TOOLS FOR SHEATHING TREATMENT DEVICES AND ASSOCIATED SYSTEMS AND METHODS

Abstract

Devices for loading intravascular treatment devices into a sheath and associated systems and methods are disclosed herein. A sheathing tool may include, for example, a first channel extending to a first opening, the first channel configured to receive a treatment device in a constrained state therethrough. The treatment device may include an elongated member and a first element and a second element at a distal region of the elongated member. The second channel may extend to a second opening, the second opening surrounded by a sidewall and configured to receive the treatment device in the constrained state therethrough, wherein the second opening is spaced apart from the first opening by a gap, and wherein a length of the gap is great enough to allow the first element to self-expand over the sidewall while the second element generally maintains its diameter in the constrained state while crossing the gap.

Claims

1. A device for sheathing a treatment device having an elongated member and a first element and a second element at a distal region of the elongated member, wherein the device comprises: a first channel extending to a first opening, the first channel configured to receive the treatment device in a constrained state therethrough; and a second channel extending to a second opening, the second opening surrounded by a sidewall and configured to receive the treatment device in the constrained state therethrough, wherein the second opening is spaced apart from the first opening by a gap, and wherein a length of the gap is great enough to allow the first element to self-expand over the sidewall while the second element generally maintains its diameter in the constrained state while crossing the gap.

2. The device of claim 1, wherein an inner diameter of the second channel tapers distally from the second opening.

3. The device of claim 1, wherein an outer diameter of the sidewall increases distally from the second opening.

4. The device of claim 1, wherein the first and second openings are fixed relative to one another such that the length of the gap is fixed.

5. The device of claim 1, wherein the first and second openings are movable relative to one another such that the length of the gap is adjustable.

6. The device of claim 1, wherein the first channel is within a first housing and the second channel is within a second housing movable relative to the first housing, and wherein the first housing has a detent configured to receive a protrusion of the second housing, or vice versa, such that the first housing is locked in place relative to the second housing.

7. The device of claim 1, wherein the first channel is configured to receive a sheath therethrough, wherein the sheath is configured to slidably receive the treatment device therein in the constrained state.

8. The device of claim 1, wherein the second channel is configured to receive a sheath therethrough, and wherein the sheath is configured to slidably receive the treatment device therein in the constrained state.

9. The device of claim 1, wherein the first element is a self-expanding element.

10. The device of claim 1, wherein the second element is a self-expanding element.

11. The device of claim 1, wherein the first element is a mesh.

12. The device of claim 1, wherein the second element is a stent.

13. The device of claim 1, wherein, in an expanded state, the first element has a flared distal region with a lumen therethrough, and wherein the lumen of the flared distal region is configured to receive the sidewall therein as the treatment device is moved through the across the gap.

14. The device of claim 1, wherein the treatment device is a clot retrieving device.

15. The device of claim 1, wherein the device is configured to be detachably coupled to a handle of a catheter, thereby placing the second channel in fluid communication with a lumen of the catheter.

16. A system for sheathing a treatment device having an elongated member and a first element and a second element at a distal region of the elongated member, wherein the device comprises: a sheath configured to receive the treatment device in a constrained state therethrough; a first channel extending to a first opening and configured to receive at least a portion of the sheath; and a second channel extending to a second opening, the second opening surrounded by a sidewall and configured to receive the treatment device in the constrained state therethrough, wherein the second opening is spaced apart from the first opening by a gap, and wherein a length of the gap is great enough to allow the first element to self-expand over the sidewall while the second element generally maintains its diameter in the constrained state while crossing the gap.

17. The system of claim 16, further comprising a fluid port coupled to a proximal end portion of the sheath.

18. The system of claim 16, wherein the sheath is a first sheath and the system further comprises a second sheath configured to receive the treatment device in a constrained state therethrough, and wherein the second channel is configured to receive at least a portion of the second sheath therein.

19. The system of claim 18, further comprising a catheter, and wherein the second sheath is configured to be coupled to the catheter.

20. A system for sheathing a treatment device having an elongated member and a first element and a second element at a distal region of the elongated member, wherein the device comprises: a sheath configured to receive the treatment device in a constrained state therethrough; a sheathing tool comprising: a first channel extending to a first opening and configured to receive at least a portion of the sheath, and a second channel extending to a second opening, the second opening surrounded by a sidewall and configured to receive the treatment device in the constrained state therethrough, wherein the second opening is spaced apart from the first opening by a gap, and wherein a length of the gap is great enough to allow the first element to self-expand over the sidewall while the second element generally maintains its diameter in the constrained state while crossing the gap; a housing configured to be detachably coupled to the sheath and the sheathing tool, wherein a majority of the length of the sheath is contained within a perimeter of the housing such that a user may position manipulate both ends of the sheath and/or treatment device without having to step side-to-side.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0079] Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale Instead, emphasis is placed on illustrating clearly the principles of the present disclosure.

[0080] FIG. 1 is a schematic overview of a treatment system configured in accordance with the present technology.

[0081] FIG. 2 is a side view of a distal portion of the treatment device shown in FIG. 1 in a second position in accordance with embodiments of the present technology.

[0082] FIG. 3A is an isometric view of a sheathing tool in a first position configured in accordance with the present technology.

[0083] FIG. 3B is an isometric view of the sheathing tool of FIG. 3A in a second position configured in accordance with the present technology.

[0084] FIG. 3C is a top view of the sheathing tool in the first position, as shown in FIG. 3A.

[0085] FIG. 3D is a top view of the sheathing tool in the second position, as shown in FIG. 3B.

[0086] FIG. 3E is an enlarged, isolated, cross-sectional view of the first channel shown in FIGS. 3A-3D.

[0087] FIG. 3F is an enlarged, isolated view, cross-sectional view of the second channel shown in FIGS. 3A-3D.

[0088] FIGS. 4A-4H illustrate a method of using a sheathing tool to sheath a treatment device.

[0089] FIGS. 5A and 5B are an isometric view and a top cross-sectional view, respectively, of a sheathing tool shown in a first position configured in accordance with some embodiments of the present technology.

[0090] FIGS. 5C and 5D are an isometric view and a top cross-sectional view, respectively, of the sheathing tool shown in FIGS. 5A and 5B in a second position configured in accordance with some embodiments of the present technology.

[0091] FIGS. 6A and 6B are a top view and a side cross-sectional view, respectively, of a sheathing tool shown in a first position configured in accordance with some embodiments of the present technology.

[0092] FIG. 7A is an isometric view of a sheathing tool in a first position configured in accordance with the present technology.

[0093] FIG. 7B is an isometric view of the sheathing tool of FIG. 7A in a second position configured in accordance with the present technology.

[0094] FIG. 7C is a side cross-sectional view of the sheathing tool as shown in FIG. 7B.

[0095] FIG. 7D is an isometric view of the connector of the sheathing tool shown in FIGS. 7A-7C.

[0096] FIG. 8A is an isometric view of a sheathing tool in a first position configured in accordance with the present technology.

[0097] FIG. 8B is a side cross-sectional view of the sheathing tool of FIG. 8A in a second position configured in accordance with the present technology.

[0098] FIG. 8C is an isometric view of the connector of the sheathing tool shown in FIGS. 8A and 8B.

[0099] FIG. 9A is an isometric view of a sheathing tool in a first position configured in accordance with the present technology.

[0100] FIG. 9B is an isometric view of the sheathing tool of FIG. 7A in a second position configured in accordance with the present technology.

DETAILED DESCRIPTION

[0101] The present technology provides devices, systems, and methods for sheathing and/or re-sheathing an intravascularly deliverable treatment device. Although many of the embodiments are described below with respect to devices, systems, and methods for removing clot material/treating embolism (such as a cerebral embolism), the sheathing tools of the present technology may be used to re-sheath any intravascularly deliverable, expandable treatment device. Other applications and other embodiments in addition to those described herein are within the scope of the technology. For example, the sheathing tools of the present technology may be used with devices for removing emboli from body lumens other than blood vessels (e.g., the digestive tract, etc.) and/or may be used to remove emboli from blood vessels outside of the brain (e.g., pulmonary blood vessels, blood vessels within the legs, etc.). In addition, the sheathing tools of the present technology may be used with devices for removing luminal obstructions other than clot material (e.g., plaque, resected tissue, etc.).

1. System Overview

[0102] FIG. 1 is a schematic representation of a system 1 (system 1) configured in accordance with the present technology. As shown in FIG. 1, the system 1 may include a treatment device 10 (shown in an expanded, unconstrained state), a catheter 100 (e.g., a microcatheter), a sheathing tool 200 (shown schematically), a support 300, and a sheath 19 for facilitating introduction of the treatment device 10 to the catheter 100 and/or sheathing tool 200. The catheter 100 may include a handle 102 and an elongated shaft 104 having a proximal portion 104a coupled to the handle 102 and a distal portion 104b configured to be positioned at a treatment site within a blood vessel lumen (e.g., a cerebral blood vessel lumen). The elongated shaft 104 is configured to slidably receive the treatment device 10 in a low-profile, constrained state (not shown) therethrough.

[0103] The sheath 19 may be configured to be detachably coupled to the catheter 100, the sheathing tool 200, and/or the support 300 and is configured to slidably receive the treatment device 10 in a low-profile, constrained state (not shown) therethrough. In some embodiments, such as the embodiment shown in FIG. 1, the sheath 19 may include a first segment 31 and a second segment 33. The first segment 31 may have a proximal portion 31a and a distal portion 31b configured to be detachably coupled to the sheathing tool 200, and the second segment 33 may have a proximal portion 33a configured to be detachably coupled to the sheathing tool 200 and a distal portion 33b configured to be detachably coupled to the handle 108 of the catheter 100, thereby creating a pathway between the lumen of the second segment and the lumen of the elongated shaft 104.

[0104] As shown in FIG. 1, the sheathing tool 200 and/or one or more portions of the sheath 19 may be configured to be detachably or permanently coupled to the support 300. For example, to secure the sheathing tool 200 and/or the sheath 19 to the support 300, the support 300 may include one or more tabs, slots, protrusions or other means 302 for engaging the sheath 19 and/or the sheathing tool 200 and/or one or more corresponding tabs, protrusions, slots, etc. on the sheath 19 and/or the sheathing tool 200. In some embodiments, the system 1 may be packaged with one or both of the sheathing tool 200 and the sheath 31 detachably or permanently mounted on the support 300.

[0105] In some embodiments, the treatment device 10 includes an elongated member 12 and a treatment assembly 14 coupled to a distal region of the elongated member 12. The treatment assembly 14 may be configured to be intravascularly positioned at or adjacent clot material within a blood vessel lumen and includes a first element 17 and a second element 15. In some embodiments, the first element 17 may be a self-expanding stent 17 (e.g., a laser-cut stent) and the second element 15 may be a self-expanding mesh (e.g., a braid, a weave, a lattice structure, a fabric, etc.). In some embodiments, the first and second elements 17, 15 may have other suitable configurations.

[0106] The first element 17 may have a proximal portion 17a coupled to the elongated member 12 and a distal portion 17b, and the second element 15 may have a free end portion 15b and a fixed end portion 15a coupled to the elongated member 12. The second element 15 may be flexible such that it is movable between a first position (FIG. 1) in which its free end portion 15b is proximal of its fixed end portion 15a, and a second position (see FIG. 2) in which the second element 15 is inverted over the first element 17 such that a distal terminus of the second element 15 is at or distal to the distal terminus of the first element 17. As shown in FIG. 2, when the second element 15 is in the second position, the free end portion 15b is distal of the fixed end portion 15a and distal of the distal terminus of the first element 17. In the second position, the second element 15 may have a flared distal region 25 that surround a lumen 27 therethrough.

[0107] Examples of suitable treatment devices 10 for use with the system 1 can be found in U.S. patent application Ser. No. 15/594,410, filed May 12, 2017, which is incorporated by reference herein in its entirety. Although the sheathing tools discussed below are described with reference to the treatment device 10 shown in FIGS. 1 and 2, the sheathing tools disclosed herein may be utilized to sheath or re-sheath any expandable treatment device deliverable through a catheter.

2. Selected Embodiments of Sheathing Tools and Associated Methods of Use

[0108] FIGS. 3A and 3C are an isometric view and a top view of a sheathing tool 200, respectively, in a first position configured in accordance with embodiments of the present technology. FIGS. 3B and 3D are an isometric view and a top view of the sheathing tool 200, respectively, in a second position configured in accordance with embodiments of the present technology. Referring to FIGS. 3A-3D together, the sheathing tool 200 may include a housing 202 having a first portion 212 and a second portion 222 slidably coupled to the first portion 212. The first portion 212 may include a first protrusion 210 and first arms 211 extending distally beyond the first protrusion 210, and the second portion 222 may include a second protrusion 220 and second arms 221 extending proximally beyond the second protrusion 220. The first and second arms 211, 221 can be coupled along at least a portion of their lengths and together surround an open interior region 208 of the housing 202 into which the first and second protrusions 210, 220 extend. As such, the first and second protrusions 210, 220 are spaced apart from the adjacent first and second arms 211, 221. In some embodiments, the first protrusion 210 is not spaced apart from the adjacent first arms 211.

[0109] FIG. 3E is an enlarged, isolated, cross-sectional view of a distal region of the first protrusion 210. As shown in FIG. 3E, the first protrusion 210 may include a first channel 216 extending distally from a proximal region of the proximal portion 212 of the housing 202 to a first opening 214. In some embodiments the first channel 216 may be configured to receive the treatment device 10 in a constrained state therethrough, and in some embodiments the first channel 216 may be configured to receive the sheath 19. In FIG. 3E, for example, the first sheath segment 31 is shown positioned within the first channel 216. The first channel 216 may be surrounded by a generally tubular sidewall having an outer diameter OD1 that tapers in a distal direction. An inner diameter ID1 of the first channel 216 may taper distally to help guide the first element 17 in a generally constrained state towards the second opening 224.

[0110] FIG. 3F is an enlarged, isolated, cross-sectional view of a proximal region of the second protrusion 220. As shown in FIG. 3E, the second protrusion 220 may include a second channel 226 extending proximally from a distal region of the distal portion 222 of the housing 202 to a second opening 224. In some embodiments the second channel 226 may be configured to receive the treatment device 10 in a constrained state therethrough, and in some embodiments the second channel 226 may be configured to receive the sheath 19. In FIG. 3F, for example, the second sheath segment 33 is shown positioned within the second channel 226. The second channel 226 may be surrounded by a generally tubular sidewall having an outer diameter OD2 that tapers in a proximal direction to facilitate positioning the second element 15 over the second protrusion 220. In some embodiments, an inner diameter ID2 of the second channel 216 may taper distally to help guide and/or deflect the first element 17 into the second channel 226 and/or the second sheath segment 33.

[0111] When the sheathing tool 200 is in a first position, the first and second openings 214, 224 are spaced apart by a gap g having a first length, and when the sheathing tool 200 is in a second position, the first and second openings 214, 224 are spaced apart by a gap g having a second length less than the first length. The second length may be great enough to allow the second element 15 to self-expand such that the second element 15 is positioned over the sidewall while the first element 17 generally maintains its diameter in the constrained state while crossing the gap g. In other words, because the first element 17 does not have enough space between the first and second openings 214, 224 to expand, the first element 17 crosses the gap g in a constrained state which allows the first element 17 to enter through the second opening 224. If the gap g is too long, the distal ends of the first element 17 may begin to expand/splay outwardly and prevent the first element 17 from entering the second channel 226. Likewise, if the gap g is too short, the second element 15 may not have enough room for the distal portion 15b to flare radially outwardly to an extent that allows the second element 15 to extend over the second protrusion 222 and/or receive the second protrusion 222 within the lumen 27 (FIG. 2) of the distal region 15b.

[0112] FIGS. 4A-4H illustrate a method of using the sheathing tool 200 to sheath and/or re-sheath the treatment device 10. As shown in FIG. 4A, in some embodiments the treatment device 10 may first be withdrawn proximally from a treatment site through the blood vessel V lumen and catheter 100. Once removed from the catheter 100, the treatment device 10 may be in an expanded, unconstrained state in the second position such that the second element 15 is inverted over the first element 17. As shown in FIG. 4B, the treatment device 10 in the second position may then be pulled proximally through the second sheath segment 33, then the sheathing tool 200, and into the first sheath segment 31. For example, a proximal end of the elongated member 12 may be inserted into an opening at the distal portion 33b of the second segment 33, and the rest of the elongated member 12 may be pushed proximally through the second sheath segment 33, the sheathing tool 200, and at least a portion of the first sheath segment 31 (and/or pulled once the proximal end of the elongated member 12 exits a proximal portion 31a of the first sheath segment 31). Once a distal portion of the treatment device 10 is aligned with or proximal of the first opening 214, the elongated member 12 may then be pushed distally, thereby advancing the first and second elements 17, 15 across the gap g, as shown in FIG. 4C. While moving the treatment device 10 across the gap, the first element 17 may maintain its cross-sectional dimension in the constrained state while the second element 15 expands over the sidewall surrounding the second opening 224. (In FIG. 4C, the first and second elements 17, 15 are shown in cross-section for ease of viewing the treatment device 10 within the gap g.) In some embodiments, the first element 17 may be advanced across the gap g and into the second opening 224 while the sheathing tool 200 is in the first position. In some embodiments, the first element 17 may only be advanced across a portion of the gap g (and not into the second opening 224) while the sheathing tool 200 remains in the first position.

[0113] As shown in FIG. 4D, the first portion 212 of the housing 202 may be moved towards the second portion 222 of the housing 202 and secured in place by one or more detents and/or other securement features of the housing 202. Moving the first and second openings towards one another forces the second protrusion 220 further within the lumen of the second element 15. As shown in FIGS. 4E and 4F, the elongated member 12 can be pushed proximally while the sheathing tool 200 is in the second position, thereby advancing the first element 17 further within the second channel 126 and/or second sheath segment 33. As the elongated member 12 is advanced distally, the second element 15 extends further distally along the second protrusion 220 until it's fixed end portion pulls the second element 15 into the second channel 226. As such, a portion of the second element may move in a first direction through the second channel while a second portion of the second element moves in a second direction opposite the first direction outside of the second channel 226. As shown in FIG. 4G, the second sheath segment 33 may then be coupled to the catheter 100. As shown in FIG. 4H, the elongated member 12 may be pushed proximally to transfer the treatment device 10 in the first position from the second sheath segment 33 to the catheter 100.

[0114] FIGS. 5A and 5B are an isometric view and a top cross-sectional view, respectively, of a sheathing tool shown in a first position configured in accordance with some embodiments of the present technology. FIGS. 5C and 5D are an isometric view and a top cross-sectional view, respectively, of the sheathing tool shown in FIGS. 5A and 5B in a second position configured in accordance with some embodiments of the present technology.

[0115] FIGS. 6A and 6B are a top view and a side cross-sectional view, respectively, of a sheathing tool 600 shown in a first position configured in accordance with some embodiments of the present technology. In some embodiments, such as that shown in FIGS. 6A and 6B, the housing 202 may be a single component and/or the first and second openings are spaced apart by a fixed distance.

[0116] FIG. 7A is an isometric view of a sheathing tool in a first position configured in accordance with the present technology. FIG. 7B is an isometric view of the sheathing tool of FIG. 7A in a second position configured in accordance with the present technology FIG. 7C is a side cross-sectional view of the sheathing tool as shown in FIG. 7B. FIG. 7D is an isometric view of the connector of the sheathing tool shown in FIGS. 7A-7C.

[0117] FIG. 8A is an isometric view of a sheathing tool in a first position configured in accordance with the present technology. FIG. 8B is a side cross-sectional view of the sheathing tool of FIG. 8A in a second position configured in accordance with the present technology. FIG. 8C is an isometric view of the connector of the sheathing tool shown in FIGS. 8A and 8B.

[0118] FIG. 9A is an isometric view of a sheathing tool in a first position configured in accordance with the present technology. FIG. 9B is an isometric view of the sheathing tool of FIG. 7A in a second position configured in accordance with the present technology.

3. Conclusion

[0119] This disclosure is not intended to be exhaustive or to limit the present technology to the precise forms disclosed herein. Although specific embodiments are disclosed herein for illustrative purposes, various equivalent modifications are possible without deviating from the present technology, as those of ordinary skill in the relevant art will recognize. In some cases, well-known structures and functions have not been shown and/or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present technology. Although steps of methods may be presented herein in a particular order, in alternative embodiments the steps may have another suitable order. Similarly, certain aspects of the present technology disclosed in the context of particular embodiments can be combined or eliminated in other embodiments. Furthermore, while advantages associated with certain embodiments may have been disclosed in the context of those embodiments, other embodiments can also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages or other advantages disclosed herein to fall within the scope of the present technology. Accordingly, this disclosure and associated technology can encompass other embodiments not expressly shown and/or described herein.

[0120] Throughout this disclosure, the singular terms a, an, and the include plural referents unless the context clearly indicates otherwise. Similarly, unless the word or is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of or in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the terms comprising and the like are used throughout this disclosure to mean including at least the recited feature(s) such that any greater number of the same feature(s) and/or one or more additional types of features are not precluded. Directional terms, such as upper, lower, front, back, vertical, and horizontal, may be used herein to express and clarify the relationship between various elements. It should be understood that such terms do not denote absolute orientation. Reference herein to one embodiment, an embodiment, or similar formulations means that a particular feature, structure, operation, or characteristic described in connection with the embodiment can be included in at least one embodiment of the present technology. Thus, the appearances of such phrases or formulations herein are not necessarily all referring to the same embodiment. Furthermore, various particular features, structures, operations, or characteristics may be combined in any suitable manner in one or more embodiments.