sheath catheter, the introducer tool is removed / withdrawn from the hemostasis valve in a proximal direction in order to minimize blood loss. The interventionalist also typically removes the introducer tool completely from the funnel catheter at this stage. If the working length of the funnel catheter is not an issue, the introducer tool may be kept in position around the shaft of the funnel catheter and only partially withdrawn to a position proximal to the hemostasis valve, only to be removed later if further advancement of the funnel catheter into the assembly is hindered when the introducer tool is in this position.

[0100] However, when the funnel catheter 175' is fully inserted into the hemostatic valve 105 and the guide sheath catheter 125, 7A to 7C The modified design in allows the introducer tool 750 to remain in place in the assembly. 7A to 7C The introducer tool shown in FIG. 1 is similar in structure to the FIG. 3A to FIG. 3D 105. The same as the introducer tool described and shown in the introduction tool, which has a tapered (in both the inner diameter and the outer diameter) distal segment 750b, the difference is that it has a conical / expanded proximal segment 750a, the size and shape of the conical / expanded proximal segment is set to be able to fit on the conical / expanded funnel catheter interface 175a that can be nested therein, so as to maximize the insertion of the funnel catheter 175' into the assembly. In the example shown, the expanded proximal segment 750a of the introducer tool 750 is conformal, matching, complementary to the size and shape of the expanded funnel catheter interface 175'a in both size and shape, so that the components can be nested together one inside the other. In addition, the maximized axial / longitudinal length of the introducer tool 750 enhances the interventional physician's grasp / holding thereof. Further, the expanded proximal segment 750a of the introducer tool 750 is prevented from being received in (i.e., entering) the lumen of the hemostatic valve 105. As previously described with respect to the earlier exemplary pre-assembly (i.e., prior to insertion into the assembly (i.e., the hemostasis valve 105 connected to the guide sheath catheter 125 via the tapered guide sheath luer connector / hub 120), the Fig. 7A The mid-infundibulum catheter 175 ′ is inserted into the introducer tool 750 . 7A to 7CThe preassembled introducer tool 750 and funnel catheter 175' are shown together as a single unit at sequential stages of insertion into the assembly. Fig. 7A , the expanded distal section of the funnel catheter 175' is radially compressed (ie, has its outer diameter reduced) as it passes through the tapered (in both the inner and outer diameters) distal section 750b of the introducer tool 750. Figure 7B As shown, during continued advancement in the distal direction, the radially compressed distal section of the funnel catheter 175 ′ transitions into the lumen 125 ′ of the introducer sheath catheter 125 . Figure 7C The funnel catheter 175' is depicted as being maximally or fully inserted into the lumen 125' of the introducer sheath catheter 125. Figure 7C In the present invention, the expanded funnel catheter interface 175'a nested in the expanded proximal segment 750a of the introducer tool 750 prevents further advancement into the assembly in the distal direction. When the funnel catheter 175' is inserted into the assembly to the maximum or completely, the funnel catheter interface 175'a and the expanded proximal segment 750a of the introducer tool 750 can be releasably locked or fixed together using conventional mechanical devices (e.g., clips, friction fit, etc.). Optionally, a gasket, O-ring or other device for forming a fluid-tight seal can be provided between the introducer tool 750 and the funnel catheter 175' to prevent blood from flowing back through it in the proximal direction during use. In addition, the strain relief device can be optionally positioned around the funnel catheter 175' on the far side of the funnel catheter interface 175a to block / occlude the distal end of the expanded proximal segment 750a, thereby preventing blood from being lost through it. This adaptive design of the expanded proximal segment 750a is sized and shaped to fit over the expanded funnel catheter hub 175'a to maximize insertion of the funnel catheter 175' through the guide sheath catheter 125 and the hemostasis valve 105 and is suitable for use with any example of the introducer tool described herein.

[0101] Fig. 8A A further modification of the introducer tool is depicted which addresses a particular problem for use with hemostatic valves having an axial / longitudinal lumen that is too small to accommodate a Figure 3AThe inner diameter of the larger outer diameter of the intermediate segment 350c of the introducer tool 350. In this case, the introducer tool 850 is modified to include an outer profile transition segment 850b disposed between two straight (i.e., cylindrical, uniform in both inner and outer diameters) segments 850c (having an outer diameter (D)) and a straight segment 850d (having an outer diameter (d)). The dimensions of the introducer tool 850 are selected so that the outer diameter (d) of the straight (i.e., cylindrical, uniform in both inner and outer diameters) segment 850d is: (i) smaller relative to the outer diameter (D) of the straight (i.e., cylindrical, uniform in both inner and outer diameters) segment 850c; and (ii) sized to be received within the hemostatic valve. The outer profile of transition segment 850b advantageously limits insertion into the hemostatic valve in the axial / longitudinal direction, thereby preventing compression of the distal end / tip of the introducer tool in the guide catheter Luer connector / interface, thereby avoiding shrinkage and excessive funnel compression of the distal end / tip of the lumen of the introducer tool. Fig. 8A The outer profile transition segment 850b is depicted as a tapered region, however, other alternatives such as stepped profiles, rings or flanges are also contemplated. Although the inner diameter of the introducer tool does not need to be constant or uniform from its proximal end to its opposite inner end, the inner diameter of each of the expanded proximal segment 850a and the straight (i.e., cylindrical, uniform in both inner and outer diameters) segment 850c of the introducer tool is capable of accommodating the distal segment of the funnel catheter 175 unimpeded (i.e., without radial compression) when the distal segment is in an expanded (i.e., open biased, radially enlarged, radially uncompressed at maximum outer diameter) state.

[0102] As in the previously described example, the funnel catheter 175 is again preassembled with the distal segment in an expanded (opening biased, radially enlarged, radially uncompressed at maximum outer diameter) state. Fig. 8A The introducer tool 850 is inserted into the guide sheath catheter 125 and the two components are advanced together as a single unit through the assembly (i.e., the hemostasis valve 105 connected to the guide sheath catheter 125 via the tapered guide sheath Luer connector / hub 120), as shown in FIG. Figure 8B As shown. Only the straight (i.e., cylindrical, uniform in both inner and outer diameters) extension segment 850d is sized to be received within the axial / longitudinal lumen of the hemostatic valve 105, while the outer contour transition segment 850b, the straight (i.e., cylindrical, uniform in both inner and outer diameters) segment 850c, and the expanded proximal segment 850a, which is too large in diameter to be received therein, remain on the proximal side (outside) of the hemostatic valve 105. As advancement (i.e., pushing in the distal direction) through the introducer tool 850 continues, the expanded (open-biased) distal segment of the funnel catheter 175 is radially compressed by the tapered inner wall of the tapered guide sheath catheter 125 as it emerges from the distal end / tip of the introducer tool. Fig. 8A In the embodiment of the present invention, the length of the straight (i.e., cylindrical, uniform in both inner and outer diameters) segment 850c in the axial / longitudinal direction (i.e., from the distal end / tip of the expanded proximal segment 850a to the proximal end / tip of the outer profile transition segment 850b) ranges from about 4 cm to about 30 cm. When inserted into the expanded proximal segment 850a and advanced in the distal direction through the straight (i.e., cylindrical, uniform in both inner and outer diameters) segment 850c of the introducer tool 850, the distal segment of the funnel catheter 175 is maintained in an expanded (i.e., open biased, radially enlarged, radially uncompressed at maximum outer diameter) state.

[0103] As yet another alternative design to limit the insertion depth in the assembly and prevent compression of the distal end / tip, both the inner and outer contours of the introducer tool shaft can be a continuous taper to the expanded proximal section 850a', such as Figure 8F As depicted in .

[0104] exist Fig. 8A , the support of the funnel catheter shaft within the straight (i.e., cylindrical, uniform in both inner and outer diameters) segment 850c of the introducer tool 850 is poor due to the space or gap therebetween. In order to enhance or improve the support of the funnel catheter shaft (i.e., reduce the space or gap between the straight (i.e., cylindrical, uniform in both inner and outer diameters) segment 850'c and the funnel catheter shaft), the difference in outer diameter of the straight (i.e., cylindrical, uniform in both inner and outer diameters) segment 850'c and the outer diameter of the straight (i.e., cylindrical, uniform in both inner and outer diameters) extension segment 850'd is minimized, preferably equalized, and the two segments are connected via an outer contour transition segment 850'b that transitions in both directions (i.e., transitions in both the proximal and distal directions). Reference Figure 8C , the outer diameter of the straight (i.e., cylindrical, uniform in both inner and outer diameters) segment 850'c and the outer diameter of the straight (i.e., cylindrical, uniform in both inner and outer diameters) extension segment 850'd are equal. The outer profile transition segment 850'b transitions bidirectionally (i.e., transitions in both the proximal and distal directions), with an intermediate straight (i.e., cylindrical, uniform in both inner and outer diameters) segment between the two opposing transitions. An external flange with a continuous inner diameter can replace the intermediate straight (i.e., cylindrical, uniform in both inner and outer diameters) segment 850'b between the two opposing transitions. Other variations of the outer profile transition segment 850'b are contemplated, as long as the configuration limits the depth to which the introducer tool is inserted into the assembly.

[0105] Alternatively, the middle straight (i.e., cylindrical, uniform in both inner and outer diameters) segment can be omitted, whereby the two opposite transition segments abut each other, which forms a diamond shape in longitudinal cross-section. Likewise, tapered transitions in opposite directions (e.g., tapering to a smaller diameter in the proximal direction and tapering to a larger diameter in the distal direction) can be replaced by a step transition. Figure 8C The size of the multi-diameter segment introducer tool 850' is set to enable the following conditions to be met when fully inserted into the hemostatic valve 105: (i) the bidirectional outer contour transition segment 850b', the straight (i.e., cylindrical, uniform in both inner diameter and outer diameter) segment 850'c and the expanded proximal segment 850'a are maintained on the outside (proximal) of the hemostatic valve 105; and (ii) compression of the distal end / tip and narrowing of the lumen of the introducer tool 850' are prevented by avoiding radial interference with the tapered inner wall / inner surface of the guide catheter Luer connector / interface 120.

[0106] exist Figure 8B , the sizes of the outer profile transition segment 850b and the straight (i.e., cylindrical, uniform in both inner and outer diameters) segment 850c are selected to be larger than the inner diameter of the lumen of the hemostatic valve, thereby preventing these segments from being inserted therein (i.e., only the straight (i.e., cylindrical, uniform in both inner and outer diameters) distal extension segment 850d is sized to be received in the lumen of the hemostatic valve). By changing Fig. 8A The size of the corresponding segment of this same construction or design of the multi-diameter introducer tool can modify the manner in which it engages with the component (i.e., the hemostasis valve connected to the introducer sheath catheter via the introducer sheath luer connector / hub). Fig.8D, the outer diameter of the straight (i.e., cylindrical, uniform in both inner and outer diameters) segment 850c is sized to be smaller than the inner diameter of the lumen of the hemostatic valve 105 so as to be accommodated (able to be inserted therein) along with the outer profile transition segment 850b (e.g., unidirectionally or bidirectionally transitioning) and the distal extension segment 850d. The distal extension segment 850d has a uniform outer diameter that is substantially equal (preferably equal) to the inner diameter of the lumen of the guide sheath catheter 125. The distal segment of the funnel catheter is unimpededly accommodated (i.e., without radial compression) when passing through the expanded proximal segment 850a and the straight (i.e., cylindrical, uniform in both inner and outer diameters) segment 850c in the distal direction when in the expanded (i.e., open biased, radially enlarged, radially uncompressed at maximum outer diameter) state. As the funnel catheter continues to be advanced through the assembly, the expanded distal segment is radially compressed (i.e., the outer diameter is reduced) as it travels through the outer profile transition segment 850b and the distal extension segment 850d, wherein the segments 850b, 850d each have an inner diameter that is less than the maximum outer diameter of the funnel in the expanded open biased state. In the axial / longitudinal direction, the length of the distal extension segment 850d is preferably minimized, thereby minimizing the distance traveled in the axial / longitudinal direction of the funnel catheter when the distal segment of the funnel catheter is in a radially compressed state (i.e., the outer diameter is reduced). The proximal region X of the funnel catheter 175 is preferably made of a harder (i.e., less flexible) material relative to the remaining region distal thereto, which is made of a more flexible (i.e., less rigid) material. Fig.8D The overall axial / longitudinal length of the introducer tool 850 in the embodiment (including the proximal segment 850a, the straight (i.e., cylindrical, uniform in both inner and outer diameters) segment 850c, and the outer profile transition segment 850b) is in the range of about 4 cm to about 8 cm. Therefore, when the introducer tool 850 is fully inserted into the assembly and its distal end / tip is in direct physical contact with the tapered inner wall / inner profile of the tapered guide sheath Luer connector / interface 120, the portion of the funnel catheter made of a more flexible material and arranged distal to the harder proximal region is undesirably not supported by the introducer tool. Fig. 8E Shows something like Fig.8D The present invention relates to an introducer tool of the present invention, but with a longer overall axial / longitudinal length (including an expanded proximal segment 850a, a straight (i.e., cylindrical, uniform in both inner and outer diameters) segment 850c, and an outer contour transition segment 850b), which is in the range of about 20 cm to about 30 cm. Increasing the overall length of the introducer tool advantageously maximizes support for the flexible expanded distal segment of the funnel catheter 175", while allowing the interventional physician to grasp the stiffer proximal region X of the introducer tool.

[0107] As previously mentioned, it is desirable to maximize the working length of the funnel catheter through the introducer tool in the axial / longitudinal direction. This can be achieved by designing the introducer tool to include an axial / longitudinal non-contractible segment 1850 and an axial / longitudinal contractible segment proximal thereto that is designed to slide into each other. In the contracted state, the telescopic concentric tubular segments 1850' are too large to be received / inserted into the hemostatic valve. Fig.18A and Fig.18B In the figure, telescopic concentric tubular segments 1850' are shown in an axially / longitudinally expanded (i.e., uncontracted, maximum axial / longitudinal length L1) state and an axially / longitudinal contracted (i.e., minimum axial / longitudinal length L2) state, respectively. Any number of telescopic concentric tubular segments 1850' may be selected to achieve a desired working length, wherein the concentric tubular segments are arranged such that the inner diameter decreases from their proximal ends to their opposite distal ends. Fig.18A In the example depicted in , the distal end of each tubular segment has a stop feature (e.g., a lip), while the proximal end of each tubular segment has an introduction flange 1865 with an external square step. The introduction flange outer surface engages the stopper on the proximal side of the tubular segment, thereby limiting the telescopic expansion while providing a smooth inner surface for the expanded distal segment of the funnel catheter to advance through it. Other mechanical arrangements for limiting the expansion of the tubular segments are within the scope of the present disclosure. When the distal segment of the funnel catheter is in an expanded state (i.e., open bias, maximum outer diameter, radially uncompressed), the funnel catheter is guided into the proximal end unhindered (i.e., without radial compression). When the funnel catheter is advanced through the telescopic concentric tubular segment 1850' while engaging with the integral stopper and the introduction flange 1865, the expanded distal segment is radially compressed. Emerging from the distal end of the introducer tool's shaft / longitudinal non-contractible segment 1850 , the outer diameter of the distal segment of the funnel catheter is sufficiently reduced in outer diameter to transfer intact into the lumen of the guide sheath catheter 125 without engaging the tapered inner wall of the tapered guide sheath Luer connector / interface 120 .

[0108] The telescoping concentric tubular segments in the axially / longitudinally expanded (uncontracted) state maximize the axial / longitudinal working length of the funnel catheter to travel through the introducer tool. This maximum working length is achieved while still allowing the telescoping concentric tubular segments 1850' to remain in position on / around / around the funnel catheter when axially / longitudinally contracted (i.e., collapsed to a minimum axial / longitudinal length L2). The axially / longitudinal non-contractible segments 1850 of the introducer tool can be retained in the hemostatic valve 105 (e.g., Fig.18B ), or completely withdrawn (pulled out) from the hemostasis valve 105 to prevent blood from leaking through the lumen of the introducer tool.

[0109] Fig.19A and Fig.19BRepresents an alternative to the introducer tool, which maximizes the working length of the funnel catheter through on the one hand, and is axially / longitudinally retractable in length on the other hand. In this alternative design, the introducer tool of the present invention has a conical / expanded proximal segment 1950a that is integral with a shaft segment disposed distally thereof, wherein the shaft segment includes an axially / longitudinally retractable segment 1950c that is integral with an axially / longitudinally non-retractable segment 1950b. The axially / longitudinally retractable segment 1950c includes a plurality of bellows (1, 2, 3, 4) that can be converted from an expanded state to a retracted state, wherein the number and arrangement of the bellows can be selected as desired.

[0110] When the axial / longitudinal collapsible segment 1950c is in the expanded state ( Fig.19A ), segments 1950b, 1950c are uniform in both inner and outer diameters. The uniform outer diameter of the non-collapsed segment 1950b enables insertion into the hemostatic valve 105. The funnel catheter is introduced into the proximal segment 1950a of the introducer tool with its distal segment in an expanded (i.e., open biased, radially uncompressed, maximum outer diameter) state. Upon entering the shaft segments (1950c, 1950b) of the introducer tool, the expanded distal segment of the funnel catheter is radially compressed (reduced in outer diameter), preferably substantially equal to the inner diameter of the lumen of the guide sheath catheter 125 into which the funnel catheter is transferred. Fig.19B The collapsible segment 1950c of the introducer tool is depicted in an axially / longitudinal contracted state (i.e., collapsed), wherein the radially expanded (i.e., maximum outer diameter) bellows (1, 2, 3, 4) are disposed proximal (i.e., outside) of the hemostatic valve 105. Likewise, the maximum working length of the introducer tool is achieved when the axially / longitudinal contractible segment 1950c is in the expanded state, while still allowing the bellows (1, 2, 3, 4) to remain on / around / around the funnel catheter when axially / longitudinal contracted (i.e., collapsed to a minimum axial / longitudinal length L2). The non-collapsed segment 1950b of the introducer tool can be retained in the hemostatic valve 105 (e.g., Fig.19B ), or completely withdrawn (pulled out) from the hemostasis valve 105 to prevent blood from leaking through the lumen of the introducer tool.

[0111] In any of the examples shown and described above, if subjected to a distal direction (such as Fig.10If excessive force is applied to the introducer tool (i.e., over-insertion) (as indicated by the arrows in the example of FIG. 1 ), the distal end / tip of the introducer tool 1050 may be undesirably compressed axially and / or radially (i.e., narrowing the inner diameter of the lumen) when in direct physical contact / engagement with the inner wall / inner contour of the guide sheath luer connector / interface 120, thereby limiting or preventing the expanded distal segment of the funnel catheter 175 from passing therethrough. Regardless of the excessive force applied to the introducer tool, it will be desirable to limit the range / depth in the axial / longitudinal direction to which the introducer tool can be advanced through the assembly in order to prevent over-insertion (i.e., axial and / or radial compression of the distal end / tip of the introducer tool against the tapered inner wall / inner contour of the tapered guide sheath interface / luer connector). Compression of the distal end / tip is prevented by designing the segment of the introducer segment that extends proximally (outwardly) of the hemostatic valve when fully inserted into the hemostatic valve to include a radially expandable compression force absorbing component. A number of mechanical structures associated with the introducer tool for absorbing excessive compressive forces applied in the axial / longitudinal direction are contemplated, and several illustrative but non-limiting examples are described herein.

[0112] FIG. 11A to FIG. 11D A first exemplary introducer tool 1150 is shown, which includes a radially expandable compression absorbing component 1195 that is constructed as a series of radial wrinkles, folds, or radial corrugations (i.e., alternating radial peaks and radial valleys) similar to an accordion. The number and spacing of the wrinkles can be modified to absorb the desired maximum axial / longitudinal compression force. Starting from its proximal end / tip, FIG. 11A to FIG. 11D The introducer tool 1150 in 1150 comprises a handle 1150d and a non-insertable segment 1150a distal to the handle, followed by an insertable straight (i.e., cylindrical, uniform in both inner and outer diameters) extension segment 1150c, wherein a transition segment 1150b (e.g., tapered or stepped) is disposed between the segments 1150a, 1150c. The insertable straight (i.e., cylindrical, uniform in both inner and outer diameters) extension segment 1150c has an outer diameter / outer profile that is sized to be received in the lumen of the hemostatic valve 105, while the non-insertable segment 1150a has an associated outer diameter / outer profile that is larger than (i.e., not receivable / not insertable) the lumen of the hemostatic valve 105. Thus, the outer diameter / outer profile of the non-insertable segment 1150a is greater than the outer diameter / outer profile of the insertable straight (ie, cylindrical, uniform in both inner and outer diameters) extension segment 1150c. Fig.11A and Fig. 11C The introducer tool 1150 itself is shown having radially expandable compression force absorbing components (i.e., corrugations) 1195 depicted in an axially / longitudinally non-compressed (expanded) state and a compressed state, respectively. Fig. 11B and Fig.11D 1 and 2, respectively, depict these respective non-compressed (expanded) and compressed states of the radially expandable compression force absorbing component (i.e., corrugation) 1195 of the introducer tool 1150 in use during insertion into the assembly (i.e., the hemostatic valve 105 connected to the guide sheath catheter 125 via the tapered guide sheath catheter luer connector / hub 120). When the radially expandable compression force absorbing component 1195 is in the non-compressed (expanded) state, the funnel catheter 175 can be advanced through the lumen of the introducer tool 1150 unimpeded with its distal segment in the expanded (i.e., opening biased, radially expanded, radially uncompressed at maximum outer diameter / outer profile) state. The funnel catheter 175 with its distal segment in the expanded (i.e., opening biased, radially expanded, radially uncompressed at maximum outer diameter) state is preassembled into the introducer tool 1150 in vitro prior to insertion into the assembly (while the radially expandable compression force absorbing component 1195 is in the non-compressed (expanded) state). The introducer tool 1150 and the funnel catheter 175 are advanced together as a single unit in the distal direction through the assembly ( Fig. 11B ). At least a portion (possibly all) of the transition segment 1150b remains on the proximal side (outside) of the hemostatic valve 105. Fig. 11B , the series of radial corrugations including the radially expandable compression force absorbing component 1195 are axially / longitudinally expanded (i.e., axially / longitudinally non-compressed (expanded) with a maximum distance spacing in the axial / longitudinal direction between adjacent radial peaks) before excessive axial / longitudinal compressive force is applied to the introducer tool 1150. When the introducer tool 1150 is subjected to over-insertion beyond full insertion without undesirably compressing the distal end / tip, as Fig.11D As shown in FIG, the series of corrugations comprising the radially expandable compression force absorbing member 1195 compresses in the axial / longitudinal direction (i.e., reducing the axial / longitudinal spacing between adjacent radial peaks) to absorb excess loads, thereby preventing undesirable compression of the distal end / tip.

[0113] exist FIG. 12A to FIG. 12DIn the present invention, the alternative scheme of the introducer tool 1250 includes a radially expandable compression force absorbing component 1295, which includes a plurality of radially outward bendable arms arranged between a series of slits defined in the non-insertable segment 1250a, wherein these slits are radially separated from each other and extend parallel to each other in the axial / longitudinal direction. The number of slits, the radial width of each slit, the axial / longitudinal length of each slit and / or the radial spacing between adjacent slits can be modified as needed to absorb the maximum compression load expected in the axial / longitudinal direction. These slits reduce the rigidity of the non-insertable segment 1250a, thereby establishing a series of weakened axial segments in those remaining areas between the slits. Based on the selection of the number of slits, the axial / longitudinal length of each slit, the width of each slit in the radial direction and / or the radial spacing between adjacent slits, the rigidity of the remaining weakened segments between adjacent slits and the maximum compression force that can be absorbed can be changed as needed. When the introducer tool is subjected to excessive compressive loads in the axial / longitudinal direction, the weakened remaining axial segments (i.e., arms) expand radially outward (the presence of the expanded distal segments of the funnel catheter 175 within the internal lumen of the introducer tool 1250 prevents radial inward compression). FIG. 11A to FIG. 11D Compared to the accordion design, FIG. 12A to FIG. 12D In an alternative design, adjacent radially outwardly bent arms are radially separated from each other. Fig. 12A and Fig. 12C Depicted is an introducer tool 1250 comprising radially outwardly bendable arms 1295 defined by a series of axially / longitudinally defined slits in a non-insertable segment 1250a, wherein the weakened remaining segment (i.e., the arms) is not subjected to excessive compressive loads ( Fig. 12A ) and subjected to excessive compressive loads ( Fig. 12C The maximum outer diameter / outer profile of the radially outwardly bent arms 1295 occurs when subjected to excessive compressive loads ( Fig. 12C ), and when not subjected to excessive compressive loads, the radially outwardly bendable arms 1295 have a minimum outer diameter / outer profile (preferably, an outer diameter / outer profile equal to the outer diameter / outer profile of the remaining non-insertable straight (cylindrical) segment 1250a of the introducer tool that does not bend radially outwardly when subjected to excessive compressive forces) ( Fig.12D ).exist Fig. 12B and Fig.12D, respectively, depict these respective uncompressed and compressed states of the introducer tool 1250 in use when inserted into an assembly (i.e., a hemostasis valve 105 connected to a guide sheath catheter 125 via a tapered guide sheath luer connector / interface 120). Similarly, when the radially expandable compression force absorbing component 1295 is in an uncompressed state (i.e., minimum outer diameter / outer profile), the funnel catheter 175 is unimpededly advanced through the lumen of the introducer tool 1250 when its distal segment is in an expanded (i.e., open biased, radially enlarged, maximum outer diameter uncompressed) state. With the radially expandable compression force absorbing component 1295 in an uncompressed state, the introducer tool 1250, together with the funnel catheter 175 inserted therein, is advanced through the assembly in a distal direction as a single unit, wherein the distal segment of the funnel catheter is in an expanded (i.e., open biased) state. The outer diameter / outer profile along at least some portions of the transition segment 1250b remains outside the hemostasis valve. Reference Fig. 12B , the radially expandable compression force absorbing member (i.e., radially outwardly bendable arm) 1295 disposed between adjacent slits has a minimum outer diameter before excessive axial / longitudinal compressive load is applied to the introducer tool 1250 (i.e., excessive pushing in the distal direction). Fig.12D As shown, when the introducer tool 1295 is subjected to over-insertion beyond full insertion without compression of the distal end / tip, the weakened remaining segments between adjacent slits open (e.g., bend) to form radially outwardly bent arms 1295 having a maximum outer diameter / outer profile. These open radially outwardly bendable arms 1295 absorb excess compressive loads, thereby preventing undesirable compression of the distal end / tip of the introducer tool.

[0114] The slits ( FIG. 12A to FIG. 12D ) are arranged parallel to each other on the axial / longitudinal axis of the introducer tool. However, the slits that are still parallel to each other can alternatively be arranged to be inclined (i.e., not parallel and not perpendicular to the axial / longitudinal axis passing through the introducer tool 1350), such as FIG. 13A to FIG. 13D Similar to FIG. 12A to FIG. 12D , the weakened remaining segments between adjacent slits open (eg, bend) to form arms 1395 that bend radially outward, thereby absorbing the compressive loads and thereby preventing compression of the distal end / tip of the introducer tool. FIG. 13A to FIG. 13D Apart from the inclined arrangement of the slits in the guide tool relative to an arrangement parallel to an axial / longitudinal axis passing through the guide tool, in all other respects the disclosure of one guide tool applies to the disclosure of the other guide tool.

[0115] It is also contemplated to stagger the slits defined in the non-insertable segment 1450a of the introducer tool in the radial direction and / or the axial / longitudinal direction, thereby providing radially expandable compression force absorbing members 1495 that bulge / expand when subjected to compressive forces. FIG. 14A to FIG. 14D In the embodiment of the present invention, the axial / longitudinal slits of the first series are defined as being parallel to the axial / longitudinal axis of the introducer tool 1450 at the same radial position. The axial / longitudinal slits of the next adjacent series are arranged in parallel with the axial / longitudinal slits of the first series, are radially separated from the axial / longitudinal slits of the first series, and are offset in the axial / longitudinal direction. It is worth noting that the slits of the radially separated series do not have to be offset relative to each other in the axial / longitudinal direction, but can be aligned in other ways. Fig.14A and Fig. 14C An introducer tool 1450 is depicted, which depicts a radially expandable compression force absorbing component 1495 in an uncompressed state and a compressed state, respectively. Fig. 14B and Fig.14D Will Fig.14A and Fig. 14C The introducer tool 1450 is depicted together with the funnel catheter as a single unit insertion assembly, depicting the radially expandable compression force absorbing component 1495 in an uncompressed state and a compressed state, respectively.

[0116] In the case where the introducer tool described previously adopts a radially expandable compressive force component, the material of the radially expandable compressive force absorbing component of the introducer tool is identical with the remaining segments that include non-insertable segments 1550a. As another possible alternative that produces wrinkles or slits, the material used for the radially expandable compressive force component can be different in rigidity. Specifically, relative to the harder / rigidity larger / flexible less material (preferably in the scope of about 40D to about 80D) of the remaining segments that include the non-insertable segments 1550a of the introducer tool, the radially expandable compressive force absorbing component 1595 of the introducer tool 1550 can be made of a softer / rigidity lower / flexible larger material (preferably in the scope of about 10D to about 40D or about 30A to about 80A). That is, a lower durometer material is used for the radially expandable compression-force absorbing component 1595 relative to the material of the remainder of the insertable straight (i.e., cylindrical, uniform in both inner and outer diameters) segment 1550a of the introducer tool. Likewise, the funnel catheter 175 is unimpededly inserted into the introducer tool with its distal segment in an expanded (i.e., open biased, maximum outer diameter / outer profile) state, while the radially expandable compression-force absorbing component has a minimum outer diameter / outer profile (preferably, the outer diameter / outer profile is uniform and equal to the remainder of the non-insertable straight (i.e., cylindrical, uniform in both inner and outer diameters) segment 1550a of the introducer tool) without applying a compressive force. Fig.15A )). When subjected to compressive forces, the less rigid material comprising the radially expandable compression force absorbing member 1595 bulges radially outward, thereby absorbing any compressive forces caused by over-insertion of the introducer tool into the assembly ( Fig. 15C In use, the introducer tool and the dilated funnel catheter therein are advanced together as a single unit in a distal direction through the assembly (while maintaining the minimum outer diameter / outer profile of the radially expandable compression force absorbing component). Fig. 15B When fully advanced into the assembly (i.e., the distal end / tip is close without physically contacting the tapered inner wall of the tapered introducer sheath luer connector / hub), additional force is applied in the distal direction (i.e., over-insertion) causing the lower stiffness material of the radially expandable compression force absorbing component 1595 to bulge (i.e., expand radially outward), thereby absorbing excess compressive loads and preventing excess compressive loads from being transferred to the distal end / tip of the introducer tool, thereby preventing compression / narrowing / collapse of the lumen ( Fig.15D ). Likewise, the amount of compressive force that can be absorbed can be varied as desired by selecting one or more of the following parameters of the radially expandable, compressive force absorbing component: (i) the material based on its stiffness; (ii) the length in the axial / longitudinal direction; and / or (iii) the thickness.

[0117] FIG. 20A to FIG. 20E Described is another example of the introducer tool 2000 according to the present disclosure. The proximal segment (including the proximal end / tip) of the introducer tool 2000 is radially split or separated (e.g., can be peeled / separated along the perforation or along the tear propagation of the polymer chain of the material) into multiple segments (preferably bisected into two 180 degree segments), wherein each split proximal segment is radially separated / bent at an angle β relative to the axial / longitudinal axis passing through the introducer tool and can be opened outward from each other to form a pair of handles / tabs 2050d. Advancing in the distal direction, the next segment of the introducer tool 2000 after the curved (bent) joint at the distal end of the split proximal segment 2050d is the first straight segment 2050a (i.e., cylindrical, uniform in both inner and outer diameters). Distal to the first straight segment 2050a is a transition segment 2050b, followed by a second straight segment 2050c (i.e., cylindrical, uniform in both inner and outer diameters). The diameter (both inner and outer diameters) of the transition segment 2050b tapers from the larger diameter (both inner and outer diameters) of the first straight segment 2050a to the smaller diameter (both inner and outer diameters) of the second straight segment 2050c. The outer diameter of the distal tapered segment 2050b' (including the distal tip) of the introducer tool 2000 is tapered while maintaining a uniform (i.e., non-tapered, straight) inner diameter, as shown in FIG. Fig.20D 2050d, the lumen 2005 defined in the introducer tool 2000 is shown in an enlarged partial axial / longitudinal cross-sectional view. Fig. 20B ) extends axially / longitudinally through the first straight segment 2050a, the transition segment 2050b, the second straight segment 2050c, and the tapered distal segment 2050b'. The distal end face of the tapered distal segment 2050b' of the introducer tool is preferably blunt (e.g., rounded) to provide a gentle or smooth interface with the conformable expanded distal segment of the funnel catheter without scraping off the hydrophilic coating when retracting proximally therethrough. For example, if the interventionalist inadvertently advances the expanded distal segment of the funnel catheter too far in the distal direction, repositioning of the funnel catheter (e.g., retracting it in the proximal direction) may occur. It is advantageous to use a transparent or translucent material for the introducer tool so that the expanded distal segment of the funnel catheter remains visible relative to the distal end / tip of the introducer during assembly of the components prior to inserting the assembled components into the hemostatic valve and subsequently advancing the expanded distal segment of the funnel catheter into the guide catheter. The particular use of a colored transparent or translucent material also allows the introducer tool to be easily positioned when resting on a surface (e.g., a surgical drape).

[0118] By way of illustrative example, Fig. 20A, the axial / longitudinal length of the split proximal segments 2050d forming the handle of the introducer tool 2000 is about 30 mm ± about 5 mm, and the angle β of radial separation / bend of each split proximal segment relative to the axial / longitudinal axis passing through the introducer tool 2000 is about 40° for the handle. Advancing in the distal direction, the axial / longitudinal lengths of the remaining segments include: a first straight segment 2050a having a length of a minimum of about 25 mm (sufficient to hold the device in the space between the finger and thumb); a transition segment 2050b having a length of about 2 mm to about 10 mm; a second straight segment 2050c having a length of about 80 mm (compatible with most readily available conventional hemostatic valves, but can be made shorter or longer); and a tapered distal segment 2050b' having a length of about 1 mm to about 3 mm. Continuing with the same illustrative example, the inner diameter of each of the corresponding segments is as follows: the first straight segment 2050a has an inner diameter of ≥ about 0.115" and a wall thickness of about 0.010" (allowing sufficient clearance for the expanded distal segment of the funnel catheter having an outer diameter of about 0.110" to pass therethrough), while the outer diameter of the first straight segment 2050a of about 0.130" is larger than the lumen of the readily available conventional hemostatic valve having an inner diameter of about 0.120", thereby preventing over-insertion of the introducer tool); the second straight segment 2050c has an inner diameter of about 0.092"±about 0.002" and a wall thickness of about 0.011"+ / -about 0.002" (the inner diameter of the second straight segment 2050c is close to the range of compatible conventional guide catheters from about 0.085" to about 0. 095" outer diameter), and the outer diameter of the second straight segment 2050c is ≤ approximately 0.0118" (smaller than the approximately 0.120" inner diameter of readily available conventional hemostatic valves); and at the distal tip / end of the distal tapered segment 2050b', the radial thickness is approximately 0.001" (so that the outer diameter at the distal tip is as close as possible to the inner diameter of the guide sheath catheter) or has a circular thickness of approximately 0.004" (to protect the hydrophilic coating on the expanded tip when the expanded tip is inadvertently retracted through the introducer, as discussed above). The outer diameters of the second straight segment 2050c and the tapered distal segment 2050b' are preferably less than approximately 0.120" to allow these segments of the introducer tool 2000 to pass through a conventional standard rotary hemostatic valve (RHV) that is typically used with a conventional guide catheter. However, the inner diameter of the first straight segment 2050a is preferably large enough to accommodate the strain relief of an aspiration catheter (e.g., a funnel catheter) therein, thereby allowing the axial / longitudinal length of the aspiration catheter to be fully inserted without having to remove the introducer tool.Moreover, the inner diameter of the first straight segment 2050a of the introducer tool is sufficient to allow the expanded distal segment of the funnel catheter to be easily loaded therein when the expanded distal segment of the funnel catheter is in a radially uncompressed or uncollapsed expanded state; and the outer diameter of the first straight segment 2050a is large enough to prevent over-insertion through the hemostatic valve.

[0119] like Fig.21A As shown in Figure 21E, the introducer tool 2100 can be further modified to be semi-separated (i.e., partially; incompletely, incompletely or insufficiently to the distal end) in the axial / longitudinal direction starting from the distal end of the handle 2150d (i.e., the proximal end / end of the lumen) and terminating proximally of the distal end / end of the second straight segment 2150c. In other words, the semi-separation or partial separation (e.g., along a continuous slit or a series of perforations) extends in the axial / longitudinal direction the length of segment "C" (representing the entire axial / longitudinal length of the first straight segment 2150a) and the length of segment "B" (representing the entire axial / longitudinal length of the transition segment 2150b, and only partially representing the axial / longitudinal length of the second straight segment 2150c (but not extending completely to the distal end / end)). The introducer tool 2100 includes an unseparated segment "A" (i.e., without any separation or separation), which includes the entire tapered distal segment 2150b' and the distal segment (including the distal tip / end) of the second straight segment 2105c. This unseparated segment "A" of the introducer tool 2100 maintains sufficient strength to prevent the inner diameter from collapsing when its distal end is pushed into the tapered guide sheath Luer connector / interface. Preferably, the axial / longitudinal length of the unseparated segment "A" of the introducer tool 2100 is approximately 20 mm. Fig. 6A and Figure 6B 21 , the introducer tool remains positioned in place about the aspiration catheter, with the semi-detachment allowing only slight radial expansion (i.e., radial accommodation) of the expanded distal segment of the aspiration catheter as it passes through that portion of the lumen having a reduced inner diameter.

[0120] With the peelable handle / tab 2150d radially separated / bent, the aspiration catheter with its expanded distal segment in a radially uncompressed / uncollapsed state is loaded into the lumen 2105 of the introducer tool 2100 via the first straight segment 2150a. The large inner diameter of the first straight segment 2150a of the introducer tool 2100 facilitates easy insertion of the aspiration catheter into the expanded distal segment of the aspiration catheter when it is in a radially uncompressed / uncollapsed state, while also providing stability when the expanded distal segment of the aspiration catheter is radially compressed / collapsed when being pushed through the reduced inner diameter of the transition segment 2150b and entering the second straight segment 2150c. When the expanded distal segment of the aspiration catheter passes through the reduced inner diameter of the lumen 2105 in the transition segment 2150b and the second straight segment 2150c, the separation seam (whether continuous or perforated) allows slight radial expansion of the introducer tool. This expansion of the radial diameter minimizes friction between the components and optimizes easy loading of the aspiration catheter by the interventionalist. Upon reaching the distal end of the transition segment 2150b, the expanded distal segment of the aspiration catheter is radially compressed / collapsed sufficiently to allow it to pass through the reduced inner diameter of the second straight segment 2150c. Thus, the inner diameter (e.g., 0.088") is maintained, through which the aspiration catheter is advanced while its expanded distal segment is radially compressed / collapsed to be received in the lumen of the guide sheath.

[0121] The inner diameter of segment "C" of the introducer tool is larger than the outer diameter of the radially uncompressed / uncollapsed expanded distal segment of the aspiration catheter, so as to facilitate easy insertion therein. When the radially uncompressed / uncollapsed expanded distal segment of the funnel catheter passes therethrough, the separation seam along segment "C" allows a slight radial expansion of the inner diameter, thereby facilitating easy insertion. In addition, the separation seam along segment "C" also provides stability when the distal end of the aspiration catheter is partially radially compressed / collapsed when being pushed through the reduced inner diameter of segment "B". Although the separation seam along segment "B" of the introducer tool in the axial / longitudinal length allows a slight or reduced radial expansion of the inner diameter along the second straight segment 2150c (i.e., less than the radial expansion in segment "C"), friction is minimized and the expansion distal segment of the aspiration catheter 2100 is easily loaded by the interventional physician. Finally, as the expanded distal segment of the aspiration catheter 2100 transitions from the slightly expanded inner diameter created by the separation gap in segments "B" and "C" to the unseparated segment "A" (whose inner diameter is reduced and not radially expandable), the expanded distal segment of the aspiration catheter is sufficiently radially compressed / collapsed proximal to the distal tapered segment 2105b' such that the distal segment is sufficiently accommodated within the inner diameter of the guide sheath lumen.

[0122] Preferably, the outer diameter of segments "A" and "B" is < approximately 0.120" to allow passage through a standard RHV valve commonly used with a guide catheter. However, the outer diameter of segment "C" of the introducer tool is preferably larger than the outer diameter of the strain relief associated with the aspiration catheter to allow its passage, thereby utilizing the full effective length of the aspiration catheter without having to remove the introducer tool.

[0123] FIG. 22A to FIG. 22C Several views are depicted of yet another possible modification of the semi-disconnected introducer tool of FIG. 21 having increased stiffness to provide greater stability when manipulated or held by an interventionalist. Fig.22A , by increasing the radial thickness "Td" of the wall of the introducer tool along the "D" segment (i.e., handle 2250d) and increasing the radial thickness "Ta" of the wall along the "C" segment (i.e., along the first straight segment 2250a) to provide enhanced stiffness of the proximal segment. Different techniques can be used to increase the thickness of the wall of the introducer tool 2200, such as by reflow welding an additional sheath or variable thickness extrusion process on the outer diameter. As previously described with respect to Fig. 20A and Fig.21A As noted, the outer diameter of segments "A" and "B" is preferably < approximately 0.120" to allow an introducer tool to pass through a conventional RHV typically provided with a guide catheter. The tapered distal tip 2250b' preferably has a tapered outer diameter having an axial / longitudinal length of approximately 1 mm to approximately 3 mm. Moreover, the edges of the distal end / tip along both the inner diameter and the outer diameter are preferably rounded or blunt to minimize scraping of the coating from the expanded distal end of the aspiration catheter when the introducer tool is withdrawn / retracted proximally, as discussed in detail above. Fig. 22B and Fig. 22C Depicted separately Fig.22A A partial axial / longitudinal cross-sectional view of the introducer tool 2200 in section 22(B) and section 22(C). Fig. 22B The axial / longitudinal cross-sectional view of depicts a uniform inner diameter and a tapered outer diameter along the tapered distal segment 2250b'. However, Fig. 22C An increased wall thickness "Td" of the shank 2250d along segment "D" and an increased wall thickness "Ta" of the first straight segment 2250a along segment "C" are shown.

[0124] exist FIG. 23A to FIG. 23D20 , 21 , and 22 in that the proximal segment "D" is eliminated from needing to be split, radially separated / bent, and flattened to form a handle. Instead, the proximal end of the introducer tool 2300 terminates at segment "C," thereby providing greater axial / longitudinal length (due to avoiding the need for a handle) and, preferably, increased stiffness due to increased wall thickness. Due to the longer length and increased stiffness, the interventionalist is able to manipulate the introducer tool without the need for a handle, as in the aforementioned examples shown in FIGS. 20 , 21 , and 22 . Starting from the proximal end / tip, Fig.23A The exemplary introducer tool 2300 in FIG. 23 includes a first straight segment 2350a (i.e., cylindrical, uniform in both inner and outer diameters), a transition segment 2350b having a tapered outer diameter and a tapered inner diameter, a second straight segment 2350c (i.e., cylindrical, uniform in both inner and outer diameters), followed by a tapered distal segment 2350b' having a uniform inner diameter and a tapered outer diameter distal portion (including a distal tip / end). As shown in FIGS. 20, 21, and 22, here, in Fig.23A In the example shown, the introducer tool 2300 is semi-separated in the axial / longitudinal direction via a series of perforations starting from the proximal end / tip of the lumen 2305 and extending completely through segments "C" and "B" without extending to the distal segment "A".

[0125] Fig. 23B The introducer tool includes Fig.23A 2350c, showing the gap space between the outer surface of the radially uncompressed / uncollapsed expanded distal segment of the aspiration catheter 2370 and the inner wall of the first straight segment 2350a of the introducer tool 2300 before entering the transition segment 2350b. When passing through the transition segment 2350b and the second straight segment 2350c, the reduced inner diameter causes the expanded distal segment of the aspiration catheter to radially compress / collapse, while the separation seam in the introducer tool allows slight (less than when passing through the second straight segment 2350c) radial expansion, similar to the previous description of Fig.21A and Fig.22A While in the radially compressed / collapsed state, the expanded distal segment passes through the second straight segment 2350c and the tapered distal segment 2350b', wherein the same separation seam allows even further radial expansion. Upon exiting from the distal end / tip of the introducer tool 2300, the radially compressed / collapsed expanded distal segment of the aspiration catheter 2370 automatically reverts to the radially expanded / uncollapsed / uncompressed state, as depicted Fig.23A An enlarged view of the axial / longitudinal section of segment "A" Fig.23Cshown.

[0126] Because in Fig.23A In the example of 2300, the split flat proximal segment forming the handle is eliminated, so the first straight segment 2350a of the introducer tool 2300 preferably has an inner diameter that is sized to allow a clearance fit on the strain relief 2360 when assembled to the proximal end of the aspiration catheter 2370. Since the strain relief 2360 can be accommodated in the lumen of the introducer tool 2300, maximum effective insertion over the axial / longitudinal length of the aspiration catheter 2370 is possible, such as Fig.23D However, over-insertion of the aspiration catheter 2370 into the introducer tool 2300 is still prevented by the proximal hub 2380. Thus, the exemplary introducer tool can remain in place throughout the procedure without having to be removed.

[0127] These are a few non-limiting examples, and other mechanical structural mechanisms are also contemplated and within the scope of the present disclosure, which absorb excessive compressive forces in the axial / longitudinal direction (i.e., over-insertion), thereby preventing the compressive forces from being transferred to the distal end / tip to prevent compression of the lumen. Regardless of the mechanical structural mechanism, a radially expandable compression force absorbing component comprising a portion of a straight (i.e., cylindrical, uniform in both inner and outer diameters) segment is disposed between the handle of the introducer tool and the outer diameter transition segment. In order not to constrain or limit radial expansion, the radially expandable compression force absorbing component is outside (i.e., proximal) the hemostatic valve when the introducer tool is fully inserted into the assembly.

[0128] In any example of the introducer tool described here, the inner profile of the lumen of the introducer tool preferably has a non-circular radial cross-sectional geometry.The non-circular radial cross-sectional geometry of the lumen of the introducer can take various configurations or designs.In an example, the non-circular radial cross-sectional geometry of the inner profile of the lumen of the introducer tool has one or more ribs protruding radially inwardly from the inner wall of the lumen and extending in an axial / longitudinal direction.The inner rib protruding radially inwardly from the inner wall of the lumen extending in an axial / longitudinal direction can be: (i) extending from the proximal end / end to the opposite distal end / end or only extending along the segments / parts of the introducer tool continuous (that is, uninterrupted) pattern / design; or (iii) discontinuous (that is, interrupted, disconnected) pattern / design (without segments / parts therebetween) of more than one axial / longitudinal segments / parts of the introducer tool.Any pattern / design of the inner rib is all expected, such as linear (i.e. straight line) and / or spiral pattern. In addition to the number of ribs, the arrangement of the ribs (i.e., the spacing between adjacent ribs) and the dimensions associated therewith (i.e., axial / longitudinal length, width perpendicular to the axial / longitudinal length, depth (from the inner wall of the lumen in a radially inward direction)) can be selected as desired. The ribs can be arranged 360° along the inner wall / inner contour / inner surface of the lumen of the introducer tool, or only along its radial portion / segment / arc, for example on 45°, 90° or 180° thereof.

[0129] Fig.16A is similar to Fig. 8A A perspective view of the distal end of the introducer tool 1650 of the introducer tool 850 in FIG, having an enlarged (or expanded) proximal segment 1650a, a proximal transition segment 1650b' (tapered or stepped to control the insertion depth into the assembly), a straight (cylindrical) segment 1650c, a distal transition segment 1605b (tapered or stepped), and another straight (cylindrical) extension segment 1650d. Fig.16A The introducer tool 1650 in also includes a plurality of ribs 1685 that protrude radially inward from the inner wall / inner surface of the lumen and extend in the axial / longitudinal direction. Fig.17E 17(E)-17(E) through the radial cross-sectional view of the raised rib 1685, and Fig. 16B Depicted Fig.16A A cross-sectional view of a perspective view of the distal end of the introducer tool 1650 in FIG. 1 , with the distal segment of the outer wall removed, clearly showing the arrangement of the internal ribs 1685 therein.

[0130] Fig.17E The raised ribs in the embodiment have a semicircular radial cross-sectional shape arranged equidistantly at 360° around the inner wall of the lumen of the introducer tool, while in Fig.17FIn the example of, the raised ribs arranged equidistantly at 360° around the inner wall of the lumen of the introducer tool have a square / rectangular radial cross-sectional shape. Other radial cross-sectional geometries of the raised ribs in the lumen of the introducer tool are contemplated and within the intended scope of the present disclosure.

[0131] Different from Fig.17F The non-circular radial cross-section of the lumen of the introducer tool may have a plurality of recesses / channels extending in the longitudinal / axial direction defined in the inner wall / inner surface of the lumen of the introducer tool, each recess / channel having a square / rectangular radial cross-section ( Figure 17G ) or any other geometric shape (e.g., semicircle, triangle, etc.).

[0132] The non-circular geometry of the lumen of the introducer tool need not include raised ribs or recessed portions / channels. By way of non-limiting example, 17A to 17C Various polygonal geometries of radial cross-sections of the lumen of the introducer tool are depicted, specifically 5-sided, 6-sided or 7-sided geometries, respectively. Any other non-circular (e.g., polygonal geometry) shape of radial cross-section of the inner contour of the lumen of the introducer is possible. 17A to 17C In the embodiment, the inner and outer contours of the introducer tool are not identical. In particular, the outer contour of the introducer tool has a circular radial cross section, while the inner contour of the lumen has a non-circular (e.g., a polygonal geometry) radial cross section. Alternatively, the non-circular inner and outer contours of the distal segment of the introducer tool may conform to / be identical to / match each other, as in Fig.17D In the example.

[0133] Any non-circular radial cross-sectional geometry of the inner contour of the lumen of the introducer tool can provide a radial offset / gap between the outer contour of the distal segment of the funnel catheter when it is in an expanded state and the inner wall of the lumen of the introducer tool, which has a dual benefit. In one aspect, when the suction catheter passes through the lumen of the introducer tool when its distal segment is in an expanded state, the non-circular radial cross-sectional geometry of the inner contour of the lumen of the introducer tool minimizes surface contact, thereby minimizing friction between the two components (compared to the introducer tool with an inner contour lumen of a circular radial cross-sectional geometry). Another benefit provided by the non-circular radial cross-sectional geometry of the inner contour of the lumen of the introducer tool is the axial / longitudinal channel / passage formed by the offset / gap between the distal segment of the suction catheter when it is in an expanded state and the inner wall of the introducer tool, thereby allowing fluid (e.g., blood and / or saline) and / or entrained air to flow therebetween.

[0134] Thus far, the discussion has been directed to the design of the introducer tool itself. The present disclosure also optionally includes a retainer suitable for use with any of the introducer tool configurations / examples described herein. The retainer can be axially / longitudinally split into two or more components that can be connected together (e.g., via snap fits, magnets, etc.) as a single unit that surrounds / surrounds the proximal portion of the introducer tool, which remains outside / outside the hemostasis valve at all times during the insertion of the introducer tool into the assembly. For example, Fig. 9 The retainer 900 in the embodiment includes two axial / longitudinal half-segments 905a, 905b that can be connected together via complementary, mating or engaging features (e.g., snap fit). As needed, the retainer 900 for the introducer tool may include more than two axial / longitudinal segments, such as three, four or more axial / longitudinal segments. The multi-component retainer provides several benefits: (i) an enhanced interventionalist gripping surface to prevent slippage; and (ii) a protective support structure for the expanded distal segment of the funnel catheter (with a softer or more flexible material relative to the material of the catheter shaft) when advancing through the introducer tool; and (iii) easy disassembly for easy removal, thereby allowing the funnel catheter to be further advanced / inserted into the assembly in the distal direction in length / depth; and (iv) because the retainer extends in the proximal direction in the axial / longitudinal length relative to the proximal end of the introducer tool, the retainer increases the "introduction" through which the funnel catheter can be advanced.

[0135] refer to Fig. 9 , the outer profile / outer surface of the depicted retainer 900 has a generally cylindrical shape, but may be modified as desired, such as having a recessed portion in an ergonomic manner in which a finger can rest to enhance the interventionalist's grip. The pieces of the multi-component retainer are designed so that a single internal passage is formed in the axial / longitudinal direction when connected together as a unit. Starting from the proximal end, the single passage has a wide, tapered proximal entrance to allow the expanded distal end of the funnel catheter to be easily and unimpededly guided therein in an open biased state. After the wide, tapered proximal entrance, the single passage has a straight (uniform inner diameter) section, the inner diameter of which is less than the maximum diameter at the proximal end of the passage, but still larger than the outer diameter of the distal section of the funnel catheter in the expanded (i.e., open biased) state, thereby allowing it to be advanced therethrough unimpeded. Thereafter, the single passage transitions to a distal portion having a wider inner diameter, which thereafter tapers in the distal direction with an inner diameter that matches the outer contour of a conical proximal segment of an introducer tool that can be accommodated therein while preventing the introducer tool from accidentally moving into the straight segment of the single passage when the interventional physician pushes the retainer in the proximal direction.

[0136] Any configuration of the introducer tool shown and described herein can be modified to include internal ribs disposed on the inner wall of the lumen and / or flushing ports defined in the lumen. It should also be noted that any introducer tool can be modified to be separated (according to FIG. 5A to FIG. 5D description) or stripping (according to Fig. 6A 6D), and this separation or stripping may or may not have a flushing port. Fig. 9 The use of the retainer shown and described herein may be used with any configuration of the introducer tool disclosed and shown herein.

[0137] Example 1

[0138] A vascular access channel system, the vascular access channel system comprising: a component, the component comprising: a guide sheath catheter (125), the guide sheath catheter having a proximal end and a lumen (125'); a tapered guide sheath Luer connector (120), the tapered guide sheath Luer connector having a proximal end, an opposite distal end and a tapered inner profile; the proximal end of the guide sheath catheter (125) is received in the distal end of the tapered guide sheath Luer connector (120); a hemostatic valve (105), the hemostatic valve having a proximal end and an opposite distal end; the proximal end of the tapered guide sheath Luer connector (120) is connected to the hemostatic valve (105); ) of the distal end thereof; an introducer tool (150, 250, 350, 450, 550, 650, 750, 850, 1050, 1150, 1250, 1350, 1450, 1550, 1650, 2000, 2100, 2200, 2300), the introducer tool comprising a shaft having a proximal end, a distal segment including a distal end, a lumen extending axially from the proximal end of the shaft to the distal end, the introducer tool (150, 250, 350, 450, 550, 650, 750, 850, 1050, 1150, 1250, 1350, 1450, 1550, 1650, 2000, 2100, 2200, 2300) 550, 1650, 2000, 2100, 2200, 2300) is inserted into the hemostatic valve (105) and the tapered guide sheath Luer connector (120) of the assembly; and an aspiration catheter (175), the aspiration catheter comprising a shaft having a radially self-expandable distal segment capable of being converted from a radially uncompressed state of maximum outer diameter to a radially compressed state of reduced outer diameter; the aspiration catheter (175) is capable of being advanced through the introducer tool (150, 250, 350, 450, 550, 650, 750, 850, 1050, 1150, 1250, 1350, 1450, said radially self-expanding distal segment of said aspiration catheter (175) being in said radially uncompressed state of maximum outer diameter;and wherein the lumen of the shaft of the introducer tool (150, 250, 350, 450, 550, 650, 750, 850, 1050, 1150, 1250, 1350, 1450, 1550, 1650, 2000, 2100, 2200, 2300) and / or the tapered inner profile of the tapered introducer sheath Luer connector (120) comprises a compression segment having an inner diameter that is smaller than the inner diameter of the radially self-expanding distal segment of the aspiration catheter (175) when in the radially uncompressed state of maximum outer diameter.;

[0139] Example 2

[0140] According to the system of embodiment 1, the distal section of the shaft of the introducer tool (250, 350, 450, 550, 650, 650', 750, 2000, 2100, 2200, 2300) has a tapered outer diameter (250b, 350b, 450b, 550b, 650b, 650'b, 750b, 2050b', 2150b', 2250b', 2350b') that matches the tapered inner profile of the tapered guide sheath Luer connector (120).

[0141] Example 3

[0142] A system according to any one of Examples 1 to 2, wherein the aspiration catheter (175) has an expanded proximal segment (175'a) that conforms in shape and size to the expanded proximal segment (750a) of the introducer tool (750) so that it can be nested in the expanded proximal segment (750a) of the introducer tool (750) when fully inserted.

[0143] Example 4

[0144] A method for using a vascular access channel system, the vascular access channel system comprising: an assembly, the assembly comprising: a guide sheath catheter (125), the guide sheath catheter having a proximal end and a lumen (125'); a tapered guide sheath Luer connector (120), the tapered guide sheath Luer connector having a proximal end, an opposite distal end, and a tapered inner profile; the proximal end of the guide sheath catheter (125) being received in the distal end of the tapered guide sheath Luer connector (120); and a hemostatic valve (105), the hemostatic valve having a proximal end and an opposite distal end, the proximal end of the tapered guide sheath Luer connector (120) being connected to the hemostatic valve the distal end of the valve (105); the system also includes an introducer tool (150, 250, 350, 450, 550, 650, 750, 850, 1050, 1150, 1250, 1350, 1450, 1550, 1650, 2000, 2100, 2200, 2300), the introducer tool including a shaft having a proximal end, a distal segment including a distal end, and a lumen; the introducer tool (150, 250, 350, 450, 550, 650, 750, 850, 1050, 1150, 1250, 1350, 1450, 1550, 1650, 2000, 2100, 2200, 2300) , 2100, 2200, 2300) the distal end of the shaft is capable of being advanced through the hemostatic valve (105) and into the tapered guide sheath Luer connector (120) of the assembly; and the system also includes an aspiration catheter (175), the aspiration catheter including a shaft having a radially self-expandable distal segment capable of being converted from a radially uncompressed state of maximum outer diameter to a radially compressed state of reduced outer diameter; the aspiration catheter (175) is capable of being advanced through the introducer tool (150, 250, 350, 450, 550, 650, 750, 850, 1050, 1150, 1250, 1350, 145 0, 1550, 1650, 2000, 2100, 2200, 2300) and into the lumen (125') of the guide sheath catheter (125); wherein at least a portion of the lumen of the shaft of the introducer tool (150, 250, 350, 450, 550, 650, 750, 850, 1050, 1150, 1250, 1350, 1450, 1550, 1650, 2000, 2100, 2200, 2300) has an inner diameter that is larger than the inner diameter of the radially self-expanding distal segment of the aspiration catheter (175) when in the radially uncompressed state of maximum outer diameter;and wherein the lumen of the shaft of the introducer tool (150, 250, 350, 450, 550, 650, 750, 850, 1050, 1150, 1250, 1350, 1450, 1550, 1650, 2000, 2100, 2200, 2300) and / or the tapered inner profile of the tapered guide sheath Luer connector (120) include a compression segment having an inner diameter smaller than the inner diameter of the radially self-expanding distal segment of the aspiration catheter (175) when in the radially uncompressed state of maximum outer diameter; the method comprising the steps of: When the distal segment is in the radially uncompressed state with the maximum outer diameter, the suction catheter (175) is preassembled into the proximal segment of the introducer tool (150, 250, 350, 450, 550, 650, 750, 850, 1050, 1150, 1250, 1350, 1450, 1550, 1650, 2000, 2100, 2200, 2300); the introducer tool (150, 250, 350, 450, 550, 650, 750, 850, 1050, 1150, 1250, 1350, 1450, 1550, 1650, 2000, 2100, 2200, 2300) is preassembled into the proximal segment of the introducer tool (150, 250, 350, 450, 550, 650, 750, 850, 1050, 1150, 1250, 1350, 1450, 1550, 1650, 2000, 2100, 2200 , 2300) and the suction catheter (175) preassembled therein are introduced into the hemostatic valve (105) and the tapered guide sheath Luer connector (120) of the assembly as a single unit; pushing the suction catheter (175) through the introducer tool (150, 250, 350, 450, 550, 650, 750, 850, 1050, 1150, 1250, 1350, 1450, 1550, 1650, 2000, 2100, 2200, 2300); and 0,1150,1250,1350,1450,1550,1650,2000,2100,2200,2300) of the shaft and / or the conical inner profile of the conical guide sheath Luer connector (120), radially compressing the radially self-expanding distal segment of the aspiration catheter (175) so that the radially self-expanding distal segment can be sufficiently received in the lumen (125') of the guide sheath catheter (125); and sliding the aspiration catheter (175) into the lumen (125') of the guide sheath catheter (125) when the radially self-expanding distal segment is radially compressed. ;

[0145] Example 5

[0146] A method according to Example 4, wherein the pushing step also includes the following steps: automatically hydrating the hydrophilic coating of the aspiration catheter (175) by the back pressure of blood passing in the proximal direction within the gap space, wherein the gap space is defined between the inner diameter of the lumen of the shaft of the introducer tool (150, 250, 350, 450, 550, 650, 750, 850, 1050, 1150, 1250, 1350, 1450, 1550, 1650, 2000, 2100, 2200, 2300) and the outer contour of the radially self-expanding distal segment of the aspiration catheter (175) when it is in the radially uncompressed state with the maximum outer diameter.

[0147] Example 6

[0148] A method according to any one of Examples 4 to 5, wherein the axis of the introducer tool (450, 550, 650') has a plurality of flushing ports (455, 555, 655) defined in the axis; and during the step of pushing the suction catheter (175) through the introducer tool (450, 550, 650') when assembled in the hemostatic valve (105), a back pressure of the blood is generated in the proximal direction and the entrained air passes through the plurality of flushing ports (455, 555, 655) and leaves the introducer tool (450, 550, 650') in the proximal direction.

[0149] Example 7

[0150] A method according to Example 6, wherein the hemostatic valve (450, 550, 650') has a side port (115); and the method further comprises the following step: flushing the lumen of the shaft of the introducer tool (450, 550, 650') through the multiple flushing ports (455, 555, 655) using fluid injected through the side port (115) of the hemostatic valve (105).

[0151] Example 8

[0152] According to the method described in any one of Examples 4 to 7, the method further includes the following steps: removing the introducer tool from around the suction catheter (175) via a longitudinal slit (560, 560', 560") defined in the introducer tool (550, 550', 550") and extending from the proximal end to the distal end of the introducer tool, thereby allowing the suction catheter (175) to be further inserted into the assembly in a distal direction.

[0153] Example 9

[0154] A method according to any one of Examples 4 to 7, wherein the shaft of the introducer tool (2100, 2200, 2300) includes a semi-detached segment, which extends from the proximal end of the lumen in the longitudinal direction and terminates proximally of the distal end of the introducer tool (2100, 2200, 2300), thereby defining an undetached distal segment distal to the introducer tool; and wherein, when the radially self-expanding distal segment of the aspiration catheter (175) is radially compressed when passing through the compression segment of the lumen of the shaft, the introducer tool (2100, 2200, 2300) radially expands along the semi-detached segment to accommodate the radially self-expanding distal segment of the aspiration catheter.

[0155] Example 10

[0156] A method according to any one of Examples 4 to 9, wherein the guiding step includes limiting the depth to which the introducer tool can be inserted into the tapered guide sheath Luer connector (120) of the assembly to prevent axial compression and narrowing of the lumen of the distal end of the shaft of the introducer tool when engaging with the tapered inner profile of the tapered guide sheath Luer connector (120).

[0157] Embodiment 11

[0158] A method according to any one of embodiments 4 to 10, wherein the shaft of the introducer tool comprises: a distal segment, wherein the distal segment comprises the distal end of the shaft of the introducer tool; a proximal segment, wherein the proximal segment comprises the proximal end of the shaft of the introducer tool; a transition segment, wherein the transition segment is arranged between the distal segment and the proximal segment of the shaft of the introducer tool; wherein each of the distal segment, the proximal segment and the transition segment of the shaft of the introducer tool is capable of being received in the passage of the hemostatic valve (105); and wherein the pushing step comprises: passing through the proximal segment of the shaft of the introducer tool while maintaining the radially self-expanding distal segment of the aspiration catheter (175) in the radially uncompressed state of the maximum outer diameter; and radially compressing the radially self-expanding distal segment of the aspiration catheter (175) when passing through the distal segment of the shaft of the introducer tool.

[0159] Example 12

[0160] A method according to any one of Examples 4 to 11, wherein the shaft of the introducer tool has a tapered inner diameter and a tapered outer diameter from the proximal end to the distal end; and the pushing step includes: entering the proximal end of the shaft of the introducer tool while maintaining the radially self-expanding distal segment of the aspiration catheter (175) in the uncompressed state; and radially compressing the radially self-expanding distal segment of the aspiration catheter (175) when emerging from the distal end of the shaft of the introducer tool.

[0161] Embodiment 13

[0162] A method according to any one of Examples 4 to 12, wherein the pushing step includes the following steps: fixing a retainer (900) comprising a plurality of parts, wherein the plurality of parts are connectable together to define a channel in the retainer, wherein the proximal segment of the introducer tool and the aspiration catheter (175) preassembled in the introducer tool are accommodated in the channel; and grasping the retainer (900) while pushing the aspiration catheter (175) through the introducer tool (350) and into the assembly; and wherein the pushing step also includes removing the retainer (900) from the aspiration catheter (175), thereby allowing further insertion into the assembly.

[0163] Embodiment 14

[0164] A method according to any one of embodiments 4 to 13, wherein the guiding step also includes: preventing compression and narrowing of the tubular cavity at the distal end of the introducer tool when the introducer tool (1150, 1250, 1350, 1450, 1550) is over-inserted into the assembly by deploying a radially expandable compression force absorbing component (1195, 1295, 1395, 1495, 1595) associated with the shaft of the introducer tool; wherein the radially expandable compression force absorbing component (1195, 1295, 1395, 1495, 1595) is: (i) a plurality of radially expandable folds; (ii) one or more radially expandable segments in the shaft of the introducer tool, the one or more radially expandable segments having a plurality of slits defined in the one or more radially expandable segments; or (iii) a material segment having reduced stiffness relative to the stiffness of the rest of the introducer tool.

[0165] Embodiment 15

[0166] A method according to any one of Examples 4 to 14, wherein the shaft of the introducer tool includes an axially non-contractible segment (1850, 1950b), which is arranged distally of an axially contractible segment (1850', 1950c); wherein the axially contractible segment (1850', 1950c) is capable of being converted from a maximum axial length state to a reduced axial length state; and wherein the radial compression step includes reducing the radially self-expanding distal segment of the aspiration catheter (175) so that when the aspiration catheter (175) passes through the axially contractible segment (1850', 1950c) of the shaft of the introducer in the maximum axial length state, the radially self-expanding distal segment can be received in the lumen (125') of the guide sheath catheter (125).

[0167] Example 16

[0168] A vascular introducer tool (850, 850', 2000, 2100, 2200, 2300), comprising: a shaft having an outer wall extending from a proximal end to an opposite distal end and a lumen extending in a longitudinal direction defined by the shaft; and the shaft comprising an intermediate transition section (850b, 850'b, 2050b, 2150b, 2250b, 2350b) arranged between the proximal end and the distal end, the intermediate transition section having a tapered inner diameter and a tapered outer diameter.

[0169] Embodiment 17

[0170] A vascular introducer tool according to Example 16, wherein the outer wall of the shaft has a plurality of flush ports defined therein that are in communication with the lumen fluid.

[0171] Embodiment 18

[0172] A vascular introducer tool according to any one of Examples 16 to 17, wherein the outer wall of the shaft is capable of being separated in the longitudinal direction from the proximal end toward the opposite distal end along any one of the following: (i) a slit defined by two longitudinal edges; or (ii) a weakened segment.

[0173] Embodiment 19

[0174] A vascular introducer tool according to any one of Examples 16 to 18, wherein the outer wall of the shaft includes a semi-detached segment, which extends from the proximal end of the lumen in the longitudinal direction and terminates proximal to the distal end of the introducer tool, thereby defining an undetached distal segment distal to the introducer tool.

[0175] Embodiment 20

[0176] A vascular introducer tool according to any one of Examples 16 to 19, wherein the proximal segment of the outer wall of the shaft is capable of being separated in the longitudinal direction into a plurality of proximal split segments, and the plurality of proximal split segments are separated from each other relative to a longitudinal axis passing through the vascular introducer tool, thereby forming corresponding tabs (2050d, 2150d, 2250d).

[0177] Embodiment 21

[0178] A vascular introducer tool according to any one of Examples 16 to 20, wherein the shaft has a lumen extending from the proximal end through the shaft to the distal end, wherein the lumen of the shaft of the introducer tool has a radial cross-section with a non-circular shape; wherein the radial cross-section with a non-circular shape includes: (i) a plurality of ribs (1685), wherein the plurality of ribs protrude radially inward from an inner wall of the lumen of the shaft of the introducer tool and extend in a longitudinal direction; or (ii) a plurality of recesses defined in the inner wall of the lumen of the shaft of the introducer tool and extend in the longitudinal direction.

[0179] Therefore, although the basic novel features of the introducer tool for suction catheters have been shown, described and pointed out, it should be understood that, without departing from the essence and scope of the present disclosure, those skilled in the art may make various omissions, substitutions and changes in form and detail to the illustrated system / device and its operation. For example, it is clearly intended that all combinations of those elements and / or steps that perform substantially the same functions in substantially the same manner to achieve the same results are within the scope of the present disclosure. It is also fully expected and conceivable that elements are replaced from one described example to another. It should also be understood that the drawings may not be drawn to scale, but they are merely conceptual in nature. Therefore, it is intended to be limited only as indicated by the scope in the appended claims.

[0180] Each issued patent, pending patent application, publication, journal article, book, or any other reference cited herein is each incorporated by reference in its entirety.

Claims

1. A vascular access channel system, comprising: A component, the component comprising: a guide sheath catheter having a proximal end and a lumen; a tapered introducer sheath Luer connector having a proximal end, an opposite distal end, and a tapered inner profile; the proximal end of the introducer sheath catheter being received in the distal end of the tapered introducer sheath Luer connector; a hemostatic valve having a proximal end and an opposite distal end; the proximal end of the tapered introducer sheath Luer connector connected to the distal end of the hemostatic valve; an introducer tool comprising a shaft having a proximal end, a distal segment including a distal end, a lumen extending axially from the proximal end of the shaft to the distal end, the distal end of the shaft of the introducer tool being inserted into the hemostatic valve and the tapered introducer sheath Luer connector of the assembly; and an aspiration catheter comprising a shaft having a radially self-expanding distal section capable of transitioning from a radially uncompressed state of maximum outer diameter to a radially compressed state of reduced outer diameter; the aspiration catheter capable of being advanced through the lumen of the introducer tool and into the lumen of the introducer sheath catheter; wherein at least a portion of the lumen of the shaft of the introducer tool has an inner diameter that is larger than an inner diameter of the radially self-expanding distal section of the aspiration catheter when in the radially uncompressed state of maximum outer diameter; and The lumen of the shaft of the introducer tool and / or the tapered inner profile of the tapered guide sheath Luer connector include a compression segment having an inner diameter that is smaller than the inner diameter of the radially self-expanding distal segment of the aspiration catheter when in the radially uncompressed state of maximum outer diameter.

2. The system of claim 1, wherein the distal section of the shaft of the introducer tool has a tapered outer diameter that matches the tapered inner profile of the tapered introducer sheath Luer connector.

3. A system according to claim 1, wherein the aspiration catheter has an expanded proximal segment that conforms in shape and size to the expanded proximal segment of the introducer tool so that it can be nested in the expanded proximal segment of the introducer tool when fully inserted.

4. A method of using a vascular access channel system, the vascular access channel system comprising: The assembly comprises: a guide sheath catheter having a proximal end and a lumen; a tapered guide sheath Luer connector having a proximal end, an opposite distal end and a tapered inner profile; the proximal end of the guide sheath catheter is received in the distal end of the tapered guide sheath Luer connector; and a hemostatic valve having a proximal end and an opposite distal end, the proximal end of the tapered guide sheath Luer connector being connected to the distal end of the hemostatic valve; the system also comprises an introducer tool, the introducer tool comprising a shaft having a proximal end, a distal segment including a distal end and a lumen; the distal end of the shaft of the introducer tool is capable of being advanced through the hemostatic valve and into the tapered guide sheath Luer connector of the assembly; and the system also comprises a suction guide The invention relates to a tube, wherein the aspiration catheter comprises a shaft having a radially self-expandable distal segment capable of being converted from a radially uncompressed state of maximum outer diameter to a radially compressed state having a reduced outer diameter; the aspiration catheter is capable of being advanced through the lumen of the introducer tool and into the lumen of the guide sheath catheter; wherein at least a portion of the lumen of the shaft of the introducer tool has an inner diameter larger than the inner diameter of the radially self-expandable distal segment of the aspiration catheter when it is in the radially uncompressed state of maximum outer diameter; and wherein the lumen of the shaft of the introducer tool and / or the tapered inner profile of the tapered guide sheath Luer connector comprises a compression segment having an inner diameter smaller than the inner diameter of the radially self-expandable distal segment of the aspiration catheter when it is in the radially uncompressed state of maximum outer diameter; the method comprises the following steps: preassembling the aspiration catheter into the proximal section of the introducer tool when the radially self-expanding distal section of the aspiration catheter is in the radially uncompressed state of maximum outer diameter; introducing the introducer tool and the aspiration catheter preassembled in the introducer tool together as a single unit into the hemostatic valve and the tapered introducer sheath Luer connector of the assembly; advancing the aspiration catheter through the introducer tool; and radially compressing the radially self-expanding distal section of the aspiration catheter while passing through the lumen of the shaft of the introducer tool and / or the compressed section of the tapered inner profile of the tapered introducer sheath Luer connector such that the radially self-expanding distal section can be sufficiently received in the lumen of the introducer sheath catheter; and The aspiration catheter is slid into the lumen of the introducer sheath catheter while the radially self-expanding distal section is radially compressed.

5. The method according to claim 4, wherein the pushing step further comprises the following steps: The hydrophilic coating of the aspiration catheter is automatically hydrated by the back pressure of blood passing in the proximal direction within the gap space, wherein the gap space is defined between the inner diameter of the lumen of the shaft of the introducer tool and the outer contour of the radially self-expanding distal segment of the aspiration catheter when in the radially uncompressed state at the maximum outer diameter.

6. A method according to claim 4, wherein the shaft of the introducer tool has a plurality of flush ports defined therein; and during the step of pushing the suction catheter through the introducer tool when assembled in the hemostasis valve, a back pressure of blood is generated in the proximal direction and entrained air passes through the plurality of flush ports and exits from the introducer tool in the proximal direction.

7. The method of claim 6, wherein the hemostatic valve has a side port; and the method further comprises the steps of: The lumen of the shaft of the introducer tool is being flushed through the plurality of flush ports with fluid injected through the side port of the hemostasis valve.

8. The method according to claim 4, further comprising the steps of: The introducer tool is removed from around the aspiration catheter via a longitudinal slit defined in the introducer tool and extending from the proximal end to the distal end of the introducer tool, thereby allowing the aspiration catheter to be inserted further into the assembly in a distal direction.

9. The method of claim 4, wherein the shaft of the introducer tool comprises a semi-detached segment extending in a longitudinal direction from the proximal end of the lumen and terminating proximally of the distal end of the introducer tool, thereby defining an undetached distal segment distal to the introducer tool; and wherein, When the radially self-expanding distal section of the aspiration catheter is radially compressed while passing through the compression section of the lumen of the shaft, the introducer tool radially expands along the semi-detached section to accommodate the radially self-expanding distal section of the aspiration catheter.

10. A method according to claim 4, wherein the guiding step includes limiting the depth to which the introducer tool can be inserted into the tapered guide sheath Luer connector of the assembly to prevent axial compression and narrowing of the lumen of the distal end of the shaft of the introducer tool when engaging with the tapered inner profile of the tapered guide sheath Luer connector.

11. The method of claim 4, wherein the shaft of the introducer tool comprises: a distal segment comprising the distal end of the shaft of the introducer tool; a proximal segment comprising the proximal end of the shaft of the introducer tool; a transition segment disposed between the distal segment and the proximal segment of the shaft of the introducer tool; wherein each of the distal segment, the proximal segment, and the transition segment of the shaft of the introducer tool is capable of being received within the passageway of the hemostatic valve; and The pushing step includes: passing the proximal segment of the shaft of the introducer tool while maintaining the radially self-expanding distal segment of the aspiration catheter in the radially uncompressed state of the maximum outer diameter; and radially compressing the radially self-expanding distal segment of the aspiration catheter while passing the distal segment of the shaft of the introducer tool.

12. The method of claim 4, wherein the shaft of the introducer tool has a tapered inner diameter and a tapered outer diameter from the proximal end to the distal end; and the pushing step comprises: Entering the proximal end of the shaft of the introducer tool while maintaining the radially self-expanding distal segment of the aspiration catheter in the uncompressed state; and radially compressing the radially self-expanding distal segment of the aspiration catheter while emerging from the distal end of the shaft of the introducer tool.

13. The method according to claim 4, wherein the pushing step comprises the following steps: securing a holder comprising a plurality of components connectable together to define a channel in the holder, in which the proximal segment of the introducer tool and the aspiration catheter preassembled in the introducer tool are housed; and grasping the holder while pushing the aspiration catheter through the introducer tool and into the assembly; and Wherein the pushing step further comprises removing the retainer from the aspiration catheter, thereby allowing further insertion into the assembly.

14. The method according to claim 4, wherein the guiding step further comprises: Compression and narrowing of the lumen at the distal end of the introducer tool when the introducer tool is over-inserted into the assembly is prevented by deploying a radially expandable, compression-force absorbing component associated with the shaft of the introducer tool; wherein the radially expandable, compression-force absorbing component is: (i) a plurality of radially expandable folds; (ii) one or more radially expandable segments in the shaft of the introducer tool, the one or more radially expandable segments having a plurality of slits defined in the one or more radially expandable segments; or (iii) a section of material having reduced stiffness relative to the stiffness of the remainder of the introducer tool.

15. A method according to claim 4, wherein the shaft of the introducer tool includes an axially non-contractible segment, which is arranged distally to the axially contractible segment; wherein the axially contractible segment is capable of being converted from a maximum axial length state to a reduced axial length state; and wherein the radial compression step includes reducing the radially self-expanding distal segment of the aspiration catheter so that when the aspiration catheter passes through the axially contractible segment of the shaft of the introducer in the maximum axial length state, the radially self-expanding distal segment can be received in the lumen of the guide sheath catheter.

16. A vascular introducer tool, the vascular introducer tool comprising: A shaft having an outer wall extending from a proximal end to an opposite distal end and a lumen extending in a longitudinal direction defined through the shaft; and the shaft includes an intermediate transition section disposed between the proximal end and the distal end, the intermediate transition section having a tapered inner diameter and a tapered outer diameter.

17. The vessel introducer tool of claim 16, wherein the outer wall of the shaft has a plurality of flush ports defined therein in fluid communication with the lumen.

18. A vascular introducer tool according to claim 16, wherein the outer wall of the shaft is capable of being separated in the longitudinal direction from the proximal end toward the opposite distal end along any of the following: (i) a slit defined by two longitudinal edges; or (ii) a weakened segment.

19. A vascular introducer tool according to claim 16, wherein the outer wall of the shaft includes a semi-detached segment, which extends from the proximal end of the lumen in the longitudinal direction and terminates proximally of the distal end of the introducer tool, thereby defining an undetached distal segment distal to the introducer tool.

20. The vascular introducer tool according to claim 16, wherein the proximal segment of the outer wall of the shaft is capable of being separated in the longitudinal direction into a plurality of proximal split segments, and the plurality of proximal split segments are separated from each other relative to a longitudinal axis passing through the vascular introducer tool to form corresponding tabs.

21. The vascular introducer tool of claim 16, wherein the shaft has a lumen extending through the shaft from the proximal end to the distal end, wherein the lumen of the shaft of the introducer tool has a radial cross-section that is non-circular in shape; The non-circular radial cross section comprises: (i) a plurality of ribs projecting radially inwardly from an inner wall of the lumen of the shaft of the introducer tool and extending in a longitudinal direction; or (ii) a plurality of recesses defined in the inner wall of the lumen of the shaft of the introducer tool and extending in the longitudinal direction.

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