NEUROVASCULAR INSERTION TOOL
20210187264 · 2021-06-24
Assignee
Inventors
Cpc classification
A61M2025/0042
HUMAN NECESSITIES
A61B17/22
HUMAN NECESSITIES
A61M39/06
HUMAN NECESSITIES
A61M2039/0626
HUMAN NECESSITIES
A61M2039/0258
HUMAN NECESSITIES
A61F2/9522
HUMAN NECESSITIES
A61B17/3423
HUMAN NECESSITIES
International classification
Abstract
An improved insertion apparatus simplifies loading of neurovascular device into 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 can include an uneven outer surface along its longitudinal body through laser ablation of material to form protrusions, forming taper features, forming wave patterns or thread extrusions.
Claims
1. An insertion apparatus for introducing a neurovascular device into a microcatheter via an RHV, comprising: a longitudinal body comprising: a lumen therethrough that allows the neurovascular device to pass through, and a tapered distal portion sized to allow partial entry into a proximal end of a microcatheter shaft.
2. The insertion apparatus of claim 1, wherein the tapered distal portion comprises an outer diameter sized to prevent complete deployment into the microcatheter.
3. The insertion apparatus of claim 1, wherein the outer diameter is greater than 0.021 inches.
4. The insertion apparatus of claim 1, wherein the longitudinal body comprises a tapered proximal portion.
5. The insertion apparatus of claim 1, wherein the tapered distal portion comprises a length of approximately 10 mm.
6. An insertion apparatus for introducing a neurovascular device into a microcatheter via an RHV, comprising: a longitudinal body defining a lumen therethrough that allows the neurovascular device to pass through, a ledge disposed on an outer surface of the longitudinal body that prevents a complete entry of the insertion apparatus into a proximal end of the RHV, when the ledge is aligned with the proximal end of the RHV, the insertion apparatus is ready for introducing the neurovascular device into the microcatheter, and the microcatheter is coupled to the RHV.
7. The insertion apparatus of claim 6, wherein the ledge comprises a width greater than a diameter of an opening of the proximal end of the RHV, the diameter of the opening allows a partial entry of the insertion apparatus into the proximal end of the RHV.
8. The insertion apparatus of claim 7, the ledge is disposed towards a distal end of the longitudinal body, the insertion apparatus comprises a second ledge disposed towards a proximal end of the longitudinal body.
9. An insertion apparatus for introducing a neurovascular device into a microcatheter via an RHV, comprising: a longitudinal body defining a lumen therethrough that allows the neurovascular device to pass through, and an uneven outer surface preventing a backward movement of the insertion apparatus from the microcatheter when introducing the neurovascular device into the microcatheter.
10. The insertion apparatus of claim 9, wherein a distal portion of the longitudinal body comprises a distalmost taper to allow the distal portion to advance partially into the microcatheter.
11. The insertion apparatus of claim 9, the uneven outer surface comprises a sealing relationship with respect to a seal of the RHV.
12. The insertion apparatus of claim 9, wherein the uneven outer surface defines a plurality of tapers along a length of the longitudinal body to reduce movement of the insertion apparatus during introduction of the neurovascular device into the microcatheter.
13. The insertion apparatus of claim 9, wherein the plurality of tapers comprises: a first plurality of tapers inclined in a first direction at a first side of the insertion apparatus, and a second plurality of tapers inclined in a second direction at a second side of the insertion apparatus, the second direction being opposite from the first direction.
14. The insertion apparatus of claim 9, wherein the longitudinal body defines a length in a range from about 410 mm to about 600 mm.
15. The insertion apparatus of claim 9, wherein the RHV further comprises: a seal comprising with a recess formed in the seal; the uneven outer surface comprises at least one threaded extrusion engaging with the recess formed in the seal of the RHV.
16. The insertion apparatus of claim 15, wherein the threaded extrusion comprises a thickness less than a width of the recess formed in the seal of the RHV.
17. The insertion apparatus of claim 16, wherein uneven outer surface comprises a plurality of protrusions, at least one protrusion comprises a length from about 2 mm to about 3 mm.
18. The insertion apparatus of claim 9, the uneven outer surface comprises a knurled surface.
19. The insertion apparatus of claim 9, the uneven outer surface comprises a wave pattern along a length of the longitudinal body, the RHV further comprises a recess of a seal comprising a complementary profile engaging with the uneven outer surface.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] The above and further aspects of this invention are further discussed with reference to the
[0022] following description in conjunction with the accompanying drawings, in which like numerals indicate like structural elements and features in various figures. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating principles of the invention. The figures depict one or more implementations of the inventive devices, by way of example only, not by way of limitation.
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DETAILED DESCRIPTION
[0042] As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” can refer to the range of values ±20% of the recited value, e.g. “about 90%” can refer to the range of values from 71% to 99%.
[0043] An example of an insertion apparatus 110 is illustrated in
[0044] The insertion apparatus 110 can have a longitudinal body 150. The longitudinal body 150 can define a lumen 152 therethrough that allows the neurovascular device 170 to pass through. The longitudinal 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 longitudinal body 150 can include a boundary 158 between the proximal portion 154 and the distal portion 156. The boundary 158 can be aligned with a proximal end 160 of an RHV 140 when the insertion apparatus 110 is correctly positioned relative to the microcatheter 130 and the RHV 140, when the microcatheter 130 is coupled to the RHV 140.
[0045] Each end of the insertion apparatus 110 can be dyed a different color. This color change can allow the physician to know when the insertion apparatus 110 has been correctly positioned into the microcatheter hub 132. During loading, the physician can see if the insertion apparatus 110 begins to slip out of location based on color change. The color change can signify correct seating.
[0046] Another example of an insertion apparatus 210 is illustrated in
[0047] As illustrated in
[0048] In one example as illustrated in
[0049] Yet another example of an insertion apparatus 410 is illustrated in
[0050] In one example as illustrated in
[0051] In one example, the outer diameter “d1” can be greater than 0.021 inches, while an inner diameter of the microcatheter 430 can be approximately 0.021 inches or greater, so that the insertion apparatus 410 can be inserted into the microcatheter 430. The outer diameter “d1” can be greater than the inner diameter of the microcatheter 430 to prevent the insertion apparatus 410 sliding into the microcatheter 430. Preferably, an inner diameter of the insertion apparatus 410 can be greater than 0.021 inches to minimize loading forces. In one embodiment, the inner diameter of the microcatheter 430 can be in a range from 0.016 inches to 0.027 inches.
[0052] In one example, the tapered distal portion 456 can have a length “TL” of approximately 10 mm.
[0053] In one example as seen in
[0054] The insertion apparatus 450 can be tapered on each end so that that each end can have an outer diameter “d1”. The outer diameter “d1” can be greater than 0.021 inches to allow it to sit inside a lumen of the microcatheter 430. This can prevent the insertion apparatus 410 being inadvertently deployed in the microcatheter hub.
[0055] Referring to
[0056] A still another example of an insertion apparatus 610, 810, 910, 1010, 1110 is illustrated in
[0057]
[0058] In one example as illustrated in
[0059] Preferably, the lumen 652 can have an inner diameter greater than 0.021 inches to minimize loading forces. In one embodiment, the lumen 652 can have an inner diameter of about 0.024 inches.
[0060] The insertion apparatus 610, 810, 910, 1010, 1110 can have one or more geometric features along its outer surface 654, 854, 954, 1154 to improve the contact between an RHV seal 642, 842, 1142 and the insertion apparatus. These geometric features can be a roughened outer surface on the insertion apparatus. The roughened outer surface can prevent the insertion apparatus 610, 810, 910, 1010, 1110 from moving distally back out of the microcatheter hub 632, therefore significantly reducing the possibility of a failed introduction or premature deployment of the neurovascular device 670.
[0061] In one example, a distal portion 656 of the longitudinal body 650 can include a distalmost taper 671 to allow the distal portion 656 to advance partially into the microcatheter 630. As shown in
[0062] In one example, with reference to
[0063] In one example, the uneven outer surface 654, 854 can form a sealing relationship with respect to a seal 642, 842, 1142 of the RHV 640.
[0064] In one example, the uneven outer surface 654 can include a plurality of tapers 672, 674 along the length of the insertion apparatus outer surface 654 to reduce movement of the insertion apparatus 610 during introduction of the neurovascular device 670 into the microcatheter 630. The plurality of tapers 672, 674 can be applied to both sides of the insertion apparatus to allow the insertion apparatus to be used from both sides. In one example, the plurality of tapers can include a first plurality of tapers 672 inclined in a first direction at a first side of the insertion apparatus 610, and a second plurality of tapers 674 inclined in a second direction at a second side of the insertion apparatus. The second direction can be opposite from the first direction. The tapers 672, 674 can server to reduce movement of the insertion apparatus when introducing the neurovascular device into the microcatheter.
[0065] In one example, the tapers 672 can be positioned at a distal end of the insertion apparatus 610, while tapers 674 can be positioned at a proximal end of the insertion apparatus 610. As illustrated in
[0066] Each of the tapers 672, 674 along the length of the insertion apparatus can have a length shorter than the length “TL” of the distalmost taper 671 or the proximal most taper 673 in order to improve the grip the closed RHV seal 642 has on the insertion apparatus 610.
[0067] In one example as illustrated in
[0068] With reference to
[0069] With reference to
[0070] In one example as illustrated in
[0071] In one example, the threaded extrusion 856 can include a thickness “T1” less than a width “W1” of the recess 844 formed in the seal 842 of the RHV 640.
[0072] In one example as illustrated in
[0073] Referring to
[0074] In one example as illustrated in
[0075] In one example as illustrated in
[0076]
[0077] At step 1202, the neurovascular device 670 can be loaded into the insertion apparatus 610.
[0078] At step 1204, the RHV 640 can be attached to the microcatheter hub 632. A physician can apply the RHV 640 to the microcatheter hub 632 before inserting the insertion apparatus 610 into the microcatheter 630. In one example, in order to ensure that the below designs work correctly the RHV 640 of a specific length must be provided.
[0079] At step 1206, the insertion apparatus 610, with the neurovascular device 670 preloaded therein, can be introduced into the RHV 640.
[0080] At step 1208, the insertion apparatus 610 can be positioned tight against a proximal end 635 of a microcatheter shaft 631 as illustrated in
[0081] At step 1210, the RHV seal 642 can be closed down on the insertion apparatus 610 to hold the insertion apparatus 610 in place.
[0082] At step 1212, the neurovascular device 670 can be moved forward from the insertion apparatus 610 into the microcatheter 630 until the neurovascular device 670 is fully introduced into the microcatheter 630.
[0083] At step 1214, once the neurovascular device 670 is fully introduced into the microcatheter 630, the RHV seal 642 can be loosened in order to remove the insertion apparatus 670.
[0084] At step 1216, the insertion apparatus 670 can be pulled proximally off a shaft 675 of the neurovascular device 670.
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[0086] At step 1302, the RHV 140 can be applied to the microcatheter 130.
[0087] At step 1304, the insertion apparatus 110 can be inserted into the microcatheter 130 through the RHV 140.
[0088] At step 1306, the boundary 158 between the proximal portion 154 and the distal portion 156 of the insertion apparatus 110 can be matched 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 different from the first color.
[0089] At step 1308, the neurovascular device 170 can be inserted into the microcatheter 130 through the lumen 152 defined in the insertion apparatus 110.
[0090]
[0091] At step 1402, the RHV 240 can be applied to the microcatheter 230.
[0092] At step 1404, the insertion apparatus 210 can be inserted into the microcatheter 230 through the RHV 240.
[0093] At step 1406, the ledge 254 disposed on the outer surface 256 of the longitudinal body 250 of the insertion apparatus 210 can be contacted to the proximal end 260 of the RHV 240.
[0094] At step 1408, the neurovascular device 270 can be inserted into the microcatheter 230 through the lumen 252 defined in the insertion apparatus 210.
[0095] In one example, the ledge 254 can have a width “W” greater than a diameter “d” of the opening 262 of the proximal end 260 of the RHV 240, allowing a partial entry of the insertion apparatus 210 into the proximal end 260 of the RHV 240 based on the diameter “d” of the opening 262.
[0096]
[0097] At step 1502, the RHV 440 can be applied to the microcatheter 430.
[0098] At step 1504, the tapered distal portion 456 of the insertion apparatus 410 can be inserted into the proximal end 432 of the microcatheter shaft 431 through the RHV 440.
[0099] At step 1506, the tapered distal portion 456 can be configured to restrict full insertion of the tapered distal portion 456 into the microcatheter 430.
[0100] At step 1508, the neurovascular device 470 can be inserted into the microcatheter 430 through the lumen 452 defined in the insertion apparatus 410.
[0101]
[0102] At step 1602, the RHV 640 can be applied to the microcatheter 630.
[0103] At step 1604, the longitudinal body 650, 1150 of the insertion apparatus 610, 810, 910, 1010, 1110 can be inserted into the microcatheter 630 through the RHV 640.
[0104] At step 1606, a backward movement of the insertion apparatus 610, 810, 910, 1010, 1110 can be prevented from the microcatheter 630 when introducing the neurovascular device 670 into the microcatheter 630 using the uneven outer surface 654, 854, 954, 1154 of the longitudinal body 650, 1150.
[0105] At 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.
[0106] Any of the example methods 1200, 1300, 1400, 1500 and 1600 can include additional steps as would be appreciated and understood by a person of ordinary skill in the art. The example method can be performed by an example system or a physician as disclosed herein, a variation thereof, or an alternative thereto as would be appreciated and understood by a person of ordinary skill in the art.
[0107] In one embodiment, the insertion apparatus may have a protrusion disposed on an outer surface of the insertion apparatus. The protrusion can form a spiral profile on the outer surface of the insertion apparatus. Both ends of the insertion apparatus may have a tapered profile to enhance ease of use and microcatheter capability.
[0108] The descriptions contained herein are examples of embodiments of the invention and are not intended in any way to limit the scope of the invention. As described herein, the invention contemplates many variations and modifications of the insertion apparatus. These modifications would be apparent to those having ordinary skill in the art to which this invention relates and are intended to be within the scope of the claims which follow.