Neurovascular access tool
By designing an insertion device with a tapered distal end, an uneven outer surface, and a lug, the problem of mismatch between existing tools and the hub of microcatheters was solved, improving the delivery success rate and safety of neurovascular devices.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- NEURAVI
- Filing Date
- 2020-12-18
- Publication Date
- 2026-07-21
AI Technical Summary
Existing insertion tools are prone to damage or delivery failure when introducing neurovascular devices into microcatheters due to inaccurate positioning or mismatch with the geometry of different microcatheter hubs. Furthermore, the insertion tool may retract from the hemostatic valve, affecting the success rate of the procedure.
An improved insertion device was designed, including features such as a tapered distal end, an uneven outer surface, and lugs, to ensure a tight fit between the insertion tool and the microcatheter and hemostatic valve, preventing the device from moving or being damaged within the microcatheter.
This improves the versatility and safety of the insertion tool, reduces the risk of neurovascular devices moving and being damaged in the microcatheter, and ensures the success of the surgery.
Smart Images

Figure CN113143400B_ABST
Abstract
Description
[0001] Cross-referencing
[0002] This application claims priority to U.S. Provisional Application No. 62 / 951742, filed December 20, 2019. The entire contents of that patent application are incorporated herein by reference. Technical Field
[0003] The present invention relates generally to endovascular medical treatment, and more specifically to an insertion device for introducing a neurovascular device into a microcatheter via a hemostatic valve. Background Technology
[0004] Typically, during thrombectomy, neurovascular devices are introduced into the microcatheter using an insertion tool via a hemostatic valve such as a rotary 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 clot removal / flow devices.
[0005] A hemostatic valve is attached to the proximal end of the microcatheter. The proximal end of the microcatheter includes a hub that allows attachment of the hemostatic valve. The geometry of these hubs varies in design and size throughout commercial microcatheter designs. The neurovascular device is loaded into the microcatheter via the hemostatic valve using an insertion tool. The insertion tool is advanced into the hub of the microcatheter via the hemostatic valve until it cannot be advanced further. The neurovascular device is then traced to the treatment site through the microcatheter. The neurovascular device should not expand during loading. In other words, the neurovascular device should remain encapsulated during its transition from the insertion tool to the microcatheter.
[0006] However, it has been observed that during the introduction of neurovascular devices, if the insertion tool is not properly positioned, the neurovascular device may be improperly loaded into the microcatheter. For example, when the hemostatic valve is not tight enough, the insertion tool is prone to movement during the introduction of the neurovascular device into the microcatheter.
[0007] Furthermore, different microcatheter hub geometries result in significant variations in the distance the insertion tool can be advanced into the microcatheter hub. If the insertion tool is advanced too far into the microcatheter, it can lead to delivery failure of the neurovascular device, potentially damaging the device. Different proximal hub geometries and hemostatic valve seals can also cause the insertion tool to be pushed distally back into the microcatheter hub. This can cause premature deployment of the neurovascular device into the hemostatic valve, resulting in introduction failure and potentially damaging the device.
[0008] The neurovascular device was damaged due to inaccurate placement of the insertion tool, when it was deployed in the hub of the microcatheter instead of transitioning directly into the axis of the microcatheter. The neurovascular device was then discarded or returned to the manufacturer as a complaint unit.
[0009] An improved insertion tool design is needed, featuring geometrical features that will make the insertion tool more versatile and compatible with a range of commercially available microcatheter hub geometries. An improved insertion tool design is needed that reduces the gap between the distal end of the insertion tool and the microcatheter to prevent potential occlusion of neurovascular devices within the microcatheter hub. An improved insertion tool design is needed that reduces the likelihood of the insertion tool retracting from the hemostatic valve during the introduction of a neurovascular device into the microcatheter. For example, improved surface finish of the insertion device is needed to improve gripping of the hemostatic valve. Summary of the Invention
[0010] The object of this invention is to provide systems, apparatus, and methods that meet the aforementioned needs. Generally, the object of this invention is to provide an improved insertion device that simplifies the process of loading neurovascular devices into microcatheters. In one example, the insertion device may include a tapered distal end, thereby allowing the insertion device to reach the microcatheter without gaps. In another example, the insertion device may include an uneven outer surface along its longitudinal body, which is formed by laser ablation of a material to create protrusions, tapered features, wavy patterns, or threaded extrusions.
[0011] An exemplary insertion device can introduce a neurovascular device into a microcatheter via an RHV. The exemplary insertion device may include a longitudinal body. The longitudinal body may define a lumen therethrough, allowing the neurovascular device to pass through. The longitudinal body may include a proximal portion. The proximal portion may include a first color. The longitudinal body may include a distal portion. The distal portion may include a second color different from the first color. The longitudinal body may include a boundary between the proximal and distal portions. Before introducing the insertion device into the microcatheter, the microcatheter may first be coupled to the RHV. When the insertion device is correctly positioned relative to the microcatheter and the RHV, the boundary may be aligned with the proximal end of the RHV.
[0012] Another exemplary insertion device for introducing a neurovascular device into a microcatheter via an RHV may include a longitudinal body. The longitudinal body may define a lumen therethrough, allowing the neurovascular device to pass through. The insertion device may include a lug disposed on the outer surface of the longitudinal body, the lug preventing the insertion device from fully entering the proximal end of the RHV. The microcatheter may be first coupled to the RHV before the insertion device is introduced into the microcatheter. When the insertion device is properly positioned relative to the microcatheter and the RHV for introducing the neurovascular device into the microcatheter, the lug may be aligned with the proximal end of the RHV.
[0013] The lug may have a width greater than the diameter of the opening at the proximal end of the RHV. The diameter of the opening allows the insertion device to partially enter the proximal end of the RHV.
[0014] The lug may be positioned toward the distal end of the longitudinal body. The insertion device may include a second lug positioned toward the proximal end of the longitudinal body.
[0015] Another exemplary insertion device for introducing a neurovascular device into a microcatheter via RHV may include a longitudinal body. The longitudinal body may include a lumen therethrough, allowing the neurovascular device to pass through. The longitudinal body may include a tapered distal portion sized to allow partial access into the proximal end of the microcatheter shaft. The tapered distal portion may include an outer diameter sized to prevent complete deployment into the microcatheter. The outer diameter may be less than approximately 0.021 inches. The longitudinal body may include a tapered proximal portion. The tapered distal portion may include a length of approximately 10 mm.
[0016] Another exemplary insertion device for introducing a neurovascular device into a microcatheter via an RHV may include a longitudinal body. The longitudinal body may define a lumen therethrough through which the neurovascular device can pass. The insertion device may include an uneven outer surface. This uneven outer surface may prevent posterior movement of the insertion device from the microcatheter when the neurovascular device is introduced into the microcatheter. A distal portion of the longitudinal body may include a distally tapered portion to allow partial advancement of the distal portion into the microcatheter. The uneven outer surface may include a sealing relationship relative to a seal of the RHV. The uneven outer surface may define a plurality of tapered portions along the length of the longitudinal body to reduce movement of the insertion device during introduction of the neurovascular device into the microcatheter. The plurality of tapered portions may include a plurality of first tapered portions that are inclined in a first direction at a first side of the insertion device. The plurality of tapered portions may include a plurality of second tapered portions that are inclined in a second direction at a second side of the insertion device. The second direction may be opposite to the first direction. The longitudinal body may be defined in length ranging from about 410 mm to about 600 mm. The RHV may also include a seal. The seal may include a recess formed therein. An uneven outer surface may include at least one threaded extrusion that engages with the recess formed in the seal of the RHV. The threaded extrusion may include a thickness less than the width of the recess formed in the seal of the RHV. The uneven outer surface may include a plurality of protrusions. At least one protrusion may include 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 wave pattern along the length of the longitudinal body. The RHV may also include a recess in the seal. The recess in the seal may include a complementary profile that engages with the uneven outer surface.
[0017] Exemplary methods for introducing a neurovascular device into a microvessel via an RHV may include one or more of the following steps, presented in a non-specific order. The method may include applying an RHV to the microvessel. The method may include inserting an insertion device into a microcatheter via the RHV. The method may include aligning the boundary between a proximal and distal portion of the insertion device with the proximal end of the RHV. The proximal portion may include a first color. The distal portion may include a second color different from the first color. The method may include inserting the neurovascular device into the microcatheter through a lumen defined in the insertion device.
[0018] Another exemplary method for introducing a neurovascular device into a microvessel via an RHV may include one or more of the following steps presented in a non-specific order. The method may include applying an RHV to the microvessel. The method may include inserting an insertion device into a microcatheter via the RHV. The method may include contacting a lug disposed on an outer surface of the longitudinal body of the insertion device with the proximal end of the RHV. The method may include inserting the neurovascular device into the microcatheter through a lumen defined in the insertion device. The method may include defining the width of the lug, which is greater than the diameter of the opening at the proximal end of the RHV. The method may include allowing the insertion device to partially enter the proximal end of the RHV based on the diameter of the opening.
[0019] Another exemplary method for introducing a neurovascular device into a microcatheter via an RHV may include one or more of the following steps presented in a non-specific order. The method may include applying an RHV to a microvessel. The method may include inserting a tapered distal portion of an insertion device into the proximal end of a microcatheter shaft via an RHV. The method may include configuring the tapered distal portion to restrict complete insertion into the microcatheter. The method may include inserting the neurovascular device into the microcatheter through a lumen defined in the insertion device.
[0020] Another exemplary method for introducing a neurovascular device into a microcatheter via an RHV may include one or more of the following steps presented in a non-specific order. The method may include applying an RHV to a microvessel. The method may include inserting a longitudinal body of an insertion device into the microcatheter via an RHV. The method may include using the uneven outer surface of the longitudinal body to prevent posterior displacement of the insertion device from the microcatheter when introducing the neurovascular device into the microcatheter. The method may include inserting the neurovascular device into the microcatheter through a lumen defined in the insertion device.
[0021] All of the above exemplary methods may include additional steps as will be understood and appreciated by those skilled in the art. Attached Figure Description
[0022] The foregoing and other aspects of the invention will be further discussed with reference to the following description and the accompanying drawings, in which similar numbers indicate similar structural elements and features in various figures. The drawings are not necessarily drawn to scale; rather, the emphasis is on illustrating the principles of the invention. The drawings depict one or more specific embodiments of the apparatus of the invention by way of example only and not by way of limitation.
[0023] Figure 1 This is an illustration of an exemplary insertion device for introducing a neurovascular device into a microcatheter via RHV according to various aspects of the present invention.
[0024] Figure 2This is an illustration of another exemplary insertion device according to various aspects of the present invention for introducing a neurovascular device into a microcatheter via RHV.
[0025] Figure 3 For the purposes of various aspects of the present invention Figure 2 Another illustration of an exemplary insertion device.
[0026] Figure 4 This is an illustration of yet another exemplary insertion device according to various aspects of the present invention for introducing a neurovascular device into a microcatheter via RHV.
[0027] Figure 5 For the purposes of various aspects of the present invention Figure 4 Another illustration of an exemplary insertion device.
[0028] Figure 6A This is an illustration of yet another exemplary insertion device according to various aspects of the present invention for introducing a neurovascular device into a microcatheter via RHV.
[0029] Figure 6B For the purposes of various aspects of the present invention Figure 6A Another illustration of an exemplary insertion device.
[0030] Figure 6C For the purposes of various aspects of the present invention Figure 6A Another illustration of an exemplary insertion device.
[0031] Figure 6D For the purposes of various aspects of the present invention Figure 6A Another illustration of an exemplary insertion device.
[0032] Figure 7 For the purposes of various aspects of the present invention Figure 6A Additional illustrations of an exemplary insertion device.
[0033] Figure 8 This is an illustration of another exemplary insertion device according to various aspects of the present invention for introducing a neurovascular device into a microcatheter via RHV.
[0034] Figure 9 This is an illustration of a specific exemplary insertion device for introducing a neurovascular device into a microcatheter via RHV, according to various aspects of the present invention.
[0035] Figure 10 This is an illustration of an additional exemplary insertion device for introducing a neurovascular device into a microcatheter via RHV, according to various aspects of the present invention.
[0036] Figure 11This is an illustration of yet another exemplary insertion device according to various aspects of the present invention for introducing a neurovascular device into a microcatheter via RHV.
[0037] Figure 12 A flowchart illustrating steps for introducing a neurovascular device into a microcatheter via an insertion device according to various aspects of the present invention is provided.
[0038] Figure 13 Another flowchart illustrating the steps for introducing a neurovascular device into a microcatheter via RHV according to various aspects of the present invention is provided.
[0039] Figure 14 This is yet another flowchart illustrating the steps for introducing a neurovascular device into a microcatheter via RHV according to various aspects of the present invention.
[0040] Figure 15 This is yet another flowchart illustrating the steps for introducing a neurovascular device into a microcatheter via RHV according to various aspects of the present invention.
[0041] Figure 16 Additional flowcharts are provided to illustrate the steps for introducing a neurovascular device into a microcatheter via RHV according to various aspects of the present invention. Detailed Implementation
[0042] As used herein, the term “about” or “approximately” for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or components to achieve the intended purpose as described herein. More specifically, “about” or “approximately” may refer to a range of ±20% of the enumerated values, for example, “about 90%” may refer to a range of values from 71% to 99%.
[0043] Figure 1 An example of an insertion device 110 for introducing a neurovascular device 170 into a microcatheter 130 via an RHV 140 is shown. The microcatheter 130 may include a microcatheter shaft 131 and a microcatheter hub 132, both of which are part of the same microcatheter assembly. Examples of the neurovascular device 170 may include, but are not limited to, mechanical thrombectomy devices, neurovascular access devices, neurovascular balloon devices, neurovascular assist devices, and neurovascular clot removal / flow devices.
[0044] The insertion device 110 may have a longitudinal body 150. The longitudinal body 150 may define a lumen 152 therethrough, which allows the neurovascular device 170 to pass through. The longitudinal body 150 may include a proximal portion 154 having a first color and a distal portion 156 having a second color different from the first color. The longitudinal body 150 may 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 may be aligned with the proximal end 160 of the RHV 140 when the insertion device 110 is properly positioned relative to the microcatheter 130 and the RHV 140.
[0045] Each end of the insertion device 110 can be stained with a different color. This color change allows the physician to know when the insertion device 110 has been correctly positioned in the microcatheter hub 132. During loading, the physician can observe whether the insertion device 110 has begun to slide out of position based on the color change. The color change indicates correct positioning.
[0046] Figure 2 Another example of an insertion device 210 for introducing a neurovascular device 270 into a microcatheter 230 via an RHV 240 is shown. The insertion device 210 may include a longitudinal body 250 defining a lumen 252 therethrough, allowing the neurovascular device 270 to pass through. The insertion device 210 may include a lug 254 disposed on an outer surface 256 of the longitudinal body 250. The microcatheter 230 may be first coupled to the RHV 240 before the neurovascular device 250 is introduced into the microcatheter 230. When the insertion device 210 is properly positioned relative to the microcatheter 230 and the RHV 240 for introducing the neurovascular device 270 into the microcatheter 230, the lug 254 prevents the insertion device 210 from fully entering the proximal end 260 of the RHV 240 when aligned with the proximal end 260 of the RHV 240.
[0047] like Figure 2 As shown, the lug 254 may include a width “W” that is greater than the diameter “d” of the opening 262 of the proximal end 260 of the RHV 240. The diameter “d” of the opening 262 allows the insertion device 210 to partially enter the proximal end 260 of the RHV 240.
[0048] In such Figure 3In one example shown, lug 254 may be positioned toward the distal end 272 of the longitudinal body 250. A second lug 258 may be positioned toward the proximal end 274 of the longitudinal body 250. Thus, lugs can be positioned at each end of the insertion device 210 to allow the physician to know when the insertion device 210 is correctly positioned within the microcatheter hub 232. During loading, the physician can observe whether the insertion device 210 begins to slip out of position when lugs 254 or 258 are not precisely in the correct position. In one example, at least one of lugs 254 and 258 may be located on the RHV 240.
[0049] Figure 4 Another example of an insertion device 410 for introducing a neurovascular device 470 into a microcatheter 430 via an RHV 440 is shown. The insertion device 410 may include a longitudinal body 450. The longitudinal body 450 may include a lumen 452 passing through it, allowing the neurovascular device 470 to pass through. The longitudinal body 450 may include a tapered distal portion 456, which is sized to allow partial access to the proximal end 432 of the microcatheter shaft 431.
[0050] In such Figure 5 In one example shown, the distal tapered portion 456 may include an outer diameter “d1” that is sized to prevent complete deployment into the microcatheter 430.
[0051] In one example, the outer diameter “d1” can be less than about 0.021 inches, while the inner diameter of the microcatheter 430 can be about 0.021 inches or larger, so that the insertion device 410 can be inserted into the microcatheter 430.
[0052] In one example, the distal portion 456 of the cone may have a length “TL” of approximately 10 mm.
[0053] In such Figure 5 In one example shown, the longitudinal body 450 may include a tapered proximal portion 458.
[0054] The insertion device 450 is tapered at each end, such that each end has an outer diameter “d1” of less than 0.021 inches to allow it to be positioned within the lumen of the microcatheter 430. This prevents the insertion device 410 from being accidentally deployed into the hub of the microcatheter.
[0055] See Figure 5The insertion device 410 may have a length "L" ranging from approximately 410 mm to approximately 600 mm. The longitudinal bodies 650 and 1150 may be defined with the same length "L" ranging from approximately 410 mm to approximately 600 mm. In one example, the length "L" may be approximately 600 mm. Physicians may preferably wrap the insertion device around their hand while holding the RHV. The length "L" (such as 600 mm) allows for a more secure clamping when introducing a neurovascular device into the microcatheter.
[0056] Figures 6A to 11 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. The insertion device 610 may include longitudinal bodies 650, 1150. The longitudinal bodies 650, 1150 may define lumens 652, 852, 1152 passing through them, allowing the neurovascular device 670 to pass through. The longitudinal bodies may include uneven outer surfaces 654, 854, 954, 1154 that prevent the insertion device 610 from retracting from the microcatheter 630 when the neurovascular device 670 is introduced into the microcatheter 630.
[0057] Figure 6B This can represent a longitudinal cross-section of the complete assembly of the insertion device 610, microcatheter 630, and neurovascular device 670. For example... Figure 6B As shown, the neurovascular device 670 can move forward into the microcatheter axis 631 in the direction indicated by arrow "F". Figure 6B In the diagram, the shaded or shaded area encapsulating the microcatheter shaft 631 and the microcatheter hub 632 can represent the microcatheter hub wall 633. For example... Figure 6B As shown, the microcatheter shaft 631 can define a microcatheter shaft lumen 634 for receiving the neurovascular device 670.
[0058] In such Figure 6D In one example shown, the insertion device 610 may define a lumen 652 therein for receiving a neurovascular device 670. The lumen 652 may have an inner diameter of about 0.024 inches.
[0059] Insertion devices 610, 810, 910, 1010, and 1110 may have one or more geometric features along their outer surfaces 654, 854, 954, and 1154 to improve contact between the RHV seals 642, 842, and 1142 and the insertion device. These geometric features may be roughened outer surfaces on the insertion devices. Roughened outer surfaces prevent the insertion devices 610, 810, 910, 1010, and 1110 from moving distally out of the microcatheter hub 632, thereby significantly reducing the likelihood of failed introduction or premature deployment of the neurovascular device 670.
[0060] In one example, the distal portion 656 of the longitudinal body 650 may include a distal tapered portion 671 to allow the distal portion 656 to partially advance into the microcatheter 630. Figure 6D As shown, the distal tapered portion 671 can be formed at an angle θ in the range of approximately 10°–20° relative to the longitudinal axis “A” of the insertion device 610. The distal tapered portion 671 allows the distal end of the insertion device 610 to be further advanced into the microcatheter hub 632. The distal tapered portion 671 allows the insertion device 610 to be advanced to the distal end of the microcatheter hub 632, thus significantly reducing the likelihood of failure in delivery of the neurovascular device 670 into the microcatheter 630, which could otherwise occur due to the geometry of the microcatheter hub 632 or the partial deployment of the neurovascular device 670 within the microcatheter hub 632.
[0061] In one example, see Figure 7 The longitudinal body 650 may have a nearest-side tapered portion 673. The farthest-side tapered portion 671 and the nearest-side tapered portion 673 may each have a length "TL" greater than 8.5 mm. In one example, the length "TL" may be approximately 10 mm. Each of the farthest-side tapered portion 671 and the nearest-side tapered portion 673 may taper from a maximum outer diameter of approximately 0.045 inches to a minimum outer diameter of approximately 0.035 inches, such as... Figure 6D , Figure 8 and Figure 11 As shown.
[0062] In one example, the uneven outer surfaces 654, 854 may form a sealing relationship with respect to the seals 642, 842, 1142 of the RHV 640.
[0063] In one example, the uneven outer surface 654 may include a plurality of tapered portions 672, 674 along the length of the outer surface 654 of the insertion device to reduce movement of the insertion device 610 during the introduction of the neurovascular device 670 into the microcatheter 630. The plurality of tapered portions 672, 674 may be applied to both sides of the insertion device to allow access to the insertion device from both sides. In one example, the plurality of tapered portions may include a plurality of first tapered portions 672 and a plurality of second tapered portions 674, the plurality of first tapered portions being inclined along a first direction at a first side of the insertion device 610, and the plurality of second tapered portions being inclined along a second direction at a second side of the insertion device. The second direction may be opposite to the first direction. When the neurovascular device is introduced into the microcatheter, the tapered portions 672, 674 can be used to reduce movement of the insertion device.
[0064] In one example, the tapered portion 672 may be positioned at the distal end of the insertion device 610, while the tapered portion 674 may be positioned at the proximal end of the insertion device 610. For example... Figure 7 As shown, the tapering directions of the tapered portions 672 and 674 can be mirrored at the midpoint of the insertion device, so that the insertion device 610 can be used in any way.
[0065] The length of each of the tapered portions 672 and 674 along the length of the insertion device may be shorter than the length "TL" of the farthest tapered portion 671 or the nearest tapered portion 673, in order to improve the clamping of the closed RHV seal 642 on the insertion device 610.
[0066] In such Figure 6C In one example shown, when the RHV seal 642 is closed on the insertion device 610, the tapered portion 672 or tapered portion 674 can be locked or clamped by the RHV seal 642 or embedded in the RHV seal 642 to provide additional clamping, thereby preventing the insertion device 610 from exiting the RHV 640 during device delivery. The RHV seal 642 can be tightly closed relative to the outer diameter of the insertion device. The RHV seal 642 can deform to form a tight clamping on the outer surface of the insertion device 610. The RHV seal 642 can flex to conform to the outer surface of the insertion device 610. At this time, the RHV seal 642 can be pulled down onto the insertion device 610 to help hold it in proper position within the microcatheter hub. Therefore, when the neurovascular device 670 is introduced into the microcatheter 630, the insertion device 610 is prevented from exiting the RHV 640.
[0067] See Figure 6C When the neurovascular device 670 is introduced into the microcatheter shaft 631, the tapered portion 672 or 674 prevents the insertion device 610 from moving backward in the direction indicated by the arrow "B".
[0068] See Figure 6D , Figure 8 and Figure 11 When the RHV seal 642 is closed on the insertion device 610, the RHV seal 642 can deform around the insertion device 610 to form a firm clamp on the insertion device 610. Therefore, when the neurovascular device 670 is introduced into the microcatheter shaft 631, the RHV seal 642 prevents the insertion device 610 from being withdrawn from the RHV 640.
[0069] In such Figure 8 In one example shown, the RHV 640 may include a seal 842. The seal 842 may include a recess 844 formed therein. The uneven outer surface 854 may include at least one threaded extrusion 856 that engages with the recess 844 formed in the seal 842 of the RHV 640.
[0070] In one example, the threaded extrusion 856 may include a thickness “T1” that is less than the width “W1” of the recess 844 formed in the seal 842 of the RHV 640.
[0071] In such Figure 9 In one example shown, a laser-engraved pattern on the outer surface of the insertion device 910 improves RHV clamping, thereby preventing movement. The uneven outer surface 954 may include multiple protrusions 980. At least one protrusion 980 may include a length “PL” of approximately 2 mm to approximately 3 mm. The length “PL” may be slightly smaller than the approximate size of the RHV seal.
[0072] See Figure 8 The threaded extrusion portion 856 can be formed along the outer surface of the insertion device to improve the tightness between the RHV seal and the insertion device when the RHV seal clamps the insertion device.
[0073] In such Figure 10 In one example shown, the uneven outer surface 1054 may include a knurled surface to improve RHV clamping.
[0074] In such Figure 11 In one example shown, the uneven outer surface 1154 may include a wave pattern 1160 along the length of the longitudinal body 1150 to improve RHV clamping of the insertion device. RHV seal 1142 may include a recess 1144. Recess 114 may include a complementary profile 1170 that engages with the uneven outer surface 1154. RHV seal 1142 may be tightly closed relative to the insertion device 1110. RHV seal 1142 may deform to conform to the wave pattern 1160.
[0075] Figure 12A flowchart illustrating an exemplary method 1200 for inserting a neurovascular device 670 into a microcatheter 630 is provided. The method 1200 may include one or more of the following steps presented in a non-specific order.
[0076] At step 1202, the neurovascular device 670 may be loaded into the insertion device 610.
[0077] At 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 example, a specific length of RHV 640 must be provided to ensure the design below works correctly.
[0078] At step 1206, the insertion device 610, in which the neurovascular device 670 is preloaded, can be introduced into the RHV640.
[0079] At step 1208, the insertion device 610 can be positioned close to the proximal end 635 of the microcatheter shaft 631, such as Figure 6B As shown.
[0080] At step 1210, the RHV seal 642 may close on the insertion device 610 to hold the insertion device 610 in place.
[0081] At step 1212, the neurovascular device 670 may be moved forward from the insertion device 610 into the microcatheter 630 until the neurovascular device 670 is fully introduced into the microcatheter 630.
[0082] At step 1214, once the neurovascular device 670 has been fully introduced into the microcatheter 630, the RHV seal 642 can be released to remove the insertion device 670.
[0083] At step 1216, the insertion device 670 can be pulled proximally away from the axis 675 of the neurovascular device 670.
[0084] Figure 13 Another flowchart illustrates an exemplary method 1300 for inserting a neurovascular device 170 into a microcatheter 130 via an RHV 140. The method 1300 may include one or more of the following steps presented in a non-specific order.
[0085] At step 1302, RHV 140 may be applied to microcatheter 130.
[0086] At step 1304, the insertion device 110 can be inserted into the microcatheter 130 via RHV 140.
[0087] At step 1306, the boundary 158 between the proximal portion 154 and the distal portion 156 of the insertion device 110 may mate with the proximal end 160 of the RHV 140. The proximal portion 154 may include a first color. The distal portion 156 may include a second color different from the first color.
[0088] At step 1308, the neurovascular device 170 can be inserted into the microcatheter 130 through the lumen 152 defined in the insertion device 110.
[0089] Figure 14 This is yet another flowchart illustrating an exemplary method 1400 for inserting a neurovascular device 270 into a microcatheter 230 via an RHV 240. The method 1400 may include one or more of the following steps presented in a non-specific order.
[0090] At step 1402, RHV 240 may be applied to microcatheter 230.
[0091] At step 1404, the insertion device 210 can be inserted into the microcatheter 230 via RHV 240.
[0092] At step 1406, the lug 254 provided on the outer surface 256 of the longitudinal body 250 of the insertion device 210 can contact the proximal end 260 of the RHV 240.
[0093] At step 1408, the neurovascular device 270 can be inserted into the microcatheter 230 through the lumen 252 defined in the insertion device 210.
[0094] In one example, the lug 254 may have a width “W” that is greater than the diameter “d” of the opening 262 of the proximal end 260 of the RHV 240, thereby 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.
[0095] Figure 15 A flowchart illustrating an exemplary method 1500 for introducing a neurovascular device 470 into a microcatheter 430 via an RHV 440 is provided. The method 1500 may include one or more of the following steps presented in a non-specific order.
[0096] At step 1502, RHV 440 may be applied to microcatheter 430.
[0097] At step 1504, the distal tapered portion 456 of the insertion device 410 can be inserted into the proximal end 432 of the microcatheter shaft 431 via RHV 440.
[0098] At step 1506, the distal conical portion 456 may be configured to restrict complete insertion of the distal conical portion 456 into the microcatheter 430.
[0099] At step 1508, the neurovascular device 470 can be inserted into the microcatheter 430 through the lumen 452 defined in the insertion device 410.
[0100] Figure 16 A flowchart illustrating an exemplary method 1600 for introducing a neurovascular device 670 into a microcatheter 630 via an RHV 640 is provided. The method 1600 may include one or more of the following steps presented in a non-specific order.
[0101] At step 1602, RHV 640 may be applied to microcatheter 630.
[0102] At step 1604, the longitudinal bodies 650 and 1150 of the insertion devices 610, 810, 910, 1010, and 1110 can be inserted into the microcatheter 630 via RHV 640.
[0103] At step 1606, when the neurovascular device 670 is introduced into the microcatheter 630, the uneven outer surfaces 654, 854, 954, 1154 of the longitudinal bodies 650, 1150 can be used to prevent insertion devices 610, 810, 910, 1010, 1110 from moving backward from the microcatheter 630.
[0104] At step 1608, the neurovascular device 670 can be inserted into the microcatheter 630 through lumens 652, 852, 1152 defined in the insertion devices 610, 810, 910, 1010, 1110.
[0105] Any of the exemplary methods 1200, 1300, 1400, 1500, and 1600 may include additional steps as will be understood and appreciated by one of ordinary skill in the art. The exemplary methods may be performed by the exemplary systems or physicians disclosed herein, variations thereof, or alternatives thereof as will be understood and appreciated by one of ordinary skill in the art.
[0106] In one embodiment, the insertion device may have a threaded profile. The two ends of the insertion device may have a tapered profile to enhance ease of use and microcatheter capacity.
[0107] The description contained herein is an example of embodiments of the invention and is not intended to limit the scope of the invention in any way. As described herein, the invention contemplates many variations and modifications of the insertion device. These modifications will be apparent to those skilled in the art and are intended to be within the scope of the following claims.
Claims
1. An insertion device for introducing a neurovascular device into a microcatheter via a RHV, the insertion device comprising: A longitudinal body defining a lumen therethrough, the lumen allowing the neurovascular device to pass through. A lug, provided on the outer surface of the longitudinal body, prevents the insertion device from fully entering the proximal end of the RHV. When the microcatheter is connected to the RHV, and when the lug is aligned with the proximal end of the RHV, the insertion device is correctly positioned relative to the microcatheter and the RHV for introducing the neurovascular device into the microcatheter.
2. The insertion device according to claim 1, characterized in that, The lug includes a width greater than the diameter of the opening at the proximal end of the RHV, the diameter of which allows the insertion device to partially enter the proximal end of the RHV.
3. The insertion device according to claim 2, characterized in that, The lug is positioned toward the distal end of the longitudinal body. The insertion device includes a second lug disposed toward the proximal end of the longitudinal body.
4. An insertion device for introducing a neurovascular device into a microcatheter via a RHV, the insertion device comprising: The longitudinal body includes: A lumen, the lumen passing through the longitudinal body, the lumen allowing the neurovascular device to pass through, and The distal conical portion is sized to allow partial access into the proximal end of the microcatheter shaft, thereby allowing the insertion device to reach the microcatheter without gaps when the microcatheter is coupled to the RHV, in order to prevent potential occlusion of the neurovascular device in the hub of the microcatheter.
5. The insertion device according to claim 4, characterized in that, The distal portion of the tapered section includes an outer diameter whose dimensions are designed to prevent it from being fully deployed into the microcatheter.
6. The insertion device according to claim 4, characterized in that, The outer diameter is less than 0.021 inches.
7. The insertion device according to claim 4, characterized in that, The longitudinal body includes a tapered proximal portion.
8. The insertion device according to claim 4, characterized in that, The distal portion of the cone comprises approximately 10 mm in length.
9. An insertion device for introducing a neurovascular device into a microcatheter via a RHV, the insertion device comprising: A longitudinal body defining a lumen therethrough, the lumen allowing the neurovascular device to pass through, and The uneven outer surface improves the contact between the RHV and the insertion device when the microcatheter is connected to the RHV and when the neurovascular device is introduced into the microcatheter, thereby preventing the insertion device from moving backward from the microcatheter.
10. The insertion device according to claim 9, characterized in that, The distal portion of the longitudinal body includes a distal tapered portion to allow the distal portion to be partially advanced into the microcatheter.
11. The insertion device according to claim 9, characterized in that, The uneven outer surface includes the sealing relationship with respect to the seal of the RHV.
12. The insertion device according to claim 9, characterized in that, The uneven outer surface defines a plurality of tapered portions along the length of the longitudinal body to reduce movement of the insertion device during the introduction of the neurovascular device into the microcatheter.
13. The insertion device according to claim 9, characterized in that, Multiple tapered sections include: A plurality of first tapered portions, the plurality of first tapered portions being inclined along a first direction at a first side of the insertion device, and A plurality of second tapered portions, the plurality of second tapered portions being inclined along a second direction at a second side of the insertion device, the second direction being opposite to the first direction.
14. The insertion device according to claim 9, characterized in that, The longitudinal body is defined in length in the range of approximately 410 mm to approximately 600 mm.
15. The insertion device according to claim 9, characterized in that, The RHV also includes: A seal, the seal including a recess formed therein; The uneven outer surface includes at least one threaded extrusion that engages with the recess formed in the seal of the RHV.
16. The insertion device according to claim 15, characterized in that, The threaded extrusion portion includes a thickness smaller than the width of the recess formed in the seal of the RHV.
17. The insertion device according to claim 16, characterized in that, The uneven outer surface includes multiple protrusions, at least one of which has a length of about 2 mm to about 3 mm.
18. The insertion device according to claim 9, characterized in that, The uneven outer surface includes a knurled surface.
19. The insertion device according to claim 9, characterized in that, The uneven outer surface includes a wave pattern along the length of the longitudinal body. The RHV also includes a recess in the seal, the recess comprising a complementary profile that engages with the uneven outer surface.