Introducer tool for an aspiration catheter

Abstract

An introducer tool for use with a vascular access system and method. While a radially self-expanding distal section of a suction catheter is in a radially uncompressed state, the suction catheter is pre-assembled into a flared proximal section of the introducer tool. Together as a single unit, the introducer tool with the suction catheter pre-assembled therein is introduced into a hemostatic valve and a tapered guide sheath hub. The suction catheter is pushed through the introducer tool. While traversing a compression section of a lumen of a shaft of the introducer tool and / or a tapered inner profile of the tapered guide sheath hub, the radially self-expanding distal section of the suction catheter is radially compressed so as to be receivable within a lumen of a guide sheath catheter. While the radially self-expanding distal section is radially compressed, the suction catheter is slid into the lumen of the guide sheath catheter.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This patent application claims the benefit of U.S. Provisional Patent Application No. 63 / 347,526, filed May 31, 2022, which is hereby incorporated by reference in its entirety.

[0002] (Field of the Invention) The present disclosure relates to introducer tools for aspiration catheters, such as funnel - shaped catheters. In particular, the present disclosure is directed to an introducer tool for guiding an aspiration catheter through a hemostatic valve into the lumen of a guide sheath catheter.

Background Art

[0003] Aspiration catheters are conventionally used during endovascular treatments or procedures, such as thrombectomy procedures, to apply a vacuum pressure to capture a target occlusion within a blood vessel. The aspiration catheter may be used in combination with a mechanical thrombectomy device (e.g., a stent retriever). When passing an aspiration catheter through a hemostatic valve into a guide catheter, it would be beneficial to protect the relatively soft, open - mouthed, flexible distal tip from damage if it catches on an edge while being guided into the lumen of the guide sheath catheter. It would also be advantageous to minimize friction, maintain the wet outer diameter of the aspiration catheter to prevent the hydrophilic coating from drying, minimize surface contact, and prevent axial loading of the aspiration catheter.

Summary of the Invention

Problems to be Solved by the Invention

[0004] It is desirable to develop an improved introducer tool for guiding an aspiration catheter through a hemostatic valve into the lumen of a guide sheath catheter to address all of these problems.

Means for Solving the Problems

[0005] One aspect of the present disclosure is directed to an introducer tool for guiding a suction catheter (e.g., a funnel-shaped catheter) through a hemostatic valve into the lumen of a guide sheath catheter.

[0006] Another aspect of the present disclosure is directed to an introducer tool for guiding a suction catheter (e.g., a funnel-shaped catheter) through a hemostatic valve into the lumen of a guide sheath catheter while protecting a relatively soft, open-mouthed, flexible distal tip that is prone to damage if snagged on an edge while being guided into the lumen of the guide sheath catheter.

[0007] Yet another aspect of the present disclosure relates to an introducer tool for guiding a suction catheter (e.g., a funnel-shaped catheter) through a hemostatic valve into the lumen of a guide sheath catheter while maintaining the wet outer diameter of the funnel-shaped catheter to prevent the hydrophilic coating from drying.

[0008] Still another aspect of the present disclosure relates to an introducer tool for guiding a suction catheter (e.g., a funnel-shaped catheter) through a hemostatic valve into the lumen of a guide sheath catheter while minimizing friction, maintaining the wet outer diameter of the suction catheter to prevent the hydrophilic coating from drying, minimizing surface contact, and preventing axial loading of the suction catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The above and other features of the present disclosure will become more readily apparent from the following detailed description and the exemplary drawings, in which like reference numerals refer to similar elements throughout several views.

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DETAILED DESCRIPTION OF THE INVENTION

[0010] In the description, the terms "distal" or "proximal" are used with respect to the position or direction relative to the treating physician or medical interventionalist in the following description. "Distal" or "distally" is a position that is far from the physician or interventionalist or in a direction away from the physician or interventionalist. "Proximal" or "proximally" or "proximate" is a position that is close to the physician or medical interventionalist or in a direction towards the physician or medical interventionalist. The terms "occlusion", "clot", or "blockage" are used interchangeably.

[0011] An aspiration catheter (e.g., a funnel-shaped catheter) has a radially self-expanding, open-mouthed, radially outwardly biased flared distal segment (including the distal end) from which an integral shaft extends proximally. To advance through tortuous vascular structures, the flared distal segment of the aspiration catheter is more conformable and the distal shaft segment is more flexible relative to the proximal shaft segment. Preferably, the axial length of the flexible distal shaft segment of the funnel-shaped catheter is 1 cm to 30 cm and the conformable flared distal segment is 2 to 10 mm. Such increased stiffness (lower flexibility) of the proximal shaft of the funnel-shaped catheter can be achieved by an embedded braided pattern or a polymer jacket having a desired durometer. When passing the aspiration catheter through a hemostatic valve into a guide catheter, a introducer tool may be used to protect a relatively soft, open-mouthed, radially expandable and conformable flared distal segment that is prone to snagging on the edges while being advanced, and a flexible distal shaft segment that is prone to buckling under axial compressive loads when the flared distal segment is collapsed and advanced through the guide catheter. The design of the introducer tool also addresses the challenges presented when inserting the radially self-expanding flared (i.e., radially outwardly biased, open-mouthed, radially enlarged, not radially compressed at the maximum outer diameter) distal flared segment of the aspiration catheter into the lumen of a smaller inner diameter of a guide sheath catheter. Further, in this field, a physician preferably pre-assembles the aspiration catheter to the introducer tool outside the body and then inserts these together as a single unit quickly through a hemostatic valve into a guide sheath catheter to minimize blood loss. Keeping the outer diameter of the aspiration catheter in a wet state to activate the hydrophilic coating is difficult because the open design of the introducer tool quickly drains any flushing fluid and dries the hydrophilic coating. In the case of a catheter having a uniform outer profile / diameter, this is not a problem because the outer diameter of the catheter is smaller than the inner diameters of the introducer tool and the guide sheath, allowing flushing therebetween.However, in the case of a suction catheter, the outer diameter of the self-expanding opening (enlarged / flared distal end) is larger than the conventional inner diameter of the guide sheath. When a conventional introducer tool is used with a uniform inner diameter close to the inner diameter of the lumen of the guide sheath catheter, the enlarged / flared distal section of the suction catheter must be radially compressed so that it can pass through it, potentially trapping air within the flared catheter when an auxiliary device (e.g., a microcatheter / mechanical thrombectomy device) is pre-loaded. However, due to the difficulties described in relation to flushing the introducer tool and maintaining the hydrophilic coating in a wet state, friction accumulates when the enlarged / flared distal section of the suction catheter passes through the introducer tool, which may limit the passage of the enlarged / flared distal section of the suction catheter through the introducer tool. Further, when advancing the suction catheter through the introducer tool, the enlarged / flared distal section may be crushed. Additionally, when advancing the flexible enlarged / flared distal section of the suction catheter through the introducer tool, a compression resistance is generated, and another concern in overcoming this force is the risk of potentially damaging the shaft of the introducer tool if it is gripped too tightly. The introducer tool of the present invention, which is suitable for use with a suction catheter, addresses these concerns. 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 also suitable for use with other types of suction catheters.

[0012] For every configuration of the introducer tool of the present invention illustrated and described herein, prior to being introduced into the body (i.e., prior to being inserted into the assembly (i.e., having a hemostatic valve connected to the guide sheath catheter via a tapered guide sheath luer / hub)), the funnel-shaped catheter is pre-assembled to the introducer tool while outside the body. Thereafter, the introducer tool, with the funnel-shaped catheter pre-assembled together as a single unit, is inserted into an assembly having a hemostatic valve attached to the guide sheath catheter via a tapered guide sheath luer / hub. The inner wall / contour of the tapered guide sheath luer / hub is tapered at its distal end having a minimum inner diameter preferably substantially equal to or close to the minimum inner diameter of the inner diameter of the lumen of the guide sheath catheter connected thereto.

[0013] Referring to the first embodiment shown in FIG. 1A, the assembly comprises 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 guide sheath luer / hub 120, the inner wall / contour of which is tapered having a minimum inner diameter substantially equal to the inner diameter of the lumen 125’ of the guide sheath catheter 125 connected thereto.

[0014] In the embodiment shown in FIG. 1A, the introducer tool 150 of the present invention has a conical / flared proximal section 150a integrated with a shaft disposed distally thereof. The shaft of the introducer tool includes a linear (i.e., cylindrically shaped in both inner and outer diameters) section 150c terminating in a linear (i.e., cylindrically shaped in both inner and outer diameters) distal section 150b as a single integral unit or connected to each other. The inner diameter of the lumen of the shaft of the introducer tool 150 is larger than the outer diameter of the distal section of the funnel catheter 175 along its entire length (axial / longitudinal direction) while in a flared (i.e., open-biased, radially expanded, not radially compressed at the maximum outer diameter) state. Thus, the funnel catheter 175 can be advanced unobstructed (i.e., not radially compressed) within the introducer tool 150 while its distal section is in a flared (i.e., open-biased, radially expanded, not radially compressed at the maximum outer diameter) state. The introducer tool 150 with the funnel catheter 175 pre-assembled together as a single unit is advanced distally through an assembly (i.e., including the hemostatic valve 105, the tapered guide sheath catheter hub 120, and the guide sheath catheter 125) until the distal end / tip of the introducer tool 150 physically contacts (i.e., abuts) directly with the tapered inner wall / contour of the guide sheath luer / hub 120. As shown in FIG. 1A by the direction arrow pointing in the proximal direction, while being advanced distally through the introducer tool 150, the hydrophilic coating of the funnel catheter 175 is automatically hydrated by the backpressure of the fluid (e.g., blood) passing proximally around the distal section while in a flared (i.e., open-biased, radially expanded, not radially compressed at the maximum outer diameter) state. Any clearance or space greater than zero between the outer diameter of the distal section of the funnel catheter 175 and the inner diameter of the introducer tool 150 while in a flared (i.e., open-biased, radially expanded, not radially compressed at the maximum outer diameter) state may be provided to allow the backpressure fluid to flow proximally around the flared distal section of the funnel catheter 175.Preferably, a nominal clearance range of about 0.002 inches to 0.005 inches is provided to allow for manufacturing tolerances between the inner diameter of the introducer tool 150 and the outer diameter of the distal section of the funnel-shaped catheter 175 while in the flared (i.e., open-biased, radially expanded, not radially compressed at the maximum outer diameter) state. After exiting the distal end / tip of the introducer tool 150, the flared distal section of the funnel-shaped catheter 175 is radially collapsed / compressed (i.e., the outer diameter is reduced) sufficiently to pass through the lumen 125' of the guide sheath catheter 125 (which has a lumen smaller than the inner diameter of the straight distal section 150b of the introducer tool 150) when in direct physical engagement with the tapered inner wall / contour of the guide sheath luer / hub 120.

[0015] Regardless of a particular embodiment of the introducer tool, one or more of the following factors may be considered when selecting a desired axial / longitudinal length (from the proximal end / tip to the distal end / tip on the opposite side). (i) A shorter length is easier for the interventionalist to manipulate. (ii) When a funnel catheter is inserted through a hemostatic valve as a single unit pre-assembled together with the introducer tool, a length sufficient to be grasped between the thumb and index finger is desirable. (iii) A longer length provides more reinforcement to the relatively soft / flexible / expandable distal section of the funnel catheter when pressing and collapsing (i.e., reducing the outer diameter) the flared distal section before entering a smaller inner diameter of the lumen of the guide sheath catheter. Preferably, the axial / longitudinal dimension of the introducer tool from the proximal end / tip to the distal end / tip on the opposite side is in the range of 4 cm to 50 cm. Note that all configurations of the introducer tool of the present invention illustrated and described herein preferably have a conical / flared proximal section 150a with both the outer diameter and inner diameter being maximum at its proximal end / tip (including the proximal end / tip), enabling easy and unobstructed insertion of the funnel catheter without radially compressing / crushing / reducing the flared (i.e., open-biased, radially expanded, not radially compressed at the maximum outer diameter) distal section. The conical / flared proximal section 150a also acts as a stop to prevent over-insertion of the introducer tool 150 into the hemostatic valve 105.

[0016] The lumen of the shaft of the introducer tool 150 shown in FIGS. 1A and 1B has an inner diameter that is larger than the inner diameter of the guide sheath catheter 125. Thus, the funnel catheter 175 can advance unobstructed (i.e., without being radially compressed) through the lumen of the introducer tool 150 from its proximal end / tip to the opposite distal end / tip while its distal segment is in a flared (i.e., open-biased, radially expanded, not radially compressed at its maximum outer diameter) state. When exiting the distal end / tip of the introducer tool 150, the flared distal segment of the funnel catheter 175 is radially compressed (i.e., its outer diameter is reduced) when engaging directly physically with the tapered inner wall / contour of the guide sheath hub / luer 120 and is radially compressed sufficiently (i.e., its outer diameter is reduced) until it can be received within the lumen 125' of the guide sheath catheter 125. However, it is also possible that the inner diameter of the shaft 150c of the introducer tool 150 having the linear segment 150c and the linear distal segment 150b (similar to those in FIGS. 1A and 1B) is of a size (preferably, substantially equal size) close to the inner diameter of the lumen 125' of the guide sheath catheter 125. In such a case, the outer diameter of the flared (i.e., open-biased, not radially compressed at its maximum outer diameter) distal segment of the funnel catheter 175 is larger than the inner diameter of the lumen passing through the linear (i.e., cylindrically homogenous in both inner and outer diameters) segments 150b, 150c of the introducer tool. Thus, when advancing through the linear segments 150b, 150c of the introducer tool, the flared distal segment of the funnel catheter 175 is radially compressed (i.e., its outer diameter is reduced) (FIG. 1C). As a result of the inner diameter of the distal segment 150b of the introducer tool 150 being 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 the flared distal segment being further radially compressed or engaging directly physically with the tapered inner wall of the guide sheath hub 120 (FIG. 1D).

[0017] Insertion of the introducer tool 150 having linear (i.e., cylindrical, non-tapered, homogenous in both outer and inner diameters) sections 150b, 150c (FIGS. 1A and 1B) into the assembly (i.e., the hemostatic valve 105, the tapered guide sheath luer / hub 120, and the guide sheath catheter 125) stops when its distal end / tip physically contacts directly the tapered inner wall of the guide sheath luer / hub 120. FIGS. 2A and 2B show a modified structure of the introducer tool of the present invention that allows further insertion. Comparing the configuration of FIGS. 1A and 1B with the configuration of FIGS. 2A and 2B, all features are the same except for one notable exception. The distal section 150b (including the distal tip / end) of the introducer tool 150 of FIGS. 1A and 1B has a linear (i.e., cylindrical, non-tapered, homogenous in both outer and inner diameters) configuration, whereas in the alternative of FIGS. 2A and 2B, only the outer diameter of the distal section 250b of the introducer tool 250 is tapered. The inner diameter of the distal section 250b of the introducer tool 250 remains uniform (i.e., non-tapered), thereby allowing unobstructed (i.e., not radially compressed) movement of the funnel-shaped catheter in a flared (i.e., open-biased, not radially compressed at the maximum outer diameter) state throughout the axial / longitudinal length of the distal section of the introducer tool 250. The taper of the outer profile of the distal section 250b of the introducer tool 250 is preferably the same as the taper of the tapered inner wall of the guide sheath luer / hub 120 in order to minimize the gap between the distal face of the introducer tool and the inner tapered face of the guide catheter luer / hub. Similar to the introducer tool 150 of FIGS. 1A and 1B, again, the introducer tool 250 of FIGS. 2A and 2B has an inner diameter large enough to accommodate unobstructed (i.e., not radially compressed) insertion of the funnel-shaped catheter 175 therein, and the distal section of the funnel-shaped catheter 175 is in a flared (i.e., open-biased, not radially compressed at the maximum outer diameter) state.The tapered outer contour / outer diameter of the distal section 250b allows the introducer tool 250 to be further inserted / pushed distally into the assembly (compared to the configurations of FIGS. 1A and 1B) before physically engaging directly with the tapered inner wall of the guide sheath luer / hub 120, providing for a smoother (i.e., obstacle-minimizing) passage / transfer of the funnel catheter 175 through the interface between the introducer tool 250 and the guide sheath catheter 125.

[0018] The linear (i.e., cylindrical, non-tapered, uniform outer profile) distal section 150b of the introducer tool 150 of FIGS. 1A and 1B creates a stepped interface, transition, or edge between the distal end of the introducer tool 150 and the tapered inner profile of the guide sheath ferrule / hub 120. When a proximal force (i.e., push) is applied to the proximal end of the funnel catheter 175, when the funnel exits the distal end of the introducer tool 150 and encounters the tapered inner wall of the guide sheath ferrule / hub 120, the stepped interface, transition, or edge between them provides a space (I1) that allows for an undesirable slight additional radial expansion (i.e., flared more than when disposed within the introducer tool 150) of the distal section of the funnel catheter 175. This undesirable stepped interface, transition, or edge is minimized or completely eliminated in the tapered outer profile distal section 250b of the introducer tool 250 of FIGS. 2A and 2B because the transfer of the funnel catheter 175 between the introducer tool 250 and the guide sheath ferrule / hub 120 occurs without flare (i.e., no additional radial outward expansion of the distal section compared to when unobstructed within the introducer tool 250). Thus, the smooth (i.e., without additional radial outward expansion of the distal section) transfer of the funnel catheter 175 from the introducer tool 250 to the guide sheath ferrule / hub 120 is provided by the tapered outer profile of the distal section 250b of the introducer tool 250 in FIGS. 2A and 2B. The tapered outer profile design of the distal section 250b of the introducer tool 250 in FIGS. 2A and 2B has the additional advantage of maximizing the degree of insertion (I1>I2), or in other words, the axial / longitudinal length (L1<L2) of the insertion of the introducer tool 250 into the assembly (i.e., the hemostatic valve 105, the tapered guide sheath ferrule / hub 120, and the guide sheath catheter 125) in the axial / longitudinal direction.Maximizing the axial / longitudinal length of the insertion of introducer tool 250 into the assembly (i.e., hemostatic valve 105, tapered guide sheath luer / hub 120, and guide sheath catheter 125) advantageously maximizes the axial / longitudinal travel distance of the funnel catheter 175 without being impeded, while its distal segment is maintained in a flared (i.e., open-biased, radially expanded, not radially compressed at the maximum outer diameter) state. In other words, by maximizing the unimpeded travel distance (in the distal axial / longitudinal direction) through the introducer tool 250, the subsequent travel distance of the funnel catheter 175 when transitioning from the distal end / tip of the introducer tool out of a constrained / compressed (i.e., unflared, reduced outer diameter, non-open-biased) state is advantageously minimized.

[0019] Figures 3A-3D illustrate yet another embodiment of introducer tool 350 where distal segment 350b is tapered, with both outer and inner diameters being non-uniform, and the respective minimum diameters (both inner and outer) being located at the distal end / tip. Similar to other embodiments, introducer tool 350 (FIG. 3A) has a flared proximal segment 350a for easy and unobstructed (i.e., not radially compressed) pre-assembly of the funnel catheter 175 therein, although the distal segment of the funnel catheter 175 is in a flared (i.e., open-biased, radially expanded, not radially compressed at its maximum outer diameter) state. Similar to those of FIGS. 2A and 2B, the distal segment 350b of the introducer tool 350 of FIG. 3A also has a tapered (non-uniform) outer diameter that maximizes the axial / longitudinal insertion length (L2) into the assembly (i.e., hemostatic valve 105, tapered guide sheath ferrule / hub 120, and guide sheath catheter 125), (i.e., minimum at the distal end / tip). As the distal segment of the funnel catheter 175 moves through the tapered (non-uniform) inner diameter of the distal segment 350b of the introducer tool 350, the distal segment of the funnel catheter 175 is radially compressed / crushed / reduced in outer diameter. At its distal end / tip, 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, providing smooth and unobstructed movement or passage of the funnel catheter 175 between the two components 350 and 125. Between each proximal segment 350a and distal segment 350b of the introducer tool 350, there is a linear (i.e., cylindrical, non-tapered, homogenous in both outer and inner diameters) segment 350c, the inner diameter of which is larger than the maximum outer diameter of the distal segment of the funnel catheter 175, and in the flared (i.e., open-biased, radially expanded, not radially compressed at its maximum outer diameter) state, allows the funnel catheter 175 to move through it unobstructed (i.e., not radially compressed).Figure 3B shows the unobstructed (i.e., not radially compressed) insertion of the pre-assembled funnel catheter 175, the distal segment of which traverses the proximal segment 350a of the introducer tool 350 and the straight (i.e., cylindrically conforming in both inner and outer diameters) segment 350c (before entering the tapered distal segment 350b) in a flared (i.e., open-biased, radially expanded, not radially compressed at the maximum outer diameter) state. By pre-assembling the funnel catheter 175 to the introducer tool 350 outside the body in this way before inserting the introducer tool 350 into the hemostatic valve 105, the risk of blood loss through the hemostatic valve 105 is minimized. The straight (i.e., cylindrically conforming in both inner and outer diameters) segment 350c of the introducer tool 350 having an inner diameter larger than the outer diameter of the funnel catheter 175 allows unobstructed movement therethrough and reduces friction even if the hydrophilic coating of the funnel catheter has dried while its distal segment is in a flared (i.e., open-biased, radially expanded, not radially compressed at the maximum outer diameter) state. When the introducer tool 350 with the funnel catheter 175 pre-assembled together as a single unit is inserted into the hemostatic valve 105 (Figure 3C), the backpressure of the blood (indicated by the direction arrows around the flared distal segment of the funnel catheter) automatically flushes / hydrates the lumen of the introducer tool 350, ensuring complete hydration (i.e., wetting) of the hydrophilic coating and optimizing advancement into the guide sheath catheter 125 while minimizing friction of the funnel catheter 175. As the funnel catheter 175 passes through the tapered inner diameter of the distal segment 350b of the introducer tool 350, its flared distal segment is radially compressed / crushed / reduced to an outer diameter substantially equal to the inner diameter of the lumen 125' of the guide sheath catheter 125, allowing smooth passage or transfer therebetween (Figure 3D). Preferably, the axial / longitudinal length of the introducer tool 350 is minimized to maximize the length of insertion of the funnel catheter 175 through the hemostatic valve 105 into the guide sheath catheter 125.

[0020] On the other hand, yet another modification of the introducer tool 450 is shown in FIGS. 4A-4D. This design of the introducer tool 450 has the same tapered distal section 450b (i.e., tapered in both inner and outer diameters) as that of FIGS. 3A-3D, but differs from that of FIGS. 3A-3D by having a plurality of venting or flushing ports (i.e., pores, holes, openings) 455 defined on its outer surface that are in fluid communication with the axial / longitudinal lumen. Any number of one or more flushing ports 455 are defined within the introducer tool 450, allowing entrained air to exit / vent therethrough as the funnel catheter 175 is advanced distally. Fluids (e.g., blood backpressure and / or flushing with positive saline introduced through the side port 115 of the hemostatic valve 105) also pass through the flushing ports 455 of the introducer tool 450. The flushing ports 455 may be arranged as desired (e.g., randomly, helically, axially / longitudinally aligned, radially aligned, radially offset). The location of the flushing ports may be at any position from the proximal end / tip to the distal end / tip of the introducer tool (i.e., including the proximal section 450a, the straight (cylindrical) section 450c, and / or the distal section 450b). When selecting the number, arrangement, and size of each of the flushing ports 455, maintaining the structural strength and integrity of the introducer tool is considered. The diameter and number of each flushing port (i.e., hole) are selected to allow blood cells to pass therethrough without shear stress that would damage the cells. Preferably, the diameter of each flushing port is about 50 μm or more. The operation of the introducer tool 450 is the same as that described above with respect to FIGS. 3A-3D. Specifically, FIG. 4B shows the pre-assembly or insertion of the funnel catheter 175 in the proximal section 450a and the straight (cylindrical) section 450c of the introducer tool 450 (i.e., unobstructed and not radially compressed), with its distal section in a flared (i.e., open-biased, radially expanded, not radially compressed at the maximum outer diameter) state.In this way, by pre-assembling the funnel catheter 175 into the introducer tool 450 outside the body before being inserted together as a single unit into the hemostatic valve 105, the risk of blood loss through the hemostatic valve 105 is minimized. The linear (i.e., cylindrically shaped in both inner and outer diameters) section 450c of the introducer tool 450 having an inner diameter larger than the outer diameter of the distal section of the funnel catheter 175 allows unobstructed (i.e., not radially compressed) movement through it while in a flared (i.e., open-biased, radially expanded, not radially compressed at the maximum outer diameter) state. Such an unobstructed passage reduces the high friction between components even under the condition of the hydrophilic coating components of the funnel catheter that are dried after flushing / wetting and before insertion into the introducer tool. When the pre-assembled introducer tool 450 and funnel catheter 175 are advanced through the assembly (Fig. 4C), the backpressure of the blood and / or positive flushing with saline through the side port 115 of the hemostatic valve automatically flushes the lumen of the introducer tool 450 through the flushing port 455. As a result of this flushing, complete hydration of the hydrophilic coating is ensured while minimizing the friction of the funnel catheter 175 and optimizing its advancement through the guide sheath catheter 125. As the funnel catheter 175 moves through the tapered inner diameter of the distal section 450b of the introducer tool 450, its flared distal section is radially compressed / crushed / reduced to an outer diameter substantially equal to the inner diameter of the lumen of the guide sheath catheter 125, allowing smooth passage or transfer between them (Fig. 4D). A drawback associated with the use of the flushing port 455 is the risk that the distal edge of the tip of the funnel catheter 175 with its flared distal section may be caught or snagged on the edge of the flushing port 455 when the funnel catheter 175 is advanced distally through the introducer tool 450.

[0021] Yet another alternative example of an introducer tool 550 having a single axial / longitudinal split portion 560 is shown in FIGS. 5A-5D. In the side view of FIG. 5A, the introducer tool 550 is similar in design to that of FIG. 3A, except for a single split portion 560 that extends axially / longitudinally from the proximal end to the opposite distal end. The introducer tool 550 separable along the split portion 560 is suitable for reuse as it can be easily removed from around the funnel-shaped catheter after insertion into the assembly (i.e., the hemostatic valve 105, the tapered guide sheath luer / hub 120, and the guide sheath catheter 125). FIG. 5B is a side view of an introducer tool 550 having a design similar to that of FIG. 5A, but with a single axial / longitudinal split portion 560 aligned (i.e., intersecting) with the flushing port 555 (e.g., intersecting the center of the flushing port). The flushing port 555 shown in the embodiment of FIG. 5B as being aligned with the single axial / longitudinal split portion 560 allows entrained air to exit through the flushing port as the funnel-shaped catheter 175 is advanced distally through the introducer tool 550. In addition to air, fluid can also pass through the flushing port 555 into the lumen of the introducer tool 550 by the backpressure of blood in the proximal direction and / or positive saline flushing through the hemostatic side port 115.

[0022] Figure 5C is yet another variant of the axial / longitudinal split design of the introducer tool 550' similar to that of Figure 5A. However, while in Figure 5A the two axial / longitudinal edges along a single split portion 560' are in direct physical contact with each other, in Figure 5C there is a radial opening or separation Δr in the split portion 560' between complementary axial / longitudinal edges (not in contact with each other, thereby having a "C"-shaped radial cross-section). The radial opening or separation allows the passage of entrained air, blood backpressure, and / or the positive saline flush through the hemostasis side port 115 into the lumen of the introducer tool 550'. The final variant of the split design of the introducer tool 550'' in Figure 5D has complementary axial / longitudinal edges along a single split portion 560'' that radially overlap each other. The radial overlap of the edges along the slit 560'' prevents the risks associated with the possible snagging of the flared distal end / tip of the funnel-shaped catheter along the slit 560'' when advanced through the introducer tool 550''. Despite being depicted for an introducer tool with a distal section that is tapered (in both inner and outer diameters), any of the split design configurations in Figures 5A - 5D are equally suitable for an introducer tool having any alternative design, such as, but not limited to, the straight (i.e., cylindrically homogenous, non-tapered in both inner and outer diameters) distal section of Figures 1A - 1B, the tapered outer diameter distal section of Figures 2A and 2B, or any other design of the introducer tool illustrated and described herein.

[0023] As yet another alternative, the introducer tool 650 of FIG. 6A may be peeled in one or more axial / longitudinal segments without the need to remove the funnel catheter from the assembly (i.e., the hemostatic valve 105, the tapered guide sheath luer / hub 120, and the guide sheath catheter 125). Along one or more weakened axial / longitudinal segments 660, the introducer tool 650 may be separated / fractured for easy removal from around the funnel catheter. The weakened portion may be (i) a series of perforations (as depicted in FIGS. 6A and 6B), (ii) a segment of weaker material (e.g., an axial / longitudinal segment of material that is weaker than the material forming the remainder of the tube diameter of the introducer tool 650), and / or (iii) a segment of thinner wall (e.g., an axial / longitudinal segment of material having a thinner wall relative to the material forming the remainder of the tube diameter of the introducer tool 650). Alternatively, the introducer tool may be made of a material having linear tearing properties, and the tear may be initiated by a cut (e.g., at the notch 651) at one end of the introducer and propagate axially / longitudinally. As an exemplary embodiment, the introducer tool 650 may include two weakened portions 660 that are radially separated from each other by 180°, enabling the tearing / peeling of two axial / longitudinal strips of the introducer tool 650 along each respective weakened portion 660. There may be three or more weakened portions that are separated from each other radially, and they may or may not be equidistant. Also contemplated is having a single weakened portion 660, along which the introducer tool can unwind or peel away from around the funnel catheter if the introducer tool is torn as a single sheet. The weakened portion 660 may be arranged axially / longitudinally or spirally. An advantage associated with the peel design is that there is no snagging of the distal edge of the tip of the funnel catheter when the introducer tool is advanced distally through the introducer tool since there is no axial / longitudinal split in the introducer tool. FIG. 6B depicts an introducer tool 650' that is again axially / longitudinally peelable along one or more weakened portions 660' that are aligned (e.g., centered with respect to a plurality of flushing ports) with the plurality of flushing ports 655.Aligning the weakened portions with some or all of the multiple flushing ports reduces the force required to tear the introducer tool along its sections, but they do not necessarily need to be aligned with each other. As noted in other previously described embodiments employing flushing ports 655, this allows for entrained air to escape as the funnel catheter is advanced distally. Fluids (e.g., blood backpressure and / or aggressive saline flushing through hemostatic side ports 115) may also pass through the flushing ports 655 and into the introducer tool 650'. Although depicted with an introducer tool whose distal section is tapered (in both inner and outer diameters), any of the peel design configurations (FIGS. 6A and 6B) are equally suitable for introducer tools having straight (i.e., cylindrical, uniform inner and outer diameters, not tapered) distal sections as in FIGS. 1A-1B, the tapered outer diameter distal section of FIGS. 2A and 2B, or any other design of introducer tools shown and described herein. The peel design configuration of the introducer tool 650, 650' of Figures 6A and 6B also preferably includes a notch 651 that coincides with the conical / flared proximal sections 650a, 650b to facilitate initial peeling and to visually indicate the area to be held and separated.

[0024] In the previous example, once the funnel catheter has been advanced into the guide sheath catheter, the introducer tool is removed / withdrawn proximally from the hemostasis valve to minimize blood loss. The interventionist typically also fully removes the introducer tool from the funnel catheter at this stage. If the working length of the funnel catheter is not a concern, the introducer tool may remain in place around the shaft of the funnel catheter and only be partially withdrawn to a position proximal to the hemostasis valve, and later removed only if further advancement of the funnel catheter into the assembly is prevented while in that position.

[0025] However, the modified designs of FIGS. 7A - 7C enable the introducer tool 750 to remain in a fixed position within the assembly when the funnel - shaped catheter 175' is fully inserted into the hemostatic valve 105 and the guide sheath catheter 125. The introducer tool shown in FIGS. 7A - 7C is fitted over a conical / flared funnel - shaped catheter hub 175'a that can be nested therein, and thus has a conical / flared proximal section 750a sized and shaped to maximize the insertion of the funnel - shaped catheter 175' into the assembly, and is structurally the same as that described and shown in FIGS. 3A - 3D having a tapered (in both inner and outer diameters) distal section 750b. In the illustrated embodiment, in both size and shape, the flared proximal section 750a of the introducer tool 750 is adapted to, mates with, and is complementary to the flared proximal section of the flared funnel - shaped catheter hub 175'a, such that the components can be nested together one within the other. Further, the maximized axial / longitudinal length of the introducer tool 750 improves its gripping / holding by the interventionalist. Further, the enlarged flared proximal section 750a of the introducer tool 750 is prevented from being received (i.e., entering) into the lumen of the hemostatic valve 105. As previously explained with respect to the previous embodiment, prior to the assembly of FIG. 7A (i.e., prior to insertion into the assembly (i.e., the hemostatic valve 105 connected to the guide sheath catheter 125 via the tapered guide sheath luer / hub 120)), the funnel - shaped catheter 175' is inserted into the introducer tool 750. FIGS. 7A - 7C show the introducer tool 750 and the funnel - shaped catheter 175' pre - assembled together as a single unit in successive stages of insertion into the assembly. Specifically, in FIG. 7A, the flared distal section of the funnel - shaped catheter 175' is radially compressed (i.e., its outer diameter is reduced) as it passes through the tapered (both inner and outer diameters) distal section 750b of the introducer tool 750. During continued forward movement in the distal direction, the radially compressed distal section of the funnel - shaped catheter 175' is transferred into the lumen 125' of the guide sheath catheter 125 as shown in FIG. 7B.The maximum or complete insertion of the funnel catheter 175' into the lumen 125' of the guide sheath catheter 125 is depicted in FIG. 7C. The flared funnel catheter hub 175'a nested within the flared proximal section 750a of the introducer tool 750 in FIG. 7C prevents further advancement distally into the assembly. When the maximum or complete insertion of the funnel catheter 175' into the assembly is achieved, the flared funnel catheter hub 175'a and the flared proximal section 750a of the introducer tool 750 may be releasably locked or secured together using conventional mechanical devices (e.g., clips, friction fits, etc.). Optionally, a gasket, O-ring, or other device for forming a fluid seal may be disposed between the introducer tool 750 and the funnel catheter 175' to prevent blood from flowing retrograde proximally therethrough during use. Further, a tension-relieving device may optionally be disposed around the funnel catheter 175' distal to the funnel catheter hub 175a' to occlude / block the distal end of the flared proximal section 750a and prevent blood loss therethrough. This adapted design of the flared proximal section 750a sized and shaped to fit the flared funnel catheter hub 175'a is suitable for use with any embodiment of the introducer tool described herein to maximize the insertion of the funnel catheter 175' through the guide sheath catheter 125 and the hemostatic valve 105.

[0026] Figure 8A depicts a further modification to the introducer tool to address its particular use with a hemostatic valve, the axial / longitudinal lumen of which has an inner diameter so small that it cannot receive within it the larger outer diameter of the intermediate section 350c of the introducer tool 350 of FIG. 3A. In such a situation, the introducer tool 850 is modified to include an outer contour transition section 850b disposed between two linear (i.e., cylindrically conforming in both inner and outer diameters) sections 850c (having an outer diameter (D)) and a linear section 850d (having an outer diameter (d)). The dimensions of the introducer tool 850 are selected such that the outer diameter (d) of the linear (i.e., cylindrically conforming in both inner and outer diameters) section 850d is (i) smaller than the outer diameter (D) of the linear (i.e., cylindrically conforming in both inner and outer diameters) section 850c and (ii) of a size that can be received within the hemostatic valve. The outer contour of the transition section 850b advantageously limits the axial / longitudinal insertion into the hemostatic valve and thus prevents compression of the distal end / tip of the introducer tool within the guide catheter luer / hub, avoiding compression of the distal end / tip of the lumen of the introducer tool and excessive funnel compression. FIG. 8A depicts the outer contour transition section 850b as a tapered region, although other alternative forms, such as a stepped contour, a ring, or a flange, are contemplated. The inner diameter of the introducer tool need not be constant or uniform from its proximal end to the inner end on the opposite side thereof; nevertheless, the inner diameter of each of the flared proximal section 850a of the introducer tool as well as the linear (i.e., cylindrically conforming in both inner and outer diameters) section 850c is capable of accommodating a distal section that is not obstructed (i.e., not radially compressed) while the funnel-shaped catheter 175 is in its flared (i.e., open-biased, radially expanded, and not radially compressed at its maximum outer diameter) state.

[0027] Similar to the embodiments described above, here too, a funnel-shaped catheter 175 having a distal segment in a flared (open-biased, radially expanded, not radially compressed at its maximum outer diameter) state is pre-assembled within the introducer tool 850 of FIG. 8A and, as shown in FIG. 8B, the two components are advanced together as a single unit through an assembly (i.e., a hemostatic valve 105 connected to a guide sheath catheter 125 via a tapered guide sheath luer / hub 120). Only the straight (i.e., cylindrically conforming in both inner and outer diameters) expansion 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., cylindrically conforming in both inner and outer diameters) segment 850c, and the flared proximal segment 850a are too large in diameter to remain proximal (outside) of the hemostatic valve 105 and are prevented from being received. Continuing to advance (i.e., push distally) the introducer tool 850, when it exits from its distal end / tip, the flared (open-biased) distal segment of the funnel-shaped catheter 175 is radially compressed by the tapered inner wall of the tapered guide sheath catheter 125. In FIG. 8A, the axial / longitudinal length of the straight (i.e., cylindrically conforming in both inner and outer diameters) segment 850c (i.e., from the distal end / tip of the flared proximal segment 850a to the proximal end / tip of the outer contour transition segment 850b) ranges from about 4 cm to about 30 cm. When inserted into the flared proximal segment 850a and advanced distally through the straight (i.e., cylindrically conforming in both inner and outer diameters) segment 850c of the introducer tool 850, the distal segment of the funnel-shaped catheter 175 is maintained in a flared (i.e., open-biased, radially expanded, not radially compressed at its maximum outer diameter) state.

[0028] As yet another alternative design for limiting the insertion depth within the assembly and preventing compression of the distal end / tip, both the inner and outer contours of the shaft of the introducer tool may be a continuous taper to the flared proximal segment 850a', as depicted in FIG. 8F.

[0029] In FIG. 8A, the support of the funnel-shaped catheter shaft within the linear (i.e., cylindrically homogenous in both inner and outer diameters) section 850c of the introducer tool 850 is insufficient due to the space or gap between them. To strengthen or improve the support of the funnel-shaped catheter shaft (i.e., to reduce the space or gap between the linear (i.e., cylindrically homogenous in both inner and outer diameters) section 850'c and the funnel-shaped catheter shaft), the difference between the outer diameter of the linear (i.e., cylindrically homogenous in both inner and outer diameters) section 850'c and the outer diameter of the linear (i.e., cylindrically homogenous in both inner and outer diameters) extended section 850'd is minimized, preferably made equal, and is connected via an outer contour transition section 850'b that transitions bidirectionally (i.e., transitions in both the proximal and distal directions). Referring to FIG. 8C, the outer diameter of the linear (i.e., cylindrically homogenous in both inner and outer diameters) section 850'c is equal to the outer diameter of the linear (i.e., cylindrically homogenous in both inner and outer diameters) extended section 850'd. The outer contour transition section 850'b transitions bidirectionally (i.e., transitions in both the proximal and distal directions) with an intermediate linear (i.e., cylindrically homogenous in both inner and outer diameters) section between the opposing transitions. An external flange having a continuous inner diameter may be used instead of the intermediate linear (i.e., cylindrically homogenous in both inner and outer diameters) section 850'b between the opposing transitions. Other variations of the contour transition section 850'b are contemplated as long as their configuration limits the depth of insertion of the introducer tool into the assembly.

[0030] Alternatively, the intermediate linear (i.e., cylindrically conforming in both inner and outer diameters) section may be omitted, whereby the opposing transition sections abut each other and form a diamond shape in the longitudinal cross-section. Also in this case, the tapered transition sections in opposite directions (e.g., tapering to a smaller diameter in the proximal direction and to a larger diameter in the distal direction) may be replaced by stepped transitions. The multi-diameter section introducer tool 850' of FIG. 8C is sized such that the following conditions are met when fully inserted into the hemostatic valve 105. (i) The bi-directional outer contour transition section 850b', the linear (i.e., cylindrically conforming in both inner and outer diameters) section 850'c, and the flared proximal section 850'a remain outside (proximal) the hemostatic valve 105, and (ii) compression of the distal end / tip and stenosis of the lumen of the introducer tool 850' are prevented by avoiding radial interference with the tapered inner wall / surface of the guide catheter luer / hub 120.

[0031] In FIG. 8B, the sizing of the outer contour transition section 850b and the linear (i.e., cylindrically conforming in both inner and outer diameters) section 850c is selected to be larger than the inner diameter of the lumen of the hemostatic valve, thereby preventing the insertion of these sections therein (i.e., sized such that only the linear (i.e., cylindrically conforming in both inner and outer diameters) distal expansion section 850d is received within the lumen of the hemostatic valve). By varying the size of each section of this same structure or design of the multi-diameter introducer tool of FIG. 8A, the manner of engaging the assembly (i.e., the hemostatic valve connected to the guide sheath catheter via the guide sheath luer / hub) can be changed. Referring to FIG. 8D, the outer diameter of the linear (i.e., cylindrically conforming in both inner and outer diameters) section 850c may be sized to be smaller than the inner diameter of the lumen of the hemostatic valve 105 that is received (insertable therein) together with the outer contour transition section 850b (e.g., transitioning in one or both directions) and the distal expansion section 850d. The distal expansion section 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 section of the funnel-shaped catheter is accommodated unobstructed (i.e., not radially compressed) while traversing distally through the flared proximal section 850a and the linear (i.e., cylindrically conforming in both inner and outer diameters) section 850c while in a flared (i.e., open-biased, radially expanded, not radially compressed at the maximum outer diameter) state. As the funnel-shaped catheter is continuously advanced through the assembly, the flared distal section is radially compressed (i.e., the outer diameter is reduced) as it moves through the outer contour transition section 850b and the distal expansion section 850d, and the sections 850b, 850d each have an inner diameter that is smaller than the maximum outer diameter of the flared, open-biased funnel. Axially / longitudinally, the length of the distal expansion section 850d is preferably minimized, thereby minimizing the distance traversed axially / longitudinally of the funnel-shaped catheter while its distal section is in a radially compressed state (i.e., the outer diameter is reduced).The proximal region X of the funnel-shaped catheter 175 is preferably made of a more rigid (i.e., less flexible) material relative to the remaining distal region thereof made of a more flexible (i.e., less rigid) material. The overall axial / longitudinal length of the introducer tool 850 of FIG. 8D (including the proximal section 850a, the linear (i.e., cylindrically homogenous in both inner and outer diameters) section 850c, and the outer contour transition section 850b) is in the range of about 4 cm to about 8 cm. Thus, when the introducer tool 850 is fully inserted into the assembly with its distal end / tip in direct physical contact with the tapered inner wall / contour of the tapered guide sheath luer / hub 120, a portion of the funnel-shaped catheter made of a more flexible material and disposed distally of the more rigid proximal region is undesirably supported by the introducer tool. FIG. 8E is similar to that of FIG. 8D but depicts an introducer tool with an overall axial / longitudinal length in the range of about 20 cm to about 30 cm (including the flared proximal section 850a, the linear (i.e., cylindrically homogenous in both inner and outer diameters) section 850c, and the outer contour transition section 850b) that is longer. Increasing the overall length of the introducer tool advantageously maximizes the support provided to the flexible flared distal section of the funnel-shaped catheter 175” while allowing the interventionalist to grip the stiffer proximal region X of the introducer tool.

[0032] As described above, it is desirable to maximize the working length in the axial / longitudinal direction of the introducer tool through which the funnel catheter passes. This may be achieved by designing the introducer tool to include a non-axially / longitudinally contractible section 1850 and, proximal thereto, an axially / longitudinally contractible section of telescopically concentric tubular sections 1850' designed to slide relative to each other. In the contracted state, the telescopically concentric tubular sections 1850' are too large to be received / inserted into the hemostatic valve. In FIGS. 18A and 18B, the telescopically concentric tubular sections 1850' are depicted in an axially / longitudinally expanded (i.e., non-contracted, maximum axially / longitudinally length L1) state and an axially / longitudinally contracted (i.e., minimum axially / longitudinally length L2) state, respectively. Any number of telescopically concentric tubular sections 1850' may be selected to achieve the desired working length using concentric tubular sections arranged such that the inner diameter decreases from its proximal end to its opposite distal end. In the embodiment depicted in FIG. 18A, the distal end of each tubular section has a stop feature (e.g., a lip), and the proximal end of each tubular section has a retractable flange 1865 with an external square step. The outer surface of the retractable flange engages with the stop on the proximal side of the tubular section to limit telescopically expansion while providing a smooth inner surface for the flared distal section of the funnel catheter to advance therethrough. Other mechanical configurations for limiting the expansion of the tubular sections are within the scope of the present disclosure. While the distal section is in a flared state (i.e., open-biased, maximum outer diameter, not radially compressed), the funnel catheter is introduced proximally unobstructed (i.e., not radially compressed). When the funnel catheter is advanced through the telescopically concentric tubular sections 1850', it engages with the integral stop and retraction section 1865, causing the flared distal section to be radially compressed. Upon exiting the distal end of the non-axially / longitudinally contractible section 1850 of the introducer tool, the outer diameter of the distal section of the funnel catheter is sufficiently reduced to be transferred directly into the lumen of the guide sheath catheter 125 without engaging the tapered inner wall of the tapered guide sheath luer / hub 120.

[0033] The telescopically expandable concentric tubular section in the axial / longitudinal direction (not contracted) maximizes the axial / longitudinal working length of the introducer tool through which the funnel catheter moves. This maximum working length is achieved while still allowing the telescopically expandable concentric tubular section 1850' to remain in place on / around / around the funnel catheter even when it is contracted in the axial / longitudinal direction (i.e., crushed to the minimum axial / longitudinal length L2). The non-contractable section 1850 of the introducer tool in the axial / longitudinal direction may remain within the hemostatic valve 105 (as depicted in FIG. 18B), or may be fully withdrawn (pulled out) from the hemostatic valve 105 to avoid leakage of blood through the lumen of the introducer tool.

[0034] Figures 19A and 19B represent, on the one hand, an alternative example of an introducer tool that maximizes the working length across which the funnel catheter traverses and, on the other hand, is axially / longitudinally contractable in length. In this alternative design, the introducer tool of the present invention has a conical / flared proximal section 1950a integrated with a shaft section disposed distally thereof, and the shaft section includes a telescopically contractable section 1950c integrated with a non-contractable section 1950b in the axial / longitudinal direction. The telescopically contractable section 1950c comprises a plurality of bellows (1, 2, 3, 4) that are transitionable from an expanded state to a contracted state, and the number and arrangement of the bellows may be selected as desired.

[0035] When the axially / longitudinally contractible section 1950c is in the expanded state (Fig. 19A), sections 1950b and 1950c have a uniform inner diameter and a uniform outer diameter. The uniform outer diameter of the non-contractible section 1950b is insertable into the hemostatic valve 105. The funnel-shaped catheter is introduced into the proximal section 1950a of the introducer tool with its distal section in the flared (i.e., open-biased, not radially compressed, maximum outer diameter) state. When entering the shaft sections (1950c, 1950b) of the introducer tool, the flared distal section of the funnel-shaped catheter is preferably radially compressed (outer diameter reduced) to be substantially equal to the inner diameter of the lumen of the guide sheath catheter 125 through which the funnel-shaped catheter is being transferred. Fig. 19B depicts the contractible section 1950c of the introducer tool in the axially / longitudinally contracted (i.e., crushed) state with radially expanded (i.e., maximum outer diameter) bellows (1, 2, 3, 4) disposed proximal (i.e., outside) of the hemostatic valve 105. Also in this case, when the axially / longitudinally contractible section 1950c is in the expanded state, the maximum working length of the introducer tool is achieved, while when axially / longitudinally contracted (i.e., crushed to the minimum axially / longitudinally length L2), it still allows the bellows (1, 2, 3, 4) to remain on / around / around the funnel-shaped catheter. The non-contractible section 1950b of the introducer tool may remain within the hemostatic valve 105 (as depicted in Fig. 19B), or may be fully withdrawn (pulled out) from the hemostatic valve 105 to avoid leakage of blood through the lumen of the introducer tool.

[0036] Illustrated and in any of the embodiments described above, when an excessive force (i.e., over-insertion) is applied in the distal direction (as indicated by the arrow in the embodiment of FIG. 10), if the distal end / tip of the introducer tool 1050 physically contacts / engages directly with the inner wall / contour of the guide sheath luer / hub 120, it is undesirably compressed axially and / or radially (i.e., narrowing the inner diameter of the lumen), thereby potentially restricting or preventing passage of the flared distal segment of the funnel-shaped catheter 175. Regardless of the application of excessive force to the introducer tool, it is desirable to limit the axial / longitudinal range / depth within which the introducer tool can advance through the assembly 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 / contour of the tapered guide sheath hub / luer). Compression of the distal end / tip is prevented by designing the segment of the introducer section that extends proximally (outwardly) of the hemostatic valve when fully inserted within the hemostatic valve to include a radially expandable compression force absorbing component. A number of mechanical structures associated with the introducer tool for absorbing the load of excessive compressive force applied axially / longitudinally are contemplated, and some exemplary but non-limiting embodiments thereof are described herein.

[0037] Figures 11A - 11D illustrate a first exemplary introducer tool 1150 that includes a radially expandable compression force absorbing component 1195 configured as a series of radially - extending pleats, folds, or radial waveforms (i.e., alternating radial peaks and radial valleys) similar to an accordion. The number and spacing of the pleats may be varied to absorb a desired maximum axial / longitudinal compression force. Starting from its proximal / distal end, the introducer tool 1150 of FIGS. 11A - 11D includes a handle 1150d, a non - insertable section 1150a distally thereof, a subsequent insertable straight (i.e., cylindrically - shaped in both inner and outer diameters) expansion section 1150c, and a transition section 1150b (e.g., tapered or stepped) disposed between section 1150a and section 1150c. The insertable straight (i.e., cylindrically - shaped in both inner and outer diameters) expansion section 1150c has an outer diameter / outer profile sized to be receivable within the lumen of the hemostatic valve 105, while the non - insertable section 1150a has a related outer diameter / outer profile that is larger than the lumen of the hemostatic valve 105 (i.e., not receivable / insertable). Thus, the outer diameter / outer profile of the non - insertable section 1150a is larger than the outer diameter / outer profile of the insertable straight (i.e., cylindrically - shaped in both inner and outer diameters) expansion section 1150c. FIGS. 11A and 11C show the introducer tool 1150 itself having a radially expandable compression force absorbing component (i.e., pleats) 1195 depicted in an axially / longitudinally uncompressed (expanded) state and a compressed state, respectively. These respective uncompressed (expanded) and compressed states of the radially expandable compression force absorbing component (i.e., pleats) 1195 of the introducer tool 1150 during use while being inserted into an assembly (i.e., the hemostatic valve 105 connected to the guide sheath catheter 125 via the tapered guide sheath catheter luer / hub 120) are depicted in FIGS. 11B and 11D, respectively.The funnel-shaped catheter 175 can be advanced through the lumen of the introducer tool 1150 without hindrance while its distal section is in a flared (i.e., open-biased, radially expanded, not radially compressed at the maximum outer diameter / contour) state, while the radially expandable compression force absorbing component 1195 is in an uncompressed (expanded) state. Prior to insertion into the assembly, outside the body, the funnel-shaped catheter 175 with its distal section in a flared (i.e., open-biased, radially expanded, not radially compressed at the maximum outer diameter) state is pre-assembled within the introducer tool 1150 (while the radially expandable compression force absorbing component 1195 is in an uncompressed (expanded) state). The introducer tool 1150 and the funnel-shaped catheter 175 are advanced together as a single unit distally through the assembly (FIG. 11B). At least a portion, and in some cases all, of the transition section 1150b remains proximal (outside) of the hemostatic valve 105. Referring to FIG. 11B, prior to the application of excessive axial / longitudinal compression force to the introducer tool 1150, a series of radial pleats with the radially expandable compression force absorbing component 1195 are axially / longitudinally expanded (i.e., not axially / longitudinally compressed (expanded) with the maximum distance separation in the axial / longitudinal direction between adjacent radial peaks). When the introducer tool 1150 receives excessive insertion beyond that for full insertion without undesirably compressing the distal end / tip as shown in FIG. 11D, a series of pleats with the radially expandable compression force absorbing component 1195 are axially / longitudinally compressed (i.e., reducing the axial / longitudinal separation between adjacent radial peaks), absorbing the excessive load and preventing undesired compression of the distal end / tip.

[0038] An alternative example of the introducer tool 1250 of the present invention includes a radially expandable compression force absorbing component 1295 having a plurality of radially outwardly bendable arms disposed between a series of slits defined within the non-insertable section 1250a in FIGS. 12A-12D, the slits being radially separated from each other and extending in an axial / longitudinal direction parallel to each other. The number of slits, the radial width of each slit, the axial / longitudinal length of each slit, and / or the radial separation between adjacent slits may be modified as desired to absorb a desired maximum compressive load in the axial / longitudinal direction. The slits reduce the rigidity of the non-insertable section 1250a and establish a series of weakened axial sections in the remaining regions therebetween. The rigidity of the remaining weakened portions between adjacent slits, and thus the maximum compressive force that can be absorbed, may be changed as needed based on the selection of the number of slits, the axial / longitudinal length of each slit, the radial width of each slit, and / or the radial separation between adjacent slits. When the introducer tool is subjected to an excessive compressive load in the axial / longitudinal direction, the weakened remaining axial sections (i.e., the arms) expand radially outward (the presence of the flared distal section of the funnel-shaped catheter 175 within the inner lumen of the introducer tool 1250 prevents radially inward compression). Compared to the accordion design of FIGS. 11A-11D where adjacent peaks 1195 are axially / longitudinally separated from each other, in the alternative design of FIGS. 12A-12D, adjacent radially outwardly bent arms are radially separated from each other. FIGS. 12A and 12C depict the introducer tool 1250 including radially outwardly bendable arms 1295 defined by a series of axially / longitudinally defined slits within the non-insertable section 1250a, the remaining weakened sections (i.e., the arms) not being subjected to an excessive compressive load (FIG. 12A) and being subjected to an excessive compressive load (FIG. 12C).The maximum outer diameter / outer profile of the radially outwardly bent arm 1295 occurs while under excessive compressive load (FIG. 12C), while the radially bendable arm 1295 has a minimum outer diameter / outer profile (preferably equal to the outer diameter / profile of the remaining non-insertable straight (cylindrical) section 1250a of the introducer tool that does not bend radially outwardly when under excessive compressive force) when not under excessive compressive load (FIG. 12D). These respective non-compressed and compressed states of the in-use introducer tool 1250 while being inserted into the assembly (i.e., the hemostatic valve 105 connected to the guide sheath catheter 125 via the tapered guide sheath lure / hub 120) are depicted in FIGS. 12B and 12D respectively. Also in this case, the funnel-shaped catheter 175 is advanced unobstructed through the lumen of the introducer tool 1250 while its distal section is in a flared (i.e., open-biased, radially expanded, not compressed at the maximum outer diameter) state, and the radially expandable compression force absorbing component 1295 is in a non-compressed state (i.e., minimum outer diameter / profile). The introducer tool 1250 having the non-compressed radially expandable compression force absorbing component 1295 is advanced distally through the assembly as a single unit with the funnel-shaped catheter 175 inserted therein with its distal section in a flared (i.e., open-biased) state. The outer diameter / outer profile along at least a portion of the transition section 1250b remains outside the hemostatic valve. Referring to FIG. 12B, prior to the application of excessive axial / longitudinal compressive load to the introducer tool 1250 (i.e., excessive pressing distally), the radially expandable compression force absorbing component (i.e., the radially outwardly bendable arm) 1295 disposed between adjacent slits has a minimum outer diameter. When the introducer tool 1295 undergoes excessive insertion beyond that for full insertion without compression of the distal end / tip as shown in FIG. 12D, the remaining weakened sections between adjacent slits spread (e.g., bend) to form the radially outwardly bent arm 1295 having a maximum outer diameter / profile.These flare-shaped radially outwardly bendable arms 1295 absorb excessive compressive loads, thereby preventing undesirable compression of the distal end / tip of the introducer tool.

[0039] The slits forming the radially outwardly bendable arms 1295 of the introducer tool 1250 (Figs. 12A - 12D) are arranged parallel to each other along the axial / longitudinal axis of the introducer tool. However, the slits, while still parallel to each other, may alternatively be arranged obliquely (i.e., non-parallel and non-perpendicular to the axial / longitudinal axis passing through the introducer tool 1350), as depicted in Figs. 13A - 13D. Similar to those in Figs. 12A - 12D, the remaining weakened segments between adjacent slits spread (e.g., bend) to form radially outwardly bent arms 1395, thereby absorbing compressive loads and preventing compression of the distal end / tip of the introducer tool. Apart from the oblique arrangement of the slits in Figs. 13A - 13D relative to the arrangement parallel to the axial / longitudinal axis passing through the introducer tool, the disclosure of one introducer tool is applicable to the disclosure of the other introducer tool in all other respects.

[0040] Furthermore, it is contemplated to provide a radially expandable compression force absorbing component 1495 that expands / extends in the radial direction when subjected to a compression force by shifting the slits defined within the non-insertable section 1450a of the introducer tool in the radial and / or axial / longitudinal directions. In FIGS. 14A - 14D, at the same radial position, a first series of axial / longitudinal slits are defined parallel to the axial / longitudinal axis of the introducer tool 1450. The next adjacent series of axial / longitudinal slits are arranged in parallel, radially separated from the first series of axial / longitudinal slits, and axially / longitudinally offset with respect to the first series of axial / longitudinal slits. It is noted that a series of slits radially separated from each other do not necessarily have to be axially / longitudinally offset with respect to each other and may be aligned in other ways. FIGS. 14A and 14C depict the introducer tool 1450 and the radially expandable compression force absorbing component 1495 in the non-compressed state and the compressed state, respectively. Similarly, FIGS. 14B and 14D depict the introducer tool 1450 of FIGS. 14A and 14C, where the introducer tool is inserted into the assembly as a single unit together with a funnel-shaped catheter, depicting the radially expandable compression force absorbing component 1495 in the non-compressed state and the compressed state, respectively.

[0041] In the aforementioned introducer tool that employs a radially expandable compression force component, the material of the introducer tool that forms the radially expandable compression force absorbing component is the same as the remaining portion including the non-insertable section 1550a. As yet another possible alternative for creating pleats or slits, the material used for the radially expandable compression force component may have different rigidities. Specifically, the radially expandable compression force absorbing component 1595 of the introducer tool 1550 may be made of a softer / less rigid / more flexible material (preferably in the range of about 10D to about 40D or about 30A to about 80A) compared to the harder / more rigid / less flexible material (preferably in the range of about 40D to about 80D) of the remaining portion of the introducer tool including the non-insertable section 1550a. That is, a lower durometer material is used for the radially expandable compression force absorbing component 1595 compared to the remaining portion of the introducer tool including the insertable linear (i.e., cylindrically homogenous in both inner and outer diameters) section 1550a. Also in this case, the funnel catheter 175 is inserted while the distal section with a flare shape (i.e., the maximum outer diameter / contour biased to be open) is not obstructed within the introducer tool, while the radially expandable compression force absorbing component without the application of a compression force has a minimum outer diameter / contour (preferably, the same outer diameter / contour as the remaining portion of the non-insertable linear (i.e., cylindrically homogenous in both inner and outer diameters) section 1550a of the introducer tool (Figure 15A)). When subjected to a compression force, the less rigid material that constitutes the radially expandable compression force absorbing component 1595 expands radially outward, thereby absorbing any compression force due to over-insertion of the introducer tool into the assembly (Figure 15C). In use, the introducer tool (while the minimum outer diameter / contour of the radially expandable compression force absorbing component is maintained) and the flare-shaped funnel catheter therein are advanced together as a single unit distally through the assembly (Figure 15B).When fully advanced into the assembly (i.e., the distal end / tip approaches without physically contacting the tapered inner wall of the tapered guide sheath / luer / hub), the application of additional force in the distal direction (i.e., over-insertion) expands the lower stiffness material of the radially expandable compression force absorbing component 1595 (i.e., expands radially outward), thereby absorbing the excessive compressive load and preventing transmission to the distal end / tip of the introducer tool, and thus preventing compression / narrowing / crushing of the lumen (Figure 15D). Again, the variation in 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 compression force absorbing component. (i) Stiffness-based material, (ii) axial / longitudinal length, and / or (iii) thickness.

[0042] Figures 20A - 20E depict yet another embodiment of the introducer tool 2000 according to the present disclosure. The proximal section (including the proximal end / tip) of the introducer tool 2000 is radially divided or split into a plurality of sections (preferably bisected into two 180 - degree sections) (e.g., peelable / separable along a perforation or tear propagation along the polymer chains of the material), and each divided proximal section is radially separated / bent at an angle β with respect to the axial / longitudinal axis passing through the introducer tool and flared outwardly from each other so as to form a pair of handles / tabs 2050d. Moving distally, the next section of the introducer tool 2000 following the curved (bent) interface at the distal end of the divided proximal section 2050d is the first linear section 2050a (i.e., cylindrical - like in both inner and outer diameters). Distal to the first linear section 2050a is a transition section 2050b, followed by a second linear section 2050c (i.e., cylindrical - like in both inner and outer diameters). The diameter (both inner and outer diameters) of the transition section 2050b is tapered from the larger diameter (both inner and outer diameters) of the first linear section 2050a to the smaller diameter (both inner and outer diameters) of the second linear section 2050c. The tapered distal section 2050b' (including the distal tip) of the introducer tool 2000 has a tapered outer diameter while maintaining a uniform (i.e., non - tapered, straight) inner diameter, as depicted in the enlarged partial axial / longitudinal cross - sectional view of FIG. 20D. Distal to the handle 2050d, a lumen 2005 (shown in FIG. 20B) defined within the introducer tool 2000 extends axially / longitudinally through the first linear section 2050a, the transition section 2050b, the second linear section 2050c, and the tapered distal section 2050b'. The distal surface of the tapered distal section 2050b' of the introducer tool is preferably smooth (e.g., rounded) and provides a gentle or smooth interface to the conformable flared distal section of the funnel - type catheter without scraping off the hydrophilic coating when the introducer tool is retracted proximally through it.For example, if an interventionalist inadvertently advances the flared distal segment of a funnel catheter too far distally, repositioning of the funnel catheter (e.g., retraction proximally) can be performed. Using a transparent or translucent material for the introducer tool is advantageous for allowing the flared distal segment of the funnel catheter to remain visible relative to the distal end / tip of the introducer while assembling the components prior to inserting the assembled components into the hemostatic valve and subsequently advancing the flared distal segment of the funnel catheter into the guide catheter. The particular use of a colored transparent or translucent material also enables the introducer tool to be easily positioned while resting on a surface (e.g., a surgical drape).

[0043] As an exemplary embodiment, in FIG. 20A, the axial / longitudinal length of the divided proximal section 2050d of the introducer tool 2000 forming the handle is about 30 mm ± about 5 mm, while the radially spreading / bending angle β of each divided proximal section with respect to the axial / longitudinal axis passing through the introducer tool 2000 is about 40° for the handle. Moving distally, the axial / longitudinal length of the remaining sections is the length of the first linear section 2050a of at least about 25 mm (sufficient space to hold the device between the fingers and thumb), the length of the transition section 2050b of about 2 mm to about 10 mm, the length of the second linear section 2050c of about 80 mm (compatible with the most readily available conventional hemostatic valve, but can be shorter or longer), and the length of the tapered distal section 2050b' of about 1 mm to about 3 mm. Continuing with the same exemplary embodiment, the inner diameter of each of the respective sections is as follows. The first linear section 2050a has an inner diameter ≧ about 0.115 inches and a wall thickness of about 0.010 inches (the flared distal section of the funnel-shaped catheter has an outer diameter of about 0.110 inches and allows sufficient clearance to pass through it), while the outer diameter of the first linear section 2050a of about 0.130 inches is larger than the lumen of an easily available conventional hemostatic valve having an inner diameter of about 0.120 inches, preventing over-insertion of the introducer tool. The second linear section 2050c has an inner diameter of about 0.092 inches ± about 0.002 inches and a wall thickness of about 0.011 inches ± about 0.002 inches (the inner diameter of the second linear section 2050c is close to the outer diameter of a compatible conventional guide catheter in the range of about 0.085 inches to about 0.095 inches), and the outer diameter of the second linear section 2050c is ≦ about 0.118 inches (smaller than the inner diameter of about 0.120 inches of an easily available conventional hemostatic valve). At the distal tip / end of the distal tapered section 2050b', the radial thickness is about 0.001 inches (thus, the outer diameter at the distal tip is as close as possible to the inner diameter of the guide sheath catheter), or has a rounded thickness of about 0.004 inches (to protect the hydrophilic coating on the flared tip in case the introducer is inadvertently retracted through as discussed above).The outer diameters of the second linear section 2050c and the tapered distal section 2050b' are preferably less than about 0.120 inches, allowing these sections of the introducer tool 2000 to pass through a conventional standard Rotating Hemostasis Valve (RHV) typically used with a conventional guide catheter. On the other hand, the inner diameter of the first linear section 2050a is preferably large enough to accommodate the relaxation portion of the aspiration catheter (e.g., a funnel-shaped catheter) therein, thereby allowing for the complete insertion of the axial / longitudinal length of the aspiration catheter without the need to remove the introducer tool. Also, the inner diameter of the first linear section 2050a of the introducer tool is sufficient to easily load the flared distal section of the funnel-shaped catheter therein while in a non-radially compressed or non-crushed flared state. On the other hand, the outer diameter of the first linear section 2050a is large enough to prevent over-insertion through the hemostasis valve.

[0044] As shown in FIGS. 21A-21E, the introducer tool 2100 may be further modified to be axially / longitudinally semi-divided (i.e., not partially, not completely to the distal end, not entirely, or not sufficiently) starting from the distal end of the handle 2150d (i.e., the proximal tip / end of the lumen) and terminating proximally of the distal tip / end of the second linear section 2150c. In other words, the semi-divided or partially divided portion (e.g., along a continuous slit or a series of perforations) extends axially / longitudinally by the length of section “C” (representing the entire axial / longitudinal length of the first linear section 2150a) and the length of section “B” (representing the entire axial / longitudinal length of the transition section 2150b and only a part of the axial / longitudinal length of the second linear section 2150c (but not completely to the distal tip / end)). The introducer tool 2100 includes an undivided section “A” (i.e., without any division or separation) that includes the entire tapered distal section 2150b’ and the distal portion (including the distal tip / end) of the second linear section 2105c. This undivided section “A” of the introducer tool 2100 maintains sufficient strength to prevent internal diameter collapse when its distal end is pushed into the tapered guide sheath ferrule / hub. Preferably, the axial / longitudinal length of the undivided section “A” of the introducer tool 2100 is about 20 mm. In contrast to the embodiments of FIGS. 6A and 6B where the division extends along the entire axial / longitudinal length of the introducer tool (i.e., from the proximal end to the distal end) and when separated, the introducer tool is removable from around the aspiration catheter, in FIG. 21, the introducer tool remains positioned in a fixed position around the aspiration catheter, and the semi-divided portion simply allows for a slight radial expansion (i.e., radial accommodation) of the flared distal section of the aspiration catheter while traversing through that portion of the lumen with a reduced internal diameter.

[0045] With the detachable handle / tab 2150d radially expanded / bent, a suction catheter having a flared distal segment in a radially uncompressed / non-crushed state is loaded into the lumen 2105 of the introducer tool 2100 via the first linear segment 2150a. The large inner diameter of the first linear segment 2150a of the introducer tool 2100 facilitates the easy insertion of the suction catheter having such a flared distal segment into it while in a radially uncompressed / non-crushed state. On the other hand, when the flared distal segment of the suction catheter is pushed into the second linear segment 2150c through the reduced inner diameter of the transition segment 2150b, it provides stability when being radially compressed / crushed. When the flared distal segment of the suction catheter passes through the reduced inner diameter of the lumen 2105 in the transition segment 2150b and the second linear segment 2150c, the split (whether continuous or perforated) allows for a slight radial expansion of the introducer tool. This radial diameter expansion minimizes friction between components and optimizes the easy loading of the suction catheter by the interventionalist. Upon reaching the distal end of the transition segment 2150b, the flared distal segment of the suction catheter is sufficiently radially compressed / crushed to allow it to pass through the reduced inner diameter of the second linear segment 2150c. Thus, the inner diameter (e.g., 0.088 inches) is maintained through which the suction catheter is advanced while its flared distal segment is radially compressed / crushed to be receivable within the lumen of the guide sheath.

[0046] The inner diameter of section "C" of the introducer tool is larger than the outer diameter of the non-compressed / crushed flared distal section of the aspiration catheter in the radial direction, facilitating its easy insertion therein. The split along section "C" allows for a slight radial expansion of the inner diameter as the non-compressed / crushed flared distal section of the funnel-shaped catheter passes therethrough, facilitating easy insertion. Further, while providing stability, the split along section "C" also causes the distal end of the aspiration catheter to be partially radially compressed / crushed when pushed through the reduced inner diameter of section "B". The axial / longitudinal length split along section "B" of the introducer tool allows for a slight or reduced (i.e., less than that in section "C") radial expansion along the second linear section 2150c, minimizing friction and allowing for easy loading by the interventionalist of the flared distal section of the aspiration catheter 2100. Finally, as the flared distal section of the aspiration catheter 2100 transitions from the slightly expanded inner diameter resulting from the splits in sections "B" and "C" to the non-split section "A" (whose inner diameter is reduced and not radially expandable), the flared distal section of the aspiration catheter is sufficiently radially compressed / crushed proximally to reach a sufficient distal tapered section 2105b' to be received within the inner diameter of the guide sheath lumen.

[0047] Preferably, the outer diameters of sections "A" and "B" are <about 0.120 inches to allow passage of a standard RHV valve conventionally used with a guide catheter. On the other hand, the outer diameter of section "C" of the introducer tool is preferably larger than the outer diameter of the tension relief portion associated with the aspiration catheter, allowing it to pass therethrough and thereby utilize the entire effective length of the aspiration catheter without the need to remove the introducer tool.

[0048] Figures 22A - 22C depict some of the further possible modifications of the semi - split introducer tool of FIG. 21, which have enhanced rigidity providing greater stability when manipulated or held by an interventionist. Referring to FIG. 22A, the enhanced rigidity of the proximal section is provided by increasing the radial thickness of the wall “Td” of the introducer tool along the “D” section (i.e., the handle 2250d) and increasing the radial thickness of the wall “Ta” along section “C” (i.e., along the first linear section 2250a). Different techniques are available to increase the wall thickness of the introducer tool 2200, such as by re - flowing an extra jacket over the outer diameter or by variable - thickness extrusion. As previously described with respect to FIGS. 20A and 21A, the outer diameters of sections “A” and “B” are preferably <about 0.120 inches and typically allow passage of the introducer tool through a conventional RHV supplied with a guide catheter. The tapered distal tip 2250b’ preferably has a tapered outer diameter with an axial / longitudinal length of about 1 mm to about 3 mm. Also, the edges of the distal end / tip along both the inner and outer diameters are preferably rounded or smooth to minimize the scraping off of the coating from the flared distal end of the aspiration catheter when the introducer tool is pulled proximally / retracted through it, as discussed in detail above. Partial axial / longitudinal cross - sectional views of the introducer tool 2200 of FIG. 22A in sections 22(B) and 22(C) are depicted in FIGS. 22B and 22C, respectively. The axial / longitudinal cross - sectional view of FIG. 22B depicts a uniform inner diameter and a tapered outer diameter along the tapered distal section 2250b’. On the other hand, FIG. 22C shows the increased wall thickness “Td” along the handle 2250d of section “D” and the increased wall thickness “Ta” along the first linear section 2250a of section “C”.

[0049] Yet another alternative example of an introducer tool according to the present disclosure is shown in FIGS. 23A-23D. This embodiment differs from the embodiments of FIGS. 20, 21, and 22 in that the proximal section "D" is not split, radially separated / bent, and flattened to form a handle. Rather, the proximal end of the introducer tool 2300 terminates in a section "C" that provides a greater axial / longitudinal length (as a result of eliminating the need for a handle) and preferably enhanced rigidity due to an increased wall thickness. As a result of the longer length and increased rigidity, the interventionalist can operate the introducer tool without the need for a handle, as in the previous embodiments shown in FIGS. 20, 21, and 22. Starting from the proximal end / tip, the exemplary introducer tool 2300 of FIG. 23A includes a first linear section 2350a (i.e., cylindrical homogenous in both inner and outer diameters), a transition section 2350b having a tapered outer diameter and a tapered inner diameter, a second linear section 2350c (i.e., cylindrical homogenous in both inner and outer diameters), and a tapered distal section 2350b' having a uniform inner diameter and a tapered outer diameter distal section including a distal tip / end. Similar to FIGS. 20, 21, and 22, in the embodiment depicted here in FIG. 23A, the introducer tool 2300 is axially / longitudinally semi-divided via a series of perforations that begin at the proximal end / tip of the lumen 2305 and extend completely through sections "C" and "B" without extending into the distal section "A".

[0050] Figure 23B is an enlarged axial / longitudinal sectional view of a portion of the introducer tool including the transition section 2350b of FIG. 23A, showing the clearance space between the outer surface of the non-radially compressed / crushed flare-shaped distal section of the aspiration catheter 2370 and the inner wall of the first linear section 2350a of the introducer tool before entering the transition section 2350b. During traversing through the transition section 2350b and the second linear section 2350c, the reduced inner diameter radially compresses / crushes the flare-shaped distal section of the aspiration catheter, and at the same time, allows for a slight (less than during traversing through the second linear section 2350c) radial expansion, similar to that described above with respect to FIGS. 21A and 22A, of the split portion of the introducer tool. The flare-shaped distal section traverses through the second linear section 2350c and the tapered distal section 2350b' while in a radially compressed / crushed state, where again the split portion allows for further radial expansion. Upon exiting the distal end / tip of the introducer tool 2300, the radially compressed / crushed flare-shaped distal section of the aspiration catheter 2370 automatically returns to a non-radially expanded / non-crushed / non-compressed state as shown in FIG. 23C, which depicts an enlarged view of the axial / longitudinal sectional view of section "A" of FIG. 23A.

[0051] Since the split flat proximal section forming the handle is excluded in the embodiment of FIG. 23A, the first linear section 2350a of the introducer tool 2300 preferably has an inner diameter sized to allow for a clearance fit over the tension relief section 2360 when assembled to the proximal end of the aspiration catheter 2370. As a result of the tension relief section 2360 being accommodatable within the lumen of the introducer tool 2300, as shown in FIG. 23D, maximum effective insertion in the axial / longitudinal length of the aspiration catheter 2370 is enabled. However, over-insertion of the aspiration catheter 2370 into the introducer tool 2300 is still prevented by the proximal hub 2380. Thus, this exemplary introducer tool can remain in a predetermined position throughout the procedure without the need to be removed.

[0052] These are some non-limiting examples, but other mechanical structural mechanisms are contemplated and within the scope of the present disclosure that absorb excessive compressive forces (i.e., over-insertion) in the axial / longitudinal direction and thereby prevent transfer to the distal end / tip to prevent compression of the lumen. Regardless of the mechanical structural mechanism, a radially expandable compressive force absorbing component that comprises a portion of a linear (i.e., cylindrically homogenous in both inner and outer diameters) section is disposed between the handle and the outer diameter transition section of the introducer tool. The radially expandable compressive force absorbing component is external (i.e., proximal) to the hemostatic valve when the introducer tool is fully inserted within the assembly so as not to limit or restrict radial expansion.

[0053] In any of the examples of the introducer tool described herein, the inner contour of the lumen of the introducer tool preferably has a non-circular radial cross-sectional shape. The non-circular radial cross-sectional shape of the lumen of the introducer can take various configurations or designs. In one example, the non-circular radial cross-sectional shape of the inner contour of the lumen of the introducer tool has one or more protrusions that project / bulge radially inwards from the inner wall of the lumen and extend axially / longitudinally. The internal protrusions that project radially inwards from the inner wall of the lumen extend axially / longitudinally and (i) extend continuously (i.e., without interruption) from the proximal end / tip of the introducer tool to the opposite distal end / tip or only along a portion / section thereof, or (iii) a discontinuous (i.e., interrupted, on / off) pattern / design along two or more axial / longitudinal sections / portions of the introducer tool, with no sections / portions therebetween. Any pattern / design of the internal protrusions, such as a linear (i.e., straight) and / or spiral pattern, is contemplated. In addition to the number of protrusions, their arrangement (i.e., the spacing between adjacent protrusions) and the associated dimensions (i.e., the axial / longitudinal length, the width perpendicular to the axial / longitudinal length, the depth (in the direction radially inwards from the inner wall of the lumen)) may be selected as desired. The protrusions may be arranged 360° along the inner wall / contour / surface of the lumen of the introducer tool or only along a radial portion / section / arc thereof, for example, over 45°, 90° or 180° thereof.

[0054] FIG. 16A is a perspective view of the distal end of an introducer tool 1650 similar to the introducer tool 850 of FIG. 8A, having an enlarged (or flared) proximal section 1650a, a proximal transition section 1650b' (tapered or stepped to control the insertion depth into the assembly), a linear (cylindrical) section 1650c, a distal transition section 1605b (tapered or stepped), and another linear (cylindrical) extension section 1650d. The introducer tool 1650 of FIG. 16A also includes a plurality of protrusions 1685 that project radially inward from the inner wall / surface of the lumen and extend axially / longitudinally. A radial cross-sectional view through the raised protrusion 1685 along line 17(E)-17(E) is shown in FIG. 17E, while FIG. 16B is a cutaway perspective view of the distal end of the introducer tool 1650 of FIG. 16A, with the distal section of the outer wall removed, clearly showing the arrangement of the internal protrusions 1685 therein.

[0055] The raised protrusion of FIG. 17E has a semi-circular radial cross-sectional shape that is equally spaced at 360° around the inner wall of the lumen of the introducer tool. However, in the embodiment of FIG. 17F, the raised protrusions that are equally spaced 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 shapes of the raised protrusions within the lumen of the introducer tool are contemplated and are within the scope intended by the present disclosure.

[0056] Instead of the raised protrusions of FIG. 17F, the non-circular radial cross-section of the lumen of the introducer tool may have a plurality of recesses / channels that extend longitudinally / axially defined on the inner wall / surface of the lumen of the introducer tool, and the radial cross-section of each recess / channel is square / rectangular (FIG. 17G) or any other geometric shape (e.g., semi-circular, triangular, etc.).

[0057] The non-circular geometry of the lumen of the introducer tool need not include raised protrusions or recesses / channels. As a non-limiting example, FIGS. 17A-17C depict various polygonal geometries of the radial cross-section of the lumen of the introducer tool, specifically as 5-sided, 6-sided, or 7-sided geometries, respectively. Any other non-circular (e.g., polygonal geometry) shape of the radial cross-section of the inner contour of the lumen of the introducer is possible. In FIGS. 17A-17C, the inner and outer contours of the introducer tool are not the same. 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., polygonal geometry) radial cross-section. Alternatively, the non-circular inner and outer contours of the distal section of the introducer tool may conform / coincide with each other as in the embodiment of FIG. 17D.

[0058] Any non-circular radial cross-sectional shape of the inner contour of the lumen of the introducer tool is possible to provide a radial offset / clearance between the outer contour of the distal section of the funnel-shaped catheter in the flared state and the inner wall of the lumen of the introducer tool, providing a dual advantage. In one aspect, the non-circular radial cross-sectional shape of the inner contour of the lumen of the introducer tool minimizes surface contact, and thus friction, between the two components when a suction catheter in the flared state passes through the lumen of the introducer tool (compared to an introducer tool having a circular radial cross-sectional shape of the inner contour lumen). Yet another advantage provided by the non-circular radial cross-sectional shape of the inner contour of the lumen of the introducer tool is that the axial / longitudinal channel / passage formed by the offset / clearance between the distal section of the suction catheter in the flared state and the inner wall of the introducer tool allows for the flow of fluid (e.g., blood and / or saline) and / or entrained air therebetween.

[0059] Previously, the considerations have been directed towards the design of the introducer tool itself. The present disclosure also optionally includes a holder suitable for use with any of the introducer tool configurations / embodiments described herein. The holder is axially / longitudinally divisible into two or more components, which can be connected together as a single unit (e.g., via snap fit, magnets, etc.) around / around the proximal portion of the introducer tool and always remain outside / externally of the hemostatic valve during insertion of the introducer tool into the assembly. For example, the holder 900 of FIG. 9 includes two axially / longitudinally split halves 905a, 905b that can be connected together via complementary, mating, or engaging features (e.g., snap fit). The holder 900 for the introducer tool may optionally include three or more axially / longitudinally segments, e.g., three, four, or more axially / longitudinally segments. Several advantages are provided by the multi-component holder. (i) An enhanced gripping surface for the interventionalist to prevent slippage, (ii) a protective support structure for the flared distal segment of the funnel-shaped catheter (of a material that is softer or more flexible relative to the catheter shaft) when advanced through the introducer tool, (iii) easily disassembled for easy removal and allowing further advancement / insertion in the distal direction of the length / depth of the funnel-shaped catheter into the assembly, (iv) since the holder extends proximally by the axially / longitudinally length with respect to the proximal end of the introducer tool, the holder thereby increases the "lead in" by which the funnel-shaped catheter can be advanced.

[0060] Referring to FIG. 9, the outer contour / surface of the depicted holder 900 generally has a cylindrical shape, but may be modified as desired, for example, to ergonomically have recesses where fingers can rest to improve gripping by an interventionalist. The components of the multi-component holder are designed to form a single internal passage in the axial / longitudinal direction when connected together as a unit. Starting from the proximal end, the single passage has a wide tapered proximal inlet to allow the flared distal end of the funnel-shaped catheter in its open-biased state to be easily introduced therein without being obstructed. Following the wide tapered proximal inlet, the single passage has a straight (uniform inner diameter) section where the inner diameter is smaller than the maximum diameter at the proximal end of the passage but still larger than the outer diameter of the distal section in the flared (i.e., open-biased) state of the funnel-shaped catheter, allowing it to advance through unobstructed. Thereafter, the single passage transitions to a distal portion with a wider inner diameter and then tapers smaller in the distal direction, matching the inner diameter of the outer contour of the conical proximal section of the introducer tool that can be accommodated therein while preventing unintentional movement of the introducer tool into the straight section of the single passage when the interventionalist pushes the holder in the proximal direction.

[0061] Any configuration for the introducer tool illustrated and described herein may be modified to include internal protrusions disposed on the inner wall of the lumen and / or the flushing port defined therein. Any introducer tool may be modified to be split (in accordance with the description of FIGS. 5A - 5D) or peeled (in accordance with the description of FIGS. 6A - 6D), and it should also be noted that such splitting or peeling may or may not be accompanied by a flushing port. Finally, the use of the holder as depicted in FIG. 9 and described herein may be employed with any configuration of the introducer tool disclosed and illustrated herein.

Example

[0062] A vascular access system, the vascular access system comprising an assembly including a guide sheath catheter (125) having a proximal end and a lumen (125'), a tapered guide sheath luer (120) having a proximal end, an opposite distal end, and a tapered inner contour, wherein the proximal end of the guide sheath catheter (125) is received within the distal end of the tapered guide sheath luer (120), a hemostatic valve (105) having a proximal end and an opposite distal end, wherein the proximal end of the tapered guide sheath luer (120) is connected to the distal end of the hemostatic valve (105); an introducer tool (150, 250, 350, 450, 550, 650, 750, 850, 1050, 1150, 1250, 1350, 1450, 1550, 1650, 2000, 2100, 2200, 2300) including a shaft, the shaft having a proximal end, a distal segment including a distal end, and a lumen extending axially from the proximal end of the shaft to the distal end, wherein the distal end 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) is inserted into the hemostatic valve (105) and the tapered guide sheath luer (120) of the assembly; and a suction catheter (175) including a shaft having a radially self-expanding distal segment capable of transitioning to a radially compressed state having an outer diameter reduced from a radially non-compressed state of a maximum outer diameter, wherein the suction catheter (175) is advanceable through the lumen of the introducer tool (150, 250, 350, 450, 550, 650, 750, 850, 1050, 1150, 1250, 1350, 1450, 1550, 1650, 2000, 2100, 2200, 2300) into the lumen (125') of the guide sheath catheter (125).An aspiration catheter (175), and at least a part 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 larger than the inner diameter of the radially self-expanding distal section of the aspiration catheter (175) while in the radially non-compressed state of the maximum outer diameter, and 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 contour of the tapered guide sheath ferrule (120) includes a compression section having an inner diameter smaller than the inner diameter of the radially self-expanding distal section of the aspiration catheter (175) while in the radially non-compressed state of the maximum outer diameter. A vascular access system.,

Example

[0063] 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 contour of the tapered guide sheath ferrule (120). The system of Example 1.

Example

[0064] The aspiration catheter (175) has a flared proximal section (175’a) that matches the shape and size of the flared proximal section (750a) of the introducer tool (750), so that when fully inserted, it can be nested within the flared proximal section of the introducer tool. The system according to any one of Examples 1 to 2.

Example

[0065] A method of using a vascular access system, the vascular access system including an assembly, the assembly including a guide sheath catheter (125) having a proximal end and a lumen (125'), a tapered guide sheath luer (120) having a proximal end, an opposite distal end, and a tapered inner contour, the proximal end of the guide sheath catheter (125) being received within the distal end of the tapered guide sheath luer (120), a hemostatic valve (105) having a proximal end and an opposite distal end, the proximal end of the tapered guide sheath luer (120) being connected to the distal end of the hemostatic valve (105), the system further including an introducer tool (150, 250, 350, 450, 550, 650, 750, 850, 1050, 1150, 1250, 1350, 1450, 1550, 1650, 2000, 2100, 2200, 2300) including a shaft, the shaft including a proximal end, a distal section including a distal end, and a lumen, the distal end 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) being advanceable through the hemostatic valve (105) of the assembly into the tapered guide sheath luer (120), the system also including a suction catheter (175) including a shaft having a radially self-expanding distal section transitionable from a radially non-compressed state with a maximum outer diameter to a radially compressed state with a reduced outer diameter, the suction catheter (175) being advanceable through the lumen of the introducer tool (150, 250, 350, 450, 550, 650, 750, 850, 1050, 1150, 1250, 1350, 1450, 1550, 1650, 2000, 2100, 2200, 2300) into the lumen (125') of the guide sheath catheter (125), the introducer tool (150, 250, 350, 450, 550, 650, 750, 850, 1050, 1150, 1250, 1350, 1450, 1550, 1650, 2000, 2100, 2200,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 section of the aspiration catheter (175) while in the radially non-compressed state of the maximum outer diameter, and 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 contour of the tapered guide sheath ferrule (120) includes a compression section having an inner diameter that is smaller than the inner diameter of the radially self-expanding distal section of the aspiration catheter (175) while in the radially non-compressed state of the maximum outer diameter. The method includes pre-assembling the aspiration catheter (175) into the proximal section of the introducer tool (150, 250, 350, 450, 550, 650, 750, 850, 1050, 1150, 1250, 1350, 1450, 1550, 1650, 2000, 2100, 2200, 2300) while the radially self-expanding distal section of the aspiration catheter (175) is in the radially non-compressed state of the maximum outer diameter, introducing the introducer tool (150, 250, 350, 450, 550, 650, 750, 850, 1050, 1150, 1250, 1350, 1450, 1550, 1650, 2000, 2100, 2200, 2300) with the aspiration catheter (175) pre-assembled therein as a single unit together into the hemostatic valve (105) and the tapered guide sheath ferrule (120) of the assembly, pushing the aspiration 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 while traversing the compression section 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 / or the tapered inner contour of the tapered guide sheath ferrule (120),A method comprising: sufficiently compressing the radially self-expanding distal section of the aspiration catheter (175) radially so as to be receivable within the lumen (125’) of the guide sheath catheter (125); and sliding the aspiration catheter (175) within the lumen (125’) of the guide sheath catheter (125) while the radially self-expanding distal section is radially compressed.

Example

[0066] The method according to Example 4, further comprising: automatically hydrating the hydrophilic coating of the aspiration catheter (175) by the back pressure of blood passing proximally within a clearance space 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 section of the aspiration catheter (175) while in the radially uncompressed state of the maximum outer diameter during the pushing step.

Example

[0067] The shaft of the introducer tool (450, 550, 650’) has a plurality of flushing ports (455, 555, 655) defined therein, generating back pressure of blood in the proximal direction and entrained air exiting proximally from the introducer tool (450, 550, 650’) through the plurality of flushing ports (455, 555, 655) during the step of pushing the aspiration catheter (175) through the introducer tool (450, 550, 650’) while assembled within the hemostatic valve (105). The method according to any one of Examples 4 to 5.

Example

[0068] The hemostatic valve (450, 550, 650') has a side port (115), and the method further includes actively flushing the lumen of the shaft of the introducer tool (450, 550, 650') with fluid that is injected through the side port (115) of the hemostatic valve (105) and passes through the plurality of flushing ports (455, 555, 655), the method according to Example 6.

Example

[0069] Removing the introducer tool from around the aspiration catheter (175) through longitudinal slits (560, 560', 560") defined within the introducer tool and extending from the proximal end to the distal end of the introducer tool (550, 550', 550"), and further including enabling further insertion of the aspiration catheter (175) distally into the assembly, the method according to any one of Examples 4 to 7.

Example

[0070] The shaft of the introducer tool (2100, 2200, 2300) includes a semi-divided section that extends longitudinally from the proximal end of the lumen, terminates proximal to the distal end of the introducer tool (2100, 2200, 2300), and defines a non-divided distal section distally. When radially compressed while traversing the compression section of the lumen of the shaft, the introducer tool (2100, 2200, 2300) expands radially along the semi-divided section to accommodate the radially self-expanding distal section of the aspiration catheter (175), the method according to any one of Examples 4 to 7.

Example

[0071] The introducing step includes preventing axial compression and narrowing of the lumen at the distal end of the shaft of the introducer tool when the introducer tool is inserted into the tapered guide sheath luer (120) of the assembly to a depth that limits insertion and engages the tapered inner contour of the tapered guide sheath luer (120), according to any of Examples 4-9.

Example

[0072] The shaft of the introducer tool includes a distal section including the distal end of the shaft of the introducer tool, a proximal section including the proximal end of the shaft of the introducer tool, and a transition section disposed between the distal section and the proximal section of the shaft of the introducer tool. Each of the distal section, the proximal section, and the transition section of the shaft of the introducer tool is receivable within the passage of the hemostatic valve (105). The pushing step includes moving the proximal section of the shaft of the introducer tool while maintaining the radially self-expanding distal section of the aspiration catheter (175) in a radially non-compressed state with a maximum outer diameter, and radially compressing the radially self-expanding distal section of the aspiration catheter (175) while passing through the distal section of the shaft of the introducer tool, according to any of Examples 4-10.

Example

[0073] The shaft of the introducer tool from the proximal end to the distal end has a tapered inner diameter and a tapered outer diameter. The pushing step includes inserting into the proximal end of the shaft of the introducer tool while maintaining the radially self-expanding distal section of the aspiration catheter (175) in the non-compressed state, and radially compressing the radially self-expanding distal section of the aspiration catheter (175) while emerging from the distal end of the shaft of the introducer tool, according to any of Examples 4-11.

Example

[0074] The pushing-in step is a step of fixing a holder (900) including a plurality of connectable components together, the holder defining a channel therein, the channel accommodating therein the proximal section of the introducer tool and the suction catheter (175) pre-assembled inside the introducer tool, the step of fixing the holder, and a step of gripping the holder (900) while pushing the suction catheter (175) into the assembly through the introducer tool (350), the pushing-in step further including removing the holder (900) from the suction catheter (175) to enable further insertion into the assembly, the method according to any one of Examples 4 to 12.

Example

[0075] The introducing step further includes preventing compression and stenosis of the lumen at the distal end of the introducer tool when the introducer tool (1150, 1250, 1350, 1450, 1550) is overly 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, the radially expandable compression force absorbing component (1195, 1295, 1395, 1495, 1595) being (i) a plurality of radially expanding pleats, (ii) one or more radially expandable sections within the shaft of the introducer tool having a plurality of internally defined slits, or (iii) a section of material having a reduced rigidity compared to the rigidity of the remaining section of the introducer tool, the method according to any one of Examples 4 to 13.

Example

[0076] The shaft of the introducer tool includes an axially non-contractible section (1850, 1950b) disposed distally of an axially contractible section (1850’, 1950c), the axially contractible section (1850’, 1950c) being transitionable from a state of maximum axial length to a state of reduced axial length, and the step of radially compressing includes reducing the radially self-expanding distal section of the suction catheter (175) such that it can be received within the lumen (125’) of the guide sheath catheter (125) when the suction catheter (175) passes through the axially contractible section (1850’, 1950c) of the shaft of the introducer while the suction catheter (175) is in the state of maximum axial length, the method according to any one of Examples 4 to 14.

Example

[0077] 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, a longitudinally extending lumen being defined through the shaft, the shaft including an intermediate transition section (850b, 850’b, 2050b, 2150b, 2250b, 2350b) disposed between the proximal end and the distal end and having a tapered inner diameter and a tapered outer diameter.

Example

[0078] The vascular introducer tool according to Example 16, wherein the outer wall of the shaft has a plurality of flushing ports defined therein that are in fluid communication with the lumen.

Example

[0079] The vascular introducer tool according to any one of Examples 16 to 17, wherein the outer wall of the shaft is longitudinally divisible from the proximal end to the opposite distal end along either (i) a slit defined by two longitudinal edges or (ii) a weakened portion.

Example

[0080] The outer wall of the shaft extends longitudinally from the proximal end of the lumen, terminates proximally of the distal end of the introducer tool, and defines a non-divided distal section distally, and includes a semi-divided section, the vascular introducer tool according to any one of Examples 16 to 18.

Example

[0081] The proximal section of the outer wall of the shaft is longitudinally divisible into a plurality of proximal divided sections separated from each other with respect to the longitudinal axis passing through the vascular introducer tool, and forms respective tabs (2050d, 2150d, 2250d), the vascular introducer tool according to any one of Examples 16 to 19.

Example

[0082] The shaft has a lumen extending therethrough from the proximal end to the distal end, the lumen of the shaft of the introducer tool has a non-circular radial cross-section, and the non-circular radial cross-section includes (i) a plurality of protrusions (1685) protruding radially inwards from the inner wall of the lumen of the shaft of the introducer tool and extending longitudinally, or (ii) a plurality of recesses defined in the inner wall of the lumen of the shaft of the introducer tool and extending longitudinally, the vascular introducer tool according to any one of Examples 16 to 20.

[0083] As such, the basic and novel features of the introducer tool for the aspiration catheter have been shown, described, and pointed out. However, it will be understood that various omissions, substitutions, and changes in the form and details of the illustrated systems / devices, as well as their operations, can be made by those skilled in the art without departing from the spirit and scope of the present disclosure. For example, it is clearly intended that all combinations of elements and / or steps that perform substantially the same function in substantially the same way to achieve the same result are within the scope of the present disclosure. Also, the replacement of elements from one embodiment described to another embodiment is fully intended and assumed. It should also be understood that the drawings are not necessarily drawn to scale and are merely conceptual. Therefore, it is intended to be limited only by what is shown by the appended claims.

[0084] All issued patents, pending patent applications, publications, articles, books, or other references cited are hereby incorporated by reference in their entirety into this specification.

[0085] [Embodiments] (1) A vascular access system, wherein the vascular access system comprises an assembly comprising a guide sheath catheter having a proximal end and a lumen, a tapered guide sheath hub having a proximal end, an opposite distal end, and a tapered inner contour, wherein the proximal end of the guide sheath catheter is received within the distal end of the tapered guide sheath hub, and a hemostatic valve having a proximal end and an opposite distal end, wherein the proximal end of the tapered guide sheath hub is connected to the distal end of the hemostatic valve. An introducer tool including a shaft, the shaft having a proximal end, a distal segment including a distal end, and a lumen extending axially from the proximal end to the distal end of the shaft, the distal end of the shaft of the introducer tool being inserted into the hemostatic valve and the tapered guide sheath luer of the assembly, the introducer tool and, A suction catheter including a shaft having a radially self-expanding distal segment capable of transitioning from a radially non-compressed state of maximum outer diameter to a radially compressed state of reduced outer diameter, the suction catheter being advanceable through the lumen of the introducer tool into the lumen of the guide sheath catheter, including, 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-expanding distal segment of the suction catheter while in the radially non-compressed state of maximum outer diameter, The lumen of the shaft of the introducer tool and / or the tapered inner contour of the tapered guide sheath luer includes a compression section having an inner diameter smaller than the inner diameter of the radially self-expanding distal segment of the suction catheter while in the radially non-compressed state of maximum outer diameter, a vascular access system. (2) The system according to embodiment 1, wherein the distal segment of the shaft of the introducer tool has a tapered outer diameter that matches the tapered inner contour of the tapered guide sheath luer. (3) The system according to embodiment 1, wherein the suction catheter has a flared proximal segment that matches the shape and size of the flared proximal segment of the introducer tool, such that when fully inserted, it can be nested within the flared proximal segment of the introducer tool. (4) A method of using a vascular access system, the vascular access system including an assembly, the assembly including a guide sheath catheter having a proximal end and a lumen, a tapered guide sheath luer having a proximal end, an opposite distal end, and a tapered inner contour, the proximal end of the guide sheath catheter being received within the distal end of the tapered guide sheath luer, the tapered guide sheath luer, and a hemostatic valve having a proximal end and an opposite distal end, the proximal end of the tapered guide sheath luer being connected to the distal end of the hemostatic valve, the system further including an introducer tool including a shaft, the shaft including a proximal end, a distal segment including a distal end, and a lumen, the distal end of the shaft of the introducer tool being advanceable through the hemostatic valve of the assembly into the tapered guide sheath luer, the system also including a suction catheter including a shaft having a radially self-expanding distal segment capable of transitioning from a radially non-compressed state with a maximum outer diameter to a radially compressed state with a reduced outer diameter, the suction catheter being advanceable through the lumen of the guide sheath catheter through the lumen of the introducer tool, at least a portion of the lumen of the shaft of the introducer tool having an inner diameter larger than the inner diameter of the radially self-expanding distal segment of the suction catheter while in the radially non-compressed state with the maximum outer diameter, the lumen of the shaft of the introducer tool and / or the tapered inner contour of the tapered guide sheath luer including a compression segment having an inner diameter smaller than the inner diameter of the radially self-expanding distal segment of the suction catheter while in the radially non-compressed state with the maximum outer diameter, the method comprising: Prior to assembling the suction catheter into the proximal segment of the introducer tool while the radially self-expanding distal segment of the suction catheter is in the radially non-compressed state with the maximum outer diameter; Introducing the introducer tool, with the suction catheter pre-assembled therein, as a single unit together into the hemostatic valve of the assembly and into the tapered guide sheath luer; The step of pushing the suction catheter through the introducer tool; While crossing the compression section of the lumen of the shaft of the introducer tool and / or the tapered inner contour of the tapered guide sheath luer, sufficiently radially compress the radially self-expanding distal section of the suction catheter so that it can be received within the lumen of the guide sheath catheter. A method of using a vascular access system, comprising: while the radially self-expanding distal section is radially compressed, sliding the suction catheter into the lumen of the guide sheath catheter. (5) The method according to embodiment 4, wherein the pushing step further includes automatically hydrating the hydrophilic coating of the suction catheter by the back pressure of blood passing proximally within a clearance space 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 section of the suction catheter while in the radially uncompressed state of the maximum outer diameter.

[0086] (6) The shaft of the introducer tool has a plurality of flushing ports defined therein, and during the step of pushing the suction catheter through the introducer tool while assembled within the hemostatic valve, generating a back pressure of blood in the proximal direction and entrained air exiting the introducer tool in the proximal direction through the plurality of flushing ports. The method according to embodiment 4. (7) The method according to embodiment 6, wherein the hemostatic valve has a side port, and the method further includes actively flushing the lumen of the shaft of the introducer tool with fluid injected through the side port of the hemostatic valve and passing through the plurality of flushing ports. (8) The method according to embodiment 4, further including removing the introducer tool from around the suction catheter through a longitudinal slit defined within the introducer tool extending from the proximal end to the distal end of the introducer tool, enabling further insertion of the assembly in the distal direction of the suction catheter. (9) The shaft of the introducer tool extends longitudinally from the proximal end of the lumen, terminates proximally of the distal end of the introducer tool, and includes a semi-divided section that defines an undivided distal section distally. When radially compressed while traversing the compression section of the lumen of the shaft, the introducer tool expands radially along the semi-divided section to accommodate the radially self-expanding distal section of the aspiration catheter. The method according to embodiment 4. (10) The introducing step includes preventing axial compression and constriction of the lumen at the distal end of the shaft of the introducer tool when the introducer tool is inserted into the tapered guide sheath luer of the assembly to a depth that limits engagement with the tapered inner contour of the tapered guide sheath luer. The method according to embodiment 4.

[0087] (11) The shaft of the introducer tool includes a distal section including the distal end of the shaft of the introducer tool, a proximal section including the proximal end of the shaft of the introducer tool, and a transition section disposed between the distal section and the proximal section of the shaft of the introducer tool. Each of the distal section, the proximal section, and the transition section of the shaft of the introducer tool is receivable within the passage of the hemostatic valve. The pushing step includes traversing the proximal section of the shaft of the introducer tool while maintaining the radially self-expanding distal section of the aspiration catheter in a radially uncompressed state of maximum outer diameter, and radially compressing the radially self-expanding distal section of the aspiration catheter while passing through the distal section of the shaft of the introducer tool. The method according to embodiment 4. (12) The shaft of the introducer tool from the proximal end to the distal end has a tapered inner diameter and a tapered outer diameter, and the pushing step includes inserting the radially self-expanding distal section of the aspiration catheter into the proximal end of the shaft of the introducer tool while maintaining the radially self-expanding distal section of the aspiration catheter in the non-compressed state, and radially compressing the radially self-expanding distal section of the aspiration catheter while it emerges from the distal end of the shaft of the introducer tool. The method according to embodiment 4. (13) The pushing step includes fixing a holder including a plurality of components connectable together, the holder defining a channel therein, the channel accommodating therein the proximal section of the introducer tool and the aspiration catheter pre-assembled inside the introducer tool, a step of fixing the holder. while pushing the aspiration catheter through the introducer tool into the assembly, a step of gripping the holder. The pushing step further includes removing the holder from the aspiration catheter to allow further insertion into the assembly. The method according to embodiment 4. (14) The introducing step further includes preventing compression and stenosis of the lumen at the distal end of the introducer tool when the introducer tool is over-inserted into the assembly by deploying a radially expandable compression force absorbing component associated with the shaft of the introducer tool, the radially expandable compression force absorbing component being (i) a plurality of radially expanding pleats, (ii) one or more radially expandable sections within the shaft of the introducer tool having a plurality of slits defined therein, or (iii) a section of material having a reduced rigidity compared to the rigidity of the remaining portion of the introducer tool. The method according to embodiment 4. (15) The shaft of the introducer tool includes an axially non - collapsible section disposed distally of an axially collapsible section, the axially collapsible section being capable of transitioning from a state of maximum axial length to a state of reduced axial length, and the step of radially compressing includes reducing the radially self - expanding distal section of the aspiration catheter so that it can be received within the lumen of the guide sheath catheter as the aspiration catheter passes through the axially collapsible section of the shaft of the introducer while the aspiration catheter is in the state of maximum axial length, the method according to embodiment 4.

[0088] (16) A vascular introducer tool, comprising a shaft having an outer wall extending from a proximal end to an opposite distal end, a longitudinally extending lumen being defined through the shaft, the shaft including an intermediate transition section disposed between the proximal end and the distal end and having a tapered inner diameter and a tapered outer diameter. (17) The outer wall of the shaft has a plurality of flushing ports defined therein that are in fluid communication with the lumen, the vascular introducer tool according to embodiment 16. (18) The outer wall of the shaft is longitudinally divisible along either (i) a slit defined by two longitudinal edges or (ii) a weakened section, from the proximal end to the opposite distal end, the vascular introducer tool according to embodiment 16. (19) The outer wall of the shaft includes a semi - divided section that extends longitudinally from the proximal end of the lumen, terminates proximally of the distal end of the introducer tool, and defines an undivided distal section distally, the vascular introducer tool according to embodiment 16. (20) The proximal section of the outer wall of the shaft is longitudinally divisible into a plurality of proximal divided sections separated from each other with respect to the longitudinal axis passing through the vascular introducer tool, forming respective tabs, the vascular introducer tool according to embodiment 16.

[0089] (21) The shaft has a lumen extending therethrough from the proximal end to the distal end, and the lumen of the shaft of the introducer tool has a non-circular radial cross-section, and the non-circular radial cross-section includes (i) a plurality of protrusions protruding radially inward from the inner wall of the lumen of the shaft of the introducer tool and extending longitudinally, or (ii) a plurality of recesses defined in the inner wall of the lumen of the shaft of the introducer tool and extending longitudinally, the vascular introducer tool according to embodiment 16.

Claims

1. A vascular access system, wherein the vascular access system comprises: An assembly, A guide sheath catheter having a proximal end and a lumen, A tapered guide sheath hub having a proximal end, an opposite distal end, and a tapered inner contour, wherein the proximal end of the guide sheath catheter is received within the distal end of the tapered guide sheath hub; a tapered guide sheath hub, A hemostatic valve having a proximal end and an opposite distal end, wherein the proximal end of the tapered guide sheath hub is connected to the distal end of the hemostatic valve; a hemostatic valve, and an assembly comprising the same, An introducer tool including a shaft, the shaft having a proximal end, a distal section including a distal end, and a lumen extending axially from the proximal end to the distal end of the shaft, wherein the distal end of the shaft of the introducer tool is inserted within the hemostatic valve and the tapered guide sheath hub of the assembly; an introducer tool, A suction catheter including a shaft having a radially self-expanding distal section capable of transitioning from a radially non-compressed state of a maximum outer diameter to a radially compressed state having a reduced outer diameter, the suction catheter being advanceable through the lumen of the introducer tool and into the lumen of the guide sheath catheter; a suction catheter, At least a portion of the lumen of the shaft of the introducer tool has an inner diameter greater than the inner diameter of the radially self-expanding distal section of the suction catheter while in the radially non-compressed state of the maximum outer diameter, The lumen of the shaft of the introducer tool and / or the tapered inner contour of the tapered guide sheath hub includes a compressed section having an inner diameter smaller than the inner diameter of the radially self-expanding distal section of the suction catheter while in the radially non-compressed state of the maximum outer diameter. A vascular access system.

2. The system according to claim 1, wherein the distal section of the shaft of the introducer tool has a tapered outer diameter that matches the tapered inner contour of the tapered guide sheath.

3. The suction catheter has a flared proximal section that matches the shape and size of the flared proximal section of the introducer tool, such that when fully inserted, it can be nested within the flared proximal section of the introducer tool. The system according to claim 1.

4. A vascular introducer tool, comprising a shaft having an outer wall extending from a proximal end to an opposite distal end, a longitudinally extending lumen defined through the shaft, and the shaft including an intermediate transition section disposed between the proximal end and the distal end and having a tapered inner diameter and a tapered outer diameter.

5. The vascular introducer tool according to claim 4, wherein the outer wall of the shaft has a plurality of flushing ports defined therein that are in fluid communication with the lumen.

6. The vascular introducer tool according to claim 4, wherein the outer wall of the shaft is longitudinally divisible along either (i) a slit defined by two longitudinal edges or (ii) a weakened section, from the proximal end to the opposite distal end.

7. The vascular introducer tool according to claim 4, wherein the outer wall of the shaft includes a semi-divided section that longitudinally extends from the proximal end of the lumen, terminates proximally of the distal end of the introducer tool, and defines an undivided distal section distally.

8. The vascular introducer tool according to claim 4, wherein the proximal section of the outer wall of the shaft is longitudinally divisible into a plurality of proximal divided sections separated from each other with respect to the longitudinal axis passing through the vascular introducer tool, forming respective tabs.

9. The shaft has a lumen extending therethrough from the proximal end to the distal end, and the lumen of the shaft of the introducer tool has a non-circular radial cross-section, and the non-circular radial cross-section includes (i) a plurality of protrusions protruding radially inward from the inner wall of the lumen of the shaft of the introducer tool and extending longitudinally, or (ii) a plurality of recesses defined in the inner wall of the lumen of the shaft of the introducer tool and extending longitudinally. The vascular introducer tool according to claim 4.

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