Neurovascular Insertion Device

Abstract

To provide an improved insertion apparatus.SOLUTION: An improved insertion apparatus simplifies loading of a neurovascular device into a microcatheter. In one example, the insertion apparatus can include a tapered distal tip, allowing the insertion apparatus to reach the microcatheter with no gap. In another example, the insertion apparatus includes an uneven outer surface along its longitudinal body through laser ablation of material to form protrusions, taper features, wave patterns or thread extrusions.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 62 / 951,742, filed December 20, 2019, the entire contents of which are incorporated herein by reference.

[0002] FIELD OF THEINVENTION The present invention relates generally to intravascular medical procedures, and more specifically to an insertion apparatus for introducing a neurovascular device into a microcatheter through a hemostatic valve. [Background technology]

[0003] Typically, during a thrombectomy procedure, an inserter is used to introduce a neurovascular device into the microcatheter through a hemostatic valve, such as a rotating hemostatic valve (RHV). Examples of neurovascular devices include, but are not limited to, mechanical thrombectomy devices, neurovascular access devices, neurovascular balloon devices, neurovascular assist devices, and neurovascular thrombectomy / flow devices.

[0004] The hemostatic valve is attached to the proximal end of the microcatheter. The proximal end of the microcatheter includes a microcatheter hub that allows for the attachment of the hemostatic valve. The geometry of these microcatheter hubs varies in design and size across commercially available microcatheter designs. The neurovascular device is loaded into the microcatheter through the hemostatic valve by using an inserter. The inserter is advanced through the microcatheter hub through the hemostatic valve until it cannot be advanced any further. The neurovascular device is then moved through the microcatheter to the treatment location. When loading the neurovascular device, the neurovascular device should not be expanded. In other words, the neurovascular device should remain covered during the transition from the inserter to the microcatheter.

[0005] However, it has been observed that if the inserter is not positioned correctly during introduction of the neurovascular device, the neurovascular device will not be loaded correctly into the microcatheter. For example, when the hemostatic valve is not tight enough, the inserter is prone to movement during introduction of the neurovascular device into the microcatheter.

[0006] Additionally, different microcatheter hub geometries can result in significant variability in the distance the inserter can be advanced into the microcatheter hub. If the inserter is too distal in the microcatheter, delivery of the neurovascular device can fail, potentially damaging the neurovascular device. Also, different proximal hub geometries and hemostatic valve seals can cause the inserter to be pushed distally back out of the microcatheter hub. This can result in premature deployment of the neurovascular device within the hemostatic valve, potentially resulting in misdirection and potentially damaging the device.

[0007] If the insert is incorrectly placed, causing the neurovascular device to be deployed within the hub of the microcatheter instead of directly into the shaft of the microcatheter, the neurovascular device will be damaged and either thrown in the trash or returned to the manufacturer as a complaint. Summary of the Invention [Problem to be solved by the invention]

[0008] There is a need for an improved inserter design with geometric features that increase the versatility of the inserter and its compatibility with the various microcatheter hub shapes available on the market. There is a need for an improved inserter design that reduces the gap between the distal end of the inserter and the microcatheter to prevent possible snagging of the neurovascular device within the microcatheter hub. There is a need for an improved inserter design that reduces the likelihood of the inserter backing out and dislodging from the hemostatic valve during introduction of the neurovascular device into the microcatheter. For example, there is a need for an improved surface finish of the inserter to improve grip on the hemostatic valve. [Means for solving the problem]

[0009] It is an object of the present invention to provide a system, device, and method that meets the above-mentioned needs. In general, it is an object of the present invention to provide an improved insertion device that simplifies the loading of a neurovascular device into a microcatheter. In one embodiment, the insertion device can include a tapered distal end that allows the insertion device to reach the microcatheter without a gap. In another embodiment, the insertion device can include a non-uniform outer surface along the elongate body that forms protrusions, tapered features, wave patterns, or threaded extrusions by laser ablation of material.

[0010] An exemplary insertion device can introduce a neurovascular device into a microcatheter through the RHV. An exemplary insertion device can include an elongate body. The elongate body can define a lumen through which the neurovascular device passes. The elongate body can include a proximal portion. The proximal portion can include a first color. The elongate body can include a distal portion. The distal portion can include a second color different from the first color. The elongate body can include a boundary between the proximal portion and the distal portion. The microcatheter can initially be coupled to the RHV prior to introducing the insertion device into the microcatheter. Once the insertion device is correctly positioned relative to the microcatheter and the RHV, the boundary can be aligned with the proximal end of the RHV.

[0011] Another exemplary insertion device for introducing a neurovascular device into a microcatheter via the RHV can include an elongate body. The elongate body can define a lumen through which the neurovascular device passes. The insertion device can include a ledge disposed on an outer surface of the elongate body that prevents the insertion device from fully entering the proximal end of the RHV. The microcatheter can initially be coupled to the RHV prior to introducing the insertion device into the microcatheter. When the insertion device is correctly positioned relative to the microcatheter and the RHV to introduce the neurovascular device into the microcatheter, the ledge can be aligned with the proximal end of the RHV.

[0012] The ledge can include a width that is greater than a diameter of the opening in the proximal end of the RHV. The diameter of the opening can allow partial entry of the insertion device into the proximal end of the RHV.

[0013] The ledge can be disposed toward a distal end of the elongate body. The insertion device can include a second ledge disposed toward a proximal end of the elongate body.

[0014] Yet another exemplary insertion device for introducing a neurovascular device into a microcatheter via the RHV can include an elongate body. The elongate body can include a lumen through which the neurovascular device passes. The elongate body can include a tapered distal section dimensioned to allow partial entry into the proximal end of the microcatheter shaft. The tapered distal section can have an outer diameter dimensioned to prevent full deployment into the microcatheter. The outer diameter can be less than about 0.021 inches. The elongate body can include a tapered proximal section. The tapered distal section can have a length of about 10 mm.

[0015] A further exemplary insertion device for introducing a neurovascular device into a microcatheter via the RHV can include an elongate body. The elongate body can define a lumen through which the neurovascular device passes. The insertion device can include a non-uniform outer surface. When introducing the neurovascular device into the microcatheter, the non-uniform outer surface can prevent the insertion device from moving backwards out of the microcatheter. The distal portion of the elongate body can include a distal-most taper that partially advances the distal portion into the microcatheter. The non-uniform outer surface can have a sealing relationship with a sealing portion of the RHV. The non-uniform outer surface can define a plurality of tapers along a length of the elongate body to reduce movement of the insertion device during introduction of the neurovascular device into the microcatheter. The plurality of tapers can include a first plurality of tapers that are angled in a first direction on a first side of the insertion device. The plurality of tapers can include a second plurality of tapers that are angled in a second direction on a second side of the insertion device. The second direction can be opposite to the first direction. The longitudinal body may define a length ranging from about 410 mm to about 600 mm. The RHV may further include a seal. The seal may include a recess formed in the seal. The uneven outer surface may include at least one threaded extrusion that engages with a recess formed in the seal of the RHV. The threaded extrusion may have a thickness that is less than a width of the recess formed in the seal of the RHV. The uneven outer surface may include a plurality of protrusions. The at least one protrusion may have a length of about 2 mm to about 3 mm. The uneven outer surface may include a knurled surface. The uneven outer surface may include a corrugated pattern along the length of the longitudinal body. The RHV may further include a recess in the seal. The recess in the seal may include a complementary contour that engages with the uneven outer surface.

[0016] An exemplary method for introducing a neurovascular device into a microcatheter via an RHV can include one or more of the following steps, presented in no particular order: The method can include applying an RHV to the microcatheter. The method can include inserting an insertion device into the microcatheter through the RHV. The method can include aligning a boundary between a proximal portion and a distal portion of the insertion device with a proximal end of the RHV. The proximal portion can include a first color. The distal portion can include a second color different from the first color. The method can include inserting the neurovascular device into the microcatheter through a lumen defined in the insertion device.

[0017] Another exemplary method for introducing a neurovascular device into a microcatheter via an RHV can include one or more of the following steps, presented in a particular order: The method can include applying an RHV to the microcatheter. The method can include inserting an insertion device into the microcatheter through the RHV. The method can include contacting a ledge disposed on an outer surface of an elongate body of the insertion device with a proximal end of the RHV. The method can include inserting the neurovascular device into the microcatheter through a lumen defined in the insertion device. The method can include defining a width of the ledge that is greater than a diameter of an opening in the proximal end of the RHV. The method can include allowing partial entry of the insertion device into the proximal end of the RHV based on the diameter of the opening.

[0018] Yet another exemplary method for introducing a neurovascular device into a microcatheter via an RHV can include one or more of the following steps, presented in a particular order: The method can include applying an RHV to the microcatheter. The method can include inserting a tapered distal section of an insertion device through the RHV and into a proximal end of the microcatheter shaft. The method can include configuring the tapered distal section to limit full insertion of the tapered distal section into the microcatheter. The method can include inserting the neurovascular device into the microcatheter through a lumen defined in the insertion device.

[0019] A further exemplary method for introducing a neurovascular device into a microcatheter via an RHV can include one or more of the following steps, presented in a particular order: The method can include applying an RHV to the microcatheter. The method can include inserting an elongate body of an insertion device into the microcatheter through the RHV. The method can include using a non-uniform outer surface of the elongate body to prevent the insertion device from moving backwards out of the microcatheter when introducing the neurovascular device into the microcatheter. The method can include inserting the neurovascular device into the microcatheter through a lumen defined in the insertion device.

[0020] The method may further include additional steps that will be recognized and understood by those of skill in the art. [Brief description of the drawings]

[0021] The above and further aspects of the present invention comprise: Consider further with reference to the following description in conjunction with the accompanying drawings, in which like numerals indicate like structural elements and features in the various drawings. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. The figures depict one or more implementations of an apparatus of the present invention, by way of example only and not by way of limitation. [Figure 1]FIG. 1 is a diagram of an exemplary insertion apparatus for introducing a neurovascular device into a microcatheter via an RHV, in accordance with an embodiment of the present invention. [Diagram 2] FIG. 13 is a diagram of another exemplary insertion apparatus for introducing a neurovascular device into a microcatheter via an RHV, in accordance with an embodiment of the present invention. [Diagram 3] FIG. 3 is another view of the example insertion device of FIG. 2 in accordance with an embodiment of the present invention. [Figure 4] FIG. 13 is a diagram of yet another exemplary insertion apparatus for introducing a neurovascular device into a microcatheter via an RHV, in accordance with an embodiment of the present invention. [Diagram 5] FIG. 5 is another view of the exemplary insertion device of FIG. 4 in accordance with an embodiment of the present invention. [Figure 6A] FIG. 13 is a diagram of yet another exemplary insertion apparatus for introducing a neurovascular device into a microcatheter via an RHV, in accordance with an embodiment of the present invention. [Figure 6B] FIG. 6B is another view of the exemplary insertion device of FIG. 6A, in accordance with an embodiment of the present invention. [Figure 6C] FIG. 6B is yet another view of the exemplary insertion device of FIG. 6A, in accordance with an embodiment of the present invention. [Figure 6D] FIG. 6B is yet another view of the exemplary insertion device of FIG. 6A, in accordance with an embodiment of the present invention. [Figure 7] 6B is an additional view of the exemplary insertion device of FIG. 6A in accordance with an embodiment of the present invention. [Figure 8] FIG. 13 is a diagram of another exemplary insertion apparatus for introducing a neurovascular device into a microcatheter via an RHV, in accordance with an embodiment of the present invention. [Figure 9] FIG. 1 is a diagram of a particular exemplary insertion apparatus for introducing a neurovascular device into a microcatheter via an RHV, in accordance with an embodiment of the present invention. [Figure 10] FIG. 13 is a diagram of an additional exemplary insertion device for introducing a neurovascular device into a microcatheter via an RHV, in accordance with an embodiment of the present invention. [Figure 11]FIG. 13 is a diagram of yet another exemplary insertion apparatus for introducing a neurovascular device into a microcatheter via an RHV, in accordance with an embodiment of the present invention. [Figure 12] 1 is a flow chart illustrating steps for introducing a neurovascular device into a microcatheter via an insertion device, in accordance with an aspect of the present invention. [Figure 13] 13 is another flowchart showing steps for introducing a neurovascular device into a microcatheter via an RHV, according to an embodiment of the invention. [Figure 14] 13 is yet another flowchart showing steps for introducing a neurovascular device into a microcatheter via an RHV, according to an embodiment of the invention. [Figure 15] 13 is yet another flowchart showing steps for introducing a neurovascular device into a microcatheter via an RHV, according to an embodiment of the invention. [Figure 16] 13 is an additional flow chart showing steps for introducing a neurovascular device into a microcatheter via an RHV, according to an embodiment of the invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] The term "about" or "approximately" as used herein with respect to any numerical value or range of numerical values ​​indicates a suitable dimensional tolerance that allows a portion of a component or a collection of components to function according to its intended purpose as described herein. More specifically, "about" or "approximately" may refer to a range of values ​​of ±20% of the recited value, for example, "about 90%" may refer to a range of values ​​of 71% to 99%.

[0023] An example of an insertion apparatus 110 for introducing a neurovascular device 170 into a microcatheter 130 via the RHV 140 is shown in Figure 1. The microcatheter 130 can include a microcatheter shaft 131 and a microcatheter hub 132, which are parts of the same microcatheter assembly. Examples of neurovascular devices 170 include, but are not limited to, mechanical thrombectomy devices, neurovascular access devices, neurovascular balloon devices, neurovascular assist devices, and neurovascular thrombectomy / flow devices.

[0024] The insertion device 110 can include an elongate body 150. The elongate body 150 can define a lumen 152 through which a neurovascular device 170 can pass. The elongate body 150 can include a proximal portion 154 having a first color and a distal portion 156 having a second color different from the first color. The elongate body 150 can include a boundary 158 between the proximal portion 154 and the distal portion 156. When the microcatheter 130 is coupled to the RHV 140, the boundary 158 can be aligned with a proximal end 160 of the RHV 140 when the insertion device 110 is correctly positioned relative to the microcatheter 130 and the RHV 140.

[0025] Each end of the insertion device 110 can be dyed a different color. This color change allows the physician to know when the insertion device 110 is correctly positioned within the microcatheter hub 132. During loading, the physician can see if the insertion device 110 is starting to slip through based on the color change. The color change can indicate correct seating.

[0026] Another example of an insertion device 210 for introducing a neurovascular device 270 into a microcatheter 230 via an RHV 240 is shown in FIG. 2. The insertion device 210 can include an elongate body 250 defining a lumen 252 through which the neurovascular device 270 passes. The insertion device 210 can include a ledge 254 disposed on an outer surface 256 of the elongate body 250. Prior to introducing the neurovascular device 250 into the microcatheter 230, the microcatheter 230 can first be coupled to the RHV 240. When the insertion device 210 is correctly positioned relative to the microcatheter 230 and the RHV 240 to introduce the neurovascular device 270 into the microcatheter 230, the ledge 254 can prevent the insertion device 210 from fully entering the proximal end 260 of the RHV 240 when the ledge 254 is aligned with the proximal end 260 of the RHV 240.

[0027] 2, the ledge 254 can include a width "W" that is greater than a diameter "d" of the opening 262 in the proximal end 260 of the RHV 240. The diameter "d" of the opening 262 can allow partial entry of the insertion device 210 into the proximal end 260 of the RHV 240.

[0028] 3, the ledge 254 can be located toward the distal end 272 of the elongate body 250. The second ledge 258 can be located toward the proximal end 274 of the elongate body 250. Thus, a ledge is positioned at each end of the insertion device 210 so the physician can know when the insertion device 210 is seated correctly within the microcatheter hub 232. During loading, the physician can see if the insertion device 210 is beginning to slip through when the ledge 254 or 258 is not seated squarely in the correct position. In one embodiment, at least one of the ledges 254, 258 can be located on the RHV 240.

[0029] Yet another example of an insertion device 410 for introducing a neurovascular device 470 into a microcatheter 430 via the RHV 440 is shown in FIG. The insertion device 410 can include an elongate body 450. The elongate body 450 can define a lumen 452 through which the neurovascular device 470 passes. The elongate body 450 can include a tapered distal portion 456 dimensioned to allow partial entry into the proximal end 432 of the microcatheter shaft 431.

[0030] In one embodiment, as shown in FIG. 5, the tapered distal section 456 can include an outer diameter “d1” that is sized to prevent full deployment within the microcatheter 430.

[0031] In one embodiment, the outer diameter "d1" can be less than about 0.021 inches, and the inner diameter of the microcatheter 430 can be greater than or equal to about 0.021 inches, so that the insertion device 410 can be inserted into the microcatheter 430.

[0032] In one embodiment, the tapered distal portion 456 can have a length "TL" of about 10 mm.

[0033] In one embodiment, as seen in FIG. 5, the elongate body 450 can include a tapered proximal portion 458 .

[0034] The insertion device 450 is tapered at each end so that each end has an outer diameter "d1" of less than 0.021 inches and can be placed within the lumen of the microcatheter 430. This prevents the insertion device 410 from being inadvertently deployed within the microcatheter hub.

[0035] With reference to FIG. 5, the insertion device 410 can have a length "L" ranging from about 410 mm to about 600 mm. The longitudinal bodies 650, 1150 can define the same length "L" ranging from about 410 mm to about 600 mm. In one embodiment, this length (L) can be about 600 mm. The physician can choose to wrap the insertion device around the hand while grasping the RHV. A length "L" such as 600 mm can allow for a more secure grip while introducing the neurovascular device into the microcatheter.

[0036] Yet another example of an insertion device 610, 810, 910, 1010, 1110 for introducing a neurovascular device 670 into a microcatheter 630 via an RHV 640 is shown in FIGS. 6A-11. The insertion device 610 can include an elongate body 650, 1150. The elongate body 650, 1150 can define a lumen 652, 852, 1152 through which the neurovascular device 670 passes. The elongate body can include an uneven outer surface 654, 854, 954, 1154 that prevents the insertion device 610 from migrating backward out of the microcatheter 630 when introducing the neurovascular device 670 into the microcatheter 630.

[0037] 6B may show a longitudinal cross-section of the entire assembly of the insertion apparatus 610, microcatheter 630, and neurovascular device 670. As shown in FIG. 6B, the neurovascular device 670 may be moved forward within the microcatheter shaft 631 in the direction represented by the arrow "F." In FIG. 6B, the cross-hatched or hatched area surrounding the microcatheter shaft 631 and microcatheter hub 632 may represent the microcatheter hub wall 633. As shown in FIG. 6B, the microcatheter shaft 631 may define a microcatheter shaft lumen 634 for receiving the neurovascular device 670.

[0038] 6D, the insertion apparatus 610 can define a lumen 652 therein for receiving a neurovascular device 670. The lumen 652 can have an inner diameter of approximately 0.024 inches.

[0039] The insertion device 610, 810, 910, 1010, 1110 can have one or more geometric features along the outer surface 654, 854, 954, 1154 to improve contact between the RHV seal 642, 842, 1142 and the insertion device. These geometric features can be a rough outer surface of the insertion device. The rough outer surface can prevent the insertion device 610, 810, 910, 1010, 1110 from being pushed distally back out of the microcatheter hub 632, significantly reducing the likelihood of mis-introduction or premature deployment of the neurovascular device 670.

[0040] In one embodiment, the distal portion 656 of the elongate body 650 can include a distal-most tapered section 671 that allows the distal portion 656 to be partially advanced within the microcatheter 630. As shown in FIG. 6D, the distal-most tapered section 671 can form an angle θ with respect to the longitudinal axis “A” of the insertion device 610 in a range of about 10 degrees to 20 degrees. The distal-most tapered section 671 allows the distal end of the insertion device 610 to be advanced further within the microcatheter hub 632. The distal-most tapered section 671 allows the insertion device 610 to be advanced to the distal-most end of the microcatheter hub 632, greatly reducing the likelihood of the neurovascular device 670 being misdelivered into the microcatheter 630 due to the geometry of the microcatheter hub 632 or partial placement of the neurovascular device 670 within the microcatheter hub 632.

[0041] 7, the elongate body 650 can have a proximal-most tapered section 673. The distal-most tapered section 671 and the proximal-most tapered section 673 can each have a length "TL" that is greater than 8.5 mm. In one embodiment, the length (TL) can be about 10 mm. The distal-most tapered section 671 and the proximal-most tapered section 673 can each taper from a maximum outer diameter of about 0.045 inches to a minimum outer diameter of about 0.035 inches, as shown in FIGS. 6D, 8, and 11.

[0042] In one embodiment, the uneven outer surface 654 , 854 can form a sealing relationship with the seal portion 642 , 842 , 1142 of the RHV 640 .

[0043] In one embodiment, the non-uniform outer surface 654 can include multiple tapers 672, 674 along the length of the insertion device outer surface 654 to reduce movement of the insertion device 610 during introduction of the neurovascular device 670 into the microcatheter 630. The multiple tapers 672, 674 can be applied to both sides of the insertion device to allow use from both sides of the insertion device. In one embodiment, the multiple tapers can include a first multiple tapers 672 that are angled in a first direction on a first side of the insertion device 610 and a second multiple tapers 674 that are angled in a second direction on a second side of the insertion device. The second direction can be opposite to the first direction. The tapers 672, 674 can function to reduce movement of the insertion device during introduction of the neurovascular device into the microcatheter.

[0044] In one embodiment, tapered section 672 can be positioned at the distal end of the insertion device 610, while tapered section 674 can be positioned at the proximal end of the insertion device 610. As shown in FIG 7, the taper direction of tapered sections 672, 674 can be symmetrical at the midpoint of the insertion device so that the insertion device 610 can be used from either orientation.

[0045] To improve gripping of the closed RHV seal 642 on the insertion device 610, the tapered portions 672, 674 along the length of the insertion device can each have a length less than the length "TL" of the distal-most tapered portion 671 or the proximal-most tapered portion 673.

[0046] In one embodiment as shown in FIG. 6C, once the RHV seal 642 is sealed onto the insertion device 610, the taper 672 or taper 674 can be locked or gripped by or recessed into the RHV seal 642 to provide additional grip and prevent the insertion device 610 from backing out of the RHV 640 during device delivery. The RHV seal 642 can tightly seal against the outer diameter of the insertion device. The RHV seal 642 can deform to form a tight grip on the outer surface of the insertion device 610. The RHV seal 642 can be deflected to match the outer surface of the insertion device 610. At this point, the RHV seal 642 can be tightened onto the insertion device 610 to help hold the insertion device in place within the microcatheter hub. As a result, when the neurovascular device 670 is introduced into the microcatheter 630, the insertion apparatus 610 can be prevented from retracting and becoming dislodged from the RHV 640.

[0047] Referring to FIG. 6C, when introducing the neurovascular device 670 into the microcatheter shaft 631, the tapered portion 672 or 674 can prevent the insertion apparatus 610 from moving backward in the direction represented by arrow "B."

[0048] 6D, 8, and 11, when the RHV seal 642 seals on the insertion device 610, the RHV seal 642 can deform around the insertion device 610 to form a tight grip on the insertion device 610. As a result, when the neurovascular device 670 is introduced into the microcatheter shaft 631, the RHV seal 642 can prevent the insertion device 610 from backing out and dislodging from the RHV 640.

[0049] 8, the RHV 640 can include a seal 842. The seal 842 can include a recess 844 formed therein. The uneven outer surface 854 can include at least one threaded extrusion 856 that engages with the recess 844 formed in the seal 842 of the RHV 640.

[0050] In one example, the threaded extrusion 856 can have a thickness “T 1 ” that is less than a width “W 1 ” of the recess 844 formed in the sealing portion 842 of the RHV 640 .

[0051] In one embodiment, as shown in FIG. 9, a laser engraved pattern on the outer surface of the insertion device 910 can improve grip on the RHV and prevent migration. The uneven outer surface 954 can include a plurality of protrusions 980. At least one protrusion 980 can include a length "PL" of about 2 mm to about 3 mm. The length "PL" can be slightly less than the approximate dimension of the RHV seal.

[0052] Referring to FIG. 8, a threaded extrusion 856 can be formed along the outer surface of the insertion device to improve the clamping between the RHV seal and the insertion device when the RHV seal grips the insertion device.

[0053] In one example, as shown in FIG. 10, the uneven outer surface 1054 can include a knurled surface to improve grip of the RHV.

[0054] 11, the uneven outer surface 1154 can include a corrugated pattern 1160 along the length of the elongated body 1150 to improve grip of the RHV on the insertion device. The RHV seal 1142 can include a recess 1144. The recess 1144 can include a complementary contour 1170 that engages with the uneven outer surface 1154. The RHV seal 1142 can seal tightly against the insertion device 1110. The RHV seal 1142 can be deformed to conform to the corrugated pattern 1160.

[0055] 12 is a flow chart illustrating an example method 1200 for inserting a neurovascular device 670 into a microcatheter 630. The method 1200 may include one or more of the following steps, which are not presented in any particular order.

[0056] In step 1202 , the neurovascular device 670 can be loaded into the insertion apparatus 610 .

[0057] In step 1204, the RHV 640 can be attached to the microcatheter hub 632. The physician can apply the RHV 640 to the microcatheter hub 632 before inserting the insertion device 610 into the microcatheter 630. In one embodiment, a specific length of the RHV 640 must be provided to ensure the following design functions correctly.

[0058] In step 1206 , the insertion apparatus 610 preloaded with the neurovascular device 670 can be introduced into the RHV 640 .

[0059] In step 1208, the insertion device 610 can be positioned snugly against the proximal end 635 of the microcatheter shaft 631, as shown in FIG. 6B.

[0060] At step 1210, the RHV seal 642 can seal over the insertion device 610 to hold the insertion device 610 in place.

[0061] In step 1212, the neurovascular device 670 can be advanced from the insertion apparatus 610 into the microcatheter 630 until the neurovascular device 670 is fully introduced into the microcatheter 630.

[0062] In step 1214 , once the neurovascular device 670 is fully introduced into the microcatheter 630 , the RHV seal 642 can be loosened to remove the insertion apparatus 670 .

[0063] At step 1216 , the insertion apparatus 670 can be pulled proximally from the shaft 675 of the neurovascular device 670 .

[0064] 13 is another flow chart illustrating an exemplary method 1300 for inserting a neurovascular device 170 into a microcatheter 130 via the RHV 140. The method 1300 may include one or more of the following steps, which are not presented in any particular order:

[0065] In step 1302, the RHV 140 can be applied to the microcatheter 130.

[0066] In step 1304, the insertion device 110 can be inserted through the RHV 140 and into the microcatheter 130.

[0067] At step 1306, the boundary 158 between the proximal portion 154 and the distal portion 156 of the insertion device 110 can be aligned with the proximal end 160 of the RHV 140. The proximal portion 154 can include a first color. The distal portion 156 can include a second color that is different from the first color.

[0068] In step 1308 , the neurovascular device 170 can be inserted into the microcatheter 130 through the lumen 152 defined in the insertion apparatus 110 .

[0069] 14 is yet another flow chart illustrating an exemplary method 1400 for inserting a neurovascular device 270 into a microcatheter 230 via the RHV 240. The method 1400 may include one or more of the following steps, which are not presented in any particular order:

[0070] In step 1402, the RHV 240 can be applied to the microcatheter 230.

[0071] In step 1404, the insertion device 210 can be inserted through the RHV 240 and into the microcatheter 230.

[0072] In step 1406 , the ledge 254 disposed on the outer surface 256 of the elongate body 250 of the insertion device 210 can be brought into contact with the proximal end 260 of the RHV 240 .

[0073] In step 1408 , the neurovascular device 270 can be inserted into the microcatheter 230 through the lumen 252 defined in the insertion apparatus 210 .

[0074] In one embodiment, the ledge 254 can have a width "W" that is greater than a diameter "d" of the opening 262 in the proximal end 260 of the RHV 240, allowing the insertion device 210 to partially enter the proximal end 260 of the RHV 240 based on the diameter "d" of the opening 262.

[0075] 15 is a flow chart illustrating an exemplary method 1500 for introducing a neurovascular device 470 into a microcatheter 430 via an RHV 440. The method 1500 may include one or more of the following steps, which are not presented in any particular order:

[0076] In step 1502, the RHV 440 can be applied to the microcatheter 430.

[0077] In step 1504, the tapered distal section 456 of the insertion device 410 can be inserted through the RHV 440 and into the proximal end 432 of the microcatheter shaft 431.

[0078] In step 1506 , the tapered distal portion 456 can be configured to limit full insertion of the tapered distal portion 456 into the microcatheter 430 .

[0079] In step 1508 , the neurovascular device 470 can be inserted into the microcatheter 430 through the lumen 452 defined in the insertion apparatus 410 .

[0080] 16 is a flow chart illustrating an exemplary method 1600 for introducing a neurovascular device 670 into a microcatheter 630 via an RHV 640. The method 1600 may include one or more of the following steps, which are not presented in any particular order:

[0081] In step 1602, the RHV 640 can be applied to the microcatheter 630.

[0082] In step 1604, the elongate body 650, 1150 of the insertion device 610, 810, 910, 1010, 1110 can be inserted into the microcatheter 630 through the RHV 640.

[0083] In step 1606, when the neurovascular device 670 is introduced into the microcatheter 630, the uneven outer surface 654, 854, 954, 1154 of the elongate body 650, 1150 can be used to prevent rearward migration of the insertion apparatus 610, 810, 910, 1010, 1110 from the microcatheter 630.

[0084] In step 1608, the neurovascular device 670 can be inserted into the microcatheter 630 through the lumen 652, 852, 1152 defined in the insertion apparatus 610, 810, 910, 1010, 1110.

[0085] Any of the exemplary methods 1200, 1300, 1400, 1500, and 1600 may include additional steps that will be recognized and understood by one of ordinary skill in the art. The exemplary methods may be performed by an exemplary system or practitioner as disclosed herein, or variations or alternatives that will be recognized and understood by one of ordinary skill in the art.

[0086] In one embodiment, the insertion device may have a helical profile, and both ends of the insertion device may have a tapered profile to improve ease of use and performance of the microcatheter.

[0087] The descriptions contained herein are examples of embodiments of the present invention and are not intended to limit the scope of the present invention in any way. As described herein, the present invention contemplates numerous variations and modifications of the insertion device that will be apparent to those skilled in the art to which the present invention pertains and are intended to be included within the scope of the following claims.

[0088] [Embodiment] (1) An insertion device for introducing a neurovascular device into a microcatheter via an RHV, comprising: an elongate body defining a lumen through which the neurovascular device is passed; a ledge disposed on an exterior surface of the elongate body that prevents the insertion device from fully entering the proximal end of the RHV; Equipped with When the ledge is aligned with the proximal end of the RHV, the insertion device is precisely positioned relative to the microcatheter and the RHV to introduce the neurovascular device into the microcatheter, and the microcatheter is coupled to the RHV. (2) The insertion device of embodiment 1, wherein the ledge has a width greater than a diameter of an opening in the proximal end of the RHV, the diameter of the opening allowing partial entry of the insertion device into the proximal end of the RHV. (3) the ledge is disposed toward a distal end of the elongate body; An insertion device as described in embodiment 2, wherein the insertion device comprises a second ledge disposed toward a proximal end of the elongate body. (4) An insertion device for introducing a neurovascular device into a microcatheter via an RHV, comprising: A longitudinal body, a lumen through which the neurovascular device passes; a tapered distal section dimensioned to allow partial entry into the proximal end of the microcatheter shaft; An insertion device comprising an elongate body. (5) The insertion device of embodiment 4, wherein the tapered distal portion has an outer diameter dimensioned to prevent full deployment within the microcatheter.

[0089] (6) The insertion device of claim 4, wherein the outer diameter is less than about 0.021 inches. (7) The insertion device of embodiment 4, wherein the elongate body includes a tapered proximal portion. (8) The insertion device of embodiment 4, wherein the tapered distal portion has a length of about 10 mm. (9) An insertion device for introducing a neurovascular device into a microcatheter via an RHV, comprising: an elongate body defining a lumen through which the neurovascular device is passed; a non-uniform outer surface that prevents the insertion tool from moving backwards out of the microcatheter when the neurovascular device is introduced into the microcatheter; An insertion device comprising: (10) The insertion device of embodiment 9, wherein the distal portion of the elongate body comprises a distal-most tapered portion that enables partial advancement of the distal portion into the microcatheter.

[0090] (11) The insertion device of embodiment 9, wherein the uneven outer surface has a sealing relationship with a sealing portion of the RHV. (12) The insertion device of embodiment 9, wherein the non-uniform outer surface defines a plurality of tapered portions along the length of the elongate body to reduce migration of the insertion device during introduction of the neurovascular device into the microcatheter. (13) The plurality of tapered portions are a first plurality of tapered sections on a first side of the insertion device that are inclined in a first direction; a second plurality of tapered sections on a second side of the insertion device that are angled in a second direction opposite the first direction; 10. The insertion device of embodiment 9, comprising: (14) The insertion device of claim 9, wherein the elongate body defines a length in the range of about 410 mm to about 600 mm. (15) The RHV is: Further comprising a sealing portion having a recess formed therein; An insertion device as described in embodiment 9, wherein the uneven outer surface comprises at least one threaded extrusion that engages with the recess formed in the sealing portion of the RHV.

[0091] (16) The insertion device of claim 15, wherein the threaded extrusion has a thickness that is less than a width of the recess formed in the sealing portion of the RHV. (17) The insertion device of embodiment 16, wherein the uneven outer surface comprises a plurality of protrusions, and at least one protrusion has a length of about 2 mm to about 3 mm. (18) The insertion device of claim 9, wherein the uneven outer surface has a knurled surface. (19) The non-uniform outer surface has a wave pattern along a length of the elongate body; 10. The insertion device of embodiment 9, wherein the RHV further comprises a sealing recess having a complementary contour that engages with the uneven outer surface.

Claims

1. A device insertion assembly, comprising: The present invention includes a microcatheter, a RHV, and an insertion device, The microcatheter comprises a microcatheter shaft and a microcatheter hub coupled to a proximal end of the microcatheter shaft, and a neurovascular device can be introduced into a first lumen of the microcatheter shaft and a second lumen of the microcatheter hub; the RHV has a distal end coupled to a proximal portion of the microcatheter hub and a proximal end, and a third lumen of the RHV through which the neurovascular device can be introduced; the insertion device introduces the neurovascular device into the microcatheter via the RHV; The insertion device comprises: an elongate body defining a fourth lumen through which the neurovascular device is passed; a ledge disposed on an exterior surface of the elongate body that prevents the insertion device from fully entering the proximal end of the RHV; Equipped with A device insertion assembly, wherein when the insertion device is moved distally and the ledge abuts the proximal end of the RHV, the insertion device is precisely positioned relative to the microcatheter and the RHV to introduce the neurovascular device into the microcatheter.

2. 2. The device insertion assembly of claim 1, wherein the ledge has a width greater than a diameter of an opening at the proximal end of the RHV, the diameter of the opening allowing partial entry of the insertion apparatus into the proximal end of the RHV.

3. the ledge is disposed near a distal end of the elongate body; The device insertion assembly of claim 2 , wherein the insertion apparatus comprises a second ledge disposed near a proximal end of the elongate body.

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